Abbvie Inc., of North Chicago, said it is helping with the experimental use of the HIV medicine Kaletra/Aluvia (lopinavir/ritonavir) to determine its efficacy in the treatment of COVID-19. The company is collaborating with select health authorities and institutions globally to determine antiviral activity as well as efficacy and safety of lopinavir/ritonavir against the virus, supporting clinical studies and basic research with lopinavir/ritonavir, working closely with European health authorities and the FDA, CDC, and NIH, and others to coordinate such efforts. Along with industry partners, the company has joined the Innovative Medicines Initiative to support research and discovery of targeted medicines against the virus. Separately, Abbvie extended the expiration date of the offers to exchange any and all outstanding notes issued by Dublin-based Allergan plc to March 27, 2020.
Aim Immunotech Inc., of Ocala, Fla., said the National Institute of Infectious Diseases in Japan will begin testing Aim's drug, Ampligen (rintatolimod), as a potential treatment for COVID-19. The experimental program will be conducted at the institute and the University of Tokyo. The testing and research are being conducted by Hideki Hasegawa, director of the Influenza Virus Research Center, and director of the World Health Organization Collaborating Center for Reference and Research on Influenza, Tokyo, and Takeshi Ichinohe, in the institute’s department of pathology.
Algernon Pharmaceuticals Inc., of Vancouver, British Columbia, said it will set aside some of its NP-120 (ifenprodil) drug supply from its planned phase II study for idiopathic fibrosis and chronic cough, to make it available on a compassionate use basis, to physicians and their patients with the most serious cases of COVID-19. The decision was made based on the results of an independent study of ifenprodil which showed a 40% improvement in mortality and significantly reduced acute lung injury in a recent H5N1 animal study. H5N1 is one of the most lethal forms of influenza known with a 53% mortality rate, the company noted. The company has scaled up manufacturing to prepare for trials.
Bayer AG, of Leverkusen, Germany, and not-for-profit Massbio, of Cambridge, Mass., have launched the Center for Regulatory Excellence, a forum offering startups academia mentorship and seminars with regulatory experts to identify and mitigate regulatory issues. Sessions will be designed to focus on specific areas of interest related to the regulatory process and will entail lectures, open dialogue and networking. The center is an extension of Massconnect, Massbio’s life sciences mentorship program.
Beroni Group Ltd., of Sydney, which is developing a medical solution using nanobody technology for COVID-19 with Tianjin University in China, advanced into cytological experiments and expects to complete them by the end of March. Beroni officials said the firm has obtained information on the coronavirus nanobody sequence and the crystal structure of SARS-CoV-2, the virus causing the infection. The joint scientific teams have already studied the biochemical characterization of the modified nanobody. The two plan to conduct animal experiments followed by clinical trials, which are expected to occur in April 2020, Beroni officials said.
Cel-Sci Corp., of Vienna, Va., said it is developing an immunotherapy with the potential to treat the COVID-19 coronavirus using its peptide technology using conserved regions of coronavirus proteins to stimulate protective cell-mediated T-cell responses and reduce viral load. The technology can be used to construct immunotherapeutic peptides that exhibit both antiviral and anti-inflammatory properties. Those products target the virus infection against which they are directed and evoke protective responses against it, company said. The research is based on previous studies conducted in collaboration with the National Institutes for Allergies and Infectious Diseases with another respiratory virus, pandemic influenza. In those studies, Cel-Sci’s peptides elicited protection of mice from morbidity and mortality after the introduction of infection by activating appropriate T-cell responses rather than an inflammatory response.
Cocrystal Pharma Inc., of Bothell, Wash., said it is developing antiviral compounds to treat COVID-19 infections. As of February, Cocrystal and the Kansas State University Research Foundation (KSURF) have a new license agreement to develop broad-spectrum antiviral compounds for treating norovirus and coronavirus infections. Cocrystal has been granted an exclusive, royalty-bearing right and license to certain antiviral compounds for humans covered by KSURF’s patents.
Cyclica Inc., of Toronto, and Beijing’s Institute of Materia Medica, Chinese Academy of Medical Sciences, are collaborating to discover antiviral drug candidates for COVID-19 and to explore opportunities to design multitargeted antiviral compounds. The institute will conduct in vitro and in vivo antiviral assessment for molecules proposed by Cyclica. The two will also engage in a longer-term effort to design multitarget antiviral compounds to reduce drug resistance. The partnership is built on a relationship between Cyclica and China that stemmed from China-Canada Angel Alliance, an investment group in Ontario, Canada.
