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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)

Minovia Therapeutics Announces FDA Clearance of IND Application for a Phase Ib Clinical Trial of MNV-201 in Low Risk Myelodysplastic Syndrome

MNV–201 is a mitochondrial cell therapy product composed of autologous hematopoietic stem cells enriched with allogeneic mitochondria

In pre–clinical studies, MNV–201 demonstrated improved engraftment and bone marrow reconstitution potential of patient derived hematopoietic stem cells

In vitro data also demonstrated improved ability to differentiate to erythroid cells, supporting potential for improvement in biomarkers of anemia

HAIFA, Israel, Sept. 26, 2024 (GLOBE NEWSWIRE) — Minovia Therapeutics Ltd, a clinical stage biopharmaceutical company advancing mitochondrial cell therapies for primary and secondary mitochondrial diseases, today announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for MNV–201, an autologous hematopoietic stem cell product augmented with allogeneic mitochondria. The IND supports the initiation of a Phase Ib dose exploration clinical trial of MNV–201 in patients with Low Risk Myelodysplastic Syndrome (MDS).

Anemia is a common and serious symptom in patients with low–risk myelodysplastic syndrome (LR–MDS), affecting almost 90% of cases and is often the primary characteristic of the disease. Anemia in MDS can have a negative impact on quality of life and may correlate with decreased progression–free survival and overall survival. 

“The FDA’s clearance of our IND marks an important achievement for Minovia, allowing us to clinically evaluate our allogeneic mitochondrial cell therapy approach and proceed with the Phase Ib clinical program for this first–in–class allogeneic mitochondrial therapy for low risk MDS patients,” said Natalie Yivgi Ohana, PhD, CEO of Minovia. “We are pleased to have safely dosed two MDS patients enrolled in an ongoing study under the Israeli Ministry of Health. We look forward to treating additional patients under this IND, as well as to learning about the potential of MAT to improve anemia in this patient population.”

The Phase Ib clinical trial is an open–label, dose exploration study to evaluate the safety and efficacy of MNV–201 in subjects with low risk MDS. This trial will continue our campaign to evaluate dose exploration and safety of single or repeat dosing of MNV–201. The trial will also enable assessment of efficacy in improving anemia and durability of response. The study is expected to enroll at least three patients each in the low, medium and high dose cohorts, and up to a total of 15 patients in total. For more information visit clinicaltrials.gov.

About MNV–201
MNV–201 is an autologous hematopoietic stem cell product enriched with allogeneic mitochondria. MNV–201 aims to restore mitochondrial function in low risk MDS patient hematopoietic stem cells, resulting in improved differentiation to erythroid lineage with the potential to improve anemia. Preclinical research suggests the potential for safe dosing with low immunogenicity risk and scalable manufacturing to address the significant number of patients who are potentially eligible for MNV–201 therapy.

About Minovia Therapeutics
Minovia Therapeutics Ltd. is a clinical stage biotechnology company advancing mitochondrial cell therapies for primary–genetic and age–related mitochondrial diseases. Minovia's clinical stage product candidate, MNV–201, is composed of mobilized peripheral blood, autologous CD34+ cells enriched with allogeneic, cryopreserved placental derived mitochondria, produced by Minovia's proprietary Mitochondrial Augmentation Technology (MAT). The enrichment of hematopoietic stem cells with healthy and functional mitochondria aims to restore stem cells function of patients suffering mitochondrial dysfunction, caused both by mtDNA mutations or deletions in pediatric patients suffering from primary mitochondrial diseases, or in adults with age–related bone marrow failure disorders. MNV–201 is currently in clinical studies for pediatric patients with single–large scale mtDNA deletion syndromes (Pearson Syndrome and Kearn Sayre Syndrome) with four patients successfully dosed; and in Low Risk Myelodysplastic Syndrome. For more information, please visit www.minoviatx.com or follow the Company LinkedIn.

About Low Risk Myelodysplastic Syndrome

Myelodysplastic syndromes (MDS) are a group of bone marrow failures that occur when the blood–forming cells in the bone marrow become abnormal leading to an abnormal differentiation and production of one or more blood cell types. Patients with MDS collectively have a high symptom burden and are also at risk of death from complications of cytopenias or progression to acute myeloid leukemia (AML). MDS is generally a disease that develops with aging; the median age at diagnosis of MDS is ~70 years.

Mitochondrial Dysfunction in MDS: Scientific literature shows a correlation between mitochondrial dysfunction and MDS progression. It is known that ineffective hematopoiesis in MDS results from increased susceptibility of clonal myeloid progenitors to apoptosis. This may be triggered by intrinsic factors, such as mitochondrial polarization due to iron retention in ringed sideroblasts. A subset of MDS patients present with sideroblastic anemia, a phenotype common in Pearson Syndrome patients and which implicates mitochondrial dysfunction of HSPCs as part of the pathology of MDS.

Contact Information: Natalie Yivgi Ohana, Co–Founder and CEO

Phone: +972–74–7039954

Email: info@minoviatx.com


GLOBENEWSWIRE (Distribution ID 9237236)

Entera Bio Reports Q2 2024 Financial Results and Provides Business Updates

JERUSALEM , Aug. 09, 2024 (GLOBE NEWSWIRE) — Entera Bio Ltd. (NASDAQ: ENTX), (“Entera” or the “Company”) a leader in the development of orally delivered peptides and small therapeutic proteins, today reported financial results and key business updates for the quarter ended June 30, 2024.

“We continue to deliver strong execution with key milestones achieved during the second quarter of 2024 across each of our N–Tab™ oral peptide programs dedicated to patients with OBGYN/endocrinology, GI and metabolic diseases,” said Miranda Toledano, Entera’s CEO. “Importantly, we are now just five months away from FDA’s potential landmark ruling on the ASBMR–FNIH SABRE regulatory endpoint for osteoporosis drugs, which we view as a major catalyst for EB613. We are especially keen to start our pivotal study of EB613 in a much wider population where injectable anabolic drugs do not play a dominant role. Because of its potential dual mechanism of action, faster onset of action as an anabolic boosting agent and oral minitablet format, we believe EB613 is uniquely positioned to support earlier osteoanabolic intervention in post–menopausal women at high risk of fracture,” she added.

