Aicuris Anti-infective Cures GmbH, of Wuppertal, Germany, is establishing an early access program for pritelivir, which is currently being tested in a phase II study for the treatment of acyclovir-resistant mucocutaneous HSV infections in immunocompromised patients. The program will be run through Amsterdam-based Mytomorrows.
Anixa Biosciences Inc., of San Jose, Calif., said its collaborators at the Moffitt Cancer Center completed and validated the reformulation of the viral vector to increase expression of follicle stimulating hormone on its autologous CAR T cells. Manufacturing is expected to take three months, putting the company on track to file an IND in 2020.
Cytodyn Inc., of Vancouver, Wash., signed a letter of intent with Long Jian International Group, of Hong Kong, to develop and license leronlimab in China. The companies plan to explore opportunities to test the monoclonal antibody targeting the CCR5 receptor as a treatment for the COVID-19 coronavirus and cancer.
Dr. Reddy’s Laboratories Ltd., of Hyderabad, India, is acquiring divisions selling branded generics in India, Nepal, Sri Lanka, Bhutan and Maldives from Wockhardt Ltd., of Mumbai, India, for Rs1,850 crore (US$259 million). Through the deal, which is expected to close during the first quarter of the fiscal 2020-2021 year, Dr. Reddy's will get 62 brands, as well as a manufacturing plant in Baddi, India.
Eusa Pharma LLC, of Burlington, Mass., noted that the National Comprehensive Cancer Network updated its recommendations for the treatment of B-cell lymphomas to include Sylvant (siltuximab) as a preferred primary treatment for patients with idiopathic multicentric Castleman disease with plasmacytic or mixed pathology.
Johnson & Johnson, of New Brunswick, N.J., is collaborating with the Biomedical Advanced Research and Development Authority (BARDA) to develop a vaccine against the COVID-19 coronavirus. BARDA will provide funding of a vaccine candidate into phase I studies and have the option for additional funding. J&J's Janssen Pharmaceutical Co. unit will upscale production and manufacturing capacities to meet public health needs.
Ligand Pharmaceuticals Inc., of San Diego, will acquire assets from Icagen Inc., of Durham, N.C., for $15 million up front and the potential for $25 million in milestone payments based on reaching certain revenue targets. The assets at Icagen's North Carolina operations include partnered programs, ion channel screening and assay platforms, x-ray fluorescence capabilities, custom screening technologies and six unpartnered preclinical molecules targeting diabetes, Parkinson’s disease, pain and other disorders. The partnered programs include a deal with Basel, Switzerland-based Roche Holding AG focused on neurological diseases and one with the Cystic Fibrosis Foundation focused on cystic fibrosis. The deal is expected to add $7 million of revenue to Ligand in 2020 and increase adjusted earnings by 5 cents per share.
Lipocine Inc., of Salt Lake City, has voluntarily dismissed its claims of patent infringement on two of its patents by Clarus Therapeutics Inc., of Northbrook, Ill., for its hypogonadism treatment, Jatenzo (testosterone undecanoate). Lipocine will continue to seek enforcement of four other patents through its lawsuit against Clarus.
Mereo Biopharma Group plc, of Redwood City, Calif., and London, is distributing about 1.2 cents cash per contingent value right, roughly $463,748, tied to the $4 million up-front milestone payment from its global license agreement with Waltham, Mass.-based Oncologie Inc. to develop and commercialize navicixizumab. The distribution will be made by March 17. Navicixizumab is designed to induce antitumor responses while mitigating certain angiogenic-related toxicities by targeting both DLL4 and VEGF. The candidate is currently in a phase Ib study in combination with paclitaxel in patients with advanced heavily pretreated ovarian cancer. In October, it received fast track designation from the FDA, and regulators also agreed in principle to the outline of a phase II trial that could speed up the approval in that indication.
