Researchers have retracted papers published online in The Lancet and The New England Journal of Medicine that claimed worse outcomes for COVID-19 patients treated with chloroquine or hydroxychloroquine, and no increased risk of death to patients treated with ACE inhibitors, respectively. After multiple scientists had raised concerns about the validity of the underlying data, as well as a lack of data-sharing and ethical oversight, the authors from Brigham and Women’s Hospital commissioned an independent audit of the raw data. However, the raw data were not made available to a third-party auditor, leading to the June 4, 2020, retractions.
Alligator Bioscience AB, of Lund, Sweden, and Scandion Oncology A/S, of Copenhagen, Denmark, signed a collaboration agreement to explore the antitumor efficacy of the CD40 antibody mitazalimab from Alligator in combination with SCO-101 from Scandion as an addition to chemotherapy in resistant preclinical tumor models. The expectation is that SCO-101 will revert chemotherapy resistance, thereby further strengthening the antitumor effects of mitazalimab. The latter enhances presentation of antigens released by cancer cells and is thought to be beneficial in combination with chemo, where large amounts of antigens are being released by dying tumor cells. SCO-101 acts by blocking resistance mechanisms in cancer cells, allowing chemo to kill previously resistant cancer cells.
Alpine Immune Sciences Inc., of Seattle, presented a new preclinical program targeting B-cell diseases in a poster session at the European Congress of Rheumatology E-Congress 2020. The poster is titled “B Cell Modulatory Variant TNF Receptor Domains (vTDs) Identified by Directed Evolution to Inhibit BAFF and APRIL, Alone or Combined with Variant Ig Domains (vIgD) that Inhibit T Cell Costimulation, for the Treatment of Systemic Lupus Erythematosus and Other Severe Autoimmune Diseases.” BAFF and APRIL are tumor necrosis factor superfamily cytokines that play key roles in B-cell development, differentiation and survival, contributing to the pathogenesis of B-cell-related autoimmune diseases such as systemic lupus erythematosus, the company noted.
Amorchem II LP, of Montreal, closed a new transaction with McGill University focusing on the work of Sidong Huang and his collaborator, Martin Schmeing, from the Rosalind and Morris Goodman Cancer Research Center. The project, financed by Amorchem, will focus on the identification of small molecules to treat small cell carcinoma of the ovary, hypercalcemic type. Through the investment, the researchers of Nuchem Therapeutics Inc., of Montreal, will join with those of the McGill team to identify and optimize small-molecule inhibitors of SL2. Its collaborations with Nuchem have been successful in the past, Amorchem noted. Separately, Amorchem invested in a research program hailing from Université Laval and the Research Center of the Centre Hospitalier Universitaire de Québec. The venture capital fund identified the opportunity in close collaboration with Sovar, a group active in the promotion of university research. Amorchem is putting money into the invention of Jean Gosselin and Serge Rivest, which targets NOD2, a key regulator of immune and inflammatory responses. Rivest, who will be leading the project, is particularly interested in the role of innate immunity in central nervous system diseases.
Astrazeneca plc, of Cambridge, U.K., said it entered agreements with the Coalition for Epidemic Preparedness Innovations (CEPI), Gavi the Vaccine Alliance, and the Serum Institute of India (SII), regarding access to the University of Oxford’s COVID-19 vaccine. The company reached a $750 million agreement with CEPI and Gavi to support the manufacturing, procurement and distribution of 300 million doses of the vaccine, with delivery starting by the end of the year. In addition, Astrazeneca reached a licensing agreement with SII to supply 1 billion doses for low- and middle-income countries, with a commitment to provide 400 million before the end of 2020. The company recently agreed to supply 400 million doses to the U.S. and U.K. after reaching a license agreement with Oxford University for its recombinant adenovirus vaccine, formerly ChAdOx1 nCoV-19 and now known as AZD-1222.
Asylia Therapeutics Inc., of Houston, a 2019 startup, said it recently finalized an exclusive worldwide license agreement with the University of Texas MD Anderson Cancer Center to develop first-in-class immune modulating therapies for cancer, autoimmune and infectious diseases. The license covers a set of antibodies targeting epitopes on the extracellular or cell surface forms of heat-shock protein 70, including lead product ASY-77A, which is designed to enhance antigen presentation and trigger antitumor immune responses. Asylia also recently disclosed a $3 million Seed Award for Product Development Research from the Cancer Prevention & Research Institute of Texas, which it will use to advance development of ASY-77A.
