Ablexis LLC and Alivamab Discovery Services LLC, both of San Diego, and Berkeley Lights Inc., of Emeryville, Calif., said they completed the generation and recovery of sequences encoding a diverse panel of human antibodies against the S1 spike protein of the SARS-CoV-2 virus, with the observed diversity including activities consistent with mechanisms of action hypothesized to provide effective antibody therapy and prophylaxis of SARS-CoV-2 infection. The companies said they plan to make the antibodies available to an organization committed to advance them into additional R&D.
Alkermes plc, of Dublin, said the Journal for Immunotherapy of Cancer published preclinical findings on immunotherapy candidate ALKS-4230. Data from multiple assays showed the IL-2 receptor agonist selectively activated the IL-2 receptor as intended. Additionally, data from a mouse B6F10 lung metastasis model showed that treatment with the asset achieved a maximum of 100% inhibition of tumor growth with one of the tested doses compared to treatment with recombinant human IL-2 (rhIL-2), which achieved a maximum of 70% inhibition of tumor growth with a tested dose. Equivalent antitumor activity was observed with intravenous and subcutaneous administration. ALKS-4230 also showed similar potency to rhIL-2 in activating mouse CD8+ T cells and natural killer cells but was approximately 1,000 times less potent than rhIL-2 in activating regulatory T cells, known to suppress cancer-fighting immune mechanisms.
Anticancer Inc., of San Diego, said it formed fully owned subsidiary, Coronacure LLC, to develop its therapeutic candidate, methioninase, to treat COVID-19. Methioninase degrades the amino acid methionine and can selectively starve SARS-CoV-2 of the amino acid, needed in high amounts to replicate. Methioninase also can starve infected cells that are producing the coronavirus in the body and reduce or eliminate inflammation that results in the cytokine storm that is a lethal event of COVID-19, according to the company.
Applied Biomath LLC, of Concord, Mass., said it formed a collaboration with Northern Biologics Inc., of Toronto, to conduct pharmacokinetic and pharmacodynamic modeling of Northern Biologics' lead preclinical cancer antibody to help inform selection of a clinical starting dose.
Asklepios Biopharmaceutical Inc. (Askbio), of Research Triangle Park, N.C., said it acquired Brainvectis SAS, a Paris-based gene therapy company and French National Institute for Health and Medical Research (INSERM) spin-out with expertise and intellectual property related to treating neurodegenerative disorders. Brainvectis is focused on therapies that restore brain cholesterol metabolism to treat Huntington’s disease (HD) and related disorders, based on the work of INSERM researcher Nathalie Cartier-Lacave, whose team is seeking to develop gene therapies to increase expression of the CYP46A1 enzyme in the brain. BV-CYP01, Brainvectis’ lead gene therapy candidate, showed proof of concept in animal models of HD and received orphan drug designation from the European Commission. Brainvectis will operate as a wholly owned subsidiary of Askbio and maintain its office in Paris. Financial terms were not disclosed.
Avacta Group plc, of Wetherby, U.K., said that it generated multiple Affimer reagents that bind the SARS-CoV-2 viral antigen as part of its collaboration with Cytiva (formerly GE Healthcare Life Sciences), of Marlborough, Mass., to develop an Affimer-based rapid test for COVID-19 infection. The work, completed ahead of schedule in four weeks, produced highly specific Affimer binders that do not cross-react with closely related viruses, including SARS and MERS. Avacta plans to characterize the Affimer reagents within several weeks and to transfer the Affimer binders to Cytiva to implement in a point-of-care test strip that would read out in minutes using a sample such as saliva. Avacta said it is actively discussing with other diagnostic companies the development of Affimer-based COVID-19 antigen tests to increase high-throughput testing capacity on a global scale.
Caladrius Biosciences Inc., of Basking Ridge, N.J., said it finalized an agreement to sell $10.9 million in New Jersey net operating losses to a qualifying and approved buyer pursuant to the New Jersey Economic Development Authority’s technology business tax certificate transfer program.
Cellphire Inc., of Rockville, Md., said the U.S. Biomedical Advanced Research and Development Authority (BARDA) exercised its third contract option, valued at $33.3 million, to support the company’s lyophilized platelet-derived hemostatic candidate, Thrombosomes, through a phase II trial in bleeding thrombocytopenic patients and to scale up manufacturing and preclinical studies required to submit an additional IND application to the FDA for a phase II trial in surgery. The option was exercised under a multiyear contract with BARDA, valued at up to $82.6 million, to advance the development of freeze-dried platelets for disaster response.
