3Sbio Inc., of Shenyang, China, said Selecta Biosciences Inc., of Watertown, Mass., the company’s partner, has made a milestone payment of $4 million to 3Sbio, triggered by the start of the phase III program in chronic refractory gout. In 2014, Selecta was authorized by 3Sbio to use pegsiticase, also known as pegadricase (a recombinant enzyme that metabolizes uric acid) in the development of SEL-212.
Actimed Therapeutics Ltd., of London, licensed additional European patent rights to S-oxprenolol in amyotrophic lateral sclerosis from Charité-Universitätsmedizin Berlin, giving Actimed global rights in that indication. The licensing of the intellectual property covers patent rights in all major European markets, including Germany, France, the U.K., Italy and Spain. Terms were not disclosed. In preclinical work, treatment of mice was shown to promote a prolongation of survival.
Aquestive Therapeutics Inc., of Warren, N.J., received the first milestone payment of $10 million under the previously announced royalty monetization agreement with an affiliate of Marathon Asset Management, bringing total cash proceeds this quarter to $50 million. Aquestive has repaid a portion of certain senior notes and plans to utilize the remaining net proceeds to fund the company’s ongoing development and commercialization of its product and pipeline candidates, as well as for working capital purposes. Under the terms of the monetization agreement, Aquestive is eligible to receive up to an additional $75 million in milestone payments.
Argenx SE, of Breda, the Netherlands, disclosed an agreement to acquire a priority review voucher from Bayer AG, of Leverkusen, Germany. Argenx expects to redeem the voucher for a future marketing application for its FcRn antagonist, efgartigimod. It will not be used for the BLA filing of intravenous efgartigimod in generalized myasthenia gravis, which is on track to be submitted in 2020.
Artelo Biosciences Inc., of La Jolla, Calif., said its wholly owned Canadian subsidiary, Artelo Biosciences Corp., and Steven Laviolette’s laboratory at the University of Western Ontario have been awarded a Mitacs Accelerate grant. The grant is expected to fund 50% of expenses related to preclinical research investigating ART-26.12 as a potential treatment for anxiety disorders. ART-26.12 is a fatty acid binding protein 5 program, licensed through an exclusive agreement and in collaboration with the Research Foundation of the State University of New York Stony Brook.
Connectyx Technologies Holdings Group Inc., of Boca Raton, Fla., is changing its name to Curative Biotechnology Inc. The new corporate name better reflects the commitment to finding therapeutics for patients with rare diseases who have unmet medical needs, the company said. The name and symbol changes (CURB) are expected to take effect in the first quarter of 2021, and the firm expects to refer to itself as Curative Bio.
Curevac NV, of Tubingen, Germany, and Wacker Chemie AG, of Munich, signed a contract for the manufacturing of Curevac's COVID-19 vaccine candidate, CVnCoV. Under the terms of the initial agreement, Wacker will ramp up GMP production of the mRNA drug substance for CVnCoV at its biotech site in Amsterdam in the first half of 2021. Preparations for the start of production, technology transfers and test runs are already underway.
Cytokinetics Inc., of South San Francisco, said Amgen Inc., of Thousand Oaks, Calif., has elected to terminate the collaboration and option agreement between the companies as of May 20, 2021. Amgen will transition development and commercialization rights for omecamtiv mecarbil and AMG-594 to Cytokinetics. Omecamtiv mecarbil is an investigational cardiac myosin activator, developed for the potential treatment of heart failure with reduced ejection fraction (HFrEF), and was recently studied in Galactic-HF, a positive phase III cardiovascular outcomes trial. AMG-594, a novel mechanism cardiac troponin activator, is in phase I development for HFrEF and other types of heart failure.
Fairjourney Biologics SA, and Iontas Ltd., both of Porto, Portugal, said they entered a discovery agreement with Pandion Therapeutics Inc., of Watertown, Mass. Pandion will access their libraries and platform to discover diverse panels of target binders for use in its platform. The agreement extends an existing relationship between the companies and gives Pandion the option to use standard phage display or mammalian display as engines for antibody discovery.
