Akers Biosciences Inc., of Thorofare, N.J., said its collaboration with Premas Biotech Inc., of Madison, Conn., has successfully completed a second milestone, the expression of the three coronavirus antigens: spike, envelope and membrane, which were selected for the companies’ vaccine candidate. The antigens have been expressed using the D-CryptTM platform at Premas, which utilizes its vectors and Saccharomyces cerevisiae strain. Premas is moving forward with purification and post-expression processing, which should lead to a scaling up of the antigens, the companies said.
Avacta Group plc, of Cambridge, U.K., signed a collaboration with Cytiva, part of Danaher Corp., of Washington. The companies will develop and manufacture an Affimer-based point-of-care rapid test intended for screening of large populations to diagnose the COVID-19 coronavirus infection. Avacta is already generating Affimer reagents that detect the COVID-19 virus and with Cytiva will develop and manufacture a test capable of diagnosing the infection in minutes using a respiratory sample such as saliva. Avacta will own the intellectual property relating to the COVID-19 Affimer-reagents and will retain all the commercial rights to future products.
Aytu Bioscience Inc., of Englewood, Colo., said Suda Pharmaceuticals Ltd., of Osborne Park, Western Australia, Aytu's Zolpimist licensing partner outside the U.S. and Canada, has signed an exclusive license agreement to commercialize Zolpimist in South Korea. The agreement is with Mitsubishi Tanabe Pharma Korea Ltd., a wholly owned subsidiary of Mitsubishi Tanabe Pharma Corp., of Osaka, Japan. Aytu will receive of portion of the up-front payment, milestone payments and royalty payments as part of the global sublicensing agreement between Aytu and Suda.
CSL Behring LLC, of King of Prussia, Pa., and SAB Biotherapeutics Inc., of Sioux Falls, S.D., said their partnership to combat the coronavirus pandemic with the rapid development of SAB-185, a COVID-19 therapeutic candidate, is on track for clinical evaluation by early summer. The partnership joins the forces of CSL’s protein science capabilities with SAB's immunotherapy platform. The candidate was generated from SAB's Diversitab platform, which the company said is capable of producing large volumes of human polyclonal antibodies targeted specifically to SARS-CoV-2.
Epivax Inc., of Providence, R.I., is using advanced computational tools to accelerate a COVID-19 vaccine candidate (EPV-CoV19) for health care workers into clinical trials in six months. The company disclosed its partnership with the nonprofit Gaia Vaccine Foundation to crowd-source funds for the project and its pledge to make a free license available to developing countries who qualify. EPV-CoV19 is a peptide-based, epitope-driven vaccine that can be rapidly and safely produced in most countries, Epivax said.
Flow Pharma Inc., of Pleasant Hill, Calif., said researchers at the University of Texas Medical Branch at Galveston will begin testing Flow’s Flowvax COVID-19 vaccine candidate by challenging nonhuman primates with SARS-CoV-2, after the animals are vaccinated this month. Flowvax vaccines utilize Flow’s patented Size Exclusion Antigen Presentation Control technology, based on the benefits of making vaccine microspheres the same size as human white blood cells.
Hitgen Inc., of Chengdu, China, signed a license agreement with Mitsubishi Tanabe Pharma Corp., of Osaka, Japan, to develop a novel class of drugs. This is the second deal disclosed by the two companies. The licensed compounds were identified using Hitgen’s technology platform, which involved screening large DNA encoded libraries, containing more than 400 billion small molecules with drug-like properties synthesized on chemically diverse scaffolds, the companies said.
Immutep Ltd., of Sydney, and EOC Pharma Group, of Shanghai, said they will continue advancing EOC-202 (efti) for treating metastatic breast cancer. Spurring them on is recent analysis of Immutep’s phase IIb trial, which, the companies said, included progression-free survival data. EOC is the exclusive licensee of Immutep’s efti for China. It will make further milestone payments to Immutep if efti achieves development milestones as well as undisclosed royalties on sales. EOC will also fund efti’s Chinese development.
Lamellar Biomedical Ltd., of Glasgow, U.K., said it has preclinical evidence showing its platform for COVID-19 treatment could reduce acute respiratory distress syndrome in patients by inhibiting fibroproliferative changes. The company said it has preclinical evidence of inhaled lamellasome in a large animal in vivo model of radiation-induced lung injury, designed to replicate the pathology found in the injured lung, which is representative of COVID-19 patient pathology. Inhaled lamellasome treatment protected lung cells and tissues from injury, pneumonitis and fibroproliferation/fibrosis at the alveolar/capillary membrane, the company added. Lamellasome vesicles are synthetic lipidic mimetics of native human lamellar bodies found in lung tissue.
