Adma Biologics Inc., of Ramsey, N.J., disclosed the commencement of operations and initiation of collections at its newest Adma Biocenters plasma collection facility located in Knoxville, Tenn. Adma also said it has submitted a BLA to the FDA seeking approval for this second plasma collection center.
Aim Immunotech Inc., of Ocala, Fla., signed a material transfer and research agreement with Japan's National Institute of Infectious Diseases and Shionogi & Co. Ltd., of Osaka, Japan, in order to test Aim's drug, Ampligen (rintatolimod), as a potential adjuvant therapy for COVID-19. Aim will provide Ampligen samples for various research projects. The details of all preclinical and clinical results will remain confidential until released by the institute and Shionogi.
Applied Therapeutics Inc., of New York, said it has uncovered fraudulent attempts to manipulate the firm’s stock. According to the company, on July 1, 2020, a fraudulent “short report” was posted on an online platform from an untraceable and anonymous source. Immediately following, individuals believed to have taken short positions in the company’s stock shared the report on social media. Applied said the report includes fabricated graphs and fraudulent data which it falsely attributes to Applied for the apparent purpose of manipulating the stock price. Shares (NASDAQ:APLT) closed July 6 at $31.37, down $1.78.
ANI Pharmaceuticals Inc., of Baudette, Minn., said it acquired fluconazole tablets USP, 50 mg, 100 mg, 150 mg and 200 mg from a private company for $3 million. ANI estimates the annual U.S. market for the drug to be about $40 million. The tablets are for treating vaginal yeast infections due to Candida and oropharyngeal and esophageal candidiasis.
Anixa Biosciences Inc., of San Jose, Calif., is shifting its business focus to develop therapeutics and vaccines for high-need patient populations, including a cancer immunotherapy program with the Moffitt Cancer Center using chimeric endocrine receptor T-cell technology. As part of the change, Anixa stopped developing its liquid biopsy technology, Cchek, which measures a patient's immunological response to a malignancy by analyzing immune system cells in peripheral blood.
Ascentage Pharma Group International, of Suzhou, China, and MSD, also known as Merck & Co. Inc., of Kenilworth, N.J., will evaluate the combination of APG-115, Ascentage's MDM2-p53 inhibitor, and Keytruda (pembrolizumab), MSD's anti-PD-1 therapy, to treat advanced solid tumors. Ascentage will sponsor an open-label, multicenter, phase Ib/II study to evaluate the combination in multiple cohorts of solid tumors. The phase II portion of the study has initiated and is expected to enroll 80 patients at multiple sites in the U.S. MSD and Ascentage will use a joint development committee to exchange information about the study.
Connectyx Technologies Holding Group Inc., of Boca Raton, Fla., said it is in discussions for the worldwide license of a novel monoclonal antibody to treat pediatric glioblastoma. The company plans to grow its product pipeline through a program of acquisition, in-licensing and sublicensing of new technologies, it said.
Curevac AG, Tübingen, Germany, entered a €75 million (US$84.8 million) financing with European Investment Bank to support ongoing development of vaccines against infectious diseases, including its vaccine candidate, CVnCoV, for preventing SARS-CoV-2 infections. The loan will support the company's efforts to expand its existing GMP-certified production capabilities and accelerate completion of its fourth production site in Tübingen. The financing is provided in three €25 million tranches upon completion of predefined milestones.
Cytodyn Inc., of Vancouver, British Columbia, said it signed an exclusive distribution and supply agreement with American Regent Inc. to distribute leronlimab for treating COVID-19 in the U.S. Cytodyn will receive quarterly payments based on a profit-sharing arrangement. The FDA granted Cytodyn fast track designation for two potential indications of leronlimab for deadly diseases: as a combination therapy with highly active antiretroviral therapy for HIV-infected patients and for treating metastatic triple-negative breast cancer. Leronlimab is a humanized IgG4 monoclonal antibody that blocks CCR5, a cellular receptor in HIV infection, tumor metastases and other diseases.
Dragonfly Therapeutics Inc., of Waltham, Mass., and Bristol Myers Squibb Co. (BMS), of New York, will collaborate to discover and develop immunotherapies for multiple sclerosis and neuro-inflammation targets. Dragonfly will grant BMS the option to license exclusive worldwide intellectual property rights to multiple candidates developed using Dragonfly's platform for multiple new targets. BMS will pay Dragonfly $55 million up front and Dragonfly will be eligible to receive additional payments associated with development, regulatory and sales milestones, as well as potential royalties on sales of approved products.
Emergent Biosolutions Inc., of Gaithersburg, Md., signed a five-year manufacturing services agreement with Janssen Pharmaceuticals Inc. for large-scale drug substance manufacturing for New Brunswick-N.J.-based Johnson & Johnson’s investigational SARS-CoV-2 vaccine, Ad26.COV2-S, recombinant. Emergent will provide contract development and manufacturing services to produce drug substance at large scale over five years, valued at approximately $480 million for the first two years. Emergent will begin providing large-scale drug substance manufacturing for Johnson & Johnson’s adenovirus-based COVID-19 vaccine in 2021. For subsequent years beginning 2023, Emergent will provide a capacity deployment model to support additional drug substance batches annually.
Entasis Therapeutics Holdings Inc., of Waltham, Mass., said it entered a contract with the NIH’s National Institute of Allergy and Infectious Diseases for an initial award of about $3 million, with a potential to increase up to $15.5 million, to develop novel molecules from its non-β-lactam inhibitor platform with expanded antimicrobial spectrum. Funding from the contract will support research toward developing molecules with expanded gram-negative spectrum against antibiotic-resistant bacterial pathogens, including E. coli, Acinetobacter, Pseudomonas and Klebsiella. Subject to achieving predefined milestones, the contract will fund work up to the IND-ready stage.
