You are here: Home ยป Archives for Biotech

Curia Unveils Brand Refresh at CPHI WW in Milan

ALBANY, N.Y., Oct. 07, 2024 (GLOBE NEWSWIRE) — Curia, a leading contract research, development and manufacturing organization, today unveiled its refreshed brand. The update introduces refined corporate messaging and a new brand hierarchy, highlighting the breadth of Curia’s CDMO capabilities across small molecules, generic APIs and biologics. This brand update underscores Curia’s role as a dedicated ally to its clients, leveraging 30+ years of industry experience and a robust global presence to accelerate product timelines by addressing both simple and complex challenges across drug discovery, development and manufacturing.

The brand refresh includes:

  • Three distinct commercial service logos – Curia has established brand logos for each of its three key service offerings across small molecules, generic APIs and biologics. This new hierarchy of service logos clearly communicates Curia’s robust portfolio of services and solutions.
  • Revamped website – Curia is pleased to simultaneously launch its updated website. The evolved design improves the user experience for clients and prospects seeking best–in–class contract development and manufacturing services in small molecules, generic APIs, biologics, analytical services and sterile fill–finish.

“This refresh reflects our unwavering commitment to being a trusted ally to our customers,” said Philip Macnabb, CEO of Curia. “Curia has decades of experience in this industry, and we have continually broadened our capabilities to meet the needs of our customers. Our new brand identity clearly communicates not just our offerings, but the unique level of expertise and collaboration we bring as we work to noble purpose to improve patients’ lives.”    

Curia began as AMRI more than 30 years ago with a focus on small molecules, and over time, expanded to offer a blend of global resources and scientific expertise. In 2021, AMRI rebranded as Curia and broadened its capabilities to include biologics with the acquisition of LakePharma and Integrity Bio. This next evolution of its brand strategically highlights Curia’s strengths as a full–service CDMO across modalities, leveraging 30+ years of industry experience, a global network of advanced facilities and an unwavering commitment to excellence and collaboration at the core.

About Curia
Curia is a contract research, development and manufacturing organization (CDMO) with over 30 years of experience, an integrated network of 20+ global sites and approximately 3,500 employees partnering with biopharmaceutical customers to bring life–changing therapies to market. Our offerings in small molecules, generic APIs and biologics span discovery through commercialization, with integrated regulatory, analytical and sterile fill–finish capabilities. Our scientific and process experts along with our regulatory compliant facilities provide a best–in–class experience across drug substance and drug product manufacturing. From curiosity to cure, we deliver every step to accelerate your research and improve patients’ lives. Visit us at curiaglobal.com.

Corporate Contact:
Viana Bhagan
Curia
+1 518 512 2111
corporatecommunications@CuriaGlobal.com


GLOBENEWSWIRE (Distribution ID 9252130)

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)

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 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)

Zenas BioPharma Announces Closing of Full Exercise of Underwriters’ Option to Purchase Additional Shares in Initial Public Offering

WALTHAM, Mass., Sept. 19, 2024 (GLOBE NEWSWIRE) — Zenas BioPharma, Inc. (“Zenas”), (Nasdaq: ZBIO) a clinical–stage global biopharmaceutical company committed to being a leader in the development and commercialization of transformative immunology–based therapies, today announced that the underwriters of its previously announced upsized initial public offering of 13,235,294 shares of its common stock, which closed on September 16, 2024, exercised in full their option to purchase an additional 1,985,294 shares at the initial public offering price of $17.00 per share. After giving effect to the full exercise of the underwriters’ option to purchase additional shares, which closed on September 19, 2024, Zenas sold 15,220,588 shares in its initial public offering, resulting in gross proceeds of approximately $258.7 million. All of the shares were sold by Zenas. Zenas’ shares began trading on the Nasdaq Global Select Market on September 13, 2024 under the ticker symbol “ZBIO”.

Morgan Stanley, Jefferies, Citigroup, and Guggenheim Securities acted as joint book–running managers for the offering.

Registration statements relating to the shares sold in the offering have been filed with the U.S. Securities and Exchange Commission (“SEC”) and became effective on September 12, 2024. The offering was made only by means of a prospectus. Copies of the final prospectus may be obtained from: Morgan Stanley & Co. LLC, Attention: Prospectus Department, 180 Varick Street, 2nd Floor, New York, NY 10014, or by email at prospectus@morganstanley.com; and from Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, New York, NY 10022, by telephone at (877) 821–7388, or by email at Prospectus_Department@Jefferies.com.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any offer or sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or jurisdiction.

About Zenas BioPharma, Inc.