Cocrystal Pharma Inc., of Bothell, Wash., said it has expanded its license agreement with Kansas State University Research Foundation (KSURF) to include rights to additional preclinical leads and further develop certain proprietary broad-spectrum antiviral compounds for the treatment of coronavirus infections. The company has been granted an exclusive, royalty-bearing right and license to certain small-molecule therapeutic inhibitors against coronaviruses, picornaviruses and caliciviruses covered by patent rights controlled by KSURF. It intends to pursue research and development of those antiviral compounds for coronavirus, including preclinical and clinical development. This license significantly expands and further advances the company's COVID-19 program by providing more targeted, potent compounds for further development. Cocrystal’s technology generates a 3D structure of inhibitor complexes at near-atomic resolution to identify novel binding sites, which allows for a rapid turnaround of structural information through highly automated X-ray data processing and refinement.
Cormedix Inc., of Berkeley Heights, N.J., said it has received approximately $5.2 million from the sale of $5.5 million of the $6 million of its available tax benefits to an unrelated, profitable New Jersey corporation through the New Jersey Economic Development Authority’s New Jersey Technology Business Tax Certificate Transfer program for state fiscal year 2019.
Emergex Vaccines Holding Ltd., of Abingdon, U.K., which is developing CD8-positive priming set-point vaccines to prevent serious infectious diseases, said it entered an agreement with George Mason University’s National Center for Biodefense and Infectious Diseases for their expertise and resources as a partner in the development of the company’s vaccines against highly pathogenic RNA viruses.
Envisagenics Inc., of New York, said it entered a research program agreement with the Lung Cancer Initiative (LCI) at New Brunswick, N.J.-based Johnson & Johnson to build predictive models for lung cancer progression and risk. The Envisagenics team will leverage its expertise in splicing and RNA-sequencing to analyze LCI's data using the company’s Splicecore software platform, which includes a proprietary database of more than 5 million potential RNA splicing errors.
Evotec SE, of Hamburg, Germany, said it will regain global development and commercialization rights to the iPSC-based program for treating diabetes developed under a collaboration agreement with Paris-based Sanofi SA. The beta cell program’s preclinical data demonstrate that they are functionally equivalent to primary human islets in their ability to normalize blood glucose levels in in vivo models over several months. Evotec also said it will explore the best strategic options for further long-term development and commercialization.
Frame Therapeutics, of Amsterdam, the Netherlands, which is focused on the development of neoantigen-based cancer vaccines, said it entered a research collaboration with Etherna Immunotherapies NV, of Niel, Belgium, to develop a new generation of off-the-shelf neoantigen cancer vaccines by combining each company’s immunotherapy expertise and unique technologies. Frame Therapeutics will contribute the discovery and development of the highly immunogenic frameshift neoantigens that are only expressed in specific tumor types and thus offer a new level of patient and tumor specificity and Etherna will apply its vaccination technology platform to elicit antitumor T-cell responses utilizing its Trimix mRNA platform.
Gilead Sciences Inc., of Foster City, Calif., Santa Monica, Calif.-based Kite, a Gilead Co., and Onko-innate, of Melbourne, Australia, said they established a three-year cancer immunotherapy research collaboration to support discovery and development of next-generation drug and engineered cell therapies focused on natural killer (NK) cells. The research will involve Onko-innate using genome-wide screening techniques and its technology platform to discover novel immune cell targets that enhance NK cell antitumor immunity and to create NK cell therapies. For Gilead, it will execute screens to identify and validate targets to seed internal Gilead immuno-oncology discovery programs. For Kite, it will create and evaluate NK constructs for Kite’s development of next-generation cell therapies. In return, it will receive an up-front payment and will be eligible to receive additional payments based on achievement of certain clinical, regulatory and commercial milestones, as well as sales royalties across the immuno-oncology and cell therapy programs.
Hoth Therapeutics Inc., of New York, reported top-line data from its cutaneous lupus erythematosus (CLE) study, with its partner Zylö Therapeutics Inc., of Greenville, S.C., for topical administration of anandamide (AEA)-loaded Z-pods. During the study, 50 female MRL/lpr mice that developed an autoimmune disease resembling systemic lupus erythematosus were scored weekly for skin lesions beginning at 12 weeks of age. The mice were tested weekly for 10 weeks, and the results show that mice treated with AEA-loaded particles experienced lesions that regressed in size and severity, while mice treated with AEA-neat experienced worsening lesions. Hoth owns an exclusive license to develop anandamide-loaded Z-pod for the treatment of CLE in North America. Anandamide, generally referred to as AEA, is one of the cannabinoids that the human body makes naturally. The company also possesses rights related to geographic expansion and to follow-on indications such as psoriasis and rheumatoid arthritis.
Immunic Inc., of New York, reported that its lead asset, IMU-838, a selective oral DHODH inhibitor, has demonstrated preclinical activity against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The compound was also observed to inhibit replication of clinical isolates of SARS-CoV-2 associated with COVID-19. In cellular assays, IMU-838 demonstrated antiviral activity at concentrations which are well below the blood concentrations associated with IMU-838 dosing regimens studied in ongoing and previous clinical trials. As a result of the findings, the company said it will prepare a clinical development program for IMU-838 as a potential treatment option for patients with COVID-19 and potential other, future viral pandemics. IMU-838 is being investigated in ongoing phase II trials in patients with relapsing-remitting multiple sclerosis, ulcerative colitis and primary sclerosing cholangitis.
