Industry News

Ionis announces publication of positive Phase 2 data for donidalorsen in New England Journal of Medicine

03/25/2022

Treatment with donidalorsen in Phase 2 study significantly reduced angioedema attacks by 90% and provided improvement in quality of life Published findings demonstrate favorable safety and tolerability profile of donidalorsen in Phase 2 study Donidalorsen is one of Ionis’ wholly owned medicines the company plans to commercialize Excerpt from the Press Release: CARLSBAD, Calif., March…

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LYNPARZA® (olaparib) reduced risk of death by 32% in the adjuvant treatment of patients with germline BRCA-mutated high-risk early breast cancer

03/24/2022

First PARP inhibitor to demonstrate overall survival benefit in early breast cancer Excerpt from the Press Release: WILMINGTON, Del.–(BUSINESS WIRE)–AstraZeneca and Merck & Co., Inc., known as MSD outside the US and Canada, today announced further positive results from the OlympiA Phase III trial showed LYNPARZA® (olaparib) demonstrated a statistically significant and clinically meaningful improvement in…

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Iovance Biotherapeutics’ Investigational New Drug Application (IND) Allowed to Proceed for TALEN®-Edited Tumor Infiltrating Lymphocyte (TIL) in Unresectable or Metastatic Melanoma and Stage III or IV Non-Small Cell Lung Cancer (NSCLC)

03/23/2022

Clinical Study Expected to Begin in 2022 to Investigate the Safety and Efficacy of IOV-4001 to Deliver TIL and PD-1 Inhibition within a Single Cancer Therapy First Genetically Modified Iovance TIL Therapy Leverages TALEN® technology Licensed from Cellectis to Inactivate PD-1 Expression Excerpt from the Press Release: SAN CARLOS, Calif., March 15, 2022 (GLOBE NEWSWIRE) — Iovance…

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Werewolf Therapeutics Announces Publication of Data Demonstrating the Preclinical Efficacy of WTX-124 in Delivering IL-2 Selectively to the Tumor Microenvironment

03/22/2022

Excerpt from the Press Release: CAMBRIDGE, Mass., March 16, 2022 (GLOBE NEWSWIRE) — Werewolf Therapeutics, Inc. (the “Company” or “Werewolf”) (Nasdaq: HOWL), an innovative biopharmaceutical company pioneering the development of conditionally activated therapeutics, announced the publication in Cancer Immunology Research of preclinical data for its lead molecule WTX-124, a systemically delivered Interleukin-2 (IL-2) INDUKINE™ molecule. The…

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Exelixis Announces Final Overall Survival Results from Phase 3 COSMIC-312 Trial of Cabozantinib in Combination with an Immune Checkpoint Inhibitor in Patients with Previously Untreated Advanced Liver Cancer

03/22/2022

Excerpt from the Press Release: ALAMEDA, Calif.–(BUSINESS WIRE)–Exelixis, Inc. (Nasdaq: EXEL) today announced results from the final analysis of the second primary endpoint of overall survival (OS) from the phase 3 COSMIC-312 trial, which evaluated cabozantinib (CABOMETYX®) in combination with atezolizumab versus sorafenib in patients with previously untreated advanced hepatocellular carcinoma (HCC). The final analysis…

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IDEAYA Biosciences Reports IDE397 Interim Phase 1 Clinical Data

03/22/2022

Observed preclinical complete suppression (~95-100%) of tumor SDMA in multiple MTAP-deleted patient derived xenograft (PDX) models across indications Interim IDE397 clinical data demonstrates robust plasma pharmacodynamic modulation, exceeding target of >60% reduction of plasma SAM across all evaluated cohorts Observed clinical exposure-dependent reduction of tumor pharmacodynamic biomarker SDMA in target tumor types, including 95% reduction…

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The Lancet Publishes Positive Results from Capricor Therapeutics’ Phase 2 Study Evaluating CAP-1002 in Late-Stage Duchenne Muscular Dystrophy

03/21/2022

-One-Year Final Data Highlights Lead Cell Therapy Asset, CAP-1002, for Safety and Efficacy in Slowing Upper Limb and Cardiac Function Deterioration in Patients- -Data Sets Stage for Pivotal Phase 3 HOPE-3 Clinical Trial- Excerpt from the Press Release: SAN DIEGO, March 11, 2022 (GLOBE NEWSWIRE) — Capricor Therapeutics (NASDAQ: CAPR), a biotechnology company focused on the development…

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Passage Bio Doses First Patient in Global Clinical Trial for Infantile Krabbe Disease, A Rare Fatal Pediatric Condition

03/21/2022

Company expects to report interim safety and biomarker data for Cohort 1 patients in the global phase 1/ 2 clinical trial, GALax-C, by end of 2022 Excerpt from the Press Release: PHILADELPHIA, March 10, 2022 (GLOBE NEWSWIRE) — Passage Bio, Inc. (Nasdaq: PASG), a clinical-stage genetic medicines company focused on developing transformative therapies for central…

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Allogene Therapeutics Receives FDA Fast Track Designation for its First Solid Tumor Candidate, ALLO-316 in the Treatment of Renal Cell Carcinoma

03/21/2022

ALLO-316 is an allogeneic CAR T therapy candidate targeting CD70, which Has Broad Potential Application Across a Variety of Solid Tumors and Hematologic Malignancies Phase 1 TRAVERSE Trial of ALLO-316 for the Treatment of Renal Cell Carcinoma (RCC) ongoing Excerpt from the Press Release: SOUTH SAN FRANCISCO, Calif., March 10, 2022 (GLOBE NEWSWIRE) — Allogene…

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Exo® Announces Mobile-First, Secure Cloud-Based Point-of-Care Ultrasound Workflow Solution

03/18/2022

The device-agnostic software seamlessly integrates with hospital IT for streamlined documentation, billing and QA management all in one platform Excerpt from the Press Release: REDWOOD CITY, Calif.–(BUSINESS WIRE)–Exo (pronounced “echo”), a pioneering health information and devices company, has unveiled Exo Works™, an intelligent and intuitive point-of-care ultrasound workflow solution that enables physicians to easily document, review,…

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