Aquestive Therapeutics Inc., of Warren, N.J., licensed its Riluzole Oral Film (ROF) for the treatment of amyotrophic lateral sclerosis in the EU to Zambon SpA, of Milan, Italy. Aquestive will receive an undisclosed up-front payment from Zambon and is eligible for development and sales milestone payments as well as low double-digit royalties on net sales of the drug in the EU. Zambon is responsible for the regulatory approval and marketing of ROF in the EU, while Aquestive will be responsible for the development and manufacturing of the drug.
Armas Pharmaceuticals Inc., of Manalapan, N.J., launched a generic of Tarceva (erlotinib, Roche Holding AG). The company noted that sales of erlotinib are approximately $150 million annually, according to sales data.
Autolus Therapeutics plc, of London, licensed the rights to PRIME (proliferation-inducing and migration-enhancing) technology secreting both IL-7 and CCL19 from Noile-Immune Biotech Inc., of Tokyo, for use in Autolus' CAR T programs against a limited number of cancer targets. Noile-Immune will receive an undisclosed up-front payment and is eligible for milestone payments as well as royalties on net sales of resulting products.
Bruce Power LP and Kinectrics Inc., both of Toronto, Framatome Canada Ltd., of Pickering, Ontario, and ITM Isotopen Technologien Muenchen AG, of Garching, Germany, are partnering to produce the medical isotope Endolucinbeta (non-carrier-added Lutetium-177) at Bruce Power using ITM's manufacturing methodology. Framatome and Kinectrics will be responsible for installation of the irradiation services at Bruce Power, which is planned for late 2021.
Cantabio Pharmaceuticals Inc., of Palo Alto, published data in Neurobiology of Disease showing that DJ-1, a protein genetically linked to early onset Parkinson's disease, aggregates into b-sheet structured fibril-like aggregates. The aggregation is promoted by oxidization of the protein's catalytic Cys106 residue by oxidative stress. Cantabio is developing small-molecule stabilizers targeting DJ-1.
Centogene AG, of Cambridge, Mass., granted Pfizer Inc., of New York, access to its data repository that includes epidemiologic, phenotypic and genetic data for patients with rare disease as well as a biobank of the patients' blood samples. The companies will mine the data and jointly agree to any collaborative research projects. Centogene will receive an up-front payment and is eligible for additional research payments under any future collaborative research projects.
Cytodyn Inc., of Vancouver, Washington, said it received approval from the institutional review board for leronlimab, its CCR5-blocker, to be administered to patients with triple-negative breast cancer (TNBC) under a compassionate use, or expanded access, program. Under the protocol, patients with locally recurrent or metastatic TNBC who had progressed within six months or less on their latest chemotherapy will receive leronlimab (PRO-140) combined with a treatment of physician's choice.
Evoke Pharma Inc., of Solana Beach, Calif., received notification from Nasdaq that the company was given an additional 180-day grace period to regain compliance with the minimum $1 bid price requirement to remain listed on the exchange. Evoke plans to resubmit the NDA for its diabetic gastroparesis treatment Gimoti this quarter.
Finch Therapeutics Group Inc., of Somerville, Mass., and Takeda Pharmaceutical Co. Ltd., of Osaka, Japan, expanded their collaboration to develop microbiome-based therapeutics using Finch's Human-First Discovery platform to include Crohn's disease. Takeda will have worldwide rights to the product developed for Crohn's disease. Financial terms of the expanded agreement weren't disclosed.
Kiniksa Pharmaceuticals Ltd., of Hamilton, Bermuda, reported preclinical data on the role of granulocyte macrophage colony-stimulating factor (GM-CSF) in giant cell arteritis (GCA) at the 2019 American College of Rheumatology/Association of Rheumatology Professionals meeting in Atlanta. GM-CSF signaling pathway molecular signature at both the mRNA and protein level was up-regulated in temporal artery biopsies from GCA patients compared to controls. Expression of PU.1, a transcription factor downstream of GM-CSF signaling, was observed in the vessel wall. Treatment of ex vivo cultures of GCA arteries with mavrilimumab, a monoclonal antibody targeting the alpha subunit of the GM-CSF receptor, suppressed expression of the GM-CSF signaling pathway.
Preclinical data on Laval, Quebec-based Liminal Biosciences Inc.'s PBI-4547 suggest the immunometabolic agent displays pleiotropic activities and reduced nonalcoholic steatohepatitis, diabetes and fibrosis in animal models. Liminal also has new data showing that its oral PBI-4050 reverses metabolic dysregulation induced by a high-fat diet in a mouse model of nonalcoholic fatty liver disease, that it promotes hepatic stellate cell autophagy/mitophagy and restores a quiescent-like phenotype. The data were presented at the The Liver Meeting in Boston.
