Sarossa Capital Ltd.

None After a few years characterised by uncertainty, the narrative across the biotech industry is changing. We have seen a steady upswell in optimism among biotech organisations and other stakeholders over the recent months as new activity announcements set the tone for a ‘return to normal’. The Financial Times noted that the US biotech sector is bouncing back, quoting data from Jeffries that shows January’s capital raised ($6.2bn) reached levels similar to the previous high-water mark of February 2021. This year has been a pivotal one as biotech organisations shift out of survival mode to keep the industry’s innovation engine running. We surveyed over 100 biotech decision-makers to get a better gauge of their positions (and dispositions) during this transition season, and the results reflected the confidence and optimism now being reported at higher levels and across investors. With the market back on track to support biotech development, companies are confident but will benefit from sharper strategic positioning. A market on the mend Despite the challenges biotech organisations faced in securing funding since 2021, there has always been plenty of capital available despite its slower flow. The Index of Biotech stocks (XBI) rose again in Q4 of 2023 and has continued climbing into 2024 and the near standstill in the IPO market has begun to move again. In 2023, the few IPOs were mostly categorised by phase 2 or later stages, which afforded more confidence in a de-risked asset. Already, 2024 has seen more activity around IPO announcements for later stage assets, with some surpassing expectations, signalling that the window is open for well-prepared companies.   M&A tends to increase under these macro market conditions, and 2023 had significant activity with more than half of the 29 disclosed deals pricing over $1bn each according to SVB’s reports. Many biotech companies turned to M&A as a more stable source of funding, given pharma’s multibillion dollar stockpile dedicated to replenishing their R&D pipelines. Of our survey respondents, nearly half received funding from large pharma while a third received VC funds. Although there are fresh VC funds closing, we expect M&A momentum to continue, especially in therapeutic areas of interest to large pharma. Biotech organisations seeking dealmaking would do well to adopt strategies that prioritise generating registration-level data to position better against increasing diligence requirements and make their program more attractive. Science that meets needs Large pharma is willing to bet on key therapeutic areas and has shown increasing interest in CNS, obesity, cardiovascular and immunology areas. Recent progress in obesity and Alzheimer’s research is promising and will continue to draw attention from pharma and developers. Cell and Gene Therapy (CGT) is an exciting space for biotech and is one where we are making a real impact. Last year we saw five CGT approvals from the FDA, which is a significant burst when compared to 2017-2022’s five approvals total. Biotech in CGT is driving real progress toward therapies for diseases previously considered uncurable. Recent progress with sickle cell and movement toward in vivo cell therapies hold exciting potential for meeting patient needs with meaningful applications. Excitement in AI innovation As we advance