FarmaKology Newsletter - Issue #70
Gel4Med is an early stage regenerative medicine company focused on developing our Therapeutic Materials Platform to address unmet clinical needs in soft tissue regeneration. Gel4Med, the Smart Materials Company paving the way to the future of regenerative medicine. We are a team of like-minded and determined individuals, all sharing a vision for the betterment of patient outcomes. We believe that our programmable materials technology has the potential to dramatically change the outcomes in tissue regeneration. We set out to change the industry as we know it, and we are doing just that.
Exscientia, a leading artificial intelligence (AI) driven pharmatech company, today announced the first AI-designed molecule for immuno-oncology to enter human clinical trials. The A2a receptor antagonist, which is in development for adult patients with advanced solid tumours, was co-invented and developed through a Joint Venture between Exscientia and Evotec, including application of Exscientia’s next generation 3-D evolutionary AI-design platform as part of Centaur Chemist®.
FDA Approves Trodelvy®, the First Treatment for Metastatic Triple-Negative Breast Cancer Shown to Improve Progression-Free Survival and Overall Survival
Gilead Sciences, Inc. announced that the FDA has granted full approval to Trodelvy® (sacituzumab govitecan-hziy) for adult patients with unresectable locally advanced or metastatic triple-negative breast cancer who have received two or more prior systemic therapies, at least one of them for metastatic disease. The approval is supported by data from the Phase 3 ASCENT study, in which Trodelvy demonstrated a statistically significant and clinically meaningful 57% reduction in the risk of disease worsening or death (progression-free survival ), extending median PFS to 4.8 months from 1.7 months with chemotherapy (HR: 0.43; 95% CI: 0.35-0.54; p<0.0001).
Roche announced the launch of the Elecsys Anti-p53 immunoassay for the in vitro quantitative determination of anti-p53 antibodies. This test is used to aid physicians to diagnose oesophageal cancer, bowel cancer and breast cancer in patients, in conjunction with other diagnostic tests. The assay is now available for all markets accepting the CE Mark.
Aprea Therapeutics Receives FDA Orphan Drug Designation for Eprenetapopt for the Treatment of Acute Myeloid Leukemia (AML)
Aprea Therapeutics, Inc. , a biopharmaceutical company focused on developing and commercializing novel cancer therapeutics that reactivate the mutant tumor suppressor protein, p53, announced that the U.S. Food and Drug Administration has granted Orphan Drug designation to eprenetapopt for treatment of AML.