Abbvie Inc., of North Chicago, and Scripps Research said they will collaborate to develop therapies for a range of diseases, including indications in oncology, immunology, neurology and fibrosis. Under terms of the license agreement, Scripps Research will conduct preclinical R&D and, in some cases, phase I trials, with Abbvie holding an exclusive option to conduct additional development and commercialization. Abbvie agreed to make an undisclosed up-front payment and a near-term milestone payment upon achievement of predetermined criteria. Should Abbvie exercise its option to a given program, Scripps Research will be eligible for additional payments, including option exercise fees, success-based development and commercial milestone payments and tiered royalties. In addition to programs initially named in the collaboration for advancement from preclinical to IND development, Scripps Research will present Abbvie with a certain number of preclinical programs of mutual interest each year for potential inclusion in the collaboration, and the partners will work in parallel to advance CD3 bispecifics against oncology targets nominated by Abbvie.
Advaite Inc., of Chicago, said it inked an exclusive license option agreement with George Washington University covering the intellectual property of an AMES-negative HDAC6 inhibitor. The agreement gives Advaite the option to exclusively license intellectual property covering methods of use and pharmaceutical compositions. Financial terms were not disclosed.
Amneal Pharmaceuticals Inc., of Bridgewater, N.J., said it inked a definitive agreement to acquire a 65.1% majority interest in Avkare Inc., of Fountain Run, Ky., and its affiliate doing business as R&S Northeast for an implied enterprise value of $340 million. Amneal will acquire its interest through an unrestricted subsidiary that will finance the purchase with a new $180 million senior secured term loan facility, approximately $75 million of balance sheet cash and a seller note of approximately $44 million, with the balance contributed through the selling shareholders’ rollover interest in Avkare, which will operate as an independent subsidiary of Amneal. Avkare is a private label provider of generic pharmaceuticals to U.S. federal agencies, primarily the Department of Defense and the Department of Veterans Affairs. The transaction is expected to close early next year.
Aptinyx Inc., of Evanston, Ill., said preclinical data on its NMDA receptor modulator, NYX-783, showed robust effects on conditioned fear in post-traumatic stress disorder models and on alcohol consumption in a stress-induced alcohol seeking model. The studies were conducted in collaboration with the Medical University of South Carolina and Northwestern University. Data also showed that the mechanism of NYX-783 appears to have differentiated effects on learning and memory processes and reduced stress-induced alcohol-seeking behavior in rats, while reducing relapse-like behavior in the model. The findings were presented at the annual meeting of the American College of Neuropsychopharmacology in Orlando, Fla.
Avitide Inc., of Lebanon, N.H., said it entered an exclusive license agreement to support the development of one of the therapeutic programs of Gemini Therapeutics Inc., of Cambridge, Mass., which receives exclusive rights to specific Avitide affinity resins for use in preclinical, clinical and commercial manufacturing. In turn, Avitide retains exclusivity for the manufacture and supply of the affinity resins.
Bioncotech Therapeutics SL, of Madrid, Spain, said it inked a phase II collaboration with a subsidiary of Merck & Co. Inc., of Kenilworth, N.J., to evaluate the combination of its lead candidate, BO-112, a TLR3 modulator, IFIH1 gene modulator and retinoic acid-inducible gene 1 modulator, with Merck’s anti-PD-1 Keytruda (pembrolizumab) in individuals with certain advanced solid tumors with liver metastases. The trial will assess whether stimulation of the innate immune system by direct intratumoral administration of BO-112, combined with systemic administration of pembrolizumab, shows safety and efficacy in patients with tumors that are poorly or only moderately responsive to monotherapy with an anti-PD-1 agent. Financial terms were not disclosed.
Bloom Science Inc., of San Diego, said it formed a research agreement with Cedars-Sinai Medical Center for a phase I study investigating the clinical utility of the ketogenic diet as adjunctive treatment in combination with standard-of-care treatment in glioblastoma. Bloom Science will leverage its discovery platform to investigate the underlying contributions of the microbiota and related metabolites in treating the indication.
Charles River Laboratories International Inc., of Wilmington, Mass., said it entered an exclusive discovery and safety services partnership with Cambridge, U.K.-based Bit Bio, that offers reprogramming of human cells for use in research, drug discovery and cell therapies. Through that partnership, Charles River plans to offer clients access to an expanding suite of authentic human cells through their use in target discovery, validation and screening services.
Cresset Discovery Services Ltd., of Cambridge, U.K., said the Narayana Nethralaya Foundation, which conducts translational ophthalmic research, in association with Narayana Nethralaya, a specialty eye care hospital in Bangalore, India, has licensed the repurposed compound RP-0217 for the treatment of ocular diseases. The anti-inflammatory activity of the candidate was discovered by Cresset, based on the work of Rod Flower of the William Harvey Research Institute, and utilizing Cresset’s computational chemistry technologies. Terms were not disclosed.
