News & Updates

IGM Biosciences Advances Novel Antibody IGM-6268 Into Clinical Trials for the Treatment and Prevention of COVID-19

02/15/2022

– In vitro studies indicate IGM-6268 exhibits potent neutralization activity against the Omicron variant and all other Variants of Concern and Variants of Interest tested – – IGM-6268 Phase 1 clinical trials advancing in U.S. and South Africa – Excerpt from the Press Release: MOUNTAIN VIEW, Calif., Feb. 09, 2022 (GLOBE NEWSWIRE) — IGM Biosciences, Inc. (Nasdaq:…

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Sunovion and Otsuka Initiate Phase 3 Clinical Development of Non-Racemic Amisulpride for the Treatment of People with Bipolar Depression

02/15/2022

Excerpt from the Press Release: MARLBOROUGH, Mass. & PRINCETON, N.J.–(BUSINESS WIRE)–Sunovion Pharmaceuticals Inc. (Sunovion) and Otsuka Pharmaceutical Development & Commercialization, Inc. (Otsuka) today announced that the first patient has been randomized in SEP380-301, a Phase 3 clinical study evaluating non-racemic amisulpride (SEP-4199) for the treatment of major depressive episodes associated with bipolar I disorder (bipolar depression). Non-racemic amisulpride…

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Newly Published Data Further Support Mosaic ImmunoEngineering’s Lead Immuno-Oncology Candidate MIE-101 in Combination with OX40 Checkpoint Treatment in Melanoma

02/14/2022

Broad, durable, and systemic anti-tumor immunity observed using inCPMV with OX40 agonist antibodies Intratumoral inCPMV administration in combination with systemic anti-OX40 controlled the progression of the primary as well as secondary untreated tumors 70% of animals survived for at least 100 days post tumor challenge without development of recurrence or metastatic disease Excerpt from the…

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AARDVARK THERAPEUTICS, INC., ANNOUNCES THE INITIATION OF ENROLLMENT FOR THREE PHASE 2 CLINICAL TRIALS OF ORAL ARD-101

02/14/2022

– Two studies evaluate ARD-101 in Obesity: one in General Obesity and the other in Refractory Weight Gain Post-Bariatric Surgery – The 3rd clinical trial is in Prader-Willi Syndrome, a rare genetic disorder characterized by persistent hyperphagia Excerpt from the Press Release: SAN DIEGO, Feb. 2, 2022 /PRNewswire/ — Aardvark Therapeutics, Inc., a clinical stage biopharmaceutical company focused…

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Oncolytics Biotech® Provides Positive Safety Update on the Pancreatic Cancer Cohort of its Multi-Indication Phase 1/2 Gastrointestinal Cancer Trial

02/14/2022

Excerpt from the Press Release: Independent safety review completed with no toxicity concerns Cohort builds on prior proof-of-concept data demonstrating clinical benefit of pelareorep-checkpoint inhibitor combination in pancreatic cancer Multi-indication trial being conducted in collaboration with Roche and AIO also includes cohorts in metastatic colorectal and advanced anal cancers SAN DIEGO and CALGARY, AB, Feb. 2, 2022 /PRNewswire/ — Oncolytics…

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UroGen Announces Start of Pivotal Single-Arm Phase 3 Trial for UGN-102, an Investigational Non-Surgical Treatment for Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer

02/11/2022

— ENVISION Study Design Similar to Successful UGN-102 Phase 2b OPTIMA II Trial — Excerpt from the Press Release: PRINCETON, N.J.–(BUSINESS WIRE)–UroGen Pharma Ltd. (Nasdaq: URGN), a biopharmaceutical company dedicated to building and commercializing novel solutions that treat urothelial and specialty cancers, today announced the initiation of its Phase 3 ENVISION study of UGN-102 (mitomycin)…

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T2 Biosystems T2SARS-CoV-2™ Panel Detects Omicron Subvariants

02/11/2022

Excerpt from the Press Release: LEXINGTON, Mass., Feb. 03, 2022 (GLOBE NEWSWIRE) — T2 Biosystems, Inc. (NASDAQ:TTOO),  a leader in the rapid detection of sepsis-causing pathogens, today announced that its T2SARS-CoV-2™ Panel detects Omicron COVID-19 subvariants BA.1, BA.2, and BA.3. According to the Centers for Disease Control and Prevention, the Omicron variant of the SARS-CoV-2 virus…

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CRISPR Therapeutics and ViaCyte, Inc. Announce First Patient Dosed in Phase 1 Clinical Trial of Novel Gene-Edited Cell Replacement Therapy for Treatment of Type 1 Diabetes (T1D)

02/11/2022

Excerpt from the Press Release: ZUG, Switzerland, and CAMBRIDGE, Mass., and SAN DIEGO, Calif., February 2, 2022 – CRISPR Therapeutics (Nasdaq: CRSP), a biopharmaceutical company focused on developing transformative gene-based medicines for serious diseases, and ViaCyte, Inc., a clinical-stage regenerative medicine company developing novel cell replacement therapies to address diseases with significant unmet needs, today…

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Pardes Biosciences Announces FDA Clearance of IND Application for PBI-0451, an Oral Antiviral Drug Candidate for the Treatment and Prevention of SARS-CoV-2 Infections

02/10/2022

CARLSBAD, Calif., Feb. 03, 2022 (GLOBE NEWSWIRE) — Pardes Biosciences, Inc. (NASDAQ: PRDS), a clinical-stage biopharmaceutical company developing PBI-0451 as a potential novel direct-acting, oral antiviral drug candidate for the treatment and prevention of SARS-CoV-2 infections and associated diseases (i.e., COVID-19), today announced that its Investigational New Drug (IND) application for PBI-0451 has been cleared…

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Synthekine Doses First Patient in Phase 1 Clinical Trial of IL-2 Partial Agonist, STK-012, for Treatment of Solid Tumors

02/10/2022

Excerpt from the Press Release: MENLO PARK, Calif.–(BUSINESS WIRE)–Synthekine Inc., an engineered cytokine therapeutics company, today announced the dosing of the first patient in a Phase 1a/1b clinical trial of its IL-2 partial agonist, STK-012, for the treatment of solid tumors. STK-012 is designed as an alpha/beta-biased IL-2 partial agonist to selectively stimulate antigen-activated T…

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