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Monica Lewinsky Visits Agnivesh Agarwal’s Primeks Medical, Advocates Against Cyberbullying in Istanbul

ISTANBUL, Oct. 31, 2024 (GLOBE NEWSWIRE) — World–renowned cyberbullying activist Monica Lewinsky visited Istanbul this October at the invitation of Agnivesh Agarwal, founder of Primeks Medical Clinics and Laboratories. Her visit, coinciding with National Cybersecurity Awareness Month, centered around raising awareness on cyberbullying and promoting Turkey’s burgeoning medical tourism industry.

During her time in Istanbul, Lewinsky addressed students at a private high school, delivering a powerful talk on the dangers and long–term effects of cyberbullying. She highlighted the importance of empathy and encouraged students to speak out against bullying and injustices, reinforcing the need for individual responsibility in combating online abuse.

In addition to her advocacy work, Lewinsky toured Primeks Medical’s state–of–the–art pathology labs and aesthetics clinics in Istanbul. She praised the facilities for their innovative health technologies and advanced diagnostic capabilities, noting that these advancements are key to Turkey’s increasing prominence in health tourism.

“Health tourism is a critical area for mental and social well–being,” Lewinsky commented, emphasizing the holistic importance of healthcare in enhancing psychological wellness.

Primeks Medical was founded in 2015 by Agnivesh Agarwal, a prominent UAE–based industrial entrepreneur who also heads Fujairah Gold in the UAE. With a mission to promote both physical and mental well–being, Primeks Medical aligns closely with Lewinsky’s advocacy, underscoring the importance of psychological health alongside medical advancements.

Agarwal, the majority shareholder of Primeks Healthcare in India, has been expanding his global footprint by acquiring diagnostic pathology labs and medical clinics in Istanbul. His investments extend to the Platinum Group Metals (PGM) recovery industry in Oklahoma, USA, and he is set to become the controlling shareholder in Aluworks Limited, a premium aluminum manufacturer in Ghana, by year–end.

Commenting on Lewinsky’s visit, Agnivesh Agarwal stated:
“As Turkey’s healthcare sector continues to grow, our focus remains on integrating mental and social well–being into health tourism. Monica Lewinsky’s fight against cyberbullying resonates deeply with our mission to improve psychological wellness. Together, we’re advancing a more comprehensive vision of health tourism that supports overall well–being.”

About Primeks Medical
Primeks Medical, founded in 2015 by Agnivesh Agarwal, is a healthcare provider dedicated to improving both physical and mental health. With operations spanning diagnostics, pathology, and aesthetics, Primeks Medical has become a leader in Istanbul’s health tourism industry, aligning with a mission of enhancing overall well–being.

Media Contact:
Ralph Rossouw
Managing Director
Primeks Medical and Fujairah Gold
Phone: +27762349868
Email: ralph@primeksmedical.com   ralph@fujairahgold.com
Website: www.primeksmedical.com

Photos accompanying this announcement are available at

https://www.globenewswire.com/NewsRoom/AttachmentNg/d0e11362–2f5a–4dbc–8313–b30c8ec5043e

https://www.globenewswire.com/NewsRoom/AttachmentNg/4387c7f6–fca8–4e42–ab9f–eff24d0da0f7


GLOBENEWSWIRE (Distribution ID 1001010714)

Advanced Care Group Makes a Strong Entrance at Global Health Exhibition, Ready to Lead at Arab Health 2025

RIYADH, Saudi Arabia, Oct. 25, 2024 (GLOBE NEWSWIRE) — Advanced Care Group is making waves in the Middle Eastern healthcare market following a powerful debut at the Global Health Exhibition in Riyadh. From October 21 to 23, Advanced Care Group captivated industry leaders, showcasing its expertise in placing hospital executives and nurse managers, along with highly skilled frontline personnel drawn from a global talent pool.

With newly established offices in both Dubai and Riyadh, Advanced Care Group is set to meet the growing demands of hospitals, medical clinics, and surgical centers across the UAE and Saudi Arabia. Specializing in recruiting hospital leaders and nurse managers, the company delivers solutions that are both customized and comprehensive, ensuring healthcare facilities can provide the highest quality of care.

“The response to our market entry has been incredible,” said Kris Stewart, Founder & CEO of Advanced Care Group. “Hospital executives and healthcare system leaders are eager to engage with us, signaling a powerful demand for our specialized expertise in recruitment. We’re thrilled to see such enthusiasm and can’t wait to further support the region’s healthcare advancements.”

Following this exciting showcase, Advanced Care Group is gearing up for its next major event at Arab Health in Dubai, set for January 2025. The company plans to further demonstrate its commitment to advancing healthcare by engaging directly with key decision–makers and stakeholders at one of the region’s largest healthcare gatherings.

For more information on how Advanced Care Group can meet your staffing needs and to connect with the team at these events, please contact:

Kris Stewart

Founder & CEO

Advanced Care Group

Tel: +971–800–03111–256

Email: kris@acgroup.global

Website: http://www.acgroup.global

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/669f4b89–e7ac–4d77–b2f1–fd2825ae667e


GLOBENEWSWIRE (Distribution ID 9256189)

Recursion announces first patient dosed in Phase 2 clinical study of REC-3964, a potential first-in-class, oral, non-antibiotic small molecule for recurrent Clostridioides difficile infection

  • REC–3964 is Recursion’s first new chemical entity developed using the RecursionOS.
  • REC–3964 represents a novel, non–antibiotic approach with a unique mechanism of action that binds and blocks catalytic activity of the toxin's innate glucosyltransferase in order to inhibit the toxin produced by C. diff. in the gastrointestinal tract.
  • There are up to 175,000 cases of recurrent C. diff. each year and more than 29,000 patients die in the U.S. from C. diff. annually. Rates of recurrent C. diff. have increased significantly in recent years, representing a major public health challenge.

SALT LAKE CITY, Oct. 22, 2024 (GLOBE NEWSWIRE) — Recursion (NASDAQ: RXRX), a leading clinical stage TechBio company decoding biology to radically improve lives, today announced that the first patient has been dosed in its Phase 2 clinical trial of REC–3964, a potential first–in–class, oral small molecule and new chemical entity for the treatment of recurrent Clostridioides difficile infection. C. diff is a toxin producing bacteria that causes diarrhea and colitis, and can be life threatening. Up to 730,000 cases are estimated to occur in the U.S. and EU5 annually, and the infection is responsible for an estimated 29,000 deaths in the U.S. each year. Recursion’s study will initially address the recurrent C. diff. (up to 175,000 cases in the United States per year) population, which costs the healthcare system approximately two billion dollars per year.

Increasing cases of recurrent C. diff. infections pose significant public health challenges. Antibiotics, the standard treatment for C. diff. infections, disturb the gut microbiome due to their non–selective nature. Despite initial success, antibiotics fail to prevent recurrence in 20–30% of primary cases. Further, the risk of subsequent recurrence rises to 40% after the first and 45–65% after two or more.

REC–3964 is the first novel small molecule developed through Recursion’s Operating System, and selectively inhibits the glucosyltransferase activity of toxin B produced by C. diff in the gastrointestinal tract, offering a unique mechanism of action. Unlike antibiotics, which disrupt the gut microbiome, REC–3964 precisely targets the bacterial toxin while sparing healthy tissue, potentially minimizing adverse events. It is being studied as part of a treatment regimen to prevent recurrent C. diff infections, a leading cause of antibiotic–associated diarrhea that can lead to significant morbidity and mortality.

