Efinaconazole

Numab to receive R&D funding for the preclinical development of ND081 Kaken Pharmaceutical receives an option to in-license ND081 in certain Asian territories in exchange for funding global development up to clinical POC HORGEN, Switzerland and TOKYO, Japan I November 15, 2024 I Numab Therapeutics AG (“Numab”), a clinical stage biotechnology company advancing a proprietary pipeline of multi-specific antibodies in immunology and oncology, and Kaken Pharmaceutical Co., Ltd. (“Kaken”), an R&D driven pharmaceutical company in Japan, announced today a new collaboration and option agreement to develop ND081, a potential first-in-class multi-specific antibody for the treatment of inflammatory bowel disease (IBD). Under the terms of the agreement, Kaken has obtained an option to acquire commercial rights to ND081 for certain key Asian territories in exchange for funding preclinical and clinical development up to Phase 2a proof of concept. Numab will receive approximately CHF 13 million as an upfront payment and will be the main executing party of preclinical and clinical development. “We are excited to once again join forces with Kaken to advance one of our multi-specific programs to the clinic as a continuation of our regional partnering strategy aimed at utilizing Numab’s unique proprietary λ-Cap TM and MATCH TM technology platforms,” said David Urech, Ph.D., Founder and Chief Executive Officer of Numab Therapeutics. “This partnership in IBD represents a validated approach for both Numab and Kaken and is built out of a strong relationship that we established from our prior collaboration on NM26, an investigational first-in-class bi-specific antibody for the treatment of atopic dermatitis, which led to an asset spin out into Yellow Jersey Therapeutics and its subsequent acquisition by Johnson & Johnson for $1.25 billion in May 2024.” “We are very pleased to enter into a new collaborative research agreement with Numab, a partner with whom we have established a trusting relationship through the joint R&D project on NM26, which culminated in our recently signed IP Transfer and Commercial Option Agreement with Johnson & Johnson. By leveraging our research and development capabilities and Numab’s unique expertise in multi-specifics, we will do our utmost to develop innovative new drugs for IBD,” said Hiroyuki Horiuchi, President and Representative Director of Kaken Pharmaceutical. About Numab Therapeutics AG Numab Therapeutics AG is a clinical-stage company developing multi-specific antibody-based immunotherapies for inflammation and cancer. Reproducible plug-and-play therapeutic design process using proprietary platforms λ-Cap TM and MATCH TM puts Numab in a unique position to overcome historical drug discovery barriers and build a pipeline of new and important medicines aimed to maximize patient benefits. Numab’s diverse research pipeline spans multiple therapeutic areas and creates the opportunity for the next generation of first-in-class and best-in-class medicines. Our lead asset, NM32, a first-in-class half-life-enhanced T-cell engager targeting ROR1, a tumor associated antigen with broad expression in solid tumors and hematological malignancies, is currently in Phase 1 trial in patients with solid tumors. Numab’s partnerships with multiple leading pharma companies continue to validate the robust proprietary platform and development capabilities. For further information, visit https://www.numab.com/ About Kaken Pharmaceutical Co., Ltd. Kaken Pharmaceutical Co., Ltd. is an R&D driven pharmaceutical company, established in 1948, and its corporate philosophy is to help improve the quality of life of patients by serving as many people as possible to return smiles of happiness to their faces, through supplying superior pharmaceuticals. Recently, KAKEN has increased its presence in dermatology and orthopedics, and Clenafin, a drug discovered in-house and first topical onychomycosis treatment in Japan, continues to grow as a global product. For more information, please visit https://www.kaken.co.jp/english/ SOURCE: Kaken Pharmaceutical Co

Efinaconazole’s low binding affinity to keratin enables it to penetrate nails effectively to treat onychomycosis. Credit: Prabodha D Herath/Shutterstock. Almirall has completed the decentralised European regulatory procedure for efinaconazole, a triazole antifungal substance with the trade name Jublia, to treat onychomycosis. This is a significant step in enhancing Almirall’s medical dermatology portfolio in Europe and the procedure is the last step before European countries can issue national marketing authorisations. Onychomycosis, a fungal infection impacting an estimated 5.5% of the world population, accounts for half of all nail disorder consultations. It is a notoriously tenacious condition, often resistant to treatments. Efinaconazole’s low binding affinity to keratin, key in nail composition, enables it to penetrate nails effectively. In May 2022, Almirall initiated the regulatory submission process for efinaconazole in Germany and Italy, utilising the European decentralised procedure. See Also: Bayer applies for EU approval of menopause drug elinzanetant ENHERTU gains conditional approval in China to treat NSCLC Germany’s regulatory authority acted as the reference member state. Almirall research and development, chief scientific officer and executive vice-president Dr Karl Ziegelbauer stated: “The completion of the decentralised regulatory procedure for efinaconazole in Europe enables European countries to approve this advanced treatment option to support people with onychomycosis. “Efinaconazole as a topical treatment is a valuable addition to our expanding onychomycosis portfolio and we are looking forward to being able to offer it to European dermatologists and their patients in the near future.” In July 2021, the company obtained exclusive development and marketing rights for efinaconazole in Europe from Kaken Pharmaceutical . Kaken received an upfront cash payment from Almirall, along with milestone payments and royalties based on net sales of the product, which is currently available in the US, Canada, Korea, Hong Kong and Macau. It has been available in Japan under the trade name Clenafin since 2014. Almirall is currently collaborating with national regulatory authorities, with authorisations anticipated in the first half of 2025. In February 2024, Almirall entered a strategic collaboration with Microsoft for drug development in dermatology.