EB613: First Oral PTH(1–34) Daily Osteoanabolic Tablets for Osteoporosis

  • In April 2024, the Journal of Bone and Mineral Research (JBMR) published “Oral daily PTH(1–34) Tablets [EB613] in Postmenopausal Women with Low BMD or Osteoporosis: A Randomized, Placebo–Controlled, 6–Month, Phase 2 Study”
  • In May 2024, Entera welcomed Dr. Rachel Wagman as Key Clinical Advisor to lead EB613 clinical development. Wagman has successfully advanced the development of five molecules, including the osteoporosis products Forteo®, Prolia® and Evenity® through registration
  • In June 2024, the JMBR published an independent editorial titled “A Novel Oral hPTH(1–34) [EB613] Unveils the Promise of Modeling–Based Anabolism with No Increase in Bone Remodeling”
  • In July 2024, Entera announced that new comparative pharmacological data for its investigational agent EB613 vs. Forteo® was selected for presentation at the ASBMR September 2024 Annual Meeting in Toronto
  • In July 2024, Entera announced that the SABRE (Study to Advance BMD as a Regulatory Endpoint) is expected to provide an update at the ASBMR September 2024 Annual Meeting in Toronto

EB612: First Oral PTH(1–34) Peptide Replacement Therapy Tablets for Hypoparathyroidism

  • In June 2024, Entera presented Phase 1 clinical data for its hypoparathyroidism focused investigational program, EB612, at the Endocrine Society ENDO 2024 Annual Meeting. Entera showed that the data supports potentially moving the BID (twice–daily) tablet dose to Phase 2 development in patients with hypoparathyroidism
  • Entera continues to collaborate with a third party on the development of another PTH replacement treatment for hypoparathyroidism

First GLP–2 Peptide Tablets for Short Bowel Syndrome

  • In March 2024, Entera announced positive in vivo PK results from its program combining OPKO Health, Inc.’s (Nasdaq: OPK) long acting GLP–2 analogue with N–Tab™ technology. Pharmacology data is expected early in the second half of 2024

First GLP–1/Glucagon Agonist (Oxyntomodulin) Peptide Tablets for Obesity

  • Collaborative work is ongoing combining N–Tab™ with OPKO’s long–acting Oxyntomodulin (OXM) analogues for potential treatment for obesity and other metabolic diseases. PK data for the oral OXM tablet are expected early in the second half of 2024

Financial Results for the Quarter Ended June 30, 2024

As of June 30,2024, Entera had cash and cash equivalents of $9.1 million. The Company expects that its existing cash resources are sufficient to meet its projected operating requirements into the third quarter of 2025.

Research and development expenses for the three months ended June 30, 2024 were $1.1 million, as compared to $1.2 million for the three months ended June 30, 2023. The decrease of $0.1 million was primarily due to a decrease of $0.3 million in clinical expenses for our Phase 1 PK study related to our new generation platform and new formulations for EB612, which completed its first stage in 2023.

General and administrative expenses for both the three months ended June 30, 2024 and 2023 were $1.1 million.

Operating expenses for the period ended June 30, 2024 were $2.2 million, as compared to $2.3 million for the quarter ended June 30, 2023.

Net loss was $2.1 million, or $0.06 per ordinary share (basic and diluted), for the quarter ended June 30, 2024, as compared to $2.3 million, or $0.08 per ordinary share (basic and diluted), for the quarter ended June 30, 2023.

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 on 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, with no prior fracture. A placebo controlled, dose ranging Phase 2 study of EB613 tablets (n= 161) met primary (PD/bone turnover biomarker) and secondary endpoints (BMD). 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. Entera is also developing the first oral oxyntomodulin, a dual targeted GLP1/glucagon peptide, in tablet form for the treatment of obesity; and first oral GLP–2 peptide tablet as an injection–free alternative for patients suffering from rare malabsorption conditions such as short bowel syndrome in collaboration with OPKO Health. For more information on Entera Bio, visit www.enterabio.com or follow us on LinkedIn, Twitter, Facebook, Instagram.

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 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 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 Entera’s product candidates; Entera’s reliance on third parties to conduct its clinical trials; Entera’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 obtain and maintain regulatory approval for any of its product candidates; 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 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 most recent Annual Report on Form 10–K filed with the SEC, as well as the company’s 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 will be realized or, even if substantially realized, that they will have the expected consequences to, or effects on, Entera. Therefore, no assurance can be given that the outcomes stated or implied in such forward–looking statements and estimates will be achieved. Entera cautions investors not to rely on the forward–looking statements Entera makes in this press release. The information in this press release is provided only as of the date of this press release, and Entera undertakes 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.

ENTERA BIO LTD.
CONSOLIDATED BALANCE SHEETS
(U.S. dollars in thousands)
 
  June 30,   December 31,
  2024   2023
  (Unaudited)   (Audited)
   
Cash and cash equivalents 9,056   11,019
Accounts receivable and other current assets 539   238
Property and equipment, net 76   100
Other assets, net 364   408
Total assets 10,035   11,765
       
       
Accounts payable and other current liabilities 1,294   1,091
Total non–current liabilities 219   288
Total liabilities 1,503   1,379
Total shareholders' equity 8,532   10,386
       
Total liabilities and shareholders' equity 10,035   11,765
 

ENTERA BIO LTD.
CONSOLIDATED STATEMENTS OF OPERATIONS
(U.S. dollars in thousands, except share and per share data)
(Unaudited)
 
  Three Months Ended
June 30,
  2024   2023  
REVENUES 57   –  
COST OF REVENUES 48   –  
GROSS PROFIT 9   –  
OPERATING EXPENSES:    
Research and development 1,086   1,209  
General and administrative 1,088   1,135  
Other income –   (14)  
TOTAL OPERATING EXPENSES 2,174   2,330  
OPERATING LOSS 2,165   2,330  
FINANCIAL INCOME, NET (20)   (5)  
NET LOSS 2,145   2,325  
     
LOSS PER SHARE BASIC AND DILUTED 0.06   0.08  
WEIGHTED AVERAGE NUMBER OF SHARES OUTSTANDING         
USED IN COMPUTATION OF BASIC AND DILUTED LOSS PER SHARE 37,090,160   28,812,375  
     


GLOBENEWSWIRE (Distribution ID 9202470)

Sabin Vaccine Institute Begins Phase 2 Clinical Trial for Sudan Ebolavirus Vaccine

Laboratory at Makerere University Walter Reed Project, where Sabin’s Phase 2 Sudan ebolavirus vaccine clinical trial begins this month.

