Agenus Inc., of Lexington, Mass., said it is considering several options regarding its Agentus Therapeutics Inc. subsidiary, including the unit’s potential spin-out and issuance of a portion of its holdings in Agentus to Agenus shareholders in the form of a stock dividend. Agenus expects to make a final decision by year-end 2020.
Agex Therapeutics Inc., of Alameda, Calif., and Farmington, Conn.-based Imstem Biotechnology Inc., which is developing human embryonic stem cell-derived mesenchymal stem cells (hES-MSC), said they signed a nonbinding letter of intent for Imstem to obtain a nonexclusive license to use Agex’s embryonic stem cell line, ESI 053, to derive Imstem’s investigational MSC product, IMS-001, for development in COVID-19 as well as acute respiratory distress syndrome due to other causes. The companies are in the process of finalizing financial terms and other provisions of the license agreement. Imstem has already used ESI 053 to derive the IMS-001 product, which is being investigated for multiple sclerosis under an IND.
Alize Pharma 3, of Lyon, France, said it is rebranding itself as Amolyt Pharma, which will focus on building and advancing a portfolio of therapeutic peptides through global approval. Specifically, it is developing AZP-3601, a parathyroid hormone analogue designed for the treatment of hypoparathyroidism, planned to enter a phase I trial later this year, as well as AZP-3404, a peptide with a new mechanism of action on fat and glucose metabolism.
Aqualung Therapeutics Corp., of Tucson, Ariz., said it was awarded a three-year NIH Fastrack Award, which will support mid- and late-stage development of a therapeutic to treat patients who undergo radiotherapy for treatment of lung and esophageal cancers and are at risk for developing radiation-induced lung injury (RILI). The initial stage of the award involves the final selection of the lead nicotinamide phosphoribosyltransferase (eNAMPT)-neutralizing humanized therapeutic monoclonal antibody between two candidates, ALT-100 and ALT-200, with selection utilizing in vitro and preclinical in vivo models of RILI. The second stage supports completion of pharmacokinetic/pharmacodynamic and toxicology studies with the lead candidate in appropriate animal models, and submission of an FDA IND application.
Astronautx Ltd., of Manchester, U.K., said it partnered with contract research organization Concept Life Sciences to support research on the identification of novel therapies for Alzheimer's disease. The alliance will focus on identifying small-molecule drugs able to modulate astrocyte biology to expand the company’s pipeline of therapeutic candidates for the treatment of Alzheimer's disease. No financial details of the agreement were disclosed.
Aytu Bioscience Inc., of Englewood, Colo., said it retired $15 million of a payment obligation owed to Deerfield CSF LLC and affiliated parties, satisfying the previously described $15 million obligation assumed through the company's purchase of the former Cerecor prescription product portfolio announced on Nov. 4, 2019.
CSL Behring of King of Prussia, Pa., and the Seattle Children's Research Institute said they established a strategic alliance to develop stem cell gene therapies for primary immunodeficiency diseases. Initially, the alliance will focus on the development of treatment options for patients with Wiskott-Aldrich syndrome and X-linked agammaglobulinemia. Those are two of more than 400 identified primary immunodeficiency diseases in which a part of the body's immune system is missing or functions improperly. Researchers from both organizations will investigate applying the platform technologies Select+ and Cytegrity to several preclinical gene therapy programs. Those technologies, which have broad applications in ex vivo stem cell gene therapy, are designed to address some of the major challenges associated with the commercialization of stem cell therapy, including the ability to manufacture consistent, high-quality products, and to improve engraftment, efficacy and tolerability.
Delta 4 GmbH, of Vienna, said its lead program, which aims at developing a therapy for focal segmental glomerulosclerosis (FSGS), a rare kidney disease affecting children and adults, concluded preclinical development with promising results. In addition to FSGS, it recently applied its drug discovery platform to COVID-19 to identify existing drugs that may have benefits in that disease. The company is evaluating a short list of potential COVID-19 therapies preclinically and is considering partners to further develop its most promising candidates.