Deinove SA, of Paris, said it has obtained, jointly with ESPCI Paris, a two-year €300,000 (US$332,860) grant from the French National Research Agency for the co-development of an innovative system for the isolation, culture and screening of bacteria. The project aims to develop an innovative microfluidic sorting system, with drops containing environmental bacteria, in which each drop constitutes a microreactor.
Diverse Biotech Inc., of Doylestown, Pa., said it has synthesized and progressed into preclinical testing its first two new chemical entities (NCEs) developed using its Custom Synthesis Platform – Conjugated Cannabinoids technology platform, which is based on advanced conjugate chemistry and comprises more than 10,000 potential conjugate molecules. Those first two NCEs will target pancreatic cancer and glioblastoma.
Emergex Vaccines Holding Ltd., of Abingdon, U.K., said it completed preclinical testing of its lead vaccine candidate for dengue fever. The vaccine construct, which comprises nature’s gene-chip peptides bound to a quantum cluster gold nanoparticle delivery system, was shown to have an excellent safety profile in a repeat-dose GLP-grade toxicology study using a standard industry model. No adverse reactions were seen at any dose level. That completes the preclinical data package, allowing progress into the clinical phases of development.
Enochian Biosciences Inc., of Los Angeles, said scientific findings reveal an innovative approach to potentially treat and cure hepatitis B. It involves AAV particles packaged with a novel vector construct that expresses a nonfunctional noncoding RNA flanked between sequences specific to the reverse transcriptase domain of HBV pol. The data, generated through a collaboration between Seraph Research Institute (SRI) and Philippe Gallay of the Scripps Institute, were presented at the HEP DART scientific conference in Kauai, Hawaii. In November, the company expanded its infectious disease pipeline through an agreement in principle to acquire an exclusive license for a novel hepatitis B virus treatment from SRI.
Engitix Ltd., of London, which is developing a portfolio of programs in fibrosis and solid tumors using its human extracellular matrix (ECM) platform, and Morphic Therapeutic Inc., of Waltham, Mass., said they entered a research collaboration to identify ECM-related drug targets in fibrostenotic inflammatory bowel disease, an intestinal fibrosis complication that affects approximately 30% of Crohn’s disease patients. Under the terms of the collaboration, Engitix will apply its tissue-specific ECM platform to identify and characterize the expression of drug targets, and cover integrin and non-integrin expression in fibrostenosis.
GVB Biopharma, of Las Vegas, a hemp cannabinoid producer, said its research and development team has identified and isolated a previously unstudied cannabinoid called cannabicitran (CBT). Not much is known about the compound that is found in highest concentrations in the distillates from the type III flowers of the cannabis plant, which have high levels of cannabidiol and low levels of tetrahydrocannabinol. Chemically, CBT is classified as a diether.
Hoth Therapeutics Inc., of New York, said, in collaboration with North Carolina State University, it will be starting a preclinical study for the treatment of asthma and allergic inflammation on Jan. 1. The goal is to determine the best approach for targeting allergic inflammation in the airways with splice-switching oligonucleotides (SSOs) and establish proof of principle by providing preclinical mouse data. The initial set of experiments look to establish the delivery of SSOs targeting the gene encoding the FcεRIβ protein in the lungs of mice by using an ultrasonic nebulizer and assessing its distribution and function in mast cells for a period of one year by using RNA scope technology. A second phase study will determine the efficacy of SSO combinations that target FcεRIβ and other genes that function in the IgE receptor pathway, in airway inflammation using humanized mouse models.
Knopp Biosciences LLC, of Pittsburgh, said it presented data characterizing KB-3061, the lead molecule in the company’s Kv7 ion channel platform, at the American Epilepsy Society’s annual meeting in Baltimore. KB-3061 fully restored the function of Kv7 potassium channels in cells engineered to express gene variants from three “hot spot” domains – the voltage sensor, the pore and the C-terminus – that cause KCNQ2 epileptic encephalopathy, a genetically defined disease associated with seizures beginning in the first days of life and profound neurodevelopmental delay. Nanomolar brain concentrations of KB-3061 conferred significant seizure protection in the maximal electroshock model of epilepsy with minimal impact on neurobehavior.
Leo Pharma A/S, of Ballerup, Denmark, has licensed Certara’s Simcyp population-based simulator and joined its simulator consortium to advance physiologically based pharmacokinetic modeling and simulation, progress new drug and biologics research, create new regulatory frontiers, and foster ongoing modeling and simulation education.
