Adocia SA, of Lyon, France, said a €7 million (US$8.4 million) nondilutive financing was approved by BNP, HSBC, LCL and Bpifrance in the form of a state-guaranteed bank loan.
Agilvax Inc., of Albuquerque, N.M., said the company triggered phase II funding worth $1.2 million from its Fast Track Small Business Innovation Research grant awarded by the National Cancer Institute. The funding will be used to conduct a preclinical efficacy study, manufacturing stability studies and a nonclinical toxicology study for AX-09, a virus-like-particle therapeutic vaccine.
Alkido Pharma Inc., of New York, said it will provide funding for a 30-day survival study in mice in collaboration with University of Kentucky related to cancer drug G4-1, a novel proteasome inhibitor. In exchange, Aikido has been granted an exclusive option to license the drug pending the results of the study.
Arcturus Therapeutics Inc., of San Diego, said it executed the definitive supply agreement provided for in the previously announced binding term sheet agreement with the Israeli Ministry of Health, to supply COVID-19 STARR mRNA vaccine candidate (ARCT-021). Delivery to Israel of doses of Arcturus’ COVID-19 vaccine candidate is contingent upon achievement of near-term clinical and regulatory milestones.
Asia Green Biotechnology Corp. (AGB), of Calgary, Alberta, said it entered an agreement with Pathway Rx Inc., in which AGB is granted an exclusive license to clinically develop and commercialize the Cannabis sativa varieties to which Pathway Rx owns the rights for prevention and for treatment of COVID-19 and other infectious diseases. The agreement grants a license to AGB to deploy the technology for the purpose of completing further research, development, testing and additional validation and establishment of practical applications with a view to commercialization of the technology in the greater region of Asia.
Avacta Group plc, of Wetherby, U.K., disclosed the expansion of its existing multitarget collaboration and development agreement with LG Chem Life Sciences, the life sciences division of LG Group, of Seoul, South Korea, to include new programs incorporating Avacta’s Affimer XT serum half-life extension system. In December 2018, Avacta and LG entered a multitarget therapeutics development agreement to develop Affimer therapeutics in several disease areas, potentially worth more than $300 million to Avacta. Specifically, the companies have agreed to broaden the partnership to include Avacta’s Affimer XT technology, which can be used to control the time a drug spends in the circulation. Included are an undisclosed additional up-front payment, plus potential near-term preclinical milestone payments and longer-term clinical development milestone rewards totaling $98.5 million for two therapeutics to be developed using Affimer XT. LG has the exclusive rights to develop and commercialize worldwide Avacta’s Affimer PD-L1 inhibitor with Affimer XT serum half-life extension.
Calcimedica Inc., of La Jolla, Calif., disclosed the publication in Critical Care of results from a randomized, controlled, open-label clinical study showing substantially improved outcomes in patients with severe COVID-19 pneumonia treated with Auxora. The company is initiating a blinded, placebo-controlled clinical trial enrolling up to 400 patients with severe COVID-19 pneumonia to assess Auxora plus standard of care compared to placebo plus standard of care. The drug is a small-molecule inhibitor of Orai1-containing CRAC channels.
Catalyst Pharmaceuticals Inc., of Coral Gables, Fla., and Kye Pharmaceuticals Inc., of Mississauga, Ontario, signed an exclusive license agreement under which Kye will commercialize Firdapse (amifampridine) in Canada. Firdapse is indicated for the symptomatic treatment of Lambert-Eaton myasthenic syndrome in adults. Catalyst will supply Firdapse to Kye, which will be responsible for promotion, sales, advertisement, marketing, product importation and distribution. Kye will also be responsible for the ongoing maintenance of the regulatory file and future communications with Health Canada.
Ceapro Inc., of Edmonton, Alberta, provided an update on its ongoing collaboration with McMaster University to develop an inhalable therapeutic for COVID-19. The project, titled “PGX-processed yeast beta-glucans [PGX-YBG] as an inhalable immunomodulating therapeutic for COVID-19 patients,” is jointly funded by McMasters’ Mitacs and Ceapro. The first milestone in the effort was to optimize the size and morphology of the best PGX-YBG for immunomodulation while the second was to examine tolerability and safety of inhaled PGX-YBG in naïve animal models. The first milestone of the project was fully achieved, and the second milestone is near completion, Ceapro said.
Cobra Biologics Ltd., part of the Cognate Bioservices Inc., of Memphis, Tenn., and Combigene AB, of Lund, Sweden, said Cobra has successfully produced master cell banks for the three plasmids used as starting material for Combigene’s gene therapy, CG-01. The goal represents a further milestone in the commercial manufacture of a drug candidate designed for the treatment of drug-resistant focal epilepsy. The three master cell banks have been developed according to cGMP standards, Cobra noted.
