Biotechnology

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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Biosplice Therapeutics Announced New Clinical Data for Cirtuvivint (SM08502) at the European Society for Clinical Oncology Meeting

10/10/2022

Results showed evidence of clinical activity for cirtuvivint in advanced cancer patients Excerpt from the Press Release: SAN DIEGO, Sept. 29, 2022 (GLOBE NEWSWIRE) — Biosplice Therapeutics, Inc. (“Biosplice”), a clinical-stage biotechnology company pioneering therapeutics based on CLK/DYRK kinase modulation for major diseases, announced today the presentation of new clinical data for cirtuvivint (SM08502), its…

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Vir Biotechnology Announces First Patient Dosed in the Phase 2 SOLSTICE Trial Evaluating VIR-2218 and VIR-3434 for the Treatment of Chronic Hepatitis D Virus Infection

10/03/2022

– Impacting more than 12 million people globally, HDV is the most aggressive form of viral hepatitis – – Novel combination strategy designed to reduce HDV viremia and block viral entry – Excerpt from the Press Release: SAN FRANCISCO, Sept. 22, 2022 (GLOBE NEWSWIRE) — Vir Biotechnology, Inc. (Nasdaq: VIR) today announced that the first…

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Excision BioTherapeutics Doses First Participant in EBT-101 Phase 1/2 Trial Evaluating EBT-101 as a Potential Cure for HIV

09/23/2022

EBT-101 is an in vivo CRISPR-based therapeutic designed to remove HIV proviral DNA from affected cell reservoirs First-in-human study will evaluate the safety and efficacy of EBT-101 in participants who chronically suppress HIV with daily antiretroviral therapy EBT-101 has been well tolerated to-date and the trial is proceeding as planned Excerpt from the Press Release:…

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Larimar Therapeutics Announces FDA Clearance to Initiate the 25 mg Cohort of a Phase 2 Dose Exploration Trial of CTI-1601 in Friedreich’s Ataxia Patients

09/20/2022

Initiation of the Phase 2 trial is expected in Q4 2022, with top-line data expected in 2H 2023 Company management hosting webcast and conference call today at 8:30 a.m. ET Excerpt from the Press Release: BALA CYNWYD, Pa., Sept. 14, 2022 (GLOBE NEWSWIRE) — Larimar Therapeutics, Inc. (“Larimar”) (Nasdaq: LRMR), a clinical-stage biotechnology company focused…

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Exelixis Announces Dose-Escalation Results from the Phase 1 STELLAR-001 Trial Evaluating XL092 Alone and in Combination with an Immune Checkpoint Inhibitor in Patients with Advanced Solid Tumors at ESMO 2022

09/20/2022

–Both single-agent XL092 and XL092 in combination with atezolizumab demonstrated encouraging efficacy and safety in a heavily pretreated patient population – – XL092 demonstrated preliminary clinical activity similar to that observed with cabozantinib in phase 1 across a range of solid tumors and dose levels, with a manageable safety profile – – Based on the…

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Ashvattha Therapeutics Announces First Patient Enrolled in a Phase 2 Study of D-4517.2 for the Treatment of Wet AMD and DME

09/14/2022

– First patient was enrolled as part of a two-stage Phase 2 study evaluating Ashvattha’s subcutaneous (SC) anti-VEGF wet AMD and DME candidate, D-4517.2 – – The first stage of the study will evaluate the safety and relative pharmacodynamic effect of different doses of subcutaneously (SC) administered D-4517.2 compared to intravitreal (IVT) injection of aflibercept,…

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