Adagio Therapeutics Inc., of Waltham, Mass., said in vitro and in vivo data published in Biorxiv showed its lead antibody candidate, ADG-2, demonstrated similar or higher potency against SARS-CoV-2 compared to monoclonal antibodies in clinical development, while also offering broad neutralization against a range of sarbecoviruses that pose a threat to humans. The drug, also known as ADG-20, is expected to enter clinical studies in early 2021.
Amarin Corp. plc, of Dublin, presented preclinical findings on Vascepa (icosapent ethyl) at the American Heart Association’s Virtual Scientific Sessions 2020. In vitro, eicosapentaenoic acid (EPA), whose stable form is the active ingredient in icosapent ethyl, inhibited LDL oxidation compared to a control vehicle and did so over a more sustained period of time than docosahexaenoic acid, or DHA, and mixed omega-3 fatty acid, which had no beneficial effect. Inhibiting LDL is associated with lowering cholesterol and oxidation of LDL is associated with making LDL atherogenic. A second in vitro study that compared the separate and combined effects of phospholipid-linked EPA and arachidonic acid on membrane structure showed 1-palmitoyl-2-eicosapentaenoyl-sn-glycero-3-phosphocholine, or PL-EPA, caused membrane stability, which may improve the signaling and function of endothelial cells.
Aphios Corp., of Woburn, Mass., said it launched a crowdfunding campaign to support the development of its pathogen inactivation technology, critical fluid inactivation (CFI), which can help to provide convalescent plasma. Aphios is crowdfunding through the Sound Affects platform to raise both funds and awareness about its pathogen inactivation technology. Research on the CFI platform is funded, in part, through a phase II SBIR grant from the National Heart, Lung and Blood Institute of the U.S. NIH.
Ardigen SA, of Kraków, Poland, and Biocollective LLC, of Denver, said they formed a research collaboration to develop microbiome-based biomarker candidates to detect early signs of Parkinson’s disease (PD) and improve disease management. The partnership will pair Ardigen’s AI microbiome translational platform with Biocollective’s metagenomic and patient metadata obtained from banked stool samples from people with PD. The companies will share resources to support the project.
Ascletis Pharma Inc., of Hangzhou, China, said its board approved a change in the use of remaining net proceeds from its 2018 HKEX IPO, raising the proportion directed to R&D of its pipeline products to 75% from approximately 65%, primarily to expand its portfolio into projects addressing clinical cure in hepatitis B virus and treatments for nonalcoholic steatohepatitis and HIV/AIDS. Ten percent of net proceeds originally were intended to advance ASC-21, an NS5B polymerase nucleot(s)ide inhibitor licensed in June 2017 from Medivir AB, of Stockholm. On Nov. 17, the companies mutually agreed to terminate their collaboration on ASC-21, which Ascletis dropped from its pipeline. Instead, Ascletis plans to focus on its in-house hepatitis C virus dual-targeted fixed-dose combination candidate, ASC-18.
Aum Biosciences Pte Ltd., of Singapore, and Newsoara Biopharma Co. Ltd., of Shanghai, said they formed a five-year strategic partnership covering co-development of up to six oncology candidates in Aum’s pipeline. Aum agreed to license exclusive rights in greater China for kinase inhibitors AUM-001, AUM-302 and AUM-003 and up to three additional oncology candidates in exchange for an undisclosed collaboration fee upon closing and up to $135 million in near-term development, regulatory and commercial milestones plus up to double-digit royalty payments. Newsoara assumed responsibility for development and commercialization and agreed to contribute potential R&D funding for current and future investigational compounds in greater China, where the companies will co-discover and co-fund candidates for mutually agreed targets and Newsoara will retain rights. Aum retained global rights outside greater China to newly discovered compounds.
Caraway Therapeutics Inc., of Cambridge, Mass., said it was awarded a second research grant from The Michael J. Fox Foundation for Parkinson’s Research, building on its drug discovery research on the role of lysosomal function and autophagy in neurodegenerative and rare diseases. The funding will enable Caraway to continue to investigate the role of TMEM175, a lysosomal ion channel genetically implicated in Parkinson’s disease, in cellular models of disease and to evaluate the utility of TMEM175 agonists as therapeutics.
Caribou Biosciences Inc., of Berkeley, Calif., said it executed an exclusive license agreement with Memorial Sloan Kettering Cancer Center for rights to fully human anti-CD371 single-chain variable fragments, or scFvs, and related intellectual property in the field of allogeneic CD371-targeted cell therapies, including CAR T, CAR-NK and iPSC-derived cell products. Financial terms were not disclosed.
Clarametyx Biosciences Inc., of Columbus, Ohio, said the global Combating Antibiotic Resistant Bacteria Biopharmaceutical Accelerator, or CARB-X, awarded the company up to $14.2 million to advance its technology platform through the completion of a phase I study. The award is divided into a base period of $2.4 million with three additional milestone-based options, subject to available funds. Clarametyx is addressing biofilm-associated infections using a platform designed to precisely remove a universal, pathogen-agnostic target within the biofilm’s protective extracellular matrix to enable rapid and effective collapse of the protective shield and sensitize bacteria to immune and antibiotic attack. Lead candidate, CMTX-101, is an immune-enabling antibody with broad-spectrum activity to treat moderate to severe pneumonia through co-administration with standard antibiotic regimens.
