Abbvie Inc., of North Chicago, and Jacobio Pharmaceuticals Co. Ltd., of Beijing, disclosed a global collaboration to develop and commercialize SHP2 inhibitors, which target a key node in cancer and immune cells. SHP2 is an important protein mediator of cellular signaling through the RAS/MAP kinase pathway. Abbvie will be granted an exclusive license to the SHP2 portfolio. Jacobio will continue to conduct early global clinical trials of JAB-3068 and JAB-3312 with Abbvie covering R&D expenses. Upon completion, Abbvie will assume global development and commercialization responsibilities. Jacobio has an option, exercisable before the initiation of registrational trials, to exclusively develop and commercialize the SHP2 program in mainland China, Hong Kong and Macau. Financial terms were not disclosed.
Acacia Pharma Group plc, of Cambridge, U.K., disclosed an amendment to the terms of its loan agreement with a wholly owned subsidiary of Cosmo Pharmaceuticals NV, of Dublin. The €10 million (US$11.1 million) loan facility that was made available on the approval of Barhemsys (amisulpride) is terminated and replaced with a €10 million equity investment at a price of €3.112 per share, which represents an approximately 4.1% premium to the closing share price on May 29 and equates to about 3.2 million shares to be issued to Cosmo. A further 367,893 shares are being issued to Cosmo (at an equity subscription price of €2.99 per share) in satisfaction of a €1.1 million break fee payable under the terms of the loan amendment. The €25 million loan facility, which will be made available by Cosmo on the approval of Byfavo (remimazolam), has not been affected by this transaction.
Alligator Bioscience AB, of Lund, Sweden, received an additional $500,000 in a second installment of the up-front payment from Biotheus Inc., of Zhuhai City, China. A first installment of $500,000 was received in August 2019 in connection with Alligator entering a licensing agreement with Biotheus with a total value up to $142 million. The agreement concerns the Chinese rights to an immune-activating antibody from the antibody library Alligator-Gold, with the intention of creating up to three new bispecific molecules.
Anixa Biosciences Inc., of San Jose, Calif., with partner Ontochem GmbH, of Halle, Germany, has synthesized four potential COVID-19 compounds that will advance to biological assay testing. Anixa and Ontochem disclosed their partnership on April 20. The initial phase of the program was designed to screen approximately 1.2 billion chemical compounds, utilizing in silico methods, against two specific enzymes of SARS-CoV-2. As the computer-based screening identified potential compounds, they would be synthesized and tested in biological assays to evaluate their potency as predicted by the molecular modeling algorithms. Should the biological activity be verified, the compounds will be tested in animal studies to further evaluate their candidacy as COVID-19 therapeutics.
Axim Biotechnologies Inc., of San Diego, said its subsidiary, Sapphire Biotech Inc., has started preclinical animal drug studies on its new compound, SPX-1009. Quiescin sulfhydryl oxidase 1 (QSOX1), an enzyme that is overexpressed by tumor cells in numerous cancers, has been shown to be involved in cancer invasion and metastasis. Earlier this year, Sapphire acquired exclusive rights to a small molecule, SBI-183, which has proved to inhibit the enzymatic activity of QSOX1 and suppress tumor cell invasion in vitro and metastasis of MDA-MB-231 breast tumor cells in vivo.
Cellectar Biosciences Inc., of Florham Park, N.J., received small and medium-sized enterprise status from the EMA.
Codiak Biosciences Inc., of Cambridge, Mass., signed collaborations with the Ragon Institute of Massachusetts General Hospital, Massachusetts Institute of Technology and Harvard to investigate the potential of its Exovacc vaccine platform in SARS-CoV-2, the virus that causes COVID-19, and in HIV. Codiak researchers will work with Bruce Walker and Gaurav Gaiha of the Ragon Institute to build integrated exosome-based vaccines aimed at inducing broad neutralizing antibody and antigen-specific T-cell protection against the viruses. Exovacc is a modular vaccine system that utilizes the properties of exosomes to deliver antigens and adjuvants simultaneously and selectively to the same antigen presenting cells.
Diffusion Pharmaceuticals Inc., of Charlottesville, Va., received written notice from Nasdaq stating that the company regained compliance with the minimum bid price for continued listing.
Emergent Biosolutions Inc., of Gaithersburg, Md., was issued a task order under an existing contract with the U.S. Biomedical Advanced Research and Development Authority. The contract is to deploy the firm’s contract development and manufacturing capacities, capabilities and expertise to support the U.S. government’s efforts to accelerate delivery of COVID-19 vaccines. The task order, valued at about $628 million, is being issued under the company’s 2012 contract that established Emergent’s Baltimore Bayview facility as a Center for Innovation in Advanced Development and Manufacturing for pandemic preparedness.
As of May 29, Hua Medicine Ltd., of Shanghai, is a constituent stock of the MSCI Hong Kong Micro Cap Index. MSCI provides research-based indexes and analytics. Hua is a global diabetes care and management company, with its phase III monotherapy trial of dorzagliatin (HMM-0301), a dual-acting glucokinase activator, hitting its 24-week primary efficacy endpoint.
