Allero Therapeutics BV, of Ghent, Belgium, and Abbreos Inc., of Miami, said they will collaborate to develop treatments for conditions associated with potentially lethal amounts of pro-inflammatory cytokines and chemokines, the cytokine storm associated with COVID-19. Allero’s OMIGPatch for the oral mucosa is designed to help patients avoid complications of acute respiratory distress syndrome. Abbreos has exclusive license to develop, manufacture and commercialize the patch for North America, with an option to obtain licenses for other major markets and certain indications. Allero obtained a major share in Abbreos and is eligible to receive further undisclosed financial compensation. Clinical trials are to be held simultaneously in Miami and Flanders, Belgium, with the first patients enrolled by early 2021.
Almirall SA, of Barcelona, Spain, said it will collaborate with the University of South Australia and Spain’s Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau to find new skin cancer and atopic dermatitis treatments. The project will focus on understanding biosignatures operating in atopic dermatitis during the diseases’ different stages.
Alvotech hf. of Reykjavik, Iceland, and Alvotech & CCHT Biopharmaceutical Co. Ltd., the China joint venture company of Alvotech hf and Changchun High & New Technology Industries Group Inc., said they will collaborate with Yangtze River Pharmaceutical Group, of Taizhou, China, to commercialize eight biosimilar medicines in China. The initial pipeline contains candidates for treating autoimmunity, ophthalmology, oncology, and severe immune and inflammatory conditions. Alvotech and Alvotech & CCHT Biopharmaceutical will be jointly responsible for development, registration and supply of biosimilars in China, while Yangtze River will exclusively commercialize the candidates.
Cytodyn Inc., of Vancouver, Wash., and Amfar, The Foundation for AIDS Research, said they will test the ability of Vyrologix (leronlimab) to mediate a functional HIV cure. Vyrologix, a CCR5 antagonist being developed by Cytodyn, has protected macaques from retroviral infection, mirroring protection from HIV seen in CCR5-deficient individuals, the company said. Cytodyn’s partnership with Amfar is designed to advance clinical studies to incorporate Vyrologix to mimic a CCR5-deficient stem cell donor and attempt to functionally cure an HIV-positive person receiving a stem cell transplant from a donor expressing CCR5.
Evotec SE, of Hamburg, Germany, said it signed a new multiyear drug development partnership with Rappta Therapeutics Oy, of Helsinki, Finland, to develop small-molecule activators of the enzyme protein phosphatase 2A, which down-regulates multiple oncogenic signaling pathways responsible for driving cancer progression. The protein is made up of three subunits that form a complete and active enzyme when bound together. No terms were announced.
Genmab A/S, of Copenhagen, Denmark, said it will not advance development of enapotamab vedotin. While the drug has shown some evidence of clinical activity, it was not optimized by different dose schedules and/or predictive biomarkers and, accordingly, data from expansion cohorts did not meet Genmab’s criteria for proof of concept, the company said. Enapotamab vedotin, an ALX-targeted antibody-drug conjugate, is fully owned by Genmab, developed using drug linker technology licensed from Seagen Inc., of Bothell, Wash.
Humanigen Inc., of Burlingame, Calif., established Humanigen Australia Proprietary Ltd. to facilitate clinical development of its programs and licensing and other business development deals in the Asia-Pacific region.
Immuron Ltd., of Melbourne, Australia, received a cash refund of AU$358,280 (US$263,400) under the Australian Government’s Research and Development Income Tax Concession incentive program for eligible research and development expenditure incurred during the company's 2020 financial year.
Ionis Pharmaceuticals Inc., of Carlsbad, Calif., licensed ION-455 to Astrazeneca plc, of Cambridge, U.K., as part of their multidrug research deal. ION-455 is an antisense medication being developed as a potential treatment for nonalcoholic steatohepatitis. Licensing ION-455 triggers a $30 million payment from Astrazeneca, which will take over development, regulatory filings and commercialization of the drug. Ionis is eligible for up to $300 million in milestone payments plus royalties on net sales.
Medicinova Inc., of La Jolla, Calif., said its contract manufacturer, Millipore Sigma Bioreliance Services, a unit of Merck KGaA, of Darmstadt, Germany, has started clinical-grade manufacturing of the master virus seed stock for its intranasal SARS-CoV-2 vaccine for COVID-19.
Neurorx Inc., of Radnor, Pa., and Relief AG, of Geneva, have enrolled more than 175 patients in an expanded access protocol for RLF-100, the companies treatment for critical COVID-19 patients with respiratory failure. Of the 90 patients who have reached 28 days of follow-up, 72% survived to day 28.
Oncosec Medical Inc., of Pennington, N.J., said it licensed exclusive rights to the Cliniporator electroporation or gene electrotransfer platform from Igea Clinical Biophysics. The license encompasses a field of use for gene delivery in oncology, including use as part of Oncosec’s visceral lesion applicator program. The FDA also has cleared the Cliniporator platform for use in the upcoming phase I trial testing Corvax12, the company’s DNA-encodable vaccine candidate for COVID-19.
Otsuka Pharmaceutical Development & Commercialization Inc., of Princeton, N.J., contracted with Columbia University Irving Center Vagelos College of Physicians and Surgeons and Mailman School of Public Health to advise the company on postmarketing safety and effectiveness studies, the development of data registries and investigations of rare exposures and outcomes. The faculty will also provide education to Otsuka's employees in the form of workshops, journal clubs, seminars and formal courses.
Polyphor AG, of Allschwil, Switzerland, was awarded up to $3.3 million from the Cystic Fibrosis Foundation to fund a phase Ib/IIa trial testing its inhaled antibiotic murepavadin. The study is planned as a follow-up to a phase Ia study in healthy volunteers, which is currently waiting for CTA approval.
Protokinetix Inc., of Marietta, Ohio, submitted a research paper on its anti-aging glycopeptide, PKX-001, to a journal specializing in tissue regeneration for peer review. In an experimental model of blindness due to retina degeneration, induced pluripotent stem cell-derived retinal precursor cells transplanted with PKX-001 produced a threefold greater improvement in electroretinography (ERG) or optokinetic tracking (OKT). Cells transplanted without PKX-001 didn't improve ERG or OKT.
Selvita SA, of Krakow, Poland, will acquire the contract research organization Fidelta d.o.o., of Zagreb, Croatia, from Mechelen, Belgium-based Galapagos NV for an enterprise value of €31.2 million (US$37 million) plus the customary adjustments for net cash and working capital. The transaction is expected to close on Jan. 4, 2021.
Symvivo Corp., of Burnaby, British Columbia, is collaborating with Janssen Biotech Inc., a unit of New Brunswick, N.J.-based Johnson & Johnson. Through the research collaboration, Janssen will have an exclusive option to research, develop and commercialize biological therapeutic candidates based on Symvivo's bacTRL gene delivery platform. Financial terms of the deal weren't disclosed.
Synthetic Biologics Inc., of Rockville, Md., was granted an extension by NYSE American LLC to regain compliance with certain continued listing standards. The company has until May 25, 2021, to rectify the deficiency and must continue to make progress on its plan to regain compliance that was accepted by NYSE American on Feb. 7, 2020.
Vivacelle Bio Inc., of Fort Wayne, Ind., was awarded $5.3 million from the Department of Defense to support a clinical trial of Vivacelle's phospholipid nanoparticle VBI-S as a treatment of septic shock due to various pathogens, including SARS-CoV-2, other viruses and/or bacteria. Vivacelle plans to run a phase IIa trial followed by a phase IIb/III study.