Presented at the 6th Edition of World Congress on Infectious Diseases, preclinical studies demonstrated its superiority over bezlotoxumab in a human disease–relevant C. diff. hamster model. Additionally, Phase 1 studies in healthy volunteers showed REC–3964 was well tolerated with no serious adverse events (SAEs), underscoring its potential safety and tolerability.

“There’s a significant unmet need for new treatment options for patients with C. diff. infection that are easier to use and more cost effective,” said Chris Gibson, Ph.D., Co–Founder and CEO of Recursion. “We are encouraged by the progress of REC–3964, the first new chemical entity from our platform to advance to Phase 2 clinical trials, and now, to the first patient dosed. We look forward to continuing to advance this trial to help patients in need and drive down billions in costs to the healthcare system for treatment.”

Christian John Lillie, Co–Founder and CEO of the Peggy Lillis Foundation, shared: “We are so pleased to learn that our partner Recursion has initiated its ALDER trial. All new therapies that can be added to the known standard of care have the potential to decrease the physical and emotional suffering of recurrent C. diff. on patients and the significant burden to the health care system.”

“Patients with C. diff face significant challenges, with 20–30% of initial infections recurring after standard treatment and a 40% chance of further recurrence, often leading to severe complications and a diminished quality of life,” said Najat Khan, Ph.D., Chief Commercial Officer and Chief R&D Officer at Recursion. “For these patients and their families, the need for safe, effective, non–antibiotic treatment options is critical. REC–3964 offers a novel, targeted approach by selectively inhibiting the bacterial toxin while sparing the host. With encouraging preclinical data and strong tolerability demonstrated in Phase 1 studies, it’s particularly rewarding to see the first drug developed using the RecursionOS and advancing to Phase 2 trials.”

The Phase 2 ALDER clinical trial is a multi–center randomized study to investigate the safety, tolerability, pharmacokinetics (PK) and efficacy of REC–3964 at doses of either 250 mg or 500 mg for the reduction of C. diff. and will include an observation only arm. Approximately 80 individuals will ultimately be enrolled in the study across the U.S. and Europe.

About Clostridioides difficile infection
Clostridioides difficile (C. diff.) infection is a bacterial disease that impacts more than 730,000 people in the U.S. and EU5 every year. Rates of recurrent C. diff. have increased significantly in recent years, representing a major public health challenge, with people 7 to 10 times more likely to get C. diff. infection while taking an antibiotic and the subsequent month. About 20–30% patients who have C. diff. infection will have it again in the subsequent 2 to 8 weeks. After the first recurrence, there’s a 40% likelihood of a second recurrence, and a 45–65% likelihood of recurrence among patients who have recurred more than twice. In total C. diff. infection is estimated to cause 29,300 deaths in the U.S. each year. More than 80% of C. diff. infection deaths occur in people aged 65 and older. On average, one in 11 patients older than 65 years diagnosed with healthcare–associated C. diff. infection will die within a month. Extended stays in healthcare settings, such as hospitals and nursing homes, also increase risk.

About REC–3964
REC–3964 is a potential first–in–class, orally bioavailable non–antibiotic small molecule that is being investigated for the potential treatment of recurrent Clostridioides difficile (C. diff.) infection. This selective inhibitor is Recursion’s first new chemical entity to reach the clinic, and binds and blocks catalytic activity of the toxin's innate glucosyltransferase. In preclinical studies, REC–3964 was found to be superior to bezlotoxumab in a human disease relevant C. diff. hamster model, with significant difference in probability of survival versus bezlotoxumab alone at the end of treatment. REC–3964 was also well tolerated in Phase 1 healthy volunteer studies, demonstrating potential safety and tolerability with no serious adverse events (SAEs).

About the Trial
Our Phase 2 ALDER clinical trial is a multi–center, open–label study to investigate the safety, tolerability, pharmacokinetics (PK) and efficacy of REC–3964 (doses of either 250 mg or 500 mg PO every 12 hours) for the reduction of Clostridioides Difficile infection (C. diff.). Approximately 80 individuals will be enrolled in this open–label Phase 2 study, randomized 1:2:1 to receive oral doses of REC–3964, 250 mg, 500 mg or observation. The purpose of this study is to investigate the safety, tolerability, pharmacokinetics (PK) and efficacy of REC–3964 for the reduction of recurrent Clostridioides difficile infection (rCDI) after initial cure with vancomycin. Participants will receive treatment with REC–3964 for 28 days.

About Recursion
Recursion (NASDAQ: RXRX) is a clinical stage TechBio company leading the space by decoding biology to radically improve lives. Enabling its mission is the Recursion OS, a platform built across diverse technologies that continuously generate one of the world’s largest proprietary biological and chemical datasets. Recursion leverages sophisticated machine–learning algorithms to distill from its dataset a collection of trillions of searchable relationships across biology and chemistry unconstrained by human bias. By commanding massive experimental scale — up to millions of wet lab experiments weekly — and massive computational scale — owning and operating one of the most powerful supercomputers in the world, Recursion is uniting technology, biology and chemistry to advance the future of medicine.

Recursion is headquartered in Salt Lake City, where it is a founding member of BioHive, the Utah life sciences industry collective. Recursion also has offices in Toronto, Montréal, London, and the San Francisco Bay Area. Learn more at www.Recursion.com, or connect on X (formerly Twitter) and LinkedIn.

Media Contact
Media@Recursion.com

Investor Contact
Investor@Recursion.com

Forward–Looking Statements

This document contains information that includes or is based upon “forward–looking statements” within the meaning of the Securities Litigation Reform Act of 1995, including, without limitation, those regarding the potential efficacy of REC–3964; timing of the Phase 2 clinical trial of REC–3964; early and late stage discovery, preclinical, and clinical programs; licenses and collaborations; prospective products and their potential future indications and market opportunities; Recursion OS and other technologies; business and financial plans and performance; and all other statements that are not historical facts. Forward–looking statements may or may not include identifying words such as “plan,” “will,” “expect,” “anticipate,” “intend,” “believe,” “potential,” “continue,” and similar terms. These statements are subject to known or unknown risks and uncertainties that could cause actual results to differ materially from those expressed or implied in such statements, including but not limited to: challenges inherent in pharmaceutical research and development, including the timing and results of preclinical and clinical programs, where the risk of failure is high and failure can occur at any stage prior to or after regulatory approval due to lack of sufficient efficacy, safety considerations, or other factors; our ability to leverage and enhance our drug discovery platform; our ability to obtain financing for development activities and other corporate purposes; the success of our collaboration activities; our ability to obtain regulatory approval of, and ultimately commercialize, drug candidates; our ability to obtain, maintain, and enforce intellectual property protections; cyberattacks or other disruptions to our technology systems; our ability to attract, motivate, and retain key employees and manage our growth; inflation and other macroeconomic issues; and other risks and uncertainties such as those described under the heading “Risk Factors” in our filings with the U.S. Securities and Exchange Commission, including our Annual Report on Form 10–K and Quarterly Reports on Form 10–Q. All forward–looking statements are based on management’s current estimates, projections, and assumptions, and Recursion undertakes no obligation to correct or update any such statements, whether as a result of new information, future developments, or otherwise, except to the extent required by applicable law.