WASHINGTON, July 15, 2024 (GLOBE NEWSWIRE) — Sabin Vaccine Institute launched a Phase 2 clinical trial for its vaccine against Sudan ebolavirus, with healthy volunteers receiving the single–dose vaccine at Makerere University Walter Reed Project (MUWRP) in Uganda. There are currently no approved vaccines for this strain of ebolavirus, which saw an outbreak end just last year. Ebolavirus disease kills on average half the people infected, according to the World Health Organization.

Sudan ebolavirus is a filovirus, in the same family as Marburg virus disease and Zaire ebolavirus, which killed 11,325 in one outbreak in West Africa from 2014–16. Ebolavirus disease spreads between people via direct contact with the blood or other bodily fluids of infected people and is highly virulent, causing hemorrhagic fever.

Based on the same cAd3 platform as its Marburg vaccine candidate, Sabin’s single–dose investigational Sudan ebolavirus vaccine was found to be promising in Phase 1 clinical and non–clinical studies, with results showing it to be safe, while eliciting rapid and robust immune responses that lasted up to 12 months.

This is Sabin’s second Phase 2 clinical trial partnership with MUWRP, based in Uganda’s capital, Kampala. A Phase 2 trial for a Marburg vaccine is already underway, having recently completed enrollment. Initial results from the Marburg trial are expected later this year.

Dr. Betty Mwesigwa, deputy executive director of MUWRP, is once again the principal investigator (PI) for the Sabin–sponsored trial for the Sudan ebolavirus vaccine. In the coming weeks, participants will also be enrolled at the Kenya Medical Research Institute in Siaya, Kenya, with Dr. Videlis Nduba serving as PI for that site. In all, 125 volunteers will participate in the trial across the two countries.

“We are delighted to advance a vaccine candidate that can thwart a deadly and devastating disease, especially one that caused a fairly recent outbreak and for which no approved treatments exist,” says Amy Finan, Sabin’s Chief Executive Officer. “Sabin’s vaccine candidate is backed by strong safety and immunogenicity data, and we hope this trial will yield further evidence to move the vaccine closer to licensure.”

The most recent outbreak of Sudan ebolavirus occurred in the fall of 2022 in Uganda, after six suspicious deaths in the Mubende district. That outbreak ultimately resulted in 55 deaths. Sabin’s vaccine was the first to arrive in Uganda during that outbreak after the World Health Organization included it as one of three vaccines for possible use in an outbreak trial. The outbreak ended on January 11, prior to vaccine being deployed for use.

“Makerere University Walter Reed Project is pleased to partner with the Sabin Vaccine Institute once again,” says Dr. Mwesigwa. “Uganda has the most experience with Sudan ebolavirus outbreaks so we understand the importance of testing and researching an effective Sudan ebolavirus vaccine that could be used in the event of an outbreak.”

The Phase 2 clinical trial will evaluate safety and immunogenicity for the vaccine among a larger group of individuals than in previous trials. This is a randomized, placebo–controlled, double–blind study, meaning that neither the participants nor the researchers will know whether trial participants receive a vaccine dose or a placebo dose until after the trial is over, an approach used to help reduce experimental bias.

Participants in the clinical trial will be monitored for a full year and will include both younger (18–50 years) and older age groups (51–70 years). Interim results are expected next year. In addition to the current trial in Uganda and Kenya, Sabin plans to conduct a similar Phase 2 clinical trial for Sudan ebolavirus vaccine in the U.S.

The Sudan ebolavirus vaccine trials are 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 between the organizations.

To date, Sabin has received around $216 million in contract awards from BARDA for furthering vaccine research and development against Sudan ebolavirus and Marburg virus diseases. BARDA and Sabin began working together in September 2019 to develop the two monovalent vaccine candidates.

This project has been supported in whole or in part with federal funds from the Department of Health and Human Services; Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority (BARDA), under contract numbers 75A50119C00055 and 75A50123C00010.

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.

About Sabin’s Vaccine R&D Using the cAd3 Platform

In August 2019, Sabin announced exclusive agreements with GSK for Sabin to advance the development of the prophylactic candidate vaccines against the deadly Zaire ebolavirus, Sudan ebolavirus and Marburg virus. The three candidate vaccines were initially developed collaboratively by the U.S. National Institutes of Health and Okairos, which was acquired by GSK in 2013. The candidate vaccines, based on GSK’s proprietary cAd3 platform, were further developed by GSK, including the Phase 2 development for the Zaire ebolavirus vaccine. Under the agreements between GSK and Sabin, Sabin exclusively licensed the technology for all three candidate vaccines and acquired certain patent rights specific to these vaccines.

About the Makerere University Walter Reed Project

MUWRP is a non–profit biomedical research organization with a mission to mitigate disease threats through quality research, health care and disease surveillance. The project’s scope includes, among others; clinical research in infectious and non–infectious diseases such as HIV, Ebola, Marburg, COVID–19, Influenza and Influenza–like illnesses, and neglected tropical diseases such as Schistosomiasis, among others. A major part of the clinical research are clinical trials, where the MUWRP has conducted more than 12 phase 1 and 2 vaccine clinical trials including the first Ebola vaccine trial in Africa.

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/7ea30f47–768e–4cd0–b0a3–19adff04b2ab


GLOBENEWSWIRE (Distribution ID 9177893)

CSL Behring Announces First Two Patients Treated with HEMGENIX® (etranacogene dezaparvovec) Gene Therapy for Hemophilia B in Europe

MARBURG, Germany, July 04, 2024 (GLOBE NEWSWIRE) — Global biotechnology leader CSL Behring (ASX: CSL) today announced that two hemophilia B patients were treated with the gene therapy HEMGENIX® (etranacogene dezaparvovec) at Hemophilia Treatment Centers in France. This milestone achievement makes HEMGENIX® the first gene therapy administered as a treatment in a real–world setting for hemophilia B in Europe.

