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Mersana Therapeutics Announces Initiation of Phase 1 Trial of XMT-2056 in HER2-Expressing Tumors

02/06/2023

First Immunosynthen ADC product candidate enters the clinic Excerpt from the Press Release: CAMBRIDGE, Mass., Jan. 25, 2023 (GLOBE NEWSWIRE) — Mersana Therapeutics, Inc. (NASDAQ: MRSN), a clinical-stage biopharmaceutical company focused on discovering and developing a pipeline of antibody-drug conjugates (ADCs) targeting cancers in areas of high unmet medical need, today announced the initiation of…

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Applied Molecular Transport Announces Positive Top-line Phase 2 Results from FILLMORE Trial of Oral AMT-101 in Patients with Chronic Pouchitis

05/04/2022

–  Met pre-specified efficacy endpoints in chronic pouchitis, a difficult-to-treat inflammatory bowel disease (IBD)–  AMT-101 demonstrated favorable clinical activity and appeared safe and well-tolerated, supporting potentially best-in-class profile–  Achieved clinically meaningful responses in stool frequency and histologic healing in both 3mg and 10mg dosage groups–  Independent Data Monitoring Committee (DMC) recommends advancing to Phase 3 in chronic…

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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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Moderna and Merck Announce mRNA-4157/V940, an Investigational Personalized mRNA Cancer Vaccine, in Combination with KEYTRUDA(R) (pembrolizumab), Met Primary Efficacy Endpoint in Phase 2b KEYNOTE-942 Trial

12/16/2022

mRNA-4157/V940, in combination with KEYTRUDA, demonstrated a statistically significant and clinically meaningful reduction in the risk of disease recurrence or death compared to KEYTRUDA monotherapy in stage III/IV melanoma patients with high risk of recurrence following complete resection Results are the first demonstration of efficacy for an investigational mRNA cancer treatment in a randomized clinical…

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Roche and Alnylam Report Positive Topline Results from Phase II KARDIA-2 Study

03/29/2024

Excerpt from the Press Release: Roche and Alnylam recently announced that the Phase II KARDIA-2 study of zilebesiran, an investigational RNAi therapeutic in development for the treatment of hypertension (high blood pressure) – the leading cause of cardiovascular disease worldwide – met its primary endpoint. People with mild to moderate hypertension treated with zilebesiran added to a…

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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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Terns Pharmaceuticals Announces First Participant Dosed in Phase 1 Clinical Trial of TERN-601 Oral GLP-1 Receptor Agonist for Treatment of Obesity

11/13/2023

Phase 1 trial underway for Terns’ first oral GLP-1R agonist candidate for obesity, with 28-day proof of concept data anticipated in 2H24 Oral GLP-1R agonist offers potential for weight loss and improved convenience compared to currently marketed injectables Excerpt from the Press Release: FOSTER CITY, Calif., Nov. 02, 2023 (GLOBE NEWSWIRE) — Terns Pharmaceuticals, Inc.…

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FDA authorizes Bodysphere 2-minute COVID-19 test

04/03/2020

Excerpt from the article: “Bodysphere announced today that it has begun distributing its 2-minute testing kit for diagnosing COVID-19 after receiving FDA emergency use authorization (EUA). The Los Angeles-based company’s two-minute testing kit uses antibodies in blood to test for current or past infection with a 91% clinical specificity rate and a 99% clinical sensitivity…

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Lyell Immunopharma Announces FDA Clearance of its IND for LYL845, a TIL Product Candidate Enhanced with its Novel Epigenetic Reprogramming Technology for Solid Tumors

10/19/2022

Autologous TIL therapy enhanced with Lyell’s Epi-R™ reprogramming technology designed to create polyclonal T cell populations with properties of durable stemness and improved function Phase 1 trial to initially enroll patients with relapsed and/or refractory metastatic or locally advanced melanoma and subsequently expand into non-small cell lung cancer and colorectal cancer Initial data presentation expected…

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Vedanta Biosciences Publishes Phase 1a/1b Results for Lead Program VE303 in Cell Host & Microbe and Highlights Planned Presentations of Phase 2 VE303 Results

04/22/2022

Full Phase 1 data analysis of VE303, a defined bacterial consortium candidate for C. difficile infection, published in Cell Host & Microbe Positive topline Phase 2 results for VE303 announced in 2021; Phase 3 preparations underway Acceptance of three abstracts for podium presentations at Digestive Disease Week 2022 Excerpt from the Press Release: CAMBRIDGE, Mass.–(BUSINESS WIRE)–Vedanta Biosciences, a…

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