Article

BridgeBio Announces Clinical Collaboration with Amgen to Study BBP-398, a Potentially Best-in-class SHP2 Inhibitor, in Combination with LUMAKRAS® (sotorasib) in Advanced Solid Tumors with the KRAS G12C Mutation

01/18/2022

Excerpt from the Press Release: – First clinical combination study of BBP-398 and LUMAKRAS set to evaluate safety and preliminary efficacy in solid tumors with the KRAS G12C mutation PALO ALTO, Calif., Jan. 13, 2022 (GLOBE NEWSWIRE) — BridgeBio Pharma, Inc. (Nasdaq: BBIO) (BridgeBio), a commercial-stage biopharmaceutical company focused on genetic diseases and cancers, today…

Read More

NIH Study Shows Using CareDx’s AlloSure Lung for Transplant Surveillance is More Effective than Diagnostic Bronchoscopy at Identifying Rejection

01/17/2022

ALARM Study Publication Shows Use of AlloSure for Home-Based, Non-invasive Surveillance Monitoring Can Provide a Safer Option for Lung Transplant Recipients Navigating the COVID-19 Pandemic Excerpt from the Press Release: SOUTH SAN FRANCISCO, Calif., Jan. 07, 2022 (GLOBE NEWSWIRE) — CareDx, Inc. (Nasdaq: CDNA) – The Transplant Company™ focused on the discovery, development, and commercialization…

Read More

4D Molecular Therapeutics Announces First Patient Dosed in Phase 1/2 Clinical Trial of 4D-150, a Dual-Transgene Intravitreal Gene Therapy for Patients with wet AMD

01/17/2022

Excerpt from the Press Release: EMERYVILLE, Calif., Jan. 06, 2022 (GLOBE NEWSWIRE) — 4D Molecular Therapeutics, Inc. (4DMT) (Nasdaq: FDMT), a clinical-stage gene therapy company harnessing the power of directed evolution for targeted gene therapies, announced that the first patient has been dosed in the Phase 1/2 clinical trial of 4D-150 for neovascular age-related macular…

Read More

Kriya Expands Gene Therapy Pipeline and Establishes Its Rare Disease Therapeutic Area Division With the Acquisition of Warden Bio

01/17/2022

Portfolio includes five investigational gene therapy programs for glycogen storage disorders that have no existing FDA-approved treatments available Warden Bio Co-Founder Kunal Kishnani joins as President of Kriya’s Rare Disease Division and will lead its overall strategic, development, and partnership activities Excerpt from the Press Release: REDWOOD CITY, Calif. & RESEARCH TRIANGLE PARK, N.C.–(BUSINESS WIRE)–Kriya…

Read More

BlueRock Therapeutics Announces Closeout of First Cohort in Phase 1 Trial in Patients with Advanced Parkinson’s Disease

01/14/2022

Excerpt from the Press Release: CAMBRIDGE, Mass., Jan. 6, 2022 /PRNewswire/ — BlueRock Therapeutics, a clinical stage biopharmaceutical company and wholly-owned subsidiary of Bayer AG, announced the closeout of the first of two cohorts in its ongoing Phase 1 (Ph1), open-label trial of pluripotent stem cell-derived dopaminergic neurons in patients with advanced Parkinson’s disease. The purpose of the Ph1 clinical trial…

Read More

Nuvalent Announces First Patient Dosed in ARROS-1 Phase 1/2 Clinical Trial of NVL-520, its Novel ROS1-selective Inhibitor

01/14/2022

ARROS-1 trial enrolling patients with advanced ROS1-positive NSCLC and other solid tumors Clinical development for parallel lead program, NVL-655, in ALK-positive cancers expected to begin in first half of 2022 Excerpt from the Press Release: CAMBRIDGE, Mass., Jan. 7, 2022 /PRNewswire/ — Nuvalent, Inc. (Nasdaq: NUVL), a biotechnology company creating precisely targeted therapies for clinically proven kinase targets in…

Read More

Clear Creek Bio Advances Its Highly Potent SARS-CoV-2 PLpro Inhibitors in Discovery of an Oral Direct-Acting Antiviral to Treat COVID-19

01/14/2022

Clear Creek Bio signed a CRADA with the NIH to support its SARS-CoV-2 PLpro inhibitor discovery This CRADA was initiated as part of the Antiviral Program for Pandemics (APP) Via APP, Clear Creek will be able to use the NIH’s current and expanded contract resources and NCATS laboratories to prioritize the advancement of antiviral candidates…

Read More

Sutro Biopharma Announces Interim Data from Dose-Expansion Cohort of STRO-002 Phase 1 Study for Patients with Advanced Ovarian Cancer

01/13/2022

Excerpt from the Press Release: – 33% Objective Response Rate (ORR) was observed in 33 RECIST evaluable patients across all FolRα expression levels and both dose levels. – Dose response was observed, with a 47% ORR in 17 patients who started at the 5.2 mg/kg dose level. – Tumor proportion score (TPS) was selected as…

Read More

Avalo Reports Positive Phase 1b Results for AVTX-002 in Moderate to Severe Crohn’s Disease Patients and Presents Additional Program Updates at 2022 Investor Event

01/12/2022

Immunology portfolio highlighted by success of a second positive study with AVTX-002 further validates the LIGHT mechanism of action in inflammatory diseases Efficacy signal demonstrated in heavily pre-treated subjects support further evaluation in inflammatory bowel disease patients’ refractory to three or more treatments, including anti-TNF alpha and other biologics Expands AVTX-002 target indications to include…

Read More

NANOBIOTIX Announces First Patient Enrolled in NANORAY-312 Global Phase III Registrational Study of NBTXR3 in Head and Neck Cancer

01/11/2022

First patient randomized in pivotal phase III study evaluating radiotherapy-activated NBTXR3 with or without cetuximab in high-risk elderly patients with locally advanced head and neck squamous cell carcinoma The randomized study is designed to demonstrate treatment outcome superiority of radiotherapy-activated NBTXR3 versus the standard of care for global registration The US Food and Drug Administration…

Read More