AIkido Pharma Inc., of New York, said it is sponsoring psychedelic research at the Mount Sinai Center for Psychedelic Psychotherapy and Trauma Research. The center examines the therapeutic potential of psychedelic compounds for post-traumatic stress disorder and other trauma-related symptoms. Aikido’s pipeline of therapeutics includes therapies for pancreatic cancer, acute myeloid leukemia and acute lymphoblastic leukemia.
Amarin plc, of Dublin, said the Canadian Cardiovascular Society and the Egyptian Heart Journal have included the company’s Vascepa (icosapent ethyl) in the 2021 society’s guidelines and in the journal’s guidance in lipid management for the reduction of cardiovascular risk. These recommendations increase to 15 the number of global organizations or medical societies that recommend the drug after its favorable outcomes study results.
Aveo Pharmaceuticals Inc. (Aveo Oncology), of Boston, said the National Comprehensive Cancer Network has updated its clinical practice guidelines to include Fotivda (tivozanib) as a recommended regimen for subsequent therapy following first-line treatment regimen recommendations for patients with clear cell histology renal cell carcinoma (RCC). Fotivda won FDA approval on March 10 for the treatment of adults with relapsed or refractory, advanced RCC who have received two or more systemic therapies.
Biohaven Pharmaceutical Holding Co. Ltd., of New Haven, Conn., enrolled the first patient in a phase II/III trial of its oral CGRP receptor antagonist zavegepant for the preventive treatment of migraine. Under the terms of its June 2018 funding agreement with Royalty Pharma Inc., Biohaven will receive $100 million for the milestone.
Cardior Pharmaceuticals GmbH, of Hanover, Germany, said a recent study published in Frontiers in Cardiovascular Medicine confirms that its lead program, the antisense oligonucleotide CDR-132L, blocks the naturally occurring microRNA miR-132 which, if overexpressed, is a key driver of heart failure. Cardior's team expects to initiate a phase II study with CDR-132L later this year, it said.
The CDC reported real-world evidence that mRNA COVID-19 vaccines are effective in preventing SARS-CoV-2 infections among health care personnel, first responders and other essential workers. The study looked at the effectiveness of vaccines from Pfizer Inc./Biontech SE and Moderna Inc. in preventing SARS-CoV-2 infections among 3,950 study participants in six states over a 13-week period from Dec. 14, 2020, to March 13, 2021. Results showed that following the second dose of vaccine, risk of infection was reduced by 90% two or more weeks after vaccination. Following a single dose of either vaccine, the participants’ risk of infection with SARS-CoV-2 was reduced by 80% two or more weeks after vaccination.
Cerecor Inc., of Rockville, Md., said its subsidiary, Aevi Genomic Medicine LLC, has entered an expanded agreement with Kyowa Kirin Co., of Tokyo, for exclusive worldwide rights to develop, manufacture and commercialize CERC-002, Kyowa Kirin’s fully human anti-LIGHT (tumor necrosis factor superfamily member 14, TNFSF14) monoclonal antibody for all indications. Kyowa Kirin will receive an up-front payment of unspecified value from Cerecor and is also eligible to receive additional payments based on achievement of regulatory and commercial milestones, as well as sales-based royalties and a share of sublicensing income.
Exagen Inc., of San Diego, will collaborate with Emory University on a new study about the long-term effects of COVID-19 infection in the development of autoimmune diseases. The longitudinal study will further evaluate the emergence of biomarkers that are known indicators for the development of lupus, rheumatoid arthritis and other autoimmune diseases, the company said.
Immune Pharmaceuticals Inc., a U.S.-based entity that's basically a public shell following Boston-based Alexion Pharmaceuticals Inc.'s purchase of its assets in November 2019, has received an unconditional acquisition offer from the U.K.-based investment firm United General Ltd., which plans to bring the public company current through filings with the SEC and then merge a new pharmaceutical project into the company. "The intent would be to reverse merge with a large pharmaceutical company once the takeover has completed," according to a statement by the companies. Success of the offer to take over the bankrupt company is dependent on court and SEC approval.
Janssen Pharmaceutica NV, part of New Brunswick, N.J.-based Johnson & Johnson, said it entered an agreement with the African Vaccine Acquisition Trust (AVAT) to make available up to 220 million doses of its single-shot COVID-19 vaccine candidate to African Union's 55 member states with delivery beginning in the third quarter of 2021. AVAT also has the potential to order an additional 180 million doses, for a combined total of up to 400 million doses through 2022. The availability of the vaccine candidate is subject to its successful approval or authorization by the national regulatory authorities of AU member states.