Fusion Antibodies plc, of Belfast, U.K., an antibody discovery, engineering and supply company, disclosed in an update that it has started proof-of-concept work on its Mammalian Antibody Library Discovery platform and hit its first milestone in the COVID-19-associated project, with the synthesis of the antibody library DNA. The company said it has also made rapid progress on the design, expression and validation of the COVID-19 antigens and now has sufficient quantities of two variants to be used in the panning of the library for specific antibody-producing cells, which is the next phase of the library development program. The multiple COVID-19 proteins generated are also being made available to diagnostic companies for potential commercial development.
Hemostemix Inc., of Calgary, Alberta, said it filed a verified complaint on June 29 and motions for a preliminary injunction and expedited scheduling on July 2, seeking to compel the immediate return of all clinical trial data from defendant Accudata Solutions Inc., and enjoining Accudata from continuing to divulge and disclose confidential information to third parties who have no ownership or custodial right to it. Hemostemix, which engaged the services of Accudata to conduct a statistical analysis of the clinical trial midpoint data, is alleging that, while refusing to return the clinical trial midpoint data to Hemostemix, Accudata produced a copy of the midpoint data and report to an agent of the former CRO Aspire Health Science LLC, and Aspire is now blocking Hemostemix from obtaining the return of its clinical trial data.
Hitgen Inc., of Chengdu, China, and Morphic Therapeutic Inc., of Waltham, Mass., said they extended their drug discovery research collaboration to identify small-molecule leads against targets specified by Morphic. The collaboration is an extension of a previous agreement which identified active lead compounds that were exclusively licensed to Morphic. Under the terms of the extended deal, Hitgen will use its DNA-encoded library (DEL) technology, based on the design, synthesis and interrogation by selection of DELs to discover ligands for targets of interest to Morphic, while Morphic will pay an assignment fee in exchange for exclusive development and commercialization rights to compounds that achieve the criteria of the collaboration.
Immune Regulation Ltd., of London, said it entered a teaming agreement with Dynport Vaccine Co. LLC, a General Dynamics Information Technology company founded in 1997 to develop vaccines and therapeutics for U.S. government customers and based in Frederick, Md. Under the agreement, the companies will jointly evaluate the potential of Immune Regulation’s drug product, ILR-201104, to treat COVID-19-related acute respiratory distress syndrome (ARDS) in U.S. clinical trials. IRL-201104 has been shown to quickly and markedly reduce the excessive infiltration of neutrophils in the lungs in a preclinical model of acute lung inflammation, the company said.
Medivir AB, of Stockholm, said it entered a research collaboration with the Drug Discovery and Development Platform (DDD) at Scilifelab on potential inhibitors of SARS-CoV-2. Through the collaboration, DDD will get access to Medivir's protease-targeted compound library. The aim is to find potential inhibitors of the main protease of SARS-CoV-2, an essential non-structural protein, Mpro, required for virus replication. DDD will mine the Medivir-developed protease-targeted compound library to identify putative inhibitors and evaluate active compounds as potential drug development candidates. Data for up to 100 top-inhibitors will be released online and will be freely available for drug development to combat COVID-19.
Nyrada Inc., of New South Wales, Australia, reported preclinical data showing that its oral PCSK9 inhibitor, NYX-PCSK9i, has the potential to replace ongoing injections for treating hypercholesterolemia. Data from a study using healthy donor human lymphocytes showed cells had increased LDL receptor levels, and the drug demonstrated equivalency to marketed monoclonal PCSK9 antibody drugs.
Precision Biosciences Inc., of Durham, N.C., said it will regain full rights and all data it generated for the in vivo chronic hepatitis B virus (HBV) program developed under its 2018 collaboration agreement with Gilead Sciences Inc., of Foster City, Calif. Under the terms of the potential $445 million collaboration agreement, signed in September 2018, Precision was primarily responsible for the development, formulation and preclinical evaluation of the investigational nucleases for HBV, while Gilead funded the research and development and was responsible for the clinical development and commercialization of potential therapies. Upon the collaboration’s conclusion, effective Sept. 4, 2020, Precision will regain full clinical development and commercialization rights to the program. The company said it will consider new partnership opportunities in HBV, though its focus is on advancing its lead gene correction program for primary hyperoxaluria type 1. It plans to nominate a clinical candidate from that program later this year. As of March 31, Precision had cash and cash equivalents of $154.2 million, which it said is expected to sufficiently fund operations into the second half of 2021.
Theratechnologies Inc., of Montreal, said data presented at the 23rd International AIDS Conference virtual meeting demonstrated that ibalizumab is active in vitro against group A and group B HIV-2. Phenotypic assays were performed on six HIV-2 clinical isolates (two group A and four group B), one ROD HIV-2 group A reference strain and one BRU HIV-1 group M reference strain. Ibalizumab inhibited viral replication in all seven HIV-2 isolates with IC50 ranging from 0.002 to 0.18µg/mL while MPI was below 80% in only two strains, between 80% and 90% in one strain and above 90% in four strains.
Tollys SAS, of Lyon, France, said it received more than €1.5 million (US$1.6 million) from Bpifrance as part of its deep tech financing program aimed at increasing support measures for breakthrough innovation in France and strengthening the country’s competitive advantage in the field. Funding consists of 50% nondilutive funding and 50% long-term loans. In May, Tollys closed a round of financing totaling €2.32 million, enabling the firm to support preclinical studies and regulatory toxicology for its cancer immunotherapy compound,TL-532, in preparation for clinical development by late 2021 or early 2022.
Zealand Pharma A/S, of Copenhagen, said it opened its new U.S. headquarters in Boston, to be led by Frank Sanders, recently appointed president of Zealand Pharma U.S.