Delmar Pharmaceuticals Inc., of San Diego, accepted an invitation from the Global Coalition for Adaptive Research (GCAR) to include VAL-083 in GCAR's Glioblastoma Adaptive Global Innovative Learning Environment Study, an adaptive clinical trial platform in glioblastoma multiforme. Delmar will use the study to serve as the basis for VAL-083's NDA submission and registration. The project is an international effort in newly diagnosed and recurrent brain cancer, utilizing an FDA-approved master protocol with multiple drugs to be tested simultaneously and over time against a common control arm.
Espero Biopharma Inc., of Jacksonville, Fla., expanded a collaborative partnering effort for its lead product candidate, tecarfarin, a phase III-ready vitamin K antagonist, which is taken once a day as an oral anticoagulant like warfarin but targets a metabolic pathway that is distinct from the one targeted by the most commonly prescribed anticoagulants. In 2019, the FDA granted orphan drug designation for the compound in end-stage renal disease and atrial fibrillation. Blood-thinning drugs may also be effective in treating COVID-19, the company noted.
Ferring Pharmaceuticals SA, of Saint-Prex, Switzerland, and Igenomix SL, of Valencia, Spain, established a two-year collaboration to discover novel targets and disease mechanisms in infertility and pregnancy-related conditions, including preeclampsia. The research will be housed in Boston and focus on investigating molecular signatures, developing functional genomic systems and creating translational tools to study for embryo implantation, endometrial microbiome interaction and decidualization biology.
Heat Biologics Inc., of Durham, N.C., disclosed further progress on its COVID-19 vaccine program. The firm has achieved stable co-expression of gp96/nCoV-S protein, as measured by both immunofluorescence and ELISA, in a clinically validated human cell line, enabling selection of a vaccine. Clinical-grade manufacturing is expected in August.
Ibio Inc., of New York, disclosed the start of preclinical immunization studies for its second COVID-19 vaccine platform. The new subunit vaccine, IBIO-201, combines antigens derived from the SARS-CoV-2 spike protein fused with the company’s patented lichenase booster molecule (Lickm), which is designed to enhance immune response. The addition of the Lickm booster to a subunit antigen is expected to improve the likelihood of achieving single-dose, prolonged immunity while also increasing manufacturing capacity through increased potency.
Immunoprecise Antibodies Ltd., of Victoria, British Columbia, is taking part in a multi-company effort with the laboratory of Frederick Dyda at the National Institute of Diabetes and Digestive and Kidney Diseases at the NIH and Javad Aman at Integrated Biotherapeutics Inc., of Rockville, Md., to better understand the molecular binding interactions of potential therapeutic antibody candidates resulting from Immunoprecise's SARS-CoV-2 programs aimed at treating or preventing COVID-19. The research consortium unites three teams for lead antibody characterization, using cryogenic electron microscopy to determine the structural details of antibodies bound to the spike protein from the SARS-CoV-2 virus. The firm will provide the well-characterized trimeric spike protein ectodomain and the receptor binding domain against which Immunoprecise’s antibodies will be characterized.
Intravacc, of Bilthoven, the Netherlands, disclosed more details on its development of an intranasal vaccine against COVID-19. The vaccine will be developed through a newly established public-private partnership that combines the vaccine development technology from Intravacc, the viral vector technology and animal technologies from Wageningen Bioveterinary Research in Lelystad, the Netherlands, and the coronavirus expertise from Dutch Utrecht University. The aim of this partnership is to develop a vaccine that will consist of a Newcastle disease virus (NDV) vector that expresses the immunogenic spike protein of SARS-CoV-2, which is an important target for neutralizing antibodies. NDV has been shown to be safe for intranasal/intratracheal delivery in mammals, including nonhuman primates.
