ClinicalResearch

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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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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Moderna Announces Submission of Initial Data to U.S. FDA for Its COVID-19 Vaccine Booster

09/16/2021

mRNA-1273 at 50 µg dose level induced robust antibody responses of more than 40x against the Delta variant (B.1.617.2) CAMBRIDGE, Mass.–(BUSINESS WIRE)–Moderna, Inc. (Nasdaq:MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced it has initiated its submission to the U.S. Food and Drug Administration (FDA) for the evaluation of a booster dose…

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Pliant Therapeutics Reports Positive Interim Results from Phase 2a PET Imaging Clinical Trial in Patients with Idiopathic Pulmonary Fibrosis

09/16/2021

Excerpt from the Press Release: – Single dose administration of PLN-74809 achieved αvβ6 target engagement up to 98% in the lungs of IPF patients – All doses achieved target engagement above the threshold for predicted anti-fibrotic activity, with an observed dose-response relationship – PLN-74809 reached highly fibrotic regions of the lung and was bound to αvβ6 in IPF…

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HeartFlow Announces Enrollment of First Three Patients in FUSION Trial

09/16/2021

Excerpt from the Press Release: National Health Care Institute of the Netherlands-supported study to evaluate role of the HeartFlow Analysis in reducing unnecessary invasive procedures REDWOOD CITY, Calif.–(BUSINESS WIRE)–HeartFlow, Inc., the leader in revolutionizing precision heart care, today announced that physicians at Erasmus MC Hospital (Rotterdam NL) have enrolled the first three patients in the…

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R3 Vascular Reports the Initiation of Its First-In-Human Clinical Study

09/15/2021

“Clinical development of our bioresorbable sirolimus-eluting scaffold for treating peripheral arterial disease (PAD) is proceeding ahead of schedule and achieving outstanding procedural results,” said Kamal Ramzipoor, CEO of R3 Vascular. Excerpt from the Press Release: MOUNTAIN VIEW, Calif.–(BUSINESS WIRE)–R3 Vascular Inc. today reported the successful initiation of its First-in-Human clinical study evaluating the technical and…

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