日前，啟明創(chuàng)投投資企業(yè)和譽(yù)生物醫(yī)藥有限公司(Abbisko Therapeutics)與美國X4制藥公司(X4 Pharmaceutics)宣布，就一款處于臨床階段的fist-in-class口服CXCR4拮抗劑mavorixafor在大中華地區(qū)的開發(fā)與商業(yè)化達(dá)成獨(dú)家合作協(xié)議。和譽(yù)醫(yī)藥獲得mavorixafor 在大中華地區(qū)腫瘤等適應(yīng)癥的商業(yè)化權(quán)益，并將主導(dǎo)其大中華地區(qū)多個(gè)腫瘤適應(yīng)癥的臨床與商業(yè)開發(fā)，啟動(dòng)多項(xiàng)mavorixofor與腫瘤免疫抑制劑或其它藥物聯(lián)合治療的臨床研究。
Mavorixafor是一款全球領(lǐng)先的first-in-class口服CXCR4拮抗劑，在WHIM綜合癥臨床II期試驗(yàn)中獲得成功 ，于2018年被FDA授予孤兒藥資格，并已啟動(dòng)臨床III期試驗(yàn)。X4還在對(duì)mavorixafor進(jìn)行針對(duì)其它多種適應(yīng)癥的臨床開發(fā)。在多項(xiàng)腫瘤臨床I/II期試驗(yàn)中，觀察到單藥及與PD-1單抗或其它腫瘤藥物聯(lián)用時(shí)良好的安全性及藥效。
X4制藥公司總裁兼首席執(zhí)行官Paula Ragan博士表示：“很高興能夠與具有豐富新藥開發(fā)經(jīng)驗(yàn)的和譽(yù)團(tuán)隊(duì)達(dá)成戰(zhàn)略合作。和譽(yù)醫(yī)藥卓越的研發(fā)團(tuán)隊(duì)能夠進(jìn)一步探索mavorixafor對(duì)晚期腫瘤的治療潛力，這也服務(wù)于為中國的腫瘤病人提供新的更有效的治療選擇這一目的。這一合作能夠讓我們把精力專注于正在進(jìn)行中的罕見病項(xiàng)目的開發(fā)。和譽(yù)醫(yī)藥擁有頂級(jí)投資團(tuán)隊(duì)的支持，全球視野下的腫瘤新藥研發(fā)經(jīng)驗(yàn)，以及在大中華區(qū)的豐富資源，這些都有利于推進(jìn)mavorixafor在多種臨床需求未滿足的腫瘤瘤適應(yīng)癥的開發(fā)?！?/p>
和譽(yù)醫(yī)藥總裁兼首席執(zhí)行官徐耀昌博士指出：“mavorixafor已在WHIM綜合癥中證明了自身的良好安全性和療效，我們希望進(jìn)一步探究mavorixafor聯(lián)合免疫檢查點(diǎn)抑制劑或其它藥物用于更多類型腫瘤適應(yīng)癥的潛力，力爭給醫(yī)療需求沒得到滿足的患者帶來治療與獲益。CXCR4是腫瘤免疫機(jī)制中非常關(guān)鍵的一個(gè)因素，我們相信mavorixafor與我們自身產(chǎn)品線的多個(gè)新藥候選化合物有非常好的協(xié)同效應(yīng)，可以大大提升我們現(xiàn)有產(chǎn)品組合的潛力。”
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, 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 Greater China to develop and commercialize maxorixa for 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.”
