More leaders of major companies have added their names to a pledge for careful testing of any potential COVID-19 vaccine to uphold scientific integrity. The companies of which CEOs have most recently joined include Astrazeneca plc, of London; Biontech SE, of Mainz, Germany; Glaxosmithkline plc, of London; Johnson & Johnson, of Whitehouse Station, N.J.; Moderna Inc., of Cambridge, Mass.; Novavax Inc., of Gaithersburg, Md.; and Sanofi SA, of Paris.
Anges Inc., of Osaka, Japan, said it entered a collaboration with Boulder, Colo.-based Brickell Biotech Inc., through which it receives the right to develop Anges’ investigational adjuvanted plasmid DNA vaccine intended to prevent SARS-CoV-2 in the U.S., South America and certain emerging markets. Anges is currently conducting phase I/II studies with its vaccine candidate in Japan, with data readouts expected in the first quarter of next year.
Anheart Therapeutics Co. Ltd., of Hangzhou, China, said through its subsidiary, Anheart Therapeutics Inc., it entered license agreements with Tokyo-based Daiichi Sankyo Co. Ltd. to acquire rights to two clinical-stage oncology candidates (previously DS-1001 and DS-1205, now AB-218 and AB-329, respectively). AB-218 is a selective mutant IDH-1 inhibitor, which has high permeability of the blood-brain barrier and has demonstrated safety and efficacy signals in a phase I trial of glioma patients. Anheart said it will develop that compound for glioma and potentially other indications, including acute myeloid leukemia and cholangiocarcinoma globally, except in Japan where Daiichi Sankyo will retain exclusive rights. AB-329 is an AXL inhibitor, which will be tested in combination with checkpoint inhibitors or third-generation EGFR inhibitors in non-small-cell lung cancer as well as other solid tumors and hematological malignancies. Under the terms of the agreements, Daiichi Sankyo is eligible to receive up-front payments, as well as development, regulatory and commercial milestone payments and royalties on net sales following market approval of the products.
Aptorum Group Ltd., of New York, joined biotech companies in Europe combating antimicrobial resistance via the Beam alliance. It’s a network of about 70 small and medium-sized firms. They are working with small-molecule antibiotics, biologics, products with a prophylaxis indication, microbiome-based and phage-based therapies, immune-targeting therapies, anti-biofilm agents and medical devices, including in vitro diagnostics.
Auris Medical Holding Ltd., of Hamilton, Bermuda, launched development of AM-301, a drug-free nasal spray for protection against airborne pathogens and allergens, based on positive data obtained in a SARS-CoV-2 assay. In order to expedite the development process, Auris set up a new subsidiary, Altamira Medica Ltd., in Zug, Switzerland, and has already obtained funding through a CHF1.5 million (US$1.6 million) convertible loan agreement. AM-301 is a gel that works by forming a protective layer on the nasal mucosa.
Aveo Oncology Inc., of Boston, regained full global rights to ficlatuzumab, a hepatocyte growth factor (HGF) inhibitory antibody which is designed to bind to the HGF ligand with high affinity and specificity to inhibit HGF/c-Met biological activities. Aveo also said it plans to fund the clinical manufacture of ficlatuzumab to enable a potential registrational phase III trial in head and neck squamous cell cancer, as well as additional potential development in phase II studies in pancreatic cancer and acute myeloid leukemia. Following the decision, Biodesix Inc., of Boulder, Colo., has exercised its contractual right to reduce its future financial obligations in exchange for reduced partnership economics.
Avidity Biosciences Inc., of San Diego, signed a collaboration supporting End-DM1, a natural history study to advance the understanding of disease progression in patients with myotonic dystrophy type 1 (DM1). It’s a non-interventional study designed and run by the Myotonic Dystrophy Clinical Research Network. DM1 is a progressive and often fatal disease caused by a triplet-repeat on the DMPK gene.
Biomica Ltd., of Rehovot, Israel, disclosed preclinical in vivo results in its immuno-oncology program for a follow-on combination of bacterial strains. In the studies, Biomica tested BMC-128, which consists of four live bacterial strains derived from Biomica's drug candidates BMC-121 and BMC-127. Treatment with BMC-128 significantly improved antitumor activity in mice.
Briacell Corp., of Berkeley, Calif., received a research grant from the Wiseman Cancer Research Foundation, a 501c(3) nonprofit organization based in Beverly Hills, Calif. The research grants are awarded to individual scientists or entities that pursue outstanding research in immuno-oncology. Charles Wiseman, Briacell’s scientific founder and director, serves as president of the Wiseman group.