Cytokinetics Inc., of South San Francisco, disclosed a $1 million grant and four-year partnership with the HCM Registry (HCMR), a global registry of patients with hypertrophic cardiomyopathy (HCM) focused on improving predictive measures of risk for complications and identifying biomarkers associated with adverse clinical outcomes. The HCMR was designed as the first prospective multinational registry to identify novel prognostic markers in HCM, including CMR markers of fibrosis, genetic markers and biomarkers. It’s funded by the U.S. NIH.
Eli Lilly and Co., of Indianapolis, and Innovent Biologics Inc., of Suzhou, China, said they expanded their strategic alliance for Tyvyt (sintilimab injection), an anti-PD-1 monoclonal antibody immuno-oncology drug they co-developed to treat relapsed or refractory classic Hodgkin's lymphoma and currently co-commercialize in China. Under the expanded agreement, Lilly will obtain an exclusive license for Tyvyt outside China and plans to pursue registration in the U.S. and other markets. In return, Innovent is set to receive $200 million up front and be eligible for up to $825 million in development and commercial milestones as well as tiered double-digit royalties. Both companies retained the right to study Tyvyt in combination with other compounds in their respective development programs. The companies are studying the drug to treat non-squamous non-small-cell lung and several other types of cancer. Lilly said the transaction will be reflected in its reported results and GAAP financial guidance, with no change to its 2020 non-GAAP earnings per share guidance.
Evotec SE, of Hamburg, Germany, and Novo Nordisk A/S, of Bagsvaerd, Denmark, entered a strategic collaboration to discover and develop therapeutics for treating chronic kidney disease. The two companies will share responsibilities during drug discovery and preclinical development. Novo Nordisk will be responsible for clinical development and commercialization. Evotec will receive an undisclosed up-front payment, research funding and milestones potentially exceeding €150 million (US$177 million) per product as well as tiered royalties on net sales.
Faron Pharmaceuticals Oy, of Turku, Finland, said it received a guarantee from Finnvera Oyj for a €2.5 million (US$3 million) loan, which will be provided by Danske Bank A/S Finland Branch, and will be used to further expand the use of a new cell line, planned to be established with the previously received Business Finland loan of €2.1 million announced on June 15, for use in the future commercial-scale production of Faron’s intravenous IFN beta-1a. Faron also announced that CDMO AGC Biologics was selected as the manufacturing house for the commercial-scale manufacture of bexmarilimab, Faron’s precision cancer immunotherapy.
Generex Biotechnology Corp., of Miramar, Fla., said it signed a memorandum of understanding with Malaysia’s Bintai Kinden Corp. to develop and commercialize the Ii-Key-SARS-CoV-2 coronavirus vaccine, which Generex said may be able to induce T-cell and antibody immune responses to provide protective immunity with long-lasting immunologic memory against SARS-CoV-2. Bintai will pay Generex up-front development fees, back-end licensing payments and 100% of the funding required for commercial development including laboratory work, manufacturing, regulatory filings and the clinical development program for regulatory approval in Malaysia. Upon approval of the Ii-Key-CoV-2 vaccine in Malaysia, Generex will earn royalties on sales of the vaccine with potential revenues of up to $150 million.
LG Chem Life Sciences, of Nanjing China, said it entered an exclusive license agreement with Transthera Biosciences Co. Ltd., of Nanjing, China, to develop and commercialize of Transthera’s TT-01025, a selective oral small-molecule inhibitor of semicarbazide-sensitive amine oxidase/vascular adhesion protein-1 that has shown efficacy in preclinical investigation in nonalcoholic steatohepatitis, the company said. TT-01025 is expected to enter a phase I trial in early 2021 in the U.S.
Lixte Biotechnology Holdings Inc., of East Setauket, N.Y., said it agreed to collaborate with the Foundation for Angelman Syndrome Therapeutics (FAST) to support preclinical studies at the University of California, Davis School of Medicine and MIND Institute on the potential benefit of Lixte’s lead compound, LB-100, in a mouse model of Angelman syndrome (AS). If the studies confirm that LB-100 reduces AS signs in rodent models, as suggested in a 2019 report in The Proceedings of The National Academy of Science, Lixte and FAST agreed to discuss additional collaborations to assess benefits of the protein phosphatase 2A inhibitor in individuals with AS.
Novartis AG, of Basel, Switzerland, said the U.S. District Court for the District of Delaware upheld the validity of its dosage regimen patent (U.S. Patent No. 9,187,405) for Gilenya (fingolimod), finding that the generic fingolimod product proposed in the abbreviated new drug application (ANDA) by HEC Pharm Co. Ltd., of Guangdong, China, and its HEC Pharm USA Inc. unit will infringe the Novartis patent, set to expire on Dec. 25, 2027. The decision may be appealed to the U.S. Court of Appeals for the Federal Circuit. Under confidential settlement terms, certain ANDA filers received permission from Novartis to launch a generic version of Gilenya on a specific date prior to the patent’s expiration. In separate proceedings, Novartis said the U.S. Court of Appeals for the Federal Circuit dismissed an appeal of the inter partes review decision from the U.S. PTO upholding the validity of the dosage regimen patent. That decision also is subject to appeal.
