Industry News

BridgeBio Announces Clinical Collaboration with Amgen to Study BBP-398, a Potentially Best-in-class SHP2 Inhibitor, in Combination with LUMAKRAS® (sotorasib) in Advanced Solid Tumors with the KRAS G12C Mutation

01/18/2022

Excerpt from the Press Release: – First clinical combination study of BBP-398 and LUMAKRAS set to evaluate safety and preliminary efficacy in solid tumors with the KRAS G12C mutation PALO ALTO, Calif., Jan. 13, 2022 (GLOBE NEWSWIRE) — BridgeBio Pharma, Inc. (Nasdaq: BBIO) (BridgeBio), a commercial-stage biopharmaceutical company focused on genetic diseases and cancers, today…

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NIH Study Shows Using CareDx’s AlloSure Lung for Transplant Surveillance is More Effective than Diagnostic Bronchoscopy at Identifying Rejection

01/17/2022

ALARM Study Publication Shows Use of AlloSure for Home-Based, Non-invasive Surveillance Monitoring Can Provide a Safer Option for Lung Transplant Recipients Navigating the COVID-19 Pandemic Excerpt from the Press Release: SOUTH SAN FRANCISCO, Calif., Jan. 07, 2022 (GLOBE NEWSWIRE) — CareDx, Inc. (Nasdaq: CDNA) – The Transplant Company™ focused on the discovery, development, and commercialization…

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4D Molecular Therapeutics Announces First Patient Dosed in Phase 1/2 Clinical Trial of 4D-150, a Dual-Transgene Intravitreal Gene Therapy for Patients with wet AMD

01/17/2022

Excerpt from the Press Release: EMERYVILLE, Calif., Jan. 06, 2022 (GLOBE NEWSWIRE) — 4D Molecular Therapeutics, Inc. (4DMT) (Nasdaq: FDMT), a clinical-stage gene therapy company harnessing the power of directed evolution for targeted gene therapies, announced that the first patient has been dosed in the Phase 1/2 clinical trial of 4D-150 for neovascular age-related macular…

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Kriya Expands Gene Therapy Pipeline and Establishes Its Rare Disease Therapeutic Area Division With the Acquisition of Warden Bio

01/17/2022

Portfolio includes five investigational gene therapy programs for glycogen storage disorders that have no existing FDA-approved treatments available Warden Bio Co-Founder Kunal Kishnani joins as President of Kriya’s Rare Disease Division and will lead its overall strategic, development, and partnership activities Excerpt from the Press Release: REDWOOD CITY, Calif. & RESEARCH TRIANGLE PARK, N.C.–(BUSINESS WIRE)–Kriya…

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BlueRock Therapeutics Announces Closeout of First Cohort in Phase 1 Trial in Patients with Advanced Parkinson’s Disease

01/14/2022

Excerpt from the Press Release: CAMBRIDGE, Mass., Jan. 6, 2022 /PRNewswire/ — BlueRock Therapeutics, a clinical stage biopharmaceutical company and wholly-owned subsidiary of Bayer AG, announced the closeout of the first of two cohorts in its ongoing Phase 1 (Ph1), open-label trial of pluripotent stem cell-derived dopaminergic neurons in patients with advanced Parkinson’s disease. The purpose of the Ph1 clinical trial…

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Biomea Fusion Releases Pre-Clinical Data with BMF-219 in Diabetes

01/13/2022

Excerpt from the Press Release: REDWOOD CITY, Calif., Jan. 06, 2022 (GLOBE NEWSWIRE) — Biomea Fusion, Inc. (“Biomea”) (Nasdaq: BMEA), a clinical-stage biopharmaceutical company dedicated to the discovery and development of irreversible small molecules to treat and improve the lives of patients with genetically defined cancers and metabolic diseases, announced today that BMF-219 displayed remarkable…

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Bolt Biotherapeutics Doses First Patient with BDC-1001 in Combination with OPDIVO® (nivolumab) in Ongoing Phase 1/2 Clinical Trial for the Treatment of HER2-Expressing Solid Tumors

01/13/2022

Excerpt from the Press Release: REDWOOD CITY, Calif., Jan. 06, 2022 (GLOBE NEWSWIRE) — Bolt Biotherapeutics, Inc. (Nasdaq: BOLT), a clinical-stage biotechnology company pioneering a new class of immuno-oncology agents that combine the targeting precision of antibodies with the power of both the innate and adaptive immune systems, today announced that the first patient has…

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Avalo Reports Positive Phase 1b Results for AVTX-002 in Moderate to Severe Crohn’s Disease Patients and Presents Additional Program Updates at 2022 Investor Event

01/12/2022

Immunology portfolio highlighted by success of a second positive study with AVTX-002 further validates the LIGHT mechanism of action in inflammatory diseases Efficacy signal demonstrated in heavily pre-treated subjects support further evaluation in inflammatory bowel disease patients’ refractory to three or more treatments, including anti-TNF alpha and other biologics Expands AVTX-002 target indications to include…

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Allarity Therapeutics and Oncoheroes Biosciences Sign Agreements to Advance Pediatric Cancer Development of Dovitinib and Stenoparib

01/10/2022

Oncoheroes will fund and advance the clinical development of both dovitinib and stenoparib in pediatric cancers, utilizing Allarity’s DRP® companion diagnostics Allarity has submitted a new drug application (NDA) for the U.S. approval of dovitinib in renal cell carcinoma (RCC) together with the Dovitinib-DRP® companion diagnostic Excerpt from the Press Release: Cambridge, MA U.S.A. (January 3, 2022) — Allarity Therapeutics, Inc. (Nasdaq: ALLR) (“Allarity” or the “Company”), a clinical-stage biopharmaceutical company developing novel oncology therapeutics…

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Relay Therapeutics Announces Dosing of First Patient in First-in-Human Trial of RLY-2608 and Initiation of Expansion Cohorts for First-In-Human Trial of RLY-4008

01/07/2022

Doses first patient in first-in-human trial of RLY-2608, a pan-mutant and isoform-selective PI3Kα inhibitor Selects 70 mg once-daily dose for RLY-4008 and initiates expansion cohorts in patients with FGFR2-altered solid tumors, including cholangiocarcinoma and breast cancer Excerpt from the Press Release: CAMBRIDGE, Mass., Jan. 04, 2022 (GLOBE NEWSWIRE) — Relay Therapeutics, Inc. (Nasdaq: RLAY), a…

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