Humanigen Inc., of Burlingame, Calif., said it is exploring clinical-stage strategies and partnerships to evaluate whether lenzilumab, the company’s anti-human-GM-CSF monoclonal antibody, can reduce or prevent the cytokine storm resulting from COVID-19 infection. Lenzilumab has been shown to prevent cytokine storm in animal models. Patients are soon expected to be enrolled in a clinical study to determine lenzilumab's effect on cytokine storm associated with the hyperactive immune response associated with CAR T therapy in a collaboration with Kite Pharma Inc., part of Foster City, Calif.-based Gilead Sciences Inc.
Innovation Pharmaceuticals Inc., of Wakefield, Mass., said it was notified by one of the 12 U.S. Regional Biocontainment Labs that it received shipment of brilacidin, Innovation’s defensin mimetic drug candidate, for testing against SARS-CoV-2, the coronavirus responsible for COVID-19. Innovation also signed a material transfer agreement with an undisclosed U.S. university to use brilacidin as a potential treatment for the coronavirus.
Marinomed Biotech AG, of Vienna, reported preclinical data showing that poorly soluble compounds mometasone, fluticasone and fluorometholone can be dissolved in large quantities with the help of the company’s Marinosolv technology. Compared to the currently marketed products, Marinosolv enabled a 50 to 200-fold improvement in solubility. Studies also show that Marinosolv supports the combination of different active ingredients. In the next step, Marinomed said it will examine the appropriate strategy for clinical trials and potential markets for those substances.
Menlo Therapeutics Inc., of Redwood City, Calif., and Foamix Pharmaceuticals Ltd., of Bridgewater, N.J., completed their merger, with Foamix becoming a wholly owned subsidiary of Menlo. The newly merged company, which is in phase III testing with pruritus candidate serlopitant, will trade on Nasdaq under the ticker MNLO.
Nanoform Finland Ltd., of Helsinki, and Orion Corp., of Espoo, Finland, said they are collaborating to apply Nanoform’s CESS technology, designed to improve bioavailability and solubility, to new chemical entities. Terms were not disclosed.
Oncosec Medical Inc., of San Diego, said the class action and related books and records litigation brought by Alpha Holdings Inc. in Nevada state court have been dismissed, with prejudice. The class action sought to enjoin the closing of a strategic investment and relationship that Oncosec secured from two partners, Grand Decade Developments Ltd. and its U.S. affiliate, Sirtex Medical US Holdings Inc. The class action was commenced in late 2019 by Alpha, a South Korea-based institutional investor in Oncosec. The company said since Alpha's cases were dismissed with prejudice, they cannot be relitigated and Oncosec has no liability to Alpha.
TFF Pharmaceuticals Inc., of Austin, Texas, said it engaged Torreya Partners LLC to serve as exclusive financial advisor for the company’s partnering efforts in China and South Korea. TFF develops drugs based on its Thin Film Freezing technology platform.
Viiv Healthcare Ltd., of London, and the University of North Carolina at Chapel Hill disclosed a five-year, $20 million renewal of a public-private research partnership focused on discovering a cure for HIV. Under the terms of the agreement, scientists from both entities will continue to work at the HIV Cure Center, which was created at the start of the collaboration five years ago and located on the UNC-Chapel Hill campus. The two also will continue to jointly own Qura Therapeutics, the company created in 2015 to manage the intellectual property, commercialization, manufacturing and governance needs of the collaboration. Research currently underway through the HIV Cure Center and Qura is centered on the concept of “induce and reduce.” That strategy is first focused on identifying the copies of HIV that may be hiding in human immune cells while the virus is suppressed through antiretroviral therapy. Once identified, the virus is driven out of hiding (induce) so that it can be eliminated (reduce).
Zydus Cadila Ltd., of Ahmedabad, India, and Xoma Corp., of Emeryville, Calif., said they entered a licensing agreement to advance an IL-2-based immuno-oncology (I-O) drug candidate that combines Zydus’ IL-2 with Xoma’s anti-IL-2 monoclonal antibody. As part of the agreement, Zydus will advance the new I-O candidate through formal clinical trials. Zydus has been granted exclusive rights to develop and commercialize the therapy in India, Brazil, Mexico and other emerging markets, and Xoma has the potential to receive single- to double-digit royalties on commercial sales in those territories. Xoma retains rights in all other territories. Through the collaboration, Zydus will develop the new candidate through human proof of concept and each company has the potential to receive predefined shares of future proceeds that may arise from licensing and commercialization activities. Specific financial terms were not disclosed.