EMD Serono, the biopharmaceutical business of Merck KGaA, of Darmstadt, Germany, said it completed negotiations with the pan-Canadian Pharmaceutical Alliance and signed a letter of intent (LOI) for Mavenclad (cladribine tablets), approved by Health Canada as monotherapy for the treatment of adult patients with relapsing-remitting multiple sclerosis (RRMS) to reduce the frequency of clinical exacerbations and delay the progression of disability. The LOI allows EMD Serono Canada to work with participating jurisdictions to implement public funding of the drug for eligible RRMS patients, which is currently reimbursed by most private drug insurance plans.
Motif Bio plc, of New York, said the company has filed with the SEC to delist the company’s American depository shares and listed warrants from Nasdaq. It expects that the last trading day on Nasdaq will be on or about Dec. 16.
PDL Biopharma Inc., of Incline Village, Nev., completed the strategic review process that it initiated in September. As a result, the company has decided to halt the execution of its growth strategy, cease additional strategic investments and pursue a formal process to unlock value by monetizing the company's assets and returning net proceeds to shareholders. The company will explore a variety of potential transactions, including a sale of the company, divestiture of its assets or businesses, a spin-off transaction, a merger or a combination thereof, PDL said.
Protalix Biotherapeutics Inc., of Carmiel, Israel, said stockholders approved an amendment to the company's certificate of incorporation, as amended, to effect a reverse stock split at a ratio of 1-for-10 and to reduce the total number of authorized shares of the common stock from 350 million shares to 120 million shares. The split will become effective Dec. 19.
Regeneron Pharmaceuticals Inc., of Tarrytown, N.Y., and Paris-based Sanofi SA disclosed their intent to simplify their antibody collaboration for Kevzara (sarilumab) and Praluent (alirocumab) by restructuring into a royalty-based agreement. Under the proposed restructuring, Sanofi is expected to gain sole global rights to Kevzara and sole ex-U.S. rights to Praluent. Regeneron is expected to gain sole U.S. rights to Praluent. Under the proposed terms, each party will be solely responsible for funding development and commercialization expenses in their respective territories. The changes are expected to increase efficiency and streamline operations for the products, the companies said. The arrangement is expected to be finalized in the first quarter of next year.
Solasia Pharma K.K., of Tokyo, signed an exclusive license agreement with Maruho Co. Ltd., of Osaka, Japan, for commercialization of Solasia’s product, SP-04, a therapeutic agent for chemotherapy-induced peripheral neuropathy, currently undergoing phase III trials in Japan. The drug’s active ingredient is calmangafodipir. Under the agreement, Maruho will commercialize the product exclusively in Japan after Solasia completes development. Based on the license agreement, Solasia will supply the product exclusively to Maruho, and Maruho will pay Solasia an up-front payment of ¥1 billion (US$9.1 million) and milestone payments based on progress in development and marketing up to a total of ¥18 billion.
Syndax Pharmaceuticals Inc., of Waltham, Mass., disclosed the publication of a preclinical report demonstrating that selective inhibition of the Menin-MLL interaction provides consistent antiproliferative and antileukemic activity across multiple mixed lineage leukemia rearranged (MLLr) samples. The article, "A Menin-MLL inhibitor induces specific chromatin changes and eradicates disease in models of MLL-rearranged leukemia," was published in the Dec. 9, 2019, issue of Cancer Cell. The company’s SNDX-5613 is a selective, small-molecule inhibitor of the Menin-MLL binding interaction that is being developed for the treatment of MLLr acute leukemias, including acute lymphoblastic leukemia and acute myeloid leukemia.
Tetra Bio-Pharma Inc., of Ottawa, Ontario, said it will be requesting a meeting with the FDA to discuss the drug development program for its orphan drug candidate, HCC-011, inhaled delta-9-tetrahydrocannabinol, in the treatment of hepatocellular carcinoma. The company intends to file an NDA for the drug via the 505(b)(2) pathway. Tetra’s phase II study will target patients with disease progression on sorafenib (Nexavar, Bayer AG), who have measurable disease and Child-Pugh Class A liver impairment.
Vaccinex Inc., of Rochester, N.Y., was granted an award, in the form of an investment of up to approximately $3 million, from the Alzheimer’s Drug Discovery Foundation to evaluate its lead drug candidate, pepinemab (VX-15/2503), in Alzheimer’s disease. This is the second award from a major Alzheimer’s research foundation to be made public recently. Last month, Vaccinex disclosed a $750,000 grant from the Alzheimer’s Association for the same program. A new 60-patient, randomized, placebo-controlled phase I study is expected to enroll the first patient in the second quarter of 2020.