Portfolio I 和誉医药与美国X4制药公司就全新CXCR4拮抗剂Mavorixafor达成独家合作协议

2019年7月16日，和誉生物医药有限公司 (Abbisko Therapeutics)与美国X4制药公司 (X4 Pharmaceuticals, NASDAQ: XFOR)宣布，就一款处于临床阶段的fist-in-class口服CXCR4拮抗剂mavorixafor在大中华地区的开发与商业化达成X独家合作协议。和誉医药获得mavorixafor在大中华地区肿瘤等适应症的商业化权益，并将主导其大中华地区多个肿瘤适应症的临床与商业开发，启动多项mavorixofor与肿瘤免疫抑制剂或其它药物联合治疗的临床研究。 

Mavorixafor是一款全球领先的first-in-class口服CXCR4拮抗剂，在WHIM综合症临床II期试验中获得成功，于2018年被FDA授予孤儿药资格，并已启动临床III期试验。X4还在对mavorixafor进行针对其它多种适应症的临床开发。在多项肿瘤临床I/II期试验中，观察到单药及与PD-1单抗或其它肿瘤药物联用时良好的安全性及药效。 

X4制药公司总裁兼首席执行官Paula Ragan博士表示：“很高兴能够与具有丰富新药开发经验的和誉团队达成战略合作。和誉医药卓越的研发团队能够进一步探索mavorixafor对晚期肿瘤的治疗潜力，这也服务于为中国的肿瘤病人提供新的更有效的治疗选择这一目的。这一合作能够让我们把精力专注于正在进行中的罕见病项目的开发。和誉医药拥有顶级投资团队的支持，全球视野下的肿瘤新药研发经验，以及在大中华区的丰富资源，这些都有利于推进mavorixafor在多种临床需求未满足的肿瘤瘤适应症的开发。”

和誉医药总裁兼首席执行官徐耀昌博士指出：“mavorixafor已在WHIM综合症中证明了自身的良好安全性和疗效，我们希望进一步探究mavorixafor联合免疫检查点抑制剂或其它药物用于更多类型肿瘤适应症的潜力，力争给医疗需求没得到满足的患者带来治疗与获益。CXCR4是肿瘤免疫机制中非常关键的一个因素，我们相信mavorixafor与我们自身产品线的多个新药候选化合物有非常好的协同效应，可以大大提升我们现有产品组合的潜力。”

和誉医药创立于2016年4月，专注于发现和开发针对癌症和其他临床需求未满足疾病的创新药物。和誉医药创始团队是在国际大型制药企业拥有丰富管理经验和卓越领导力的科学家，参与了多款被FDA批准新药的开发。经过过去三年的发展，和誉医药已经建立起了一条由多款小分子新药组成的极具竞争力的肿瘤药物管线。

英文新闻稿：

Cambridge, MA and Shanghai — July 16, 2019 — X4 Pharmaceuticals, Inc. (Nasdaq: XFOR), a clinical-stage biopharmaceutical company focused on the development of novel therapeutics for the treatment of rare diseases, and Abbisko Therapeutics, a company with an extensive pipeline of targeted therapeutics with first-in-class or best-in-class potential, today announced they have entered into an agreement to develop and commercialize X4’s product candidate, mavorixafor, in combination with checkpoint inhibitors or other agents in Greater China for oncology indications. Mavorixafor is a potentially first-in-class, once-daily, oral, small molecule antagonist of chemokine receptor CXCR4.

This agreement provides Abbisko with the exclusive rights in China,  Taiwan, Hong Kong and Macau to develop and commercialize maxorixafor in combination with checkpoint inhibitors or other agents in oncology indications – including pancreatic cancer, ovarian cancer and triple negative breast cancer, which will be explored initially. X4 retains full rest-of-world rights to develop and commercialize mavorixafor outside of Greater China for all indications, and the ability to utilize any data generated pursuant to the Abbisko collaboration for rest-of-world development.