HEMGENIX® is the first one–time gene therapy approved in Europe for the treatment of adults with severe and moderately severe hemophilia B, an inherited bleeding disorder caused by the lack of Factor IX (a protein needed to produce blood clots to stop bleeding). It is used in adults without a history of Factor IX inhibitors.1

Following European Commission approval, HEMGENIX® was the first ever therapy to be granted Direct Access in France2, thus enabling the first patients to be treated in Europe outside of the clinical program.

Though effective, current therapies can be time intensive and require regular treatment that can have a substantial impact on a patient’s daily life.3 HEMGENIX® offers a one–time treatment, allowing people living with hemophilia B to produce their own Factor IX, which can lower the risk of bleeding.4

“Only a few decades ago, gene therapy for hemophilia was a distant concept, which has now become reality. Accordingly, the first two patients treated with HEMGENIX® since receiving European approval is a major accomplishment and a testament to the joint commitment of the hemophilia B community, as well as the access and reimbursement authorities, in bringing innovative therapies to patients,” said Dr Lutz Bonacker SVP and General Manager, CSL Behring Commercial Operations Europe. “This milestone has been made possible by the innovative Direct Access scheme adopted in France, allowing patients to benefit from early access to pioneering treatments. We are encouraged to see increasing access to gene therapies in European countries and are fully committed to ensuring that access to potentially life–changing treatment continues.”

HEMGENIX® was granted conditional marketing authorisation by the European Commission (EC) for the European Union and European Economic Area in February 2023, following approval from the U.S. Food and Drug Administration (FDA) in November 2022. It has also been approved by Health Canada, the United Kingdom's Medicines and Healthcare products Regulatory Agency (MHRA), Switzerland’s Swissmedic and Australia’s Therapeutic Goods Administration (TGA).

The multi–year clinical development of HEMGENIX® was led by uniQure and sponsorship of the clinical trials transitioned to CSL after it licensed global rights to commercialise the treatment.

About Hemophilia B

Hemophilia B is a life–threatening rare disease. People with the condition are particularly vulnerable to bleeds in their joints, muscles, and internal organs, leading to pain, swelling, and joint damage. Current treatments for moderate to severe hemophilia B include life–long prophylactic infusions of factor IX to temporarily replace or supplement low levels of the blood–clotting factor.  

About HEMGENIX®

HEMGENIX® is a gene therapy that reduces the rate of abnormal bleeding in eligible people with hemophilia B by enabling the body to continuously produce factor IX, the deficient protein in hemophilia B. It uses AAV5, a non–infectious viral vector, called an adeno–associated virus (AAV). The AAV5 vector carries the Padua gene variant of Factor IX (FIX–Padua) to the target cells in the liver, generating factor IX proteins that are 5x–8x more active than normal. These genetic instructions remain in the target cells, but generally do not become a part of a person’s own DNA. Once delivered, the new genetic instructions allow the cellular machinery to produce stable levels of factor IX.

About the Pivotal HOPE–B Trial

The pivotal Phase III HOPE–B trial is an ongoing, multinational, open–label, single–arm study to evaluate the safety and efficacy of HEMGENIX®. Fifty–four adult hemophilia B patients classified as having moderately severe to severe hemophilia B and requiring prophylactic factor IX replacement therapy were enrolled in a prospective, six–month or longer observational period during which time they continued to use their current standard of care therapy to establish a baseline Annual Bleeding Rate (ABR). After the six–month lead–in period, patients received a single intravenous administration of HEMGENIX® at the 2×10^13 gc/kg dose. Patients were not excluded from the trial based on pre–existing neutralizing antibodies (NAbs) to AAV5.

A total of 54 patients received a single dose of HEMGENIX® in the pivotal trial, with 52 patients completing at least three years of follow–up. The primary endpoint in the pivotal HOPE–B study was ABR 52 weeks after achievement of stable factor IX expression (months 7 to 18) compared with the six–month lead–in period. For this endpoint, ABR was measured from month seven to month 18 after infusion, ensuring the observation period represented a steady–state factor IX transgene expression. Secondary endpoints included assessment of factor IX activity.

No serious treatment–related adverse reactions were reported. One death resulting from urosepsis and cardiogenic shock in a 77–year–old patient at 65 weeks following dosing was considered unrelated to treatment by investigators and the company sponsor. A serious adverse event of hepatocellular carcinoma was determined to be unrelated to treatment with HEMGENIX® by independent molecular tumour characterization and vector integration analysis. No inhibitors to factor IX were reported. 

Long–term three–year data presented at the 17th Annual Congress of the European Association for Haemophilia and Allied Disorders (EAHAD) 2024 continue to reinforce the potential long–lasting efficacy and safety of HEMGENIX® and the ongoing benefit of this treatment for people living with hemophilia B.

About CSL
CSL (ASX:CSL; USOTC:CSLLY) is a global biotechnology company with a dynamic portfolio of lifesaving medicines, including those that treat hemophilia and immune deficiencies, vaccines to prevent influenza, and therapies in iron deficiency and nephrology. Since our start in 1916, we have been driven by our promise to save lives using the latest technologies. Today, CSL – including our three businesses: CSL Behring, CSL Seqirus and CSL Vifor – provides lifesaving products to patients in more than 100 countries and employs 32,000 people. Our unique combination of commercial strength, R&D focus and operational excellence enables us to identify, develop and deliver innovations so our patients can live life to the fullest. For inspiring stories about the promise of biotechnology, visit CSL.com/Vita. For more information about CSL, visit CSL.com.

