OncoImmune, Inc.

The merger grows OncoC4’s pipeline and geographical footprint, with in-house clinical manufacturing capabilities in China. OncoC4 is taking AcroImmune—and its in-house clinical manufacturing capabilities—under its wing in an all-stock merger.Both cancer biotechs were co-founded by OncoC4 CEO Yang Liu, Ph.D., and OncoC4 Chief Medical Officer Pan Zheng, M.D., Ph.D, according to a Sept. 25 release.OncoC4 is a spinout from Liu- and Zheng-founded OncoImmune, which was acquired in 2020 by Merck & Co. for $425 million. Now, the private, Maryland-based biotech is acquiring 100% of all AcroImmune’s outstanding equity interests. The companies have a similar shareholder base, according to the release.The new biotech will operate under OncoC4’s name and will continue to be led by CEO Liu. Specific financials of the deal were not disclosed. The merger adds AI-081, a preclinical bispecific antibody targeting PD-1 and VEGF, to OncoC4’s pipeline. The AcroImmune asset is prepped for an investigational new drug (IND) filing, with the submission expected in the last quarter of this year, according to the companies.AI-081 could expand checkpoint therapy’s potential across cancers, CMO Zheng said in the release.OncoC4 also gains AI-071, a phase 2-ready siglec agonist that is set to be studied in an acute respiratory failure trial and an immune-related adverse advents study. The novel innate immune checkpoint was discovered by the OncoC4 co-founders and is designed for broad application in both cancer and excessive inflammation.The merger also grows OncoC4’s geographical footprint with in-house clinical manufacturing capabilities in China, according to Liu.  “Collectively, these synergies further strengthen the potential of OncoC4 to deliver differentiated and novel immunotherapies spanning multiple modalities for difficult to treat solid tumors and hematological malignancies,” Liu said in the release. OncoC4 already touts a siglec program, dubbed ONC-841, which is a monoclonal antibody (mAb) designed that just entered phase 1 testing. The company’s preclinical assets include a CAR-T cell therapy, a bispecific mAb and ADC.   The biotech’s latest-stage program is gotistobart, a next-gen anti-CTLA-4 antibody candidate in joint development with BioNTech. In March 2023, BioNTech paid $200 million upfront for development and commercial rights to the CTLA-4 prospect, which is currently in phase 3 development for immunotherapy-resistant non-small cell lung cancer.     

BETHESDA, Md., April 08, 2024 (GLOBE NEWSWIRE) -- Gain Therapeutics, Inc. (Nasdaq: GANX) (“Gain”, or the “Company”), a clinical-stage biotechnology company leading the discovery and development of the next generation of allosteric small molecule therapies, today announces the appointment of Gene Mack, MBA as its chief financial officer, effective as of April 8, 2024. “We are thrilled to welcome Gene as our new CFO,” commented Gain CEO Matthias Alder. “His experience as an operational CFO with a track record of successful financing, M&A and other strategic transactions combined with his scientific background and career as an equity research analyst