Jounce Therapeutics Inc., of Cambridge, Mass., said it regained worldwide rights to JTX-8064 from Bristol Myers Squibb Co., of New York. JTX-8064, a potential first-in-class antibody that targets the leukocyte immunoglobulin-like receptor B2 on macrophages, was licensed in July 2019 to Celgene Corp., which was later acquired by BMS. As part of its Celgene integration process, BMS said it is streamlining its pipeline and notified Jounce that the JTX-8064 license agreement is being terminated. Shares of Jounce (NASDAQ:JNCE) gained to close June 4 at $5.76, up 15 cents.
Les Laboratoires Servier SAS, of Paris, said it completed the acquisition of Symphogen A/S, of Ballerup, Denmark, which now will function as Servier's antibody center of excellence across multiple therapeutic areas, including oncology. As a Servier subsidiary, Symphogen will maintain operational autonomy and continue to maintain its headquarters in Denmark.
Lunac Therapeutics Ltd., of Leeds, U.K., selected U.K. CRO Xenogesis Ltd. to support discovery work for anticoagulant therapies that have reduced risk of bleeding compared to current therapies. The aim of the partnership is to discover a drug that inhibits the protease target, activated factor XII. The Xenogesis team is providing the DMPK consultancy, PK modeling and dose prediction support.
Macrogenics Inc., of Rockville, Md., said research published in Science Translational Medicine describes a gene expression signature of the tumor microenvironment in patients with acute myeloid leukemia (AML) that is associated with resistance to chemotherapy and response to flotetuzumab, an investigational, bispecific CD123 x CD3 DART molecule in clinical development for the treatment of primary induction failure and early relapsed AML. The study analyzed several hundred primary bone marrow samples from independent cohorts of pediatric and adult AML patients to identify differences in immune gene expression in the bone marrow tumor microenvironment across age groups and molecular subtypes. The data indicated that an inflammatory signature related to INF-gamma gene expression was predictive of resistance to chemotherapy and potential response to flotetuzumab immunotherapy in patients with primary refractory or early relapsed AML.
Memo Therapeutics AG (MTx), of Schlieren, Switzerland, said it identified several SARS-CoV-2-specific virus-neutralizing antibodies with the potential for development as a COVID-19 immunotherapy. Blood samples were collected from the clinically selected donors and used with MTx’s microfluidic Dropzylla discovery platform, which enables the generation of complete recombinant human antibody repertoires, preserving all specificities present in each of the patient’s B cells. By processing more than 2 million memory B cells from the COVID-19 donors, the company was able to identify ultra-rare antibodies with superior virus-neutralizing activity within just six weeks of first patient enrollment. The most potent of those antibodies will now undergo clinical development as a passive immunotherapy for COVID-19, with a clinical proof-of-concept program anticipated for the fourth quarter of this year, the company said.
Mind Medicine Inc., of New York, said it launched Project Lucy, a commercial drug development program for the treatment of anxiety disorders. The company intends to initiate a phase IIb efficacy trial that will focus on experiential doses of LSD, administered by a therapist. It marks the first experiential, psychedelic-assisted therapy to be added to the company's drug development pipeline.
Neurasic Therapeutics Inc., of Montreal, was created by Admare Bioinnovations, Canada’s global life sciences venture, along with partners McGill University and Amorchem II Fund LP, an early stage venture capital fund. Neurasic is based on research by Philippe Séguéla, professor of neuroscience at McGill in Montreal, that was validated and further advanced by Admare. His research lab at the Montreal Neurological Institute investigates genes, cells and circuits involved in pain perception and analgesia.
Novavax Inc., of Gaithersburg, Md., is partnering with CRO Polypeptide Group on large-scale GMP production of two key intermediates used in the production of Matrix-M, the adjuvant component of Novavax’s coronavirus vaccine, which is being used to enhance the vaccine’s immune response and stimulate high levels of neutralizing antibodies. NVX-CoV2373 is a stable, prefusion protein made using Novavax’s nanoparticle technology.
Orion Corp., of Espoo, Finland, said it is developing an immuno-oncology drug discovery platform in the national research and innovation consortium Cancer IO. The project will develop new solutions to enhance immunotherapy treatments and support the introduction of new therapies. Orion is one of the companies participating in the project, and the aim is to develop and establish an immuno-oncology drug discovery platform at Orion.
Portage Biotech Inc., of Toronto, said its shares will commence trading on a 100-for-1 reverse split basis, effective June 5.
