Agene Bio Inc., of Baltimore, has been awarded a Small Business Innovative Research grant of up to $2.9 million over 3.5 years from the National Institute on Aging, adding to about $11 million of prior NIH investment in the company to date. It also received an award of $500,000 from the Alzheimer's Drug Discovery Foundation, a longtime supporter of the company. The funds will be used to accelerate the development of the company's preclinical GABA-A a5 positive allosteric modulation program, which targets mild cognitive impairment due to Alzheimer's disease (AD). The company is also working on AGB-101, a phase III candidate being investigated to target hippocampal overactivity to slow progression to and delay the onset of AD. (See BioWorld, Jan. 18, 2019.)

Adhera Therapeutics Inc., of Research Triangle Park, N.C., agreed to work with Princeton, N.J.-based Indegene Inc. to expand commercialization for the Adhera hypertension drug Prestalia (perindopril arginine and amlodipine) in the U.S.

Adial Pharmaceuticals Inc., of Charlottesville, Va., said its previously manufactured supply of clinical trial material of AD-04, a repurposed formulation of ondansetron for the potential treatment of alcohol use disorder, successfully passed retesting for use in trials. The outcome means about 52,000 blister packs of the tablet-form drug that were previously produced will be usable in a phase III trial, it said.

Axim Biotechnologies Inc., of New York, said its contract manufacturer, Ghent, Belgium-based Eurofins Amatsigroup NV, has begun manufacturing Axim's cannabinoid-based chewing gum with dronabinol for use in the company's upcoming clinical studies on cannabis as a treatment for chemotherapy-related symptoms. In the coming months, Axim intends to conduct a bioequivalence study between its chewing gum and an FDA-approved synthetic capsule.

Biorestorative Therapies Inc., of Melville, N.Y., said it expanded its off-the-shelf brown adipose-derived stem cell therapeutic pipeline to target polycystic ovarian syndrome (PCOS). The mechanisms of action involve both metabolic remodeling and endocrine secretions of the transplanted brown adipocytes that target both the PCOS metabolic symptoms as well as endocrine dysregulation.

Dance Biopharm Holdings Inc., of Durham, N.C., said it formed an alliance with digital therapeutics company Dariohealth Corp., of New York, to expand access to a personalized digital health management platform for patients with chronic diseases. Under the terms, Dance will integrate its mist smart inhaler into Dariohealth's platform. Financial terms were not disclosed.

Daré Bioscience Inc., of San Diego, said an article published in the International Journal of Pharmaceuticals highlights findings from an animal study, including availability and local tolerability of vaginally delivered tamoxifen. Two dose levels (1 mg or 20 mg) administered intravaginally to female rabbits once daily over a 28-day period revealed little to no vaginal or systemic accumulation of tamoxifen following once-daily dosing, with vaginal irritation minimal to none at both doses. Daré is advancing DARE-VVA1, a vaginal application of the selective estrogen receptor modulator, as an alternative to estrogen-based therapies for the treatment of vulvar and vaginal atrophy in women with or at risk for hormone receptor-positive breast cancer.

Disarm Therapeutics Inc., of Cambridge, Mass., reported preclinical data at the European Committee for Treatment and Research in Multiple Sclerosis meeting in Stockholm, demonstrating that deleting SARM1 has a robust axonal-protective effect in experimental autoimmune encephalomyelitis (EAE), a well-accepted animal model of multiple sclerosis (MS). Data from the EAE model showed SARM1 homozygous and heterozygous gene deletion markedly attenuates the increase in plasma neurofilament light (NfL), a biomarker of axonal degeneration and disease progression in MS. The magnitude of SARM1 effect on NfL was gene-dosage dependent. Axonal protection through SARM1 deletion led to a statistically significant reduction in demyelination via histological examination.

Enterin Inc., of Philadelphia, said an article published in Frontiers in Neuroscience demonstrated that colonic motility and neural signaling from the gut to the brain via the vagus nerve were significantly diminished in old mice compared to young mice, and the addition into the gut of squalamine restored colonic motility and vagal firing rates back to the levels of young mice. Enterin is developing ENT-01, a synthetic derivative of squalamine currently being tested in clinical trials in Parkinson's patients.

Genprex Inc., of Austin, Texas, said independent researchers reported in Nature that TUSC2, a tumor suppressor gene and active agent in the company's Oncoprex immunogene therapy, prevented tumor growth in triple-negative breast cancer (TNBC). The study first found microRNA-138 as a diagnostic biomarker for TNBC, and depletion of miR-138 was found to lead to apoptotic cell death in vitro and prevented tumorigenesis in vivo. TUSC2 was found to be a direct target of miR-138, and TUSC2 mimics the effects of miR-138 knockdown, preventing tumor growth.