ideally complement our executive management team as we expand our outreach to the investor community and progress our lead drug candidate GT-02287 in the clinic.” Gene has over 25 years of experience in the life sciences sector spanning clinical research, financing and capital markets, investing, corporate strategy and business development. Prior to joining Gain, Gene was CFO at privately held Imcyse SA between 2021 and 2023. Prior to Imcyse, Gene was CFO at OncoC4, a privately held biotechnology company that spun out of Merck & Co’s (MSD) $475 million acquisition of OncoImmune in 2020 where he had also been CFO. Before that, he has held the CFO role for several development- and commercial-stage biopharmaceutical companies, raising over $350 million in IPO and other equity transactions. Prior to his operational experience, Gene covered the biotechnology and life sciences sector as a senior publishing analyst at various investment banks, including Gruntal & Co, Lazard, Mizuho, and HSBC. Gene received his BS in Biochemistry and MBA in Finance from Fordham University. “I am excited to join Gain Therapeutics during this important stage of corporate growth and scientific progression. The company is well-positioned to deliver on upcoming clinical milestones with its lead drug candidate GT-02287 and I look forward to working with Gain’s exceptionally talented and experienced team to bring this best and first-in-class treatment to Parkinson’s patients,” added Mr. Mack. Inducement Grant In connection with his appointment, the Company granted Mr. Mack an option to purchase 200,000 shares of the Company’s common stock at an exercise price equal to $3.56 per share, the closing price of the Company’s common stock on April 5, 2024, the last trading day preceding Mr. Mack’s employment start date and date of grant. This award was approved by Gain’s Board of Directors and granted under the Gain Therapeutics, Inc. 2021 Inducement Equity Incentive Plan, as an inducement material to Mr. Mack entering into employment with Gain, in accordance with Nasdaq Listing Rule 5635(c)(4). The stock option vests over four years, with one-fourth (1/4th) of the shares subject to the option vesting on the first anniversary of Mr. Mack’s employment start date (the “Initial Vesting Date”) and the remaining three-fourths (3/4ths) of the shares subject to the option vesting in a series of thirty-six (36) successive equal monthly installments on each subsequent monthly anniversary of the Initial Vesting Date, subject to Mr. Mack being continuously employed by the Company as of such vesting dates. The Company is providing this information in accordance with Nasdaq Listing Rule 5635(c)(4). About GT-02287 Gain Therapeutics’ lead drug candidate, GT-02287, is in clinical development for the treatment of GBA1 Parkinson’s disease (GBA1-PD). The orally administered, brain-penetrant small molecule is an allosteric protein modulator that restores the function of the lysosomal protein enzyme glucocerebrosidase (GCase) which becomes misfolded and impaired due to a GBA1 gene mutation, the most common genetic abnormality associated with PD. In preclinical models