Media Contacts
Stephanie Fuchs
Mobile: +49 151 584 388 60
Email: Stephanie.Fuchs@cslbehring.com

References

1 European Medicines Agency. First Gene therapy to treat haemophilia B. Available at: https://www.ema.europa.eu/en/news/first–gene–therapy–treat–haemophilia–b. [Accessed May 2024].
2 Republique Française. Légifrance: Article 62 of Law No. 2021–1754. Available at: https://www.legifrance.gouv.fr/jorf/id/JORFTEXT000048551003 [Accessed May 2024].
3 Leebeek, F & Miesbach, W. (2021) Gene therapy for haemophilia: a review on clinical benefit, limitations, and remaining issues. Blood. Vol 138, Issue 11. pp923–931.
4 Coppens M et al. Etranacogene dezaparvovec gene therapy for haemophilia B (HOPE–B): 24–month post–hoc efficacy and safety data from a single–arm, multicentre, phase 3 trial. The Lancet Haematology 2024; 11(4):E265–E275.


GLOBENEWSWIRE (Distribution ID 1000969961)

Fortrea lance un studio d’innovation en IA pour galvaniser les solutions technologiques et humaines afin d’améliorer la réalisation des essais cliniques

DURHAM, État de Caroline du Nord, 28 juin 2024 (GLOBE NEWSWIRE) — Fortrea (Nasdaq : FTRE), un organisme de recherche sous contrat (« ORC ») de premier plan au niveau mondial, a annoncé aujourd’hui le lancement de son studio d’innovation en intelligence artificielle (« IA »), marquant ainsi un investissement stratégique visant à remodeler l’exécution des essais cliniques aujourd’hui et à l’avenir.

Le studio développera et déploiera des technologies d’IA et d’apprentissage automatique visant à favoriser la rapidité, l’agilité, la qualité et le renforcement de la sécurité des patients dans le processus de recherche clinique en équipant et en habilitant les personnes à se concentrer sur l’élément humain critique des essais cliniques.

« Partout dans le monde, des patients attendent des traitements novateurs qui changeront leur vie. Grâce à l’IA, nous avons désormais le pouvoir — et l’obligation — de les aider à trouver des solutions plus rapidement », a déclaré Alejandro Martinez Galindo, directeur des systèmes d’information de Fortrea, avant d’ajouter :

« Le studio d’innovation en IA de Fortrea offrira des capacités technologiques améliorées qui permettront aux systèmes dotés d’IA d’exécuter des processus de pointe, tels que des simulations d’essai, des analyses prédictives et la reconnaissance de motifs, ainsi que des tâches administratives répétitives, « adaptées aux machines ». Cela permet de libérer la disponibilité des personnes pour qu’elles puissent apporter leur créativité humaine et leur connexion à l’essai clinique de demain et se concentrer sur ce qui compte : le patient. »

Le studio d’innovation en IA de Fortrea vise à :

  • établir des partenariats au sein de Fortrea et avec nos clients afin de fournir des solutions technologiques pour des stratégies d’innovation sur mesure pour les centres et les promoteurs ;
  • développer de nouvelles innovations technologiques nettes qui améliorent de manière globale la réalisation des essais cliniques pour les promoteurs, les centres, les patients et nos équipes ; et
  • soutenir l’infrastructure et les opérations existantes avec une technologie améliorée afin de permettre de nouvelles et meilleures méthodes de travail et créer les meilleures expériences pour les utilisateurs.

Les technologies en cours de développement dans le studio comprennent la collecte de données à l’aide de smartphones, des modèles linguistiques spécialisés à grande échelle pour la compréhension et la génération de textes, l’IA symbolique avec une logique à valeurs réelles (c.–à–d. la construction d’une logique de décision à l’aide de scénarios et de données en situation réelle), la réalité mixte et l’intelligence augmentée, l’exploration de données avancées et l’analyse prédictive, ainsi que le jumelage numérique.

L’application stratégique de ces technologies devrait permettre des avancées significatives en matière de recrutement et de fidélisation des patients, de création et d’optimisation des protocoles, de contrôle de la qualité en fonction des risques, ainsi que de rapidité et de qualité globales des prestations. Ces technologies peuvent également améliorer l’expérience des patients et la productivité des clients, des centres et des employés de Fortrea.

Les développements du studio d’innovation en IA seront essentiels pour la plateforme technologique clinique de Fortrea, qui est conçue pour intégrer la technologie des essais cliniques dans une expérience utilisateur, indépendante de la localisation, omnicanale et basée sur les personas, accessible à partir d’un seul écran.

« Fortrea se concentre sur une vision future du secteur des ORC, ce qui nous permet de construire POUR l’avenir plutôt que POUR le passé », a déclaré Brian Dolan, vice–président du Département d’intelligence artificielle et d’apprentissage automatique, avant d’ajouter : « Nous accordons une grande attention au développement et au déploiement responsables et éthiques de l’IA, en privilégiant les bonnes actions pour les bonnes raisons et en protégeant la sécurité et la vie privée des patients, ainsi que la propriété intellectuelle de nos clients. »

À propos de Fortrea
Fortrea (Nasdaq : FTRE) est l’un des principaux fournisseurs mondiaux de solutions de développement clinique dans le secteur des sciences de la vie. Nous nous associons à des entreprises émergentes et établies du secteur biopharmaceutique, de la biotechnologie, des dispositifs médicaux et du diagnostic pour stimuler l’innovation dans le domaine de la santé et accélérer la mise à disposition de traitements révolutionnaires pour les patients. Fortrea propose des services de gestion d’essais cliniques de phase I à IV, de pharmacologie clinique et de consulting. Nos solutions s’appuient sur 30 ans d’expérience dans 20 domaines thérapeutiques, une passion pour la rigueur scientifique, des connaissances exceptionnelles et un solide réseau de centres de recherche. Notre équipe talentueuse et diversifiée répartie dans plus de 90 pays est dimensionnée pour fournir des solutions ciblées et agiles à nos clients, partout dans le monde. Pour en savoir plus sur la manière dont Fortrea est un moteur d’influence du pipeline au patient, rendez–vous sur Fortrea.com et suivez–nous sur LinkedIn et X (anciennement Twitter).

