Altimmune Inc., of Gaithersburg, Md., reported preclinical data on ALT-702, a synthetic peptide designed to retain and concentrate immunostimulants within the tumor environment. In a murine CT26 colorectal carcinoma cell line model with two tumors, three injections of ALT-702 in one tumor plus an anti-CTLA4 antibody administered intraperitoneally produced 88% tumor regression in the injected tumors and 38% reduction of the non-injection lesions. Overall survival of mice treated with ALT-702 plus anti-CTLA4 was markedly better than mice treated with either agent alone.
Basilea Pharmaceutica Ltd., of Basel, Switzerland, will present preclinical data on derazantinib at the Gastrointestinal Cancers Symposium of the American Society of Clinical Oncology in San Francisco. In patient-derived mouse models of biliary, gastric and colorectal cancer with FGFR gene fusions, mutations and amplifications, derazantinib produced strong responses, including complete tumor regression in gastric cancer models with FGFR2 gene fusions.
Duckhorn Ventures Ltd., of Vancouver, British Columbia, and Enosi Life Sciences Corp. restructured their proposed transaction. Duckhorn will be issued 825,000 shares of Enosi to satisfy the obligations Enosi owed to Duckhorn.
Evoke Pharma Inc., of Solana Beach, Calif., and Eversana Life Science Services LLC, of Chicago, are collaborating on the U.S. commercialization and distribution of Gimoti, Evoke's nasal spray for acute and recurrent diabetic gastroparesis. Eversana will fund and manage substantially all of the sales activities for Gimoti. Certain costs will be reimbursed by Evoke, and Eversana will earn a percentage of product profits in the mid to high teens when Gimoti net sales surpass certain administrative, manufacturing and commercialization costs. Evoke will record sales of the drug and retain more than 80% of profits for the product. The FDA is currently reviewing the marketing application for Gimoti, with a PDUFA date of June 19, 2020.
Evotec SE and Indivumed GmbH, both of Hamburg, Germany, entered a second research collaboration, which will focus on treatments for non-small-cell lung cancer. Indivumed will contribute its Indivutype cancer database and artificial intelligence capabilities, while Evotec adds its bioinformatics analysis platform Panhunter, as well as its small-molecule and antibody discovery capabilities. Financial terms of the deal weren't disclosed.
Inovio Pharmaceuticals Inc., of Plymouth Meeting, Pa., said the Coalition for Epidemic Preparedness Innovations (CEPI) has awarded Inovio a grant of up to $9 million to develop a vaccine against the recently emerged strain of coronavirus (2019-nCoV) that has killed numerous people and infected hundreds more in China. The initial CEPI funding will support Inovio's preclinical and clinical development through phase I testing of INO-4800, its new coronavirus vaccine matched to the outbreak strain. CEPI previously awarded Inovio a grant of up to $56 million for the development of vaccines against Lassa fever and Middle East respiratory syndrome, also caused by a coronavirus.
Moderna Inc., of Cambridge, Mass., is collaborating with the Coalition for Epidemic Preparedness Innovations (CEPI) to develop an mRNA vaccine against the 2019-nCoV coronavirus. CEPI will fund the manufacturing, which Moderna will conduct. The National Institute of Allergy and Infectious Diseases will conduct IND-enabling studies and a phase I trial.
Onconova Therapeutics Inc., of Newtown, Pa., regained the rights to rigosertib in greater China. Onconova regained the rights from Hanx Biopharmaceuticals Inc., of Wuhan, China, as a result of the termination of the Onconova-Hanx license agreement pursuant to its terms due to Hanx failing to make required payments under the agreement. In exchange for transition assistance and upon further regulatory, development and commercial progress in greater China, Hanx may be eligible to receive from Onconova incentive milestones and royalty payments.
Paion AG, of Aachen, Germany, is due milestone payments of between €1.5 million (US$1.7 million) and €2.5 million from Mundipharma International Ltd., of Cambridge, U.K., triggered by Japanese regulators’ approval of Anerem (remimazolam) for use in general anesthesia.
Pfizer Inc., of New York, has launched two new biosimilars, Zirabev (bevacizumab-bvzr) and Ruxience (rituximab-pvvr), in the U.S. and plans to launch a third, Trazimera (trastuzumab-qyyp), on Feb. 15, 2020. The company plans to price the drugs at the lowest wholesale acquisition cost for the equivalent biosimilar drugs currently on the market. In separate news, Pfizer launched its Vaccines Division’s Centers of Excellence Network with the first Center of Excellence at the University of Louisville. Pfizer will provide funding of up to $6.5 million for a one-year study of the incidence of infectious diarrhea and up to $4.5 million for a one-year study of the incidence of pneumonia. A second global center is scheduled to be launched in the first half of 2020. Pfizer also disclosed that, through its Greenstone unit, it is collaborating with digital health clinical Ro, of New York, through its Roman digital health care clinic for men, to sell an authorized generic version of Viagra (sildenafil citrate). Roman will source its generic exclusively from Greenstone. Terms of the deal weren't disclosed.
Sanofi SA, of Paris, completed its acquisition of Synthorx Inc., of San Diego, for $68 per share in cash. The minimum tender condition and all of the other conditions to the offer have been satisfied. Sanofi and its wholly owned subsidiary, Thunder Acquisition Corp., accepted for payment and will promptly pay for all shares validly tendered and not properly withdrawn.
Seelos Therapeutics Inc., of New York, offered an update regarding its development programs for SLS-005 (trehalose) in Europe and the U.S. Seelos has scheduled a meeting in March 2020 to meet with the EMA to seek scientific advice and protocol assistance for a European clinical study of SLS-005 in patients with Sanfilippo syndrome type A and B. Seelos also has submitted to the FDA a protocol for its planned expanded access study for Sanfilippo syndrome type C and D patients as well as type A and B patients who do not meet the phase IIb/III trial entry criteria.
Summit Therapeutics plc, of Oxford, U.K., said the Biomedical Advanced Research and Development Authority has expanded its award for the clinical and regulatory development of Summit’s precision antibiotic ridinilazole for the treatment of Clostridium difficile infection by $8.8 million. The additional funding is being provided to support a new trial in adolescent patients and brings the total value of the award to up to $72.5 million. The adolescent trial is expected to support an NDA for ridinilazole and also form part of a package of work with the potential to provide an additional six months market exclusivity in the U.S. and Europe.