Juvenescence Ltd., of Douglas, Isle of Man, and G3 Therapeutics Inc., of Midlothian, Va., formed Juvenomics Ltd., a joint venture. Juvenomics will focus on developing validated nutraceuticals and medicines to combat aging and aging-related diseases such as those of the musculoskeletal system. Juvenomics is built on the combination of G3’s multi-omic biological dataset, consisting of trillions of datapoints collected in the global clinical study (NCT01738828) of more than 7,500 patients, and the machine learning platforms assembled by Juvenescence, the companies said. Terms were not disclosed.
New proof-of-concept data from Kalytera Therapeutics Inc., of San Francisco, show R-107 reduced tissue damage and preserved organ function in a lethal rodent model of sepsis resembling circulatory shock seen with COVID-19-associated lung disease. R-107, an injectable liquid prodrug of nitric oxide, demonstrated increased survival from 10% to 90% in septic mice over a week of follow-up. Blood tests and microscopy showed full tissue protection in all the organs examined, including the liver, lung and small intestine, the company said.
Mateon Therapeutics Inc., of Agoura Hills, Calif., noted two peer-reviewed items based on the company’s COVID-19-related R&D, specifically regarding the virus as a TGF-beta disease. “Selectively targeting TGF-β with Trabedersen/OT-101 in treatment of evolving and mild ARDS in COVID-19” appeared in Clinical Investigation and “Targeting Transforming Growth Factor-beta for Treatment of COVID-19-associated Kawasaki Disease in Children” appeared in the Journal of Clinical Research in Pediatric Endocrinology.
Mimivax LLC, of Buffalo, N.Y., said it will assess the combination of Survaxm and Kenilworth, N.J.-based Merck & Co. Inc.’s Keytruda (pembrolizumab) in a phase II study for treating recurrent glioblastoma. Patients at first recurrence of glioblastoma who failed prior chemotherapy and radiation are eligible. Survaxm is designed to trigger T-cell immunity simultaneously with antibody-mediated antitumor responses.
Motif Bio plc, of London, reclassified as an AIM Rule 15 cash shell, has appointed Peel Hunt LLP, an investment bank focused on corporate broking, advisory, research, sales and trading, as a strategic adviser. Peel Hunt will provide guidance to the directors on strategic initiatives, including selecting an appropriate reverse takeover candidate. The selection is required under AIM rules to occur by July 28.
New data from Oryzon Genomics SA, of Cambridge, Mass., and Madrid, describe the design and characterization of vafidemstat, a CNS-optimized LSD1 inhibitor, and includes a detailed analysis of its mechanism of action and the evaluation of its pharmacological properties. Vafidemstat is designed to inhibit brain lysine-specific histone demethylase 1 (LSD1, also known as KDM1A) at doses suitable for long-term treatment. It corrects memory deficits and behavior alterations such as aggressiveness and lack of sociability in animal models, the company said, adding that inhibition of LSD1 was shown to be key in achieving efficacy, the company said. Vafidemstat is being evaluated in several phase II studies in different psychiatric and neurodegenerative diseases and a phase II study in COVID-19.
Proteostasis Therapeutics Inc., of Boston, said in vitro studies conducted at Calibr, the drug discovery division of Scripps Research, show PTI-129 demonstrated the potential to reduce viral protein production in host cells by activating adaptive branches of the unfolded protein response pathway and reducing levels of misfolded proteins. The in vitro studies are evaluating PTI-129 as a COVID-19 treatment. PTI-129 is a once-daily, oral small molecule originally designed to treat protein misfolding disorders involving the unfolded protein response.
PTC Therapeutics Inc., of South Plainfield, N.J., said it completed its acquisition of Censa Pharmaceuticals Inc., of Wellesley, Mass., which is developing CNSA-001 (sepiapterin), a clinical-stage therapy for orphan metabolic diseases, including phenylketonuria and other diseases associated with defects in the tetrahydrobiopterin (BH4) biochemical pathways diagnosed at birth. CNSA-001 is an oral formulation of synthetic sepiapterin, a precursor to intracellular tetrahydrobiopterin, an enzymatic cofactor involved in the metabolism and synthesis of numerous metabolic products. The phase II trial evaluating CNSA-001 for phenylketonuria met its primary and secondary endpoints in December. PTC paid $10 million up front for Censa, plus 850,000 shares of common stock valued around $40 million, plus additional rewards for achieving development, regulatory and commercial milestones.
Rakuten Medical Inc., of San Mateo, Calif., said it established a cancer research alliance network, the Illuminox Alliance Institutes, to develop cancer therapies. The National Cancer Center Japan (NCC) will be the first institution to join. The center is conducting clinical trials with ASP-1929, Rakuten's first investigational drug developed on the Illuminox platform. NCC and Rakuten will pursue multiple avenues to advance Illuminox-based cancer therapies. NCC will designate a lead principal who will act as an Illuminox advisor. ASP-1929, an antibody-drug conjugate composed of the antibody cetuximab and a light activatable dye, binds to epidermal growth factor receptors, a cancer antigen expressed in multiple types of solid tumors, including head and neck cancer, esophageal cancer, lung cancer, colon cancer and pancreatic cancer.
