Cerimon Pharmaceuticals, Inc.

10月3日，一家专注于释放巨噬细胞疗法治疗炎症和纤维化疾病的再生潜力的临床阶段生物制药公司Resolution Therapeutics宣布完成6350万英镑（约5.8亿元）的B轮融资。此次融资由Syncona领投。在融资的同时，Resolution还宣布任命Paul Sekhri为董事会主席。 B轮融资的收益将用于推进Resolution的主要候选药物RTX001，一种专门用于为终末期肝病患者的自体、工程化、促再生的巨噬细胞疗法。EMERALD是Resolution的首个人体I/II期临床试验，将在英国和西班牙进行，预计将于2024年第四季度开始招募患者。收益的其他用途包括投资公司的制造平台，并将其管道扩展到其他炎症和纤维化适应症，包括移植物抗宿主病（GVHD）和肺纤维化。 Resolution是由爱丁堡大学Stuart Forbes教授实验室分拆成立。 Stuart Forbes实验室与当时由John Campbell教授领导的苏格兰国家输血服务中心（SNBTS）的细胞治疗小组合作，通过MATCH试验将一种非工程化的自体巨噬细胞疗法推向临床。这项小规模的安全性研究的结果于2019年发表，证明了巨噬细胞在治疗肝硬化患者方面的前景。随后，爱丁堡大学MATCH II进行了一项安慰剂对照的II期试验，以测试单剂量非工程巨噬细胞对代偿性肝硬化患者的疗效。2024年6月在米兰举行的EASL会议上公布了初步结果，表明巨噬细胞疗法有可能显著减少肝硬化的临床并发症。除了最近能够制造和储存增强巨噬细胞产品的进展，以及通过基因工程增强其功能的能力外，MATCH试验还推动了Resolution Therapeutics的建立。 Resolution首席执行官Amir Hefni博士表示：“随着我们准备在今年将RTX001推向临床，RTX001是我们治疗终末期肝病的领先研究性巨噬细胞疗法，具有一流的潜力，我们非常感谢Syncona的持续支持。此外，我们很高兴欢迎Paul Sekhri加入我们的董事会。Paul在领导顶级公司开发突破性药物方面拥有丰富的经验，包括为自身免疫性疾病患者开发新的治疗方法。我和团队期待着与Paul合作，为有需要的患者带来新的巨噬细胞疗法，如RTX001。 我还要代表董事会感谢Lisa Bright在过去4年担任Resolution主席期间做出的有影响力的贡献。她的远见和领导力在推动我们的战略举措、培养卓越的科学文化以及将Resolution推向临床阶段方面发挥了重要作用。我们祝愿她一切顺利。” Syncona管理合伙人兼Resolution非执行董事Edward Hodgkin表示：“Resolution迄今为止在这一新兴医学领域产生的数据令人鼓舞，我们认为，这表明了巨噬细胞在治疗终末期肝病方面的潜力。这是一种潜在的一流产品，正在为患者没有有效治疗选择的疾病开发，患者通常面临肝移植或病情进一步恶化，这通常是致命的。我们很高兴继续支持Resolution的B轮融资，这与Syncona专注于将资本分配给临床阶段资产和即将进入临床阶段的资产是一致的。我们也很高兴欢迎Paul Sekhri，他在整个开发周期中为公司提供支持方面有着良好的记录，并将为公司不断壮大的高管团队提供宝贵的意见。” Paul Sekhri已被任命为董事会主席。Paul在生命科学行业拥有超过35年的经验，包括在主要制药和生物技术公司领导业务开发和战略，在这些公司，他在合作、并购和融资方面有着成功的记录。目前，Paul是vTv Therapeutics总裁兼首席执行官。在此之前，他曾担任eGenesis和Lycera总裁兼首席执行官。此前，他曾在赛诺菲、Teva、TPG Biotech、Cerimon Pharmaceuticals、ARIAD Pharmaceuticals和Novartis AG担任过高管职务。Paul拥有马里兰大学学士学位，并在马里兰大学医学院完成了研究生学习。 参考资料：公司官网 内容来源于网络，如有侵权，请联系删除。

Financing to advance lead asset RTX001, an engineered, pro-regenerative macrophage therapy with first-in-class potential for end-stage liver disease, into the Phase I/II EMERALD study Proceeds also strengthen manufacturing capabilities and support macrophage therapy pipeline growth in inflammatory and fibrotic indications beyond liver disease Paul Sekhri, seasoned life sciences executive with decades of drug development and extensive business development experience, appointed Chair of the Board of Directors EDINBURGH, Scotland and LONDON, Oct. 3, 2024 /PRNewswire/ -- Resolution Therapeutics Limited ("Resolution"), a clinical-stage biopharmaceutical company focused on unlocking the regenerative potential of macrophage therapy for the treatment of inflammatory and fibrotic diseases, today announces it has raised £63.5 million in Series B financing. The financing was led by Syncona Ltd. Alongside the financing, Resolution also announces the appointment of Paul Sekhri as Chair of the Board of Directors. "As we prepare to advance RTX001, our lead investigational macrophage therapy with first-in-class potential for the treatment of end-stage liver disease, into the clinic this year, we are grateful for Syncona's continued support," said Amir Hefni, Ph.D., Chief Executive Officer of Resolution. "In addition, we are pleased to welcome Paul Sekhri to our Board of Directors. Paul brings a wealth of experience leading top-tier companies to develop breakthrough medicines, including novel treatments for patients with autoimmune disease. The team and I look forward to working with Paul to bring novel macrophage therapies, like RTX001, to patients in need." Amir continued, "On behalf of the Board of Directors, I would also like to thank Lisa Bright for her impactful contributions as Chair of Resolution over the last 4 years. Her vision and leadership have been instrumental in driving our strategic initiatives, fostering a culture of scientific excellence and getting Resolution to clinical stage. We wish her all the best." The proceeds from the Series B financing will be used to advance Resolution's lead candidate, RTX001, an autologous, engineered, pro-regenerative macrophage cell therapy specifically designed to deliver transformative outcomes in patients with end-stage liver disease. EMERALD, Resolution's first-in-human Phase I/II clinical trial, will be conducted in the UK and Spain and is anticipated to initiate patient recruitment in Q4 2024. Additional