Mateon Therapeutics Inc., of Agoura Hills, Calif., said its antiviral screening program found artemisinin, a derivative of the Asian herb Artemisia annua that has been used to treat malaria, inhibits the COVID-19-causing virus, SARS-CoV-2, from multiplying. The company said it will seek support to evaluate clinical proof-of-concept studies. The availability of artemisinin as a pre-existing dietary supplement may allow it to be deployed immediately in developing countries where the health care system can easily be overwhelmed, the company added.
Medicinova Inc., of La Jolla, Calif., said it will initiate a clinical trial of MN-166 (ibudilast) for acute respiratory distress syndrome caused by COVID-19. The study will be conducted by Yale’s Advanced Therapies Group. MN-166 is an oral small-molecule macrophage migration inhibitory factor inhibitor and phosphodiesterase -4 and -10 inhibitor that suppresses pro-inflammatory cytokines and promotes neurotrophic factors. Medicinova is developing MN-166 for amyotrophic lateral sclerosis, progressive multiple sclerosis and other neurological conditions such as degenerative cervical myelopathy, glioblastoma, substance abuse/addiction and chemotherapy-induced peripheral neuropathy.
Metriopharm AG, of Zurich, said it obtained positive data from a preclinical study in a model for chronic obstructive pulmonary disease showing that its MP-1032 inhibits the formation of 3-nitrotyrosine in the pulmonary parenchyma caused by cigarette smoke, as proven in an ex vivo model of the isolated and perfused lung. MP-1032 is an immune modulator, the company said, that could modulate oxidative stress-mediated activation state of macrophages. MP-1032, the company added, does not impact T cells and preferentially affects macrophages at inflammation sites. Metriopharm is developing treatments for chronic inflammatory diseases such as psoriasis, arthritis and multiple sclerosis.
Nascentbiotech Inc., of San Diego, said two of its independent consultants have begun preliminary research for treating COVID-19 patients with the company’s pritumumab, designed to interfere with the virus’ binding to target cells. In vitro studies have begun on the company’s lead asset, which may be a receptor used by viruses for infection. Testing focuses on pritumumab’s ability to interfere with the virus' binding to its target cells. Pritumumab is a monoclonal antibody targeting vimentin. Cell surface vimentin is thought to be a potential target for the treatment of coronavirus infections.
Novacyt Group, of Paris, is collaborating with Astrazeneca plc, of Cambridge, U.K., and the University of Cambridge to support the U.K. government’s plan to increase testing for COVID-19. A new laboratory will be set up by Astrazeneca and London-based Glaxosmithkline plc and the university’s Anne McLaren laboratory to be used for high-throughput screening for COVID-19 testing and to explore the use of alternative chemical reagents for test kits in order to help overcome current supply shortages.
Ossianix Inc., of Philadelphia, said it is developing therapeutic single-domain VNAR antibodies to the COVID-19 spike protein. According to the company, single-domain VNAR antibodies have large CDR3 binding domains that preferentially bind cavities and buried epitopes in proteins, which are often the sites of protein-protein interactions, making it likely that screening of multi-isoform VNAR libraries built on a non-immunogenic scaffold will identify hits that will be different from those isolated from human B cells or other immunization approaches. Once identified, VNAR single domain antibodies that block the viral entry can then be developed using the well-established pathway for conventional antibodies, Ossianix said. In addition, the company said it has identified and patented VNAR antibodies that bind to the human transferrin receptor and have the capability to specifically target the lung in rodents and nonhuman primates. Those VNARs can be fused to antibodies or other therapeutics creating bispecific biologics for targeted delivery to the lung, which is a major site of infectivity.
Oxford Biomedica plc, of Oxford, U.K., said it joined a consortium led by the Jenner Institute, Oxford University, to rapidly develop, scale up and manufacture a potential vaccine candidate for COVID-19, called ChAdOx1 nCov-19. That vaccine candidate is expected to be the U.K.'s first COVID-19 vaccine in clinical trials later this month. The consortium also includes the Vaccines Manufacturing and Innovation Centre, Pall Life Sciences, Cobra Biologics and Halix BV. The Oxford vaccine candidate relies on adenoviral vector technology, ChAdOx1, developed at the Jenner Institute. Oxford Biomedica said it will provide access to its large-scale GMP manufacturing facilities for viral vectors, including its new Oxbox facility. Shares of Oxford Biomedica (LSE:OXB) gained 26% to close April 8 at £7.05 (US$8.73).
