Lineage Signs an Exclusive Option Agreement with Amasa Therapeutics to Supply and Use of Clinical-Grade Hystem Published: June 18, 2021 | Tags: Lineage, Option Agreement, Amasa Therapeutics, Clinical-Grade Hystem BioNTech Reports First Patient Dosing in P-II Clinical Trial of BNT111 to Treat Advanced Melanoma Published: June 18, 2021 | Tags: BioNTech, P-II, Clinical Trial, BNT111, […]Read More
Shots: Lineage to receive an upfront payment in cash and, if the option is exercised, Lineage will be eligible for additional payments, including event-specific payments, royalties on net sales and sublicense fees and royalties Amasa gets an exclusive option to royalty-bearing license to use Lineage’s HyStem technology to develop and commercialize therapies for solid tumors […]Read More
Shots: The first patient has been dosed in a P-II cancer vaccine trial evaluating the efficacy, tolerability & safety of BNT111 + Libtayo in combination or as monothx in 120 patients with anti-PD1 r/r unresectable Stage III or IV melanoma in EU. The company also plans to start P-II trial in 2 additional programs with […]Read More
Shots: CytoReason reports the initiation of a project with Sanofi by utilizing its cell-centered models and deconvolution techniques to counsel mechanistic insights for each asthma endotype The focus of the project is to drive a better understanding of heterogeneity in asthma patients and identify stable and reproducible asthma endotypes alongwith associated diagnostic features by using […]Read More
Shots: The first patient has been dosed in global P-III AdvanTIG-302 trial evaluating ociperlimab + tislelizumab in 605 naïve patients with locally advanced, unresectable, or metastatic NSCLC whose tumors exhibit high PD-L1 expression and do not harbor EGFR-sensitizing mutations or ALK translocations across the US, Australia & other countries globally The 1EPs of the trial […]Read More
Shots: Shoreline is eligible to receive ~$2.3B including upfront, development and commercialization milestones and additional payments along with royalties. The agreement follows Kite’s investment in Shoreline’s recent Series A financing The collaboration will utilize Shoreline’s iPSC differentiation and genetic reprogramming with Kite’s cell therapy to develop novel allogeneic therapies for hematologic malignancies Initially, the collaboration […]Read More
Shots: The first patient has been dosed in the P-III TOPAZ-1 study evaluating efficacy & safety of BIIB059 vs PBO in 540 adults with active SLE for 52 wks. The trial is expected to conduct at ~135 sites globally The 1EPs of study are to demonstrate a reduction in disease activity, proportion of patients achieve […]Read More
The US FDA has approved 4 NDAs and 1 BLAs in 2021, leading to treatments for patients and advances in the health care industry. The Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) have approved 29 novel products in 2021. Additionally, last year in 2020, the US FDA […]Read More
Shots: The P-II TANGO study evaluating the safety & efficacy of gosuranemab vs PBO in 654 patients aged 50–80 yrs with MCI due to AD or with mild AD for 78 wks across 97 sites, followed by a dose-blind long term extension period The trial did not meet its 1EPs i.e change from baseline on […]Read More
Shots: Atea Pharma achieved a milestone related to the development of AT-527 and is expecting to receive a related payment of $50M under its license agreement with Roche. The company believes that AT-527 is suitable for use in both pre-and post-exposure prophylactic settings and complementary to vaccines The companies are jointly developing AT-527 for the […]Read More
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