Industry News

GT Biopharma Presented Preclinical Data Demonstrating Novel Mesothelin-Targeted TriKE® Driving Cytotoxicity Across All Stages of Non-Small Cell Lung Cancer at ESMO TAT 2022

03/18/2022

– Results suggest that mesothelin-targeted TriKE can work alongside current standard of care and provide benefit even in the hypoxic environment of a solid tumor Excerpt from the Press Release: BRISBANE, Calif., March 9, 2022 /PRNewswire/ — GT Biopharma, Inc. (NASDAQ: GTBP), a clinical stage immuno-oncology company focused on developing innovative therapeutics based on the Company’s proprietary tri-specific…

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Pipeline Therapeutics Reports Positive Phase 1 Clinical Results for PIPE-307, a Neuroregenerative Therapeutic for the Treatment of Multiple Sclerosis

03/17/2022

Excerpt from the Press Release: SAN DIEGO–(BUSINESS WIRE)–Pipeline Therapeutics, a clinical-stage biopharmaceutical company pioneering precision neuroregeneration, today reported positive clinical data from its recently completed Phase 1 clinical trial evaluating the safety and tolerability of PIPE-307 in healthy volunteers. PIPE-307, the company’s lead program for myelin restoration, is an oral, highly selective antagonist of the…

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eGenesis Announces Research Collaboration with the University of Miami to Evaluate Human Compatible Islet Cells in Diabetes Model

03/17/2022

Excerpt from the Press Release: CAMBRIDGE, Mass., March 09, 2022 (GLOBE NEWSWIRE) — eGenesis, a gene-editing company developing human-compatible (HuCo™) organs and cells, today announced the initiation of a research collaboration with the University of Miami Leonard M. Miller School of Medicine. The collaboration will encompass the evaluation of gene-edited pancreatic HuCo™ islet cells in…

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Intellia Therapeutics Receives U.S. FDA Orphan Drug Designation for NTLA-5001 for the Treatment of Acute Myeloid Leukemia

03/17/2022

NTLA-5001, a novel T cell receptor (TCR)-T cell therapy, is currently being evaluated in a Phase 1/2a study in adults with persistent or recurrent acute myeloid leukemia Excerpt from the Press Release: CAMBRIDGE, Mass., March 09, 2022 (GLOBE NEWSWIRE) — Intellia Therapeutics, Inc. (NASDAQ:NTLA), a leading clinical-stage genome editing company focused on developing potentially curative…

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NorthStar Medical Radioisotopes and Convergent Therapeutics Announce Supply Agreement for Therapeutic Radioisotope Actinium-225 (Ac-225)

03/16/2022

− NorthStar’s high purity non-carrier-added (n.c.a.) Ac-225 to be used in Convergent’s lead, dual-targeted radionuclide program for prostate cancer, CONV01-α − Excerpt from the Press Release: BELOIT, Wis. & CAMBRIDGE, Mass.–(BUSINESS WIRE)–NorthStar Medical Radioisotopes, LLC, a global innovator in the development, production and commercialization of radiopharmaceuticals used for therapeutic applications and medical imaging, and Convergent Therapeutics, Inc., a…

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AmMax Bio Announces Positive Phase 2 Results Demonstrating Proof-of-Concept for the Novel Local Delivery of AMB-05X in Patients with Tenosynovial Giant Cell Tumor (TGCT)

03/10/2022

Intra-Articular Injection Strategy Shows Efficacy Across Multiple Clinical Endpoints and Favorable Safety Profile After 12 Weeks of Therapy   Data From the Phase 2 Study Support the Potential of AMB-05X as a Best-in-Class Therapy for Treatment of TGCT Excerpt from the Press Release: REDWOOD CITY, Calif., March 02, 2022 (GLOBE NEWSWIRE) — AmMax Bio, Inc. (“AmMax”),…

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PURIFY Investigators Announce First Patient Enrolled in a US Randomized Controlled IDE Trial Evaluating Seraph 100 for the Treatment of Septic Shock

03/10/2022

Excerpt from the Press Release: MARTINEZ, Calif.–(BUSINESS WIRE)–Investigators today announced the first patient enrollment in the Blood Purification for the Treatment of Pathogen Associated Shock (PURIFY-RCT) trial. PURIFY-RCT is a prospective interventional multicenter randomized controlled trial, sponsored by the Department of Defense in collaboration with the Henry M. Jackson Foundation and the Uniformed Services University of Health…

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Dragonfly Therapeutics Announces Achievement of Phase 1 Clinical Development Milestone for IL-12 Investigational Immunotherapy Program with Bristol Myers Squibb

03/09/2022

Dragonfly receives a milestone payment from Bristol Myers Squibb for progression of its Phase 1 DF6002-001 study with a PK profile and peripheral PD consistent with preclinical models Excerpt from the Press Release: WALTHAM, Mass., March 1, 2022 /PRNewswire/ — Dragonfly Therapeutics, Inc. (“Dragonfly”) today announced the achievement of a Phase 1 clinical development milestone for the…

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Karyopharm Provides U.S. Regulatory Update on Selinexor in Advanced or Recurrent Endometrial Cancer

03/08/2022

Following Discussion with the FDA, Karyopharm Plans to Initiate a New Placebo-Controlled Randomized Study of Selinexor in the Advanced or Recurrent Endometrial Cancer p53 Wild-Type Population to Support a Future sNDA Submission as the Current Topline Data from the SIENDO Study are Unlikely to Support an sNDA Approval Karyopharm is Encouraged by the SIENDO p53…

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BioCardia Receives No Objection Letter from Health Canada, Enabling Company to Expand CardiAMP Cell Therapy Heart Failure Trial into Canada

03/08/2022

Excerpt from the Press Release: SUNNYVALE, Calif., March 01, 2022 (GLOBE NEWSWIRE) — BioCardia®, Inc. (Nasdaq: BCDA), a developer of cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today announced that it has received a No Objection Letter from Health Canada, the country’s health services agency, allowing the CardiAMP® Heart Failure Trial to…

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