Coordonnées de Fortrea :
Hima Inguva (Investisseurs) – 877–495–0816, hima.inguva@fortrea.com
Jennifer Minx (Médias) – 919–410–4195, media@fortrea.com
Kate Dillon (Médias) – 646–818–9115, kdillon@prosek.com


GLOBENEWSWIRE (Distribution ID 9170901)

Fortrea startet KI-Innovationsstudio, um Technologie und menschliche Lösungen zur Verbesserung der Durchführung klinischer Studien zu bündeln

DURHAM, N.C., June 28, 2024 (GLOBE NEWSWIRE) — Fortrea (Nasdaq: FTRE), ein führendes globales Auftragsforschungsinstitut (CRO), gab heute die Einführung seines Innovationsstudios für künstliche Intelligenz (KI) bekannt und signalisiert damit eine strategische Investition in die Neugestaltung der Durchführung von klinischen Studien heute und in Zukunft.

Das Studio wird KI–Technologien und Technologien für maschinelles Lernen (ML) entwickeln und einsetzen, um den klinischen Forschungsprozess zu beschleunigen, flexibler zu gestalten, die Qualität zu verbessern und die Patientensicherheit zu erhöhen, indem es die Mitarbeitenden in die Lage versetzt, sich auf das kritische menschliche Element der klinischen Studien zu konzentrieren.

„Weltweit warten Patienten auf neue, lebensverändernde Behandlungen. Mit KI haben wir jetzt die Möglichkeit – und die Verpflichtung – ihnen schneller Lösungen zu liefern“, sagte Alejandro Martinez Galindo, Chief Information Officer von Fortrea.

„Das KI–Innovationstudio von Fortrea wird erweiterte technologische Fähigkeiten ermöglichen, die KI–fähigen Systemen erlauben, innovative Prozesse wie Versuchssimulationen, prädiktive Analysen und Mustererkennung sowie sich wiederholende, administrative, 'maschinenfreundliche Aufgaben' durchzuführen. Das gibt Menschen die Freiheit, ihre menschliche Kreativität und Verbundenheit in die klinische Studie von morgen einzubringen und sich auf das zu konzentrieren, was zählt: den Patienten.“

Das KI–Innovationsstudio von Fortrea zielt auf Folgendes ab:

  • Partnerschaft mit Fortrea und unseren Kunden, um Technologielösungen für maßgeschneiderte Innovationsstrategien für Standorte und Sponsoren zu entwickeln;
  • Entwicklung neuer technologischer Innovationen, die die Durchführung von klinischen Studien für Sponsoren, Standorte, Patienten und unsere Teams ganzheitlich verbessern; und
  • Unterstützung bestehender Infrastruktur und Abläufe durch verbesserte Technologie, um neue, verbesserte Arbeitsweisen zu ermöglichen und erstklassige Benutzererfahrungen zu schaffen.

Zu den Technologien, die im Studio entwickelt werden, gehören Smartphone–gestützte Datenerfassung, spezialisierte große Sprachmodelle für Textverständnis und –generierung, symbolische KI mit realwertiger Logik (d.h. Aufbau von Entscheidungslogik unter Verwendung von Szenarien und Daten aus der realen Welt), gemischte Realität und erweiterte Intelligenz, fortgeschrittenes Data Mining und prädiktive Analysen sowie digitale Zwillinge.

Es wird erwartet, dass die strategische Anwendung dieser Technologien zu bedeutenden Fortschritten bei der Rekrutierung und Bindung von Patienten, der Erstellung/Optimierung von Protokollen, der risikobasierten Qualitätsüberwachung sowie der allgemeinen Bereitstellungsgeschwindigkeit und –qualität führen wird. Diese Technologien können auch zu einem verbesserten Patientenerlebnis und einer höheren Produktivität für Kunden, Standorte und Mitarbeitende von Fortrea führen.

Die Entwicklungen des KI–Innovationsstudios werden für die klinische Technologieplattform von Fortrea von entscheidender Bedeutung sein. Sie soll die Technologie für klinische Studien in eine verbrauchergerechte, ortsunabhängige, kanalübergreifende und personenbezogene Erfahrung integrieren, die über einen einzigen Bildschirm zugänglich ist.

„Fortrea konzentriert sich auf eine Zukunftsvision der CRO–Branche, die uns ermöglicht, FÜR die Zukunft zu bauen und nicht VON der Vergangenheit aus“, sagte Brian Dolan, Vice President of Artificial Intelligence & Machine Learning. „Wir legen großen Wert auf die verantwortungsvolle und ethische Entwicklung und den Einsatz von KI. Dabei ist es uns wichtig, das Richtige aus den richtigen Gründen zu tun und die Sicherheit der Patienten und den Schutz ihrer Daten sowie das geistige Eigentum unserer Kunden zu schützen.“

Über Fortrea
Fortrea (Nasdaq: FTRE) ist ein weltweit führender Anbieter von Lösungen für die klinische Entwicklung in der Biowissenschaftsbranche. Wir arbeiten mit aufstrebenden und großen biopharmazeutischen, biotechnologischen, medizintechnischen und diagnostischen Unternehmen zusammen, um Innovationen im Gesundheitswesen voranzutreiben, die das Angebot lebensverändernder Therapien für Patienten beschleunigen. Fortrea bietet Management von klinischen Studien der Phasen I–IV, klinische Pharmakologie und Beratungsdienste an. Die Lösungen von Fortrea basieren auf drei Jahrzehnten Erfahrung in mehr als 20 Therapiegebieten, einer Leidenschaft für wissenschaftliche Strenge, außergewöhnlichen Erkenntnissen und einem starken Netzwerk von Prüfzentren. Unser talentiertes und vielseitiges Team in über 90 Ländern ist so skaliert, dass wir unseren Kunden weltweit gezielte und flexible Lösungen anbieten können. Mehr darüber, wie Fortrea zu einer transformativen Kraft von der Pipeline bis zum Patienten wird, erfahren Sie auf Fortrea.com und wenn Sie uns auf LinkedIn und X (früherTwitter) folgen.

