7 Hills Pharma, of Houston, said it launched a coronavirus (COVID-19) vaccine program for older adults. It will evaluate its lead compound, 7HP-349, a next-generation small-molecule integrin activator, as an oral adjuvant with a novel recombinant coronavirus vaccine, laying the foundation for potential clinical testing late this year. In research with several universities, the company has demonstrated that 7HP-349 augments prophylactic vaccine responses against influenza, Chagas disease and tuberculosis in preclinical models.
Aligos Therapeutics Inc., of South San Francisco, said it expanded its existing license agreement with Luxna Biotech Co. Ltd., of Osaka, Japan, relating to the latter’s modified nucleic acid technology. The amended deal grants Aligos exclusive rights to use Luxna’s technology to target the genomes of certain families of respiratory viruses, including Coronaviridae, which includes SARS-CoV-2, the virus causing COVID-19.
Applied DNA Sciences Inc., of Stony Brook, N.Y., completed design qualification, production and shipment of five COVID-19 vaccine candidates to Takis Biotech Srl, of Rome, Italy. The vaccine candidates were produced by the company’s LinearDNA manufacturing systems. Preliminary animal test results from the plasmid-based vaccine templates were immunogenic and induced a strong production of antibodies across all five vaccine candidates, Applied said.
Applied Biomath LLC, of Concord, Mass., which uses mathematical modeling and simulation to provide quantitative and predictive guidance to assist drug research and development, said it established a collaboration with Oncomyx Therapeutics Inc., of Phoenix, and will develop a systems pharmacology model to mechanistically evaluate the pharmacokinetics and pharmacodynamics of Oncomyx's oncolytic myxoma virus platform and therapeutic programs. Oncomyx is developing oncolytic immunotherapies based on the platform to orchestrate an immune response and treat various cancers.
Axovant Gene Therapies Ltd., of Basel, Switzerland, disclosed a collaboration with Invitae Inc., of San Francisco, a medical genetics company, in a program to facilitate faster diagnoses for children with lysosomal storage disorders, including GM1 gangliosidosis and GM2 gangliosidosis, also known as Tay-Sachs/Sandhoff disease.
Bellicum Pharmaceuticals Inc., of Houston, closed the sale of its Houston facility to the University of Texas MD Anderson Cancer Center at a purchase price of $15 million. The preferred supply agreement provides Bellicum access to cell therapy product supply while reducing operating expenses, the firm said. In January, Bellicum entered an asset purchase agreement under which MD Anderson would acquire Bellicum’s 60,000-square-foot Houston facility, including manufacturing, office and laboratory space. As part of the transaction, Bellicum also entered a master services agreement with MD Anderson. Following completion of the transaction, MD Anderson will operate the Houston facility for its own internal programs as well as manufacture Bellicum’s Gocar and other cellular therapy programs for clinical trials and potentially early commercial supply.
Benitec Biopharma Inc., of Hayward, Calif., said the previously disclosed transaction to redomicile from Australia to the U.S. has been fully implemented. The move was approved by Benitec shareholders at a scheme meeting held on March 26, and confirmed by the Supreme Court of Queensland on March 30. Shares of the firm will trade on Nasdaq under the symbol BNTC.
Bold Therapeutics Inc., of Vancouver, British Columbia, started a partnership with researchers from the University of Ottawa to explore the potential utility of BOLD-100 as a novel antiviral agent. The entities will be using Bold’s lentiviral-based infection system, derived from HIV, equipped with the SARS-CoV-2 (COVID-19) spike, to study the impact of BOLD-100 on viral entry. The candidate’s main mechanism of action is to inhibit stress-induced up-regulation of GRP78. There is extensive literature suggesting that GRP78 plays a critical role in host recognition, viral entry and viral replication, Bold said.
Ensysce Biosciences Inc., of San Diego, is exploring the opportunity to initiate a clinical trial of oral nafamostat mesylate, an ingredient from its opioid overdose protection platform, as a treatment for COVID-19. The synthetic protease inhibitor will be investigated in preventing or reducing the lethal outcome of COVID-19 infection. Ensysce is planning a phase I/II trial to examine an oral solution of nafamostat, a route of administration that has not been explored for the drug.
Flow Pharma Inc., of Pleasant Hill, Calif., said Oakwood Laboratories Inc., of Oakwood Village, Ohio, will begin working with Flow to interface Oakwood's microsphere-based, GMP pharmaceutical manufacturing operations to the Flowvax vaccine platform manufacturing system. Flowvax vaccines utilize Flow's Size Exclusion Antigen Presentation Control technology, based on the benefits of making vaccine microspheres the same size as human white blood cells.
Fujifilm Corp., of Tokyo, said it increased manufacturing capacity at its Toyama Chemical Co. Ltd. and Wako Pure Chemical Co. Ltd. sites to increase production of RNA polymerase inhibitor Avigan (favipiravir) for treating COVID-19 patients. Fujifilm said it expects to progressively increase Avigan’s monthly production up to 100,000 treatment courses by July, about 2.5 times higher than in March. The company said it plans to produce up to 300,000 treatment courses by September. The Japanese government said it plans to stockpile 2 million treatment courses of Avigan as part of its emergency economic package. A treatment course is the amount of Avigan described by the Japanese Association for Infectious Diseases for a COVID-19 treatment regimen.
