News & Updates

Frontier Medicines Advances First Development Candidate, FMC-376, a Uniquely Differentiated Inhibitor of Both Active and Inactive KRASG12C, into IND-Enabling Studies

01/17/2023

FMC-376 directly, rapidly, and completely blocks both active and inactive forms of KRASG12C to overcome non-response and resistance seen with prior generation KRASG12C inhibitors The company has also advanced two additional precision oncology programs against historically undruggable disease-causing targets into lead optimization Pamela Klein, M.D., seasoned oncology drug developer, elected to board of directors Excerpt…

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Carmot Therapeutics Launches Spin-Off, Kimia Therapeutics, to Focus on Metabolic Disease

01/16/2023

– Spin-off of technology platform to newly-formed Kimia Therapeutics intended to maximize the full potential of Carmot’s metabolic portfolio while enabling Kimia to pursue a broad range of opportunities across oncology, immunology and inflammation – – Encouraging clinical data from CT-388 and CT-868, Carmot’s dual GLP-1/GIP receptor modulators, represent significant opportunity for Carmot to advance…

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ArsenalBio Announces First Patient Dosed in Phase 1 Clinical Trial of AB-1015 in Development as a Treatment for Ovarian Cancer

01/16/2023

Company will provide a business overview including product pipeline during an upcoming presentation on January 10th at the J.P. Morgan 41st Annual Healthcare Conference Excerpt from the Press Release: SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Arsenal Biosciences, Inc. (ArsenalBio), a privately held, clinical stage, programmable cell therapy company engineering advanced CAR T cell therapies for solid tumors,…

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Aligos Therapeutics on Track to Complete Phase 2-Enabling Activities in 2023 for its Clinically Validated THR-ß Drug Candidate for NASH, ALG-055009

01/16/2023

– Final cohort of Phase 1 study projected to be complete in H1 2023 – – Phase 2-enabling GLP toxicology studies projected to be complete in H2 2023 – – Clinical update on all pipeline programs to be presented at the 2023 J.P. Morgan Healthcare Conference on January 12 at 10:30 a.m. PT – Excerpt…

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FDA Approves IND Submission Allowing ABVC BioPharma to Proceed With Clinical Study of ABV-1519 for Treatment of Non-Small Cell Lung Cancer

01/13/2023

Excerpt from the Press Release: FREMONT, CA, Jan. 05, 2023 (GLOBE NEWSWIRE) — via NewMediaWire – ABVC BioPharma, Inc. (NASDAQ: ABVC), a clinical stage biopharmaceutical company developing therapeutic solutions in oncology/hematology, CNS, and ophthalmology today announced that the US Food & Drug Administration notified the company that the IND application for the proposed clinical investigation…

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Madrigal Announces Additional Positive Results from the Pivotal Phase 3 MAESTRO-NASH Clinical Trial of Resmetirom for the Treatment of NASH with Liver Fibrosis

01/13/2023

As previously reported, resmetirom demonstrated improvements in NASH and liver fibrosis on liver biopsies, the primary endpoints of the MAESTRO-NASH trialA supportive analysis using consensus reads of digitized biopsy images by the central pathologists replicated the positive primary endpoint resultsThese data will be presented at the NASH-TAG Conference on Friday January 6th, 2023 Excerpt from…

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Integral Molecular Reveals Mechanism Underlying Exquisite Specificity of Claudin 6 Therapeutic Antibody Being Developed for Solid Tumors

01/13/2023

Excerpt from the Press Release: PHILADELPHIA–Integral Molecular, the industry leader in antibody discovery for membrane proteins, has published the targeting mechanism enabling best-in-class specificity of its Claudin 6 (CLDN6) antibody CTIM-76 being developed for cancer therapy with Context Therapeutics. CLDN6 is a tumor-specific protein found in multiple solid tumors—including ovarian, endometrial, lung, gastric, and testicular—but…

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Helius Extends its Patient Therapy Access Program (PTAP), Bringing the Benefits of its PoNS® Device to More People with Multiple Sclerosis

01/12/2023

Excerpt from the Press Release: PTAP Lowers the Cost of PoNS Therapy™ for Qualified Americans NEWTOWN, Pa., Jan. 05, 2023 (GLOBE NEWSWIRE) — Helius Medical Technologies (NASDAQ: HSDT) today announced the extension of a program that puts the company’s Portable Neuromodulation Stimulator (PoNS®) into the hands of qualified Americans with multiple sclerosis (MS) at a…

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Sionna Therapeutics Announces Advancement of Cystic Fibrosis Pipeline Programs and Presentation at J.P. Morgan 41st Annual Healthcare Conference

01/12/2023

– Enrolling Phase 1 study of lead NBD1 modulator, SION-638, following IND clearance from the FDA; data expected in the second half of 2023 – – SION-109, targeting complementary mechanism ICL4, on-track for IND submission in the first half of 2023 – – Three additional development candidates nominated for progression including two Series 2 NBD1…

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Orchard Therapeutics Announces U.S. FDA Clearance of IND Application for OTL-203 in MPS-IH

01/12/2023

Global registrational trial expected to commence in the second half of 2023 Excerpt from the Press Release: BOSTON and LONDON, Jan. 05, 2023 (GLOBE NEWSWIRE) — Orchard Therapeutics (Nasdaq: ORTX), a global gene therapy leader, today announced the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for OTL-203, a…

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