Sorrento Therapeutics rallies on DARPA-JPEO contract to SmartPharm
Defense Advanced Research Projects Agency (DARPA) co-funded by the Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND) awarded SmartPharm Therapeutics, wholly-owned subsidiary of Sorrento Therapeutics (NASDAQ:SRNE) +17% PM, a contract for developing a rapid countermeasure to COVID-19.
Under the contract, SmartPharm would be provided with $34M for development through Phase 2 clinical studies of a gene-encoded antibody (Gene MAb) that could enable rapid protection from and/or treatment of SARS-CoV-2 infection and COVID-19.
It would seek further funding for EUA approval and large-scale manufacturing pending successful clinical studies.
For the Gene MAb approach, the SmartPharm/Sorrento team will produce plasmid DNA encoding the SARS-CoV-2 neutralizing antibody STI-2020; currently, FDA is reviewing IND filings for STI-2020 as an IV-delivered neutralizing antibody and STI-2099 as an intranasal-delivered neutralizing antibody for the treatment of COVID-19.
Exelixis/Takeda’s Cabometyx Ok’d in Japan for liver cancer
Exelixis’ (NASDAQ:EXEL) partner Takeda Pharmaceutical (NYSE:TAK) has received Japanese approval to manufacture and market Cabometyx as a treatment for patients with unresectable hepatocellular carcinoma (HCC) that has progressed after prior systemic therapy.
Per the terms of Exelixis and Takeda’s license agreement, Exelixis is eligible to receive a $15M milestone payment from Takeda upon the first commercial sale of Cabometyx for HCC, which is expected to occur in Q4 2020.
FDA OKs Rhythm Pharma’s Imcivree for weight management in obese patients
The FDA has approved Rhythm Pharmaceuticals’ (NASDAQ:RYTM) Imcivree (setmelanotide) for chronic weight management in adult and pediatric patients 6 years of age and older with obesity due to proopiomelanocortin (POMC), proprotein convertase subtilisin/kexin type 1 (PCSK1) or leptin receptor (LEPR) deficiency confirmed by genetic testing.
With this approval, Imcivree becomes the first-ever FDA approved therapy for these rare genetic diseases of obesity.
The company expects to make Imcivree commercially available in U.S. in Q1 2021.
With this approval, the FDA issued a Rare Pediatric Disease Priority Review Voucher to Rhythm. The voucher can be used for accelerated approval of a future application or it can be sold to a third party.
Rhythm’s marketing application for setmelanotide to treat people living with obesity is currently under EMA review.
The company will host conference call today at 9:30 a.m. ET to discuss the FDA approval of Imcivree.
Shares up 4% premarket.
AstraZeneca to supply 26M doses of COVID-19 vaccine to Thailand
Thailand has signed a deal to procure 26M doses of AstraZeneca’s (NASDAQ:AZN) COVID-19 vaccine developed in collaboration with Oxford University. Vaccine delivery is expected in mid-2021.
Thailand’s National Vaccine Institute signed a non-refundable advance market commitment contract worth 2.38B baht ($79M) with AZN to reserve the supply of the vaccine candidate.
Another 3.67B baht ($121M) agreement for the purchase of the trial vaccine, known as AZD1222, was signed by the Health Ministry’s Disease Control Department.
Under a separate deal in October, the Health Ministry, Siam Bioscience and the SCG business conglomerate signed a letter of intent with AstraZeneca on the manufacturing and supply of the AZD1222.
It would allow Siam Bioscience to produce the vaccine at its own plant, with a starting date targeted for the mid 2021.
Astellas Pharma and FibroGen’s roxadustat Ok’d in Japan for renal anemia
Japan’s Ministry of Health, Labor and Welfare has approved Astellas Pharma (OTCPK:ALPMF) and FibroGen’s (NASDAQ:FGEN) EVRENZO (roxadustat) for the treatment of anemia in non-dialysis-dependent adults with stage 3-5 chronic kidney disease.
The approval is based on results obtained from three clinical studies in more than 500 Japanese patients with anemia of CKD not on dialysis. Previously, the company announced positive results from a Phase 3 clinical trial, DOLOMITES, evaluating roxadustat for the treatment of anemia in non-dialysis-dependent adults with stage 3-5 chronic kidney disease. Roxadustat was generally well tolerated, and the safety profile was comparable with that of darbepoetin alfa.
The other two studies (one Phase 3 and one Phase 2) support the safety and efficacy of roxadustat in erythropoiesis-stimulating agent (ESA)-untreated patients.
The approval of the supplementary New Drug Application (sNDA) for roxadustat triggers a milestone payment of $15M by Astellas to FibroGen.
Roxadustat is an orally administered small molecule inhibitor of hypoxia-inducible factor (HIF) prolyl hydroxylase. HIF is a protein transcription factor that “turns on” the production of red blood cells (erythropoiesis). Its value proposition is the ability to maintain hemoglobin levels without affecting inflammation and potentially avoiding the need for ongoing intravenous iron repletion therapy as needed with bone marrow stimulating agents like Aranesp and Johnson & Johnson’s (JNJ) Procrit (epoetin alfa).