Egenesis Inc., of Cambridge, Mass., said it will expand its 2017 research collaboration with the Center for Transplantation Sciences at Massachusetts General Hospital. The ongoing preclinical research includes testing of transgenic solid organs as well as cell therapies in nonhuman primate recipients to advance the company’s organ-tissue-cell transplantation pipeline toward the clinic. The company platform is focused on the transplants from one species to another.
Hemogenyx Pharmaceuticals plc, of London, said it extended its development agreement with an anonymous company for three additional months to complete tasks delayed by COVID-19. Hemogenyx said it receives free technical support, access to advanced methods of discovering, developing and engineering antibodies, and certain intellectual property necessary for the successful preclinical development of its lead candidate bispecific CDX antibody. The original agreement was drawn up in 2018.
Newly published research about modeling innate immune system response following tissue damage and inflammation from Hesperos Inc., of Orlando, Fla., describes an in vitro, pumpless, three-organ system containing functional human cardiomyocytes, skeletal muscle and hepatocytes in a serum-free medium, along with recirculating human monocyte THP-1 immune cells. Monocytes are immune system cells involved in wound healing, pathogen clearance and activation of the innate immune response but are also responsible for the cytokine storm found in conditions such as sepsis. Researchers evaluated two different innate immune responses: targeted immune response following tissue-specific damage, which simulates indirect activation of THP-1 cells, and pro-inflammatory immune response following direct activation of immune cells, mimicking acute inflammation and the cytokine storm. In the targeted immune response experiments, the cardiotoxic compound amiodarone was used to selectively damage cardiac cells to evaluate how THP-1 immune cells affect the three-organ system. The presence of both amiodarone and THP-1 immune cells led to a more pronounced reduction in cardiac force, conduction velocity and beat frequency compared to amiodarone alone, the company said. THP-1 cells were also found to infiltrate the damaged cardiomyocytes and induce significantly increased cytokine IL-6 expression, indicating an M2 macrophage phenotype. No immune-activated damage was reported in the skeletal muscle or liver cells.
Intravacc, of Bilthoven, the Netherlands, and Epivax Inc., of Providence, R.I., will collaborate to advance a COVID-19 vaccine. Intravacc will combine its outer membrane vesicle delivery platform with synthetically produced COVID-19 epitopes (protein allergens), to generate a T-cell response against SARS-CoV-2 and related coronaviruses. Intravacc will use its in-house pilot-scale facility for the GMP production of the OMV-peptide vaccine for phase I studies expected to start in the fourth quarter of this year.
Moderna Inc., of Cambridge, Mass., took June 2 to highlight early stage scientific efforts at the company, including an ongoing collaborations with the International AIDS Vaccine Initiative, National Institute of Allergy and Infectious Diseases and Bill & Melinda Gates Foundation toward development of an HIV vaccine intended to deliver an engineered HIV immunogen. In addition, company scientists discussed efforts to engineer both mRNAs and encoded proteins to improve and extend therapeutic effect and new research aimed at optimizing its lipid nanoparticles. The company, which has received both significant attention and funding recently for its efforts to develop an mRNA-based vaccine for COVID-19, did not discuss those efforts, according to analyst reports. Moderna has 23 mRNA development candidates in its portfolio with 13 in clinical studies, it said. Company shares (NASDAQ:MRNA), which traded at as much as $87 each on May 17, fell 3.7% on Tuesday to $59.87.
Modular Bioscience Inc., of Silicon Valley, Calif., said it has a definitive agreement with the University of Illinois for an exclusive global patent license to the school’s artificial restriction enzyme platform. Modular's initial focus will be on synthetic biology, diagnosis of inherited genetic diseases, liquid biopsy and detecting infectious disease agents such as COVID-19.
Personalis Inc., of Menlo Park, Calif., and Sarepta Therapeutics Inc., of Cambridge, Mass., will collaborate to characterize immune response to precision genetic therapeutics. Personalis is a cancer genomics company that provides molecular data about patient cancer and immune response. No financial details were disclosed.
Pfizer Inc., of New York, said it has created the Pfizer Breakthrough Growth Initiative to make non-controlling equity investments in clinical-stage public biotech companies, with a primary focus on companies with small- to medium-sized market capitalizations across a range of therapeutic categories consistent with Pfizer’s core areas of focus, including internal medicine, inflammation and immunology, oncology and rare disease.