Generex Biotechnology Corp., of Miramar, Fla., and subsidiary Nugenerex Immuno-Oncology said their COVID-19 vaccine development partner, Bintai Kinden Corp., of Malaysia, and its subsidiary, Bintai Healthcare, executed their exclusive option to license and distribute the vaccine in Australia and New Zealand if approved by the FDA and Malaysian authorities. Nugenerex is developing immunotherapeutic peptide vaccines for cancer and infectious disease based on its CD4 T-cell activation platform.
Hifibio Therapeutics Inc., of Cambridge, Mass., said it will collaborate with Pharmsynthez PJSC, of St. Petersburg, Russia, and the Russian Academy of Sciences, of Moscow, to advance HFB-30132A, a SARS-CoV-2 neutralizing antibody. Pharmsynthez will purchase HFB-30132A for clinical trials in Russia. If approved, Pharmsynthez will commercialize the product as the exclusive partner of Hifibio in Russia. Hifibio retains all rights and continues to develop and commercialize HFB-30132A globally.
Horizon Therapeutics plc, of Dublin, and Halozyme Therapeutics Inc., of San Diego, entered a global collaboration and license agreement giving Horizon exclusive access to Halozyme's drug delivery technology for subcutaneous formulation of medicines targeting IGF-1R. Horizon said it plans to develop a formulation of Tepezza (teprotumumab-trbw) for treating thyroid eye disease. Horizon will pay $30 million up front to Halozyme and is obligated to make potential future payments of up to $160 million in the aggregate, subject to achievement of specified development, regulatory and sales-based milestones. Halozyme is entitled to receive mid-single-digit royalties on sales of commercialized medicines using its technology.
New clinical data from Immunitybio Inc., of Culver City, Calif., showed its Anktiva, an IL-15 superagonist also known as N-803, improved interferon-gamma (IFN-γ) production and killing of tumor cells in vitro and in vivo by CD34-positive progenitor-derived NK cells. Anktiva is being evaluated in late-stage clinical trials in combination with El Segundo, Calif.-based Nantkwest Inc.’s NK cell therapies for multiple indications, including metastatic pancreatic cancer, triple-negative breast cancer, bladder cancer and lung cancer. The data showed that Anktiva induced HPC-NK cell proliferation in a dose-dependent manner and that treatment with Anktiva increased IFN-gamma production in CD34-positive hematopoietic progenitor-derived NK cells stimulated with leukemia cells lines and improves killing of primary AML samples from patients.
Immunoprecise Antibodies Ltd., of Victoria, British Columbia, said it selected more than 10 unique monoclonal antibodies for further preclinical development. The antibodies can be combined to create up to 12 cocktail therapies containing mixtures of two, three or four antibodies, each of which has been shown to work synergistically to prevent viral entry into cells in vitro, according to Immunoprecise. The company said it nominated the first cocktail consisting of four human, synergistic antibodies to enter preclinical testing. The upcoming preclinical trial will examine the safety, tolerability and efficacy of the proposed therapeutic cocktail in the SARS-CoV-2 Syrian hamster model.
ISD Immunotech ApS, of Copenhagen, said it joined a research collaboration with Biogen Inc., of Cambridge, Mass., to develop ISD's lead compound, ISD-017, which is being developed to treat severe systemic lupus erythematosus. ISD-017 is a peptide therapeutic that inhibits stimulation of interferon genes. ISD is a spinout of Denmark’s Aarhus University.
Ligand Pharmaceuticals Inc., of San Diego, said two multinational pharmaceutical companies with a license to Ligand’s discovery platform have reached clinical development milestones with their programs, resulting in $4.5 million in payments to Ligand.
Mustang Bio Inc., of Worcester, Mass., and Minaris Regenerative Medicine GmbH, of Munich, agreed to enable technology transfer and GMP clinical manufacturing of Mustang’s MB-107 lentiviral gene therapy program for treating X-linked severe combined immunodeficiency in Europe. Minaris will perform technology transfer of the manufacturing and analytical processes, as well as their adoption to the European regulatory environment, for the GMP-compliant manufacturing of the drug product at its site in Ottobrunn, Germany, with the goal of supplying clinical trials in Europe.
