Adamas Pharmaceuticals Inc., of Emeryville, Calif., said it signed a memorandum of understanding to settle the class-action lawsuit Plymouth v. Adamas Pharmaceuticals, Inc., et al pending in the California Superior Court for the County of Alameda. The settlement calls for paying $7.5 million to eligible settlement class members to resolve claims asserted against Adams, its officers, directors and other defendants. The settlement will be paid by Adamas’ director and officer liability insurance. Adamas said it agreed to the settlement to resolve the disputes, avoid the costs and risks of further litigation, and avoid further distractions to management.
Addex Therapeutics Ltd., of Geneva, said the research term of an agreement signed with Indivior plc, of Slough, U.K., in January 2018 has been extended to June 30, 2021. The collaboration covers discovery of novel oral gamma-aminobutyric acid receptor subtype B positive allosteric modulator compounds as potential therapies for multiple disease areas. As part of the amended agreement, Indivior said it will pay Addex $2.8 million in research funding and expand the therapeutic areas where Addex has exclusivity to develop retained compounds.
Blue Water Vaccines Inc., of Cincinnati, said it identified a new influenza strain in pigs with the capacity to infect humans and is developing a vaccine to protect against H1, H3 and flu B. The company said it completed initial design and in vivo analysis of the H1 vaccine candidate design. The H3 and flu B constructs are entering the final in vivo stage of testing prior to moving the universal program into manufacturing, the company added.
Calithera Biosciences Inc., of South San Francisco, said it was awarded up to $2.4 million from the Cystic Fibrosis Foundation to support clinical development of CB-280, Calithera’s arginase inhibitor, which promotes higher tissue levels of nitric oxide to reduce the risk of infections in people with cystic fibrosis (CF). Calithera’s ongoing randomized, double-blind, placebo-controlled, multiple ascending dose-escalation study is exploring CB-280 vs. placebo in adults with CF and chronic infection with Pseudomonas aeruginosa who are stable on cystic fibrosis medications, including cystic fibrosis transmembrane conductance regulator modulators. Calithera expects interim data in 2021.
CNS Pharmaceuticals Inc., of Houston, said it completed manufacturing of berubicin for clinical study and plans to file an IND this quarter. Berubicin, an anthracycline designed to interfere with topoisomerase II, is in development for glioblastoma multiforme.
Daewoong Pharmaceutical Co. Ltd., of Seoul, South Korea, said it is partnering with Tufts Medical Center to run a study testing DWRX-2003, an intramuscular formulation of niclosamide, for treating COVID-19. The company is planning a pre-IND meeting with the FDA.
Decibel Therapeutics Inc., of Cambridge, Mass., said it entered exclusive license agreements with the University of Florida (UF) and the University of California, San Francisco for an AAV gene therapy technology designed to restore hearing to individuals with profound, congenital hearing loss caused by otoferlin gene mutations. Otoferlin is a protein in the inner hair cells of the cochlea that is important for communication between inner ear sensory cells and the auditory nerve by regulating release of neurotransmitters. The company said it is using a dual-vector approach to deliver the gene in two separate AAV vectors, which it said resulted in expression of the complete otoferlin gene, restored signaling connection between the ear and the brain and rescued normal hearing in a deaf, otoferlin-deficient mouse model.
Endo International plc, of Dublin, said its wholly owned indirect subsidiary, Beta Acquisition Corp., commenced its previously announced tender offer to acquire all outstanding shares of Biospecifics Technologies Corp.’s common stock at $88.50 per share. The offer is part of a merger in which Biospecifics will become a wholly owned subsidiary of Endo. Biospecifics discovered and developed a form of injectable collagenase, which is currently marketed by Endo as Xiaflex in North America for treating Dupuytren's contracture and Peyronie's disease.
Eurofins Discovery, of St. Charles, Mo., said a new agreement allows Amphilix AG, of Bettingen, Basel-Stadt, Switzerland, to use Eurofins’ integrated drug discovery platform to find a development candidate. The two companies said they expect this to be the first of multiple collaborations between them.
Fusion Pharmaceuticals Inc., of Hamilton, Ontario, said it will collaborate with Astrazeneca plc, of Cambridge, U.K., to develop and commercialize next-generation alpha-emitting radiopharmaceuticals and combination therapies to treat cancer. The collaboration leverages Fusion's targeted alpha therapies platform and experience with radiopharmaceuticals with Astrazeneca's portfolio of antibodies and cancer therapeutics, including DNA damage response inhibitors.