Kontakt zu Fortrea:
Hima Inguva (Investoren) – 877–495–0816, hima.inguva@fortrea.com
Jennifer Minx (Medien) – 919–410–4195, media@fortrea.com
Kate Dillon (Medien) – 646–818–9115, kdillon@prosek.com


GLOBENEWSWIRE (Distribution ID 9170901)

Fortrea Lança AI Innovation Studio para Galvanizar Tecnologia e Soluções Humanas para Aprimoramento da Entrega de Ensaios Clínicos

DURHAM, N.C., June 28, 2024 (GLOBE NEWSWIRE) — A Fortrea (Nasdaq: FTRE), uma organização líder global de pesquisa por contrato (CRO), anunciou hoje o lançamento do seu AI Innovation Studio, sinalizando um investimento estratégico na reformulação da execução de ensaios clínicos hoje e no futuro.

O Studio desenvolverá e implantará tecnologias de IA e aprendizado de máquina (ML) para impulsionar a velocidade, agilidade, qualidade e segurança aprimorada do paciente no processo de pesquisa clínica, equipando e capacitando as pessoas a se concentrarem no elemento humano tão essencial nos ensaios clínicos.

“Pacientes de todo o mundo estão esperando por novos tratamentos que irão mudar suas vidas. Com a IA, agora temos o poder – e a obrigação – de ajudar a fornecer soluções para esses pacientes mais rapidamente”, disse o diretor de informações da Fortrea, Alejandro Martinez Galindo.

“O AI Innovation Studio da Fortrea viabilizará os recursos tecnológicos aprimorados que permitirão que os sistemas habilitados para IA executem processos de ponta – como simulações de testes, análises preditivas e reconhecimento de padrões – além de tarefas repetitivas, administrativas e fáceis de operar. Isso permite que as pessoas possam contribuir com a criatividade humana e a conexão com o ensaio clínico futuro e se concentrar no que é o mais importante: o paciente.”

O AI Innovation Studio da Fortrea visa:

  • Estabelecer parcerias em toda a Fortrea e com nossos clientes para fornecimento de soluções tecnológicas para estratégias de inovação sob medida para locais e patrocinadores;
  • Desenvolver inovações tecnológicas novas e inovadoras que aprimorem holisticamente a entrega de ensaios clínicos para patrocinadores, locais, pacientes e nossas equipes; e
  • Apoiar a infraestrutura e as operações existentes com tecnologia aprimorada para viabilizar novas e aprimoradas maneiras de trabalho e criação das melhores experiências de usuário da categoria.

As tecnologias em desenvolvimento no Studio incluem coleta de dados habilitada para smartphones; grandes modelos de linguagens especializados para compreensão e geração de texto; IA simbólica com lógica de valor real (ou seja, criação de lógica de decisão com cenários e dados do mundo real); realidade mista e inteligência aumentada; mineração avançada de dados e análise preditiva; e geminação digital.

A aplicação estratégica dessas tecnologias deve resultar em avanços significativos no recrutamento e retenção de pacientes, criação/otimização de protocolos, monitoramento de qualidade baseado em risco e velocidade e qualidade gerais da entrega. Essas tecnologias também podem proporcionar uma melhor experiência para o paciente e maior produtividade para os clientes, locais e funcionários da Fortrea.

Os desenvolvimentos do AI Innovation Studio serão fundamentais para a plataforma de tecnologia clínica da Fortrea que está sendo projetada para integrar a tecnologia de ensaios clínicos em uma experiência de nível de consumidor, independente de localização, omnicanal e baseada em persona, acessível por meio de uma única tela.

“A Fortrea está focada em uma visão de futuro da indústria de CRO que nos permite criar Voltados para o futuro e Não para o passado”, disse Brian Dolan, Vice–Presidente de Inteligência Artificial e Aprendizado de Máquina. “Estamos sendo bem cautelosos e levando em consideração o desenvolvimento e a implantação responsáveis e éticos da IA, priorizando fazer a coisa certa pelas razões certas e protegendo a segurança e a privacidade do paciente e a propriedade intelectual dos nossos clientes.”

Sobre a Fortrea
A Fortrea (Nasdaq: FTRE) é fornecedora líder global de soluções para o desenvolvimento clínico para a indústria de ciências da vida. Fazemos parcerias com grandes e emergentes empresas biofarmacêuticas, de biotecnologia, de dispositivos médicos e de diagnóstico para impulsionar a inovação na saúde que acelera terapias que mudam a vida dos pacientes. A Fortrea fornece gerenciamento de testes clínicos de fase I–IV, farmacologia clínica e serviços de consultoria. As soluções da Fortrea utilizam suas três décadas de experiência abrangendo mais de 20 áreas terapêuticas, sua dedicação ao rigor científico, insights excepcionais e uma forte rede de pesquisadores. Nossa equipe talentosa e diversificada que trabalha em mais de 90 países é dimensionada para fornecer soluções focadas e ágeis para clientes de todo o mundo. Saiba mais sobre como a Fortrea está se tornando uma força transformadora de pipeline para pacientes na Fortrea.com e siga–nos no LinkedIn e X (antigo Twitter).

Contatos da Fortrea:
Hima Inguva (Investidores) – 877–495–0816, hima.inguva@fortrea.com
Jennifer Minx (Mídia) – 919–410–4195, media@fortrea.com
Kate Dillon (Mídia) – 646–818–9115, kdillon@prosek.com


GLOBENEWSWIRE (Distribution ID 9170901)

Fortrea Launches AI Innovation Studio to Galvanize Technology and Human Solutions to Improve Clinical Trial Delivery

DURHAM, N.C., June 27, 2024 (GLOBE NEWSWIRE) — Fortrea (Nasdaq: FTRE), a leading global contract research organization (CRO), today announced the launch of its artificial intelligence (AI) Innovation Studio, signaling a strategic investment in reshaping the execution of clinical trials today and into the future.

The studio will develop and deploy AI and machine learning (ML) technologies to drive speed, agility, quality and enhanced patient safety in the clinical research process by equipping and empowering people to focus on the critical human element of clinical trials.

“Patients around the world are waiting for novel, life–changing treatments. With AI, we now have the power—and the obligation—to help deliver solutions to them faster,” said Fortrea’s Chief Information Officer Alejandro Martinez Galindo.

