Affinium Pharmaceuticals Ltd.

John Mendlein, Ph.D., Chairman of Laronde, Becomes Interim CEO as Pablo J. Cagnoni, M.D., Chief Executive Officer, Assumes Role as President and Head of Research & Development of Incyte Trevor J. Hallam, Ph.D., President of Research and CSO of Sutro Biopharma, Named as Laronde’s Chief Scientific Officer SOMERVILLE, Mass.--(BUSINESS WIRE)-- Laronde, the company pioneering Endless RNA™ (eRNA) – a novel, engineered form of RNA that can be programmed to express proteins inside the body for breakthrough treatments – today announced that Pablo J. Cagnoni, M.D., will step down from his role as Chief Executive Officer effective May 26, 2023, to become President and Head of Research & Development of Incyte. Dr. Cagnoni will remain a member of Laronde’s Board of Directors. John Mendlein, Ph.D., the company’s Chairman, will become its interim Chief Executive Officer. Laronde also announced the appointment of Trevor J. Hallam, Ph.D., as Chief Scientific Officer, effective May 15, 2023. Dr. Hallam joins Laronde from Sutro Biopharma, where he was President of Research and Chief Scientific Officer. Avak Kahvejian, Ph.D., Laronde Co-founder and Flagship Pioneering General Partner, who has been serving as Laronde’s interim Chief Scientific Officer and member of the Board of Directors, will continue as a member of the Board and advisor to the CEO and Chairman. “Laronde is an incredible company and I believe that our eRNA platform has the potential to create an entirely new class of medicines across several therapeutic areas,” said Pablo J. Cagnoni, M.D., Chief Executive Officer of Laronde. “I am taking the opportunity of a lifetime to lead a large research and development organization and I will miss the highly talented team at Laronde. Over the past several months, we have made significant progress in advancing our platform and research programs and I am excited to remain an active member of Laronde’s Board to support John, Avak, and the team who have pioneered the Laronde platform from the beginning as we continue this exciting journey.” “Over the last year, our scientists have made tremendous progress unlocking the promise of eRNA therapeutics as a new class of treatments with far-ranging in vivo applications, including vaccines, rare diseases, gene editing, and antibodies. At this exciting juncture, we are thrilled to welcome Trevor to the team as we continue to build on this momentum,” said John Mendlein, Ph.D., Laronde Chairman and incoming interim Chief Executive Officer. “Trevor brings to Laronde more than 35 years of experience in drug discovery from big pharma and biotech as well as over a decade of scientific leadership building platforms and translating them into commercial and partnering opportunities. Laronde was built around a unique programmable eRNA platform with vast therapeutic