Abbvie Inc., of North Chicago, Harbour Biomed Therapeutics Ltd., of Cambridge, Mass., Utrecht University (UU) and Erasmus Medical Center (EMC) said they entered a collaboration to develop a novel antibody therapeutic to prevent and treat COVID-19. The focus of the collaboration is on advancing the fully human, neutralizing antibody 47D-11 discovered by UU, EMC and Harbour and recently reported in Nature Communications. That antibody targets the conserved domain of the spike protein of SARS-CoV-2. Under the terms, Abbvie will support UU, EMC and Harbour through the preclinical activities, while simultaneously undertaking preparations for later-stage preclinical and clinical development work. Abbvie will receive an option to exclusively license the antibody from the three parties for therapeutic clinical development and commercialization worldwide.
Aeterna Zentaris Inc., of Charleston, S.C., said it received a positive decision from Nasdaq granting the company’s request for an extension through Oct. 5, 2020, to achieve compliance with the minimum $2.5 million stockholders‘ equity requirement for continued listing.
Astrazeneca plc, of Cambridge, U.K., said results from a peer-reviewed case series of 19 hospitalized COVID-19 patients, published in Science Immunology, showed that BTK inhibitor Calquence (acalabrutinib) reduced markers of inflammation and improved clinical outcomes of patients with severe COVID-19 disease. The company said the data informed initiation of global phase II trials.
Avita Medical Ltd., of Valencia, Calif., and Melbourne, Australia, a regenerative medicine company, said it received confirmation from the Foreign Investment Review Board that the Commonwealth has no objection in relation to the firm’s U.S. subsidiary acquiring all of the issued shares of the company under the proposed scheme of arrangement to effect a redomiciliation from Australia to the U.S.
CSL Ltd., of Melbourne, Australia, the Coalition for Epidemic Preparedness Innovations (CEPI) and the University of Queensland (UQ) said they entered a new partnering agreement to accelerate the development, manufacture and distribution of a COVID-19 vaccine candidate pioneered by researchers at UQ. The agreement formalizes the support provided by CSL to UQ and CEPI from the outset of the pandemic earlier this year. CEPI and CSL will fund the development and manufacture of UQ's molecular clamp-enabled vaccine for COVID-19. Funding contributions will be used to provide support for the pending phase I safety study being led by UQ followed by subsequent late-stage clinical trials, and industrial-scale manufacturing to allow the production of potentially millions of doses a year, should the product be approved. If successful, CSL said it anticipates the production technology can be scaled to produce up to 100 million doses toward the end of 2021.
Healios K.K., of Tokyo, said it has been creating Universal Donor Cells (UDCs), which are next-generation induced pluripotent stem cells created with gene-editing technology to engineer a low risk of immune rejection regardless of HLA types. The company said it has successfully established a proprietary UDC research line and characterized its gene expression and other features. It plans to combine its UDC technology with its existing efforts in next-generation cancer-targeting immune cells, ophthalmology and organ buds to create a line of regenerative medicine therapies with the highest possible safety and efficacy profile.
Kalytera Therapeutics Inc., of San Francisco, reported in vivo data showing that R-107 exhibits rapid conversion to its active payload of R-100 in rats, followed by sustained release of nitric oxide from R-100. The company intends to submit an IND in the second quarter to support a phase Ia study.
Magenta Therapeutics Inc., of Cambridge, Mass., presented preclinical data at the European League Against Rheumatism meeting showing successful immune reset with a single dose of its CD45-ADC in models of three autoimmune diseases: multiple sclerosis, systemic sclerosis and inflammatory arthritis.
Novavax Inc., of Gaithersburg, Md., said it was awarded a contract by the U.S. Department of Defense (DoD) for the manufacturing of NVX‑CoV2373, Novavax’ COVID-19 vaccine candidate. NVX‑CoV2373 consists of a stable, prefusion protein antigen made using its nanoparticle technology and includes Novavax’s Matrix‑M adjuvant. JPEO-CRBND-EB, through funding provided by the Defense Health Program, has agreed to fund up to $60 million to support Novavax in its production of several components of the vaccine that will be manufactured in the U.S. The agreement includes a 2020 delivery of 10 million doses of NVX‑CoV2373 for DoD that could be used in phase II/III trials or under an emergency use authorization if approved by the FDA.
Ryvu Therapeutics Inc., of Krakow, Poland, said it signed a grant agreement with the National Centre for Research and Development for the development of targeted immuno-oncology therapy. The grant provides Ryvu with almost $5.6 million of nondilutive financing to discover, develop and select a clinical candidate targeting cancers considered in the past as largely undruggable using rational approaches. Total net value of the project amounts to more than $8.9 million and the anticipated project duration is until December 2023.
Sorrento Therapeutics Inc., of San Diego, said it completed a preclinical batch of the STI-4398 (COVIDTRAP) protein and reported positive results from preclinical testing of its ability to neutralize and inhibit SARS-CoV-2 virus from infecting ACE2-expressing cells, VERO/E6. In an in vitro assay, STI-4398 completely inhibited the ability of SARS-CoV-2 virus to infect VERO/E6 cells at a low concentration. Sorrento has discussed with the FDA the development of the drug and has received guidance on the path forward to a clinical trial for STI-4398 for both the potential treatment of infected patients and as a potential prophylactic treatment to COVID-19.
UCB SA, of Brussels, Belgium, said it acquired Engage Therapeutics Inc., of Summit, N.J., a clinical-stage company developing Staccato Alprazolam for the rapid termination of an active epileptic seizure, for $125 million in cash (subject to certain adjustments) and up to $145 million in further potential milestone payments related to clinical development, submission and launch of Staccato Alprazolam.
United Therapeutics Corp., of Silver Spring, Md., said it filed a lawsuit in U.S. District Court for the District of Delaware against Liquidia Technologies Inc., of Research Triangle Park, N.C., for infringement of patents relating to United Therapeutics' pulmonary arterial hypertension product Tyvaso (treprostinil) inhalation solution, specifically U.S. Patent Nos. 9,604,901 and 9,593,066, both of which expire in December 2028. The lawsuit is based on an NDA filed by Liquidia with the FDA seeking approval to market LIQ-861, a dry powder inhalation formulation of treprostinil. The NDA was filed under the 505(b)(2) regulatory pathway with Tyvaso as the reference listed drug. In April, United Therapeutics received a Paragraph IV notification letter from Liquidia indicating that Liquidia's NDA contains a certification alleging that LIQ-861 will not infringe any of the patents then listed in the Orange Book for Tyvaso because those patents are not valid, not enforceable and/or will not be infringed by the commercial manufacture, use or sale of LIQ-861. In March, Liquidia filed petitions for inter partes review seeking to invalidate the '901 and '066 patents. United Therapeutics filed its lawsuit within 45 days of receipt of notice from Liquidia of its NDA filing. As a result, under the Hatch-Waxman Act, the FDA is automatically precluded from approving Liquidia's NDA for up to 30 months or until the resolution of the litigation, whichever occurs first.