BioSpace Global Roundup: June 27
Prestige BioPharma – Singapore-based Prestige BioPharma announced its biosimilar candidate HD201 hit late-stage endpoints in comparison to Genentech’s Herceptin (trastuzumab). The top-line results demonstrate HD201’s exceptional similarity to Herceptin in terms of clinical response and PK, in addition to a comparable safety profile to the range previously observed in other trastuzumab biosimilar clinical trials, Prestige said in its announcement. The equivalence trial compared the two products in patients with HER2+ Early Breast Cancer. Lisa S. Park, chief executive officer of Prestige BioPharma, said the late-stage study puts the company one step closer to the commercialization of HD201.
Expedeon – Expedeon, with offices in both Germany and the United Kingdom, introduced Lightning-Link Metal Labeling Kits for use in multiple immunoassay-based applications to support single cell analysis. The new kits will enable users to dramatically enhance the phenotypic analysis of heterogeneous cell populations, providing increased multiplexing capability compared to fluorophore labeling, improving sample throughput and research output, the company said. Metal labeling is a technique using rare metal isotopes as opposed to fluorophores for antibody labeling, distinctly increasing the available analytical spectrum. Because the metals do not produce the background noise associated with fluorophores, multiplexing capabilities are greatly increased. This technique is utilized in numerous fields such as immunology, oncology, phospho-proteomics and hematology.
Clinigen – Clinigen Group plc signed an exclusive agreement with Accord Healthcare to supply and distribute the U.K. company’s specialty medicines, Cardioxane and Savene in Poland. Cardioxane is used as a cardio protectant with cancer chemotherapy (anthracycline) treatment. Savene is used as an important emergency treatment for extravasation (leakage) at the site of infusion of chemotherapy (anthracycline) treatment. Clinigen will continue to be the point of contact for both products in Poland until responsibility for the supply and distribution of the products has transitioned to Accord, which is expected to be in August 2019.
Horizon Therapeutics – Based in Ireland, Horizon Therapeutics launched a clinical trial evaluating Krystexxa (pegloticase injection) in combination with methotrexate as a strategy to increase the durability of response for patients living with chronic gout whose disease is uncontrolled. Treatment with biologic medicines can, in some patients, trigger the body’s immune system to develop anti-drug antibodies. These anti-drug antibodies can reduce the effectiveness of biologic therapy. The trial will evaluate the use of methotrexate as an immunomodulator to meaningfully reduce immune response to Krystexxa in adult patients living with uncontrolled gout. The primary endpoint will be the ability of Krystexxa with methotrexate versus Krystexxa alone to maintain a serum uric acid of less than 6 mg through six months.
PhoreMost Ltd – PhoreMost Limited, a U.K.-based biopharmaceutical company dedicated to drugging “undruggable” disease targets, signed a neurodegeneration drug discovery collaboration agreement with C4X Discovery Holdings plc. The agreement will combine the two companies’ platforms to validate novel targets, the initial focus will be on Parkinson’s disease. The aim of the collaboration is to bolster the C4XD drug discovery pipeline of novel neurodegeneration drug targets. Under the terms of the agreement, PhoreMost’s next-generation phenotypic screening platform, SITESEEKER, will be used to guide selection of novel targets identified by C4XD’s proprietary target identification platform, Taxonomy3, and provide chemical starting points to launch drug discovery programs. Initially, SITESEEKER will enable the progression of several Parkinson’s disease targets to multi-target disease area partnering arrangements, or in-house C4XD drug discovery programs, the company said.
GenFit – France-based GenFit signed an agreement with Terns Pharmaceuticals, a global biopharmaceutical company based in the U.S. and China with a focus on developing novel and combination therapies to treat liver disease. Under the agreement, Terns will have the rights to develop and commercialize elafibranor, GenFit’s proprietary compound, in Greater China, for the treatment of non-alcoholic steatohepatitis (NASH) and primary biliary cholangitis (PBC). As part of the deal, GENFIT and Terns will also undertake joint R&D projects in liver disease, including the development of elafibranor in combination with Terns’ proprietary compounds. GenFit believes that Terns is well-positioned to maximize elafibranor’s value in China. New regulations currently being implemented in China are expected to accelerate and facilitate the approval of innovative therapies developed by both domestic and international companies.
Cobra Biologics – Cobra Biologics, a U.K.-based contract development and manufacturing organization (CDMO) focused on viral vector drug substance production, completed a collaboration with Symbiosis Pharmaceutical Services to “develop synergistic and world-leading capabilities.” The collaboration increases both companies’ existing commercial capacity and simplifies the supply chain process for the manufacture of viral vectors for use in gene therapy and immunotherapy, Cobra said.
Ono Pharmaceutical – Japan-based Ono entered into an out-licensing agreement with New Jersey-based Rafael Pharmaceuticals for development and commercialization of CPI-613 (devimistat), Rafael’s first-in-class clinical lead compound, which targets cancer metabolism enzymes and other related compounds. Under the terms of the agreement, Rafael will receive a one-time upfront payment of approximately $12.9 million and up to an additional $150.3 million if certain development and commercial milestones are achieved.
NervGenPharma Corp. – Vancouver-based NervGen intends to apply its proprietary platform drug technology beyond spinal cord injury to multiple sclerosis. Two separate studies demonstrated that NervGen’s technology has facilitated nerve remyelination in both spinal cord injury and MS animal models, making NervGen’s NVG-291 compound an attractive opportunity to become a therapeutic for multiple sclerosis, the company said.