Endo International plc, of Dublin, disclosed expiration of the required waiting period under the Hart-Scott-Rodino Antitrust Improvements Act in connection with its tender offer to acquire the outstanding common shares of Biospecifics Technologies Corp. at $88.50 apiece. The transaction is expected to close in early December 2020.
Generex Biotechnology Corp., of Miramar, Fla., said it closed a licensing and development agreement with a consortium of partners in China covering the Ii-Key vaccine platform technology from its subsidiary, Nugenerex Immuno-Oncology. Generex is set to receive a licensing fee of up to $50 million for exclusive use of the Ii-Key platform for infectious disease and cancer in China and its territories. For each product developed using the technology under the platform license, Generex will receive an up-front payment; full funding of product development, regulatory approval and commercialization in China; a milestone payment upon product approval; and a royalty to be determined on a case-by-case basis. The agreement incorporated the first Ii-Key platform project, development and commercialization of the Ii-Key-SARS-CoV-2 coronavirus vaccine in China, calling for a $5 million up-front licensing fee; full funding for manufacturing, development and commercial registration; $20 million upon approval of a Ii-Key-SARS-CoV-2 vaccine in China; and royalty payments for COVID-19 vaccine sales in China with the potential to reach several billion dollars. The agreement included provisions to advance the development of Ii-Key vaccines for infectious diseases and cancer under separate contracts.
Inmed Pharmaceuticals Inc., of Vancouver, British Columbia, and Baymedica Inc., of Incline Village, Nev., said they agreed to a broad reciprocal research collaboration to explore synergies between their cannabinoid-based technologies. Baymedica will gain access to elements of Inmed's Integrasyn platform to produce cannabinoids and will assess the potential of Inmed's high-efficiency enzyme gene sequences to produce cannabinoids in Baymedica's catalogue. Inmed agreed to pursue preclinical investigation of therapeutic compounds selected from Baymedica's library of cannabinoid analogues and to compare the therapeutic potential of analogue compounds in selected neuroprotection disease models to naturally occurring cannabinoids. Should the initial research phases yield meaningful results, the collaborative research agreement provides a mechanism for each company to license the other’s technology.
Mymetics SA, a subsidiary of Mymetics Corp., of Épalinges, Switzerland, and Insel Gruppe AG, of Bern Switzerland, said they were awarded a grant from Innosuisse, the Swiss Innovation Agency, that will allow Mymetics to collaborate with researchers in the department of pneumology at Inselspital, Bern University Hospital and the department of biomedical research at Bern University on a preclinical study of the company’s virosome-based COVID-19 nasal vaccine candidate, CoV RBD219-N1. The study will assess the candidate’s safety and tolerance and its capacity to elicit protective respiratory immunity to block nasal infection and spread of the virus to the lungs and brain.
Obsidian Therapeutics Inc., of Cambridge, Mass., and the University of Texas MD Anderson Cancer Center said they formed a multiyear strategic collaboration to expedite the R&D of engineered tumor infiltrating lymphocytes (TILs) to treat solid tumors. The partnership, which pairs Obsidian’s Cytodrive technology platform with MD Anderson's capabilities in TIL cell therapy, is focused on developing TIL armored with regulated membrane-bound IL15, referred to as CytoTIL, with the potential to enhance antitumor efficacy and reduce tumor burden. The collaboration will encompass process and analytical development and clinical readiness activities.
Contract development and manufacturing organization Probiogen AG, of Berlin, said it closed a master service agreement with Asahi Kasei Pharma Corp., of Tokyo, to deploy technologies such as its Cho.Right cell line development platform and Directedluck transposase technology to advance Asahi Kasei’s biologics pipeline.
Relief Therapeutics Holding AG, of Geneva, selected Syneos Health Inc., of Morrisville, N.C., to run its European clinical trial testing RLF-100TM (aviptadil) in patients with severe COVID-19-induced lung injury, as well as future trials in other indications to be conducted in Europe. The COVID-19 study is expected to start in the first quarter of 2021. Relief also announced that it selected Albany Molecular Research Inc. (AMRI), of Albany, N.Y., to provide aseptic fill/finish manufacturing of RLF-100 at its Glasgow, U.K., facility.
Revive Therapeutics Ltd., of Toronto, is collaborating with Pharmather Inc., a unit of Toronto-based Newscope Capital Corp., to develop psilocybin as a treatment for cancer and for the discovery of novel uses of undisclosed psychedelic compounds. Pharmather discovered that psilocybin has the potential to treat certain cancers such as liver carcinoma, melanoma, breast neoplasms, kidney neoplasms and acute myeloid leukemia. Revive will have rights to use those data to develop psilocybin for the treatment of cancer. Pharmather will use its panaceAI platform to discover new uses for other psychedelic compounds.
Sunshine Biopharma Inc., of Montreal, entered a collaboration agreement with an undisclosed Montreal-based company to develop and implement chemical synthesis procedures for Sunshine's cancer treatment, Adva-27a. The company will also test the drug on various types of cancer cells grown in culture and conduct studies in mice if the in vitro studies are successful.
Ultivue Inc., of Cambridge, Mass., and Indivumed GmbH, of Hamburg, Germany, are collaborating to develop products and services for research and drug development in the area of personalized oncology. Ultivue will contribute its Insituplex platform for high-throughput multiplex immunofluorescence, while Indivumed adds its vast array of tissue biospecimens and analytical experience in immunohistochemistry technology.