Olvimulogene nanivacirepvec

目前，全球市面上4款溶瘤病毒产品当中，中国的安科瑞占据一席之地，这预示着我国溶瘤病毒药物开发走在国际前列。然而，已上市的溶瘤病毒产品面临着销售乏力、疗效有待提升、用药途径限制了推广等挑战。溶瘤病毒药物开发过程当中，有哪些困难与挑战？采取哪些策略才能克服呢？ 目前已上市的4款溶瘤病毒产品一览表 2024年10月26-27日，第二届溶瘤病毒创新与合作大会在武汉召开。大会设置了“溶瘤病毒药物开发策略与挑战”PANEL讨论环节，深圳市华药康明生物药业有限责任公司创始人、董事长袁明担任主持人，与广州威溶特医药科技有限公司董事长颜光美、上海允英生物医药科技有限公司CEO张道允、浙江理工大学生命科学与医药学院教授&杭州功楚生物科技有限公司首席科学家李恭楚、武汉博威德生物技术有限公司董事长兼首席科学家蔡立刚、上海美迪西生物医药股份有限公司首席科学官彭双清等嘉宾同台，从技术层面和监管层面探讨了溶瘤病毒药物开发遇到的痛点和难点，寻求破局之道。 袁明：溶瘤病毒发展滞后有哪些因素，溶瘤病毒开发面临的主要挑战是什么？ 张道允：溶瘤病毒做了100多年了，为什么还没有很惊艳的效果出来？溶瘤病毒属于免疫治疗的一份子，它在整个免疫治疗当中处于什么样的地位，怎么和其他药物联用，才能够达到比较好的效果，这是目前的核心，也是我们所努力的方向。溶瘤病毒治疗实体瘤，联用是一个比较好的选择，到底怎么联用需要大家再探索。 颜光美：我们要等待机会，等溶瘤病毒推进到重要的临床阶段。目前滨会生物的OH2做到了三期，其他公司更多是在一期、二期，等我们进入到更后期，或者有更多适应症用溶瘤病毒，可能就会产生惊艳的结果。我们不要忘记免疫治疗PD-1、PD-L1等，在很长一段时间内，没有一个肿瘤学家把它当一回事，一直到它效果显现。溶瘤病毒的优势是安全性好，随着给药方式的改良，随着一些好的结果出现，一定会有引人注目的一天。    李恭楚：溶瘤病毒真正应用实践的历史还比较短，我们对溶瘤病毒感染过程中的调控细节尚未完全清楚，比如哪些是正向的调控，哪些是负向的调控?只有我们对病毒知道得越多，才能知道怎样让它更好地应用。 蔡立刚：首先，加强教育，包括受众的教育和医生的教育。我们从事溶瘤病毒研究的人，不仅仅是要研究自己的病毒，而且要开展教育活动，就像刘滨磊教授一样，经常举办这样的教育活动。人们普遍认为病毒对人体是有侵害作用的，感染病毒以后要用抗病毒的药物，然而病毒改造后可以用于抗肿瘤、治疗疾病，这需要加强教育、转变观念。 其次，优化监管，促进溶瘤病毒行业的发展。比如监管部门对产品的宿主DNA残留含量要求是否要跟疫苗一样的标准，疫苗主要是针对儿童的，它要把表征宿主DNA的残留维持在很低的水平，但对一个肿瘤病人来说稍微增加一点点也无妨。监管要求越严，企业在这个问题上花费的时间越多，一定程度上延缓了研究进程。要提高溶瘤病毒的发展速度，要从各个方面进行改善。 彭双清：我们做的是一个裁判官的工作，要评价病毒的安全性和有效性，而且是在临床前。人类跟病毒作斗争有相当长的历史，病毒的危害大家都记忆犹新。利用病毒，它所面临的挑战主要是风险问题，所以临床前基础者要与临床研究者紧密合作。 袁明：在当前溶瘤病毒产品的开发中，怎样更好地提高产品的成药性？ 张道允：我认为要不停地试，各个癌种都要尝试一下。 蔡立刚：提高溶瘤病毒产品的成药性，首要因素是要安全性，溶瘤病毒的产品在安全性方面应该没有大的问题；其次是有效性，需要在动物和人身上验证；另外，它的制作过程要可及，即成本要低，如果溶瘤病毒产品生产出来后几十万一针，病人用不起，它的成药性就低，成药性和可使用性有很大的关系。 颜光美：一方面是技术层面的东西，需要采取正确的研发的路径，可以借助协作机构的力量，比如彭教授代表的CRO的应用，极大地推动了中国包括溶瘤病毒在内的成药的过程，提高了成药性。 另一方面是监管层面，建议监管部门借鉴先进经验，改良监管机制，比如日本的监管既有科学、严谨、细致的一面，也有非常讲道理的一面，如果在IIT当中验证过产品的安全可靠性，正式做临床试验的时候可以沿用相关数据。 李恭楚：这涉及溶瘤病毒将来的发展趋势，到底是单药还是联用还不明朗，我觉得联用的可能性更大。溶瘤病毒第一特性是通过复制来裂解，其次才是免疫，将来有可能和谁去联合，随着研究的进展慢慢地会显示出来，它是一个需要积累的过程。 彭双清：成药性就是要保证它的安全性、有效性以及质量可控性，而且要满足未被满足的临床需求。与会同期，有关部门也召集了专家研讨包括溶瘤病毒在内的新型治疗产品的发展问题，相信随着监管的改进，成药性会增强。 袁明：我也补充一点在成药性的有效性方面，虽然溶瘤病毒是一个广谱治疗实体瘤的方式，因为溶瘤病毒有不同的嗜性，每一种溶瘤病毒有其擅长的适应症。在此基础上要筛选出哪一部分病人适合这种治疗方法，这牵涉到生物标志物的筛选，病人的选择是非常重要的。临床方案上，现有的获批的四个溶瘤病毒产品，在临床方案的应用上存在一定的缺陷，长时间间隔的用药方式有非常大的不合理性，这里面有很大的优化空间。比如JX594治疗癌症的临床效果比Olvi-Vec差，主要是用药方案的不同，JX594用药方案基本上是静脉用药，间隔两周或者三周，而Olvi-Vec是连续5天静脉用药，我认为Olvi-Vec的用药方案远远好于JX594。只有一个更合理的用药方案才能产生最佳的治疗效果，怎么测试、优化出一个更科学、有效的临床方案，才能把你产品的治疗潜力发挥到极致，是临床开发中需要考虑的问题。 另外一个是联合用药的问题，溶瘤病毒大概率要联合用药，肿瘤治疗中非常少有单药应用。因为肿瘤是一个复杂性的疾病，有多维度的复杂性，所以想要解决它不能靠单一的方式，那么联合哪些治疗方式，方案设计也非常重要。 一个药物产品的成药性主要是安全、有效、可生产，不管你多有效、多安全，如果你这个药的可生产性很差，那这个药在临床上推广或成药性方面有很大的问题，可生产性主要在于质量控制和成本控制。 接下来请大家从自身角度出发，分享你们在溶瘤病毒开发中遇到的难点。 张道允：困难是一个接着一个克服的，比如像CMC，其实很难做，有一些点控制不下来就是不合格。比如核酸的残留必须控制在10纳克以下，这个是一个硬指标，不管它合理也好、不合理也好，现行的标准就是这样，否则过不去。我们讲产品质量源于设计，有时候监管要求尽管很苛刻，但也得照着去做，往往是在戴着镣铐跳舞。 颜光美：我们做的是一个全新的病毒，去申报的时候碰到的困难相对多一些，经验的积累是很重要的。回过头来想，我们在创新的过程中团队的培养和经验的积累是困难的，基本上每前进一步，都是用钱烧出来的，要付出很多的代价。 蔡立刚：我们公司做的产品可以说是一个地地道道的原创，柯萨奇病毒B3重组后用于静脉注射，是一个新靶点，用药的途径是新途径，静脉注射相比局部注射/瘤内注射更难获得监管部门批准。从2010年开始，到今年14年了，还在申报临床批件阶段，我们还在坚持，痛并快乐着。第二个痛点，研发需要不断地砸钱，钱从哪里来呢？感谢我的房东、投资人、股东，不断地给钱。我们为溶瘤病毒这个产品的赛道不断地充实而努力，我想肯定会成功的，溶瘤病毒是值得我们付出毕生精力的赛道和产品，值得我们一搏。 彭双清：溶瘤病毒这一类型的modality可以说是一个现代科学高度集中的表现，是现代分子生物学的最前沿，通过基因分子修饰，把危害人类的病毒变为人类的宝贝，来拯救人类的身体健康，里面有很多的科学问题尚未解决。它的研发是一个多学科的整合，针对它的监管不能用传统的模式，将来不管是CRO也好，还是研发者也好，目标都是共同一致的，希望形成一种独特的审评机制，这是我们共同努力的一个方向。 总之，随着溶瘤病毒药物研发技术的提升及监管的优化，相信未来会有更多的溶瘤病毒产品被研发出来，并应用到肿瘤的临床治疗当中，造福更多的癌症患者。 声明：本文由现场对话整理而成，未经嘉宾审核，仅供交流之用，不构成投资建议。 END ------------------------------ 「长按」二维码添加小达「进群」 与更多行业伙伴共探市场前沿资讯 艾美达医药咨询 艾美达（北京）医药信息咨询有限公司，成立于2014年4月，是一家专业的医药行业咨询服务提供商。公司致力于将产业政策研究与真实世界的数据挖掘深度结合，洞悉行业政策对市场的影响，通过专业的研究提供前瞻性的市场分析，为企业产品上市后的市场准入提供整体解决方案。

