PanGenetics BV

Incyte宣布收购由Medicxi投资孵化的Villaris Therapeutics公司，并获得后者的在研抗IL-15Rβ单克隆抗体药物auremolimab(VM6)。Villaris Auremolimab是一种全新超人源化（ultra-humanized）的抗IL-15Rβ(CD122)单克隆抗体，旨在靶向和消耗组织驻留记忆T细胞（resident memory T cells，TRM）。在临床前模型中已证明auremolimab可有效治疗白癜风，目前正在IND准备阶段，预计将于2023年进入临床试验。 根据协议条款，Incyte通过收购Villaris，将获得开发和商业化auremolimab包括白癜风和其他自身免疫性和炎症性疾病在内所有治疗潜在疾病的全球独家权利。 Incyte将向Villaris股东支付7000万美元的预付款，其股东未来还将有资格在实现某些开发和监管里程碑后获得高达3.1亿美元，以及产品净销售额高达10.5亿美元的额外商业里程金。 Incyte认为现有收购将补充其验证和自身免疫产品产品管线，并探索auremolimab在皮肤病学之外的潜在适应症。 Villaris总部位于北卡罗来纳州卡里，由Medicxi和医学博士John Harris于 2019年创立，旨在开发一种潜在的变革性新疗法，以改善白癜风患者的生活。 Villaris是Medicxi投资孵化的创新biotech之一，该机构此前投资孵化的多家公司已经被收购，比如：Impact Biomedicines（被Celgene收购）；XO1（被杨森制药收购）；SynthorX（被赛诺菲收购）；Miro Bio（被吉利德收购）；和PanGenetics（被雅培收购）。

Villaris shareholders to receive upfront payment of $70 million, with potential for up to $1.36 billion in additional milestone payments Pre-clinical data for auremolimab demonstrate high potency, selectivity and efficacy in vitiligo Acquisition will complement Incyte’s existing Inflammation and AutoImmunity portfolio with potential applications for auremolimab beyond Dermatology WILMINGTON, Del.--(BUSINESS WIRE)-- Incyte (NASDAQ:INCY) today announced that the Company has entered into an agreement to acquire Villaris Therapeutics, an asset-centric biopharmaceutical company seeded by Medicxi and focused on the development of novel antibody therapeutics for vitiligo. Its lead asset, auremolimab (VM6), an anti-IL-15Rβ monoclonal antibody (mAb), is expected to enter clinical development in 2023. This press release features multimedia. View the full release here: Under the terms of the agreement, Incyte will acquire Villaris and the exclusive global rights to develop and commercialize auremolimab for all uses, including in vitiligo and other autoimmune and inflammatory diseases. Incyte will make an upfront payment of $70 million, and Villaris shareholders will be eligible for up to $310 million upon achievement of certain development and regulatory milestones, as well as up to an additional $1.05 billion in commercial milestones on net sales of the product. “This acquisition complements our current portfolio, providing us the opportunity to further enhance treatment options for people with vitiligo, leveraging the expertise we established in the Dermatology space through our successful launch of Opzelura™ (ruxolitinib) Cream,” said Hervé Hoppenot, Chief Executive Officer, Incyte. “People living with immune-mediated dermatologic diseases like vitiligo face significant challenges and we are committed to developing novel therapies like auremolimab, which may address these unmet needs.” John E. Harris, M.D., Ph.D., Professor and Chair of Dermatology at the University of Massachusetts Chan Medical School and Founder of Villaris, commented, “I am really excited by the potential for auremolimab to treat vitiligo and other diseases with significant unmet need, and to see that it will now be driven forward with the capabilities and resources of Incyte. Back in 2019, I was very pleased to partner with Michèle Ollier and the Medicxi team to create Villaris as a single-purpose, asset-centric company with a laser focus on developing auremolimab for people with vitiligo who are in desperate need of better treatments. This next phase of development with Incyte will help to make that a reality.” “Our mission at Medicxi is to partner with world-class innovators like John Harris, who are developing novel treatments for major unmet needs,” said Nick Williams, Partner at Medicxi. “Auremolimab has the potential to transform the lives of people living with vitiligo, and we are extremely excited to be partnering with Incyte, a pioneering company in this indication with the capabilities to explore the broader potential of auremolimab.” The agreement is subject to clearance by the U.S. antitrust authorities under the Hart-Scott-Rodino Act and will become effective as soon as this condition has been met. PJT Partners advised Villaris on the transaction. About Auremolimab Auremolimab (VM6) is a novel, ultra-humanized, anti-IL-15Rβ (CD122) antibody designed to target and deplete autoreactive resident memory T cells (TRM) that has demonstrated efficacy as a treatment for vitiligo in preclinical models. IND-enabling studies are currently underway, and clinical development is expected to begin in 2023. About Incyte Dermatology Incyte’s science-first approach and expertise in immunology has formed the foundation of the company. In Dermatology, the Company’s research and