SurVaxM

Investors feature leading brain tumor venture philanthropy funds including the Brain Tumor Investment Fund (BTIF) and The Sontag Innovation The along with MEDA Angels, Varia Ventures and private investors. Investment catalyzed by positive results from Phase 2a study of SurVaxM in newly diagnosed glioblastoma (ndGBM) published in the Journal of Clinical Oncology. Funding will support the ongoing Phase 2b clinical study and subsequent registration-related initiatives. BUFFALO, N.Y., Jan. 9, 2024 /PRNewswire/ -- MimiVax, Inc., a biotechnology company focused on the development of SurVaxM, a survivin-targeted vaccine therapy for glioblastoma and other cancers, today announced new investments from the venture philanthropy arms of leading brain tumor patient organizations, VC, private and existing investors. Continue Reading MimiVax Announces New Investments to Support Clinical Development of SurVaxM in Glioblastoma Post this (PRNewsfoto/MimiVax, LLC) The investments from the Brain Tumor Investment Fund (BTIF), an affiliate of the National Brain Tumor Society (NBTS), the Sontag Innovation Fund, LLC, a subsidiary of the Sontag Foundation, the MEDA Angels, LLC, Varia Ventures and private investors will support the ongoing phase 2b clinical study, subsequent registration-related work and prepare the company for commercialization of SurVaxM for ndGBM. Glioblastoma is a rare but deadly cancer with median overall survival of only about 16 months. SurVaxM was developed to bring a paradigm shift to a field that has seen little advancement in decades. MimiVax is rapidly enrolling subjects in its SURVIVE trial [NCT05163080], a randomized, blinded, placebo-controlled Phase 2b clinical trial of SurVaxM among patients with ndGBM at 11 cancer centers across the USA. This follows the successful Phase 2a study published in the Journal of Clinical Oncology having met its primary endpoint, achieving a median overall survival (mOS) of 25.9 months – and further reporting that 41% of the patients receiving SurVaxM survived at least 3 years, with several long term progression-free survivors. Investment funding is designed to help MimiVax achieve its goal of revolutionizing the landscape of brain tumor treatment. "We are honored to receive significant investments from The Brain Tumor Investment Fund, The Sontag Innovation Fund, MEDA Angels, Varia Ventures along with our private investors. "Their confidence in our mission further propels our efforts to make a meaningful impact in the lives of those affected by brain tumors," said Michael Ciesielski, CEO, MimiVax, Inc. The Brain Tumor Investment Fund, known for its dedication to funding pioneering solutions in neuro-oncology, expressed enthusiasm about the partnership. "Brain tumor patients and caregivers desperately need better outcomes. The results seen in previous trials of SurVaxM make us optimistic for the SURVIVE Phase 2b trial and the potential for a new treatment on the horizon" said John Higgins, Managing Director of BTIF. The MEDA Angels, (part of the Tech Coast Angels (TCA) network) are a health-care focused investor group founded by physician, payers and scientist-angel investors, supported by a team of regulatory, reimbursement, legal and financial advisors. "We knew the grave unmet need for game-changing therapy for glioblastoma, a devasting brain cancer with so limited average survival time of 16 months. After review of MimiVax' approach, targeting a strong epitope and the data through their Phase 2a, we became confident they were well worth backing." -MEDA Angels The Sontag Innovation Fund, building on the reputation of the Sontag Foundation as one of the largest private funders of brain tumor research in North America, is proud to have MimiVax as a portfolio company. "There is an extraordinary unmet need for new treatments that make a major impact in the brain tumor space. We are excited to play a role in the development of promising therapies like SurVaxM" said Scott Davis, Managing Director of the Sontag Innovation Fund. MimiVax extends its gratitude to The Brain Tumor Investment Fund, The Sontag Innovation Fund, MEDA Angels, Varia Ventures and our private investors for their support and confidence in the company's vision. This investment fortifies MimiVax's position as a key player in the quest for innovative solutions in the fight against brain tumors. About MimiVax, Inc MimiVax, Inc. is a Delaware-incorporated, clinical-stage biotechnology company focused on immunotherapy research and clinical translation of new agents for cancer treatment. The Company was formed to develop and commercialize its lead candidate SurVaxM. For more information on MimiVax, visit or email [email protected]. About SurVaxM SurVaxM is a first-in-class, patented immunotherapy that targets survivin, a cell-survival protein. SurVaxM is delivered subcutaneously and stimulates a patients' own immune response to control tumor growth and prevent future disease recurrence. Because survivin is present in many forms of cancer, SurVaxM could potentially have wide therapeutic applicability. About the Brain Tumor Investment Fund The Brain Tumor Investment Fund (BTIF) is the non-profit venture philanthropy arm of the National Brain Tumor Society (NBTS), the largest patient advocacy organization in the United States committed to curing brain tumors and improving the lives of patients and families. BTIF BTIF) invests in innovative biotechnology, pharmaceutical, and medical device companies developing promising new treatment opportunities for patients with brain cancer. () About The Sontag Innovation Fund The Sontag Innovation Fund, a wholly-owned venture subsidiary of The Sontag Foundation, one of the largest private funders of brain cancer research in the United States, made the investment. The Sontag Innovation Fund invests in early stage and innovative technologies with the potential to drive cures and improve the quality of life or life expectancy for brain cancer patients. () About MEDA Angels The MEDA Angels are a healthcare-focused angel investor group that invests liberally across mid-seed and Series A healthcare opportunities: both disease management and prevention. Importantly, many startups see an investment by MEDA as validation of the merits of their technology, as potential users, and payer friendly products. () About Varia Ventures Varia Ventures is a next generation venture capital platform for professional organizations interested in building wealth for themselves and their members through investing in a portfolio of highly curated, emerging companies, originating from their organizations. Varia's platform blends insights from key opinion leaders, strategic partners, and industry experts through its "end-to-end" technology solution designed to support early stage companies while providing compelling investment opportunities to its investors. () SOURCE MimiVax, Inc.