uses of proceeds include investment in the Company's manufacturing platform and expansion of its pipeline into other inflammatory and fibrotic indications, including graft-vs-host disease (GVHD) and lung fibrosis. "The data that Resolution has generated to date in this emerging area of medicine is encouraging and, in our view, demonstrates the potential that macrophages have in treating end-stage liver disease. This is a potential first-in-class product being developed for a disease where patients have no effective therapeutic options and typically face a liver transplant or further deterioration of their condition, which is often fatal," said Edward Hodgkin, Managing Partner of Syncona Investment Management Limited and Non-Executive Director of Resolution. "We are delighted to continue to support Resolution with our commitment to its Series B financing, in-line with Syncona's focus on allocating capital to clinical-stage assets and assets approaching clinical entry. We are also very pleased to welcome to Resolution Paul Sekhri, who brings a demonstrable track record in supporting companies through the development cycle and will act as a valuable sounding board for the company's growing executive team." Paul Sekhri has been appointed as Chair of the Board of Directors. Paul has over 35 years of experience in the life sciences industry, including leading business development and strategy in major pharmaceutical and biotechnology companies where he has a successful track record of partnering, M&A and financing. Currently, Paul is President and Chief Executive Officer of vTv Therapeutics, Inc. Before that, he served as President and Chief Executive Officer of eGenesis, Inc. and Lycera Corp. Prior to that, he held positions of increasing responsibility at Sanofi, Teva Pharmaceutical Industries, Ltd., TPG Biotech, Cerimon Pharmaceuticals, Inc., ARIAD Pharmaceuticals, Inc., and Novartis AG. Paul holds a B.S. degree from the University of Maryland and completed post-graduate studies at the University of Maryland School of Medicine. Paul Sekhri, Chair of the Board of Directors, said, "I am delighted to join Resolution at such an exciting time as it prepares to enter the clinic with RTX001 and expand pipeline efforts into new indications where significant unmet patient need exists. I look forward to collaborating with Amir, the entire Resolution team and supporting the Company as it expands its leadership in macrophage therapy." About RTX001 RTX001 is an engineered autologous macrophage cell therapy designed to deliver increased anti-fibrotic and anti-inflammatory effects in patients with end-stage liver disease. The product candidate is engineered using a unique combination of therapeutic genes known to be expressed in macrophages to enhance the inherent regenerative properties of the modality for superior efficacy and durability. The clinical development program for RTX001 currently consists of two clinical studies. The ongoing OPAL study is a multi-center natural history study in patients with liver cirrhosis who have been hospitalized for the first time with hepatic decompensation. The objective of the OPAL study is to generate novel data on disease trajectory to act as the control arm for the EMERALD study. The Phase I/II EMERALD study is an open-label first-in-human study of RTX001 in end-stage liver disease measuring clinical events as the primary efficacy endpoint. The EMERALD study has received clinical trial authorization from the UK MHRA and is expected to initiate patient recruitment in the fourth quarter of 2024. About Resolution Therapeutics Resolution Therapeutics is a clinical-stage biopharmaceutical company focused on unlocking the regenerative potential of macrophage therapy for the treatment of inflammatory and fibrotic diseases. The Company leverages its proprietary cell characterisation and engineering platform to develop autologous macrophages with distinct pro-regenerative properties for superior patient outcomes across the spectrum of inflammatory and fibrotic diseases. Resolution's initial focus is on developing RTX001, its lead product candidate with first-in-class potential supported by preclinical