WESTLAKE VILLAGE, Calif., Nov. 14, 2024 (GLOBE NEWSWIRE) -- Genelux Corporation (NASDAQ: GNLX), a late clinical-stage immuno-oncology company, today announced financial results for the third quarter of 2024 and provided general business updates. The Company initiated its second lung cancer trial, a US-based, Phase 2 trial (VIRO-25) treating patients with recurrent advanced or metastatic non-small cell lung cancer (NSCLC) with Olvi-Vec, followed by platinum-doublet chemotherapy + immune checkpoint inhibitor. Additionally, a Phase 1b/2 lung cancer trial is ongoing in recurrent small cell lung cancer (SCLC) in China which is co-sponsored with Newsoara BioPharma Co., Ltd. Both trials utilize Olvi-Vec delivered intravenously to treat patients who have previously failed platinum-based chemotherapy. The trials are designed based on earlier clinical results, including Olvi-Vec demonstrating (i) positive outcomes in patients with primary or metastatic lung cancer when delivered intravenously and (ii) clinical reversal of platinum resistance and refractoriness in a Phase 2 trial in platinum-resistant/refractory ovarian cancer (PRROC). "Over the past quarter, we marked another important step forward in our efforts to advance the systemic delivery of Olvi-Vec and to demonstrate the re-sensitization to platinum-based chemotherapy in multiple tumor types," said Thomas Zindrick, President, CEO and Chairman of Genelux. "With interim data from our SCLC trial anticipated by the end of 2024 and data releases from our Phase 3 registration trial in PRROC and Phase 2 trial in NSCLC anticipated in 2025, we are confident that Genelux is positioned to make a meaningful impact in the lives of cancer patients." Pipeline Highlights The Company’s clinical program is designed to position Olvi-Vec as an ideal backbone of combination cancer therapy due to its unique mechanism of action to modify the tumor immune microenvironment. Building on the promising results from our previous clinical trials, we see the potential of Olvi-Vec to induce platinum re-sensitization as a strategy to enhance patient response and extend survival in platinum-resistant populations. In addition, the VIRO-25 trial expands the program to include combination therapies with immune checkpoint inhibitors as we aim to unlock synergistic activity that amplify the immune response against tumors. Patient enrollment continues to progress in the Phase 3 OnPrime/GOG-3076 trial for PRROC, now active at over 25 sites (NCT05281471). Topline results are anticipated in the latter half of 2025. Phase 2 VIRO-25 is actively enrolling recurrent NSCLC patients (NCT06463665), with interim data expected by mid-2025. Interim results from the Phase 1b portion of a Phase 1b/2 SCLC trial projected by end of 2024. Third Quarter 2024 Financial Results Cash and cash equivalents, and short and long-term investments were $35.1 million as of September 30, 2024. The Company expects its existing cash and cash equivalents, and short and long-term investments will provide runway into the first quarter of 2026. Research and development (R&D) expenses $4.1 million and $2.8 million for the three months ended September 30, 2024 and 2023, respectively, an