2020年秋天，61岁的W先生被确诊为最致命的脑肿瘤--胶质母细胞瘤，生命进入倒计时，因为这类癌症的平均生存时间仅为 12 至 18 个月...幸运的是，他找到了一种可以延缓复发的癌症疫苗--SurVaxM。令他万万没想到的是，接受治疗后他的脑瘤至今未复发，目前3年过去了，他仍在旅行并享受生活。 近期，美国FDA传来喜讯，授予“胶质瘤治疗性疫苗SurVaxM”快速通道认定，用于治疗四级胶质母细胞瘤患者。SurVaxM疫苗正在克利夫兰和罗斯维尔公园癌症研究所进行临床试验，结果显示：在 63 名患者参与的试验中显示，其生存时间几乎延长了一倍。有望给处于绝境的胶质瘤患者带来救赎。 延缓复发！新型疫苗让晚期患者恶性脑肿瘤患者重回正常生活 2020年秋天，家住纽约州的61岁大叔 J先生 被诊断出患有胶质母细胞瘤。据美国国家脑肿瘤协会发言人汤姆哈尔金称，去年美国有超过 14,000 人被确诊。它几乎占所有恶性脑肿瘤的一半。这种疾病对患者和家庭来说是毁灭性的，五年生存率仅为 6.8% 。 更糟的是，胶质母细胞瘤极难治疗，因为它们会像 蜘蛛网或章鱼触手的形式在大脑内蔓延 ，即使手术，也无法完全清除，除非每个癌细胞都被消灭，否则 100% 的患者会面临复发！ 幸运的是，J先生的女儿在美国罗斯威尔公园综合癌症中心工作，当时这家权威的癌症中心正在进行一项专门针对这类恶性脑瘤的新型癌症疫苗的临床实验。 医生说，这种名为 SurVaxM 的疫苗以一种在肿瘤中发现的名为Survivin的细胞存活蛋白质为目标，当疫苗注射入体内时，能够刺激免疫系统杀死含有 survivin 的肿瘤细胞。此外，SurVaxM疫苗可以训练免疫系统瞄准并攻击癌细胞，因此当癌细胞复发时，身体可以迅速将它们清除掉，控制肿瘤生长和预防或延缓肿瘤复发。 这听起来像是一个遥不可及的幻想： 一种可以延迟胶质母细胞瘤复发的疫苗？ 胶质母细胞瘤可是最致命和治疗耐药的癌症之一！实际上，在一项早期临床试验中，SurVaxM 疫苗被证实可以将被诊断患有脑癌的人的平均生存时间从大约12个月延长至 26 个月 ，这是非常了不起的突破！ 经过多番申请，J先生幸运的通过“同情用药”计划接受了这款前沿的癌症疫苗的治疗。 这种疫苗就像流感疫苗或新冠疫苗一样注射在手臂上，由四剂组成，分期两个月，然后每两个月注射一剂加强剂量。 两年半后，J先生仍在旅行并享受生活——这对于平均存活时间仅为1年的恶性脑瘤患者来说是非常罕见的。 （注：为保护患者隐私，文中均使用化名，病情及治疗经过略有删减，想查看原文献的可以点击文末链接。） 延缓恶性脑肿瘤复发！FDA授予SurvaxM快速通道认定 看了上面的报道，相信很多人想知道这款疫苗究竟是何方神圣？ SurVaxM，也称为SVN53-67 / M57-KLH，是一款全球首创的肽模拟肿瘤疫苗，可以靶向一种叫做 Survivin的细胞存活蛋白 。Survivin是一种抗凋亡蛋白，可帮助癌细胞抵抗常规治疗，在许多癌症（包括95%的恶性神经胶质瘤，多发性骨髓瘤，神经内分泌，髓母细胞瘤，黑素瘤，肾脏，乳腺和卵巢肿瘤）中都高度表达。 SurVaxM疫苗具有独特的细胞和抗体介导的抗肿瘤反应，能够同时触发T细胞和B细胞免疫以及抗体导向survivin通路抑制的双重作用机制，刺激免疫系统杀死含有survivin的肿瘤细胞，控制肿瘤生长和预防或延缓肿瘤复发。 由于这是一种合成疫苗，是由天然氨基酸制成的，并且在产生免疫反应时会分解，因此副作用很小。 2017年SurVaxM被美国食品和药物管理局（FDA）授予了孤儿药称号。 2023年10月，FDA再次授予这款疫苗快速通道制定。 2023年3月，SurVaxM的Ⅱa期临床试验数据发表在国际知名肿瘤期刊 《临床肿瘤学杂志》 上。