Kalos Therapeutics Inc., of La Jolla, Calif., said it is progressing in its efforts to discover and develop a multidrug cocktail of peptide KTH-222 and immune-stimulating agents that can be administered as prophylaxis before exposure to the SARS-CoV-2 virus or as a treatment for immune-compromised cancer patients already infected. Kalos said it identified numerous immune-stimulating agents and will target two based on safety and efficacy, as well as other desirable attributes, to begin development. Kalos also said it is discussing funding opportunities with the U.S. Biomedical Advanced Research and Development Authority.
Tokyo’s Linical Co. Ltd. will provide consulting services and regulatory guidance to Stuart, Fla.-based Alpha Cognition Inc.’s development of Alpha-1062, an acetyl choline esterase inhibitor being investigated as an oral tablet and nasal spray delivery system for treating Alzheimer’s disease. Parallel development programs are ongoing with a targeted approval in the U.S. in late 2022 or early 2023 with a subsequent approval in Japan. Regulatory guidance provided by the FDA indicates that pivotal clinical trials can be initiated in late 2020, the companies said.
Nuritas Ltd., of Dublin, said it received a grant from the Partnership for Advanced Computing in Europe to identify therapeutic peptides for treating COVID-19 patients. Nuritas will use its AI platform to identify peptides with antiviral properties and peptides with cytokine regulatory properties to mitigate viral replication and modify the cytokine-based inflammatory response that drives respiratory damage.
Oncology Venture A/S, of Hørsholm, Denmark, and the Pathogen and Microbiome Institute at Northern Arizona University will test the antiviral activity of 2X-121, Oncology’s PARP inhibitor, against coronavirus. The cancer drug 2X-121 is a small-molecule, targeted inhibitor of PARP, a DNA damage repair enzyme active in tumors and is being evaluated to treat advanced ovarian cancer in a phase II trial. If the study results for 2X-121 are positive, the company said it will advance to clinical studies as a potential antiviral therapy to treat COVID-19.
Pharnext SA, of Paris, and the University Hospital Institute Méditerranée Infection said they will jointly focus on testing in vitro a number of already approved drugs and drug combinations identified by Pharnext as potential candidates for fighting COVID-19 using the company’s AI platform. The institute is the only such entity in France devoted specifically to research in infectious and tropical diseases and clinical microbiology.
Q Biomed Inc., of New York, and Mannin Research said they are accelerating development of drugs to treat COVID-19 and other viral infections. Q Biomed and Mannin said they hope to have at least one treatment in human trials this year. The accelerated development is the result of a joint venture between Mannin, with its small-molecule platform that addresses vascular leakage, and Toronto’s Cyclica Inc., which has an AI-augmented drug discovery platform. Several diseases increase the risk of vascular leakage through blood vessels, including acute respiratory distress syndrome, sepsis, malaria and viral infections. Mannin is developing therapeutics with a mechanism of action involving the angiopoietin-Tie2 signaling pathway, which is a regulator of vascular development, vessel remodeling, postnatal angiogenesis and vessel permeability.
Som Biotech SL, of Barcelona, Spain, said it applied its AI-based screening technology to identify inhibitors of the 3CL proteases of SARS-CoV-2, SARS-CoV and MERS-CoV viruses as potential candidates to treat COVID-19. Within the three identified and validated drug candidates, one – eravacycline – is already approved. The second compound, prexasertib, is in clinical development and the third, cynarine, is a natural compound used as a dietary supplement. All three drugs can be repurposed to treat COVID-19, the company said.
Targovax ASA, of Oslo, Norway, and Valo Therapeutics Ltd., of Helsinki, Finland, are collaborating to test the use of Valo's Pepticrad to coat oncolytic adenoviruses with Targovax's TG mutant RAS peptides. The companies will test in vitro activity and in vivo immune activation of the candidate before jointly determining how to proceed.
Wize Pharma Inc., of Hod Hasharon, Israel, said its partner, Bonus Biogroup Ltd., of Haifa, Israel, started a preclinical study of its activated mesenchymal stromal cell product, Mesencure, as a treatment for acute and life-threatening respiratory distress and pneumonia as a result of COVID-19 or other virus or bacterial infections or exposure to other contaminants. Preliminary data from the study are expected in May 2020 and the study is scheduled to be complete in the third quarter of 2020.
Wuxi Biologics Co. Ltd., of Shanghai, completed the acquisition of a manufacturing facility in Leverkusen, Germany, from Bayer AG, of Leverkusen. The plant will offer sterile filling and freeze-drying services of up to 10 million vials per year.