of PD, GT-02287 restored GCase enzymatic function, reduced aggregated α-synuclein, neuroinflammation and neuronal death, increased dopamine levels and improved motor function. Additionally, GT-02287 significantly reduced plasma neurofilament light chain (NfL) levels, an emerging biomarker for neurodegeneration. Gain’s lead program in Parkinson’s disease has been awarded funding support from The Michael J. Fox Foundation for Parkinson’s Research (MJFF) and The Silverstein Foundation for Parkinson’s with GBA, as well as from the Eurostars-2 joint program with co-funding from the European Union Horizon 2020 research and Innosuisse – Swiss Innovation Agency. About GBA1 Parkinson’s Disease GBA1 Parkinson’s disease is caused by mutations in the GBA1 gene, found in up to 15% of patients with Parkinson’s disease and making it the primary genetic risk factor. The mutation causes dysfunctional misfolding of the lysosomal enzyme glucocerebrosidase (GCase), reducing its activity in the brain and leading to the subsequent accumulation of α-synuclein and degeneration of dopamine-containing nerve cells. Patients with GBA1-PD tend to have earlier onset and faster symptom progression than those with sporadic PD, a progressive neurodegenerative disease characterized by a motor syndrome consisting of bradykinesia (slowness of movement), rigidity, resting tremors, and postural instability. With current therapies treating only the symptoms of Parkinson’s disease without affecting the underlying progression of the disease, there is an unmet need to develop novel disease-modifying therapies such as GT-02287 that have the potential to slow or stop disease progression and help improve outcomes in this patient population. About Gain Therapeutics, Inc. Gain Therapeutics, Inc. is a clinical-stage biotechnology company leading the discovery and development of next generation allosteric therapies. Gain’s lead drug candidate GT-02287 for the treatment of GBA1 Parkinson’s disease, is currently being evaluated in a Phase 1 clinical trial. Leveraging AI-supported structural biology, proprietary algorithms and supercomputer-powered physics-based models, the company’s Magellan™ drug discovery platform can identify novel allosteric binding sites on disease-implicated proteins, pinpointing pockets that cannot be found or drugged with current technologies. Magellan™ is the next generation of Gain’s original SEE-Tx® (Site-Directed Enzyme Enhancement Therapy) platform, which was enhanced and expanded with new AI and machine-learning tools and virtual screening capabilities to access the emerging on-demand compound libraries covering vast chemical spaces of over 50 billion compounds. Gain’s unique approach enables the discovery of novel, allosteric small molecule modulators that can restore or disrupt protein function. Deploying its highly advanced platform, Gain is accelerating drug discovery and unlocking novel disease-modifying treatments for untreatable or difficult-to-treat disorders including neurodegenerative diseases, rare genetic disorders and oncology. For more information, please visit GainTherapeutics.com and follow us on