Annovis Bio Inc., of Berwyn, Pa., received a $1.7 million NIH grant to continue chronic toxicology studies in animals of its lead compound, ANVS-401, an oral, brain-penetrant inhibitor of neurotoxic proteins. The studies are expected to conclude in the third quarter of this year. Previously, the NIH supported Annovis through the National Institute on Aging ADCS grant to fund an ongoing phase IIa trial in treating Alzheimer’s disease.
Ascletis Pharma Inc., of Hangzhou and Shaoxing, China, advanced its coronavirus pneumonia clinical trial of oral Ganovo (danoprevir) and ritonavir combination therapy, as the company noted that three patients were discharged from a hospital after treatment. On Feb. 16, the clinical trial received approval from the ethics committee of the Ninth Hospital of Nanchang. The first patient diagnosed with coronavirus pneumonia was enrolled for the combination therapy Feb. 17. Ganovo, an oral hepatitis C virus protease inhibitor, was approved by China’s National Medical Products Administration for market launch in June 2018 for treating chronic hepatitis C.
In Cellular and Molecular Immunology, Atyr Pharma Inc., of San Diego, highlighted the role that histidyl tRNA synthetase (HARS) plays in the modulation of immune cell engagement in a broad range of disease states, including interstitial lung diseases. In mouse and rodent models of acute inflammatory disease, researchers found that HARS administration down-regulated immune response. In contrast, HARS neutralization through targeting antibodies was associated with immune system activation and the perpetuation of chronic and acute autoimmune diseases, including interstitial lung diseases. Atyr’s lead candidate, ATYR-1923, is being evaluated in a phase Ib/IIa trial in patients with pulmonary sarcoidosis, which is characterized by the formation of granulomas, clumps of inflammatory cells in the lungs.
Basilea Pharmaceutica Ltd., of Basel, Switzerland, noted that its licensed partner, Pfizer Inc., of New York, launched its antifungal Cresemba (isavuconazole) in Australia, triggering the first milestone payment related to Asia-Pacific territory from Pfizer to Basilea. In June 2017, Basilea entered a licensing agreement with Pfizer for isavuconazole in Europe (excluding the Nordics), Russia, Turkey and Israel. The agreement was extended in November 2017 to China, including Hong Kong and Macao, and 16 countries in the Asia-Pacific region. Basilea is eligible for regulatory and sales milestone payments of about $635 million in addition to receiving midteen royalties on in-market sales of Cresemba. In Australia, Cresemba is approved to treat adults with invasive aspergillosis and to treat mucormycosis in adults for whom amphotericin B is inappropriate.
Boehringer Ingelheim GmbH, of Ingelheim, Germany, and Trutino Biosciences Inc., of San Diego, said they entered a research collaboration and worldwide licensing agreement based on Trutino’s On-Demand-Cytokine (ODC) platform. Under the terms, Boehringer gains access to Trutino’s technology for the generation and development of up to three new ODC candidates. Trutino’s ODC platform is designed to mask the activity of cytokines until they reach the tumor site and become fully activated, sparing systemic exposure and potentially leading to a higher margin of safety and greater efficacy than conventional cytokine treatments. Trutino will generate the new ODC molecules and carry out preclinical validation, handing over development to Boehringer for late preclinical testing through the rest of development. Specific financial terms were not disclosed, but Boehringer will provide an up-front payment, near-term preclinical milestone payments and clinical, regulatory and commercial milestone payments, including royalties on future product sales.
The ongoing collaboration between Can-Fite Biopharma Ltd., of Petach Tikva, Israel, and Univo Pharmaceuticals Ltd., of Tel Aviv, Israel, generated preclinical data demonstrating cannabidiol’s (CDB) antineoplastic effect against liver cancer, the companies said. The studies on human liver cancer cells used cannabinoid fractions enriched for CBD, in nano- and picomolar concentrations. Marked inhibition of Hep-3b, liver cancer cell proliferation was noted and was mediated via the A3 adenosine receptor, the target of Can-Fite’s drug platform. The two companies are expanding the agreement to allow the testing of minute CBD concentrations/dosages in combination with namodenoson on liver cancer and additional oncological indications. Can-Fite will fund the R&D for the two new indications, to be jointly performed, for $200,000 per indication.
