COVID19 pipeline advances as Novartis begins phase III trial of hydroxychloroquine; and advancements in RCC, and HER2 positive breast cancer market

The U.S. FDA has given its nod to Seattle Genetics for its Tukysa (tucatinib) for advanced unresectable or metastatic HER2-positive breast cancer

Tukysa (tucatinib) is a tyrosine kinase inhibitor of the HER2 protein, administered orally in combination with chemotherapy agents trastuzumab and capecitabine to adults with metastatic HER2+ breast cancer. The drug has shown inhibitory properties in phosphorylation of HER2 and HER3 under in-vitro lab studies. The study observed a significant reduction in the risk of cancer progression or death (PFS) compared to patients who received trastuzumab and capecitabine alone.

The drug came is a collaborative project of Project Orbis, a multinational partnership between the FDA, the Australian Therapeutic Goods Administration (TGA), Health Canada, Health Sciences Authority (HSA, Singapore) and Swissmedic (SMC, Switzerland).

Novartis announces to begin a Phase III trial to evaluate the efficacy of hydroxychloroquine in hospitalized patients with COVID-19 disease

Sandoz, a generic drug developer subsidiary of Novartis manufactures hydroxychloroquine for the treatment of lupus, malaria, and rheumatoid arthritis. However, recent claims, anecdotal evidences, and political debate regarding the drug has touted the drug the one that might upend all the Covid-19 concerns. 
The trial will be conducted at various sites in the United States, with the enrolment of the 440-patient trial over the next few weeks. Novartis is not the only one in the field studying the effect of hydroxychloroquine on COVID-19 patients. The University of Minnesota, the University of Washington, the National Institutes of Health are conducting trails along with others in China that have reportedly shown benefits in providing relief to COVID-19 patients. COVID-19 pipeline is further being advanced by several pharma companies including Roche, GSK, Gilead, Regeneron, Inovio Pharmaceuticals, and others.

Bristol Myers Squibb and Exelixis anticipates for approval of their combination therapy of Opdivo and Cabometyx for renal cell carcinoma

In a late-stage, pivotal Phase III CheckMate -9ER study, a combination of Opdivo and Cabometyx successfully met its primary endpoint of progression-free survival.The trial showed significant improvement in progression-free survival, and secondary endpoints of overall survival and objective response rate vs. sunitinib in previously untreated renal cell carcinoma. BMS’ checkpoint inhibitor Opdivo (nivolumab) and Renal cell carcinoma drug Cabometix (cabozantinib) were tested against Pfizer’s Sutent (sunitinib), another approved RCC drug.

SOM Biotech announces the beginning of in-vitro validation of three drug candidates as new therapies for the treatment of COVID-19

 The three drug candidates, Eravacycline, Prexasertib, and Cynarine – are inhibitors of the main protease of SARS-CoV-2, and are underway to be repurposed to treat COVID-19. The company is leveraging its AI-based screening technology – SOMAIPRO – for the identification of inhibitors of the 3CL proteases of SARS-CoV-2, SARS-CoV and MERS-CoV viruses as potential candidates to treat COVID-19.

The drugs were discovered in joint research conducted by SOM Biotech and the Department of Pharmacy and Pharmaceutical Sciences led by Professor Dong-Hae Shin from Ewha Woman’s University in South Korea.