Noxopharm Ltd., of Sydney, said independent research published in European Urology Oncology showed the combination of 177Lu-PSMA-617 radioligand therapy and Veyonda (idronoxil), its sphingosine-1-phosphate inhibitor, was safe and effective, with median overall survival (OS) of 17.1 months in late-stage prostate cancer patients who exhausted standard treatment options. Median OS in a study conducted in a comparable population who received standard chemotherapy was 4.5 months.
Pharmabcine Inc., of Daejeon, South Korea, said it concluded a materials cooperative research and development agreement, or MCRADA, with the U.S. NIH’s National Institute of Allergy and Infectious Diseases, which will assess the efficacy of PMC-403, Pharmabcine’s TEK tyrosine kinase receptor inhibitor, to treat systemic capillary leak syndrome, also known as Clarkson disease. NIAID researchers will assess PMC-403 in preclinical models, and Pharmabcine will discuss the potential for development collaboration with the NIH as the study progresses.
Pharming Group NV, of Leiden, the Netherlands, said data published in Frontiers in Immunology from a compassionate use program of five patients with confirmed COVID-19 infections hospitalized with related severe pneumonia treated with Ruconest (recombinant human C1 inhibitor, conestat alfa) at the University Hospital Basel, Switzerland, showed fever resolved in four of the five within 48 hours, and laboratory markers of inflammation decreased significantly. One patient had increased oxygen requirement and was temporarily transferred to the ICU for intubation but over the subsequent days made a full recovery.
Premier Inc., of Charlotte, N.C., said it achieved a milestone in its partnership with Astrazeneca plc, of Cambridge, U.K., aimed at reducing hospitalizations among individuals with hyperkalemia. In the first phase of the partnership, in which Premier’s applied sciences unit implemented evidence-based care practices in nearly 370 hospitals across the U.S., Premier conducted a study to examine the clinical characteristics of patients with hyperkalemia and assessed hyperkalemia-related readmissions, emergency room presentations, outpatient visits and costs. In the second phase, the company will use a linked sample from its health care database and a large commercial claims database to assess the association between use of Astrazeneca’s Lokelma (sodium zirconium cyclosilicate) and clinical outcomes such as hyperkalemia, cost, readmissions and other hospital visits among treated patients. The final component of the de-identified study will examine the impact of a hyperkalemia discharge protocol on cost and health care resource utilization among hospitalized patients.
Tetra Bio-Pharma Inc., of Ottawa, Ontario, said it issued a contract to manufacture the active pharmaceutical ingredient, HU-308, and the intravenous, sterile, finished drug candidate, ARDS-003, to Dalton Pharma Services Inc., of Toronto. HU-308 is a synthetic small molecule that targets the human cannabinoid CB2 receptor.
Therapure Biomanufacturing, a division of Therapure Biopharma Inc., of Mississauga, Ontario, said it inked an agreement with VBI Vaccines Inc., of Cambridge, Mass., to manufacture VBI’s coronavirus vaccine candidates. Therapure assumed responsibility for biomanufacturing of the vaccine drug substance as well as aseptic fill of the drug product.
Triplet Therapeutics Inc., of Cambridge, Mass., said it agreed to participate in END-DM1 (Establishing Biomarkers and Clinical Endpoints in Myotonic Dystrophy Type 1), an international natural history study seeking to advance understanding of myotonic dystrophy type 1 (DM1) and to support development of clinical approaches to address the repeat expansion disorder (RED). Triplet’s development efforts target the DNA damage response pathway, which has been implicated in the disease process in DM1 and other REDs.
Vasomune Therapeutics, of Toronto, said it received a peer-reviewed medical research program grant award of $2.8 million from the U.S. Department of Defense to develop its TEK tyrosine kinase receptor stimulator, AV-001, to treat COVID-19-associated acute lung injury and acute respiratory distress syndrome.
Zosano Pharma Corp., of Fremont, Calif., said it agreed to conduct a feasibility study with Mitsubishi Tanabe Pharma Corp., of Osaka, Japan, involving use of its microneedle patch system to formulate a pharmaceutical agent in development by Mitsubishi. R&D activities will encompass both in vitro and in vivo phases, with Mitsubishi receiving the right to exercise an option to negotiate an exclusive license to the relevant Zosano technologies in the defined field upon success of the studies. Additional details were not disclosed.