Industry News

Janssen Initiates First-of-its-Kind Clinical Study to Bridge Critical Gaps in Care for People of Color with Moderate to Severe Plaque Psoriasis

03/29/2022

The only large-scale prospective study in dermatology designed to generate key disease insights among Black, Hispanic, Asian, Indigenous and other people of color Study reinforces Janssen’s commitments to inclusive clinical research and addressing health inequities Excerpt from the Press Release: HORSHAM, Pa., March 22, 2022 /PRNewswire/ — Psoriasis (PsO) can take a physical, psychological, and emotional toll…

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Alladapt Announces Initiation of Encore Open-Label Extension Study for its Harmony Phase 1/2 Study of ADP101 for Treatment of Food Allergy

03/28/2022

Harmony remains ongoing, with OLE study intended to gain insights into long-term exposure to ADP101 in qualifying patients Excerpt from the Press Release: MENLO PARK, Calif., March 17, 2022 (GLOBE NEWSWIRE) — Alladapt Immunotherapeutics Inc., a private, clinical-stage biopharmaceutical company developing prescription therapeutics to address IgE-mediated food allergy, today announced the first patient has been…

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Soligenix COVID-19 Vaccine, CiVax™, Boosts Neutralizing Activity against SARS-CoV-2, including Delta and Omicron

03/28/2022

CiVax™ booster vaccine administered seven months after primary vaccination with COVID-19 adenovirus vaccine shows rapid enhancement of neutralizing antibody responses in non-human primates Neutralizing antibodies against Delta and original strain increased by up to 27-fold within one week and up to 243-fold within three weeks Omicron neutralizing antibody levels were undetectable prior to booster vaccination, and…

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Eiger’s Single-dose Peginterferon Lambda for COVID-19 Reduced Risk of Hospitalization or ER Visits by 50% in a Predominantly Vaccinated Population in Phase 3 TOGETHER Study

03/25/2022

Second largest study to date in COVID-19 outpatients (N=1,936) Highly superior compared to placebo, with a probability of superiority of 99.91% on the primary endpoint 60% reduced risk of COVID-19-related death Primary endpoint achieved across multiple SARS-CoV-2 variants, including omicron Eiger plans to submit data to FDA for Emergency Use Authorization (EUA) Management to host…

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Biological Dynamics Study Demonstrates Detection of Early-Stage Cancers

03/25/2022

In a Nature Communications Medicine publication, the Verita™ proprietary platform detected 96 percent of stage 1 pancreatic cancers and three-quarters of stage 1 ovarian cancers using isolated exosomes and AI-enabled protein marker analysis Excerpt from the Press Release: SAN DIEGO–(BUSINESS WIRE)–Biological Dynamics, Inc. announces the publication of its study, Early-Stage Multi-Cancer Detection Using an Extracellular Vesicle…

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Ionis announces publication of positive Phase 2 data for donidalorsen in New England Journal of Medicine

03/25/2022

Treatment with donidalorsen in Phase 2 study significantly reduced angioedema attacks by 90% and provided improvement in quality of life Published findings demonstrate favorable safety and tolerability profile of donidalorsen in Phase 2 study Donidalorsen is one of Ionis’ wholly owned medicines the company plans to commercialize Excerpt from the Press Release: CARLSBAD, Calif., March…

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LYNPARZA® (olaparib) reduced risk of death by 32% in the adjuvant treatment of patients with germline BRCA-mutated high-risk early breast cancer

03/24/2022

First PARP inhibitor to demonstrate overall survival benefit in early breast cancer Excerpt from the Press Release: WILMINGTON, Del.–(BUSINESS WIRE)–AstraZeneca and Merck & Co., Inc., known as MSD outside the US and Canada, today announced further positive results from the OlympiA Phase III trial showed LYNPARZA® (olaparib) demonstrated a statistically significant and clinically meaningful improvement in…

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Iovance Biotherapeutics’ Investigational New Drug Application (IND) Allowed to Proceed for TALEN®-Edited Tumor Infiltrating Lymphocyte (TIL) in Unresectable or Metastatic Melanoma and Stage III or IV Non-Small Cell Lung Cancer (NSCLC)

03/23/2022

Clinical Study Expected to Begin in 2022 to Investigate the Safety and Efficacy of IOV-4001 to Deliver TIL and PD-1 Inhibition within a Single Cancer Therapy First Genetically Modified Iovance TIL Therapy Leverages TALEN® technology Licensed from Cellectis to Inactivate PD-1 Expression Excerpt from the Press Release: SAN CARLOS, Calif., March 15, 2022 (GLOBE NEWSWIRE) — Iovance…

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Werewolf Therapeutics Announces Publication of Data Demonstrating the Preclinical Efficacy of WTX-124 in Delivering IL-2 Selectively to the Tumor Microenvironment

03/22/2022

Excerpt from the Press Release: CAMBRIDGE, Mass., March 16, 2022 (GLOBE NEWSWIRE) — Werewolf Therapeutics, Inc. (the “Company” or “Werewolf”) (Nasdaq: HOWL), an innovative biopharmaceutical company pioneering the development of conditionally activated therapeutics, announced the publication in Cancer Immunology Research of preclinical data for its lead molecule WTX-124, a systemically delivered Interleukin-2 (IL-2) INDUKINE™ molecule. The…

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Exelixis Announces Final Overall Survival Results from Phase 3 COSMIC-312 Trial of Cabozantinib in Combination with an Immune Checkpoint Inhibitor in Patients with Previously Untreated Advanced Liver Cancer

03/22/2022

Excerpt from the Press Release: ALAMEDA, Calif.–(BUSINESS WIRE)–Exelixis, Inc. (Nasdaq: EXEL) today announced results from the final analysis of the second primary endpoint of overall survival (OS) from the phase 3 COSMIC-312 trial, which evaluated cabozantinib (CABOMETYX®) in combination with atezolizumab versus sorafenib in patients with previously untreated advanced hepatocellular carcinoma (HCC). The final analysis…

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