applications. Trevor’s experience in transforming novel technology platforms into clinical-stage therapeutics will be invaluable as we continue to advance our platform. We thank Pablo for his efforts on behalf of Laronde over the past few months and look forward to continuing to leverage his deep expertise building platform companies as a member of our Board.” “Laronde’s platform is an entirely new way to approach medicine, and the range of therapeutic possibilities enabled by eRNA could have a great impact on the lives of many patients in need,” said Trevor J. Hallam, Ph.D., incoming Chief Scientific Officer of Laronde. “I am thrilled to work alongside John, Avak, and the entire team in place at Laronde and to continue to explore the vast potential of eRNA.” About Trevor J. Hallam, Ph.D. Dr. Hallam joins Laronde from Sutro Biopharma where he spent the last 12 years, most recently as President, Research and Chief Scientific Officer. During his tenure at Sutro Biopharma, Dr. Hallam was instrumental in the transformation of Sutro’s cell-free protein synthesis platform from an early technology platform into a clinical-stage, multi-modality platform with proven manufacturing capability. Dr. Hallam was also responsible for the strategic refocusing of the company to oncology and designing differentiated and innovative oncology development candidates for Sutro’s wholly owned asset portfolio, including two medicines that are advancing to Phase 2 studies for the treatment of b-cell malignancies, and ovarian and endometrial cancers. While at Sutro, Dr. Hallam was also instrumental in securing strategic collaborations with Celgene (now BMS), EMD-Serono, Merck, and Astellas. Prior to joining Sutro, Dr. Hallam was Executive Vice President of R&D at Palatin Technologies, Inc., and held several senior management positions in various major pharmaceutical companies over 20 years, including AstraZeneca, Roche, and Glaxo SmithKline. Dr. Hallam is a member of the Scientific Advisory Board for Sutro Biopharma. Dr. Hallam received a BSc (Hons) in Biochemistry from the University of Leeds and a Ph.D. in Biochemistry from Kings College, University of London. He then conducted post-doctoral training at the Physiological Laboratory, University of Cambridge. About John Mendlein, Ph.D. John Mendlein is an executive partner at Flagship Pioneering, contributing to Flagship’s strategic and operational objectives, including the growth stage companies like Laronde. A longtime member of Flagship’s broader ecosystem of companies, John is an experienced biotech entrepreneur. Prior to joining Flagship, John served as president of corporate and product strategy at Moderna and was a member of Moderna’s board of directors from 2012 to 2018. He has also played leadership or founder roles at multiple biotech enterprises, including Aurora Biosciences (acquired by Vertex Pharmaceuticals), Adnexus Therapeutics (acquired by BMS), Fate Therapeutics (FATE), aTyr Pharma (LIFE) and Affinium Pharmaceuticals (acquired by Debiopharm Group). John also worked at Smith Kline and French (now GSK) as a scientist. John currently serves on the boards of Flagship companies Empress, Laronde, Omega, and Senda Biosciences. John is also a co-author or co-inventor of over 210 publications and published patents. For more about John Mendlein, see here. About Endless RNA™ Ribonucleic Acids, or RNAs, play a significant role in biology. Among their functions, they provide the “code” that instructs cells to produce or regulate proteins, the building blocks of life and important regulators of disease processes. Because RNAs provide coded instructions to cells, they can be programmed to produce specific effects. This approach has been validated by the successful development of several important RNA-based medicines, but RNA’s potential as a drug development modality has just begun. Endless RNA™, or eRNA, was invented at Flagship Labs and is a new class of synthetic, closed-loop RNA. Because eRNA has no free ends, it is not recognized by the immune system and is very stable, enabling a long duration of protein expression. In addition, eRNA can serve protein-coding and non-protein-coding functions, and its protein translation capabilities are completely modular — switching an eRNA “protein sequence cassette” enables the expression of a different protein or multiple proteins that can be tuned as needed on an application-by-application basis. About Laronde Laronde is pioneering a platform that offers a completely novel way of modulating human biology. Endless RNA™ (eRNA), invented at Flagship Labs, is a uniquely engineered RNA that can be programmed to express diverse proteins inside the body. It is non-immunogenic, allows for repeat dosing, and offers flexibility in formulation and delivery. Laronde was founded in 2017 by Flagship Labs, the innovation foundry of Flagship Pioneering. The company is rapidly scaling to support the parallel development of multiple programs across many disease areas. To learn more, please visit the company’s website at or Twitter and LinkedIn. View source version on businesswire.com: Contacts Marissa Hanify, Director of Communications mhanify@laronde.bio Media: Courtney Heath courtney@scientpr.com Source: Laronde View this news release online at:

猎药人专刊是由猎药人俱乐部与E药经理人联合出品，将定期就医药行业高度关注的热点问题发挥媒体优势进行调查与分析，以推动中国创新药行业健康发展。第二期调研主题为“创新药企进击术”，通过访谈创新药企创始人、CEO、CMO等，解析Biotech在新周期中的差异化竞争力构建，敬请持续关注！3月末的昌平生命科技园，浸润着鲜活的气息。专注于细胞治疗领域的Biotech华夏英泰内部，更是如此，门口几尾鱼色彩鲜艳，与阳光相互映照。从窗口望向对面，可以看见其研发及GMP级细胞制备中心。2022年的资本寒冬，这家公司却有能力完成B+轮融资，目前正在准备C轮融资，两大创新型T细胞改造平台STAR-T和enTCR-T是其技术底气，自主研发的双靶点CD19/CD20 STAR-T候选产品HXYT-001细胞注射液已进入到临床Ⅰ期。“五年想要两款产品上市。”CEO潘国华博士，是位拿得起、放得下的温州“冒险家”，目标坚定，基于其在生物制药领域二十多年的经验，回国后毅然选择了做细胞疗法，并持续思考如何突破局限，将差异化优势越做越大。Q=E药经理人 猎药人俱乐部A=华夏英泰CEO潘国华博士Q：简单介绍下公司接下来布局以及差异化优势？A：我们朝着通用型，单靶点向双靶点，单功能向多功能，血液瘤转向实体瘤的产品方向发展，不仅要把肿瘤细胞消除掉，也要解决肿瘤微环境中的免疫抑制性细胞带来的问题，以提高抗肿瘤能力。我们STAR-T 技术平台主要具备三大优势：浸润能力强，敏感度高，以及能打造多靶点、多功能的形式。从技术验证，到发展做通用型，一步步地去开辟发展之路。Q：公司立项逻辑是什么？A：任何项目上，我们首要考虑临床需求，然后思考怎样做出差异化、发挥优势，并考虑产品成功率，以临床价值为导向，制定具体的策略。保证差异化越做越大，而不是越做越小。国内一些公司可能在项目刚开始阶段，并不会考虑那么长远，但实际应该考虑那么远。尤其是创新疗法，资金、人才需求大，如果到后面不能做，就非常麻烦，必须做好充分的准备。Q：公司现在主要面临哪些挑战？A：做细胞创新疗法，75%的成功在于优化工艺和生产，这需要搭建、丰富一个较好的人才团队，但并不容易。当然在整个产业链上，一些环节会交给CDMO去做，但到目前，中国做细胞疗法CDMO的企业总体来看发展虽很快，但部分仍不太成熟，其发展速度实际落后于细胞疗法本身的发展速度。另外，做细胞疗法，资金方面挑战较大。Q：您觉得中国创新药的研发，有没有真正融入到全球的体系中？A：我觉得真正意义上还没有。近两年虽然license-out交易项目很多，但真正融合的关键因素，我认为是产品商业化上的成功，即技术真正被验证了，在全球范围内的市场真正打开了。即使成功被BD出去，但也有可能在一两年之后被退回来。不过，要实现商业国际化，还是得有好的、具备差异化的产品，在知识产权上、临床数据质量等方面真正实现“硬核”，没有的话或许就只能靠碰运气。当然，我们也希望能够找到一个好的合作伙伴，一起打造出一款好的细胞疗法。Q：您觉得一个比较良好的、有助于药物创新的生态，应该是什么样子的？A：首先，这个生态需要政策、企业、资本等各方共同努力去打造。生态里要具备良好的审评审批体系及医保体系、较好的投资环境等等，为医药创新形成一个有机的、强有力的支持。如果说一个健康发展的企业像一张板凳，有四只腿。技术、团队和管线是三只腿，三只腿的板凳可以站立，但仍不稳定。从企业来说，特别是年轻企业，希望投资是第四只腿，能帮助企业稳步发展。我个人认为国内有不少投资方对被投企业支持是很大的。希望更多投资方都能跟上来，增强对生物医药公司予以支持的经验，比如协助解决“由内而生”的企业人力资源需求等。另外，相较于国内的投资者，国外投资者对创新研发失败的容忍度或接受能力要较强一些，明白First in class的产品可以做，但是需要一定的时间。这方面，国内投资者还需要加强，也希望接下来三五年能够看到改变。不仅是投资方在一定时间段内需要去转变、成长，整个细胞疗法“生态”实际都还正在探索性地往前走，基于诸多限制，现在还不能很快看清楚这条路应该怎么走。好多市场教育、知识的问题都还需要搞清楚。Q：您如何去评价国内投资机构当下对中国创新药、创新疗法的态度？A：前两年，国内投资太热情了，有一点感情故事就投资，过于盲目，但最近一段时间又太冷淡了。究其根本，我觉得还是对这个行业缺乏深层次了解。这个行业真的是起起落落的，一会儿暖春，一会儿寒冬。同时，新药研发，第一个出来的，不一定是最好的，没做过，可能就不知道有什么缺陷，还需要改进。有的公司六个月产品能够实现改进，有的可能需要三年。这个过程实际上和医生建立联系也有很大关系，每一个做临床研究的医生，或经过具体训练的人，都有一个intellectual curiosity，他知道这个东西为什么比人家的好，会将一些产品需要改进的关键信息反馈给企业。公司一定要出去和医生交流沟通。Q：细胞与基因疗法存在的商业化的挑战已是“老生常谈”，但也的确悬而未决，对此您怎么看？A：这确实不是一天两天就可以解决的问题，国外也还在向成熟的阶段迈进。那么企业应该做好的事情是什么？简而言之，就是不要把自己的产品“做坏了”，追求更高水平疗效或安全性，以真正解决临床问题。先让技术得以验证，然后发展通用型，去降低成本，再想想怎么样拓宽市场和适应证。外部环境的改变需要一定时间，而且是很长的时间，眼下得把自己的事情做好，再寻找机会。寒冬一来，投资人要撤了，态度变谨慎了，小型Biotech生存变得十分艰难，这也是一个周期里的一个经验和教训。好像Biotech想生存，大家都让它生存，但一旦碰到“寒冬”就只能在ICU里生存。开始投的时候缺乏选择性，结束的时候也缺乏选择性，如此在资源上可能造成很大的浪费。Q：您觉得在未来，来自中国的创新药可能会产生一款重磅炸弹，或超级重磅炸弹吗？A：如果是一款很好的产品，毫无疑问具备成为重磅炸弹的潜质，一个小药也可以具备很大的市空间。但这与市场策略、企业家思考逻辑都有关系。企业家是否有冒险精神？有时候并非是管线越多越好，那该怎么去布局和梳理？能不能讲出和做出真正的差异化？都要去回答。再者，一款药的成功，往往基于整个团队的努力。不仅是做研发的、做临床的，还有销售人员等等。中国有好多相对小的公司还缺乏完整的团队。除了内部团队完整，外部合作也很重要，合作应是常态，而不是到了寒冬，才去找合作。潘国华 华夏英泰CEO多伦多大学分子和医学遗传学博士，多伦多大学和密歇根大学进行博士后研究。拥有超过25年的研发和管理经验，覆盖小分子药物，抗体和细胞治疗领域。曾联合创始多家初创公司，包括新型细胞治疗研发公司Exacis Biotherapeutics，并任研发负责人。曾任加拿大Centre for Commercialization of Antibodies and Biologics（CCAB）副总裁，以及Toronto Recombinant Antibody Centre（TRAC）科学领袖。曾担任Campbell家庭乳腺癌研究所、大学健康网络药物发现和治疗的负责人。在Affinium Pharmaceuticals 和Genentech Inc. 担任过各种科学研究及管理职务。曾参与多个授权交易和融资活动，在《科学》等杂志上发表超过50篇科学论文，被引超过1万次。60多项专利和专利申请的发明人和共同发明人。关于猎药人俱乐部猎药人俱乐部是由国内一线基金创始合伙人、企业家、科学家共同发起的一个非营利性质的专业组织机构，于2021年11月5日在上海张江“药谷”成立。我们怀着“做医药人的灵感迸发地”的初衷，秉承“创新、交流、共享”的理念，营造轻松、愉悦、自由、开放的艺术文化氛围，组织策划碰撞灵感、激发创新的话题活动，汇聚志趣相投的新药研发创业者、投资者、研发人员及医药行业精英，分享经验，共享资源。猎取信息、捕捉灵感，让医药人的真知灼见有地可栖。