technology and ways of working, we open opportunities to improve development or explore new modalities to deliver innovations to patients – another contributor to the industry optimism. Artificial intelligence (AI) is one of the most significant recent innovations for biotechnology development programs as its rapid advancement has generated many different options for application. When asked which factors have the greatest potential to accelerate their drug development, 26% of survey respondents indicated AI-enabled asset selection in drug discovery. However, some of the other top-indicated areas are also leveraging AI, including remote monitoring technologies in clinical trials, leveraging existing datasets to steer drug discovery and faster site selection and study start-up. As we iterate AI and tailor its applications with growing datasets, leveraging AI can improve trial designs and data generation and analysis. As biotech organisations prioritise registration-level data, AI capabilities can mitigate costly, time consuming risks while driving R&D forward. We have had noteworthy successes leveraging our Symphony Health datasets and our AI and machine learning technology to generate real-world data and evidence, gain insights into patient journeys, and to identify target populations and ideal sites to improve study startup efficiencies and generate richer, representative trial data. Optimising the optimism Respondents in our biotech survey were generally confident in meeting their next investment milestones and in their overall program success, but the realities of the market and the complexity of the development and regulatory landscape mean optimism should be tempered with optimisation. According to our survey, clinical development is still more of a challenge than securing funding despite the recent focus on funding accessibility. The inherent development challenges compound across phases and when organisations have multiple ongoing trials, which most biotech do. The majority have at least two trials while half have four or more. Optimising R&D spend with earlier planning, more efficient and adaptive strategies and higher quality data generation will be even more important for biotech companies as they position for exit strategies. Deeper and more strategic partnerships at earlier stages will help biotech companies optimise their R&D budgets, streamline end-to-end operations and more efficiently reach their next inflection point. Taking advantage of the resources and expertise offered by larger global CROs with dedicated biotech units will help close gaps in capacity, grant access to cutting edge technology and build value into their program. Resourceful biotech companies are already making the most of their lean structures by leveraging the full-spectrum benefits of global CRO partnerships, as reflected in a significant 41% of survey respondents indicating that medium or large sized CROs are preferred when it comes to clinical development, as they have a global presence and a wide service offering. Brighter days ahead Overall, the proof of the market’s upturn has solidified the sense of optimism that has been brewing among biotech organisations in recent months and the higher-level narrative is reflecting the same. The optimism isn’t blue-sky naivete, it’s more of a silver lining as biotech companies are