Biotechnology

Ocugen Announces Completion of Dosing in OCU400 Phase 1/2 Cohort 2

10/21/2022

• No safety concerns noted in ongoing clinical trial• Study timeline remains on track Excerpt from the Press Release: MALVERN, Pa., Oct. 12, 2022 (GLOBE NEWSWIRE) — Ocugen, Inc. (Ocugen or the Company) (NASDAQ: OCGN), a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies and vaccines, today announced that the…

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BMF-219 Enters the Clinic for KRAS Solid Tumors

10/20/2022

Biomea Fusion announces FDA clearance of Investigational New Drug (IND) application for covalent menin inhibitor BMF-219 in KRAS solid tumors. Biomea Fusion will now initiate a Phase I/Ib clinical trial (COVALENT-102) of BMF-219 as a monotherapy in patients who have unresectable, locally advanced, or metastatic non-small cell lung cancer (NSCLC), colorectal cancer (CRC) or pancreatic…

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Allogene Therapeutics Initiates Industry’s First Allogeneic CAR T Phase 2 Trial

10/19/2022

ALPHA2 Trial, Evaluating ALLO-501A in Relapsed/Refractory Large B Cell Lymphoma Patients, is Designed to Leverage the Ease and Convenience of a Single Dose of ALLO-501A Protocol Supported by Clinical and Translational Data from Phase 1 Trial Indicating Deep Responses are Achievable with a Single Dose of ALLO-501A When Used with a Lymphodepletion Regimen That Includes…

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Elicio Therapeutics Announces Publication of Preclinical Data in Science Translational Medicine Demonstrating the AMP Platform Promotes Uptake of Intranasal Vaccine in the Mucosa Amplifying Immune Response

10/18/2022

AMP-protein-based vaccines administered intranasally to mice and nonhuman primates (NHPs) were transported across the epithelial lining to the nasal-associated lymphoid tissue (NALT) and persisted in the nasal mucosa eliciting immune responses at both local and distal mucosal sites Intranasal immunization with AMP-conjugated HIV Env gp120 or SARS-CoV-2 receptor binding domain (RBD) proteins elicited 100- to…

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Myrtelle Completes Dosing of 8 Patients with Canavan Disease in Its Phase 1/2 Clinical Trial of the Investigational Gene Therapy rAAV-Olig001-ASPA

10/17/2022

Eight patients have been treated in the ongoing Phase 1/2 First-in-Human clinical trial with favorable safety and tolerability observed to date Assessments of the initial 3 patients reaching their six-month follow-up showed improvements on validated functional scales and increases in brain white matter and myelin content Encouraging efficacy and safety data support further development of…

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Abcuro Initiates Phase 1/2 Trial Evaluating ABC008 in Patients with T Cell Large Granular Lymphocytic Leukemi

10/17/2022

T-LGLL is an autoimmune disorder characterized by cytotoxic T lymphocytes which attack neutrophils and red blood cell precursors Excerpt from the Press Release: NEWTON, Mass.–(BUSINESS WIRE)–Abcuro, Inc., a clinical-stage biotechnology company developing therapies for the treatment of autoimmune diseases and cancer through precise modulation of cytotoxic T and NK cells, today announced initiation of a…

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Immuneering Announces FDA Clearance of IND Application for Phase 1/2a Clinical Trial of IMM-1-104 to Treat Advanced Solid Tumors with RAS Mutations

10/12/2022

Initiation of Phase 1/2a Clinical Trial Expected to Occur in Q4 2022 Excerpt from the Press Release: CAMBRIDGE, Mass., Sept. 30, 2022 (GLOBE NEWSWIRE) — Immuneering Corporation (Nasdaq: IMRX), a biopharmaceutical company that aims to create medicines for all patients with solid tumors driven by RAS mutations and other MAPK pathway activation events, today announced…

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Persephone Biosciences Announces First Participant Enrolled in Proprietary My Baby Biome Study of Infant Gut Health

10/11/2022

– My Baby Biome is an observational study to determine gut biomarkers associated with health outcomes in infancy and later life – – The study, the largest of its kind, is expected to enroll 600 infants for a total duration of seven years – – Data from the study will be used to develop specially…

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Jaguar Health Subsidiary Napo Pharmaceuticals Announces Activation by FDA of Investigational New Drug (IND) Application for NP-300, a Novel Drug Candidate for the Symptomatic Relief and Treatment of Diarrhea from Cholera and Other Pathogens

10/11/2022

Excerpt from the Press Release: SAN FRANCISCO, CA / ACCESSWIRE / September 29, 2022 / Napo Pharmaceuticals, Inc. (“Napo”), the wholly-owned subsidiary of Jaguar Health, Inc. (NASDAQ:JAGX) (“Jaguar” or the “Company”) today announced the activation by the U.S. Food and Drug Administration (FDA) of the Investigational New Drug (IND) application for Napo’s NP-300, a novel…

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Eureka Therapeutics Announces New England Journal of Medicine Publication of Clinical Study Demonstrating GPRC5D as an Active Target for the Treatment of Multiple Myeloma

10/10/2022

Excerpt from the Press Release: EMERYVILLE, Calif.–(BUSINESS WIRE)–Eureka Therapeutics, Inc., a clinical-stage biotechnology company developing novel T cell therapies to treat cancer, today announced the publication of a study in the New England Journal of Medicine entitled “GPRC5D-Targeted CAR T Cells for Myeloma.” The study was led by Dr. Eric Smith of the Dana-Farber Cancer…

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