Canbridge Pharmaceuticals Inc., of Beijing and Cambridge, Mass., expanded its gene therapy collaboration with the Horae Gene Therapy Center at the University of Massachusetts Medical School. The second sponsored research program will focus on the development of customized adeno-associated virus vectors expected to have broad applications for the treatment of neuromuscular diseases. Earlier this year, Canbridge made public its first agreement with Horae.
CN Bio Innovations Ltd., of Cambridge, U.K., signed a collaboration with Imperial College London. The work will harness CN Bio’s Liver-on-Chip technology to advance the understanding of the underlying mechanisms of alcoholic hepatitis and uncover novel targets for drug discovery and development, the company said. CN’s Physiomimix technology has been adopted by professor Mark Thursz, a leading academic in hepatology, to further his research into the disease by providing human-relevant data in vitro.
New data from Cymerus Therapeutics Ltd., of Melbourne, Australia, showed efficacy in its induced pluripotent stem cell-derived mesenchymal stem cells in a preclinical rodent model of idiopathic pulmonary fibrosis (IPF). Treatment using the stem cells led to statistically significant improvements in multiple harmful effects of IPF, including interstitial fibrosis, dynamic lung compliance and airway resistance. IPF results in extensive scarring of the lungs and may often be advanced by the time the patient is diagnosed.
Destiny Pharma plc, of Brighton, U.K., and Sporegen Ltd., of Englefield Green, U.K., said they will collaborate to develop SPOR-COV as a preventive COVID-19 treatment. The companies, which will share costs and commercial returns, said they plan to begin a clinical trial within the next 18 months. SPOR‑COV is a formulation of Bacillus bacteria administered nasally as a spray. Innovate UK awarded the companies an £800,000 (US$1.94 million) grant for the project.
Exelixis Inc., of Alameda, Calif., has entered two new collaborations develop multiple antibody-drug conjugates (ADCs). Exelixis and NBE Therapeutics AG, of Basel, Switzerland, said they will collaborate to discover and develop multiple ADCs for oncology applications. Exelixis will make an up-front payment of $25 million to NBE in exchange for an exclusive option to nominate a defined number of target programs on NBE’s platform over a two-year period. The companies said they plan to advance multiple ADCs into preclinical development with Exelixis contributing R&D support. For each individual target program, prior to filing an IND application, Exelixis will be able to exercise its option to an exclusive worldwide license, and afterward continue clinical development and commercialization activities for that target program. Also, Exelixis and Catalent Inc., of Somerset, N.J., said they plan to use Catalent’s site-specific bioconjugation technology to build ADCs using monoclonal antibodies from Exelixis’ preclinical pipeline. In exchange for an up-front payment to Catalent of $10 million, Exelixis received an exclusive option to nominate up to a fixed number of targets using the ADC platform over a three-year period. The companies plan to advance the ADCs into preclinical development and, prior to filing an IND, Exelixis may exercise its exclusive option to a worldwide license of the related ADC program and continue clinical development and commercialization.
Exmceuticals Inc., of Vancouver, British Columbia, said it received a €302,000 (US$356,258) COVID-19 R&D-focused grant from the EU and the Portuguese government. The company said it plans to create functional, natural and biocide formulations targeting and attacking molecules that make up COVID-19. The research will focus on the virucidal action of naturally occurring bioactive compounds from the cannabis plant, in addition to others.
Grifols SA, of Barcelona, Spain, said it will acquire Alkahest Inc., of San Carlos, Calif., to enhance discovery and R&D to identify therapies for age-related diseases based upon an understanding of the human plasma proteome for $146 million. The transaction is expected to close in early 2021. In addition to the clinical development of specific plasma fractions and protein inhibitors, Alkahest said it is focused on developing a complete understanding of the human plasma proteome.
Humanigen Inc., of Burlingame, Calif., said it will effect a 1-for-5 reverse split of its outstanding shares of common stock. The reverse stock split is expected to occur at 4:30 p.m. ET on Sept. 11, with trading expected to begin on a split-adjusted basis on the OTCQB Venture Market on Sept. 14.
Icanomab GmbH, of Polling, Germany, a new and privately funded biotech focused on preclinical and clinical development of canonical antibodies for treating cancer, immune system-related diseases and COVID-19, said it secured three clinical candidates in IND-enabling stage and funding from Mab Discovery GmbH, of Neuried, Germany. Mab sold its antibody production platform and laboratory to Mainz, Germany-based Biontech SE in 2019.