aware of the current challenges they still face in the complex and ever-changing development landscape. They will have to be mindful about balancing scientific ambition with fiscal pragmatism while they continue to drive their innovations forward. However, biotech companies’ renewed focus on optimising their R&D spend and partnering more strategically will help carry them through tough times into the brighter days ahead. Dr. Chris Smyth, President, ICON Biotech Dr. Smyth has 30 years' operational and therapeutic experience, most notably in biotech, MedTech and oncology. Prior to ICON, Dr. Smyth spent 10 years in IQVIA Biotech, where he held EVP Oncology and Chief Operating Officer roles before assuming global leadership as President of the division. Dr. Smyth also previously led global clinical operations for 8 years at an oncology biotech company, Antisoma. Dr. Smyth holds a Bachelor of Science degree in Biochemistry from the University of Kent at Canterbury, a PhD in Reproductive Biology from the University of Edinburgh Medical School, and an MBA from Henley Management College.

2021年Delytact®在日上市，掀起一股溶瘤病毒热潮。根据动脉橙数据库显示，2021年溶瘤病毒资本市场热度回升，全年投融资金额达7.95亿美元。其中复诺健完成共2亿美元D轮融资，滨会生物完成3亿人民币B轮融资，映辉医药完成2轮数千万人民币PreA融资，ImmVirX完成2500万美金A轮融资。直到2023年，溶瘤病毒领域投融资不断：TILT完成1070万美元和2200万欧元融资；CG Oncology完成共计2.2亿美元融资。但2年过去，仍未有重磅产品问世，溶瘤病毒的潜力仍待显现。溶瘤病毒（Oncolytic Virus, OV），一类能选择性地感染并杀死肿瘤细胞而不损伤正常细胞的天然或重组病毒。据《溶瘤病毒治疗恶性肿瘤临床应用上海专家共识（2021）》，与传统免疫治疗相比，溶瘤病毒具有靶向性好、不良反应小、杀伤途径多、不易产生耐药性等优势。多项临床研究表明，溶瘤病毒可以为不同类型、不同进展阶段，甚至转移性和无法治愈的肿瘤患者带来临床收益。随着基因结构与功能认识的不断加深，溶瘤病毒也在不断更迭。新一代溶瘤病毒要能够高效调节肿瘤微环境，通过肿瘤特异性免疫实现对原发性、转移性或复发性肿瘤细胞的杀伤。同时，大量研究致力于改良OV减毒策略和提高OV抗肿瘤免疫活性。新一代溶瘤病毒药物即将孕育而出，并有望成为下一个肿瘤免疫治疗风口。三代更迭，尚待提升的疗效和系统给药效率AACR（美国癌症研究协会年会）连续三年将溶瘤病毒、免疫检查点抑制剂（CPI）、CAR-T、肿瘤新生抗原（neoantigen）/肿瘤疫苗视为最有潜力的肿瘤免疫治疗手段。CPI总体上只对约25%肿瘤病人显示有效；CAR-T在部分血液肿瘤里显现出显著疗效，但对实体瘤效果不佳；肿瘤新生抗原在低潮探索多年后迎来了有改进的临床反应，但疫苗所产生的特异T细胞向肿瘤组织内的富集和活性仍受到限制。临床前和初步临床研究已显示，溶瘤病毒为这些免疫疗法提供了潜在的增效方式——可使原先对免疫治疗药物反应欠佳的瘤种变得敏感，即“冷肿瘤”变为“热肿瘤”，与化疗、放疗、免疫治疗等联合使用时，展现出良好的协同增效作用。具体而言，溶瘤病毒的抗肿瘤作用主要分为三大机制：溶瘤病毒裂解肿瘤细胞机制● 直接杀伤机制溶瘤病毒可以在肿瘤细胞中复制，裂解肿瘤细胞并释放出子代病毒感染邻近细胞，诱导肿瘤细胞死亡。● 激活抗肿瘤免疫机制溶瘤病毒具有激活抗肿瘤免疫的机制，包括固有免疫和适应性免疫。病毒裂解细胞后可刺激分泌多种细胞因子，促进固有免疫系统活化，如扩增NK细胞的数量和活性杀伤；极化促进肿瘤进展的M2 巨噬细胞变为可杀伤MHCI丢失的肿瘤细胞。同时，多种肿瘤细胞裂解后，肿瘤相关抗原和新抗原释放，激活肿瘤特异性T细胞杀伤肿瘤细胞、肿瘤特异性抗体所诱导的ADCC杀伤肿瘤作用。● 破坏肿瘤血管系统部分溶瘤病毒可以感染并杀伤肿瘤微环境中的内皮和基质细胞。这两种细胞在肿瘤发展和转移中发挥重要作用。此外，经过基因修饰的OV也可以表达相关因子以抑制肿瘤新生血管生成。临床前及临床研究表明，溶瘤病毒对人体安全性能高，副作用以发热、注射局部反应和流感样症状为主。溶瘤病毒诱导“原位”疫苗接种效应和肿瘤特异性免疫应答，促进T细胞向肿瘤免疫微环境浸润，因此可与大多数抗肿瘤疗法联合或辅助应用，包括放化疗、免疫治疗、靶向治疗、肿瘤切除手术等。目前，溶瘤病毒已经历一代野生病毒株、二代基因改造病毒株，三代基因编辑病毒株的多次迭代。新一代病毒株减毒方面已有较大进步，但疗效有限仍是一大难题。已上市溶瘤病毒产品在保证安全性的前提下，新一代溶瘤病毒欲提升疗效，急需解决以下问题：①进一步提升OV本身的溶瘤效果②降低自体免疫对病毒的过早、过快清除③多途径给药和高效系统给药（静脉注射）④增加OV在体内向远程癌组织的散播⑤针对不同肿瘤微环境特异性，提升OV抗肿瘤免疫反应及抗癌效果，加速癌症应用⑥找到更好的OV疗效动物评估模型   解决以上核心问题，必须建立在长期、系统地研究病毒的分子生物学特性、分子肿瘤学和分子免疫学基础，因此全球具备新一代特征的新型溶瘤病毒尚少。微可蔚打造了新一代OV平台，具有高特异性、高效系统给药和强散播能力，有望突破OV瓶颈。深耕超20年的国际溶瘤病毒团队微可蔚（VacV Biotherapeutics）于2022年在英国伦敦成立，致力于开发针对难治性肿瘤的下一代肿瘤免疫疗法。微可蔚来自于创始人王尧河教授24年溶瘤病毒应用研究的成果转化。同年完成比邻星创投独家领投的数百万美元天使轮融资。王尧河教授为伦敦大学的肿瘤细胞与基因治疗首席教授、肿瘤病毒免疫治疗实验室主任，多个国际期刊编委和研究基金的评审专家。曾兼任郑州大学“国家细胞与基因治疗国际联合研究中心”主任、中英分子肿瘤学研究中心执行主任兼首席科学家。王尧河教授在溶瘤病毒领域做出若干原创性发现，如发现第一代和第二代溶瘤腺病毒复制能力弱，体内清除快的基因结构缺陷，研制了高效、安全的第三代溶瘤腺病毒。基于此腺病毒载体研发的I类新药BIOTTT001现已成功转化， 在复发性脑胶质瘤和不可切除的弥漫内生性脑桥胶质瘤病人临床治疗中均显示出疗效。联合创始人、科学顾问委员会主席Prof. Nicholas Lemoine为中国工程院外籍院士、英国医学科学院院士、中国医学科学院学部委员、基因治疗科学家，分子病理学先驱。曾为国际期刊《GENE THERAPY》主编20年，现担任英国国家健康研究院临床网络部主任及伦敦玛丽女王大学巴茨癌症研究所所长。