Feb. 22 Quick Takes: Sanofi, J&J in COVID vaccine manufacturing deal; plus AZ, Regeneron-Sanofi, Incyte, Ascletis, Novo-Altasciences, Regor
Sanofi (Euronext:SAN; NASDAQ:SNY) will formulate and fill about 12 million doses per month of the single-shot COVID-19 vaccine from Johnson & Johnson (NYSE:JNJ) following authorization. The candidate is under FDA and EMA review.
Sanofi is already producing more than 125 million doses of Comirnaty for Pfizer Inc. (NYSE:PFE) and BioNTech SE (NASDAQ:BNTX), and will continue to develop its own COVID-19 vaccine programs with partners GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) and Translate Bio Inc. (NASDAQ:TBIO).
AstraZeneca withdraws Imfinzi in U.S. for bladder cancer
AstraZeneca plc (LSE:AZN; NASDAQ:AZN) said it has withdrawn PD-L1 inhibitor Imfinzi durvalumab from the U.S. for the indication of previously treated patients with locally advanced or metastatic bladder cancer after the Phase III DANUBE trial failed to confirm earlier results. Imfinzi received accelerated approval in 2017 based on overall response data from the Phase I/II Study 1108 trial. AZ is still evaluating Imfinzi in three other Phase III trials for different types of bladder cancer: metastatic (the NILE trial); muscle invasive (NIAGARA); and non-muscle invasive (POTOMAC).
FDA approves Libtayo for first-line NSCLC
Regeneron Pharmaceuticals Inc. (NASDAQ:REGN) and Sanofi said FDA approved Libtayo cemiplimab-rwlc for first-line treatment of patients with advanced non-small cell lung cancer (NSCLC) whose tumors have high PD-L1 expression confirmed by companion diagnostic PD-L1 IHC 22C3 pharmDx from Agilent Technologies Inc. (NYSE:A). The PD-1 inhibitor gained its first FDA approval this month, for advanced basal cell carcinoma.
Lilly Asia Ventures leads $90M round for Regor
Regor Therapeutics raised $90 million in a series B financing led by Lilly Asia Ventures with participation from Loyal Valley Capital, Lanting Capital, TF Capital and Vertex Ventures China. Founded in July 2018 with backing from Qilu Pharmaceutical Co. Ltd., the Shanghai company is developing therapies to treat cancer, immune disorders and metabolic diseases.
Two priority reviews for Incyte’s ruxolitinib franchise
Incyte Corp. (NASDAQ:INCY) said FDA accepted and granted priority review for two applications for its JAK1/JAK2 inhibitor ruxolitinib: an sNDA for Jakafi ruxolitinib to treat graft-versus-host disease (GvHD) and an NDA for ruxolitinib cream to treat atopic dermatitis. Incyte used a Priority Review Voucher acquired for $120 million in September to shorten the review of ruxolitinib cream, which has a PDUFA date of June 21. The PDUFA date for the GvHD application is June 22.
Novo Holdings buys CRO Altasciences
Novo Holdings A/S is acquiring Altasciences from Audax Private Equity for an undisclosed amount. Headquartered in Quebec, Altasciences has six U.S.- and Canada-based facilities and offers preclinical safety testing, clinical pharmacology, bioanalytical, CRO and CDMO services.
Ascletis to advance THRβ agonist into Phase II NASH trial
Gannex, the non-alcoholic steatohepatitis (NASH) unit of Ascletis Pharma Inc. (HKEX:1672), plans to advance ASC41 into Phase II for NASH after preliminary data showed the THRβ agonist dosed over 28 days led to significant reductions in LDL-C, triglyceride and total cholesterol versus placebo in overweight and obese patients with elevated LDL-C.
JAK1 –Janus-like kinase 1
JAK2 –Janus-like kinase 2
PD-L1 (B7-H1; CD274) –Programmed cell death 1 ligand 1
THRβ – Thyroid hormone receptor β