Immunomedics discontinues its trial early – hopes for accelerated approval of Sacituzumab govitecan for mTNBC
Immunomedics– a New Jersey-based pharmaceutical company has announced to freeze its Phase III confirmatory ASCENT clinical trial of sacituzumab govitecan aimed at treating metastatic triple-negative breast cancer (mTNBC).
An independent Data Safety Monitoring Committee (DSMC) recommended they stop the trial because of “compelling evidence of efficacy.”
The company, focused on developing antibody-drug conjugates for the treatment of cancer, is waiting on the results of its resubmission of accelerated approval of the drug under review by the FDA. The company is hopeful of getting the recommendation upon a successful meeting of multiple endpoints in the ASCENT study.
GSK, Vir Biotechnology collaborates to advance therapy development for COVID-19
GlaxoSmithKline has announced to partner with Vir Biotechnology to improve research and development and develop a cure for the treatment of COVID-19.
The collaboration has planned to use Vir’s proprietary monoclonal antibody platform technology to identify new anti-viral antibodies and accelerate the development of existing ones to be used as a therapeutic option against COVID-19. However, the primary focus would be on the development of VIR-7831 and VIR-7832 – which have shown a high affinity for SARS-CoV-2 SPIKE PROTEIN.
Under terms of the deal, GSK has made a USD 250 million equity investment into Vir.
FDA accepts IND application for Inovio’s INO-4800 – DNA vaccine against SARS CoV-2
Inovio Pharmaceuticals has received Investigational New Drug (IND) for its INO-4800 by the FDA, facilitating its way ahead to initiate Phase I clinical trials.
The company would initiate Phase 1 clinical testing of INO-4800 in healthy volunteers beginning today. The trial would recruit up to 40 healthy adults in Philadelphia and Kansas. Preclinical data shows hopeful immune response results across multiple animal models. Additional preclinical trials, including challenge studies, will continue in parallel with the Phase 1 clinical trial.
Pfizer and The Pfizer Foundation commits USD 40 Million, fosters the efforts to combat COVID crisis
Pfizer and The Pfizer Foundation has announced to donate USD 40 million in medical and charitable cash grants to encourage the efforts to tackle COVID-19 in the US and all over the world.
The company plans on expanding product assessment and mobilize its colleagues to Combat COVID-19 Pandemic. The donation would be used to address the urgent needs of its partners working to prevent the transmission of the virus.
Pfizer is also evolving its US Patient Assistance Program and donating additional critical medicines and vaccines.