Hillstream Biopharma Inc., of Bridgewater, N.J., said its Cooperative Research and Development Agreement with the National Center for Advancing Translational Sciences (NCATS), part of the U.S. NIH, has been renewed for a second time. The agreement enables NCATS's use of the company's Quatramer drug delivery technology, which will be used to develop formulations of HDAC6-PI3Kδ dual inhibitors for the treatment of rare cancers, including acute myeloid leukemia and acute lymphoid leukemia.
Horizon Therapeutics plc, of Dublin, is expanding a partnership with CDMO AGC Biologics to produce thyroid eye disease drug Tepezza (teprotumumab-trbw) at AGC’s new facility in Boulder, Colo.
Isofol Medical AB, of Gothenburg, Sweden, said it entered a definitive license agreement with Endo Ventures Ltd., a subsidiary of Endo International plc, of Dublin, for the registration and commercialization of arfolitixorin as a first-line treatment for metastatic colorectal cancer on an exclusive basis in Canada. With the consent of Isofol, Endo Ventures designated Paladin Labs Inc., an operating company of Endo, to be responsible for seeking regulatory approval in Canada and, upon approval, to be responsible for commercialization. Isofol may receive up to $23.05 million as up-front, development, regulatory and sales-based milestones and will receive tiered royalties on net sales in solid double-digit figures.
Mylan NV, of Hertfordshire, U.K., and Pfizer Inc., of New York, said the U.S. FTC accepted a proposed consent order, which concludes the agency’s review of the proposed combination of Mylan and Pfizer’s Upjohn business. The combination is expected to close on Nov. 16, at which time the combined company will be renamed Viatris Inc.
Mymetics Corp., of Epalinges, Switzerland, said it started a second preclinical study for its COVID-19 virosome-based vaccine candidates. This study, at the Helmholtz Center of Infection Research in Germany, will evaluate the safety and immunogenicity of different virosome-based COVID-19 vaccine candidates by intramuscular and intranasal administrations. The virosome formulations will incorporate and evaluate two different SARS-CoV-2 antigens, one full-length stabilized S protein, for which Mymetics is collaborating with the group of Rogier Sanders at the Amsterdam Medical Center of the University of Amsterdam, the Netherlands, and a second as a receptor binding domain recombinant protein of SARS-CoV-2.
Novavax Inc., of Gaithersburg, Md., said it is expanding its Maryland campus to accommodate rapid growth and its work to develop a candidate vaccine against COVID-19, while advancing an influenza vaccine for global markets.
Prevail Therapeutics Inc., of New York, said the arbiter in a proceeding brought in 2019 by Alector Inc., of South San Francisco, against Prevail founder and CEO Asa Abeliovich rejected all of Alector’s principal claims, including those alleging misappropriation or misuse of trade secrets.
Recombinetics Inc., of Eagan, Minn., said it launched a study to improve outcomes for patients diagnosed with tuberous sclerosis complex (TSC). The company will work with Boston's Brigham and Women's Hospital to advance research by creating reproducible and reliable animal models for preclinical studies, leading to new treatments for TSC.
Regulus Therapeutics Inc., of La Jolla, Calif., said it achieved the remaining $5 million milestone payment associated with interim enrollment under its deal with Paris-based Sanofi SA for development of miR-21 programs. The milestone was triggered by an enrollment metric in the phase II study testing RG-012 in Alport syndrome. The proceeds of the milestone will be used to pay down Regulus’ term loan with Oxford LLC.
Rexahn Pharmaceuticals Inc., of Rockville, Md., said stockholders approved the plan of merger with Ocuphire Pharma Inc., of Farmington Hills, Mich., and reorganization, resulting in a reverse stock split of Rexahn stock, at a ratio of one for every three to five shares outstanding, and change of the company’s name to Ocuphire Pharma Inc. The merger is expected to close on or about Nov. 5., after which the company’s shares will trade on Nasdaq under the ticker OCUP.
Samsung Biologics Co. Ltd., of Incheon, South Korea, and Checkpoint Therapeutics Inc., of New York, said they expanded a long-term manufacturing partnership for Checkpoint’s anti-PD-L1 antibody, cosibelimab, in which Samsung will provide additional commercial-scale drug substance. Under the new agreement, Samsung will commence manufacturing in 2021. In separate news, Samsung Biologics entered a partnership with Genequantum Healthcare Co. Ltd., of Suzhou, China, to jointly develop an antibody-drug conjugate for the treatment of non-small-cell lung carcinoma, triple-negative breast cancer and other solid tumors. Terms were not disclosed.
