News & Updates

Vigeo Therapeutics Advances VT1021 Into Phase 2-3 Registrational Study for Glioblastoma

01/28/2022

VT1021 Selected by Global Coalition for Adaptive Research (GCAR) for Inclusion in Its GBM AGILE Phase 2-3 Adaptive Platform Trial for Patients with Glioblastoma Excerpt from the Press Release: CAMBRIDGE, Mass., Jan. 20, 2022 /PRNewswire/ — Vigeo Therapeutics, a clinical-stage immuno-oncology company pioneering novel cancer therapies, today announced its lead candidate VT1021 will advance into a Phase 2-3 registrational…

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Jubilant Therapeutics Announces FDA Clearance of IND for JBI-802, a Novel Dual LSD1 and HDAC6 Inhibitor, for treatment of Solid Tumors

01/28/2022

Excerpt from the Press Release: BEDMINSTER, N.J., Jan. 6, 2022 /PRNewswire/ — Jubilant Therapeutics Inc, a biopharmaceutical company advancing small molecule precision therapeutics to address unmet medical needs in oncology and autoimmune diseases, today announced U.S. Food and Drug Administration (FDA) clearance of the investigational new drug application (IND) for JBI-802, a novel, oral, potent and selective dual…

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Xilio Therapeutics Announces Initiation of Patient Dosing in Phase 1/2 Clinical Trial of XTX202 for the Treatment of Patients with Solid Tumors

01/28/2022

Excerpt from the Press Release: WALTHAM, Mass., Jan. 20, 2022 (GLOBE NEWSWIRE) — Xilio Therapeutics, Inc. (Nasdaq: XLO), a biotechnology company developing tumor-selective immuno-oncology therapies for people living with cancer, today announced that the first patient has been dosed in the company’s Phase 1/2 clinical trial evaluating XTX202 for the treatment of solid tumors. XTX202 is a modified form…

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Turning Point Therapeutics Announces FDA Clearance of Investigational New Drug (IND) Application for Combination of Elzovantinib and Aumolertinib in EGFR Mutant Met-Amplified Non-Small Cell Lung Cancer

01/27/2022

Excerpt from the Press Release: SAN DIEGO, Jan. 20, 2022 (GLOBE NEWSWIRE) — Turning Point Therapeutics, Inc. (NASDAQ: TPTX), a precision oncology company developing next-generation therapies that target genetic drivers of cancer, today announced that the company has received clearance from the FDA for the company’s Investigational New Drug (IND) application for the combination of…

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Bluestar Genomics Presents Positive Results of its Pancreatic Cancer Test Performance Evaluation at 2022 ASCO GI Cancers Symposium

01/27/2022

Excerpt from the Press Release: SAN DIEGO–(BUSINESS WIRE)–Bluestar Genomics, Inc., an early cancer detection company leading the development and commercialization of next-generation liquid biopsy approaches initially focused on non-invasive detection of high-mortality cancers, today announced positive performance evaluation study results for its pancreatic cancer test. These data confirm that its pancreatic cancer test detects the…

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Senhwa’s Silmitasertib Receives US FDA Orphan Drug Designation for the Treatment of Biliary Tract Cancer

01/27/2022

Excerpt from the Press Release: TAIPEI and SAN DIEGO, Jan. 20, 2022 /PRNewswire/ — Senhwa Biosciences, Inc. (TPEx: 6492), a drug development company focusing on first-in-class therapeutics for oncology, rare diseases, and novel coronaviruses, announced that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) for Silmitasertib, a highly selective inhibitor of…

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LANNETT ANNOUNCES FDA COMPLETES REVIEW OF INVESTIGATIONAL NEW DRUG (IND) APPLICATION FOR BIOSIMILAR INSULIN GLARGINE

01/26/2022

–FDA States Pivotal Clinical Trial May Proceed, Trial Expected to Commence By March 2022– Excerpt from the Press Release: PHILADELPHIA, Jan. 21, 2022 /PRNewswire/ — Lannett Company, Inc. (NYSE: LCI) today announced that the U.S. Food and Drug Administration (FDA) has notified the company that they have completed the safety review of the Investigational New…

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Circulating Tumor Cell (CTC) Isolation with TellDx Technology Could Inform Personalized Drug Treatment in Prostate Cancer

01/26/2022

— Single-cell proteomics can elucidate kinase activity in prostate cancer models — — Kinase activity in bone metastases and epithelial circulating tumor cells is elevated — Excerpt from the Press Release: BEVERLY, Mass., Jan. 20, 2022 (GLOBE NEWSWIRE) — TellBio, Inc., a development stage biotechnology company focused on revolutionizing the detection of cancer through its…

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Kura Oncology Receives FDA Authorization to Proceed with Phase 1b Study of KO-539 in Acute Myeloid Leukemia

01/26/2022

– FDA lifts partial clinical hold following agreement on mitigation strategy for differentiation syndrome – – KOMET-001 study to resume screening and enrollment of new patients – – Encouraging safety, tolerability and clinical activity observed among patients on study – Excerpt from the Press Release: SAN DIEGO, Jan. 20, 2022 (GLOBE NEWSWIRE) — Kura Oncology,…

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Yingli Pharma and MD Anderson Initiate Strategic Collaboration to Advance Development of Multiple Oncology Programs

01/25/2022

Five-year collaboration to provide support for clinical and preclinical efforts as Yingli Pharma expands its U.S. presence with robust oncology pipeline Excerpt from the Press Release: SAN FRANCISCO and HOUSTON, Jan. 20, 2022 (GLOBE NEWSWIRE) — Yingli Pharma US, Inc. (the “Company” or “Yingli”), a biotechnology company developing innovative small molecules, and The University of…

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