Norgine BV, of Amsterdam, entered three global commercialization deals for Plenvu, its bowel-cleaning powder for use by adults before a medical procedure. The deals are with Faes Farma SA for Chile, Colombia, Costa Rica, the Dominican Republic, Ecuador, El Salvador, Guatemala, Honduras, Mexico, Nicaragua, Panama and Peru; Pharmacare Ltd. for the Republic of Southern Africa, Lesotho, Eswatini, Botswana and Namibia; and Swixx Biopharma for central and eastern Europe including Bosnia and Herzegovina, Bulgaria, Croatia, Czech Republic, Hungary, Kosovo, Montenegro, North Macedonia, Poland, Romania, Serbia, Slovakia and Slovenia. No financial details were released.
Oblato Biotech Co., of Oklahoma City, entered an agreement with Auditus LLC for exclusive rights to advance NHPN-1010 into a phase II study for treating and preventing hearing loss. NHPN-1010 is a combination of HPN-07 (2,4-disulfonyl α-phenyl tertiary butyl nitrone) and N-acetylcysteine, which is approved for intravenous use in liver toxicity. No financial details were released.
Fresh data from two preclinical tauopathy models for the lead compound from Oligomerix Inc., of New York, show the small molecule inhibits tau self-association. The compound reduced soluble tau self-association levels and caused a dose-dependent reduction of insoluble tau aggregates and phosphorylated insoluble tau aggregates in the brains of htau mice, which represents tauopathy in Alzheimer’s disease. The drug also showed dose-dependent reduction of self-associated tau, insoluble tau aggregates and phosphorylated tau in JNPL3 mice, representing an inherited form of tauopathy. Oligomerix is developing small molecules targeting tau for Alzheimer’s and related neurodegenerative disorders.
OSE Immunotherapeutics SA, of Nantes, France, disclosed a collaboration agreement with Mabsilico, a Tours, France-based technology startup, to use artificial intelligence-based solutions for therapeutic antibody drug development. Mabsilico solutions have already been tested and validated by OSE and will be used for six antibody programs, including novel bispecific antibodies. Financial terms were not disclosed.
Proof-of-concept results show Lyon, France-based Poxel SA’s PXL-770 for treating nonalcoholic steatohepatitis (NASH) improved inflammation score assessed by histology. A decrease in multiple subtypes of inflammatory cells in the liver, including macrophages and B-lymphocytes, in addition to suppressing elevated chemokine levels, correlated with the decrease in liver monocyte-derived macrophages. PXL-770 is being assessed in a pharmacokinetic and pharmacodynamic trial and a phase IIa efficacy and safety study for NASH treatment. PXL-770 is a direction adenosine monophosphate-activated protein kinase.
Revive Therapeutics Ltd., of Toronto, signed a letter of intent with Psilocin Pharma Corp., an arm’s-length party incorporated pursuant to the laws of the Province of Ontario. Pursuant to the terms of the letter, Revive will acquire all of the issued and outstanding securities of Psilocin for $2.75 million. The price will be satisfied through the issuance of an aggregate of 55 million common shares in the capital of Revive at a deemed price of 5 cents per share. Upon the execution of the letter, Revive agreed to deposit 10 million common shares in the capital of Revive, for an aggregate consideration of $500,000, into escrow as a deposit of the price.
Synspira Therapeutics Inc., of Framingham, Mass., said it signed an agreement with the Cystic Fibrosis Foundation to support the development of SNSP-003, its oral, non-porcine enzyme replacement therapy designed to treat malabsorption syndromes, a group of life-threatening disorders that result from defects in the digestion and absorption of macronutrients. Synspira describes SNSP-003 as a rationally designed treatment including a precise combination of three purified enzymes (lipase, protease and amylase), with the potential to improve clinical outcomes and reduce treatment burden by improving dosing convenience.
Vir Biotechnology Inc., of San Francisco, has identified two monoclonal antibodies that bind to SARS-CoV-2 (previously known as 2019-nCoV), which were originally found because they bind and neutralize the original SARS-CoV. The antibodies target the SARS-CoV-2 spike protein in the region that the virus uses to enter cells through the cellular receptor ACE2. Infection with SARS-CoV-2 causes the newly named disease, COVID-19, or the coronavirus.