Kazia Therapeutics Ltd., of Sydney, said it entered a licensing agreement with Simcere Pharmaceutical Group Ltd., of Nanjing, China, to develop and commercialize Kazia’s brain-penetrant PI3k/Akt/mTOR inhibitor, paxalisib, in greater China. Under the terms, Simcere will assume responsibility for the development, registration and commercialization of paxalisib in greater China, while Kazia retains rights in all other territories and will continue to drive forward the GBM AGILE pivotal study as planned, including in China. Kazia will receive an up-front payment of $11 million, comprising $7 million in cash and a $4 million equity investment, priced at a 20% premium to recent trading. Kazia will also receive contingent milestone payments of up to $281 million for glioblastoma, with further milestones payable for indications beyond glioblastoma. Simcere will additionally pay to Kazia midteen percentage royalties on commercial sales.
Lineage Cell Therapeutics Inc., of Carlsbad, Calif., said a patient with adult-onset vitelliform macular dystrophy has been treated with Opregen on a named-patient compassionate use approval granted by the Israeli Ministry of Health. Opregen is an investigational cell therapy consisting of allogeneic retinal pigment epithelium cells administered to the subretinal space and is currently being investigated in a 24-patient phase I/IIa trial for the treatment of dry age-related macular degeneration with geographic atrophy.
Menarini Group, of Florence, Italy, said it entered an exclusive license agreement for the development and commercialization of Elzonris (tagraxofusp) in Japan with Nippon Shinyaku Co. Ltd., of Kyoto, Japan. Terms were not disclosed. Elzonris is approved for treating patients with blastic plasmacytoid dendritic cell neoplasm in the U.S. and Europe.
Mitolytix Research Ltd., of Dorval, Quebec, said data appearing as a preprint whitepaper showed that a biomolecule targeting malignant cells from the metabolic perspective – as complex I dysfunctions in energy metabolism (NADH-ubiquinone oxidoreductase complex I dysfunction) – has potential for increasing overall survival rates in patients with cancers that express with free radical dysfunction, a predisposing hallmark factor in the initiation and progression of most tumor cells and their metastatic potential.
Moderna Inc., of Cambridge, Mass., said it has shipped the 100 millionth dose of its COVID-19 vaccine to the U.S. government.
Tempest Therapeutics Inc., of South San Francisco, and Millendo Therapeutics Inc., of Ann Arbor, Mich., said they entered a definitive agreement under which Millendo will merge with Tempest in an all-stock transaction. The combined company will focus on advancing Tempest’s oncology pipeline of small-molecule therapeutics that have the potential to address a wide range of tumors. Upon shareholder approval, the combined company is expected to operate under the name Tempest Therapeutics and trade on Nasdaq under the ticker TPST. In support of the merger, Tempest secured commitments from a syndicate of health care investors, including Versant Ventures, Rock Springs Capital, F-Prime Capital, Monashee Investment Management, Quan Capital, Lyfe Capital, Maven Investment Partners US, Lilly Asia Ventures and Eight Roads Ventures, for a $30 million PIPE financing, expected to close concurrent with the completion of the merger. Together with the cash expected from both companies at closing, the net proceeds of the merger and financing are expected to fund the further development of Tempest’s three oncology programs and operate the company into early 2023. The financing and merger are expected to close in the first half of 2021.
Therapeutic Solutions International Inc., of Elk City, Idaho, reported new data demonstrating its new immunotherapy derived from inducible pluripotent stem cells (iPSC) induces potent and selective killing of cancer associated blood vessels. In contrast to other approaches, the current immunotherapy involves transfection of the enzyme alpha1,3-galactosyltransferase into the iPSC, after which iPSC cells are transformed into tumor endothelial-like cells and used for immunization. Side by side comparison between the currently described approach and approaches such as placental-derived cancer endothelial vaccines suggest significantly higher level of immunity toward cancer angiogenesis can be obtained with the former, the company said.
Valeo Pharma Inc., of Montreal, said it entered a commercialization and supply agreement with Novartis Pharmaceuticals Canada Inc., part of Basel, Switzerland-based Novartis AG, for the Canadian commercialization by Valeo of asthma therapies Enerzair Breezhaler (indacaterol/glycopyrronium/mometasone furoate) and Atectura Breezhaler (indacaterol/mometasone furoate). Under the terms, Valeo will be responsible for medical and commercial activities for both products for an initial eight-year period.
Y-Biologics Inc., of Daejeon, South Korea, and Pierre Fabre SA, of Castres, France, said they concluded a strategic research collaboration and optional license agreement concerning several immuno-oncology targets. The collaboration is set to run for three years, with the possibility of a two-year extension. Each year during the collaboration, Y-Biologics and Pierre Fabre will jointly study up to three targets. While Pierre Fabre will have a licensing option for the jointly found leading antibodies, Y-Biologics will have an opt-in option to participate in preclinical and clinical development and continue joint development of antibody drugs with Pierre Fabre.