2015年3月5日讯 /生物谷BIOON/ --百时美施贵宝（BMS）近日与合作伙伴Bavarian Nordic签署一项高达9.75亿美元的独家授权协议，获得了一种治疗性前列腺癌疫苗Prostvac，目前该疫苗处于临床III期评估用于无症状或轻微症状的转移性去势抵抗前列腺癌（mCRPC）患者的治疗。该笔重大交易似乎预示，当碰到所谓的免疫检查点抑制剂，癌症疫苗可能真的迎来了春天。
不同于传统的预防性疫苗，治疗性癌症疫苗专为患有特定癌症的患者设计，其目的是增强患者的免疫系统来消灭癌症。这一理念看起来很好很丰满，然而现实却很残酷，临床实验中一系列治疗性癌症疫苗均以惨败告终，包括默克的Stimuvax和葛兰素史克的MAGE-3。而唯一获FDA批准上市的治疗性前列腺癌疫苗Provenge，最终也未能实现其商业价值，该疫苗的开发商Dendreon最近宣布破产并被Valeant以区区4亿美元收购。
不过，百时美施贵宝认为，治疗性癌症疫苗配合其免疫检查点抑制剂（如Yervoy）将发挥巨大作用。就在一周前，百时美与Bavarian Nordic公布了一项I期研究的早期数据，该研究在30例转移性去势抵抗性前列腺癌（mCRPC）患者中开展，数据显示，最佳剂量Yervoy（10mg）+Prostvac联合治疗组中位总生存期（OS）达到了37.2个月，而更为激动人心的是，其中有20%的患者在启动治疗后80个月仍然存活。
当前，将治疗性癌症疫苗与检查点抑制剂相结合的免疫鸡尾酒理念已在业界达成共识，并于去年9月在马德里举行的第39届欧洲肿瘤内科年会（ESMO）上成为会议焦点。罗氏首席执行官Severin Schwan去年接受路透社采访时也表示，该公司正在探索将其免疫检查点抑制剂与癌症疫苗相结合的组合疗法。
目前，包括罗氏、百时美施贵宝、默沙东、阿斯利康在内的制药巨头正在免疫治疗领域展开激烈竞争，有分析师预计，该市场最终的年销售额将超过300亿美元。（生物谷Bioon.com）
英文原文：Bristol-Myers Squibb Signs Exclusive Agreement with Bavarian Nordic for PROSTVAC?, a Prostate-Specific Antigen-Targeting Cancer Immunotherapy
Bavarian Nordic to receive up to $975 million, inclusive of $60 million upfront and potential exercise payment; potential development, regulatory and commercialization milestone payments; additional tiered double-digit royalties on future sales
KVISTGAARD, Denmark & NEW YORK--(BUSINESS WIRE)--Bavarian Nordic (OMX:BAVA) (OTC:BVNRY) and Bristol-Myers Squibb Company (NYSE:BMY) announced today an agreement that provides Bristol-Myers Squibb an exclusive option to license and commercialize PROSTVAC?, Bavarian Nordic’s investigational Phase 3 prostate-specific antigen (PSA)-targeting cancer immunotherapy in development for the treatment of asymptomatic or minimally symptomatic metastatic castration-resistant prostate cancer (mCRPC).
Under terms of the agreement, Bavarian Nordic will receive an upfront payment of $60 million. Bristol-Myers Squibb can exercise the option in its sole discretion within a designated time after data is available from the ongoing Phase 3 trial. Bavarian Nordic would be entitled to a payment of $80 million upon exercise of the option plus additional incremental payments starting at $50 million, but with a potential to exceed $230 million should the median overall survival benefit of PROSTVAC exceed the efficacy seen in Phase 2 results. Furthermore, Bavarian Nordic could receive regulatory milestone payments of $110 million, up to $495 million in sales milestones as well as tiered double-digit royalties on future sales of PROSTVAC. The parties have also agreed to enter into a supply contract, under which Bavarian Nordic will undertake the future commercial manufacturing of PROSTVAC.
An investigator sponsored Phase 2 study is currently in the planning stages to investigate the combination of Bristol-Myers Squibb’s YERVOY (ipilimumab) and PROSTVAC. The companies have also entered into an agreement by which they may conduct one or more exploratory combination studies of PROSTVAC and agents from Bristol-Myers Squibb’s immuno-oncology portfolio.
“While additional treatment options have become available, metastatic castration-resistant prostate cancer remains largely incurable,” said Michael Giordano, Head of Development, Oncology, Bristol-Myers Squibb. “Our agreement with Bavarian Nordic reflects our commitment to following the emerging science in immuno-oncology and supports our strategy to transform the treatment of cancer across multiple tumor types, lines of therapy and stages of disease.”
Bristol-Myers Squibb has an ongoing Phase 3 program for YERVOY in prostate cancer, and scientific rationale exists to evaluate PROSTVAC in combination with YERVOY, and other agents from Bristol-Myers Squibb’s immuno-oncology portfolio.
“We are proud to partner with Bristol-Myers Squibb whose excellence and leadership in immuno-oncology provides a strong foundation for advancing PROSTVAC, which has the potential to become an essential component in the treatment of prostate cancer,” said Paul Chaplin, Ph.D. and Chief Executive Officer of Bavarian Nordic. “Leveraging the capabilities of Bristol-Myers Squibb’s science, we look forward to exploring the full potential of PROSTVAC in the future treatment paradigm of prostate cancer.”
About PROSTVAC
PROSTVAC is a ready to use immuno-oncology agent that stimulates an immune response that attacks prostate cancer cells. Administered subcutaneously, PROSTVAC employs Bavarian Nordic’s active immunotherapy (vaccinia-fowlpox/TRICOM) technology platform. When PSA-TRICOM is presented to the immune system in the PROSTVAC regimen, cytotoxic T lymphocytes (CTLs) are generated that may recognize and kill PSA-expressing cancer cells and trigger an immune response to other tumor antigens. PROSTVAC is currently being evaluated in a global, randomized, double-blind, placebo-controlled phase 3 study (PROSPECT), that has fully enrolled at 1,298 patients with asymptomatic or minimally symptomatic metastatic castration-resistant prostate cancer (mCRPC). Previous clinical studies of PROSTVAC, either as single-agent therapy or in combination with anti-androgen therapies, radiation therapies or immune checkpoint inhibitors have indicated possible therapeutic synergies for these treatment combinations and PROSTVAC has been generally well-tolerated.
About Prostate Cancer
Prostate cancer is the second most frequently diagnosed cancer and the sixth most deadly cancer in men. Most deaths will be caused by metastatic castration-resistant prostate cancer, which occurs when the cancer becomes resistant to standard hormonal treatment and spreads from the prostate to other organs in the body.
About Bavarian Nordic
Bavarian Nordic is an international biotechnology company developing and manufacturing novel cancer immunotherapies and vaccines for infectious diseases. Lead product candidates are PROSTVAC?, an immunotherapy product candidate for advanced prostate cancer that is the subject of an ongoing pivotal Phase 3 clinical trial, and IMVAMUNE?, a non-replicating smallpox vaccine candidate in Phase 3 development, which is being developed and supplied for emergency use to the U.S. Strategic National Stockpile under a contract with the U.S. Government. The vaccine is approved in Canada under the trade name IMVAMUNE and in the European Union under the trade name IMVANEX.