最新结果表明，免疫疗法SurVaxM疫苗即使在最难治疗的患者亚组中也具有安全性，良好的耐受性，并且能够延长生存期延长的生存期。引起巨大轰动。 63例新诊断为胶质母细胞瘤的患者进行了标准护理加SurVaxM的治疗。研究表明： 该治疗组合耐受良好。观察到的副作用通常是轻度的，在这项研究中看到的唯一副作用是注射部位周围的皮肤反应或皮疹； 96.7％的患者在开始这种治疗组合后的头六个月内未经历疾病进展； 94.2％的研究参与者在诊断后一年还活着，这大大超过了仅标准护理的历史研究（65％）； 接受SurVaxM的患者的中位总体生存时间为30.5个月，而接受标准护理的患者为14.8个月。翻了一倍多。 目前SurVaxM 疫苗的临床实验计划招募 270 名患者。预计将在美国和中国的 10 多个地点进行，将注射疫苗与接受标准护理的患者进行比较。一旦开始招募，这将是全球脑瘤患者的福音。期待这款疫苗能够早日获批上市。 溶瘤病毒、树突疫苗、电场疗法等众多疗法为脑瘤患者打开长生存大门 在过去15年中，400多个胶质母细胞瘤临床试验都失败了....终于，针对这一毁灭性癌症，近两年众多新疗法横空出世，除了上文值得期待的脑瘤疫苗，溶瘤病毒、树突疫苗、电场疗法等也为脑瘤患者带来了全新的生机。 一： 全球首款脑瘤溶瘤病毒获批上市！ 2021年6月11日，世界上首款治疗原发性脑瘤的溶瘤病毒疗法teserpaturev在日本获批的喜讯在癌友圈中刷屏，给病友们带来了新的生存希望，2021年11月1日，溶瘤病毒疗法正式在日本获批用于临床治疗。 二：15年磨一剑！脑瘤疫苗横空出世 研究人员花费了将近20年的时间致力于激活抗脑癌的树突状细胞。近期，令全球备受瞩目的脑瘤树突细胞疫苗DCVax®-L研究终于公布了III期临床实验的顶线数据，结果显示，DCVax®-L疫苗能够显著延长脑胶质瘤患者的生存期，最值得一提的是，5 年生存率统计显示：疫苗组为13%，而对照组仅为5.7%，翻了一倍多！至此，这项长达15年的研究终于交出了满意的答卷，也给无数饱受摧残的脑瘤患者带来了全新的希望！ 三：5年无复发！无创抗癌新技术成功治疗恶性脑瘤 电场疗法被称为是脑瘤治疗的里程碑！这是十多年来第一次，出现了一种非有效地疗法，能够显著的提高脑质母细胞瘤患者的生存期！已经有研究表明，手术、化疗和放疗来治疗脑胶质瘤，5年的生存几率为 5%。如果75% 的时间佩戴 Optune，存活几率会增加到 13%。如果有 90% 到 100% 的时间穿着它，5年生存率会增加到 29%，几乎可以延长6倍！给脑瘤患者带来了史无前例的生存突破 除了上面的这些疗法，对于脑瘤患者，现在医学界更提倡通过多种治疗手段进行综合治疗，包括局部放化疗、靶向和免疫等，需要针对患者的具体情况综合考虑，量身定制。因此，在如何选择最佳治疗方案和用药上可以通过全球肿瘤医生网求助于国内外权威专家，这样才能让广大癌友们少走弯路，得到最大的临床获益。想寻求电场疗法及其他国内外治疗新技术帮助，且经济条件允许的情况下，可以提交资料全球肿瘤医生网医学部进行初步评估。脑瘤并不可怕，希望大家坚定信心，通过规范合理的治疗，获得更长的生存期！ 参考资料： https://www.nbcnews.com/health/health-news/brain-tumor-vaccine-experimental-shot-shows-promise-glioblastoma-rcna83362 DOI: 10.1200/JCO.22.00996 Journal of Clinical Oncology 41, no. 7 (March 01, 2023) 1453-1465.