LinkedIn. Cautionary Note Regarding Forward-Looking Statements This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. All statements in this press release other than statements of historical facts are “forward-looking statements”. In some cases, you can identify these statements by forward-looking words such as "may," "might," "will," "should," "expect," "plan," "anticipate," "believe," "estimate," "predict," "goal, " "intend," "seek, " "potential" or "continue," the negative of these terms and variations of these words or similar expressions that are intended to identify forward-looking statements, although not all forward-looking statements contain these words. Forward-looking statements in this press release include, but are not limited to, statements regarding: the development of the Company’s current or future product candidates including GT-02287; expectations regarding the timing of results from a Phase 1 clinical study for GT-02287; and the potential therapeutic and clinical benefits of the Company’s product candidates. These forward-looking statements are based on the Company’s expectations and assumptions as of the date of this press release. Each of these forward-looking statements involves risks and uncertainties that could cause the Company’s preclinical and future clinical development programs, future results or performance to differ materially from those expressed or implied by the forward-looking statements. These statements are not historical facts but instead represent the Company's belief regarding future results, many of which, by their nature, are inherently uncertain and outside the Company's control. Many factors may cause differences between current expectations and actual results, including the impacts of the post-COVID-19 environment and other global and macroeconomic conditions on the Company’s business; clinical trials and financial position; unexpected safety or efficacy data observed during preclinical studies or clinical trials, clinical trial site activation or enrollment rates that are lower than expected; changes in expected or existing competition; changes in the regulatory environment; the uncertainties and timing of the regulatory approval process; and unexpected litigation or other disputes. Other factors that may cause the Company’s actual results to differ from those expressed or implied in the forward-looking statements in this press release are identified in the section titled “Risk Factors,” in the Company’s Annual Report on Form 10-K filed with the Securities and Exchange Commission on March 26, 2024 and its other documents subsequently filed with or furnished to the Securities and Exchange Commission from time to time. All forward-looking statements contained in this press release speak only as of the date on which they were made. The Company undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law. Investor Contact: CORE IR(516) 222-2560 ir@gaintherapeutics.com Media Contacts: Russo PartnersNic Johnson and Elio Ambrosionic.johnson@russopartnersllc.comelio.ambrosio@russopartnersllc.com(212) 845-4242

