Pfizer and Arvinas to jointly develop and commercialise breast cancer drug


2021-07-23 23:01:02 PHARMACEUTICAL


Pfizer and Arvinas have collaborated to co-develop and co-commercialise ARV-471, an investigational oral Protac estrogen receptor protein degrader. The estrogen receptor (ER) is a well-known disease driver in most breast cancers and the primary driver of hormone receptor positive breast cancer. Wholly owned by Arvinas, ARV-471 is currently being assessed for the treatment of patients with ER positive / human epidermal growth factor receptor 2 (HER2) negative (ER+/HER2-) locally advanced or metastatic breast cancer in a Phase II dose expansion clinical trial. Under the collaboration agreement, Arvinas will receive an upfront payment of $650m as well as a $350m equity investment. As per the terms of the deal, the worldwide development costs, commercialisation expenses, as well as the profits will be shared equally between the two companies. The partnership will help to combine Arvinas’ investigational estrogen receptor-targeting breast cancer therapy with Pfizer’s experience in breast oncology therapeutics. Arvinas CEO John Houston said: “This collaboration has the potential to be transformational, as it combines our leadership in targeted protein degradation with Pfizer’s global capabilities and deep expertise in breast cancer. “This should significantly enhance and accelerate the development and potential commercialization of ARV-471 while also advancing Arvinas’ strategy of building a global, integrated biopharmaceutical company. “We share Pfizer’s deep commitment to people with breast cancer and are thrilled to partner with them to develop this potentially best-in-class therapy. Despite advancements in oncology in recent years, considerable unmet need persists in the treatment of HR+ breast cancer.” Currently, the company is also testing its ARV-471 to treat metastatic breast cancer in a Phase 1 dose escalation study, a Phase 1b combination study using Pfizer’s IBRANCE (palbociclib), and a Phase 2 monotherapy dose expansion study (VERITAC). In this year, the companies are also planning to commence two more trials of ARV-471 that include a second Phase 1b combination trial with everolimus and a trial in the neoadjuvant setting. In 2018, Arvinas and Pfizer had announced a separate research collaboration and license agreement for the development of drug candidates using PROTAC technology.
辉瑞和Arvinas已经合作共同开发和共同商业化ARV-471,一种研究性口服Protac雌激素受体蛋白降解剂。 雌激素受体(ER)是大多数乳腺癌的疾病驱动因子,是激素受体阳性乳腺癌的主要驱动因子。 ARV-471由Arvinas全资拥有,目前正在进行II期剂量扩大临床试验,用于治疗ER阳性/人表皮生长因子受体2(HER2)阴性(ER+/HER2-)局部晚期或转移性乳腺癌患者。 根据合作协议,Arvinas将获得6.5亿美元的预付款和3.5亿美元的股权投资。 根据交易条款,全球开发成本、商业化费用以及利润将由两家公司平分。 这项合作将有助于将Arvinas研究性的雌激素受体靶向乳腺癌治疗与辉瑞在乳腺肿瘤治疗方面的经验结合起来。 Arvinas首席执行官约翰·休斯顿(John Houston)表示:“这种合作有可能发生变革,因为它将我们在靶向蛋白质降解方面的领导地位与辉瑞在乳腺癌方面的全球能力和深厚专业知识结合起来。 “这将大大加强和加速ARV-471的开发和潜在的商业化,同时也推进Arvinas建立全球一体化生物制药公司的战略。 “我们分享辉瑞对乳腺癌患者的深切承诺,并很高兴与他们合作开发这种潜在的一流疗法。尽管近年来肿瘤学取得了进展,但在HR+乳腺癌的治疗中,仍有大量未满足的需求。“ 目前,该公司还在1期剂量升级研究中测试其ARV-471治疗转移性乳腺癌,使用辉瑞的IBRANCE(palbociclib)进行1B期联合研究,以及2期单一治疗剂量扩大研究(VERITAC)。 今年,两家公司还计划开始另外两项ARV-471试验,包括与依维莫司的第二阶段1B联合试验和在新佐剂环境中的试验。 2018年,Arvinas和辉瑞宣布了一项单独的研究合作和许可协议,用于使用PROTAC技术开发候选药物。