Month: September 2021

TCR² Therapeutics Announces Positive Interim Results from Ongoing Phase 1/2 Trial of Gavo-cel for Treatment Refractory Mesothelin-Expressing Solid Tumors

09/22/2021

Excerpt from the Press Release: – Clinical activity observed in all three mesothelin-expressing tumor types treated – Gavo-cel disease control rate (DCR) 81% with tumor regression in 15 of 16 evaluable patients – Overall response rate (ORR) 31% in patients infused with gavo-cel following lymphodepletion – Meaningful survival benefit at 11.2 months for patients with…

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Moderna Announces Health Canada Approves its COVID-19 Vaccine

09/21/2021

Excerpt from the Press Release: CAMBRIDGE, Mass.–(BUSINESS WIRE)–Moderna, Inc. (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced Health Canada has approved the New Drug Submission (NDS-CV) for SPIKEVAX™ (elasomeran mRNA vaccine), which has been known as COVID-19 Vaccine Moderna, for active immunization to prevent COVID-19 in individuals 12 years…

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Bristol Myers Squibb Receives Positive CHMP Opinion for Opdivo (nivolumab) + Chemotherapy for Patients with HER2-Negative Advanced or Metastatic Gastric, Gastroesophageal Junction or Esophageal Adenocarcinoma whose Tumors Express PD-L1 with CPS ≥ 5

09/21/2021

Recommendation based on positive results from the pivotal Phase 3 CheckMate -649 trial in which Opdivo plus chemotherapy demonstrated superior overall survival versus chemotherapy Excerpt from the Press Release: PRINCETON, N.J.–(BUSINESS WIRE)–Bristol Myers Squibb (NYSE: BMY) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has…

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F-star Therapeutics to Present FS120 Phase 1 Trial-in-Progress Update at ESMO 2021

09/21/2021

Excerpt from the Press Release: Preclinical Data Indicates a Broad Therapeutic Window for F-star’s First-in-Class Tetravalent Dual T cell Agonist CAMBRIDGE, United Kingdom and CAMBRIDGE, Mass., Sept. 16, 2021 (GLOBE NEWSWIRE) — F-star Therapeutics, Inc. (NASDAQ: FSTX), a clinical-stage biopharmaceutical company dedicated to developing next generation bispecific immunotherapies to transform the lives of patients with cancer,…

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Carrick Therapeutics Presents Encouraging Initial Efficacy for Samuraciclib (CT-7001) in Combination with Fulvestrant in Advanced HR+, HER2- Breast Cancer Patients at ESMO Congress 2021

09/20/2021

Excerpt from the Press Release: Phase 2a Tolerability and Efficacy Data Supports Further Clinical Development of Samuraciclib in Combination with Fulvestrant in HR+, HER2- Breast Cancer Previously Treated with a CDK4/6 Inhibitor DUBLIN, Ireland and BOSTON, Sept. 16, 2021 (GLOBE NEWSWIRE) — Carrick Therapeutics, an oncology-focused biopharmaceutical company discovering and developing highly differentiated therapies, today…

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Combination of Balstilimab Plus Zalifrelimab Doubles Responses in 2L Cervical Cancer in Data to Be Presented at ESMO

09/20/2021

Excerpt from the Press Release: Objective response rate of 33% and median duration of response not reached with 19.4 months median follow-up in PD-L1+ tumors; expands benefit of anti-PD-1 alone Improved responses seen across all histology subgroups including populations of patients unresponsive to other therapies Dr. David O’Malley to present data in an oral presentation…

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Gritstone Announces Dosing of First Solid Tumor Patient with Optimized SLATE “Off-the-Shelf” Mutant KRAS-directed Neoantigen Immunotherapy in Phase 2 Clinical Trial

09/20/2021

Excerpt from the Press Release: SLATE version (v) 1, Gritstone’s “off the-shelf” neoantigen immunotherapy (including KRAS, TP53 mutations), elicited multiple molecular responses and an unconfirmed RECIST radiologic response in patients with NSCLC who had progressed on prior immunotherapy SLATE v2 (a mutant KRAS-focused version), which is optimized for increased immune response, has been administered to…

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Lucence Presents Data at ESMO 2021 Showing Liquid Biopsy Detects Actionable Genomic Alterations in Bladder Cancer Patients Undergoing Immunotherapy

09/17/2021

Study conducted with investigators at Dana-Farber Cancer Institute showed ctDNA changes pre- and post-ICI therapy associated with resistance to treatment; Suggests liquid biopsy may be a useful tool for personalizing immunotherapy in patients with metastatic urothelial carcinoma Excerpt from the Press Release: PALO ALTO, Calif.–(BUSINESS WIRE)–Precision oncology company Lucence, in collaboration with researchers at Dana-Farber…

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Kinnate Biopharma Inc. Presents Preclinical Data on its Lead FGFR Inhibitor Candidate at the JCA-AACR Precision Cancer Medicine International Conference

09/17/2021

KIN-3248 demonstrates highly-selective, potent, and broad-spectrum activity against mutations in both the FGFR2 and FGFR3 kinase domains – including acquired gatekeeper, molecular brake, and activation loop resistance mutations Excerpt from the Press Release: SAN FRANCISCO and SAN DIEGO, Sept. 13, 2021 (GLOBE NEWSWIRE) — Kinnate Biopharma Inc. (Nasdaq: KNTE) (“Kinnate”), a biopharmaceutical company focused on…

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GT Biopharma Advances GTB-3650, a Second-Generation Tri-Specific Killer Engager -TriKE®, Into IND-Enabling Studies

09/17/2021

– GTB-3650 is a novel molecule based on camelid single-domain antibody technology with advantages that build upon the strong proof-of-concept data from the Company’s first-generation TriKE® program, GTB-3550 – GTB-3650 has shown significantly higher potency than GTB-3550 in preclinical models, as detailed in a recent peer reviewed publication¹ – Company now plans to accelerate its…

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