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Curia Revela Marca Atualizada na CPHI WW em Milão

ALBANY, N.Y., Oct. 08, 2024 (GLOBE NEWSWIRE) — A Curia, uma organização líder em contratos de pesquisa, desenvolvimento e fabricação, divulgou sua marca atualizada. A atualização introduz mensagens corporativas refinadas e uma nova hierarquia de marca, destacando a amplitude dos recursos de CDMO da Curia em pequenas moléculas, APIs genéricas e produtos biológicos. A marca atualizada ressalta o papel da Curia de aliada dedicada aos seus clientes que utiliza os mais de 30 anos de experiência no setor e uma presença global robusta para acelerar os prazos para o lançamento dos produtos, abordando desafios simples e complexos na descoberta, desenvolvimento e fabricação de medicamentos.

A marca atualizada inclui:

  • Três logotipos de serviços comerciais distintos – A Curia estabeleceu logotipos de marca para cada uma das suas três principais ofertas de serviços de pequenas moléculas, APIs genéricas e produtos biológicos. Essa nova hierarquia de logotipos de serviços comunica claramente o portfólio robusto de serviços e soluções da Curia.
  • Site renovado – A Curia tem o prazer de lançar simultaneamente seu site atualizado. O novo design aprimora a experiência do usuário para clientes e clientes em potencial que buscam os melhores serviços de desenvolvimento e fabricação de contratos em pequenas moléculas, APIs genéricos, produtos biológicos, serviços analíticos e acabamento de enchimento estéril.

“Essa atualização é um exemplo do nosso compromisso inabalável de ser um aliado confiável dos nossos clientes”, disse Philip Macnabb, CEO da Curia. “A Curia tem décadas de experiência neste setor e ampliamos continuamente nossas capacidades para atender às necessidades dos nossos clientes. A nova identidade da nossa marca comunica claramente não apenas as nossas ofertas, mas o nível único de experiência e colaboração que oferecemos com um propósito nobre de aprimorar a vida dos pacientes.”

A Curia começou como AMRI há mais de 30 anos com foco em pequenas moléculas e, com o tempo, expandiu–se para oferecer uma mistura de recursos e experiência científica globais. Em 2021, a AMRI mudou de nome para Curia e ampliou suas capacidades para incluir produtos biológicos com a aquisição da LakePharma e Integrity Bio. A próxima evolução da sua marca destaca estrategicamente os pontos fortes da Curia como CDMO de serviço completo em todas as modalidades, utilizando os mais de 30 anos de experiência no setor, uma rede global de instalações avançadas e um compromisso inabalável com a excelência e a colaboração no núcleo.

Sobre a Curia
A Curia é uma Organização de Desenvolvimento e Fabricação por Contratos (CDMO) com mais de 30 anos de experiência, uma rede integrada de mais de 20 locais em todo o mundo e aproximadamente 3.500 funcionários em parcerias com clientes biofarmacêuticos para lançamento no mercado terapias que mudam a vida. Nossas ofertas de pequenas moléculas, APIs genéricos e produtos biológicos resultam em descobertas através da comercialização, com integridade regulatória, de capacidade analítica e acabamento de enchimento estéril. Nossos especialistas científicos e de processos, juntamente com nossas instalações em conformidade regulatórias oferecem a melhor experiência em fabricação de medicamentos e produtos farmacêuticos. Da curiosidade à cura, proporcionamos todas as etapas necessárias para acelerar sua pesquisa e melhorar a vida dos pacientes. Visite–nos em curiaglobal.com.

