Industry News

IASO Biotherapeutics’ World’s First Fully Human CD19/CD22 Dual-Targeted CAR-T Drug Receives Two IND Clearances, Enters Clinical Trials

08/07/2021

Excerpt from the Press Release: PLEASANTON, Calif. & NANJING, China & SHANGHAI–(BUSINESS WIRE)–IASO Biotherapeutics (IASO Bio), a clinical-stage biopharmaceutical company advancing the development of novel cell therapies for cancer, today announced the clearance from China’s National Medical Products Administration (NMPA) of two Initial New Drug (IND) applications for CT120, the company’s in-house developed fully human CD19/CD22…

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Seres Therapeutics Announces Topline Results for SER-287 Phase 2b Study in Mild-to-Moderate Ulcerative Colitis

08/06/2021

Excerpt from the Press Release: CAMBRIDGE, Mass.–(BUSINESS WIRE)–Seres Therapeutics, Inc. (Nasdaq: MCRB), a leading microbiome therapeutics company, today announced topline results from the Phase 2b ECO-RESET study evaluating SER-287 in patients with mild-to-moderate ulcerative colitis (UC). The study did not meet its primary endpoint of improving clinical remission rates compared to placebo. Both dosing regimens of…

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NIH Advances ACTIV-5/BET-B Trial Evaluating Lenzilumab from a Phase 2 Exploratory Study to a Phase 2/3 Study for the Treatment of COVID-19

08/06/2021

Excerpt from the Press Release: BURLINGAME, Calif.–(BUSINESS WIRE)–Humanigen, Inc. (Nasdaq: HGEN) (“Humanigen”), a clinical-stage biopharmaceutical company developing a first-in-class GM-CSF neutralizing antibody to prevent and treat an immune hyper-response called ‘cytokine storm’ across multiple therapeutic indications, has announced that the NIH has advanced the ACTIV-5/BET-B study to a Phase 2/3 study and modified the primary…

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EUREKA THERAPEUTICS ANNOUNCES INITIATION OF PHASE I/II ARYA-3 CLINICAL TRIAL OF GPC3 TARGETING ARTEMIS® T CELL THERAPY IN LIVER CANCER

08/06/2021

Excerpt from the Press Release: Emeryville, California, July 21, 2021 — Eureka Therapeutics, Inc., a clinical-stage biotechnology company developing novel T cell therapies to treat solid tumors, today announced the initiation of a Phase I/II clinical trial of ECT204, a GPC3 targeting ARTEMIS® T-cell therapy for the treatment of hepatocellular carcinoma (HCC), the predominant type of…

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Radicle Science Launches Largest Longitudinal Real World Evidence Study to Determine Effectiveness of CBD Products

08/06/2021

Excerpt from the Press Release: SAN DIEGO–(BUSINESS WIRE)–Radicle Science, a transformative healthtech B-corp validating natural products for the first time, announces the launch of the Radicle ACES (Advancing CBD Education and Science) study. Using a virtual, direct to consumer (D2C) approach, Radicle ACES is the largest and most comprehensive randomized controlled trial (RCT) of its…

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Sorrento Announces Dosing of COVID-19 Patients in Phase 2 Clinical Trial for COVIDROPS, a Highly Potent Neutralizing Antibody Against SARS-CoV-2 Including Delta and Alpha Variants of Concern, in an At-Home Outpatient Setting in United Kingdom

08/06/2021

Excerpt from the Press Release: SAN DIEGO, July 21, 2021 (GLOBE NEWSWIRE) — Sorrento Therapeutics, Inc. (Nasdaq: SRNE, “Sorrento”) today announced that COVID-19 patients have been dosed in its Phase 2 efficacy trial. Approximately 350 outpatients with COVID-19 who are asymptomatic or have mild symptoms will be enrolled in this large double-blind, randomized clinical trial evaluating COVIDROPS doses of…

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Prometheus Biosciences Announces Initiation of Global Phase 2 Clinical Trial of PRA023 in Moderate-to-Severe Ulcerative Colitis (UC)

08/05/2021

Excerpt from the Press Release: SAN DIEGO, July 19, 2021 (GLOBE NEWSWIRE) — Prometheus Biosciences, Inc. (Nasdaq: RXDX), a biotechnology company pioneering a precision medicine approach for the discovery, development, and commercialization of novel therapeutic and companion diagnostic products for the treatment of immune-mediated diseases, starting first with inflammatory bowel disease (IBD), today announced the…

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Vertex Initiates Phase 2 Clinical Trial Program for VX-548 for the Treatment of Acute Pain

08/05/2021

Excerpt from the Press Release: BOSTON–(BUSINESS WIRE)–Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that it has begun a Phase 2 proof-of-concept (POC) study in acute pain following bunionectomy surgery with the selectiveNaV1.8 inhibitor VX-548 and that it expects to commence a second Phase 2 study in acute pain following abdominoplasty surgery in the coming weeks. “Based…

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Advaxis Announces Initiation of Phase 1 Clinical Trial of ADXS-504 for the Treatment of Early Prostate Cancer

08/05/2021

Excerpt from the Press Release: MONMOUTH JUNCTION, N.J., July 15, 2021 (GLOBE NEWSWIRE) — Advaxis, Inc. (Nasdaq: ADXS), a clinical-stage biotechnology company focused on the development and commercialization of immunotherapy products, today announced the initiation of its Phase 1 clinical study evaluating ADXS-504 in patients with biochemically recurrent prostate cancer. The study, being conducted at…

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Pear Therapeutics Reports Nine-Month Real-World Healthcare Utilization Data for reSET-O®

08/04/2021

Excerpt from the Press Release: BOSTON & SAN FRANCISCO–(BUSINESS WIRE)–Pear Therapeutics, Inc. today announced results from an extended retrospective analysis of real-world data analyzing healthcare resource utilization for reSET-O®, the first and only FDA-authorized Prescription Digital Therapeutic (PDT) for the treatment of opioid use disorder (OUD). Results from a nine-month real-world data analysis show a continued…

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