Novellus Ltd., of Jerusalem, and Chicago-based Tempus Labs Inc., have agreed to work together to accelerate patient enrollment for Novellus' BRAF inhibitor program, presumed to be the asset it in-licensed from Plexxikon Inc., now part of Daiichi Sankyo Co. Ltd. Novellus will participate in the Tempus Integrated Molecular Evaluation (TIME) Trial Network.
Ology Bioservices Inc., an Alachua, Fla.-based contract development manufacturing organization, said the Department of Defense (DoD) has awarded the company $37 million to develop, manufacture and obtain FDA licensure for an anti-COVID-19 monoclonal antibody cocktail called ADM-03820. In addition, Ology will support the DoD with a request for an emergency use authorization and/or expanded access to the candidate for at-risk military personnel.
Persephone Biosciences Inc., of San Diego, initiated the Argonaut study to determine the impact of gut microbiome composition and function on the immune system and efficacy of cancer treatment. The company said the longitudinal, prospective, observational study will enroll up to 4,000 advanced-stage cancer patients of diverse racial backgrounds to collect data for the development of precision microbiome medicines and for the identification of companion diagnostics to guide therapeutic decisions. Four types of cancers will be profiled: non-small-cell lung cancer, triple-negative breast cancer, colorectal cancer and pancreatic cancer.
Schrödinger Inc., of New York, will receive $55 million up front and up to $2.7 billion in milestone payments as part of a new discovery collaboration with New York-based Bristol Myers Squibb Co. Additionally, Schrödinger is entitled to royalties on net sales of any product of the collaboration commercialized by BMS. The multiyear deal, which spans multiple indications, includes two of Schrödinger’s early stage programs and additional undisclosed targets. Schrödinger will be responsible for the discovery of development candidates for each of the targets under the collaboration. BMS is responsible for development, manufacturing, and commercialization of the candidates. Schrödinger shares (NASDAQ:SDGR) rose 11.6% to close at $67.65 on Nov. 23.
Sotira Inc., of Phoenix, disclosed the completion of the second phase of preclinical testing for its COVID-19 therapeutic and vaccine-alternative, Keptide COVID, confirming that the therapy completely prevented the entry of SARS-CoV2 in the lungs and kidney. Data were published in Biorxiv.
Teneobio Inc., of Newark, Calif., said San Diego-based Poseida Therapeutics Inc. exercised four options to commercial licenses for Teneobio human heavy chain-only domain antibodies to develop new CAR T therapies. Teneobio said that in addition to commercial licensing fees, it is eligible to receive future research, development and regulatory milestone payments for each candidate with total potential earnings of more than $250 million for CAR T therapies developed by Poseida. It would also receive royalties on worldwide net sales of each therapy.
Tracon Pharmaceuticals Inc., of San Diego, highlighted the publication in Cancer Cell of clinical data that it said provide molecular insight into the mechanism of action for TRC-102 (methoxyamine) and the patient populations most likely to respond to treatment with the candidate. TRC-102 is a small-molecule inhibitor of the DNA base excision repair pathway.
Twist Bioscience Corp., of South San Francisco, announced preclinical data for three of its antibodies against the S1 protein in SARS-CoV-2. It said the data show that TB202-3 and TB202-63, both single-domain VHH nanobodies, protect against weight loss, a key indicator of disease severity, at the lowest dose of 1 mg/kg in a preclinical hamster challenge model. In addition, TB181-36, an IgG antibody discovered through Twist's collaboration with Vanderbilt University Medical Center, was found to protect against weight loss at 5 mg/kg and 10 mg/kg. Twist said it intends to explore opportunities for further development of all three antibodies both internally and potentially with partners.
Y-biologics Inc., of Daejeon, South Korea, said it has established a collaboration with Pierre Fabre SA, of Toulouse, France, to identify and develop monoclonal antibodies targeting key immunosuppressive mechanisms activated within solid tumors. Y-biologics will contribute its human antibody display platforms to generate therapeutic and diagnostic monoclonal antibodies directed against key molecular targets designated by Pierre Fabre. Under terms of the partnership, initially slated to span three years, Pierre Fabre would have the option to acquire all rights on the antibodies developed. The rights will be subject to payments of discovery fees, milestones and royalties to Y-biologics.