Zenas is a clinical–stage global biopharmaceutical company committed to becoming a leader in the development and commercialization of transformative immunology–based therapies for patients in need. Our core business strategy combines our experienced leadership team with a disciplined product candidate acquisition approach to identify, acquire and develop product candidates globally that we believe can provide superior clinical benefits to patients living with autoimmune diseases. Zenas’ lead product candidate, obexelimab, is a bifunctional monoclonal antibody designed to bind both CD19 and FcγRIIb, which are broadly present across B cell lineage, to inhibit the activity of cells that are implicated in many autoimmune diseases without depleting them.

Investor Contact:
Matthew Osborne
Investor Relations and Corporate Communications
Matt.osborne@zenasbio.com

Media Contact:
Argot Partners
Zenas@argotpartners.com


GLOBENEWSWIRE (Distribution ID 9233662)

Zenas BioPharma Announces Pricing of Upsized Initial Public Offering

WALTHAM, Mass., Sept. 12, 2024 (GLOBE NEWSWIRE) — Zenas BioPharma, Inc. (“Zenas”), (Nasdaq: ZBIO) a clinical–stage global biopharmaceutical company committed to being a leader in the development and commercialization of transformative immunology–based therapies, today announced the pricing of its upsized initial public offering of 13,235,294 shares of its common stock at an initial public offering price of $17.00 per share. All of the shares are being offered by Zenas. The gross proceeds from the offering, before deducting underwriting discounts and commissions and other offering expenses, are expected to be approximately $225.0 million. Zenas’ common stock is expected to begin trading on the Nasdaq Global Select Market on September 13, 2024 under the ticker symbol “ZBIO”. The offering is expected to close on September 16, 2024, subject to the satisfaction of customary closing conditions. In addition, Zenas has granted the underwriters a 30–day option to purchase up to an additional 1,985,294 shares of common stock at the initial public offering price, less underwriting discounts and commissions.

Morgan Stanley, Jefferies, Citigroup, and Guggenheim Securities are acting as joint book–running managers for the offering.

Registration statements relating to the shares being sold in the offering have been filed with the U.S. Securities and Exchange Commission (“SEC”) and became effective on September 12, 2024. The offering is being made only by means of a prospectus. Copies of the final prospectus, when available, may be obtained from: Morgan Stanley & Co. LLC, Attention: Prospectus Department, 180 Varick Street, 2nd Floor, New York, NY 10014, or by email at prospectus@morganstanley.com; and from Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, New York, NY 10022, by telephone at (877) 821–7388, or by email at Prospectus_Department@Jefferies.com.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any offer or sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or jurisdiction.

About Zenas BioPharma, Inc.

Zenas is a clinical–stage global biopharmaceutical company committed to becoming a leader in the development and commercialization of transformative immunology–based therapies for patients in need. Our core business strategy combines our experienced leadership team with a disciplined product candidate acquisition approach to identify, acquire and develop product candidates globally that we believe can provide superior clinical benefits to patients living with autoimmune diseases. Zenas’ lead product candidate, obexelimab, is a bifunctional monoclonal antibody designed to bind both CD19 and FcγRIIb, which are broadly present across B cell lineage, to inhibit the activity of cells that are implicated in many autoimmune diseases without depleting them.

Forward–Looking Statements

This press release contains forward–looking statements. Investors are cautioned not to place undue reliance on these forward–looking statements, including statements about the completion, timing and size of the initial public offering and the commencement of trading on the Nasdaq Global Select Market. Each forward–looking statement is subject to the inherent uncertainties in predicting future results and conditions and no assurance can be given that the initial public offering discussed above will be completed on the terms described or at all. Completion of the proposed initial public offering and the terms thereof are subject to numerous factors, many of which are beyond the control of Zenas, including, without limitation, market conditions, failure of customary closing conditions and the factors discussed in the “Risk Factors” section of the prospectus that forms a part of the registration statement, in the form last filed with the SEC. These forward–looking statements speak only as of the date of this press release and Zenas undertakes no obligation to publicly update or revise any forward–looking statements, whether as a result of new information, future events or otherwise.

Investor Contact:
Matthew Osborne
Investor Relations and Corporate Communications
Matt.osborne@zenasbio.com

Media Contact:
Argot Partners
Zenas@argotpartners.com


GLOBENEWSWIRE (Distribution ID 9230259)

“لايفيرا أوميكس” تعيّن خبير الجينوم الكريّع رئيساً للقسم الطبي والجينومي

  • لايفيرا أوميكس تستهدف تعزيز مكانة المملكة عالمياً في مجال الجينوم البشري متعدد الجينات.
  • لايفيرا، المملوكة بالكامل لصندوق الاستثمارات العامة، توسع نطاق عملياتها في لايفيرا أوميكس، وتستثمر في بناء فريق عالمي من الخبراء السعوديين والعالميين.