GLOBENEWSWIRE (Distribution ID 9259643)

Angelini Pharma Enters Into An Exclusive Option Agreement With Cureverse to License Global Development and Commercialization Rights For A Novel and Innovative Clinical-Stage Brain Health Asset

  • The agreement gives Angelini Pharma an option to exclusive licensing rights to develop and commercialize CV–011, a clinical Phase 1 investigational novel compound with broad potential to treat brain health diseases
  • Cureverse receives undisclosed upfront payments and is eligible for future milestone–dependent payments and royalties, while retaining rights to commercialize CV–01 in the Republic of Korea, China, Hong Kong, Macau and Taiwan
  • The collaboration builds on Angelini Pharma’s strong portfolio and deep therapeutic expertise in brain health as well as Cureverse’s early development know–how and capabilities

ROME, Oct. 21, 2024 (GLOBE NEWSWIRE) — Angelini Pharma, part of the privately owned Angelini Industries, and Cureverse Inc., an early–stage research and development company, announced today that they entered into an exclusive global option agreement for the development and commercialization of Cureverse’s innovative brain health asset CV–01.

Under the terms of the agreement, Angelini Pharma will lead all the development efforts for CV–01 and, following an initial option period, will have the right to obtain the global exclusive development and commercialization license for the compound, outside of the Republic of Korea, China, Hong Kong, Macau and Taiwan. CV–01 is a novel and innovative investigational compound that activates protective pathways regulated by the nuclear factor erythroid 2–related factor 2 (Nrf2) and has a strong potential to be a medication with disease–modifying properties across a range of brain health disorders, including epilepsy.i CV–01 is an investigational compound currently undergoing a Phase 1 clinical trial in the Republic of Korea and is being developed by Cureverse for Alzheimer’s Disease.

Cureverse will receive an upfront payment and will also be eligible to receive additional payments upon pre–defined development and commercial milestones of up to approx. US$360 million, as well as tiered royalties on post–approval net sales.

“Our strategic collaboration with Cureverse further strengthens Angelini Pharma’s position as an emerging leader in brain health,” said Jacopo Andreose, Chief Executive Officer of Angelini Pharma. “Neurological conditions such as epilepsy are among leading causes of disease burden worldwide.ii While significant progress has been achieved in the past 15 years, many people living with epilepsy are still unable to reach seizure control despite combination treatment of several anti–seizure medications.iii Through the development of CV–01 and potentially other compounds, we aim to provide much–needed solutions for people living with brain health conditions across the world.”

“Our research has unveiled the remarkable potential of CV–01 to transform the landscape of brain health, from epilepsy to Alzheimer’s and Parkinson’s Disease,” said Sung Jin Cho, Chief Executive Officer at Cureverse Inc. “We are truly delighted to be partnering with Angelini Pharma on this journey. Their deep therapeutic expertise and commitment to brain health perfectly align with our vision. Together, we are not just developing a treatment—we are paving the way for a future where patients with neurological conditions have access to truly life–changing therapies.”

About Brain Health
Brain health as a therapeutic area includes both neurological and mental health conditions.iv Brain health is defined by the World Health Organization as a state of brain functioning across cognitive, sensory, social–emotional, behavioral and motor domains, allowing a person to realize their full potential over the course of their life, irrespective of the presence or absence of disorders.v

Brain health represents an urgent global health priority. An estimated 179 million Europeans are living with brain health conditionsvi and more than 18% of all health loss around the world is associated with brain conditions.vii Additionally, brain health conditions are responsible for considerable individual, economic and societal impact, including loss of independence, reduced productivity, strained relationships, increased risk of suicide as well as high healthcare costs.viii There is an urgent need to raise awareness, and reduce stigma, prejudice and discrimination, to ensure that brain health is valued, promoted and protected for all.v

About Epilepsy
Epilepsy is one of the most widespread neurological diseases in the world, affecting globally approximately 50 million people of all ages.ix In Europe, up to six million people are estimated to be living with this disease.x Epilepsy can have multiple potential causes, including structural, metabolic, genetic and other factors, though approximately half of cases worldwide do not have a known cause.ix

The complications associated with epilepsy are severe, with a risk of premature mortality up to three times higher than the general population.ix The recurrent seizures associated with this condition also have wide–ranging effects on a person’s broader physical and mental health, education and employment opportunities and other quality of life factors. ix

Treatments are available to help reduce seizures and improve quality of life, however approximately 40% of people living with epilepsy are still uncontrolled despite the treatment with two anti–seizure medications.iii

About Angelini Pharma
Angelini Pharma is an international pharmaceutical company, part of the privately owned multi–business Angelini Industries. The Company researches, develops and commercializes health solutions with a focus on the areas of Brain Health, including Mental Health and Epilepsy, and Consumer Health. Founded in Italy at the beginning of the 20th century, Angelini Pharma operates directly in 20 countries, employing more than 3,000 people. Its products are marketed in over 70 countries through strategic alliances with leading international pharmaceutical groups. For more information about Angelini Pharma please visit https://www.angelinipharma.com.

About Angelini Industries
Angelini Industries is a multinational industrial group founded in Ancona in 1919 by Francesco Angelini. Today, Angelini Industries represents a solid and diversified industrial reality that employs approximately 5,800 employees and operates in 21 countries around the world with revenues of over 2 billion euros, generated in the health, industrial technology, and consumer goods sectors. A targeted investment strategy for growth; constant commitment to research and development; deep knowledge of markets and business sectors, make Angelini Industries one of the Italian companies of excellence in the sectors in which it operates. To learn more visit www.angeliniindustries.com.

About Cureverse Inc.
Founded in 2021, Cureverse has rapidly become a key innovator in the Korean biotech landscape, with a bold vision to revolutionize brain health on a global scale. Specializing in cutting–edge small–molecule therapies, Cureverse focuses on tackling central nervous system (CNS) disorders like Alzheimer’s disease (AD), aiming to bring hope to millions worldwide. While many AD drugs have made it to market, a true breakthrough has yet to be realized—until now. At the heart of our innovation is CV–01, a 'First–in–Class' therapy that uniquely targets the Keap1/Nrf2 pathway, activating Nrf2 through precise modulation. This approach offers unprecedented selectivity, effectively controlling neuroinflammation with precision unmatched by existing treatments. Alongside CV–01, Cureverse is actively advancing CV–02, a biased S1P1 agonist that is now IND–ready, as well as several promising follow–up non–clinical programs. With recent IND approvals and strong clinical progress, Cureverse is well–positioned to transform the way we treat neurological conditions and improve patients' lives across the globe.

Media Contact                
Chiara Antoniucci
Global Head of Brand and Media Communications, Angelini Pharma
Phone: +39 3477133926
Email: chiara.antoniucci@angelinipharma.com

Sung Jin Cho
Chief Executive Officer, Cureverse Inc.
Email: sjcho@cureverse.co.kr, sjcho@kist.re.kr

________________________________

1 CV–01 is an investigational compound, not approved for use by regulatory authorities

i Data on file from Cureverse.
ii Institute for Health Metrics and Evaluation. Global burden of conditions affecting the nervous system. Available at: https://www.healthdata.org/research–analysis/library/global–burden–conditions–affecting–nervous–system Last accessed: October 2024.
iii Chen Z, Brodie MJ, Liew D, Kwan P. Treatment Outcomes in Patients With Newly Diagnosed Epilepsy Treated With Established and New Antiepileptic Drugs: A 30–Year Longitudinal Cohort Study. JAMA Neurol. 2018 Mar 1;75(3):279–286.
iv Winkler AS, et al. Lancet Glob Health. 2024;12(5):e735–e736.
v World Health Organization. Optimizing brain health across the life course: WHO position paper. Geneva: World Health Organization; 2022.
vi Nutt D, et al. Eurohealth (Int) 2017;23:21–5.
vii Institute for Health Metrics and Evaluation. Understanding brain health around the world. Available at: https://brainhealthatlas.org/ Last accessed: October 2024.
viii World Health Organization. World mental health report: transforming mental health for all. Geneva: World Health Organization; 2022.
ix WHO. “Epilepsy Key Facts.” N.p., 9 Feb. 2023. Web. 24 Aug. 2023.
x Behr et al. Epidemiology of epilepsy. Revue Neurologique 2016 Jan; 172(1):27–36. doi: 10.1016/j.neurol.2015.11.003.