微可蔚还拥有来自英国癌症研究院、伦敦国王学院、英国皇家内科医师学院等科研机构的病毒GMP生产专家，分子生物学家、临床肿瘤学家、溶瘤病毒产品转化科学家组成的科学顾问委员会，已与王尧河教授团队建立多年紧密合作，领导和参与过10余项OV临床试验。公司拥有完善的全球专利保护，3项核心专利已获多个国家授权，系列成果也发表在国际高影响因子的顶尖期刊。同时，团队开发世界首创的多种转基因黄金仓鼠，为评价溶瘤病毒和开发新型肿瘤免疫疗法提供了特有的动物模型。开创高特异性与高效静脉注射的新一代OV平台，技术获得国际认可微可蔚研发团队聚焦解决溶瘤病毒核心瓶颈，即在保证安全性的前提下提高疗效，现已打造出全新一代VacV技术平台。这一载体平台由优化后的痘苗病毒组成，具备高效免疫诱导能力和全身散播能力，主要具有下列主要优势：● 安全性高选用安全性高、疗效好的痘苗病毒李斯特株，删除病毒基因TK和N1L，安全性高，确保静脉给药过程中病毒产品毒性最小。● 高效系统性递送能力强VacV自研专利的静脉给药方式可使低剂量病毒到达肿瘤部位，增强病毒产品播散能力。通过提升能抵抗机体抗体和补体EEV产量，感染远处播散或转移的肿瘤细胞，使病毒感染和杀伤肿瘤细胞效果显著提升。给药途径的多样化，临床应用种可根据肿瘤部位和特征，在不同时间点选择更为有效的给药方式，尤其是有效治疗转移和播散的晚期肿瘤。● 治疗效果显著特选痘苗病毒对肿瘤细胞感染性广、特异性强，具有靶向特异性，基因装载量可达25kbp。特选启动子使带载的治疗基因表达稳定性高，可表达免疫调节基因，作为免疫佐剂进一步增强抗肿瘤效果。同时，可明显增强免疫检查点抑制剂药物抗肿瘤治疗效果，明显改善疗效并防止癌症复发。临床前试验中，VacV001腹腔给药后，80%胰腺癌动物模型生存可超300天。得益于该产品在无药可用的“癌王”胰腺癌中取得的瞩目疗效，王尧河教授团队荣获英国政府MRC348万英镑的资助，用于加快VacV001的临床开发。    打通平台化研发路径，加速开启临床试验基于原创性OV平台，微可蔚已组建了经验丰富的研发团队、临床试验团队、药效评价体系，并建立起一系列差异化的溶瘤病毒产品。 微可蔚VacV000系列产品管线布局目前已推出VacV000系列的6条产品管线，适用症包括胰腺导管腺癌、胶质母细胞瘤、转移性结直肠癌等。其中针对胰腺癌、转移性大肠癌的2条管线即将进入临床试验阶段。VacV001已经开始GMP生产，计划在明年在英申报IND。微可蔚拥有符合欧盟GMP标准的病毒生产包装细胞和工艺，并在英国和中国组建起经验丰富的商业管理团队。公司高管团队拥有在GSK、Abbott、Antisoma、第一三共制药等大型药企、Biotech的管理及BD经验，保证微可蔚高效和高质量推进其产品线。写在最后根据Sullivan最新研究报告，全球溶瘤病毒治疗药物市场仍保持快速增长，预计到2025年和2030年，市场总额将达到67.9亿美元和247.9亿美元。除Biotech外，不少MNC也已布局，包括Merck、Amgen、Boehringer Ingelheim、Astellas Pharma、MedImmune LLC等。过去的十年，免疫系统激活疗法彻底改变了癌症治疗领域。但免疫疗法有限的适用症、局限的受益人群、高要求的给药方式远远未满足广泛的临床需求。因此，癌症治疗领域迫切需要具有更好免疫诱导机制、可扩大已批准免疫疗法疗效的方案，填补巨大市场需求空缺。OV所面对的正是这一直接治疗与协同联用的广阔市场，并显现出完全实现这一方案的强大潜力。从2022年11月开始，美国的CG Oncology凭借其溶瘤病毒亮眼的临床Ⅱ期数据及其正在进行的临床Ⅲ期试验，8个月内完成了2.2亿美元融资，其产品有望于2024年底在美国获批上市。新型溶瘤病毒产品的上市，并且针对重大迫切临床需求的适应症，预计将再度引起对溶瘤病毒的关注，给予行业更多信心。“经过这么多年的积累和摸索，溶瘤病毒领域的突破时点和下一波热潮应该很快会到来。”王尧河教授谈到，“溶瘤病毒开发涉及到病毒本身，宿主免疫系统，以及肿瘤微环境这些复杂的系统，必须需要进行系统的基础研究积累和行业的共同努力，才能真正开发出安全有效的溶瘤病毒产品，把OV的潜力发挥出来，为病人提供更多有效治疗选项。”王尧河教授已在这条路上前行了24年。未来，王教授希望能够与各个领域的伙伴合作，将微可蔚建设成专注开发新型溶瘤病毒药物，具有全球竞争力的癌症免疫治疗公司。近期推荐声明：动脉网所刊载内容之知识产权为动脉网及相关权利人专属所有或持有。未经许可，禁止进行转载、摘编、复制及建立镜像等任何使用。动脉网，未来医疗服务平台

Mr. Rongen appointed as CEO and member of the Board bringing 30 years of executive leadership experience and expertise across a number of therapeutic areas Bolstered expertise on Board of Directors with addition of Dr. Rogers who brings significant leadership and expertise spanning both public and private sectors in health care and the biopharmaceutical industry DELRAY BEACH, FL / ACCESSWIRE / January 17, 2023 / Adolore Biotherapeutics, Inc. ("Adolore" or the "Company"), a biotechnology company focused on developing breakthrough opioid-free pain relieving (analgesic) treatments for chronic pain, today announced the appointments of Roelof Rongen, MSE, MBA as Chief Executive Officer and Director, and Mark C. Rogers, MD, MBA as a member of the Company's Board of Directors. "We are delighted to welcome Roelof and Mark at this pivotal time in the evolution of Adolore," commented Roy C. Levitt, MD, Founder and Executive Chairman of Adolore Biotherapeutics. "The addition of these well-known and well-respected industry leaders represents clear acknowledgement of the solid foundation of our breakthrough platform technology leveraging our novel gene therapy approach for the treatment of chronic pain and other nervous system diseases and conditions. Roelof and Mark are distinguished trailblazers in the biopharmaceutical industry and bring business, operational and financial acumen, along with a wealth of business