الرياض، المملكة العربية السعودية, Sept. 10, 2024 (GLOBE NEWSWIRE) —  أعلنت شركة لايفيرا أوميكس، المشروع المشترك الذي أُطلق في يناير 2024، تعيين الخبير العالمي والباحث السعودي في مجال علم الوراثة الجزيئي، البروفيسور فوزان سامي الكريّع، رئيساً للقسم الطبي والجينومي و اللذي سينضم لمجلس إدارة لايفيرا أوميكس ، ليساهم بخبرته الممتدة لأكثر من 17 عاماً في تحقيق أهداف الشركة الرامية لتطوير حلول مبتكرة في مجال الطب الجينومي.

برز الكريّع، الرئيس السابق لمركز الجينوميات الانتقالية بمستشفى الملك فيصل التخصصي ومركز الأبحاث في الرياض، والأستاذ الحالي لعلم الوراثة البشرية في جامعة الفيصل، كرائد في مجال الطب الجينومي، حيث ساهم بأكثر من 590 بحثاً علمياً نُشرت في مجلات عالمية مرموقة، وكمُتحدث رئيسي في المؤتمرات العلمية الدولية حول الطب الجيني والرعاية الصحية الدقيقة.

نال الكريّع عدة جوائز مرموقة من بينها جائزة وليام كنج بويز لطب الوراثة من معهد هارفارد للطب الشخصي في بوسطن، وجائزة الملك سلمان لأبحاث الإعاقة (فرع العلوم الصحية والطبية)، وجائزة ”كرت ستيرن” من الجمعية الأمريكية للوراثة البشرية، كأول فائز يحصل عليها من خارج الولايات المتحدة الأمريكية. و كما فاز بجائزة الكويت (فرع العلوم الطبية الأساسية), و جائزة الشيخ حمدان بن راشد آل مكتوم للعلوم الطبية.

حصل البروفيسور الكريّع –على شهادة البورد من جامعة هارفارد بالاضاقة إلى العديد من شهادات البورد المهنية، وحقق إنجازاتٍ بارزةً في مجال الوراثة البشرية، شملت اكتشاف الوظائف الفسيولوجية والتركيبية لمئات الجينات، ما ساعد في تشخيص العديد من الاعتلالات الوراثية، فضلاً عن أهمية اكتشافاته في تكريس مفهوم العلاقة الوثيقة بين الجينات وصحة الإنسان.

وفي هذا الصدد، علّق الدكتور إبراهيم الجفالي، رئيس مجلس إدارة شركة لايفيرا، قائلاً: “نحن سعداء بانضمام البروفيسور الكريّع إلى فريق العمل في لايفيرا أوميكس، وستكون الخبرات العلمية والعملية المتراكمة لديه أداة أساسية لمساعدة الشركة في تحقيق رسالتها الساعية لتعزيز مقدرات المملكة في قطاع الأدوية الحيوية وتمكين الاستراتيجية الوطنية للتقنية الحيوية“.

نبذة عن لايفيرا

لايفيرا، المملوكة بالكامل لصندوق الاستثمارات العامة، هي شركة متخصصة في إجراء التعاقدات المتعلقة بتطوير وتصنيع المنتجات الدوائية الحيوية (CDMO)، تم إطلاقها في عام 2023 ومقرها الرياض. تتمثل رسالة الشركة في تعزيز مقدرات المملكة في قطاع الأدوية الحيوية وتمكين الإستراتيجية الوطنية للتقنية الحيوية، في حين يكمن هدفها في تسويق وتطوير وصناعة العلاجات المتقدمة وغيرها من الأدوية واللقاحات الأساسية. في يناير 2023 أتمت لايفيرا الاستثمار في حصة الأغلبية بمصنع سعودي بيو المتخصص في تصنيع الأدوية البيولوجية في الرياض. وتعمل الشركة حالياً على تطوير هذا المصنع ليكون جاهزاً للتشغيل في عام 2026 وفق المعايير العالمية لتصنيع الأدوية بنظام التعاقد، ومن بينها الإنسولين وغيرها من الأدوية البيولوجية للشركات الدوائية العالمية الرائدة التي تخدم السوق السعودي والإقليمي. وتعمل لايفيرا على تطوير مقدرات تصنيع بيولوجية إضافية، عبر شركتها الفرعية لايفيرا أوميكس، وتمكن عملاءها من تطوير وتسويق العلاجات المتقدمة.