GLOBENEWSWIRE (Distribution ID 1000998317)

Sabin Vaccine Institute Delivers Marburg Vaccines to Combat Outbreak in Rwanda

[Caption] Sabin Vaccine Institute delivered 700 doses of its Marburg vaccine to Rwanda on Oct. 5, 2024.

WASHINGTON, Oct. 05, 2024 (GLOBE NEWSWIRE) — The Sabin Vaccine Institute has provided its investigational Marburg vaccine to Rwanda to support the ongoing outbreak response. The initial shipment of approximately 700 vaccine doses will be used in a trial targeting frontline workers, including healthcare professionals who have been hardest hit by the deadly virus. 

Sabin has entered into a clinical trial agreement with the Rwanda Biomedical Centre, the trial sponsor, to provide investigational doses for the Phase 2 rapid response open–label study. Per the approved protocol, approximately 700 high–risk adults, starting with health care providers, will be dosed at 6 clinical trial sites in Rwanda. Pending a request from Rwandan officials and authorization from BARDA, Sabin plans to supply additional vaccines. 

Currently, there are no licensed vaccines or treatments for Marburg, which has a mortality rate of up to 88%. Sabin’s single–dose vaccine, based on the cAd3 platform, is in Phase 2 trials in Uganda and Kenya with no safety concerns reported to date. Results from Phase 1 clinical trials and nonclinical studies indicate that the vaccine is safe and elicits rapid, robust immune responses.

Rwanda declared the Marburg outbreak on September 27, and as of October 5, it had infected 46 people and claimed 12 lives. While most cases are among health workers in two facilities in Kigali, the capital, a smaller number are spread across a few other districts. 

Sabin has been working directly with Rwandan officials and partners since the outbreak began to mount a response.

“We were able to ship Marburg vaccine doses within 7 days of being contacted by the Rwanda government for assistance. Working alongside our partners, we moved with lightning speed to prepare shipments, finalize protocols, and secure the necessary regulatory and legal approvals,” says Sabin Chief Executive Officer Amy Finan. “This swift emergency response demonstrates that a dedicated, collaborative group of individuals and organizations can achieve remarkable results when united by a common cause: to contain a lethal disease outbreak and prevent further loss of life.” 

Rwanda’s Minister of Health Dr. Sabin Nsanzimana points out that “in emergency situations, the success of clinical trials relies on quick, strategic, global partnerships that bring together expertise, resources, and innovation. Today, a week after this Marburg outbreak was first confirmed, we are receiving doses of the Sabin Vaccine Institute’s Marburg vaccine candidate to protect our health workers and other high–risk groups, and also advance scientific tools which will ensure this virus can be effectively controlled now and in the future.” 

Sabin’s manufacturing partner, Italy–based ReiThera, has produced the drug substance and filled and finished doses for shipment to Rwanda. “At ReiThera, we believe in the transformative power of global collaboration to advance science and create lasting impact,” says ReiThera CEO Stefano Colloca. “Our partnership with Sabin highlights our shared commitment to developing a life–saving vaccine against Marburg disease with a mutual goal: to save lives and ensure that even the most vulnerable communities around the world have access to vital and equitable protection.” 

Once rare, Marburg virus disease outbreaks have surged in Africa in recent years, with incidents reported in 2023 in Tanzania (Rwanda's neighbor) and Equatorial Guinea. Marburg belongs to the same virus family as Ebola and is transmitted from fruit bats to humans, spreading from person to person through contact with infected bodily fluids. 

Sabin’s Phase 2 clinical trials for Marburg, which began last year, are currently monitoring participants in Uganda and Kenya, including younger (18–50 years) and older age groups (51–70 years). Interim results are expected next year, and Sabin also plans to launch a similar Phase 2 trial in the U.S. next year. 

Sabin’s development program, which includes clinical trials and manufacturing of clinical trial material that have been leveraged in this donation, is supported by the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response within the U.S. Department of Health and Human Services, under multi–year contracts. BARDA has to date obligated $235 million to Sabin for advancing vaccine research and development against Sudan ebolavirus and Marburg virus diseases. 

In addition to ReiThera and Rwanda’s government, Sabin is grateful for all these organizations including CEPI, GSK, IQVIA, kENUP Africa, National Institutes of Health's Vaccine Research Center, WHO, and World Courier who have contributed to our past and current efforts.

About the Sabin Vaccine Institute

The Sabin Vaccine Institute is a leading advocate for expanding vaccine access and uptake globally, advancing vaccine research and development, and amplifying vaccine knowledge and innovation. Unlocking the potential of vaccines through partnership, Sabin has built a robust ecosystem of funders, innovators, implementers, practitioners, policy makers and public stakeholders to advance its vision of a future free from preventable diseases. As a non–profit with three decades of experience, Sabin is committed to finding solutions that last and extending the full benefits of vaccines to all people, regardless of who they are or where they live. At Sabin, we believe in the power of vaccines to change the world. For more information, visit www.sabin.org and follow us on X, @SabinVaccine.

Media Contact: 
Monika Guttman 
Media Relations Specialist 
Sabin Vaccine Institute 
+1 (202) 662–1841 
press@sabin.org 

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/2e9400c0–1467–4956–b52d–64891ed3fc1d


GLOBENEWSWIRE (Distribution ID 9251765)

Recursion Announces FDA Clearance of Investigational New Drug Application for REC-1245, a Potential First-In-Class RBM39 Degrader for Biomarker-Enriched Solid Tumors and Lymphoma

  • First program to combine Recursion’s end–to–end suite of AI–enabled active learning modules, resulting in target identification to IND enabling studies in under 18 months
  • Plan to initiate dosing of Phase 1/2 in Q4 2024 to evaluate REC–1245 in a biomarker enriched patient population, including patients with solid tumors and lymphoma

SALT LAKE CITY, Oct. 02, 2024 (GLOBE NEWSWIRE) — Recursion (NASDAQ: RXRX), a leading clinical stage TechBio company decoding biology to industrialize drug discovery, today announced that the U.S. Food and Drug Administration (FDA) has cleared an investigational new drug (IND) application for a Phase 1/2 clinical trial of REC–1245, a new chemical entity for the treatment of biomarker–enriched solid tumors and lymphoma.

Chris Gibson, Ph.D., Co–founder and CEO of Recursion said, “REC–1245 is a prime example of using an expansive AI–enabled platform for drug discovery. After exploring many predicted biological and chemical relationships across our maps of biology, we identified RMB39 as a novel target that looks functionally similar to the well–known but hard to drug target CDK12. We also identified and optimized small molecules that target RBM39 without directly impacting CDK12 or CDK13 using these same AI–enabled maps. In under 18 months, leveraging some of our newer chemistry tools, Recursion rapidly progressed REC–1245 from novel target biology to preclinical drug candidate, more than twice the speed of industry average.”

