Oncology

Innovent Announces NMPA Acceptance of a Supplemental New Drug Application for Sintilimab in Combination with Chemotherapy as First-Line Treatment for Advanced or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma

11/09/2021

Excerpt from the Press Release: SAN FRANCISCO and SUZHOU, China, Nov. 4, 2021 /PRNewswire/ — Innovent Biologics, Inc. (Innovent) (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of cancer, metabolic, autoimmune and other major diseases, today announced that the National Medical Products Administration (NMPA) of China has accepted the supplemental New Drug Application…

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Ambrx Biopharma Inc. Announces First Patient Dosed in its Global Phase 2 ACE-Breast-03 Clinical Study of ARX788 for the Treatment of HER2-Positive Metastatic Breast Cancer

11/08/2021

Excerpt from the Press Release: SAN DIEGO–(BUSINESS WIRE)–Ambrx Biopharma Inc., or Ambrx, (NYSE: AMAM), a clinical stage biopharmaceutical company using an expanded genetic code technology platform to create Engineered Precision Biologics, today announced the first patient has been dosed in its global ACE-Breast-03 Phase 2 clinical study of ARX788 in patients with HER2-positive metastatic breast…

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Kezar Announces First Patient Dosed in Phase 1 Trial of KZR-261 in Advanced Solid Tumor Malignancies

11/05/2021

Excerpt from the Press Release: SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Kezar Life Sciences, Inc. (Nasdaq: KZR), a clinical-stage biotechnology company discovering and developing breakthrough treatments for immune-mediated and oncologic disorders, today announced that the first patient has been dosed in KZR-261-101, a Phase 1 clinical trial evaluating KZR-261, a novel, broad-spectrum, anti-tumor agent that acts through direct…

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DiaCarta’s ColoScape™ Assay Detects Precancerous Colorectal Cancer Lesions and Colorectal Cancer Mutations with High Sensitivity

11/05/2021

Excerpt from the Press Release: PLEASANTON, Calif., Oct. 27, 2021 /PRNewswire/ — DiaCarta Inc., a precision molecular diagnostics company and leading developer of novel oncology tests using liquid biopsy, today announced the publication of a study in PLOS ONE that demonstrates that DiaCarta’s ColoScape™ Xenonucleic Acid (XNA)-mediated quantitative real-time polymerase chain reactions (qPCR) clamping assay detects mutant cell-free DNA (cfDNA)…

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XtalPi and Signet Expand AI Drug Discovery Collaboration to Novel Cancer Target

11/04/2021

Excerpt from the Press Release: SHENZHEN, China and BOSTON, Oct. 27, 2021 /PRNewswire/ — Signet Therapeutics and XtalPi Inc., a physics-based, AI-powered drug R&D company, announced the expansion of their AI drug discovery collaboration to include a new first-in-class program against a novel cancer target identified by Signet. The two companies entered into a strategic collaboration in 2020 and…

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Candel Therapeutics Announces Patient-Reported Tolerability Data of Intraprostatic Injections in Ongoing Phase 3 Clinical Trial of CAN-2409 in Patients with Localized Prostate Cancer

11/04/2021

Excerpt from the Press Release: NEEDHAM, Mass., Oct. 28, 2021 (GLOBE NEWSWIRE) — Candel Therapeutics, Inc. (Nasdaq: CADL), a late clinical stage biopharmaceutical company developing novel oncolytic viral immunotherapies, today announced that data on patient-reported tolerability assessment of intraprostatic injections will be presented in a virtual poster session at the 28th Annual Prostate Cancer Foundation Scientific Retreat.  Date: Thursday, October 28, 2021  Presenter: Laura K. Aguilar, MD, PhD, Chief Medical Officer at…

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Synthekine Advances IL-2 Partial Agonist, STK-012, into Clinical Investigation for Treatment of Solid Tumors

11/03/2021

Excerpt from the Press Release: MENLO PARK, Calif.–(BUSINESS WIRE)–Synthekine Inc., an engineered cytokine therapeutics company, today announced it is advancing its IL-2 partial agonist, STK-012, into clinical investigation following clearance of its investigational new drug (IND) application by the U.S. Food and Drug Administration (FDA). Synthekine will evaluate STK-012 in a Phase 1a/1b, open-label, multi-center,…

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HUYABIO Announces FDA Clearance to Initiate a Phase 1 Trial of SHP2 Inhibitor in Patients with KRAS and EGFR Mutated Tumors

11/01/2021

Excerpt from the Press Release: SAN DIEGO, Oct. 28, 2021 /PRNewswire/ — HUYABIO International (HUYABIO™), the leader in accelerating global development of China’s pharmaceutical innovations, announced today the FDA clearance of HBI-2376 as an Investigational New Drug, or IND, for a Phase 1 study. The authorization to proceed enables the first testing in patients for whom…

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Gilead Announces Clinical Trial Collaboration With Merck to Evaluate Trodelvy® (sacituzumab govitecan-hziy) in Combination With KEYTRUDA® (pembrolizumab) in Patients With First-Line Metastatic Triple-Negative Breast Cancer

11/01/2021

Excerpt from the Press Release: FOSTER CITY, Calif.–(BUSINESS WIRE)–Oct. 28, 2021– Gilead Sciences, Inc. (Nasdaq: GILD) today announced it has entered into a clinical trial collaboration and supply agreement with Merck (known as MSD outside of the United States and Canada) to evaluate the efficacy of Gilead’s Trop-2 targeting antibody-drug conjugate Trodelvy® (sacituzumab govitecan-hziy) in…

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BridgeBio Pharma Announces Collaborations with Columbia University and Mount Sinai to Develop Potential Therapies for Genetic Diseases and Cancers

11/01/2021

– The new agreements mean BridgeBio has collaborations with 25 leading academic institutions focused on genetic disease and precision oncology Excerpt from the Press Release: PALO ALTO, Calif., Oct. 29, 2021 /PRNewswire/ — BridgeBio Pharma, Inc. (Nasdaq: BBIO), a commercial-stage biopharmaceutical company focused on genetic diseases and cancers, today announced two new academic collaborations with Columbia University…

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