Advaxis Inc., of Princeton, N.J., said it inked a research collaboration with the University of California, Los Angeles to conduct preclinical studies testing the company’s Lm technology in mouse tumor models of glioblastoma multiforme, specifically investigating antitumor immunity and antitumor responses generated by Lm vaccines that express diverse glioblastoma neoantigens.
Aruna Bio Inc., of Athens, Ga., was awarded a $4.5 million Small Business Innovation Research phase II grant by the NIH to support preclinical development of AB-126, its neural stem cell-derived extracellular vesicles for the treatment of acute ischemic stroke. Aruna plans to file an IND for AB-126 in 2021.
Avacta Group plc, of Cambridge, U.K., is collaborating with ADC Therapeutics SA, of Lausanne, Switzerland. The companies plan to use Avacta’s Affimer technology with ADC Therapeutics’ pyrrolobenzodiazepine-based warhead and linker technologies to develop drugs to three undisclosed cancer targets. ADC Therapeutics will carry out preclinical research and will have options, on a target-by-target basis, to license the drugs for clinical development and commercialization. ADC Therapeutics will cover Avacta’s cost of development, and Avacta is eligible to receive undisclosed option fees, development and commercialization milestones, as well as a single-digit royalty on sales.
Can-Fite Biopharma Ltd., of Petach Tikva, Israel, said preclinical data published in the International Journal of Molecular Medicine showed namodenoson, an A3 adenosine receptor agonist, ameliorated nonalcoholic steatohepatitis (NASH) in mice. The study tested the drug’s effects on two different NASH models and on a cell line of human liver cells, resembling the metabolic phenotype observed in NASH patients. Data showed namodenoson induced significant anti-inflammatory, antisteatotic and antifibrotic effects mediated by deregulation of the Wnt/beta-catenin pathway, known to be active in nonalcoholic fatty liver disease/NASH.
Clinigen Group plc, of Burton-on-Trent, launched a managed access program for Progenics Pharmaceuticals Inc., of Tarrytown, N.Y., to provide its radiotherapeutic, Azedra (iobenguane I 131), outside the U.S.
Delpor Inc., of Brisbane, Calif., was awarded a grant from the NIH through the NIH Helping to End Addiction Long-term (HEAL) initiative to develop a once-yearly naltrexone product for the prevention of relapse to opioid dependence. Delpor expects to receive $5.7 million from NIH HEAL during the first two years and may receive additional funding during the subsequent three years if it meets milestones during the initial funding period.
Distributed Bio Inc., of South San Francisco, released version 3.0 of its Superhuman antibody discovery platform that can be used to generate bispecific antibodies that share a common light chain.
Enlivex Therapeutics Ltd., of Ness Ziona, Israel, said preclinical data presented at the XVIII Congress of the European Shock Society and IX Congress of the International Federation of Shock Societies in Crete, Greece, showed 10-fold increased survival for study subjects with acute sepsis who were treated with immunotherapy candidate Allocetra-OTS and antibiotics and fluids, as compared to subjects treated solely with antibiotics and fluids. Specifically, the levels of cytokine storms and organ failures were dramatically lower in the Allocetra-OTS group, leading to improved survival.
Evotec SE, of Hamburg, Germany, said its subsidiary, Just-Evotec Biologics, and Biocon Biologics, a wholly owned subsidiary of Biocon Ltd., of Bangalore, India, entered a licensing agreement for an early stage, preclinical biosimilar asset. Under the terms, Biocon will take the asset through end-to-end development, IND filing, manufacturing and commercialization, under its own label in global markets. Evotec received an undisclosed license fee and will be eligible for development, regulatory and commercial milestone payments.