Recursion identified the novel regulatory role of RBM39 associated with CDK12 using its maps of biology and first reported this relationship in early 2023 at Download Day, Recursion’s R&D and investor event. Recursion believes the modulation of RBM39 may be associated with a therapeutic effect in certain biomarker–enriched solid tumors and lymphoma. Additionally, Recursion estimates that the initially addressable population for this potential therapeutic to be >100,000 patients in the US and EU5. REC–1245 is a potent and selective RBM39 degrader with a potential first–in–class profile. Preclinical data support that RBM39 degradation induces splicing defects which downregulate DNA Damage Response (DDR) networks and cell cycle checkpoints.

“RBM39 degraders may offer a promising therapeutic approach for patients with solid tumors, particularly those with limited treatment options,” said Najat Khan, Ph.D., Chief R&D Officer and Chief Commercial Officer at Recursion. “Recursion’s platform was among the first to rapidly uncover the therapeutic potential of RBM39 degradation, a finding now validated by independent research. This mechanism provides new opportunities for targeting tumors, which are often resistant to conventional treatments. By advancing this research, we aim to deliver a critical option for patients facing significant unmet needs, ultimately improving their prognosis and quality of life.”

The Phase 1/2 clinical trial will evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and potential monotherapy efficacy of REC–1245, and is expected to initiate in Q4 2024.

About Recursion

Recursion (NASDAQ: RXRX) is a clinical stage TechBio company decoding biology to industrialize drug discovery. Enabling its mission is the Recursion OS, a platform built across diverse technologies that continuously expands one of the world’s largest proprietary biological and chemical datasets. Recursion leverages sophisticated machine–learning algorithms to distill from its dataset a collection of trillions of searchable relationships across biology and chemistry unconstrained by human bias. By commanding massive experimental scale — up to millions of wet lab experiments weekly — and massive computational scale — owning and operating one of the most powerful supercomputers in the world, Recursion is uniting technology, biology and chemistry to advance the future of medicine.

Recursion is headquartered in Salt Lake City, where it is a founding member of BioHive, the Utah life sciences industry collective. Recursion also has offices in Toronto, Montréal, London, and the San Francisco Bay Area. Learn more at www.Recursion.com, or connect on X (formerly Twitter) and LinkedIn.

Media Contact
Media@Recursion.com

Investor Contact
Investor@Recursion.com

Forward–Looking Statements

This document contains information that includes or is based upon “forward–looking statements” within the meaning of the Securities Litigation Reform Act of 1995, including, without limitation, those regarding the potential efficacy of REC–1245; timing of and plans to initiate dosing of Phase 1 clinical trial of REC–1245; early and late stage discovery, preclinical, and clinical programs; licenses and collaborations; prospective products and their potential future indications and market opportunities; Recursion OS and other technologies; business and financial plans and performance; and all other statements that are not historical facts. Forward–looking statements may or may not include identifying words such as “plan,” “will,” “expect,” “anticipate,” “intend,” “believe,” “potential,” “continue,” and similar terms. These statements are subject to known or unknown risks and uncertainties that could cause actual results to differ materially from those expressed or implied in such statements, including but not limited to: challenges inherent in pharmaceutical research and development, including the timing and results of preclinical and clinical programs, where the risk of failure is high and failure can occur at any stage prior to or after regulatory approval due to lack of sufficient efficacy, safety considerations, or other factors; our ability to leverage and enhance our drug discovery platform; our ability to obtain financing for development activities and other corporate purposes; the success of our collaboration activities; our ability to obtain regulatory approval of, and ultimately commercialize, drug candidates; our ability to obtain, maintain, and enforce intellectual property protections; cyberattacks or other disruptions to our technology systems; our ability to attract, motivate, and retain key employees and manage our growth; inflation and other macroeconomic issues; and other risks and uncertainties such as those described under the heading “Risk Factors” in our filings with the U.S. Securities and Exchange Commission, including our Annual Report on Form 10–K and Quarterly Reports on Form 10–Q. All forward–looking statements are based on management’s current estimates, projections, and assumptions, and Recursion undertakes no obligation to correct or update any such statements, whether as a result of new information, future developments, or otherwise, except to the extent required by applicable law.


GLOBENEWSWIRE (Distribution ID 9249970)

Curium Announces Strategic Partnership with PeptiDream for Prostate Cancer Theranostics in Japan

  • Collaboration to include the clinical development, regulatory filing, and commercialization in Japan of 177Lu–PSMA–I&T and 64Cu–PSMA–I&T
  • Builds on long–standing relationship between the two companies
  • In Japan around 90,000 new cases of prostate cancer are diagnosed each year

PARIS, Oct. 01, 2024 (GLOBE NEWSWIRE) — Curium, a world leader in nuclear medicine, announced today that it has entered into a strategic partnership with PDRadiopharma Inc, a wholly–owned subsidiary of PeptiDream, for the clinical development, regulatory filing, and commercialization in Japan of 177Lu–PSMA–I&T and 64Cu–PSMA–I&T. The two agents 177Lu–PSMA–I&T and 64Cu–PSMA–I&T target prostate specific membrane antigen (PSMA) expressed on prostate cancer cells and are being investigated for prostate cancer treatment and diagnostics. Both target tumors with high levels of PSMA expression and thus potentially forming a theranostic (therapeutic & diagnostic) pair.

Under the terms of the partnership, Curium and PDRadiopharma will jointly collaborate on clinical development activities of 177Lu–PSMA–I&T and 64Cu–PSMA–I&T in Japan, with PDRadiopharma leading regulatory filing, manufacturing, commercialization, and distribution activities in Japan. Curium will continue to lead global development of the two agents and support PDRadiopharma through technology transfer to support the set–up of manufacturing lines in Japan – including a high throughput Copper 64 manufacturing line based on Curium’s proprietary technology.

Patrick C. Reid, President & CEO of PeptiDream commented: “Targeted radiopharmaceuticals are rapidly revolutionizing how we both diagnose and treat cancer. At PeptiDream and PDRadiopharma we are focused on expanding our pipeline of these powerful targeted therapies, and we are thrilled to be able to accelerate those efforts by partnering with Curium to bring their highly promising prostate cancer targeting radiopharmaceuticals to patients in Japan.”

Masato Murakami, President of PDRadiopharma & CMO of PeptiDream commented: “We are excited to partner with Curium in the development of 177Lu–PSMA–I&T and 64Cu–PSMA–I&T, highly promising products for both the diagnosis and treatment of PSMA–expressing prostate cancer. We look forward to working with Curium to deliver these much–needed agents to prostate cancer patients in Japan as quickly as possible.”

Chaitanya Tatineni, Curium’s CEO International Markets commented: “As a global innovator in the field of radiopharmaceuticals with a promising late–stage oncology pipeline, Curium is delighted to partner with PDRadiopharma which has more than four decades of experience in Japan. Curium and PDRadiopharma plan to leverage their complementary strengths to accelerate the development of innovative products for the benefit of prostate cancer patients in Japan.”

Prostate cancer continues to be widely prevalent in Japan. Annually, there are approximately 90,000 – 100,000 new cases, with patients with metastatic castration–resistant prostate cancer having an overall survival rate of approximately three years in clinical trial settings, and even shorter in the real–world, and there remains a significant unmet medical need for therapies.