“We are pleased to enter into this strategic partnership with the experienced team at Abbisko. This collaboration enables us to leverage Abbisko’s research and development expertise to explore mavorixafor’s potential benefit in advanced cancer patients and to potentially capture value from the growing oncology markets in Greater China, while enabling X4 to maintain its focus on the company’s ongoing rare disease programs,” commented Paula Ragan, Ph.D., President and Chief Executive Officer of X4 Pharmaceuticals. “Abbisko’s top-notch investor syndicate, strong leadership with global oncology R&D experience, and broad healthcare network in Greater China provide a complementary opportunity to expand mavorixafor’s potential for patients into solid tumor oncology indications, which represent areas of significant unmet need.” 

“Mavorixafor has demonstrated proof of concept and a favorable safety profile in a Phase 2 trial in patients with WHIM syndrome, which is caused by compromised immune cell trafficking. We look forward to further realizing mavorixafor’s potential in broad oncology indications in combination with immune checkpoint inhibitors and other therapies, for the benefit of patients with significant unmet medical needs,” said Dr. Yaochang Xu, Chief Executive Officer of Abbisko Therapeutics. “Targeting CXCR4 has strong mechanistic rationales in oncology and we believe mavorixafor will bring transformative value to Abbisko’s portfolio with clear synergies with our internal pipeline programs.” 

About Mavorixafor

X4 Pharmaceutical’s lead product candidate, mavorixafor (X4P-001), is a potentially first-in-class, once-daily, oral inhibitor of CXCR4, currently in Phase 3 development for the treatment of WHIM syndrome, a rare, inherited, primary immunodeficiency disease caused by genetic mutations in the CXCR4 receptor gene. Mavorixafor has demonstrated proof of concept in WHIM in a Phase 2 trial, including clinically meaningful increases in neutrophil and lymphocyte biomarker counts, as well as a trend of reduction in infection rates and wart burden, and a favorable safety profile. Mavorixafor was designated orphan drug status by the U.S. Food and Drug Administration in 2018 for the treatment of WHIM and is also in development for Severe Congenital Neutropenia (SCN), Waldenström’s macroglobulinemia (WM), andclear cell renal cell carcinoma (ccRCC). 

About X4 Pharmaceuticals

X4 Pharmaceuticals is developing novel therapeutics designed to improve immune cell trafficking to treat rarediseases, including primary immunodeficiencies and certain cancers. The company’s oral small molecule drug candidates antagonize the CXCR4 pathway, which plays a central role in immune surveillance. X4’s most advanced product candidate, mavorixafor (X4P-001), is in a global Phase 3 pivotal trial in patients with WHIM syndrome, a rare, inherited, primary immuno deficiency disease, and is currently also under investigation in combination with axitinibin the Phase 2a portion of an open-label Phase 1/2 clinical trial in clear cell renal cell carcinoma (ccRCC). X4 is also planning to commence clinical trials of mavorixafor in Severe Congenital Neutropenia (SCN) and Waldenström’smacroglobulinemia (WM) in 2019. The company was founded and is led by a team with extensive biopharmaceutical product development and commercialization expertise and is committed to advancing the development of innovative medicines on behalf of patients with limited treatment options. X4 is a global company that is headquartered in Cambridge, Massachusetts with research offices based in Vienna, Austria. For more information, please visit www.x4pharma.com.

About Abbisko Therapeutics

Founded in April 2016, Abbisko Therapeutics Co., Ltd. is a biopharmaceutical company dedicated to discovering and developing innovative therapeutics to treat cancer and other diseases with unmet medical needs. The founders and leadership team of Abbisko are a group of industrial veterans with strong leadership and managerial experiences from top international pharmaceutical companies. They have led and participated in the discovery and development of multiple FDA-approved drugs. In three years, Abbisko has established a strong oncology pipeline with multiple programs entering the clinic.

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