Aicuris Anti-infective Cures GmbH said it will change its legal form from GmbH, a limited liability company, to AG, (Aktiengesellschaft), a stock corporation. The switch, the Wuppertal, Germany-based company said, provides increased flexibility to operate globally and broadens fundraising options. The first product from Aicuris, spun out from Bayer in 2006, was Prevymis (letermovir) for treating cytomegalovirus infections in transplant patients.
Algernon Pharmaceuticals Inc., of Vancouver, British Columbia, said it created a research program for treating stroke with AP-188 (N, N-Dimethyltryptamine or DMT), a psychedelic that is part of the tryptamine family. Algernon said it plans to begin a clinical trial in 2021. Preclinical data, the company added, shows it helps promote neurogenesis plus structural and functional neural plasticity, factors in the brain’s ability to form and reorganize synaptic connections. Other drugs in the tryptamine family include psilocybin and psilocin.
Akari Therapeutics plc, of New York and London, said it is developing a second clinical candidate, votucalis, which inhibits histamine. Votucalis comes from the same research program as lead candidate nomacopan and shares a similar mode of action: capturing and binding to ligands such as C5 plus leukotriene B4 (LTB4; nomacopan) or histamine (votucalis). Nomacopan is a C5 complement inhibitor that inhibits LTB4 activity.
Fresh data from Cognition Therapeutics Inc., of Pittsburgh, has identified a receptor integral in Parkinson’s disease pathology. Cognition said it screened to identify compounds that rescue neurons from α-synuclein oligomer-induced deficits, specifically in autophagy and trafficking processes. The compounds that had the most profound effects were discovered to be σ-2 receptor antagonists, the company said. This is consistent with findings reported in the literature describing σ-2 receptor components, TMEM97 and PGRMC1, as regulators of these pathways, the company said, adding this is the first time σ-2 antagonists have demonstrated having effects against α-synuclein oligomers. The findings were published in the Journal of Neuroscience Research.
Curevac NV, of Tübingen, Germany, and contract development and manufacturing organization Rentschler Biopharma SE, of Laupheim, Germany, said they initiated the set-up of manufacturing capabilities for Curevac´s COVID-19 vaccine candidate, CVnCoV. Rentschler is responsible for manufacturing of the active pharmaceutical ingredient, downstream processing and formulation of drug substance for CVnCoV at its site in Laupheim. With the phase IIb/III trial of the COVID19 spike glycoprotein modulator underway, optimization of the production process was initiated to increase mRNA yield, with production expected to exceed 100 million annual doses.
Gilead Sciences Inc., of Foster City, Calif., and Emeryville, Calif.-based Gritstone Oncology Inc. have agreed to work together to develop a vaccine-based immunotherapy for HIV. The program will use Gritstone’s prime-boost vaccine platform, comprised of self-amplifying mRNA and adenoviral vectors, with antigens developed by Gilead. Preclinical work at Gritstone used simian immunodeficiency virus-derived antigens, which are very similar to HIV-1, said Gritstone R&D chief Karin Jooss. Terms of the deal call for a $60 million payment at closing, consisting of a $30 million up-front cash payment and a $30 million equity investment at a premium. Gilead will be responsible for conducting a phase I study and holds an exclusive option under the collaboration to obtain an exclusive license to develop and commercialize the HIV-specific therapeutic vaccine beyond phase I. If the option is exercised and certain clinical and regulatory milestones are achieved, Gritstone will be eligible to receive up to an additional $725 million, plus mid-single-digit low double-digit tiered royalties. Separately, Gilead increased its stake in Hayward, Calif.-based Arcus Biosciences Inc. to 19.5% by purchasing about 5.7 million additional shares of the company's stock (NYSE:RCUS) at a premium $39 per share. Proceeds from the transaction totaled $220 million and will further support the companies' 10-year partnership to co-develop and co-commercialize next-generation cancer immunotherapies, Arcus said. Arcus expects its cash and investments to fund its operations through at least 2023.
Iterum Therapeutics plc, of Dublin, said it has engaged commercial services provider Eversana Inc., of Chicago, ahead of an anticipated FDA decision on its NDA for oral sulopenem, expected on or before an assigned July 25 PDUFA date. The priority review is for an application to market the drug for the treatment of uncomplicated urinary tract infections in patients with a quinolone non-susceptible pathogen. Ahead of the decision, Iterum said it will work with Eversana on U.S. market access, strategic marketing, medical education and patient services.
Kadmon Holdings Inc., of New York, said preclinical data has demonstrated that KD-033, the company's anti-PD-L1/IL-15 fusion protein, achieved "robust anti-tumor responses" in multiple syngeneic tumor models. The data were published in Molecular Cancer Therapeutics. KD-033 is currently being evaluated in a phase I study in patients with metastatic or locally advanced solid tumors.
Kamada Ltd., of Rehovot, Israel, said it is acquiring a plasma collection center and certain related rights and assets from privately held Blood and Plasma Research Inc of Beaumont, Texas. The facility specializes in the collection of hyper-immune plasma used for Anti-D immunoglobulin, which is manufactured by Kamada and distributed in international markets. Kamada CEO Amir London said his company plans to "significantly expand our hyperimmune plasma collection capacity," both by investing in the Texas facility and leveraging its FDA license to open additional centers in the U.S.
