Aclipse Therapeutics Inc., of Radnor, Pa., said the company and its collaborator, The Sheffield Institute for Translational Neuroscience at the University of Sheffield in the U.K., were awarded a drug development research grant of £1.6 million (US$2.2 million) from the Medical Research Council, one of the larger funders of medical research worldwide, to support the translational development of M-102, Aclipse’s drug candidate for the treatment of amyotrophic lateral sclerosis (ALS). M-102 is a potentially disease-modifying drug candidate that has shown promise to impede ALS disease progression in a wide array of preclinical models, the company said.
Adagio Therapeutics Inc., of Waltham, Mass., published in vitro and in vivo data in Science on its lead antibody candidate, ADG-2, which demonstrated similar or higher potency against SARS-CoV-2 compared to other monoclonal antibodies in clinical development and strong binding to all known SARS-CoV-2 variants. ADG-2 also showed broad and potent neutralization against a range of sarbecoviruses that pose a threat to humans and protective efficacy in murine models of SARS and COVID-19. The data show that ADG-2 effectively binds to and has the potential to protect against common circulating SARS-CoV-2 variants as well as future SARS-related viruses with pandemic potential.
Adamis Pharmaceuticals Corp., of San Diego, signed a nonbinding letter of intent with a potential buyer for sale of substantially all of the assets of its U.S. Compounding Inc. subsidiary. Under the terms, the buyer would agree to pay a total gross consideration that could range from about $10 million to $20 million, before transaction fees and expenses and other potential post-closing adjustments.
Adial Pharmaceuticals Inc., of Charlottesville, Va., closed the acquisition of Purnovate LLC, also of Charlottesville, Va. Purnovate has extensively studied adenosine analogues as potential therapies for non-opioid pain reduction and the treatment of cocaine addiction. Purnovate has also explored the application of adenosine analogues and other chemical compounds referred to as purines, which are found throughout the body, including in DNA and RNA, to address other disease states, the companies said.
Agenus Inc., of Lexington, Mass., signed a clinical collaboration with Nelum Corp., of New York, to evaluate the safety and efficacy of zalifrelimab, Agenus’ anti-CTLA4 antibody, in combination with NLM-001, Nelum’s small-molecule hedgehog inhibitor, and chemotherapy for first-line advanced pancreatic cancer. Nelum’s NLM-001 is a best-in-class small-molecule hedgehog inhibitor that targets cancer-associated fibroblasts. It synergizes with checkpoint inhibitors by promoting immune cell infiltration into the tumor microenvironment and increases tumor penetration of chemotherapy. NLM-001 is active and well-tolerated in patients with solid tumors, as demonstrated in a phase I study, the company said.
Allarity Therapeutics A/S, of Horsholm, Denmark, disclosed plans to further test the antiviral activity of stenoparib, its PARP inhibitor, against SARS-CoV-2 lineage B 1.1.7, also known as Coronavirus Variant B117 (the “British variant”), at the Pathogen and Microbiome Institute at Northern Arizona University. The variant has been found to have spread rapidly within the U.K., and has been identified in the U.S. in several states.
Amarin Corp. plc, of Dublin, disclosed an expansion of the scope of its Vascepa (icosapent ethyl) cardiovascular risk reduction patent infringement lawsuit against Hikma Pharmaceuticals plc, of London, to include a health care insurance provider in the U.S., Health Net LLC, of Woodland Hills, Calif. The lawsuit was filed in the U.S. District Court in Delaware.
New data from Aslan Pharmaceuticals Ltd., of Singapore, showed that out of a panel of six dihydroorotate dehydrogenase (DHODH) inhibitors tested, ASLAN-003 had the lowest potential for hepatotoxicity. The data also showed, the company added, that ASLAN-003’s activity is mechanistically distinct from the hepatotoxicity associated with leflunomide and teriflunomide. The data suggest that toxicities observed in the study may not be related to the potency of the compound against DHODH, the company said.