Marking another success for its five-year-old company creation alliance with Glaxosmithkline plc, of London, Avalon Ventures said the U.K. drugmaker has agreed to buy Sitari Pharmaceuticals Inc., a La Jolla, Calif.-based company incubated at COI Pharmaceuticals Inc., an incubator for companies funded by the partners. Sitari has been developing a new treatment for celiac disease and was the first company formed under the GSK-Avalon venture collaboration in 2013. Financial terms of the deal were not disclosed. (See BioWorld, Nov. 22, 2013.)

Immunic Inc., of San Diego, presented preclinical data at the European Committee for Treatment and Research in Multiple Sclerosis meeting in Stockholm, summarizing the profile of its lead oral compound, IMU-838, as compared to dihydroorotate dehydrogenase (DHODH) inhibitor teriflunomide, including its selectivity for DHODH. IMU-838 showed strong cytokine inhibition on stimulated human peripheral blood lymphocytes and its short blood half-life of about 30 hours should make it favorable for once-daily dosing and rapid wash-out if needed, the company said. Treatment also resulted in fast onset, reaching steady state concentrations within five to seven days. IMU-838 is in phase II development for relapsing-remitting multiple sclerosis and ulcerative colitis.

Lexicon Pharmaceuticals Inc., of The Woodlands, Texas, said it reached an agreement on terminating its alliance with Paris-based Sanofi SA for development and commercialization of SGLT2 inhibitor Zynquista (sotagliflozin) and settled related disputes with the big pharma, each effective as of Sept. 9. In connection to the termination, Lexicon regains all rights to Zynquista and will assume full responsibility for worldwide development and commercialization in both type 1 and type 2 diabetes. Under the terms, Sanofi will pay Lexicon $260 million, of which $208 million is payable up front, with the remainder payable within 12 months. Sanofi also will coordinate with Lexicon in the transition of responsibility for ongoing clinical studies and other activities. The four-year alliance came to a halt in late July, when Sanofi decided to end the $1.7 billion diabetes collaboration, following two trials in which Zynquista failed to hit statistical significance in blood sugar control in patients with chronic kidney disease, and said it would not launch the product in Europe, where it previously gained approval as an adjunct to insulin therapy for type 1 diabetes. At that time, Lexicon called notice of the termination by Sanofi a breach of contract. Upon disclosing terms of the termination late Tuesday, Lexicon said regaining full rights to the product allows the firm to "realize the full value of the Zynquista program as we prepare for regulatory filings in the U.S. and in Europe in type 2 diabetes," with additional data expected over the coming months. In its second-quarter earnings in late July, Lexicon reported cash and investments totaling $106 million. The company's shares (NASDAQ:LXRX) jumped 27.9%, or 48 cents, on news of the termination terms, closing Wednesday at $2.20. (See BioWorld, July 30, 2019.)

Omeros Corp., of Seattle, said it's working to establish "an expansive and exclusive intellectual property position" directed to inhibition of GPR174, a member of the family of G protein-coupled receptors, which it said can be combined with and significantly improve the tumor-killing effects of adenosine pathway inhibitors. GPR174-targeting immunotherapy is expected to be applicable to all solid tumors, the company said.

Q Biomed Inc., of New York, and contract services provider Chemveda Life Sciences said, after successful chemical synthesis of uttroside B showed efficacy as a potential chemotherapy treatment for liver cancer, the two firms formalized a collaboration to continue work and to scale-up manufacturing of cGMP product for planned preclinical and clinical testing. Under the terms, and depending upon reaching certain milestones, Q Biomed agreed to pay Chemveda a combination of cash and stock and capped royalty on net sales of any and all drug products resulting from the deal. Specific terms were not disclosed.

Spherix Inc., of New York, said it executed an exclusive option agreement with the University of Kentucky related to its cancer drug, G4-1, a proteasome inhibitor. Spherix's option includes two issued patents, each having expiration dates in the mid-2030s. Under the option, Spherix has until late November to complete its due diligence and execute a license agreement for commercial development.

Tubulis GmbH, of Munich, Germany, and Glycotope GmbH, of Berlin, said they signed a research and feasibility agreement, providing Glycotope access to Tubulis' antibody-drug conjugate (ADC) technologies. Under the terms, Glycotope will have nonexclusive access to the Tub-tag technology, which allows for site-specific and stable ADC conjugation, for one of its ADC candidates. Glycotope also receives the option to evaluate the potential of Tubulis' ADC screening platform, P5. Financial terms were not disclosed.

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