New research testing Kevetrin, a p53 drug candidate from Innovation Pharmaceuticals Inc., of Beverly, Mass., shows it arrested cell growth and caused cell death in acute myeloid leukemia cells. Multiple p53 targets, several cellular processes and oncogenic pathways were also shown to be positively impacted by Kevetrin, the company said. Kevetrin was further shown to exhibit preferential cytotoxic activity against leukemia blast cells, while largely not affecting the immune microenvironment, supporting a less toxic drug profile.
Inovio Inc., of Plymouth Meeting, Pa., said Thermo Fisher Scientific signed a letter of intent to manufacture Inovio’s DNA COVID-19 vaccine candidate, INO-4800. Thermo Fisher joints other CDMOs in the company’s manufacturing consortium, aimed at scaling commercial production of the vaccine. Inovio plans to have 100 million doses manufactured in 2021, subject to FDA approval for use in COVID-19. At peak capacity, Thermo Fisher projects that it could produce at least 100 million doses of INO-4800 annually.
Intravacc, of Bilthoven, the Netherlands, said it was awarded a contract with base and options that may total $9.4 million from the U.S. National Institute of Allergy and Infectious Diseases, part of the NIH, for the development of a prophylactic vaccine against enterovirus D68 (EV D68). EV D68 is a respiratory virus that can cause childhood paralysis, or acute flaccid myelitis. Intravacc will develop an inactivated EV D68 vaccine, based on its Vero cell technology, from early product selection through to phase I testing.
Kite Pharma, of Santa Monica, Calif., a unit of Gilead Sciences Inc., said the Center for International Blood and Marrow Transplant Research reached a study enrollment goal two years early, with 1,500 B-cell lymphoma patients now enrolled in the postmarketing safety study of CAR T therapy Yescarta (axicabtagene ciloleucel). The trial is designed to generate real-world evidence to assess long-term safety and effectiveness, with researchers following participants for at least 15 years. The study is a requirement of the FDA.
Lineage Cell Therapeutics Inc., of Carlsbad, Calif., said it was awarded a new research and development grant for 2020 of up to INS1.95 million (US$574,831) from the Israel Innovation Authority, which provides funding for the development of a bio-retinal patch for the treatment of retinal diseases by Lineage’s subsidiary, Cell Cure Neurosciences Ltd., in partnership with Israel-based Precise Bio Ltd.
Mylan NV, of Hertfordshire, U.K., said it agreed to acquire the related intellectual property and commercialization rights of Durban, South Africa-based Aspen Pharmacare Holdings Ltd.’s thrombosis business in Europe for €641.9 million (US$757.3 million), with the transaction expected to be immediately accretive to Mylan upon closing and to be accretive to Viatris, the new company to be formed upon completion of Mylan's previously announced combination with Upjohn, a division of New York-based Pfizer Inc., which is expected to close in the fourth quarter of 2020.
Orthopaedic Research UK and Embryo Ventures said they formed London-based Novara Therapeutics, a joint venture to commercialize a bone-targeting contrast agent. Novara will focus on preclinical development of the proprietary imaging and therapeutic technology to advance diagnosis and treatment of bone disease in patients.
Pharmacyte Biotech Inc., of Laguna Hills, Calif., said it completed the second container closure integrity test required by the FDA for its Cypcaps product, to be used in the company’s planned clinical trial in locally advanced, inoperable pancreatic cancer.
Pharmamar SA, of Madrid, Spain, said it created a new virology unit to research, develop and provide medicines for viral diseases, for which there are, up to today, no effective treatments. The unit’s current priority will focus on finding an effective treatment for SARS-CoV-2, and the firm is in clinical development with plitidepsin against COVID-19, with results expected in October. The unit will be led by Belén Sopesén, director of corporate affairs at Pharmamar, with José María Jimeno taking over clinical direction as the vice president and global head of the virology unit.
Phoremost Ltd., of Cambridge, U.K., and Xtalpi Inc., of Cambridge, Mass., said they entered a collaboration to identify and develop compounds to advance a drug discovery program against targets that epigenetically regulate tumor progression, and have been previously classified as undruggable. The companies will use a combination of machine learning and physics-based computation methods, using Xtalpi’s intelligent digital drug discovery and development (ID4) platform, to explore novel sites discovered by Phoremost’s Siteseeker platform. Financial terms were not disclosed.
Protalix Biotherapeutics Inc., of Carmiel, Israel, said it received notification from the NYSE American LLC that the company has regained compliance with all of the continued listing standards.