Chromadex Corp., of Los Angeles, disclosed the publication of a preclinical study in Aging and Mechanisms of Disease, part of Nature Partner Journals. Conducted by the National Institute on Aging and the National Institute on Deafness and Other Communication Disorders, components of the NIH, and the University of Copenhagen, the study demonstrated a reduction of hearing loss from Niagen (nicotinamide riboside chloride) supplementation in mice. The findings are potentially meaningful for those with Cockayne syndrome as well as the broader aging population who experience hearing loss, the company said. About one in three people between the ages of 65 and 74 experiences hearing loss and nearly half of those older than 75 have difficulty hearing. The hearing loss experienced by Cockayne syndrome patients is similar to the sensorineural age-related hearing loss commonly found in older adults, Chromadex noted.
Hikma Pharmaceuticals plc, of London, and Glenmark Specialty SA, a subsidiary of Glenmark Pharmaceuticals Ltd., of Mumbai, signed an exclusive U.S. license agreement to commercialize Ryaltris (olopatadine hydrochloride and mometasone furoate nasal spray), a fixed-dose combination nasal spray for the treatment of seasonal allergic rhinitis. Glenmark will be responsible for the continued development and regulatory approval of Ryaltris by the FDA. Hikma will be responsible for the commercialization of the drug in the U.S. following approval. Hikma would also have the ability to produce the product utilizing its nasal manufacturing capabilities in Columbus, Ohio. Hikma will provide Glenmark with an up-front payment, regulatory approval and commercial milestone payments as well as royalties. Exact terms were not disclosed.
Innovation Pharmaceuticals Inc., of Wakefield, Mass., signed a material transfer agreement with one of the country’s 12 regional biocontainment labs to research its lead defensin mimetic drug candidate, brilacidin, as a potential novel coronavirus treatment. The first shipments of brilacidin will be made in the coming days, Innovation said. Scientific research partners at the lab plan to evaluate brilacidin’s potential antiviral and anti-inflammatory properties in the context of viral infections, including inhibition of SARS-CoV-2, the virus responsible for COVID-19.
Nervgen Pharma Corp., of Vancouver, British Columbia, provided an update to its development plan for its lead program, NVG-291. The changes are the result of a number of factors, including feedback from the FDA on the recently submitted IND. Nervgen has decided to delay the initiation of its phase I study from the first quarter of 2020 to the fourth quarter. Although Nervgen said it believes it would have been possible to initiate the study in the second quarter on a restricted basis, the company has decided to delay the start of the study in order to provide additional information in its IND application and to broaden the scope of the study. In the interim period, Nervgen intends to perform additional preclinical studies to support the IND application. NVG-291 works by inhibiting the activity of the protein tyrosine phosphatase sigma, a neural receptor that blocks nerve regeneration following tissue damage. Nervgen previously said that its first study in patients would be a phase Ib study in spinal cord injury patients. The company now intends to progress directly in spinal cord patients with an adaptive design phase II study, with the objective of generating proof-of-concept data as early as possible. Subject to successful completion of the phase I study in healthy volunteers, the phase II study in spinal cord injury patients is still expected to be initiated in the second half of 2021.
PDS Biotechnology Corp., of Princeton, N.J., started work under an amended and restated material transfer agreement with Farmacore Biotechnology Ltda, of Ribeirão Preto, Brazil. The effort is to develop a novel tuberculosis (TB) immunotherapy based on Farmacore’s TB antigens and PDS’s Versamune platform technology. The prior agreement under which preliminary work commenced was changed in December 2019 due to promising early preclinical results and to progress to the next phase of development.
Soligenix Inc., of Princeton, N.J., said that in collaboration with the University of Hawai'i at Manoa and Honolulu-based Hawaii Biotech Inc., it has demonstrated the feasibility of developing heat stable subunit protein vaccines for filovirus. The collaborators are now focusing on accelerating development of a Marburg virus vaccine.
Tetra Bio-Pharma Inc., of Ottawa, signed a co-development agreement with Burlington, Mass.-based Makscientific LLC providing Tetra with access to new molecules targeting the cannabinoid receptors CB1 and CB2. Makscientific will develop the new molecules and Tetra will screen them for efficacy in various indications, including cancer, pain and inflammation.