“Fortrea’s AI Innovation Studio will enable enhanced technological capabilities that will allow AI–enabled systems to perform cutting–edge processes—such as trial simulations, predictive analytics and pattern recognition—as well as repetitive, administrative, ‘machine–friendly tasks’. This frees up people to contribute human creativity and connection to the clinical trial of tomorrow and focus on what counts: the patient.”

Fortrea’s AI Innovation Studio aims to:

  • Partner across Fortrea and with our customers to provide technology solutions for bespoke site and sponsor innovation strategies;
  • Develop net new, greenfield technology innovations that holistically improve the delivery of clinical trials for sponsors, sites, patients and our teams; and
  • Support existing infrastructure and operations with enhanced technology to enable new, improved ways of working and create best–in–class user experiences.

Technologies under development in the studio include smartphone–enabled data collection; specialized large language models for text comprehension and generation; symbolic AI with real–valued logic (i.e., building decision logic using real–world scenarios and data); mixed reality and augmented intelligence; advanced data mining and predictive analytics; and digital twinning.

Strategic application of these technologies is expected to result in meaningful advancements in patient recruitment and retention, protocol creation/optimization, risk–based quality monitoring and overall delivery speed and quality. These technologies can also deliver an improved patient experience and greater productivity for Fortrea customers, sites and employees.

Developments from the AI Innovation Studio will be critical to Fortrea’s clinical technology platform, which is being designed to integrate clinical trial technology into a consumer–grade, location–agnostic, omni–channel, persona–based experience accessible thorough a single screen.

“Fortrea is focused on a future vision of the CRO industry, allowing us to build TO the future rather than FROM the past,” said Brian Dolan, Vice President of Artificial Intelligence & Machine Learning. “We are exercising great care and consideration to the responsible and ethical development and deployment of AI, prioritizing doing the right thing for the right reasons and protecting patient safety and privacy, and the intellectual property of our customers.”

About Fortrea
Fortrea (Nasdaq: FTRE) is a leading global provider of clinical development solutions to the life sciences industry. We partner with emerging and large biopharmaceutical, biotechnology, medical device and diagnostic companies to drive healthcare innovation that accelerates life–changing therapies to patients. Fortrea provides phase I–IV clinical trial management, clinical pharmacology and consulting services. Fortrea’s solutions leverage three decades of experience spanning more than 20 therapeutic areas, a passion for scientific rigor, exceptional insights and a strong investigator site network. Our talented and diverse team working in more than 90 countries is scaled to deliver focused and agile solutions to customers globally. Learn more about how Fortrea is becoming a transformative force from pipeline to patient at Fortrea.com and follow us on LinkedIn and X (formerly Twitter).

Fortrea Contacts:
Hima Inguva (Investors) – 877–495–0816, hima.inguva@fortrea.com
Jennifer Minx (Media) – 919–410–4195, media@fortrea.com
Kate Dillon (Media) – 646–818–9115, kdillon@prosek.com


GLOBENEWSWIRE (Distribution ID 9170022)

Derm-Biome Pharmaceuticals’ topical therapy shows positive results in preclinical skin cancer trial: drug prevents the development of precancerous skin conditions and treats existing skin cancers with no observable side effects. 

VANCOUVER, British Columbia, April 17, 2024 (GLOBE NEWSWIRE) — The rates of precancerous skin conditions and skin cancers are soaring in many parts of the world. Actinic keratosis (AK) is the most common form of precancer, with over 40 million Americans a year developing this condition. Treating AKs before the cells become cancerous and spread to other parts of the body is crucial. For those patients with multiple AKs, common treatment options are chemotherapy creams and photodynamic therapy. Although effective, these treatments come with significant side effects, such as redness, blistering, and peeling, with recovery times that can be lengthy and uncomfortable. The global actinic keratosis treatment market size is projected to reach as high as $10 billion USD by 2031, fuelled by increasing cases of AK and rising healthcare spending.

Derm–Biome Pharmaceuticals is a Vancouver–based biopharmaceutical company that has developed a topical anticancer treatment for patients with or at high risk of developing multiple AKs. In a recent UV–induced skin cancer trial, mice were exposed to UVB radiation over a period of 25 weeks. The prolonged exposure mimics chronic sun exposure over time and replicates the gradual progression from precancerous skin conditions to cutaneous squamous cell carcinoma (cSCC). Topical application of Derm–Biome’s compound prior to UVB exposure significantly reduced the number and size of precancer lesions, while treatment blocked the progression of squamous cell carcinoma tumors.

Frédéric Couture, Researcher and Head of Pharmaceutical Sciences at TransBIOtech: “My research group conducted this study using Derm–Biome’s compound. The compound exhibited a significant protective effect without toxicity or side effects. Moreover, existing tumor progression was blocked with drug treatment. We actually noticed an improvement to the look of skin treated with the compound.”

Dr. Poul Sorensen, University of British Columbia Professor and Distinguished Scientist at BC Cancer Research Centre, and Derm–Biome CSO: “The results of these studies are very promising. We tested our compound using a very aggressive UV–induced skin cancer model. We observed highly significant decreases in the number of tumors in treated mice and strong preventative effects when mice were pretreated with the compound. These findings suggest that our compound has great potential to be a highly effective and well–tolerated agent for both the treatment and prevention of squamous cell carcinoma.”

Derm–Biome CEO Gordon Eberwein: “Currently available topical treatments cause debilitating side effects that make them unattractive to patients. There is a real need for safer and more targeted topical therapies.”

Derm–Biome expects to start topical formulation development this summer, with IND–enabling studies slated to begin in Q4.

About Derm–Biome Pharmaceuticals, Inc.
Derm–Biome Pharmaceuticals, Inc. is a preclinical biopharmaceutical company dedicated to improving skin health. We are developing novel topical therapies for inflammatory skin diseases and precancer/non–melanoma skin cancers that are both highly effective and well tolerated by skin.

Derm–Biome is about to kick off a $3M USD seed funding round. For investor inquiries please contact:

Gordon Eberwein
geberwein@derm–biome.com
https://derm–biomepharmaceuticals.com

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/54b222f0–2c93–417d–8bba–33853a2dd94a

 


GLOBENEWSWIRE (Distribution ID 9091271)