Rakuten Medical Inc., of San Mateo, Calif., and the University of Texas MD Anderson Cancer Center entered a collaboration to advance the development of new cancer therapies based on Rakuten's Illuminox technology platform. Under the terms, the two will work to conduct studies based on the Illuminox technology platform and to determine study designs, combination therapies and target patient populations for future clinical trials. The alliance is designed to expand development of the technology and bring a novel therapeutic approach to patients with cancer, with an initial focus on those with head and neck cancers, the company said. The agreement expands upon an existing sponsored research agreement between Rakuten and MD Anderson.
Takis Srl, of Rome, and Rottapharm Biotech Srl, of Monza, Italy, said they plan to collaborate on joint development of Takis’ vaccine against SARS-CoV-2 infection, COVID-eVax. Rottapharm will provide Takis with operational support and financial resources to complete phase I/II trials, including €3 million (US$3.4 million) already allocated to ongoing activities. In animal studies, the COVID-19 spike glycoprotein modulator showed strong immunological response, eliciting both neutralizing antibodies and T-cell immunity. The development plan includes the completion of preclinical studies and GMP manufacturing of the first vaccine batch, with an initial clinical study expected to begin by year-end.
Targovax ASA, of Oslo, Norway, said it inked a collaboration agreement with the Explorations in Global Health Division of Leidos Holdings Inc., of Reston, Va., to evaluate whether Leidos’ Microtide microbially derived checkpoint inhibitor peptides are suited for delivery to Oncos viruses, thus adding checkpoint inhibitor functionality to such viruses. Under the agreement, Leidos and Targovax will investigate the technical feasibility, in vitro and in vivo immune modulatory and anticancer properties of encoding Microtide checkpoint peptides in the Oncos adenovirus backbone. If successful, the combined constructs may serve as a platform that enables add-on functionality to stimulate multiple complementary antitumor mechanisms.
Tetraphase Pharmaceuticals Inc., of Watertown, Mass., said it entered a definitive merger agreement with Melinta Therapeutics Inc., of Morristown, N.J., in which Melinta would acquire Tetraphase, through a tender offer, for an aggregate of $39 million in cash, plus an additional $16 million in cash potentially payable under contingent value rights to be issued in the proposed acquisition. The board of Tetraphase unanimously recommends that stockholders tender their shares in the Melinta tender offer once it is commenced. The deal would bring Melinta rights to tetracycline Xerava (eravacycline), approved in 2018 to treat complicated intra-abdominal infections. On June 4, Tetraphase terminated its previously announced merger agreement with Acelrx Pharmaceuticals Inc., of Redwood City, Calif., which declined to revise its offer for Tetraphase following Melinta’s bid. Tetraphase will pay Acelrx a termination fee of about $1.8 million.
Tiziana Life Sciences plc, of London, said that Howard Weiner, who chairs the company’s scientific advisory board, received a research grant from the NIH to investigate nasal anti-CD3 to treat Alzheimer’s disease (AD). The company is exploring the use of nasally administered foralumab, a CD3 antagonist, to treat AD and other neurodegenerative diseases.
Vascular Biogenics Ltd. (VBL Therapeutics), of Tel Aviv, Israel, presented data implicating the potential of its motile sperm domain protein 2 (MOSPD2) inhibitor to treat rheumatoid arthritis (RA) during the European League Against Rheumatism virtual 2020 congress, noting that biopsies from RA patients showed strong staining for monocytes expressing MOSPD2. Moreover, mice in which the MOSPD2 gene was knocked out did not develop disease in a collagen antibody-induced arthritis model for RA, and treatment with the anti-MOSPD2 monoclonal antibody inhibited arthritis progression in the model (p<0.005). Anti-MOSPD2 also showed higher activity than anti-TNF-alpha in the advanced phase of the disease.
Vivebiotech SL, of San Sebastián, Spain, said it agreed to collaborate with Xyphos Biosciences Inc., a unit of Astellas Pharma Inc., of Tokyo, to develop and manufacture GMP-grade lentiviral vectors. The agreement calls for Vivebiotech, a gene transfer technologies CDMO, to supply lentiviral vectors for the preclinical and clinical phases of Xyphos’ trial of its lead convertibleCAR T program.