AB2 Bio Ltd., of Lausanne, Switzerland, and Wuxi Biologics, of Shanghai, said they entered a collaboration to set up and accelerate commercial-scale manufacturing of Tadekinig alfa, AB2 Bio’s recombinant IL-18 binding protein. Per the agreement, AB2 Bio is in the process of transferring manufacturing of Tadekinig alfa to Wuxi Biologics, where commercial scale manufacturing will be conducted. AB2 Bio will prepare the submission of the license application to the FDA and initiate commercialization activities.
Abcellera Biologics Inc., of Vancouver, British Columbia, and Kodiak Sciences Inc., of Palo Alto, Calif., said they are partnering to generate therapeutic antibody candidates in ophthalmology. Following a previously successful collaboration, Abcellera will use its AI-powered antibody discovery technology to discover and identify a large panel of antibodies against new targets designated by Kodiak. Abcellera will receive research and development payments and is eligible for downstream milestone payments, as well as royalties on net sales. Other financial terms were not disclosed.
Acura Pharmaceuticals Inc., of Palatine, Ill., said it amended its license, development and commercialization agreement regarding its Limitx LTX-03 candidate, with Abuse Deterrent Pharmaceuticals LLC, of Louisville, Ky., to extend the FDA acceptance date to July 31, 2021, expand the product licenses for Limitx patents to LTX-02 (oxycodone/acetaminophen) and LTX-09 (alprazolam), and revise the license payment schedule. The changes were due to delays in the manufacturing scale-up for LTX-03, including the purchase and installation of auxiliary manufacturing equipment and COVID-19 risk mitigation strategies.
Anabios Corp., of San Diego, in collaboration with Orion Corp., of Espoo, Finland, and researchers at the Faculty of Medicine in Helsinki, Finland, and at University of Szeged, Hungary, focused on a new compound targeted against a cardiac protein implicated in heart failure, ischemia and arrhythmia. Work published in the British Journal of Pharmacology outlines the discovery and characterization of ORM-11372, a positively inotropic sodium-calcium exchanger/inhibitor. In the study, Anabios provided ex vivo data from human heart tissue to assess the pro-arrhythmic risk.
Arcus Biosciences Inc., of Hayward, Calif., said it is collaborating with Astrazeneca plc, of Cambridge, U.K., to evaluate domvanalimab (AB-154), Arcus’s investigational anti-TIGIT antibody, in combination with Imfinzi (durvalumab) in a registrational phase III trial in patients with unresectable stage III non-small-cell lung cancer. Under the terms, each company will retain existing rights to their respective molecules and any future commercial economics. Astrazeneca will conduct the trial, and each company will supply its respective cancer agent. The parties will share costs for the trial.
Atyr Pharma Inc., of San Diego, said it entered a research collaboration with the Medical University of South Carolina that aims to accelerate the development of therapeutic antibodies that selectively target specific NRP2 isoforms and validate their potential use in the treatment of lung cancer.
Bone Therapeutics SA, of Gosselies, Belgium, and Catalent Pharma Solutions Inc. said they signed share purchase and supply agreements designed to streamline and economize the manufacturing operations of Allob, Bone Therapeutics’ allogeneic cell therapy product, and that will enable Bone Therapeutics to focus its strategy on the development of products from its differentiated mesenchymal stromal cell platform of cell and gene therapeutic targets for orthopedics and other indications. Under the terms, Catalent will acquire Bone Therapeutics’ cell therapy manufacturing subsidiary, Skeletal Cell Therapy Support SA, for gross proceeds of €12 million (US$14 million). The transaction is expected to close in November.