Ginkgo Bioworks Inc., of Boston, will collaborate with Moderna Inc., of Cambridge, Mass., to generate raw materials used in mRNA vaccine manufacturing, including Moderna’s mRNA-1273 candidate for treating COVID-19. In the past five years, Ginkgo said it invested $400 million in automated bioengineering and brings microbial discovery, production and fermentation, along with academic researchers, to the table for the deal. The candidate is an mRNA vaccine against SARS-CoV-2 encoding for a prefusion stabilized form of the Spike (S) protein.
Halix BV, of Leiden, the Netherlands, said it joined a consortium guided by the University of Oxford to provide GMP manufacturing services supporting large-scale production of the COVID-19 vaccine ChAdOx1 nCoV-19, which is being developed by the university’s Jenner Institute. The scale-up is designed to support the candidate’s clinical trials. The vaccine is based on the institute’s adenovirus vaccine vector technology. Halix has worked to develop and GMP manufacture viral vectors used against infectious diseases such as HIV, Zika, chikungunya and influenza.
Hansoh Pharmaceutical Group Co. Ltd., of Shanghai and San Francisco, said it expanded its partnership with Atomwise Inc., of San Francisco, after identifying and confirming several compounds for treating an unnamed target. The collaboration began in November 2019 and screened a virtual library of more than 12 billion compounds to end up with 200 candidates. Atomwise uses artificial intelligence for small-molecule drug discovery.
New preclinical data from Histogen Inc., of San Diego, showed treating full thickness osteochondral lesions with HST-003, an extracellular matrix scaffold to treat articular cartilage defects, resulted in hyaline cartilage and mature bone formation in rats (O’Driscoll score p<0.001), and rabbits (p<0.001). Similar results were seen in the large defect goat model, where the untreated lesions showed only scar tissue and human extracellular matrix treated defects had excellent regeneration with normal tissue. Histogen said it plans to submit an IND to study HST-003 in regenerating focal cartilage lesions in the knee in the third quarter of 2020.
Khondrion BV, of Nijmegen, the Netherlands, published a paper in Preprints hypothesizing that the inflammatory lipid modulator prostaglandin E2 (PGE2) may play a role in the pathophysiology of COVID-19. The article suggests that researchers measure PGE2 in COVID-19 patients. Khondrion is developing sonlicromanol, which blocks microsomal prostaglandin E synthase-1, resulting in lower PGE2 production.
LFB SA, of Les Ulis, France, signed an agreement with Xenothera SAS, of Nantes, France, to produce Xenothera's XAV-19 antibody product for the treatment of coronavirus infections, including COVID-19. The first clinical batch is scheduled to be produced in May 2020. Terms of the deal weren't disclosed.
LNC Therapeutics SA, of Bordeaux, France, said it entered an exclusive license agreement with the University of Valencia, Spain, for its patent dedicated to therapeutic applications of Christensenella gut bacteria in mood disorders. The license grants LNC worldwide research, manufacturing and marketing rights of therapeutics development for disorders such as depression or anxiety. Financial terms were not disclosed.
Mannkind Corp., of Westlake Village, Calif., received a loan of approximately $4.9 million as part of the Coronavirus Aid, Relief and Economic Security Act's Paycheck Protection Program. The loan may be forgiven by the U.S. Small Business Administration (SBA) if the company meets the SBA requirements. Mannkind also announced plans to cut pay of employees whose payroll costs exceed $100,000 by 20% for at least 10 weeks.
Promis Neurosciences Inc., of Toronto, is collaborating with the Hans Frykman lab at the BC Neuroimmunology Lab and Neurocode Labs to develop a serological test to assess COVID-19 immunity. Financial terms of the collaboration weren't disclosed.
Pylum Biosciences Inc., of South San Francisco, in collaboration with researchers at the University of California, Los Angeles and The University of Texas Medical Branch, said data published in Nature describes key structural mechanisms of action for a class of naturally occurring bacteria killers, R-type pyocins. By leveraging the innate ability of pyocins, Pylum has built a platform to engineer a class of antibacterial agents it has termed Avidocin proteins, that are designed to be highly specific, stable and targetable with the potential to treat drug-resistant bacteria.
Samsung Bioepis Co. Ltd., of Incheon, Korea, launched Ontruzant (trastuzumab-dttb), a biosimilar of Herceptin (trastuzumab, Roche Holding AG), in the U.S. for the treatment of HER2-overexpressing breast cancer, metastatic breast cancer and metastatic gastric cancer or gastroesophageal junction adenocarcinoma. The 150-ml vial of the drug was approved by the FDA in January 2019, and a 420-mg vial was approved in March 2020.
TFF Pharmaceuticals Inc., of Austin, Texas, entered a Cooperative Research and Development Agreement with the U.S. Army Medical Research Institute of Infectious Diseases to collaborate on developing TFF's thin film freezing technology for a monoclonal antibody against alphaviruses and a vesicular stomatitis virus vaccine against filoviruses.
Transcelerate Biopharma Inc., of Philadelphia, said its 21 member companies plan to share the data from their past, ongoing and future clinical trials for COVID-19 on the company's Datacelerate platform.
Xylyx Bio Inc., of New York, disclosed the availability of products designed to recreate the lung environment in vitro to provide a predictive model for insight into efficacy of COVID-19-related drug candidates.
Y-mabs Therapeutics Inc., of New York, licensed the use of the SADA-BiDE (2-step Self-Assembly and DisAssembly-Bispecific DOTA-Engaging antibody system) pre-targeted radioimmunotherapy platform from Memorial Sloan Kettering Cancer Center (MSK) and the Massachusetts Institute of Technology. The license also includes constructs developed by MSK. Y-mabs has the right to sublicense the SADA technology.