Atai Life Sciences Inc., of New York, signed a collaboration with Massachusetts General Hospital and its new initiative, the Center for Neuroscience of Psychedelics, to advance novel mental health treatments through the study of mechanisms underlying the therapeutic effects of psychedelic agents. The hospital recently established its center to better understand how psychedelics enhance the brain's capacity for change to optimize current treatments and create new treatments for mental illness.
Bicycle Therapeutics Ltd. plc, of Cambridge, U.K., and Boston, posted new preclinical data showing that its bicyclic peptide, the Bicycle, technology produced systemic cell agonists and tumor-targeted immune cell agonists that can bind to key co-stimulatory receptors and couple with tumor antigen binding Bicycles to produced tumor localized receptor agonism. The company said the new method of cancer immunotherapy using small-molecule agonism of TNF superfamily receptors could lead to a clinical trial of its lead program, BT-7480, in 2021.
The Biomed X Institute, of Heidelberg, Germany, said its new collaboration with Janssen Pharmaceutical Cos., part of New Brunswick, N.J.-based Johnson & Johnson, is designed to discover novel transport mechanisms in the human intestinal tract and could be used for oral delivery of diverse therapeutic modalities. This is the third research program for drug delivery the companies have undertaken. Biomed X is an independent research institute at the University of Heidelberg.
Bridgebio Pharma Inc., of Palo Alto, Calif., said it completed acquisition of all outstanding shares of Eidos Therapeutics Inc., of San Francisco. Eidos is developing acoramidis, a potential therapy for patients with transthyretin amyloidosis, and encaleret, a CaSR inhibitor for treating autosomal dominant hypocalcemia type 1.
Curadigm SAS, of Paris, said its Nanoprimer technology has been selected for Paris-based Sanofi SA’s Itech Awards Program and will receive €100,000 (US$121,636) in funding. The one-year agreement is part of Sanofi’s program to improve gene therapy candidate efficacy. Curadigm is a subsidiary of Nanobiotix SA, also of Paris.
Entasis Therapeutics Inc., of Waltham, Mass., said an expanded access program (EAP) for sulbactam-durlobactam (SUL-DUR) for U.S. patients with Acinetobacter baumannii infections, including carbapenem and multidrug-resistant strains, is now available. SUL-DUR is an I.V.-delivered investigational drug that is a combination of sulbactam, an I.V. beta-lactam antibiotic, and durlobactam, a novel broad-spectrum I.V. beta-lactamase inhibitor.
Enzychem Lifesciences Corp., of Englewood Cliffs, N.J., said it was awarded a $150,000 grant from NASA’s Human Research Program to research its lead compound, EC-18, and how it impacts astronaut health and performance during future long-duration missions beyond low-Earth orbit. EC-18 will be investigated whether it can provide protection against both radiation and pathogen-induced tissue damage and inflammation. The study’s primary objective study is to evaluate the cumulative effect of low-dose radiation and microgravity on the food borne pathogen Salmonella Typhimurium on astronaut health using a 3D biomimetic human intestine model. Enzychem's lead compound, EC-18, is an immunomodulator that, the company said, is known to facilitate the host's intrinsic defense mechanism to holistically remove danger signals and pathogens and dampen the pro-inflammatory signaling cascades for early return to homeostasis.
Galmed Pharmaceuticals Ltd., of Tel Aviv, Israel, said data supporting the antifibrotic mechanism of its stearoyl CoA desaturase-1 (SCD1) inhibitor, Aramchol (arachidyl amido cholanoic acid), are set to be published this week in JHEP Reports. Findings from an academic research collaboration showed that Aramchol down-regulated SCD1 in hepatic stellate cells to attenuate cellular fibrogenesis. Aramchol, which has advanced into the phase III Armor study in people with nonalcoholic steatohepatitis and fibrosis, also is the subject of a partnership with fellow Israeli biotech company Mybiotics Pharma Ltd.
