BHI News Section

FDA Clears Rise Therapeutics’ IND Application to Initiate a Phase 1 Clinical Study of Its Novel Oral Immunotherapy for the Treatment of Rheumatoid Arthritis

ROCKVILLE, Md., Oct. 19, 2023 /PRNewswire/ — Rise Therapeutics a biotechnology company engaged in developing novel oral immunotherapeutics, today announced that the U.S. Food and Drug Administration (FDA) has accepted its investigational new drug (IND) application to proceed with a rheumatoid arthritis Phase 1 clinical trial for its program candidate, R-2487. This is Rise Therapeutics’ second clinical program developed using synthetic biology and its proprietary oral biologics delivery platform.

Immunomic Therapeutics Reports Positive Results from Its Phase 1 Clinical Trial of ITI-3000 in Patients Diagnosed with Merkel Cell Carcinoma

ROCKVILLE, Md.–(BUSINESS WIRE)–Immunomic Therapeutics, Inc. (ITI), a privately-held clinical-stage biotechnology company pioneering the development of LAMP-mediated nucleic acid-based immunotherapy, today announced safety and tolerability results from its phase 1 clinical trial evaluating ITI-3000, a plasmid DNA (pDNA) vaccine, targeting patients with Merkel cell carcinoma (MCC), a rare but aggressive form of skin cancer that is typically caused by the Merkel cell polyomavirus (MCPyV). ITI-3000 was granted Fast Track Designation (FTD) by the U.S. Food and Drug Administration (FDA) in November 2022.

The Maryland Industrial Partnerships (MIPS) program announced that it is providing matching grants for 17 technology product development projects in Maryland.

Each project pairs University System of Maryland faculty members with Maryland-based companies to develop new technology products or processes. Projects are jointly funded by both MIPS and participating companies. All funding goes to the university research.

Ascentage Pharma and AstraZeneca Enter into Clinical Collaboration on the Registrational Phase III Study of Bcl-2 Inhibitor Lisaftoclax in Combination with BTK Inhibitor Acalabrutinib in Treatment-Naïve Patients with First-Line CLL/SLL

SUZHOU, China, and ROCKVILLE, Md., Oct. 15, 2023 /PRNewswire/ — Ascentage Pharma (6855.HK), a global biopharmaceutical company engaged in developing novel therapies for cancer, chronic hepatitis B (CHB), and age-related diseases, announced today that it has entered into a clinical collaboration with AstraZeneca Investment (China) Co., Ltd. (or “AstraZeneca”). The two companies will jointly conduct a registrational Phase III study of the Bcl-2 inhibitor, APG-2575 (lisaftoclax), in combination with AstraZeneca’s Bruton’s tyrosine kinase (BTK) inhibitor, CALQUENCE® (acalabrutinib), in treatment-naive patients with first-line chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL).

Are you interested in exploring cutting-edge autoimmune medicines? In this episode of BioTalk with Rich Bendis, we’re delving deep into the world of transformative therapies with two remarkable guests, Dr. Chris Chapman and Dr. Adam Kaplin, from MyMD Pharmaceuticals. MyMD Pharmaceuticals is on a mission to make that a reality. Their lead clinical candidate, MYMD-1®, has the potential to reshape the entire field. But how does MYMD-1 work, and what sets it apart from current treatments? Join us as we unravel the science behind this revolutionary therapy and explore the potential indications and patient populations it could benefit. And that’s not all. We also spotlight Supera-CBD, a novel synthetic cannabidiol with incredible potency and anti-inflammatory effects. How could this innovation change the landscape of chronic pain and anxiety management? Don’t miss this episode of BioTalk with Rich Bendis as we embark on a journey into the future of autoimmune medicine with MyMD Pharmaceuticals. Tune in now and be part of the conversation.

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Published: 10/10/2023

With an increasing number of U.S. biopharmaceutical firms feeling the financial constraints imposed by the Inflation Reduction Act (IRA) and subsequently shutting down or suspending their research programs in the rare disease domain, hundreds of millions of patients in both the U.S. and India face the grim prospect of not receiving a breakthrough treatment for their condition within their lifetimes. IndoUSrare, a US-based nonprofit committed to stanching rare diseases, launches the inaugural Bridging RARE conference to forge a path for affordable clinical innovation via strengthened Indo-US collaborations and more inclusive clinical trials for minimizing the devastating health consequences arising from this policy shift.

(HERNDON, Va.) October 10, 2023: Rare diseases, as defined by the World Health Organization (WHO), refer to some 10,867 medically significant conditions, each with a prevalence of one or less per 1,000 individuals. With only about 8% of them being treatable,¹ rare diseases include congenital malformations, autoimmune disorders, lysosomal storage disorders, thalassemia, muscular dystrophies, and infrequent forms of cancer and infections. Despite substantial progress during the 40 years since the enactment of the Orphan Drug Act of 1983, which incentivized the U.S. private sector to develop 1,100 FDA-approved orphan treatments,² the global thrust against rare diseases is on the verge of losing steam.