177Lu–PSMA–I&T, a PSMA inhibitor conjugated with the radioisotope Lutetium 177, is currently being tested by Curium in a global pivotal Phase 3 ECLIPSE trial (ClinicalTrials.gov identifier; NCT05204927). ECLIPSE is a multi–center, open–label, randomized clinical trial comparing the safety and efficacy of 177Lu–PSMA–I&T versus hormone therapy in patients with metastatic castration–resistant prostate cancer. The ECLIPSE trial enrolled over 400 patients, across 51 trial sites in the United States and Europe.

64Cu–PSMA–I&T PET is currently being investigated in 2 multicenter Phase 3 trials; SOLAR RECUR testing the diagnostic performance in men with biochemical recurrence of prostate cancer (ClinicalTrials.gov identifier NCT06235099) and SOLAR STAGE testing the diagnostic performance in men with newly diagnosed unfavorable intermediate– to high–risk prostate cancer (ClinicalTrials.gov identifier; NCT06235151). The first in human Phase 1/2 SOLAR trial met the co–primary endpoints of region–level correct localization rate and patient–level correct detection rate in patients with histologically–proven metastatic prostate cancer. PSMA–targeted PET/CT imaging is increasingly emerging as a highly sensitive method for detection of locally recurrent or metastatic lesions in the context of biochemical recurrence and for localization of primary prostate cancer.

Curium and PDRadiopharma have a long–standing relationship in the radiopharmaceutical field.

For more information:

PeptiDream Inc.
Yuko Okimoto, IR & Public Affairs
info@peptidream.com

PDRadiopharma Inc.
Noriko Tanaka, General Affairs
s–info–hq@pdradiopharma.com

Curium
Ross Bethell
VP, Head of Global Communications
communications@curiumpharma.com

About PeptiDream Inc.
PeptiDream Inc. (Tokyo Stock Exchange Prime Market 4587) is leading the translation of macrocyclic peptides into a whole new class of innovative medicines to address unmet medical needs and improve the quality of life of patients worldwide. In its radiopharmaceutical business, through its wholly–owned subsidiary PDRadiopharma, PeptiDream markets and sells a number of approved radiopharmaceuticals and radiodiagnostics in Japan, as well as leveraging its proprietary Peptide Discovery Platform System (PDPS) technology to discover and develop a deep pipeline of innovative targeted radiotherapeutics and radiodiagnostics, spanning both wholly–owned internal programs and globally partnered programs. In its non–radiopharmaceutical business, PeptiDream is similarly leveraging PDPS to discover and develop a broad and diverse pipeline of investigational peptide therapeutics, peptide drug conjugates (PDC) and multi–functional peptide conjugates (MPC) across an extensive global network of discovery and development partners.   PeptiDream is headquartered in Kawasaki, Japan. For more information about our company, science and pipeline, please visit www.peptidream.com/en

About PDRadiopharma
PDRadiopharma, a wholly–owned subsidiary of PeptiDream since 2022, has been providing high–quality radiopharmaceuticals through the research and development, manufacturing, regulatory and sales as a forerunner in the field in radiopharmaceuticals, since it started its business in 1968. PDRadiopharma currently markets 21 radiodiagnostic products (spanning both SPECT and PET products) and 8 radiotherapeutic products (3 product categories) in Japan. Additionally, PDRadiopharma and PeptiDream are developing a broad pipeline of radiotherapeutics and radiodiagnostics for both the Japan and global markets. For more information about PDRadiopharma, please visit www.pdradiopharma.com/en

About Curium
Curium is a world leader in nuclear medicine. We develop, manufacture, and distribute world–class radiopharmaceutical products to help patients around the globe. Our proven heritage combined with a pioneering approach are the hallmarks to deliver innovation, excellence, and unparalleled service. With manufacturing facilities across Europe and the United States, Curium delivers SPECT, PET and therapeutic radiopharmaceutical solutions for life–threatening diseases to over 14 million patients annually. The name ‘Curium’ honors the legacy of pioneering radioactive materials researchers Marie and Pierre Curie, after whom the radioactive element curium was named and emphasizes our focus on nuclear medicine. To learn more, visit www.curiumpharma.com    


GLOBENEWSWIRE (Distribution ID 9249316)

Entera Bio and OPKO Health Provide Update on PK/PD Results of Oral Oxyntomodulin (GLP-1/Glucagon) Peptide Tablet Candidate for Obesity and Metabolic Disorders

JERUSALEM and MIAMI, Sept. 25, 2024 (GLOBE NEWSWIRE) — Entera Bio Ltd. (NASDAQ: ENTX) (Entera), a leader in the development of orally delivered peptides, and OPKO Health, Inc. (NASDAQ: OPK) (OPKO) announced today topline pharmacokinetic/pharmacodynamic (PK/PD) results from their ongoing collaborative research combining a proprietary long–acting oxyntomodulin (OXM) analog developed by OPKO and Entera’s proprietary N–Tab™ technology. The program is focused on developing the first oral dual agonist GLP–1/glucagon peptide as a potential once–daily treatment for patients with obesity, metabolic and fibrotic disorders. OXM is a naturally occurring peptide hormone found in the small intestine that acts to suppress appetite and induce weight loss.

Entera and OPKO have completed in vivo proof–of–concept PK/PD studies in rodent and pig models. The studies’ objectives were met with oral OXM exhibiting significant systemic exposure following a single dose in both models. Furthermore, a favorable PK profile and bioavailability were shown with oral OXM. In the pig model, oral OXM achieved high plasma concentrations with prolonged systemic exposure, which is consistent with the reported half–life for semaglutide (Rybelsus®), the only approved oral GLP–1 analog.

To assess the pharmacologic effect of oral OXM, a glucose tolerance test was performed in rats. Oral OXM showed a statistically significant reduction in plasma glucose levels post–glucose administration compared with placebo. Entera and OPKO plan to present these data at an upcoming clinical conference.

“We are very pleased with the progress we are making in our collaboration with OPKO. These bioavailability and pharmacological data support continuing toward IND–enabling efforts for the program,” said Miranda Toledano, Entera Chief Executive Officer.

OPKO previously reported that weekly injections of pegylated OXM demonstrated significant weight loss and reduction in HbA1, triglyceride and cholesterol levels in 113 obese and diabetic patients in a Phase 2B study. The OXM agonist peptide has since been modified to maintain its long–acting profile while increasing its potential potency. Currently, there are no approved OXM agonists available, and those in development by others are small molecules or require subcutaneous injections.

About Entera Bio

Entera is a clinical–stage company focused on developing oral peptide or protein replacement therapies for significant unmet medical needs where an oral tablet form holds the potential to transform the standard of care. The Company leverages a disruptive and proprietary technology platform (N–Tab™) and its pipeline includes five differentiated, first–in–class oral peptide programs, expected to enter the clinic (Phase 1 to Phase 3) by 2025. The Company’s most advanced product candidate, EB613 (oral PTH (1–34)), is being developed as the first oral, osteoanabolic (bone building) once–daily tablet treatment for post–menopausal women with low BMD and high–risk osteoporosis. A placebo controlled, dose ranging Phase 2 study of EB613 tablets (n=161) met primary (PD/bone turnover biomarker) and secondary (BMD) endpoints. Entera is preparing to initiate a Phase 3 registrational study for EB613 pursuant to the FDA’s qualification of a quantitative BMD endpoint, which is expected to occur by January 2025. The EB612 program is being developed as the first oral PTH (1–34) tablet peptide replacement therapy for hypoparathyroidism. In collaboration with OPKO Health, Entera is also developing the first oral oxyntomodulin, a dual targeted GLP–1/glucagon peptide, in tablet form for the treatment of obesity; and the first oral GLP–2 peptide tablet as an injection–free alternative for patients suffering from rare malabsorption conditions such as short bowel syndrome. For more information, visit www.enterabio.com or follow us on LinkedIn, X (formerly Twitter), Facebook and Instagram.

