Aeterna Zentaris Inc., of Charleston, S.C., licensed a preclinical program developing parathyroid hormone fusion polypeptides with delayed clearance to treat primary hypoparathyroidism from the University of Sheffield for £100,000 (US$140,000) up front. The university is also eligible for milestone payments for the achievement of certain development, regulatory and sales milestones, as well as low single-digit royalty payments on net sales of those products and certain fees payable in connection with sublicensing.
Annovis Bio Inc., of Berwyn, Pa., signed a manufacturing agreement for up to 10 kg of ANVS-401, which inhibits neurotoxic proteins, for the company’s planned late-stage studies in Parkinson's disease, Alzheimer’s disease and Alzheimer's in Down syndrome.
Betterlife Pharma Inc., of Vancouver, British Columbia, entered a letter of intent with Pontificia Universidad Católica de Chile to conduct a clinical trial of AP-003, which is being developed by Betterlife’s subsidiary, Altum Pharmaceuticals. The In2covid study of AP-003, an inhaled interferon alpha-2b product, in patients with COVID-19 is expected to start in the second quarter of 2021 and be complete by the end of the third quarter of 2021.
Glaxosmithkline plc, of London, is partnering with the Cell and Gene Therapy Catapult facility in Stevenage, U.K., to advance its early stage pipeline of cell and gene therapies and to streamline technical transfer.
Hoth Therapeutics Inc., of New York, contracted with Reprocell Ltd., of Glasgow, U.K., to test the effect of its anti-inflammatory drug, HT-003, on biomarkers in tissue from patients with ulcerative colitis and Crohn's disease.
Interna Technologies BV, of Utrecht, the Netherlands, was awarded a Clinical Innovation Credit of €2.7 million (US$3.24 million) from the Dutch government. The award will support the development of Interna’s lead candidate, INT-1B3, a microRNA mimic being studied as a treatment of solid tumors.
Neonmind Biosciences Inc., of Vancouver, British Columbia, said Certara Inc., of Princeton, N.J., will provide strategic integrated drug development to support investigation of Neonmind’s psilocybin-based candidates for treating obesity. Neonmind said its first drug candidate uses synthetic psilocybin to enhance a patient's ability to alter behaviors that cause weight loss through psychedelic-assisted cognitive therapy. The second drug candidate proposes low-dose synthetic psilocybin as a treatment to suppress appetite.
Orgenesis Inc., of Germantown, Md., said it entered the second phase of its collaboration with Hospital Infantil Universitario Niño Jesús, of Madrid, focusing on an exclusive license agreement to further develop and commercialize the hospital’s bone marrow-derived Celyvir therapy for treating solid tumors. The agreement follows an initial collaboration establishing a point-of-care center enabling hospitals and health care facilities to develop, optimize and manufacture cell and gene therapies through a point-of-care network of global health care facilities.
PDS Biotechnology Corp., of Florham Park, N.J., said its COVID-19 vaccine consortium, which includes Farmacore Biotechnology Ltd., of Taiwan, and Blanver Farmoquímica SA, of Sao Paulo, Brazil, received a commitment from the Brazilian government to fund up to approximately $60 million to support clinical development and commercialization of a COVID-19 vaccine in Brazil. The study is anticipated to start in the second or third quarter of 2021, according to PDS. The majority of the capital will fund manufacturing process scale-up, production and the phase III trial. Versamune-CoV-2FC combines a Farmacore-developed recombinant SARS-CoV-2 protein with PDS’ platform nanotechnology.
Pfizer Inc., of New York, Biontech SE, of Mainz, Germany, and the Israel Ministry of Health said real-world evidence demonstrated lower incidence rates of COVID-19 in individuals fully vaccinated with the Pfizer-Biontech vaccine, BNT-162b2. The latest analysis from the ministry, according to Pfizer, showed that two weeks after the second dose, vaccine effectiveness was at least 97% in preventing symptomatic disease, severe/critical disease and death. The latest data analysis finds unvaccinated individuals were 44 times more likely to develop symptomatic COVID-19 and 29 times more likely to die from COVID-19, Pfizer added.
Phasebio Pharmaceuticals Inc., of Malvern, Pa., and CDMO Biovectra Inc., of San Diego, entered a commercial scale supply agreement to produce bentracimab, Phasebio’s lead candidate, which is in a phase III trial. Bentracimab is designed to reverse antiplatelet activity of ticagrelor in major bleeding and urgent surgeries. Biovectra will help manufacture the active pharmaceutical ingredient of bentracimab for use in Phasebio’s ongoing global clinical trials and for global commercial use upon regulatory approval.
Sosei Group Corp., of Tokyo, said that Formosa Pharmaceuticals Inc., of Cambridge, U.K., dosed the first patient in a 370-patient randomized phase III trial of APP-13007 in the U.S., triggering a $2.5 million payment to Sosei Heptares from Formosa.
New preclinical data from Vistagen Therapeutics Inc., of South San Francisco, demonstrated the potential mechanism of action of PH-10, its phase II investigational pherine nasal spray with potential as a rapid-onset, standalone treatment for major depressive disorder (MDD), does not involve direct activation of GABA-A receptors, in distinct contrast to the mechanism of action of benzodiazepines, which act as direct positive modulators of GABA-A receptors. Instead, according to Vistagen, PH-10 is designed to engage receptors in nasal chemosensory neurons, which in turn regulate neurons in the limbic amygdala that release excitatory neurotransmitters producing rapid-onset antidepressant effects.