Aligos Therapeutics Inc., of South San Francisco, reported preclinical data on its SARS-CoV-2 3-chymotrypsin-like cysteine protease inhibitor candidate, ALG-097111, at the 28th Conference on Retroviruses and Opportunistic Infections. In hamsters challenged with the SARS-CoV-2 coronavirus, ALG-097111 produced a 3.5 log10 (RNA copies/mg) reduction of the viral RNA copies and a 3.7 log10 (TCID50/mg) reduction in the infectious virus titers in the lungs. In human small airway epithelial cell cultures, ALG-097111 reduced viral RNA yield at the apical site of the culture by more than 3 log10 RNA copies/mg.
Amryt Pharma plc, of Dublin, and Medison Pharma Canada, a unit of Medison Pharma Ltd., of Petach Tikva, Israel, signed a distribution agreement for Medison to market Amryt's leptin deficiency treatment, Myalepta (metreleptin), in Canada. Financial terms of the deal weren't disclosed.
Aridis Pharmaceuticals Inc., of Los Gatos, Calif., licensed rights to its Apex monoclonal antibody pathogen discovery platform to Kermode Biotechnologies Inc., which will have rights to develop the antibodies and vaccines that are discovered in veterinary indications. Aridis will retain rights to develop any products discovered in the collaboration for human uses.
Bavarian Nordic A/S, of Copenhagen, reported preclinical data on its capsid virus-like particle COVID-19 vaccine candidate, ABNCoV2, which was licensed from Adaptvac, of Horsholm, Denmark. The low and high dose of the vaccine plus adjuvant, as well as the high dose without adjuvant induced SARS-CoV-2 neutralizing antibodies at comparable levels to those measured in convalescent human samples. A second non-adjuvanted dose increased titers more than 50-fold. In a challenge study, no virus was detected in the majority of animals vaccinated with two high doses of ABNCoV2. The company plans to start a phase I/II study of ABNCoV2 shortly.
Betterlife Pharma Inc., of Vancouver, British Columbia, entered an agreement with Carleton University to study its second-generation lysergic acid diethylamide derivative molecule, TD-0148A, in preclinical models of depression.
Cleave Therapeutics Inc., of San Francisco, licensed rights for the development and commercialization of its cancer treatment, CB-5339, a VCP/p97 inhibitor, in mainland China, Taiwan, Hong Kong and Macau to CASI Pharmaceuticals Inc., of Rockville, Md. Cleave will receive $5.5 million up front and is eligible for up to $74 million in development and commercial milestone payments plus tiered royalties in the high-single to mid-double-digit range on net sales of CB-5339. CASI is also making a $5.5 million investment in Cleave.
Cortexyme Inc., of South San Francisco, partnered with the Parkinson Study Group to form an advisory board to leverage the group’s expertise and further develop the company’s Parkinson’s disease (PD) program. Also, Cortexyme will present new data further demonstrating the role of Porphyromonas gingivalis in the development of Alzheimer’s disease at AD/PD 2021, the 15th international conference on Alzheimer’s & Parkinson’s Diseases, held virtually this week.
Exelixis Inc., of Alameda, Calif., and Wuxi Biologics Inc., of Shanghai, signed an exclusive license agreement to support the continued expansion of Exelixis’ oncology biologics pipeline. The agreement is the latest in a series of biologics-focused transactions for Exelixis as the company builds out its pipeline behind Cabometyx (cabozantinib), which received its fourth approval from the FDA in January. Under the terms of the agreement, Exelixis will make a “modest” up-front payment to Wuxi in exchange for an exclusive license to a panel of monoclonal antibodies to a preclinically validated target, discovered based on Wuxi’s technology platforms, for the development of antibody-drug conjugate, bispecific and certain other novel tumor-targeting biologics applications. Wuxi will be eligible for development and commercialization milestone payments, as well as tiered royalties on net sales of any potential products commercialized from the panel.
Preclinical research from Galectin Therapeutics Inc., of Norcross, Ga., showed the company’s galectin-3 inhibitor reduced tumor progress when combined with an anti-OX40 monoclonal antibody compared to either agent alone. Galectin-3 plays a major role in diseases that involve scarring of organs, including fibrotic disorders of the liver, lung, kidney, heart and vascular system, the company said. Preclinical data in animals have shown that belapectin has promising treatment effects in reversing liver fibrosis and cirrhosis, the company added.