Hillstream Biopharma Inc., of Chester, N.J., disclosed the renewal of a Cooperative Research and Development Agreement with the National Center for Advancing Translational Sciences (NCATS), part of the NIH, which enables the use of the company’s Quatramer drug delivery technology to develop formulations of HDAC6-PI3K-delta dual inhibitors for the treatment of rare cancers, including acute myeloid leukemia and acute lymphoid leukemia. The primary objective of the study is encapsulation of NCATS-developed dual inhibitors into Hillstream’s nanoparticle tumor-infiltrating Quatramer suspension to assist with enhanced and safer delivery into malignant cells.
Immutep Ltd., of Sydney, said it received €1.6 million (AU$2.5 million; US$1.7 million) in an R&D tax incentive payment in cash from the French government via its Crédit d’Impôt Recherche (Research Tax Credit) scheme, under which French companies conducting R&D in Europe can be reimbursed 30% of their eligible expenditure. Immutep qualifies through its subsidiary, Immutep SAS. Funds will be used to support ongoing and planned global clinical development of eftilagimod alpha and preclinical development of IMP-761.
Innovent Biologics Inc., of Suzhou, China, and Hutchison China Meditech Ltd., of London, expanded their agreement testing Innovent’s PD-1 antibody, Tyvyt (sintilimab), with Chi-Med’s VEGFR inhibitor, fruquintinib, to include testing the combination of Tyvyt with Chi-Med’s angio-immuno kinase inhibitor, surufatinib, in solid tumors with global unmet medical needs.
Jaguar Health Inc., of San Francisco, said it engaged Angel Pond Capital LLC to explore potential licensing agreements in China for Mytesi (crofelemer), a product approved by the U.S. FDA for symptomatic relief of noninfectious diarrhea in adults with HIV/AIDS on antiretroviral therapy. Mytesi also is in development for possible follow-on indications, including cancer therapy-related diarrhea, supportive care in inflammatory bowel disease, irritable bowel syndrome and idiopathic/functional diarrhea.
Mustang Bio Inc., of New York, said City of Hope was awarded $4.1 million in grants for a clinical trial testing Mustang’s IL13Ralpha2 CAR T, MB-101, in combination with Opdivo (nivolumab, Bristol-Myers Squibb Co.) and Yervoy (ipilimumab, BMS) in patients with recurrent malignant glioma. The funding includes $3.3 million over five years from the NIH as well as $800,000 for Gateway for Cancer Research.
Neumentum Inc., of Palo Alto, Calif., said it entered a global licensing agreement with Janssen Pharmaceutica NV and McNeil Consumer Pharmaceuticals Co., both part of New Brunswick, N.J.-based Johnson & Johnson, for rights to oral analgesic JNJ-10450232, plus a portfolio of backup compounds. Financial terms were not disclosed. JNJ-10450232, described as neither an opioid nor a nonsteroidal anti-inflammatory drug, is in development for treating moderate to moderately severe acute pain and has completed phase IIa studies.
As of Oct. 10, the stock of Novelion Therapeutics Inc., of Vancouver, British Columbia, is trading under the symbol NVLNF on the over-the-counter stock market. That follows the Oct. 8, announcement that its shares would be delisted and suspended from trading on Nasdaq, effective at the open of business Oct. 9.
Oligomerix Inc., of New York, received a $2.18 million Small Business Innovation Research grant from the NIH to develop small-molecule inhibitors of tau oligomer formation to treat Alzheimer’s disease and related neurodegenerative diseases with tau pathology for clinical development. Oligomerix’s preclinical data show tau oligomers are neurotoxic, inhibit signal transmission between neurons and impair formation of memory in mice.
Oncosec Medical Inc., of Pennington, N.J., will receive a $30 million investment from Grand Decade Developments Ltd. at $2.50 per share, subject to shareholder approval. Once the deal closes, Grand Decade and Sirtex Medical U.S. Holdings Inc. will hold 53% of Oncosec’s common shares and three Oncosec board seats. In exchange, Oncosec will grant Grand Decade and its affiliates an exclusive license to develop, manufacture, commercialize, or otherwise exploit Oncosec’s current and future products, including Tavo and Oncosec’s new Visceral Lesion Applicator (VLA), in greater China and 35 other Asian countries. Grand Decade will pay up to 20% royalties on the net sales of such products in the 35 other countries. Sirtex will support and assist Oncosec with premarketing activities for Tavo and VLA in exchange for low single-digit royalties on Tavo and VLA net sales outside the 35 Asian country territory.