这是一个机会与风险并存的时代，长周期的生物创新药投入与风险都影响着行业的前行。见微知著，Bio-ONE会务组聚焦生物药工艺与药物创新前端的中小企业，将于11月23日下午在上海举办Bio-ONE2023项目路演，推动资本与产业的再次对话，共度寒冬，砥砺前行。参与方式 2023年11月23日（周四）下午13:30-16:20 上海建工浦江皇冠假日酒店（一楼会议厅1）上海市闵行区陈行公路3701号欢迎识别上方二维码或点击文末“阅读原文”报名路演项目13:30-13:55  以甲状腺相关眼病和老视为主的眼科创新药物开发苏州普乐康医药科技有限公司公司秉承临床价值优先的企业发展战略，全方位布局具有新的作用机制的眼科和自身免疫性疾病的新药产品管线，特别是免疫相关性眼科新药的开发，同时关注罕见病领域的药物研发。在成立较短的时间内已将数个在研管线项目从药物发现和筛选推进至CMC阶段，其中治疗甲状腺相关眼病的药物已经获批临床，有望成为国内第一款自主研发治疗该疾病的药物，以满足国内甲状腺眼病病人的临床急需。13:55-14:20  基于免疫调控的广谱癌症治疗和抑制抗药抗体形成的First in class药物杭州复力生物医药有限公司公司拥有多个调控特异性免疫（T细胞、B细胞）反应的项目，可通过免疫重启广谱治疗癌症；可配合T细胞治疗（CAR-T，TCR-T，TILs）在实体瘤实现药效；可特异性抑制抗药抗体形成，突破高免疫原性重组蛋白药的开发瓶颈，拓展它们的临床应用和市场价值。所融资金将用于一款抗体的临床试验以及另一款抗体的CMC和非临床研究。它们都属于全球首创新药，真正first-in- class。14:20-14:45  从IGF-1开始的罕见病治疗全新创新药浙江台州乐长制药有限公司公司的使命专注于孤儿药开发，愿景是让罕见病治疗不再罕见。第一个药物IGF-1的的生产研发，已经到了中试阶段，希望将IGF-1的质量和产量提高到业界领先水平。同时第一个临床试验，在浙江省儿童医院等医院已经获得伦理批准并入组患者。这个临床试验的目的主要是快速调查中国患者的基因背景，同时争取把这类患者基因诊断率提高到业界领先水平。14:45-15:10  以RNA分子设计和修饰的技术优势打造新型mRNA药物上海伊诺瑞康生物医药科技有限责任公司公司成立于2022年，以“创新RNA技术，使不可治愈的疾病成为可能”为使命，专注于RNA序列设计和核酸修饰的通用性底层技术研发，以关键技术创新推动RNA药物产业化和临床治疗应用。2022年获得数千万天使投资，在一年半时间内高效完成团队组建，博士和硕士学历占总人数50%以上。在技术创新方面，公司在新的核酸修饰技术以及AI序列优选算法方面具有行业领先优势和特色；发明Exneo核酸修饰技术显著提升mRNA在细胞和动物体内的翻译效率和稳定性；自复制samRNA技术打造长效表达技术，实现在动物体内稳定表达蛋白质长达30天；开发LSTM深度学习肿瘤新抗原AI优选算法，为个性化肿瘤免疫治疗药物提供最优解决方案。目前，公司在肿瘤免疫治疗以及传染病疫苗管线进展顺利，已完成动物药效实验。公司即将开启PreA轮融资，用于推进管线进入临床研究阶段。15:10-15:30  茶歇15:30-15:55  新型肿瘤免疫抗体及双功能ADC药物的研发安普生物医药科技（深圳）有限公司公司成立于2021年，是一家专注于肿瘤免疫生物药研发的生物科技公司，以自主创新为驱动，建有GPCR单抗ˎ肿瘤免疫双抗和双功能ADC创新药自研体系，已有两个产品进入临床前开发阶段，分别为已经显示有积极临床前动物药效结果的全球首创(FIC)的A2aR拮抗型抗体和具有全球同类最优(BIC)潜力的PD-L1 ADC项目治疗晚期实体瘤。本次拟融资5000万元，已有一个产业基金愿意出资近2000万跟投，募集的资金的用途：4000万用于A2aR抗体完成IND中美双报，PD-L1 ADC完成预毒理PK，以及NKCE双抗等其他自研管线进行持续的创新布局；1000万用于公司运营及国内实验室和研发团队建设。15:55-16:20  通过表型靶标验证及作用机理深度挖掘的药物开发策略，加速癌症和自身免疫性疾病生物药物开发和转化苏州逻晟生物医药有限公司公司2019年成立于中国苏州，并于2021年扩展到美国圣地亚哥，是一家充满活力的临床阶段生物医药公司，我们研究的重点是癌症和自身免疫性疾。通过严谨的科学探究和转化研究，我们发现了解决癌症和自身免疫性疾病复杂挑战的新治疗方法。为了确保可持续和强大的管线，我们在研究和开发过程中采用了最先进的方法。我们整合了尖端的计算机数据挖掘、分析和表型靶标验证系统，使我们能够优化我们的方法并加速新疗法的发现。这种对先进技术的战略性利用使我们能够保持在科学进步的前沿。我们始终相信，通过我们不懈努力和科学创新，将能够为患者提供更多的创新药物，为改善人类健康作出更大的贡献。评委嘉宾易  华● 国投招商董事总经理易华，博士，现任国投招商董事总经理，负责生命健康领域的投资，投资阶段主要覆盖中早期到成熟期。加入国投招商以前，曾任职于深圳基石资本，尚华医药，早期在法国国家科学研究中心(CNRS) 和上海药物所从事博士后研究工作，在新药研发和风险投资等领域积累了超过十五年的健康医疗行业相关经验。黎敏奇● 惠每资本董事总经理黎敏奇，惠每资本董事总经理，获有美国约翰霍普金斯大学生物技术硕士学位；美国特许金融分析师CFA持证人。投资案例：OncoImmune（默沙东全资收购）、OncoC4、KBP Biosciences（诺和诺德资产收购）等。金家齐● 礼来亚洲VP金家齐博士于2019年加入礼来亚洲基金，现在担任投资副总裁。在此之前，金博士在波士顿咨询公司（BCG）上海办公室担任资深咨询顾问，主要为大型生物制药公司和医疗健康领域私募基金提供帮助。金博士2016年于耶鲁大学获得遗传学博士学位，2010年本科毕业于复旦大学生物技术专业。徐  荣● Techln科创界创始合伙人复旦大学生物学博士,上海市科委入库专家，原上海技术交易所创新研究院院长，曾创立宇墨咨询UMORE，创建运营全球环境能源技术合作平台CLEANCONNECT，主导多项跨境技术交易案例，完成交易总额3.5亿，服务中国大型企业、驻华外资企业开展跨境技术投资与创新合作，任上海技术交易所副总裁，参与国家级知识产权和科技成果产权交易平台建设和运营并服务高校院所医疗机构科技成果转化。吴  迪● 同创伟业董事总经理普林斯顿大学金融硕士、复旦大学金融硕士、中国科大生物科学与技术学士。从事医疗风险投资10年，现任同创伟业董事总经理，负责生物医药投资，曾任职达晨创投、广发证券。在生物医药以及医疗产业具有深厚的专业经验。成功投资了一系列龙头上市公司，如：疫苗龙头康希诺（A股科创板上市，港股上市，688185.SH，06185.HK），市值曾高达1600亿；宠物医疗龙头瑞鹏宠物，亚洲最大的宠物连锁医院；其他上市公司如马应龙（600993.SH）、兰卫医学（301060.SZ）等。宁高见● 元生创投董事总经理简介稍后公布，敬请期待.....由华东理工大学和佰傲谷BioValley联合主办的2023第五届生物工艺产业年度峰会（Bio-ONE2023）将于11月22-23日在上海建工浦江皇冠假日酒店举办，本届会议以简化、优化、强化为主旨，聚焦全球最新工艺技术，囊括抗体、细胞与基因治疗、核酸药物等多个领域，共研工艺放大与商业化的最优解。截止目前，80+生物工艺大咖、1500+CMC同仁已确认加盟，群贤毕至，盛会将启~Bio-ONE 大会框架向上滑动查看五大主题论坛报名参会Bio-ONE2023开幕在即，CMC生物工艺人的年度盛会不容错过！！！点击“阅读原文”,即可报名项目路演~