About OPKO Health

OPKO Health is a multinational biopharmaceutical and diagnostics company that seeks to establish industry–leading positions in large, rapidly growing markets by leveraging its discovery, development and commercialization expertise, and its novel and proprietary technologies. For more information, visit www.opko.com.

Cautionary Statement Regarding Forward Looking Statements
Various statements in this press release are “forward–looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. All statements (other than statements of historical facts) in this press release regarding our prospects, plans, financial position, business strategy and expected financial and operational results may constitute forward–looking statements. Words such as, but not limited to, “anticipate,” “believe,” “can,” “could,” “expect,” “estimate,” “design,” “goal,” “intend,” “may,” “might,” “objective,” “plan,” “predict,” “project,” “target,” “likely,” “should,” “will” and “would,” or the negative of these terms and similar expressions or words, identify forward–looking statements. Forward–looking statements are based upon current expectations that involve risks, changes in circumstances, assumptions and uncertainties. Forward–looking statements should not be read as a guarantee of future performance or results and may not be accurate indications of when such performance or results will be achieved.

Important factors that could cause actual results to differ materially from those reflected in Entera’s and OPKO’s forward–looking statements include, among others: changes in the interpretation of clinical data; results of our clinical trials; the FDA’s interpretation and review of our results from and analysis of our clinical trials; unexpected changes in our ongoing and planned preclinical development and clinical trials, the timing of and our ability to make regulatory filings and obtain and maintain regulatory approvals for our product candidates; the potential disruption and delay of manufacturing supply chains; loss of available workforce resources, either by Entera or its collaboration and laboratory partners; impacts to research and development or clinical activities that Entera or OPKO may be contractually obligated to provide; overall regulatory timelines; the size and growth of the potential markets for our product candidates; the scope, progress and costs of developing our product candidates; Entera’s reliance on third parties to conduct its clinical trials; Entera and OPKO’s expectations regarding licensing, business transactions and strategic collaborations; Entera’s operation as a development stage company with limited operating history; Entera’s ability to continue as a going concern absent access to sources of liquidity; Entera’s ability to comply with Nasdaq’s minimum listing standards and other matters related to compliance with the requirements of being a public company in the United States; Entera’s and OPKO’s intellectual property position and its ability to protect its intellectual property; and other factors that are described in the “Cautionary Statements Regarding Forward–Looking Statements,” “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections of Entera’s and OPKO’s most recent Annual Report on Form 10–K filed with the SEC, as well as the companies’ subsequently filed Quarterly Reports on Form 10–Q and Current Reports on Form 8–K. There can be no assurance that the actual results or developments anticipated by Entera and OPKO will be realized or, even if substantially realized, that they will have the expected consequences to, or effects on, Entera or OPKO as applicable. Therefore, no assurance can be given that the outcomes stated or implied in such forward–looking statements and estimates will be achieved. Entera and OPKO caution investors not to rely on the forward–looking statements made in this press release. The information in this press release is provided only as of the date of this press release, and Entera and OPKO undertake no obligation to update or revise publicly any forward–looking statements, whether as a result of new information, future events or otherwise, except to the extent required by law.


GLOBENEWSWIRE (Distribution ID 9236250)

Recursion Announces Phase 2 Data of REC-994, a First-in-Disease Investigational Treatment for Symptomatic Cerebral Cavernous Malformation (CCM), has Met its Primary Endpoint of Safety and Tolerability

SALT LAKE CITY, Sept. 03, 2024 (GLOBE NEWSWIRE) — Recursion (NASDAQ: RXRX), a leading clinical stage TechBio company decoding biology to radically improve lives, today announced top–line results of the SYCAMORE trial, a 12–month Phase 2 randomized double–blind, placebo–controlled, safety, tolerability and exploratory efficacy study for REC–994 in symptomatic CCM patients.

REC–994 met its primary endpoint of safety and tolerability, demonstrating a similar profile across placebo and both 200mg and 400mg dosage–arms with regard to the frequency and severity of adverse events after 12 months of treatment. Magnetic resonance imaging–based secondary efficacy endpoints showed a trend towards reduced lesion volume and hemosiderin ring size in patients at the highest dose (400mg) as compared to placebo. Time–dependent improvement in these trends at the 400mg dose was also observed in this signal–finding study. Improvements in either patient or physician–reported outcomes were not yet seen at the 12 month time point. A meeting with the FDA is anticipated as soon as practical to discuss plans for an additional clinical study. Recursion plans to present data from this trial at a forthcoming medical conference and intends to submit these data for publication in a peer reviewed scientific journal.

“These studies are making significant strides in the development of therapeutics for CCM. The data from this readout is an impressive start and will provide a valuable contribution to the existing CCM literature and strongly supports the need for a future study, with a longer duration and a larger patient cohort,” said Dr. Jan–Karl Burkhardt, MD, Division Head, Cerebrovascular Surgery, University of Pennsylvania and Principal Investigator of the study. Connie Lee, Psy.D., founder and CEO of the Alliance to Cure Cavernous Malformation added: “I speak for the patients who have participated in the trial and those who have been cheering from the sidelines while waiting for news. This promising start is a critical step forward and will bring hope to thousands of families who currently have no options but brain or spinal cord surgery. The Alliance to Cure Cavernous Malformation looks forward to partnering with Recursion as they move to the next stage of the REC–994 program.”

“We are encouraged by the recent data from our signal–finding Phase 2 study in CCM, where the trial successfully met its primary safety endpoint and became the first investigational therapy to demonstrate safety alongside some promising trends in exploratory efficacy endpoints. These results provide critical insights that will inform our next study design, including exploring study duration, higher doses, and a larger cohort of patients,” said Najat Khan, Ph.D., Chief R&D Officer and Chief Commercial Officer of Recursion. “This is the first of several key clinical readouts for the company and represents an early proof–of–platform milestone for our constantly evolving Recursion OS, as we build upon our success in drug discovery with expertise and execution in mid–phase development. We are deeply grateful to the patients and investigators, and we are committed to advancing potential transformational therapies for CCM and beyond.”

Background on Cerebral Cavernous Malformation (CCM)

CCM is a neurovascular condition that impacts approximately 360,000 symptomatic individuals in the US and EU5. The disease is often underdiagnosed and potentially affects over 1 million patients worldwide. CCM manifests as vascular malformations of the spinal cord and brain characterized by abnormally enlarged capillary cavities without intervening brain parenchyma. Patients with CCM lesions are at substantial risk for seizures, headaches, progressive neurological deficits, and potentially fatal hemorrhagic stroke. Currently, only non–pharmacologic treatments including microsurgical resection and stereotactic radiosurgery are available options for this high unmet need patient population. However, surgical resection or stereotactic radiosurgery is not always feasible because of location and may not be curative.

About REC–994

REC–994 is an orally bioavailable, superoxide scavenger small molecule under development for the treatment of symptomatic CCM. The potential of REC–994 in CCM was demonstrated using the earliest version of what would become the foundational technology underlying the Recursion OS. Subsequently, REC–994 demonstrated preclinical activity in models for CCM and tolerability and suitability for chronic dosing in Phase 1 single ascending dose escalation (SAD) and multiple ascending dose escalation (MAD) trials in healthy volunteers directed and executed by Recursion. Recursion has sought and received Orphan Drug Designation for REC–994 in symptomatic CCM in the US and Europe.

