Biopharmaceutical

Blue Earth Therapeutics Announces Promising Results of Preclinical Biodistribution and Efficacy Evaluation of 177Lu-rhPSMA-10.1 in Treatment of Prostate Cancer

06/23/2022

− 177Lutetium-labelled radiohybrid Prostate-Specific Membrane Antigen (177Lu-rhPSMA-10.1) is in development as a highly optimized, next generation therapeutic radiopharmaceutical – − 177Lu‑rhPSMA-10.1 demonstrated favorable tumor:kidney ratio and statistically significant tumor growth suppression in preclinical studies − − Phase 1/2 clinical trial of 177Lu-rhPSMA-10.1 in men with metastatic castrate‑resistant prostate cancer recently cleared to proceed in United…

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Fusion Pharmaceuticals Presents Imaging Data from Cold Antibody Sub-Study in the Phase 1 Study of FPI-1434

06/23/2022

– Study evaluates pre-administration of cold antibody prior to administration of imaging agent – Imaging shows favorable gain in tumor lesion uptake versus normal tissue when cold antibody is pre-administered – Data presented at the SNMMI 2022 Annual Meeting Excerpt from the Press Release: HAMILTON, ON and BOSTON, June 14, 2022 /PRNewswire/ — Fusion Pharmaceuticals Inc.…

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Kymera Therapeutics Doses First Patients in Phase 1 Oncology Trials of STAT3 and IRAKIMiD Degraders KT-333 and KT-413

06/22/2022

KT-333 is a first-in-class heterobifunctional degrader of the transcriptional regulator STAT3 in development for T cell malignancies and solid tumors KT-413 is a first-in-class degrader of IRAK4 and the IMiD substrates Ikaros and Aiolos in development for MYD88-mutant B cell lymphomas  Initial safety and proof-of-mechanism clinical data for both programs to be shared in second…

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Omega Therapeutics Announces Submission of Investigational New Drug Application for OTX-2002, an Omega Epigenomic Controller, for MYC Driven Hepatocellular Carcinoma

06/22/2022

Investigational New Drug Application Submitted by Omega Represents the First Epigenomic Controller in a New Class of Programmable mRNA Therapeutics Excerpt from the Press Release: CAMBRIDGE, Mass., June 15, 2022 /PRNewswire/ — Omega Therapeutics, Inc. (Nasdaq: OMGA) (“Omega”) today announced the submission of an Investigational New Drug (IND) application to the U.S. Food and Drug…

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NEUSPERA MEDICAL® ANNOUNCES SECOND PHASE OF SANS-UUI IDE CLINICAL TRIAL WITH THE NUVELLA™ SYSTEM

06/22/2022

Pivotal trial to study the safety and efficacy of sacral nerve stimulation in patients with urinary urgency incontinence symptoms Excerpt from the Press Release: SAN JOSE, Calif., June 14, 2022 /PRNewswire/ — Neuspera® Medical, a medical device company developing implantable devices for patients battling chronic illnesses, today announced it will begin enrollment in its pivotal clinical trial…

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HUYABIO INTERNATIONAL ANNOUNCES INITIATION OF HBI-3000 PHASE 2 TRIAL

06/21/2022

Excerpt from the Press Release: SAN DIEGO, June 14, 2022 /PRNewswire/ — HUYABIO International today announced that the first three patients had been dosed in an ongoing Phase 2 study of HUYABIO’s novel drug for pharmacological cardioversion of atrial fibrillation (AF). Dr. Mireille Gillings, President, CEO & Executive Chair, said, “We are excited to proceed with…

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Entrepreneurial spirit shines brightly for young CEO helping people with limited mobility in their hands

06/21/2022

At 22, with her degree from McMaster’s program in Integrated Biomedical Engineering and Health Sciences in hand, Lianna Genovese already holds two patents in the United States and Canada, as well as four trademarks. Excerpt from the Press Release: Passion, drive and a good idea turned Lianna Genovese into a corporate entrepreneur long before she…

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Immunome Announces Initiation of Phase 1b Study of IMM-BCP-01 for the Treatment of COVID-19

06/20/2022

First study subject has been dosed in a single dose/dose escalation study of recently diagnosed COVID-19 patients Study will evaluate safety as the primary end point with pharmacokinetics (PK) and virology as secondary assessments Excerpt from the Press Release: EXTON, Pa.–(BUSINESS WIRE)–Immunome, Inc. (Nasdaq: IMNM), a biopharmaceutical company that utilizes its human memory B cell…

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ORYZON Announces FDA Orphan Drug Designation Granted to Iadademstat for Treatment of Small Cell Lung Cancer

06/17/2022

Excerpt from the Press Release: Now has orphan drug designation for SCLC and AML MADRID, Spain and CAMBRIDGE, Mass., June 08, 2022 (GLOBE NEWSWIRE) — Oryzon Genomics, S.A. (ISIN Code: ES0167733015, ORY), a clinical-stage biopharmaceutical company leveraging epigenetics to develop therapies in diseases with strong unmet medical need, announced today that the U.S. Food and…

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Cend Therapeutics Announces First Patient Treated in Phase 2b Trial of CEND-1 led by Australasian Gastro-Intestinal Trials Group

06/17/2022

Excerpt from the Press Release: SAN DIEGO, June 09, 2022 (GLOBE NEWSWIRE) — Cend Therapeutics, Inc. (“Cend”) today announced that the first patient has been treated in the Phase 2b study of CEND-1, Cend’s lead investigational drug, in patients with first-line metastatic pancreatic ductal adenocarcinoma. The ASCEND trial is a 125-patient, double-blind, randomized, placebo-controlled clinical…

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