Adaptvac ApS, of Hørsholm, Denmark, said it is partnering with AGC Biologics, a contract development and manufacturing organization, to develop and produce a COVID-19 vaccine using its virus-like particle technology. The company, together with its EU Horizon 2020 sponsored PREVENT-nCoV consortium partners, are developing a SARS-CoV-2 vaccine. Adaptvac is a joint venture between Expres2ion Biotechnologies ApS, a subsidiary of Expres2ion Biotech Holding AB and University of Copenhagen spin-out Nextgen Vaccines ApS. The goal is to create a world class unit for the development of vaccines and therapeutics against infectious diseases, cancer and immunological disorders.

Agastiya Biotech LLC, of San Diego, said that based on in silico models, its cancer-targeting small molecule, AB00-1, is a viable SARS-CoV-2 therapeutic. It acts on ACE-2 to inhibit the entry of the virus into the cell and also works on NSP15 to prevent its replication. AB00-1 is highly bioavailable, has multiple targets and is immunomodulatory besides being an antiviral agent. The company intends to begin human trials this year.

Axovant Gene Therapies Ltd., of Basel, Switzerland, said it has prepaid in full its $15.7 million outstanding loan from Hercules Capital Inc., including interest, fees and other amounts due. Following the prepayment, the credit facility and loan agreement with Hercules Capital was terminated.

Emergent Biosolutions Inc., of Gaithersburg, Md., said it will deploy its contract development and manufacturing services to support the manufacturing of New Brunswick, N.J.-based Johnson & Johnson’s lead vaccine candidate for COVID-19 that leverages the Advac and PER.C6 technologies from its Janssen Pharmaceutical unit. Under the agreement, valued at approximately $135 million, Emergent will provide drug substance manufacturing services supported by investments from Johnson & Johnson beginning this year, and will reserve certain large-scale manufacturing capacity to pave the way for commercial manufacturing of Janssen’s adenovirus-based COVID-19 vaccine beginning next year.

Hoth Therapeutics Inc., of New York, said Voltron Therapeutics Inc., also of New York, has selected the peptides required to complete the structure of special purpose subsidiary Halovax LLC for development and progression into preclinical animal testing of the Halovax Self-Assembling Vaccine. Voltron will take two different vaccines, with differing sets of targets into preclinical testing, in order to identify the best balance of immune responses for prevention of infection. The vaccine is designed to protect patients at risk of COVID-19 infection. Initiation of the first animal study for the vaccine candidates is expected to begin during May 2020. The vaccine candidates are built on a base of a heat-shock protein that activates the cellular portion of the immune system; that is different from most other vaccine efforts, which used adjuvants such as alum, the companies said.

Nexstim plc, of Helsinki, Finland, said innovation funding agency Business Finland has decided that a total of €900,000 (US$972,053) from the capital and interest of three loans granted for Nexstim’s research and development projects has been settled by debt cancellation. Business Finland decided to cancel part of the loan capital and interest because Nexstim’s R&D activities for stroke rehabilitation carried out between 2009 and 2017 were unsuccessful and it was therefore not possible to financially utilize the project results in full, the company said. The company has decided to allocate limited financial resources to the treatment of other brain diseases, such as severe depression and chronic neuropathic pain.

Scancell Holdings plc, of Oxford, U.K., started a program to develop a vaccine for COVID-19. The project will be led by Lindy Durrant, chief scientific officer and professor of cancer immunotherapy at the University of Nottingham, in collaboration with scientists in the newly established Center for Research on Global Virus Infections and the new Biodiscovery Institute at the University of Nottingham, and Nottingham Trent University. Scancell’s DNA vaccines target dendritic cells to stimulate high avidity T cells that survey and destroy diseased cells.

Sumitomo Dainippon Pharma Co. Ltd., of Osaka, Japan, and the National Institutes of Biomedical Innovation, Health and Nutrition signed a joint research agreement, aiming at the practical application of a universal influenza vaccine that provides broader protection against most influenza. In the joint research, using Sumitomo’s Toll-like receptor 7 adjuvant (DSP-0546LP)-containing vaccine formulations, the institutes will develop immunoanalysis techniques employing next-generation flow cytometers and other advanced technologies, and conduct clinical biomarking. Sumitomo will carry out nonclinical and clinical work.

Takeda Pharmaceutical Co. Ltd., of Osaka, Japan, entered an agreement to divest a portfolio of select noncore over-the-counter (OTC) and prescription pharmaceutical products sold in Europe, and two manufacturing sites located in Denmark and Poland to Orifarm Group A/S, of Odense, Denmark, for up to about $670 million. The portfolio to be divested includes a variety of OTC products and food supplements as well as select prescription products in the respiratory, anti-inflammatory, cardiovascular and endocrinology therapeutic areas sold predominantly in Denmark, Norway, Belgium, Poland, Finland, Sweden, the Baltics and Austria. The portfolio generated fiscal year 2018 net sales of about $230 million.

Tiziana Life Sciences plc, of New York and London, said, pursuant to an asset purchase agreement, it has acquired all of the intellectual property relating to a nanoparticle-based formulation of actinomycin D from Rasna Therapeutics Inc., of New York, to expand its pipeline for a consideration of an initial $120,000 up-front payment and milestone payments of up to an additional aggregate $630,000. Act D, an antibiotic drug, was approved initially for infectious diseases in the U.S. in 1964 and was shown to exhibit anticancer activity in 1974. Tiziana will evaluate the safety and efficacy of the nanoparticle version.

Tracon Pharmaceuticals Inc., of San Diego, retained global rights to and has sole responsibility for development and commercialization of TRC-253 based on the decision by Johnson & Johnson (J&J), of Brunswick, N.J., not to exercise its option to reacquire global rights following a review of the phase II data in prostate cancer patients with acquired resistance to Xtandi (enzalutamide, Astellas Pharma Inc./Pfizer Inc.) or Erleada (apalutamide, Johnson & Johnson). Under the original agreement, Tracon is obligated to make certain payments to J&J if future development and regulatory milestones are achieved and to pay a royalty on net sales of the product. Tracon has initiated an out-licensing process to identify a corporate partner to develop and commercialize TRC-253 in China, where androgen receptor inhibitors are not widely accessible to patients with prostate cancer.

Viralclear Pharmaceuticals Inc., a subsidiary of Westport, Conn.-based Biosig Technologies Inc., said preclinical studies of the antiviral candidate merimepodib have shown it capable of decreasing viral production of SARS-Cov-2 more than Foster City, Calif.-based Gilead Sciences Inc.'s remdesivir at clinically meaningful drug concentrations. An article describing the work has been accepted by F1000 Research, the company said. On April 24, Viralclear submitted an IND seeking FDA approval to run a phase II trial of the drug as a potential treatment for COVID-19. Merimepodib was earlier developed as a treatment for chronic hepatitis C and psoriasis by Vertex Pharmaceuticals Inc., of Boston.

Vistin Pharma ASA, of Oslo, Norway, said its board approved an expenditure of about NOK100 million (US$9.4 million) to support installation of a second production line, doubling its production capacity at its dedicated metformin manufacturing facility. Commercial volumes from the new production line is expected to be available in 2022, it said.

No Comments