Santhera Pharmaceuticals Holding AG, of Pratteln, Switzerland, said it implemented an organizational restructuring to focus on vamorolone, a dissociative steroid, to which the firm recently obtained global rights in all indications. The drug is currently in a pivotal phase IIb study in Duchenne muscular dystrophy (DMD) patients, with a six-month readout expected in the second quarter of 2021. The refocusing follows discontinuation of Puldysa (idebenone), which had also been tested in DMD. Santhera said it is reducing its workforce by more than 50 positions to 47 full-time equivalent employees, resulting in one-time costs of about CHF3 million (US$3.3 million) against recurring annual cost reductions of CHF10 million. External development, marketing and other operating costs will decrease significantly as activities related to the terminated Puldysa program are closed out. The company also will incur a one-time non-cash expense of CHF9 million resulting from an impairment of inventory and other assets related to Puldysa as well as the reduction in infrastructure use arising from the organizational restructuring. Following the impairment, annualized amortization costs will be reduced by about CHF1 million. The moves are expected to extend Santhera’s cash reach to its next major value-enhancing inflection point in the second quarter of 2021, the company said.
SK Biopharmaceuticals Co. Ltd., of Pangyo, Korea, said it signed an agreement with life science venture capital firm Lifesci Venture Partners to collaborate on open innovation through a fund. The fund will invest primarily in private health care companies developing novel therapies and innovative technologies.
Telix Pharmaceuticals Ltd., of Melbourne, Australia, said it entered a license and commercial partnership with China Grand Pharmaceutical and Healthcare Holdings Ltd., of Hong Kong, for Telix’s portfolio of Molecularly-Targeted Radiation (MTR) products. Telix has appointed China Grand Pharma its exclusive partner for the greater China market and grants China Grand Pharma exclusive development and commercialization rights to Telix’s portfolio of prostate, renal and brain (glioblastoma) cancer imaging and therapeutic MTR products in the territory. Terms include a $25 million up-front payment, up to $225 million in regulatory and commercial milestones, program-related investment of up to $65 million and royalties on sales in the territory. Additionally, China Grand Pharma will make a simultaneous one-time strategic equity investment of $25 million.
Tempus Inc., of Chicago, an AI and precision medicine company, said it entered a collaboration with Janssen Research & Development LLC, a unit of New Brunswick, N.J.-based Johnson & Johnson, in which Tempus will work with Janssen data scientists and oncologists. The collaboration is part of a multiyear data agreement, which is facilitating predictive AI/machine learning projects, as well as Janssen’s participation in Tempus’ TIME Trial Network to accelerate patient enrollment in select biomarker-driven trials. As part of the collaboration, Tempus is developing a predictive model using machine learning techniques to enhance enrollment in Janssen’s biomarker-driven clinical trials.
TFF Pharmaceuticals Inc., of Austin, Texas, and Augmenta Bioworks Inc., of Menlo Park, Calif., said they entered a worldwide joint development and collaboration agreement to develop products incorporating Augmenta’s human-derived monoclonal antibodies for potential COVID-19 therapeutics. Under the terms, both companies will collaborate to develop one or more commercial therapeutics based on, derived from and/or incorporating Augmenta’s human monoclonal antibodies to potentially treat patients with COVID-19. The products will be developed utilizing TFF Pharmaceuticals’ Thin-Film Freezing technology to manufacture dry powder formulations for inhalation delivery directly to the lungs of patients. The agreement also includes the development of formulations suitable for parenteral administration, where the Thin Film Freezing dry powder formulations can be reconstituted, potentially mitigating the impacts of cold-chain storage and handling. TFF Pharmaceuticals will also have the option to develop two additional Augmenta monoclonal antibodies for indications other than COVID-19. The companies agreed to a 50-50 split of all costs and expenses and a 50-50 split of all revenues, cash payments and/or future cash payments related to the sale and/or license of the products resulting from development to a third party.
Titan Pharmaceuticals Inc., of South San Francisco, said it completed its agreement to settle all of its debt obligations with Molteni & C. dei F.lli Alitti Società di Esercizio SpA and Horizon Credit LLC II, as well as its agreement to acquire Mount Pleasant, S.C.-based JT Pharmaceuticals Inc.'s kappa opioid agonist peptide, JT-09, for use in combination with Titan's Proneura long-term, continuous drug delivery technology, for the treatment of chronic pruritus.
Zucara Therapeutics Inc., of Toronto, said it expanded the development of ZT-01, a somatostatin receptor 2 antagonist, to type 2 diabetes. Work will be supported, in part, by advisory services and up to $415,000 in nondilutive research and development funding from the National Research Council of Canada Industrial Research Assistance Program (NRC IRAP). NRC IRAP previously awarded Zucara with up to $400,000 in funding for the development of ZT-01 for type 1 diabetes.