contacts, all of which we believe will be invaluable to Adolore as we drive the Company through its next stage of growth." Mr. Rongen added, "The Adolore team has developed a cutting-edge approach to opioid-free pain relief and their data is incredibly compelling. I, along with the leadership team, are committed to advancing this innovative gene therapy toward anticipated IND filings and clinical studies. I am pleased to join the Company and look forward to building on the momentum generated thus far." Dr. Rogers added, "I am very excited to be joining Adolore's Management team and Board, at what I believe is a very important transitional period for the Company. Adolore's gene therapy approach has received validation and recognition by the NIH and Adolore's osteoarthritis program is fully funded by the NIH's HEAL program to combat the opioid crisis. I look forward to working closely with Roy, Roelof and the rest of the senior management team to advance the Company's development programs and achieve its ambitious goals, thus creating life-changing products for patients with chronic pain." Roelof Rongen, MSE, MBA Mr. Rongen is a serial entrepreneur and R&D / Commercial Development leader with extensive experience across many therapeutic areas and functions. He founded and progressed Matinas BioPharma (omega-3 and lipid-crystal nano-particle drug delivery) into a public company (NYSE:MTNB); and he was integral to the development and commercialization of blockbuster products such as Humira® and Lovaza®. Prior to founding Matinas BioPharma, Mr. Rongen was the architect behind Trygg Pharma which facilitated Norway's Aker Group's entry into the prescription omega-3 business. Before his work with Aker, he was VP for IP and Portfolio Management at Reliant Pharmaceuticals (acquired by GlaxoSmithKline) where he in-licensed Lovaza® and led development and pre-launch activities. Earlier in his career, Mr. Rongen was Global Product Director for Humira® and other Immunology Programs at BASF Pharma (acquired by Abbott/Abbvie). Mr. Rongen started his professional career as a management consultant at Arthur D. Little's Technology Innovation Management practice in Amsterdam, the Netherlands, followed by his work in New York City as biotech/pharmaceutical consultant at The Wilkerson Group (acquired by IBM). Mr. Rongen holds a Master of Science in Engineering (MSE) in Molecular Sciences (with Biotechnology/Bio-Process Technology focus) graduate degree from Wageningen University in the Netherlands and an MBA from Kellogg GSB at Northwestern University. Mark C. Rogers, MD, MBA Dr. Rogers is a physician, serial entrepreneur, professor, and hospital administrator, who brings leadership and expertise in health care and the biopharmaceutical industry spanning both private and public sectors with significant board and operational experience. Most notably, Dr. Rogers was CEO of Duke Hospital and Health Network before joining Perkin Elmer as Chief Technology Officer (NYSE:PKI) where he was in charge of the company's human genome sequencing program, amongst other responsibilities. He then moved into medical venture capital becoming CEO of Paramount Capital. Later, before founding Gibson Oncology, Dr. Rogers served as founder, Chairman, and CEO of numerous companies including Innovative Drug Delivery Systems, a pharmaceutical development