Cstone Pharmaceuticals Co. Ltd., of Suzhou, China, disclosed a licensing agreement with Legochem Biosciences Inc., of Daejeon, South Korea, for the development and commercialization of LCB-71, described as a potential first-in-class/best-in-class antibody drug conjugate. Cstone obtains the exclusive global right to lead development and commercialization of LCB-71 outside the Republic of Korea. Legochem will bank an upfront payment of $10 million and up to $353.5 million in cumulative milestone payments, plus tiered royalties. The product targets receptor tyrosine kinase-like orphan receptor 1, a target in multiple solid and hematological malignancies
Dr. Reddy’s Laboratories Ltd., of Hyderabad, India, disclosed a partnership with Biotechnology Industry Research Assistance Council, Department of Biotechnology, Government of India, for advisory support on clinical trials of Sputnik V vaccine for COVID-19 in India. The partnership will allow Dr. Reddy’s to identify and use some of the council’s clinical trial centers for the vaccine. The company will have access to Good Clinical Laboratory Practice labs to conduct immunogenicity assay testing of the vaccine, Earlier this month, Dr. Reddy’s and Russia Direct Investment Fund received approval from regulatory authorities in India to conduct an adaptive phase II/III human clinical trial for Sputnik V vaccine there.
Emulate Inc., of Boston, said it entered a Cooperative Research and Development Agreement (CRADA) with the FDA to enable multiple studies across FDA offices in priority research areas, including programs to evaluate COVID-19 vaccines and understand human immune response against SARS-CoV-2, the virus that causes COVID-19. Under the CRADA, the FDA will use a range of Organ-Chips from Emulate to study the safety, efficacy and mechanisms of drugs regulated by the FDA. The new agreement follows the successful completion of the first Emulate CRADA with the FDA initiated in 2017 that focused on toxicity studies using the Liver-Chip.
Engene Inc., of Boston, said it received an award from the Cystic Fibrosis Foundation for the discovery of genetic medicines to treat patients with cystic fibrosis (CF), as part of the foundation’s $500 million Path to a Cure initiative to accelerate the discovery and development of treatments that address the underlying cause of the disease. Engene is developing an inhalable gene therapy for CF, coupling a nonviral DNA payload to the firm’s biocompatible DDX carrier in an effort to create genetic medicines that allow repeatable and titratable dosing to achieve meaningful efficacy.
Field Trip Health Ltd., of Toronto, provided an update on its in vivo and in vitro studies on FT-104, its lead drug candidate. Earlier the company confirmed the successful GLP synthesis of FT-104 and that FT-104 is a serotonin 5HT2A receptor agonist, calling the drug a potent psychedelic molecule with rapid onset and a short duration, with potential to treat mood disorders. FT-104's binding constant (Ki) for the 5HT2A receptor is 120 nM, which indicates a potency similar to psilocybin, and a 2 mg/kg subcutaneous dose to rats resulted in peak concentrations of the active agonist of 150+/-51 ng/ml at 60 min (Tmax) and bioavailability of 89%.
Immatics NV, of Tuebingen, Germany, reported preclinical data on IMA-401, its lead T-cell receptor bispecifics program directed against MAGEA4/8, demonstrating specific targeting and T cell recruitment to target-positive tumors, leading to complete remissions of human-derived tumors in xenograft mouse models. Data showed IMA-401 TCER can kill tumor cells in vitro with MAGEA4/8 peptide levels similar to levels found in cancer patients, and the drug showed a minimum of 1,000-fold therapeutic window between normal tissue cell reactivity and tumor cell reactivity in vitro. The molecule also showed favorable pharmacokinetics with terminal half-life of 10 to 11 days in mice, and positive purity and stability characteristics with high production yields. Immatics anticipates an IND submission by the end of 2021.
Immutep Ltd., of Sydney, said it entered a license and collaboration agreement with Labcorp to support development of immuno-oncology products or services. Under the terms, Immutep is eligible to receive potential undisclosed milestone and service-related payments. The collaboration with Labcorp is unrelated to any of Immutep’s own in-house pharmaceutical development programs in cancer or autoimmune disease.
Inivata Inc., of Research Triangle Park, N.C., and Cambridge, U.K., said it is collaborating with Maverick Therapeutics Inc., of Brisbane, Calif., to use the former’s Radar assay for the detection and monitoring of residual disease and recurrence. Radar will be used to monitor circulating tumor DNA in patients enrolled in Maverick’s phase I/II study testing MVC-101, a conditionally active, T cell-engaging COBRA molecule designed to target EGFR. The study is set to start in the first quarter of 2021.