LG Chem Life Sciences, the life sciences division of LG Chem Ltd., of Seoul, South Korea, expanded its collaboration with Avacta Group plc, of Cambridge, U.K., to include a second and third drug target. Avacta has already used its Affimer platform to develop a large number of Affimer proteins that bind to the first drug target nominated by LG Chem and is in the process of optimizing the candidate, at which point LG Chem will take over preclinical development. Financial terms of the deal weren't disclosed.
Merck & Co. Inc., of Kenilworth, N.J., said its Ervebo Ebola Zaire vaccine (rVSVΔ-ZEBOV-GP live) has been awarded prequalification status by the World Health Organization (WHO). It is the first vaccine to be prequalified by the WHO for the prevention of Ebola virus disease. WHO prequalification follows the European Commission's grant of a conditional marketing authorization earlier this week. Ervebo is under review in the U.S., with an FDA PDUFA date of March 14, 2020.
Moleculin Biotech Inc., of Houston, began preclinical testing of its metabolism/glycosylation inhibitor, WP-1122, to treat highly glycolytic tumors such as pancreatic cancer and glioblastoma. In animal models, data show WP-1122, a prodrug of 2-deoxy-D-glucose (2-DG), significantly increased the half-life of 2-DG and allowed for increased uptake to targeted organs and tumors such as brain tumors and pancreatic cancer. New data suggested that such a glucose decoy could impact glycosylation and glycan formation, enabling increased immune system response to cancer cells by impacting PD-L1 function.
RDD Pharma Ltd., of Tel Aviv, Israel, entered a nonbinding letter of intent to acquire Richmond, Calif.-based Naia Rare Diseases Inc., which develops drugs to treat short bowel syndrome (SBS) and other rare gastrointestinal diseases. The deal is expected to close after the merger of RDD and Innovate Biopharmaceuticals Inc., which will be renamed 9 Meters Biopharma Inc. Naia receives a combination of cash and shares in 9 Meters, subject the merger's close. In the deal, 9 Meters acquires Naia's NB-1001, a long-acting glucagon-like peptide-1 receptor agonist that combines exenatide with an extended half-life technology to treat SBS.
Recro Pharma Inc., of Malvern, Pa., said the SEC declared effective the registration statement on Form 10 filed by Baudax Bio Inc. Recro expects the separation of Baudax Bio into an independent, publicly traded pharma company focused on advancing non-opioid analgesics and other products for acute care settings on Nov. 21. Nasdaq has approved the listing for Baudax Bio common stock under the symbol BXRX, which will begin trading on a when-issued basis under the ticker BXRXV Nov. 14.
Sandoz, of Holzkirchen, Germany, a unit of Novartis AG, reported real-world data from the Compact observational study of Erelzi (etancercept-szzs), a biosimilar of Enbrel, in rheumatoid arthritis patients, showing improvements in effectiveness and functional disability. Data were presented at the ACR/ARP meeting in Atlanta.
Seattle Genetics Inc., of Bothell, Wash., submitted an arbitration demand to the American Arbitration Association to resolve the dispute with Daiichi Sankyo Co. Ltd., of Tokyo, regarding ownership of certain technology used by Daiichi Sankyo in its metastatic breast cancer drug candidate, DS-8201 ([Fam-] trastuzumab deruxtecan), among other product candidates. Seattle Genetics' wants the arbitration to take place in Seattle. Seattle Genetics contends the linker and other antibody-drug conjugate (ADC) technology used in those drug candidates are improvements to Seattle Genetics' ADC technology, the ownership of which was assigned to Seattle Genetics under the terms of a 2008 collaboration agreement between the two companies. Seattle Genetics said it abided by the agreement's dispute resolution provisions and that recently Daiichi Sankyo attempted to circumvent the dispute resolution process underway between the parties by filing a declaratory judgment action in the U.S. District Court for the District of Delaware.
National Health Service Wales accepted Boston-based Vertex Pharmaceuticals Inc.'s offer for all of Vertex's currently licensed cystic fibrosis (CF) medicines and their future indications of the medicines. Once the contract is finalized, Welsh CF patients ages 2 and older with two copies of the F508del mutation in the CF transmembrane conductance regulator gene can access Orkambi (lumacaftor/ivacaftor) and CF patients ages 12 and older with two copies of the F508del mutation or one copy of the F508del mutation and a copy of one of the other 14 licensed mutations can access Symkevi (tezacaftor/ivacaftor) in combination with ivacaftor. The agreement also offers expanded access to Kalydeco (ivacaftor) to include those patients ages 12 months and older with one of the nine licensed gating mutations.