data demonstrating anti-fibrotic and anti-inflammatory advantages relative to non-engineered macrophages, for patients diagnosed with end-stage liver disease. The Company is also advancing efforts to expand the potential of its platform into indications beyond liver disease where engineered macrophages have therapeutic potential. Resolution, a spinout from Professor Stuart Forbes's lab at the University of Edinburgh, is based in Edinburgh and London. Learn more by visiting and engage with us on LinkedIn. About Syncona Syncona's purpose is to invest to extend and enhance human life. We do this by creating, building and scaling companies to deliver transformational treatments to patients in areas of high unmet need. We aim to build and maintain a diversified portfolio of 20-25 globally leading life science businesses, across development stage, modality and therapeutic area, for the benefit of all our stakeholders. We focus on developing treatments that deliver patient impact by working in close partnership with world-class academic founders and experienced management teams. Our balance sheet underpins our strategy, enabling us to take a long-term view as we look to improve the lives of patients with no or poor treatment options, build sustainable life science companies and deliver strong risk-adjusted returns to shareholders. SOURCE Resolution Therapeutics WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

HIGH POINT, N.C., July 27, 2022 (GLOBE NEWSWIRE) -- vTv Therapeutics Inc. (Nasdaq: VTVT), a clinical stage biopharmaceutical company focused on the development of orally administered treatments for type 1 diabetes (T1D), today announced that Paul Sekhri will lead the company as President and Chief Executive Officer, effective August 1, 2022. Rich Nelson, who has been serving as Interim Chief Executive Officer since March 2, 2022, will continue to support the company as Executive Vice President, Corporate Development and as a member of the Board of Directors. Mr. Sekhri will also join vTv’s Board of Directors. Paul joins vTv as it sets to launch Phase 3 pivotal studies for its most advanced product, TTP399, which was granted Breakthrough Therapy designation by the U.S. Food and Drug Administration (FDA) in April 2021 as an oral adjunctive therapy for the treatment of T1D. Positive results from the Phase 2 study showed treatment with TTP399 resulted in a statistically significant improvement in HbA1c relative to placebo and a clinically meaningful 40% decrease in the frequency of severe and symptomatic hypoglycemia. Last month, vTv announced a $25 million investment by G42 Investments AI Holding RSC Ltd. and entry into a collaboration and license agreement with affiliates of G42 Healthcare whereby G42’s affiliate will be funding a significant portion of the Phase 3 clinical trials for TTP399. "While I’ve served in the Interim CEO role for the past four months, we diligently searched for the right candidate to steer the company through this final stage of TTP399 development and are highly confident that Paul is the right person for the role," said Rich Nelson. "We are thrilled to have Paul join vTv at this very exciting time in the company’s lifecycle as we actively engage in activities in preparation of the initiation of our Phase 3 trials and continue to have positive discussions with institutions in the biotech community about further investment in vTv. Paul brings extensive experience as CEO of several prominent healthcare companies and has strong ties to the biotech investment community. We are very excited to have Paul on board and I look forward to continuing to support vTv in my new role and to support Paul in his.” Mr. Sekhri brings nearly 30 years of healthcare experience, including serving as President and CEO of several healthcare companies such as eGenesis, Lycera Corp., Cerimon Pharmaceuticals, as well as senior business development and strategy roles at Sanofi, Teva Pharmaceutical Industries Ltd., TPG Biotech, Cerimon, Ariad Pharmaceuticals and Novartis Pharma AG. He has been a director on more than 30 private, public company and non-profit boards and is currently a Director at Ipsen, S.A., Compugen, Pharming