Intec Pharma Ltd., of Jerusalem, said it has executed a 1-for-20 reverse share split of its outstanding ordinary shares. The split became effective after trading closed Oct. 29.
Jaguar Health Inc., of San Francisco, said Nasdaq granted the company an extension through Dec. 23 to comply with the minimum bid price requirement. To comply, Jaguar must have a closing bid price of at least $1 per share for a minimum of 10 consecutive business days by Dec. 23. Jaguar is developing plant-based, non-opioid treatments for people and animals with chronic diarrhea.
Mebias Discovery Inc., of Philadelphia, said it secured grant funding from the National Institute on Drug Abuse. The $7.1 million award will be used to progress the company’s lead candidate, MEB‑1170, an analgesic drug candidate for the prevention and treatment of opioid use disorder, through IND filing and phase I trials. The grant is part of the Helping to End Addiction Long-term Initiative.
Moleculin Biotech Inc., of Houston, said it entered an agreement with the University of Campinas in São Paulo, Brazil to further enable collaboration into its research on the anti-viral capabilities of its drug candidate WP-1122, specifically for the coronavirus. Recently the University of Campinas published independent research in Cell Metabolism demonstrating that SARS-CoV-2 infection is supported by elevated glucose levels and that inhibition of glycolysis with 2-deoxy-D-glucose effectively eliminated viral load in vitro. WP-1122 is a pro-drug of 2-DG.
Novocure Inc., of St. Helier, N.J., signed an alliance with the NYU Grossman School of Medicine’s radiation oncology department that provides a framework for preclinical and clinical development projects studying Novocure’s Tumor Treating Fields (TTFs), electric fields that disrupt cancer cell division. Translational research will seek to further understand the interaction between TTFs and radiation therapy, to study them in combination with various pharmacological agents, and to identify new indications for use.
Sorrento Therapeutics Inc., of San Diego, reported preclinical data in Biorxiv showing that hamsters infected with SARS-CoV-2recovered from the infection with noticeable differences in weight loss between the control IgG and those given its investigational neutralizing antibody, COVI-AMG, that reached a maximum at day five after infection. Intranasally-COVI-DROPS-treated animals showed evidence, as early as day two into the experiment, of prevention of disease progression with limited weight loss in the very early stages of infection and reduced duration of disease symptoms as compared to COVI-AMG IV-treated animals.
Sanofi SA, of Paris, and Merck & Co. Inc., of Kenilworth, N.J., entered into an agreement to test Sanofi's non-alpha IL-2, THOR-707, with Merck's anti-PD-1-antibody, Keytruda (pembrolizumab), in various types of cancer. Sanofi will run the trials, and Merck will provide Keytruda for the studies.
Syneos Health Inc., of Morrisville, N.C., agreed to acquire Synteract Inc., a contract research organization based in Carlsbad, Calif. Financial terms of the acquisition weren't disclosed. The transaction is expected to close by the end of 2020.
Synedgen Inc., of Claremont, Calif., said it received supplemental funding from the National Eye Institute (NEI) to identify a lead molecule from the company’s ocular mustard gas injury program to move into animal studies. Synedgen has developed a class of glycopolymers with the ability to suppress inflammation, reduce infection and improve healing at mucosal surfaces. To date, the firm has used NEI funding to synthesize and test a suite of molecules, with the potential to treat the acute and chronic effects of ocular chemical toxicity. The additional funding provides resources to optimize down-selection to a lead molecule to advance into animal studies.
Takeda Pharmaceutical Co. Ltd., of Osaka, Japan, Moderna Inc., of Cambridge, Mass., and Japan’s Ministry of Health Labour and Welfare established an agreement in which Takeda will import and distribute 50 million doses of Moderna's COVID-19 vaccine, mRNA-1273, starting in the first half of 2021, pending the vaccine being licensed. Takeda will be responsible for securing the necessary regulatory approvals. Financial terms of the deal weren't disclosed.