Contato Corporativo:
Viana Bhagan
Curia
+1 (518) 512 2111
[email protected]


GLOBENEWSWIRE (Distribution ID 9252992)

Curia dévoile une marque plus moderne à l'occasion du salon de la CPHI Worldwide qui se tient à Milan

ALBANY, New York, 08 oct. 2024 (GLOBE NEWSWIRE) — Curia, l’un des principaux organismes de recherche, de développement et de fabrication sous contrat, a dévoilé aujourd’hui une identité de marque actualisée. Ce rafraîchissement instille un message d’entreprise sophistiqué et une nouvelle hiérarchie de marque, mettant en évidence toute l’étendue des capacités CDMO de Curia en matière de petites molécules, d’IPA génériques et de produits biologiques. Il souligne le rôle de Curia en tant que partenaire dévoué à ses clients, qui s’appuie sur plus de 30 ans d’expérience dans l’industrie et une solide présence mondiale pour accélérer les délais de production en relevant des défis simples et complexes en matière de découverte, de développement et de fabrication de médicaments.

Ce rafraîchissement de marque inclut :

  • Trois logos de services commerciaux différents : Curia a créé des logos pour chacune de ses trois offres de services clés concernant les petites molécules, les IPA génériques et les produits biologiques. Cette nouvelle hiérarchie de logos présente clairement le solide portefeuille de services et de solutions proposés par Curia.
  • Site Internet modernisé : Curia est heureuse de lancer simultanément son site Internet remanié. Sa conception évoluée améliore l’expérience utilisateur des clients et prospects à la recherche des meilleurs services de développement et de fabrication sous contrat dans le domaine des petites molécules, des IPA génériques, des produits biologiques, des services analytiques et de remplissage et finition aseptiques.

« Ce rafraîchissement témoigne de notre volonté sans faille d’être un partenaire de confiance pour nos clients », a déclaré Philip Macnabb, PDG de Curia. « Forte de plusieurs décennies d’expérience dans ce secteur, Curia élargit constamment ses capacités pour répondre aux besoins de ses clients. Cette nouvelle identité de marque ne se limite pas à nos offres. Elle souligne également le niveau d'expertise et de collaboration unique que nous apportons dans le cadre de notre noble mission qui consiste à améliorer la vie des patients. »

Curia a vu le jour sous le nom d’AMRI il y a plus de 30 ans. Elle s’est d’abord concentrée sur les petites molécules et s’est développée, au fil du temps, pour offrir un mélange de ressources mondiales et d’expertise scientifique. Rebaptisée Curia en 2021, elle a élargi son offre pour intégrer les produits biologiques avec l’acquisition de LakePharma et Integrity Bio. Cette nouvelle évolution de la marque met stratégiquement en valeur les atouts de Curia en tant que CDMO proposant des services complets et s’appuyant sur plus de 30 ans d’expérience dans l’industrie, un réseau mondial d’installations de pointe et une volonté d’excellence et de collaboration inébranlable.

À propos de Curia
Curia est une organisation de recherche, de développement et de fabrication sous contrat (CDMO) avec plus de 30 ans d’expérience. Elle exploite un réseau intégré de plus de 20 sites à travers le monde et emploie environ 3 500 collaborateurs travaillant en partenariat avec des clients biopharmaceutiques pour commercialiser des traitements qui ont un véritable impact sur la vie des gens. Nos offres en matière de petites molécules, d'IPA génériques et de produits biologiques couvrent le cycle complet, de la découverte à la commercialisation, avec des capacités réglementaires, analytiques et de remplissage et finition stérile. Nos scientifiques, nos experts en processus ainsi que nos installations respectueuses des réglementations fournissent une expérience de premier ordre dans la fabrication de substances et de produits pharmaceutiques. De la curiosité au traitement, nous exécutons toutes les étapes pour accélérer vos recherches et améliorer la vie des patients. Consultez notre site à l’adresse curiaglobal.com.

Contact de l’entreprise :
Viana Bhagan
Curia
+1 518 512 2111
[email protected] 


GLOBENEWSWIRE (Distribution ID 9252992)

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
[email protected]


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 
[email protected] 

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
[email protected]

Investor Contact
[email protected]

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: [email protected]


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 [email protected]; 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 [email protected].

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
[email protected]

Media Contact:
Argot Partners
[email protected]


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 [email protected]; 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 [email protected].

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
[email protected]

Media Contact:
Argot Partners
[email protected]


GLOBENEWSWIRE (Distribution ID 9230259)