Regeneron Pharmaceuticals Inc., of Tarrytown, N.Y., has agreed to pay Cambridge, Mass.-based Intellia Therapeutics Inc. $70 million up front, alongside making a $30 million equity investment in the company, in an expansion of an ongoing partnership, first inked in April 2016. The revised collaboration provides Regeneron with rights to develop products for additional in vivo CRISPR/Cas9-based therapeutic targets and for the companies to jointly develop potential products for the treatment of hemophilia A and B. Regeneron also receives nonexclusive rights to independently develop and commercialize ex vivo gene edited products. Furthermore, the term of the companies' existing collaboration is extended until April 2024, with Regeneron having an option to renew for an additional two years. Per the terms of the original agreement, Regeneron would still pay potential royalties and milestone payments for the in vivo products it independently develops and will receive a royalty-bearing, nonexclusive license to certain Intellia intellectual property to develop and commercialize up to 10 ex vivo CRISPR/Cas9 products in defined cell types.
Resverlogix Corp., of Calgary, Alberta, said it's moving forward with a plan to further evaluate the impact of apabetalone, a bromodomain and extra-terminal inhibitor, on COVID-19. The company will first investigate whether apabetalone treatment of human cells susceptible to 2019-nCoV infection will impact the replication cycle of the virus. Company plans then call for moving into an open-label study to assess the safety and efficacy of oral apabetalone in hospitalized subjects with COVID-19 on top of standard of care vs. standard of care alone.
Revance Therapeutics Inc., of Newark, Calif., and Hertfordshire, U.K.-based Mylan NV have agreed to move with development of a proposed biosimilar to Botox (onabotulinumtoxinA, Allergan plc). The decision, following an initial agreement between the companies in February 2018, triggered a $30 million milestone payment to Revance from Mylan. The collaboration and license agreement also provides for an additional $70 million in milestone payments, contingent upon the achievement of further clinical and regulatory milestones and potential sales target milestone payments and royalties for Revance.
Sanofi SA, of Paris, has sold almost its entire equity investment in Regeneron, excluding 400,000 Regeneron Pharmaceuticals Inc. shares, which Sanofi is retaining, for total gross proceeds of $11.7 billion.
Shanghai Junshi Biosciences Co. Ltd., of Shanghai, and Merck KGaA, of Darmstadt, Germany, said they are collaborating on a clinical trial program designed to investigate the efficacy and safety of anti-PD-1 monoclonal antibody Tuoyi (toripalimab) in combination with EGFR-targeting antibody Erbitux (cetuximab) as a treatment for recurrent and/or metastatic squamous cell carcinomas of the head and neck in China.
Spark Therapeutics, of Philadelphia, part of Roche Holding AG, said preclinical data published in Nature Medicine demonstrated that treatment with immunoglobulin G-degrading (IgG) enzyme of Streptococcus pyogenes (IdeS) resulted in rapid and transient reduction of neutralizing anti-adeno-associated virus (AAV) antibodies and restored gene therapy efficacy in controlled laboratory tests of animal models. AAV-mediated gene therapy allows for the treatment of a growing number of diseases; however, the presence of neutralizing anti-AAV antibodies can lead to limitations of that technology. Researchers demonstrated efficacy in vivo using animal models of liver gene transfer, including hemophilia A and B. In both mice and nonhuman primates with neutralizing anti-AAV IgG, IdeS treatment prior to the injection of AAV vectors eliminated neutralizing IgG and rescued the expression of the factor VIII or IX in hepatocytes.
Synlogic Inc., of Cambridge, Mass, highlighted the publication in Nature Communications of preclinical data supporting its first clinical immuno-oncology program, SYNB-1891, which is being evaluated in a phase I trial in patients with advanced solid tumors or lymphoma. Data described in the publication demonstrate that SYNB-1891 treatment cleared tumors and stimulated antitumor immunity in preclinical models of cancer, the company said.
Tonix Pharmaceuticals Holding Corp., of New York, said Fujifilm Diosynth Biotechnologies will provide contract manufacturing and development services to support the manufacturing of its COVID-19 vaccine candidate, TNX-1800, for clinical trial supply. TNX-1800 is a modified horsepox virus that is designed to express a protein from SARS-CoV-2.
Twist Bioscience Corp., of South San Francisco, and Singapore-based Proteona Pte. Ltd. said they'll work together as part of an international alliance to develop broadly neutralizing antibodies against coronaviruses, including SARS-CoV-2. Twist will employ its DNA synthesis platform to support the manufacture of millions of oligos of different lengths, enabling its Twist Biopharma division to identify numerous neutralizing antibody sequences and use in-house capability to generate and optimize IgG antibodies ready for analysis, it said.
Vault Pharma Inc., of Los Angeles, said it's working with the University of California, Los Angeles, and other universities to advance a vaccine with the potential to treat SARS-CoV-2 in addition to protecting against it. Candidate vaccines will be tested at Northern Arizona University.