Humanetics Corp., of Minneapolis, said it has received funding from the U.S. Department of Defense to conduct a series of studies with its new drug candidate, BIO-300, which is believed to prevent and mitigate acute and chronic inflammatory diseases and radiation toxicities. The studies will focus on the ability of BIO-300 to mitigate progressive pulmonary inflammation caused by COVID-19, which leads to acute respiratory distress. If adopted, the drug may prevent hospitalizations and mitigate progressive and long-term pulmonary effects that are becoming increasingly evident in COVID-19 patients, the company said.
Moderna Inc., of Cambridge, Mass., reported that 30.4 million doses of its COVID-19 vaccine, mRNA-1273, were supplied to the U.S. government and that the company is on track to deliver its commitment of approximately 100 million doses to the U.S. government by the end of the first quarter of 2021, with 200 million doses available by the end of the second quarter. The COVID-19 vaccine product delivered in the U.S. comes from Moderna’s dedicated supply chain in the U.S. Moderna also said it continues to add resources and staff to supply potentially 1 billion doses in 2021, up from a projected increase to 600 million doses in 2021 reported on Jan. 4.
Morphosys AG, of Planegg, Germany, said it is set to receive a $1.5 million milestone payment under its license agreement with I-Mab Biopharma Co. Ltd., of Shanghai, in conjunction with initial dosing in a U.S. phase I study of TJ-210/MOR-210, a monoclonal antibody targeting complement factor C5a receptor 1, in people with relapsed/refractory advanced solid tumors.
Pharmacyte Biotech Inc., of Laguna Hills, Calif., said it initiated studies requested by the FDA to determine the sequence of DNA encoding of the enzyme in the cells of its Cypcaps candidate to treat pancreatic cancer and the stability of the sequences. The cell clone used to produce Cypcaps was augmented to produce cytochrome P450, which converts ifosfamide from an inactive to cancer-killing form as the mechanism for the CYP2B1 gene modulator.
Silo Pharma Inc., of Englewood Cliffs, N.J., said it exercised an option for an exclusive license to patents owned by the University of Maryland Baltimore for the treatment of neuroinflammatory disease. Exercising the agreement allows Silo to negotiate an exclusive patent license based on pre-negotiated business terms, which were not disclosed.
Synaptogenix Inc. (formerly Neurotrope Bioscience Inc.), of New York, said a preclinical report published by Scientific Reports showed the potential of bryostatin-1 to regenerate synapses in degenerative brain disorders that produce autistic spectrum behaviors. The study, conducted in collaboration with the Fragile X Foundation and scientists in the U.K., showed that bryostatin-1, a protein kinase C epsilon stimulator, rescued autistic and cognitive phenotypes in fragile X mice.
Therapeutic Solutions International Inc., of Oceanside, Calif., said preclinical data showed enhancement of natural killer and T-cell activity by Stemvacs following treatment with homotaurine, a blood-brain barrier-permeable GABA A-R-specific agonist. The data suggested that neurologically acting molecules, such as homotaurine, an amyloid protein deposition inhibitor that functions as an anti-inflammatory molecule, may be an unexplored area for discovering immune modulators. Therapeutic Solutions is advancing Stemvacs, an umbilical cord-generated dendritic cell immunotherapy candidate, to treat solid tumors.
Vaxart Inc., of South San Francisco, said histology data from its SARS-CoV-2 hamster challenge study showed that animals that received two doses of the oral tablet vaccine had reduced lung inflammation in comparison to unvaccinated hamsters. The company also reported data, published in Nature Medicine, from a collaboration with Stanford University scientists on its COVID-19 vaccine candidates. Stanford’s in vitro human organoid system generated immune responses to three of the company’s candidates, enabling Vaxart to narrow its selection of a vaccine construct. The candidate selected for trials was designed to express not only the SARS-CoV-2 S protein but also the nucleocapsid, or N, protein, which was included to generate antiviral T-cell responses against a more conserved protein than the S protein, providing for potentially better cross-protection.