increase of $1.2 million. Significant variations between periods are primarily a result of a $0.4 million increase in stock-related compensation in 2024, relating to the increased cost of stock options and restricted stock units in 2024; and a $0.9 million increase in clinical and regulatory expenses relating to increased clinical trial costs associated with our Phase 3 OnPrime Registration trial in 2024. General and administrative (G&A) expenses were $2.9 million and $2.5 million for the three months ended September 30, 2024 and 2023, respectively, an increase of $0.4 million. Significant variations between periods are primarily a result of a $0.7 million increase in stock compensation expense in 2024, due to the increase in the cost of stock options and restricted stock units in 2024; offset by a $0.3 million decrease in professional service expenses in 2024, primarily resulting from decreased corporate legal costs. Net loss was $6.5 million for the third quarter of 2024 or a net loss per share of $0.19, as compared to net loss of $5.3 million for the third quarter of 2023, or a net loss per share of $0.20. About Genelux Corporation Genelux is a late-stage clinical biopharmaceutical company focused on developing a pipeline of next-generation oncolytic immunotherapies for patients suffering from aggressive and/or difficult-to-treat solid tumor types. The Company's most advanced product candidate, Olvi-Vec (olvimulogene nanivacirepvec), is a proprietary, modified strain of the vaccinia virus. Olvi-Vec currently is being evaluated in OnPrime/GOG-3076, a multi-center, randomized, open-label Phase 3 registrational trial evaluating the efficacy and safety of Olvi-Vec in combination platinum-doublet + bevacizumab compared with physician's choice of chemotherapy and bevacizumab in patients with platinum-resistant/refractory ovarian cancer. The core of Genelux's discovery and development efforts revolves around its’ proprietary CHOICE™ platform from which the Company has developed an extensive library of isolated and engineered oncolytic vaccinia virus immunotherapeutic product candidates, including Olvi-Vec. For more information, please visit www.genelux.com and follow us on Twitter @Genelux_Corp and on LinkedIn. Forward-Looking Statements This release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and such forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. “Forward-looking statements” describe future expectations, plans, results, or strategies and are generally preceded by words such as “believes,” “anticipates,” “expect,” “may,” “plan” or “will”. Forward-looking statements in this release include, but are not limited to, statements related to Genelux’s future plans and prospects, Genelux’s anticipated cash runway and the sufficiency of its resources to support its planned operations, the planned timing of Genelux’s data results in its ongoing clinical trials and continued development of Olvi-Vec, and the potential capabilities and advantages of Olvi-Vec. Such statements are subject to a multitude of risks and uncertainties that could cause future circumstances, events, or results to differ materially from those projected in the forward-looking statements. These and other risks are identified under the caption “Risk Factors” in Genelux’s filings with the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made