Common stock of Relmada Therapeutics Inc., of New York, began trading Oct. 10 on Nasdaq under the symbol RLMD. Relmada’s lead program, dextromethadone (REL-1017), an N-methyl-D-aspartate receptor antagonist, is being designed to treat psychiatric and neurological disorders associated with a variety of cognitive, neurological and behavioral symptoms.
Respira Therapeutics Inc., of Albuquerque, N.M., said it regained full worldwide research, development and licensing rights to its inhaled drug-device combination product, RT-234, following a decision by United Therapeutics Corp., of Silver Spring, Md., to conclude its 2017 collaboration with Respira based on a strategic prioritization of assets within United Therapeutics’ product development portfolio. RT-234, which contains vasodilator vardenafil as its active ingredient, recently concluded phase I testing and is in phase II studies for a pulmonary arterial hypertension indication. United Therapeutics has no further funding obligations to the program, but it does retain a minority preferred equity stake in Respira.
Rheostat Therapeutics Inc., of Cambridge, Mass., has rebranded itself as Caraway Therapeutics. Caraway is designing treatments for neurodegenerative diseases, including Alzheimer’s disease and amyotrophic lateral sclerosis, by preserving neurons to toxic materials and defective components from cells.
Scynexis Inc., of Jersey City, N.J., said it received notification from the state of New Jersey of its available unused net operating losses (NOLs) and R&D tax credits that can be sold under the New Jersey Economic Development Authority’s (NJEDA) Technology Business Tax Certificate Transfer program. Scynexis anticipates it will be able to monetize those unused NOLs and tax credits and expects to receive about $3.3 million in cash by the end of 2019. The exact amount of NOLs and tax credits to be sold will be determined by the NJEDA after reviewing all qualified applications. Scynexis previously received about $6.7 million in January through the sale of unused New Jersey NOLs for the tax years 2015, 2016 and 2017.
Sensyne Health plc, of Oxford, U.K., said it has joined Bayer AG’s Lifehub U.K., a global network of its innovation hubs, in an extension of its existing collaboration with the Leverkusen, Germany-based company to accelerate the development of new treatments using clinical artificial intelligence. Sensyne Health will be one of the first companies to have a presence in the Lifehub and will work on the development of AI-enabled radiology to enhance patient outcomes. It will analyze research from 3 million anonymized, ethically sourced NHS patient records and imaging data provided through Sensyne Health’s partnerships with NHS trusts, developing digital solutions to help radiologists improve the quality of the diagnosis and increase efficiency for patients receiving the right treatment in a timely manner.
Siteone Therapeutics Inc., of Bozeman, Mont., said it has received a notice of award from the NIH’s National Institute on Drug Abuse for grant funding under the Helping to End Addiction Long-term (NIH HEAL) initiative, to support development of the company’s lead therapeutic candidate, ST-2427, a NaV1.7 sodium channel inhibitor for the treatment of acute postoperative pain. The grant is a UG3/UH3 Phase Innovation Awards Cooperative Agreement involving two phases. The UG3 phase will support a project with specific milestones to be accomplished by the end of a two-year period. The UH3 phase will provide funding for a further three years to a project that successfully completed the milestones set in the UG3 phase. Application budgets are limited to $3 million direct costs per year and UG3 projects that have met their milestones will be considered and prioritized for transition to the UH3 phase, with the total funding currently expected to be available under both the UG3 and UH3 phases to be a maximum of $15 million in direct costs.
Theratechnologies Inc., of Montreal, said its shares began trading on Nasdaq under the symbol TXTX on Thursday. Shares will continue to be listed on the Toronto Stock Exchange under the symbol TH.