development efforts are focused on leveraging our knowledge of the JAK-STAT pathway to identify and develop topical and oral therapies with the potential to modulate immune pathways driving uncontrolled inflammation and help restore normal immune function. Currently, Incyte is exploring the potential of JAK inhibition for additional immune-mediated dermatologic conditions with a high unmet medical need, including hidradenitis suppurativa. To learn more, visit the Dermatology section of Incyte.com. About Incyte Incyte is a Wilmington, Delaware-based, global biopharmaceutical company focused on finding solutions for serious unmet medical needs through the discovery, development and commercialization of proprietary therapeutics. For additional information on Incyte, please visit Incyte.com and follow @Incyte. About Villaris Based in Cary, North Carolina, Villaris was founded in 2019 by Medicxi and John Harris, M.D., Ph.D. to develop a potentially transformational new treatment to improve the lives of people living with vitiligo. Villaris is a paradigmatic example of Medicxi’s asset-centric development model, which combines world-class insights and experience with capital and expertise to fully power the program from its initial design to its improvement through ultra-humanization. About Medicxi Medicxi is a healthcare-focused investment firm with the mission to create and invest in companies across the full drug development continuum. Medicxi invests in early and late-stage therapeutics with a product vision that can fulfill a clear unmet medical need. Many of its portfolio companies have been acquired including: Impact Biomedicines (acquired by Celgene); XO1 (acquired by Janssen Pharmaceuticals); SynthorX (acquired by Sanofi); Miro Bio (acquired by Gilead); and PanGenetics (acquired by Abbott). Several portfolio companies are now publicly listed, including: GenMab (Copenhagen: GEN.CO); Molecular Partners (SIX: MOLN); Vaxcyte (NASDAQ: PCVX); Aura Biosciences (NASDAQ: AURA); and Centessa Pharmaceuticals (NASDAQ: CNTA). For more information, please visit: . Incyte Forward-Looking Statements Except for the historical information set forth herein, the matters set forth in this press release, including statements regarding whether and when auremolimab will be approved for use; whether and when Incyte will bring auremolimab to market; the potential of auremolimab to treat patients with vitiligo or for any other indication; the potential for Villaris and its shareholders to receive payments from Incyte for development, regulatory and commercial milestones; and the potential for Incyte to broaden its ability to bring new medicines to patients, contain predictions, estimates and other forward-looking statements. These forward-looking statements are based on the Company's current expectations and are subject to risks and uncertainties that may cause actual results to differ materially, including unanticipated developments in and risks related to: unanticipated delays; further research and development and the results of clinical trials possibly being unsuccessful or insufficient to meet applicable regulatory standards or warrant continued development; the ability to enroll sufficient numbers of subjects in clinical trials; the effects of the COVID-19 pandemic and measures to address the pandemic on the Company’s clinical trials, supply chain, other third-party providers and development and discovery operations; determinations made by regulatory authorities; the Company’s dependence on its relationships with its collaboration partners; the efficacy or safety of the Company’s products and the products of the Company’s collaboration partners; the acceptance of the Company’s products and the products of the Company’s collaboration partners in the marketplace; market competition; sales, marketing, manufacturing and distribution requirements; and other risks detailed from time to time in the Company’s reports filed with the Securities and Exchange Commission, including its annual report and its quarterly report on Form 10-Q for the quarter ended June 30, 2022. The Company disclaims any intent or obligation to update these forward-looking statements. View source version on businesswire.com: Contacts Incyte: Media Catalina Loveman +1 302 498 6171 cloveman@incyte.com Investors Christine Chiou +1 302 274 4773 cchiou@incyte.com Medicxi: Optimum Strategic Communications Mary Clark/Nick Bastin/Manel Mateus +44 (0) 20 8148 3040 medicxi@optimumcomms.com Source: Incyte View this news release online at: