Altimmune Inc., of Gaithersburg, Md., said it was awarded $4.7 million from the U.S. Army Medical Research and Development Command to fund its phase I/II trial of T-COVID, an investigational intranasal immune modulator, for treating outpatients with early COVID-19. The award was granted in collaboration with the Medical Technology Enterprise Consortium, a 501(c)(3) biomedical technology consortium partnering with the Department of Defense. The award is expected to provide Altimmune funding to cover the study’s entire cost.
Artelo Biosciences Inc., of La Jolla, Calif., said it expanded its existing research and worldwide commercial license agreement with The Research Foundation For The State University of New York, Stony Brook. Artelo now has exclusive rights to recently developed, third-generation fatty acid binding protein 5 (FABP5) inhibitors. The company said it plans to select a lead cancer therapeutic compound from those compounds, as well as to identify additional candidates for pain, inflammation and other conditions. FABP5 inhibition has been shown to suppress the growth and migration of breast and prostate cancers in preclinical models and possibly treat pain, based on animal studies where elevated levels of endocannabinoids showed beneficial effects on measures of stress, pain and inflammation, the company said.
Avita Medical Ltd., of Cambridge, U.K., continued redomiciliation for itself and its subsidiaries from Australia to the U.S. by transferring its ordinary shares to Avia Therapeutics Inc., which is now the regenerative medicine company’s sole shareholder and the ultimate parent company.
Bioarctic AB, of Stockholm, and the University of Oslo signed a research agreement to investigate apolipoprotein E as a drug target for treating Alzheimer’s disease. Bioarctic will provide financial support for a two-year research position, with a potential extension. The goals of the collaboration are to understand the mechanistic involvement of apolipoprotein E in Alzheimer's disease pathogenesis and to generate pharmacological efficacy data with drug candidates.
Eli Lilly and Co., of Indianapolis, and Sanford Burnham Prebys Medical Discovery Institute inked a research agreement to characterize Lilly’s next-generation anti-SARS-CoV-2 antibodies. Those studies aim to build on Lilly’s current portfolio of neutralizing antibodies by exploring novel cocktails, half-life extension technologies and strategies to further enhance potency. Neutralizing antibodies have the potential for both prevention and treatment of COVID-19 and may be particularly important for groups hardest hit by the disease, such as the elderly and those with compromised immune systems, the partners said.
Immunoprecise Antibodies Ltd., of Victoria, British Columbia, said it identified numerous lead candidate antibodies with highly potent neutralizing activity in vitro, which are being manufactured for further testing and possible inclusion in the company's Polytope monoclonal antibody therapy to combat the COVID-19 pandemic. The company is preparing to test those lead antibodies against additional, documented, mutated strains of the virus. Preclinical studies are set to start this summer.
Jaguar Health Inc., of San Francisco, and its wholly owned subsidiary, Napo Pharmaceuticals Inc., jointly entered an amendment to a May 12 accounts receivable purchase agreement in which Oasis agreed to purchase additional accounts receivable related to the sales of Mytesi (crofelemer) to Cardinal Health for the period of May through June 24. The Spring 2020 Accounts Receivable have a gross value of about $2.9 million. Mytesi is an antidiarrheal for treating noninfectious diarrhea in adults with HIV/AIDS on antiretroviral therapy.
Preclinical data from Waltham, Mass.-based Morphic Therapeutic Inc. demonstrate MORF-057’s inhibition of α4β7-expressing lymphocyte migration to the gut, a contributor to inflammatory bowel disease. In mice, its inhibitory activity demonstrated potency comparable to an anti-α4β7 antibody, the company said. In nonhuman primate (NHP) models, MORF-057 demonstrated important proof of mechanistic activity by driving accumulation of mucosal homing α4β7-high expressing T cells in the peripheral blood, in an analogous manner to the approved anti-α4β7 antibody, vedolizumab. Importantly, a MORF-057 analogue demonstrated >90% receptor occupancy of α4β7 in NHPs, providing an important indicator of the product candidate’s target engagement. MORF-057 is a selective, oral small-molecule inhibitor of the α4β7 integrin for patients with inflammatory bowel disease.
Oncology Venture A/S, of Hørsholm, Denmark, said it signed a definitive agreement to out-license two clinical pipeline assets, Liplacis and 2X-111, to Smerud Medical Research International for further clinical and commercial development. Oncology Venture will receive regulatory milestone fees of nearly $30 million plus royalties on sales for each drug if all milestones are met. The company also terminated its prior license agreement with Cadila Pharmaceuticals Ltd., of Ahmedabad, India, to develop Liplacis, the liposomal formulation of cisplatin, for treating metastatic breast cancer, in India.
Oncopeptides AB, of Stockholm, said the company agreed to take over Solna, Sweden-based Kancera AB’s drug development facility. Terms were not disclosed.
Peel Therapeutics Inc., of Salt Lake City, said a study published in Blood sheds light on the blood clots and inflammation in patients with COVID-19 and describes a new medicine that may block that inflammation. Investigators discovered large amounts of free-floating DNA in blood collected from hospitalized patients with COVID-19. That DNA is a biomarker for neutrophil extracellular traps, or NETs, that are normally released from immune cells to catch invading pathogens. Scientists found that higher levels of NETs correlated with the risk of needing a ventilator and dying from COVID-19. Using a natural blocker of NETs, the scientists prevented NETs in healthy immune cells exposed to plasma from the blood of COVID-19 patients. That natural NET inhibitor was first discovered in newborn babies and is being developed by Peel as a possible treatment for inflammation in COVID-19.
Pharmabcine Inc., of Daejeon, South Korea, said it signed a contract manufacturing organization agreement with CDMO Binex for additional production of investigational olinvacimab (TTAC-0001), Pharmabcine's lead antibody for oncology. Under the terms, Binex is responsible for large-scale manufacturing of clinical investigational material for global phase II trials testing the antibody in combination with immunotherapy for metastatic triple-negative breast cancer and trials on various common solid tumors.
Shasqi Inc., of San Francisco, reported preclinical data at the American Association for Cancer Research Virtual Annual Meeting II, showing that SQ-3370 produced robust antitumor responses both at the target site and at distal lesions in a preclinical cancer model. SQ-3370 uses bioorthogonal “click” chemistry reactions to capture and activate an attenuated anthracycline prodrug at the target tumor site, enabling higher doses of the cancer drug while reducing side effects commonly experienced with conventional chemotherapy. In mice bearing two tumors, where the target lesion was injected with the SQL70 biomaterial and the distal lesion was not, treatment with SQ-3370 significantly prolonged overall survival by reducing target lesions compared to controls. SQ-3370 also reduced tumor growth at the distal lesion, which was not injected with the SQL70 biomaterial. Together, that suggests SQ-3370 can induce both local and systemic antitumor responses.
Supernus Pharmaceuticals Inc., of Rockville, Md., said it sued generic drug maker Apotex Inc. and Apotex Corp., of Toronto, for infringement of nine patents covering its antiepileptic drug, Oxtellar XR. The patents cover once-a-day oxcarbazepine formulations and methods of treating seizures using the formulations. Those nine patents do not expire until April 13, 2027. The complaint filed in the U.S. District Court for the District of New Jersey alleges that Apotex infringed Supernus's patents by submitting an ANDA to the FDA seeking to market a generic version of Oxtellar XR prior to the expiration of Supernus's patents.
Tiziana Life Sciences plc, of London, said it has executed an agreement with STC Biologics Inc. for GMP manufacturing of TZLS-501, an anti-IL-6 receptor monoclonal antibody acquired from Geneva-based Novimmune SA in 2017. Tiziana is simultaneously developing an inhalation technology, in collaboration with Hicksville, N.Y.-based Sciarra Laboratories Inc., for the direct delivery of the drug into the lungs using a handheld inhaler or nebulizer for treatment of patients with COVID-19.
Verve Therapeutics Inc., of Cambridge, Mass., said new preclinical proof-of-concept data in nonhuman primates demonstrated the successful use of base editing to turn off a gene in the liver and thereby lower blood levels of either LDL cholesterol or triglyceride-rich lipoproteins, two factors leading to coronary atherosclerosis. Verve co-founder and CEO Sekar Kathiresan said his team expects to choose a lead program employing the approach by year-end, with the goal of initiating clinical studies within the next three years. The company is using adenine base editing technology licensed from Beam Therapeutics Inc., of Cambridge, Mass.
Vitrac Therapeutics LLC, of Boston, said it initiated global clinical development of VIC-1911 (formerly TAS-119), an oral Aurora A inhibitor licensed from Taiho Pharmaceutical Co. Ltd., of Tokyo, that is being advanced for the potential treatment of cancer. Vitrac also made an alliance with JS Innomed Holdings Ltd., of Shanghai, by sublicensing the China rights of VIC-1911 to accelerate the global development.