Predictive Oncology Inc., of Minneapolis, said it completed acquiring the assets of Soluble Therapeutics Inc., of Birmingham, Ala., and Biodtech Inc., also of Birmingham, each of which is a wholly owned subsidiary of Inventabiotech Inc. The assets include certain intellectual property relating to contract research organization services, technology and equipment in exchange for 125,000 shares of common stock in addition to waiving all remaining amounts due and payable to Predictive under a secured promissory note of Inventabiotech for $1.07 million relating to advances made by Predictive in 2017.
Siga Technologies Inc., of New York, disclosed its first international delivery of smallpox drug Tpoxx (tecovirimat), with 2,500 courses delivered to the Canadian Department of National Defense (CDND). On April 3, the firm said the CDND is expected to purchase up to 15,325 courses of oral Tpoxx over four years for a total value of $14.3 million. Remaining purchases of 12,825 courses, at the option of the CDND, are expected to occur after regulatory approval of oral Tpoxx by Health Canada.
Tetraphase Pharmaceuticals Inc., of Watertown, Mass., said its board has received a revised proposal from Melinta Therapeutics Inc., of Morristown, N.J., and has determined that the amended Melinta proposal is a superior offer. The company has given notice to Acelrx Pharmaceuticals Inc., of Redwood City, Calif., of the amended proposal. Acelrx has until the end of the day June 3 to make another proposal.
Trevena Inc., of Chesterbrook, Pa., signed a collaboration with Imperial College London to evaluate the potential of TRV-027, an AT1 receptor selective agonist, to treat acute lung injury contributing to acute respiratory distress syndrome in COVID-19 patients. Imperial College will be sponsoring and funding that study, with additional support through the British Heart Foundation Center for Research Excellence Award.
Valirx plc, of London, signed a collaboration agreement with Oncolytika Ltd., of Cambridgeshire, U.K., and Black Cat Bio Ltd., of Hinckley, U.K., to explore the use of VAL-201 in a combination treatment for patients suffering a hyperimmune response to coronavirus SARS-CoV2 infection. Oncolytika has proposed a combination therapy, which includes a selective SRC kinase inhibitor (which inhibits a potential oncogenic pathway), alongside one or two complementary treatments to treat the excessive response of the immune system. Oncolytika and Black Cat have filed a patent to protect the proposed use of the combination therapy.
Vitro Diagnostics Inc., of Golden, Colo., said it entered an exclusive memorandum of understanding with Global Institute of Stem Cell Therapy and Research Inc. (Giostar), of San Diego, to collaborate on an IND using Vitro Biopharma’s umbilical cord mesenchymal stem cell product, Allorx Stem Cells, in a clinical trial to treat COVID-19 patients. Giostar has already obtained the expedited compassionate use authorization from the FDA for using stem cell treatment for severe COVID-19 hospitalized patients using Allorx Sem Cells. Vitro will continue to seek FDA authorization of its pending IND.
Vivus Inc., of Campbell, Calif., updated its agreement regarding its corporate debt with Icahn Enterprises Holdings LP (doing business as the Delaware corporation IEH Biopharma LLC), which holds a principal amount of approximately $170.2 million of the company’s convertible senior notes. The company will continue to work with IEH on an exclusive basis in respect of any restructuring, financing or other material transaction concerning the company or its assets, with the exception that the company is granted a 30-day period to refinance and pay in full in cash all amounts due and owing under the notes to IEH. If the company is unable to refinance on or before June 30, 2020, the company and IEH will exclusively pursue an in-court plan of reorganization. In the event certain conditions are satisfied under the plan of reorganization, stockholders of Vivus will receive a pro rata share of $5 million and a nontransferable contractual contingent value right to earn another $2 per share if certain financial milestones are met in 2021 and 2022. IEH will take 100% ownership of Vivus.
Vizuri Health Sciences LLC, of Fairfax, Va., has completed a reorganization to form two new corporations. The new entities are Propella Therapeutics Inc., focusing on prescription drugs, and Vizuri Health Sciences Consumer Healthcare Inc., developing non-prescription pain management products. The restructuring, which occurred on May 1, is designed to strengthen the capacity of both companies to quickly bring new products to market, Vizuri said.