GT Biopharma Inc., of Beverly Hills, Calif., disclosed preclinical results with its ROR1 TriKE product candidate as a therapy for the treatment of prostate cancer. Tyrosine kinase transmembrane receptor ROR1 has recently been shown to be overexpressed on certain cancer cells, and appears to play a functional role in promoting migration/invasion and influencing the metastatic potential of various solid tumor cancers, the company noted. The product was evaluated in several preclinical models of prostate cancer, and was found to be effective at promoting NK cell killing of multiple prostate cancer cells including LnCAP, C4-2, PC-3, DU-145, VCaP and 22RV1.
Iontas Ltd., and Fairjourney Biologics S.A., both of Porto, Portugal, signed an agreement with Quell Therapeutics Ltd., of London, regarding their libraries and technology platforms. Quell is harnessing the suppressive capacity of T regulator cells (Tregs) to develop engineered Treg cell therapies to address several conditions of immune dysfunction. Iontas and Fairjourney will provide Quell with a diverse panel of target binders, ranging in affinities, to enable Quell to select functional binders for chimeric antigen receptor development against undisclosed targets. The collaboration is nonexclusive, and further terms were not disclosed.
Iqvia Inc., of Danbury, Conn., said that since September 2020, it has been collaborating with Johnson & Johnson, of New Brunswick, N.J., through Janssen Research & Development LLC, on phase III COVID-19 vaccine trials. The studies leverage Iqvia’s suite of decentralized trial solutions that support on-site and remote study delivery through a mix of telehealth technologies, virtual oversight and digital patient engagement strategies. Such capabilities enabled participants to be screened remotely to determine their risk status, to schedule an appointment at a nearby site, and to report potential COVID-19 symptoms, the company noted.
A new analysis from Medincell SA, of Montpellier, France, showed the company anticipates no safety concern that would prevent health authorities from assessing the use of ivermectin against COVID-19 as a new indication. The analysis, written by a toxicologist, is based on a review of more than 350 articles. Medincell has ivermectin, which binds glutamate-gated chloride channels, in a phase I trial for COVID-19 prophylaxis.
Moderna Inc., of Cambridge, Mass., said it has an agreement with the government of the Philippines to supply 13 million doses of the company’s COVID-19 vaccine. Deliveries begin in mid-2021, according to Moderna. A separate agreement with the Philippines government and the country’s private sector to supply an additional 7 million doses is also anticipated, the company added. Also, Moderna signed with Baxter International Inc. to provide fill/finish sterile manufacturing services and supply packaging for approximately 60 million to 90 million doses of Moderna’s vaccine in 2021. Baxter, a CRO that specializes in injectable pharmaceuticals, will manufacture the vaccine in Bloomington, Ind.
Pathios Therapeutics Ltd., of Oxford U.K., was awarded £350,000 (US$475,000) though a Smart Grant from Innovate UK to support development of inhibitors of the innate immune checkpoint GPR65. Pathios will work with the Department of Oncology at the University of Oxford on the project, which will start with the treatment of melanoma that's resistant to other treatments.
Pneumagen Ltd., of St. Andrews, Scotland, said research showed that in a hamster model of COVID-19 infection, Neumifil was efficacious, significantly reducing clinical signs and weight loss in animals infected with SARS-CoV-2. Pneumagen also said that Neumifil binds with equally high affinity to SARS-CoV-2 spike proteins from the Wuhan (Wuhan-Hu-1), U.K. (B.1.1.7) and South Africa (B.1.351) variants. In further experiments, Pneumagen also demonstrated high affinity Neumifil binding to the ACE2 receptor, which is used by the SARS-CoV-2 virus to infect the host, the company added. Neumifil is a carbohydrate binding module, a modality that binds to receptors used by pathogens to enter respiratory airways, and is designed to prevent infection and avoid resistance.
Wugen Inc., of St. Louis, said it entered an exclusive license and collaboration agreement with Shanghai-based Alpha Biopharma Inc. to manufacture, develop and commercialize allogeneic cell products in Asia, including China, Hong Kong, Macao, Taiwan and Singapore. Products included in the agreement incorporate Wugen's technology to manufacture off-the-shelf memory natural killer and CAR T cells for treating solid tumors, T-cell malignancies, acute myeloid leukemia and multiple myeloma. Alpha is responsible for development and commercialization, including manufacturing, clinical, regulatory, marketing and sales. The two companies will equally share profits and data to support territory and global approvals.