company with three pain-related drugs which went public and was acquired for approximately $230 million. He was founder and Chairman of Aptamera, an oncologic pharmaceutical development company that was acquired by a London public company Antisoma. He was founder and Chairman of Cardiome, a NASDAQ listed cardiac arrhythmia company that reached an $800 million-dollar market capitalization while Dr. Rogers was Chair. He also was Executive Chair of PolaRX which developed Arsenic Trioxide as a cure for Acute Promyelocytic Leukemia and which, after FDA approval, was subsequently sold to a large pharmaceutical company for $100 million. Dr. Rogers trained in four medical specialties (critical care, pediatrics, cardiology, and anesthesiology) and was a Professor and Chair at Johns Hopkins at age 37. The author of well over 100 papers and Editor of 12 books, he is a member of the National Academy of Medicine, is a former Fulbright scholar, and former Chair of the Reagan-Udall Foundation, the U.S. Congress public advisory group on the FDA. Dr. Rogers earned his undergraduate degree at Columbia University, his Medical Doctorate from SUNY and his MBA from the Wharton School at Pennsylvania University. About Adolore Biotherapeutics, Inc. Adolore Biotherapeutics, Inc., is a biotechnology company focused on developing novel therapies for the treatment of chronic pain and other pain and nervous system conditions or disorders. Our best-in-class lead programs are long-acting locally acting gene-therapies that are opioid-free Disease Modifying Anti-Pain therapies (DMAPs) for the treatment of a variety of chronic pain indications. The Company's two current CA8* gene therapy programs are in preclinical development for treatment of patients suffering from erythromelalgia, a life-long heritable chronic pain condition representing an orphan drug disease with no approved therapy, and chronic osteoarthritis knee pain, affecting a large number of patients that is often treated with opioids due to the lack of alternatives, thus contributing to the ongoing opioid crisis. For more information, visit adolore.com. Forward Looking Statements To the extent this announcement contains information and statements that are not historical, they are considered forward-looking statements within the meaning of the federal securities laws. You can identify forward-looking statements by the use of the words "believe," "expect," "anticipate," "intend," "estimate," "project," "will," "should," "may," "plan," "intend," "assume" and other expressions which predict or indicate future events and trends and which do not relate to historical matters. You should not rely on forward-looking statements, because they involve known and unknown risks, uncertainties and other factors, some of which are beyond the control of the Company. These risks and uncertainties include, but are not limited to, those associated with drug development. These risks, uncertainties and other factors may cause the actual results, performance or achievements of the Company to be materially different from the anticipated future results, performance or achievements expressed or implied by the forward-looking statements. Investor Relations Contact JTC Team, LLC Jenene Thomas 833-475-8247 adolore@jtcir.com SOURCE: Adolore Biotherapeutics, Inc. 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