and are based on management’s assumptions and estimates as of such date. Genelux does not undertake any obligation to publicly update any forward-looking statements, whether as a result of the receipt of new information, the occurrence of future events or otherwise. Investor and Media Contacts Ankit Bhargava, MDAllele Communications, LLCgenelux@allelecomms.com Source: Genelux Corporation Genelux CorporationCondensed Balance Sheets(in thousands, except for share amounts and par value data) September 30, December 31, 2024 2023 ASSETS(Unaudited)Current Assets Cash and cash equivalents$6,102 $9,418 Short-term investments 27,955 13,773 Prepaid expenses and other current assets 1,910 1,012 Total Current Assets 35,967 24,203 Property and equipment, net 1,278 1,170 Right of use assets 1,930 2,428 Long-term investments 1,003 - Other assets 92 92 Total Other Assets 4,303 3,690 TOTAL ASSETS$40,270 $27,893 LIABILITIES AND SHAREHOLDERS' EQUITY Current Liabilities Accounts payable and accrued expenses$4,454 $3,784 Accrued payroll and payroll taxes 686 2,117 Lease liabilities, current portion 415 653 Total Current Liabilities 5,555 6,554 Lease liabilities, long-term portion 1,624 1,866 Total Liabilities 7,179 8,420 Shareholders' Equity Preferred stock, par value $0.001, 10,000,000 shares authorized; no shares issued and outstanding, respectively; - - Common stock, par value $0.001, 200,000,000 shares authorized; 34,538,185 and 26,788,986 shares issued and outstanding 35 27 Treasury stock, 433,333 shares, at cost (433) (433)Additional paid-in capital 275,782 241,389 Accumulated other comprehensive income 124 14 Accumulated deficit (242,417) (221,524)Total Shareholders' Equity 33,091 19,473 TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY$40,270 $27,893 The accompanying notes are an integral part of these condensed financial statements. Genelux CorporationCondensed Statements of Operations(in thousands, except for share amounts and per share data) Three Months Ended Nine Months Ended September 30, September 30, 2024 2023 2024 2023 (Unaudited) (Unaudited) Revenues$- $- $8 $170 Operating expenses: Research and development 4,051 2,819 12,478 8,607 General and administrative 2,890 2,488 9,478 8,727 Total operating expenses 6,941 5,307 21,956 17,334 Loss from operations (6,941) (5,307) (21,948) (17,164) Other income (expenses): Interest income 474 4 1,055 4 Interest expense - - - (167)Debt discount amortization - - - (649)Financing costs - (42) - (3,152)Debt extinguishment costs - (402)Total other income (expenses), net 474 (38) 1,055 (4,366) NET LOSS$(6,467) $(5,345) $(20,893) $(21,530) LOSS PER COMMON SHARE - BASIC AND DILUTED$(0.19) $(0.20) $(0.69) $(0.91) WEIGHTED-AVERAGE COMMON SHARES OUTSTANDING - BASIC AND DILUTED 34,532,355 26,210,068 30,405,615 23,640,995 The accompanying notes are an integral part of these condensed financial statements. Genelux CorporationCondensed Statements of Comprehensive Loss(in thousands) Three Months Ended Nine Months Ended September 30, September 30, 2024 2023 2024 2023 (Unaudited) (Unaudited) Net loss$(6,467) $(5,345) $(20,893) $(21,530) Other comprehensive loss: Net unrealized gain on short and long-term investments 135 - 110 - Comprehensive loss$(6,332) $(5,345) $(20,783) $(21,530) The accompanying notes are an integral part of these condensed financial statements.