Pacific Biosciences of California Inc., of Menlo Park, Calif., said it is working with commercial, academic and government research teams investigating SARS-CoV-2, the coronavirus responsible for the COVID-19 pandemic. The company said the long reads produced by its Single Molecule, Real-Time sequencing technology can be used to resolve variants of the virus that exist within one individual or across a population of patients, which is critical to developing and maintaining effective diagnostics, vaccines and medicines.
Pharmacyte Biotech Inc., of Laguna Hills, Calif., said it entered a license agreement with Hai Kang Life Corp. Ltd., of Hong Kong, in which Hai Kang granted to Pharmacyte a license to certain technology related to COVID-19 diagnostic kits. Under the terms, Pharmacyte may directly (or through a third party) conduct research, use, develop, market, sell, distribute, import and export products for human and veterinary uses in North America, the U.K. and certain other European cites. Pharmacyte agreed to pay a monthly fee to Hai Kang in the amount of $6,000, which would increase to $50,000 once the first product receives regulatory approval from the U.S. FDA. Upon the first commercial sale, Pharmacyte is required to make quarterly royalty payments equal to 10% of net sales.
Polarityte Inc., of Salt Lake City, said it received correspondence from the U.S. SEC advising the firm that the SEC’s investigation relating to a range of securities, financial, personnel and other matters has concluded. The correspondence states that, based on the information the SEC has received to date, the SEC staff does not intend to recommend an enforcement action by the SEC against Polarityte.
Quell Therapeutics Ltd., of London, said it entered a collaborative research agreement with Hannover Medical School to accelerate the discovery and validation of multiple CAR Treg cell therapies. No terms were disclosed.
Recce Pharma Ltd., of Sydney, said it formalized a phase I trial agreement to conduct a first-in-human study of lead compound RECCE-327 in 40 healthy subjects. The first patients in the study are expected to be dosed in the second half of 2020. RECCE-327 is a broad-spectrum synthetic antibiotic formulated using synthetic polymer technology to treat blood infections and sepsis derived from Escherichia coli and Staphylococcus aureus bacteria.
Recordati Rare Diseases, part of Recordati SpA, of Milan, Italy, disclosed the transfer of the European marketing authorization for Isturisa (osilodrostat) to include all EU member states plus the U.K., Norway, Iceland and Liechtenstein. Isturisa, an inhibitor of 11β-hydroxylase, is authorized for the treatment of adult patients with Cushing’s syndrome.
Regeneron Pharmaceuticals Inc., of Tarrytown, N.Y., and Zai Lab Ltd., of Shanghai, said they formed a strategic collaboration to develop and commercialize REGN-1979 (odronextamab), a CD20/CD3 modulator and the lead asset from Regeneron’s bispecific antibody platform, in mainland China, Hong Kong, Taiwan and Macau. Regeneron is set to receive $30 million up front and is eligible for up to $160 million in regulatory and sales milestones. Zai agreed to contribute to global development costs for the candidate in certain trials in exchange for rights to develop and exclusively commercialize the asset in oncology in greater China. Zai also agreed to make profit-sharing payments to Regeneron based on net sales in its region. Regeneron assumed responsibility for the manufacture and supply of REGN-1979 for development and commercialization in the region.
Revive Therapeutics Ltd., of Toronto, said it retained Novotech (Australia) Pty Ltd., of Sydney, as the clinical research organization for human studies of its repurposed formulation of bucillamine, a xanthine oxidase inhibitor, to treat infectious diseases, including COVID-19, in the Asia-Pacific region.
Tarveda Therapeutics Inc., of Watertown, Mass., and Organovo Holdings Inc., of San Diego, said they terminated their merger agreement after Organovo’s stockholders rejected the proposal on April 7 during a reconvened special meeting. Organovo stockholders approved a proposal to execute a reverse stock split of 1 share for every 20 to 40 common shares, to be implemented at the board’s discretion.
T-Cure Bioscience Inc., of Los Angeles, said it inked an exclusive global license with the National Cancer Institute (NCI) for intellectual property related to a T-cell receptor (TCR)-based candidate targeting tumors that express Kita-Kyushu lung cancer antigen 1 (KK-LC-1) to treat KK-LC-1-expressing malignancies such as gastric, lung and breast cancers. T-Cure expects to advance the candidate into a phase I study in the second quarter of 2020 under the direction of Christian Hinrichs, principal investigator at the NCI’s Experimental Transplantation and Immunology Branch, and to conduct an independent phase I trial in 2021. T-Cure also forged a Cooperative Research and Development Agreement with the NCI to support the TCR candidate’s preclinical and clinical research program and to use the company’s TCR discovery platform, Isort, to identify other potential assets targeting KK-LC-1.