نبذة عن لايفيرا أوميكس

تأسست لايفيرا أوميكس، التابعة لشركة لايفيرا، في يناير 2024 لتطوير السعة المختبرية متعددة الجينوميات –الجافة والرطبة– على نطاق واسع وفق أعلى المعايير العالمية، وللمساعدة في تمكين أهداف الجينوم في الإستراتيجية الوطنية للتقنية الحيوية في المملكة. وتتعاون لايفيرا أوميكس مع العملاء لتلبية احتياجاتهم السريرية وصحة السكان والأبحاث والتطوير، وتهدف إلى تعزيز سرعة ودقة التشخيصات السريرية عبر أنظمة الرعاية الصحية في المملكة، وتمكين الطب الدقيق للأمراض النادرة والمتكررة، من خلال الحلول المبتكرة القائمة على البيانات، والاستفادة من الخبرة الرائدة في مجال التشخيص والشراكات.

contact@liferaomics.com.sa

https://www.globenewswire.com/NewsRoom/AttachmentNg/3b2d5898–1176–4073–a7c7–4e7891ab6d3e/ar الصورة المصاحبة لهذا الإعلان متاحة على


GLOBENEWSWIRE (Distribution ID 9228307)

Lifera Omics Appoints Prof. Fowzan Alkuraya, a Renowned Genomics Expert as Chief Medical and Genomic Officer

  • Lifera, a biopharma company wholly owned by the Public Investment Fund (PIF), launched in 2023, is scaling up its subsidiary Lifera Omics and developing a team of leading Saudi and global talent to fulfil its mission
     
  • Lifera Omics aims to elevate Saudi Arabia’s role in multiomics globally

RIYADH, Saudi Arabia, Sept. 10, 2024 (GLOBE NEWSWIRE) — Lifera Omics, a subsidiary of Lifera that was launched in January 2024, announced the appointment of renowned Saudi human geneticist, Prof. Fowzan Sami Alkuraya, as its Chief Medical and Genomics Officer, who will be also added to the Board of Lifera Omics. Prof. Alkuraya’s deep experience in human genomics built over 17 years will contribute significantly in enabling Lifera Omics’ objectives.

Prof. Alkuraya, a former Chairman of Translational Genomics at King Faisal Specialist Hospital and Research Centre in Riyadh and current Professor of Human Genetics at Alfaisal University, has significantly contributed to the field of genomics, through over 590 scientific publications in prestigious international journals and as a frequent speaker at international scientific conferences on genomic medicine and precision health.

Prof. Alkuraya garnered numerous prestigious awards, including the William King Wilson Prize in Genetics from Harvard Medical School, the King Salman Award for Disability Research, and the Curt Stern Award from the American Society of Human Genetics – the first non–US based recipient of this honor. He also won Kwiat Prize for Basic Medical Science Subject Area and Sheikh Hamdan Bin Rashid Al Maktoum Award for Medical Sciences.

Prof. Alkuraya was granted his post graduate board certification from Harvard University, in addition to several other board certifications. His contributions to human genetics have been instrumental in elucidating the physiological and structural roles of hundreds of genes, resulting in the diagnosis of many genetic disorders. His discoveries have significantly advanced the understanding of the intricate relationship between human genes and health.

“We are delighted to welcome such a trusted and respected leader to the Lifera Omics Executive Leadership team,” said Dr. Ibrahim Juffali, Chairman of Lifera. “Dr. Fowzan’s deep clinical and scientific expertise will be instrumental in helping Lifera achieve its mission to improve Saudi Arabia’s biopharma resilience and to enable the National Biotech Strategy.”

About Lifera

Lifera is a biopharma contract and development manufacturing organization (CDMO) wholly owned by the Public Investment Fund (PIF), launched in 2023 based in Riyadh, Saudi Arabia. Lifera’s mission is to improve Saudi Arabia’s biopharma resilience and enable the National Biotech Strategy. Lifera’s goal is to commercialize, develop and manufacture advanced therapeutics and other life–saving and essential medicines and vaccines. In January 2023, Lifera completed a majority stake investment in SaudiBio, a brownfield biologics drug product manufacturing plant in Riyadh. Lifera is currently upgrading this plant to be commissioned in 2026 to global standards to contract manufacture insulins, biosimilars and other biologics for leading global pharmaceutical companies serving the KSA and regional markets. Lifera is in the process of developing additional biomanufacturing capacity and through its subsidiary Lifera Omics, further enables Lifera’s customers to develop and commercialize advanced therapeutics.

About Lifera Omics

Lifera Omics, a subsidiary of Lifera, was established in January 2024 to develop at–scale multiomic dry and wet lab capacity to the highest global standards and to help enable the genomics goals of Saudi Arabia’s National Biotech Strategy. Lifera Omics partners with customers to serve their clinical, population health and R&D needs. Lifera Omics aims to enhance the speed and accuracy of clinical diagnoses across health systems in Saudi Arabia, and to enable precision medicine for rare and common diseases through innovative, data–driven solutions, leveraging industry–leading diagnostic expertise and partnerships.

contact@liferaomics.com.sa

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/3b2d5898–1176–4073–a7c7–4e7891ab6d3e


GLOBENEWSWIRE (Distribution ID 9228307)