Recce Pharmaceuticals Ltd., of Sydney, presented updated data from its SARS-CoV-2 in vitro (organoid) studies at Path Bioanalytics and the University of Tennessee Health Science Centre. Data indicate concentration-dependent reductions from baseline of the SARS-CoV-2 (COVID-19) virus by R-327 and R-529 as compared to a control group. The concentrations utilized were far lower than the suite of preclinical data on the R-327 intravenous infusion program, Recce said. In a separate study, R-327 and R-529 indicated an excellent toxicity profile with less than 0.25% effect on Vero (monkey) cells at the concentrations tested. Should a separate study of R-327 against COVID-19 in Australia be successful, it would be expected to assess administration by intravascular administration, providing optimum administration route and dose/concentration for potential human COVID-19 therapy, the company said.
Redhill Biopharma Ltd., of Tel Aviv, Israel, said its sphingosine kinase-2 inhibitor, opaganib, dosed at 1 mg/ml, blocked viral replication as measured after three days incubation in an in vitro model of human bronchial tissue, comparing favorably with remdesivir (Veklury, Gilead Sciences Inc.), the study’s positive control. Treatment of cells infected with SARS-CoV-2 resulted in dose-dependent inhibition of virus production without compromising cell membrane integrity.
Regenerx Biopharmaceuticals Inc., of Rockville, Md., said scientists from eight American research centers published a paper on new therapeutic approaches for COVID-19 in which they propose that thymosin beta 4 (Tβ4), because of its ability to induce fibrinolysis, among other activities, may be useful in treating patients with the COVID-19 virus. The work was published in eLife. Regenerx is working on therapeutic peptides, including Tβ4.
Silence Therapeutics plc, of London, said in connection with a listing of American depositary shares (ADSs) on Nasdaq, the U.S. SEC declared effective registration statements with respect to such securities, while Nasdaq has approved the ADS for listing. ADSs began trading under the ticker SLN Sept. 8, ending the day at $19.50.
Takeda Pharmaceutical Co. Ltd., of Osaka, Japan, said it entered an agreement to divest a portfolio of select noncore pharmaceutical products sold predominantly in Europe and Canada to specialty pharma firm Cheplapharm Arzneimittel GmbH, of Greifswald, Germany. Under the terms, Takeda will receive an up-front payment of about $562 million. The products, which include cardiovascular/metabolic and anti-inflammatory products along with calcium, generated fiscal year (FY) 2019 sales of about $260 million. Proceeds from the transaction, set to close by the end of FY 2020, will be used by Takeda to reduce its debt and accelerate de-leveraging toward its target of 2x net debt/adjusted EBITDA within FY 2021 to 2023.
Vaxart Inc., of South San Francisco, said preclinical data published on preprint server Biorxiv describes development of a SARS-CoV-2 (COVID-19) vaccine based on Vaxart’s oral adenovirus platform. Findings show immunization with the vaccine candidate induced IgA response in the lungs of animals, which is indicative of a mucosal immune response. Of particular note, neutralizing antibodies in the lungs were observed at a very high percentage of the total antibody response. Immunization with the vaccine candidate expressing full-length S and N proteins induced IgG responses in a dose-dependent manner. Antigen-specific CD4-positive and CD8-positive T cells also were induced at both low and high doses. Administration of the vaccine induced only low levels of IL-4 production, suggesting little risk of vaccine- dependent disease enhancement, the company said.
Vaxil Bio Ltd., of Ness Ziona, Israel, said results from an in vivo immunogenicity study demonstrated both cellular and humoral responses to multiple signal peptides as well as to Corvax, which is composed of multiple signal peptides. These results further confirm the potential in the design of Vaxil’s COVID-19 vaccine candidate and provide additional evidence that it generates the anticipated immune response. Testing in two mouse strains showed both exhibited a humoral response, developing antibodies as early as 10 days after last injection. Both strains also displayed activated T cells against the signal peptides.
Vyne Therapeutics Inc., of Bridgewater, N.J., completed its name change from Menlo Therapeutics Inc. and changed its ticker to VYNE, effective as of opening of trading on Sept. 8.
Zyversa Therapeutics Inc., of Weston, Fla., said the Journal of Neuroinflammation published a review article demonstrating how different inflammasome signaling pathways contribute to the etiology of multiple sclerosis (MS). Among the data reported were results on Zyversa’s IC-100, an inflammasome ASC inhibitor, in an EAE mouse model of MS. Data reveal that IC-100 resulted in a significant reduction in CD4 and CD8 T-cell infiltration into the spinal cord, which was associated with improved functional outcomes in EAE mice. IC-100 also reduced microglial activation, a hallmark of MS pathogenesis and progression.