N.V., Veeva Systems, Longboard, Spring Discovery and eGenesis. Additionally, he is on the Board of Directors of the Metropolitan Opera. "During my long career as a biotechnology executive, I have been attracted to truly novel therapeutic approaches that address serious medical challenges and/or improve patient care," said Mr. Sekhri. "T1D is a challenging enough disease for patients to manage without also having to worry about hypoglycemia. A treatment that significantly reduces the risk of hypoglycemia while also improving Hb1Ac would be a significant advance for treating this disease. I look forward to working with the vTv team to initiate and successfully complete our Phase 3 trials." On July 26, 2022, Mr. Sekhri was granted stock options (the “Options”) to purchase 2,200,000 shares of the Class A common stock of vTv at an exercise price of $0.79 per share pursuant to an inducement award agreement (the “Inducement Award Agreement”). Subject to potential acceleration upon the achievement of certain performance metrics as set forth in the Inducement Award Agreement, 25% of the Options will vest on the first anniversary of the grant date and thereafter the Options will vest in equal quarterly installments over the next three years. Upon certain terminations of employment, a portion of the Options will vest on a pro rata basis based on the number of days employed during the four-year term. The grant of Options was made as an inducement grant under NASDAQ Listing Rule 5635(c)(4). About vTv TherapeuticsvTv Therapeutics Inc. is a clinical stage biopharmaceutical company focused on developing oral, small molecule drug candidates. vTv has a pipeline of clinical drug candidates led by programs for the treatment of type 1 diabetes and cystic fibrosis related diabetes. vTv’s development partners are pursuing additional indications in type 2 diabetes, chronic obstructive pulmonary disease, renal disease, primary mitochondrial myopathy, and pancreatic cancer. For more information, please visit www.vtvtherapeutics.com. Forward-Looking StatementsThis release contains forward-looking statements, which involve risks and uncertainties, including statements regarding the potential grant of the FDA Approval. These forward-looking statements can be identified by the use of forward-looking terminology, including the terms “anticipate,” “believe,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would” and, in each case, their negative or other various or comparable terminology. All statements other than statements of historical facts contained in this release, including statements regarding the agreements and transactions described in this release are forward-looking statements. These statements involve known and unknown risks, uncertainties and other important factors, including the risk that the FDA Approval is not received on a timely basis or at all, that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Important factors that could cause our results to vary from expectations include those described under the heading “Risk Factors” in our Annual Report on Form 10-K and our other filings with the SEC. These forward-looking statements reflect our views with respect to future events as of the date of this release and are based on assumptions and subject to risks and uncertainties. Given these uncertainties, you should not place undue reliance on these forward-looking statements. These forward-looking statements represent our estimates and assumptions only as of the date of this release and, except as required by law, we undertake no obligation to update or review publicly any forward-looking statements, whether as a result of new information, future events or otherwise after the date of this release. We anticipate that subsequent events and developments will cause our views to change. Our forward-looking statements do not reflect the potential impact of any future acquisitions, merger, dispositions, joint ventures or investments we may undertake. We qualify all of our forward-looking statements by these cautionary statements. Contact: vTv:Katie Larch / Robert Flamm, Ph.D.Burns McClellan, Inc.klarch@burnsmc.com / rflamm@burnsmc.com