About the Trial

Our Phase 2 SYCAMORE clinical trial is a randomized, double–blind, placebo–controlled study of two doses of REC–994 in participants with CCM. The primary endpoint of the study is safety and tolerability. Secondary efficacy endpoints include MRI–based endpoints, clinician and patient reported outcomes, as well as selected biomarkers. This trial was fully enrolled in June 2023 with 62 participants, and 80% of participants who completed 12 months of treatment have entered the long–term extension study. This signal–finding study was not powered to demonstrate statistical significance.

About Recursion

Recursion (NASDAQ: RXRX) is a clinical stage TechBio company leading the space by decoding biology to radically improve lives. Enabling its mission is the Recursion OS, a platform built across diverse technologies that continuously generate one of the world’s largest proprietary biological and chemical datasets. Recursion leverages sophisticated machine–learning algorithms to distill from its dataset a collection of trillions of searchable relationships across biology and chemistry unconstrained by human bias. By commanding massive experimental scale — up to millions of wet lab experiments weekly — and massive computational scale — owning and operating one of the most powerful supercomputers in the world, Recursion is uniting technology, biology and chemistry to advance the future of medicine.

Recursion is headquartered in Salt Lake City, where it is a founding member of BioHive, the Utah life sciences industry collective. Recursion also has offices in Toronto, Montréal, London, and the San Francisco Bay Area. Learn more at www.Recursion.com, or connect on X (formerly Twitter) and LinkedIn.

Media Contact
Media@Recursion.com

Investor Contact
Investor@Recursion.com

Forward–Looking Statements

This document contains information that includes or is based upon “forward–looking statements” within the meaning of the Securities Litigation Reform Act of 1995, including, without limitation, those regarding Recursion’s anticipated meeting with the FDA; Recursion’s plans to present SYCAMORE trial data at a medical conference and submit the data for publication; the clinical relevance of the SYCAMORE trial data and obtaining additional confirmatory data; promising trends in REC–994 efficacy endpoints; advancing potential transformational therapies for CCM and beyond; subsequent REC–994 studies and their results and advancing Recursion’s REC–994 program further; the size of the potential CCM patient population; Recursion OS and other technologies potential and advancement of the future of medicine; business and financial plans and performance; and all other statements that are not historical facts. Forward–looking statements may or may not include identifying words such as “plan,” “will,” “expect,” “anticipate,” “intend,” “believe,” “potential,” “continue,” and similar terms. These statements are subject to known or unknown risks and uncertainties that could cause actual results to differ materially from those expressed or implied in such statements, including but not limited to: challenges inherent in pharmaceutical research and development, including the timing and results of preclinical and clinical programs, where the risk of failure is high and failure can occur at any stage prior to or after regulatory approval due to lack of sufficient efficacy, safety considerations, or other factors; our ability to leverage and enhance our drug discovery platform; our ability to obtain financing for development activities and other corporate purposes; the success of our collaboration activities; our ability to obtain regulatory approval of, and ultimately commercialize, drug candidates; our ability to obtain, maintain, and enforce intellectual property protections; cyberattacks or other disruptions to our technology systems; our ability to attract, motivate, and retain key employees and manage our growth; inflation and other macroeconomic issues; and other risks and uncertainties such as those described under the heading “Risk Factors” in our filings with the U.S. Securities and Exchange Commission, including our most recent Annual Report on Form 10–K, our subsequent Quarterly Reports on Form 10–Q, and our Current Reports on Form 8–K. All forward–looking statements are based on management’s current estimates, projections, and assumptions, and Recursion undertakes no obligation to correct or update any such statements, whether as a result of new information, future developments, or otherwise, except to the extent required by applicable law.


GLOBENEWSWIRE (Distribution ID 9223929)

Healthcare, Technology Leaders Gather in Johannesburg for Healthcare Innovation Summit Africa 2024

JOHANNESBURG, Aug. 23, 2024 (GLOBE NEWSWIRE) — Technology is revolutionizing healthcare in Africa, from enhancing patient care with electronic health records to enabling remote consultations via telemedicine. These advancements are making healthcare more efficient, accessible, and cost–effective.

IT News Africa is excited to announce the 9th Healthcare Innovation Summit Africa (HISA) 2024, set for August 29, 2024, at The Maslow Sandton in Johannesburg. Themed “Transforming African Healthcare: Harnessing Technology for Universal Access and Innovation,” the event will explore how cutting–edge technologies can improve patient outcomes, healthcare delivery, and system sustainability.

Key Topics and Agenda Highlights

The summit will address critical challenges in African healthcare, focusing on technology's role in achieving universal healthcare. Key topics include:

  1. Integrating AI in African Healthcare – Exploring AI's role in diagnostics and patient management.
  2. Digitizing Healthcare Records – The challenges and successes of migrating to cloud solutions.
  3. Telemedicine – Expanding access to healthcare in remote regions.
  4. The Role of Technology in Implementing Universal Healthcare

Key Speakers

HISA 2024 will feature industry experts discussing digital health, telemedicine, and AI integration. Notable speakers include:

  • Dr. Mohamed El Sahili, CEO of Medland Hospital, Zambia
  • Shiraz Dadar, Head of IT at M.P. Shah Hospital, Nairobi
  • Nhlanhla Xaba, ICT Manager at Mediclinic
  • Margot Brews, Head of Health Risk Management at Momentum Health Solutions

Sponsorship and Exhibition Opportunities

HISA 2024 offers IT service providers, HealthTech startups, and medical device companies the chance to showcase their solutions, connect with key stakeholders, and enhance brand visibility through sponsorship and exhibition opportunities.

Registration Discounts

Use the code HISA@25OFF for a 25% discount on registration, giving medical professionals, healthcare IT executives and healthcare decision–makers, the chance to network and learn about the latest trends in African healthcare.

Past Attendees Praise HISA

Participants from previous HISA events have shared their positive experiences, highlighting the event's impact on their professional growth and networking opportunities.

Marketing Director at Meditech South Africa affirmed that #HISA events are enlightening to attend. “I think this event is great; it brings in various stakeholders in the healthcare industry. It's all about innovation, disruptive technology, and digital health. I think it is a great platform for sharing ideas, dialogue, and debates about issues in the healthcare industry.”

The MEC for Health in the Free State Province emphasized the importance of HISA, stating, “Summits like these are important because they help us deliver quality health services using technology and teach us how to use innovative methods to ensure that the services we provide are effective and cost–efficient. It benefits both the government and the community.”

Andrew Raynes, Chief Information Officer from Papworth Hospital NHS Foundation, UK, added, “It’s been a real privilege to be here. I’ve learned so much about South African culture in the health space and what we are all striving to achieve. I now look forward to reflecting on the conference’s outcomes and sharing them with colleagues back home in the UK. It’s been a great opportunity to be part of HISA, and thank you to IT News Africa for having me as one of the keynote speakers.”

Attendees can expect a dynamic day filled with informative sessions, engaging discussions, and valuable networking opportunities. By participating in HISA 2024, stakeholders will play a crucial role in shaping the future of healthcare in Africa.

For more information about the conference, registration, and sponsorship opportunities, visit www.healthcareinnovationsummit.co.za.

Hashtag: #HISA2024


GLOBENEWSWIRE (Distribution ID 1000987984)