Noveome Biotherapeutics Inc., of Pittsburgh, said it has finalized a new cooperative research and development agreement (CRADA) with Walter Reed Army Institute of Research (WRAIR). The research will test Noveome’s lead candidate, ST-266, in animal models of closed traumatic brain injury (TBI). Nyrada Inc., of Sydney, is also working with the WRAIR on TBI. Under the terms of its CRADA, with an initial term of two years, together with the University of New South Wales Sydney, researchers will evaluate Nyrada's lead preclinical neuroprotection compound on mitochondrial calcium dynamics, an important determinant of cell fate. They will also evaluate the compound in a controlled cortical impact animal model. Results from initial studies of Nyrada's compound are expected within 12 months.
Pfizer Inc., of New York, and Biontech SE, of Mainz, Germany, said preclinical data in nonhuman primate and mouse models from mRNA-based vaccine candidates BNT-162b1 and BNT-162b2 for the prevention of COVID-19 were published in Nature. Results found immunization of rhesus macaques with either the BNT-162b1 or BNT-162b2 vaccine candidate elicited SARS-CoV-2 neutralizing geometric mean titers 8.2 to 18.2 times that of a SARS-CoV-2 convalescent human serum panel. The vaccine candidates also protected macaques from SARS-CoV-2 challenge, with BNT-162b2 protecting the lower respiratory tract from the presence of viral RNA and with no evidence of disease enhancement. In mice, one intramuscular dose of either vaccine candidate elicited a dose-dependent antibody response with high virus-entry inhibition titers and strong TH1 CD4+ and IFNg + CD8+ T-cell responses.
Sonnet Biotherapeutics Holdings Inc., of Princeton, N.J., said it completed a nonhuman repeat-dose study of SON-1010, a fully human interleukin-12 therapeutic candidate configured using Sonnet’s FHAB platform, which is designed to target tumor tissue, providing a mechanism for dose sparing and an opportunity to improve the safety and efficacy profile of immunomodulatory cytokines. Results showed repeat dosing intravenous and subcutaneous routes of administration were tolerated at both dose levels examined. SON-1010-related changes in the physiological observations, body weight, pathology, cytokines and immunophenotyping were seen, all of which were consistent with those on-target effects previously observed in single dose studies. A significant increase in interferon-gamma levels, a key pleiotropic cytokine associated with antitumor activity, was observed following the initial dose of SON-1010 with lower interferon-gamma levels observed following the second dose. Pharmacokinetic analysis indicated a mean serum half-life of about 40 hours for animals administered SON-1010 via subcutaneous injection.
Sosei Group Corp., of Tokyo, and Metrion Biosciences Ltd., of Cambridge, U.K., entered a collaboration in which Sosei will apply its structure-based drug design expertise and platform to ion channels, a class of integral membrane proteins that regulate the flow of ions across the cell membrane as a means of conducting signals between cells and their environment. As a first step, Sosei Heptares and Metrion will combine their respective capabilities in a drug discovery program to identify novel, highly specific drug leads for further development against a single ion channel associated with neurological diseases. Sosei Heptares will have exclusive, full global rights to all molecules identified and directed to the targets for development by Sosei Heptares. No further financial details are disclosed.
Sumitomo Dainippon Pharma Co. Ltd., of Osaka, Japan, said it entered an agreement with Kicker Venture Partners I LLC, under which Sumitomo Dainippon will invest up to a cumulative total of $20 million in Kicker Ventures I LP, a venture capital fund created by Kicker Venture Partners in January 2021. The fund is focused on investing in early stage companies that seek business opportunities primarily in the U.S., Canada and Japan by harnessing digital health care technologies such as digital therapy, smart devices, data analysis and artificial intelligence, personalized medicine and cutting-edge therapeutic devices and pharmaceutical products.
Titan Pharmaceuticals Inc., of South San Francisco, said studies of its kappa opioid agonist peptide, JT-09, demonstrated high potency and specificity for the human kappa-opioid receptor. JT-09 is being developed for use in combination with Titan's Proneura long-term, continuous drug delivery technology for the treatment of moderate to severe chronic pruritus.
Valneva SE, of Saint-Herblain, France, said the U.K. government exercised its option to order 40 million doses of its inactivated, adjuvanted COVID-19 vaccine candidate for supply in 2022. That brings the total volume of the Valneva vaccine ordered by the U.K. government to 100 million doses, and the U.K. government retains options over a further 90 million doses for supply between 2023 and 2025. The total value of the 190 million doses, if all options are exercised, is up to €1.4 billion (US$1.7 billion). Valneva has commenced production in parallel to the ongoing clinical studies in order to optimize the timeline for potential deliveries of the vaccine. The phase I/II study is now fully enrolled and is expected to read out within the next three months.
Vir Biotechnology Inc., of San Francisco, said research published in Biorxiv characterize a novel site of vulnerability on the SARS-CoV-2 spike protein – specifically the N-terminal domain (NTD). These data, along with results on immune evasion by mutations elsewhere in the spike protein published in Cell, indicate the importance of carefully targeting conserved regions of the spike for vaccines and clinical monoclonal antibodies. The new research indicates the NTD as another site that, like the receptor binding motif, contains mutations as well as deletions in emerging variants, the company said.