Sangamo Therapeutics France SAS

PISCATAWAY, N.J., Sept. 14, 2024 /PRNewswire/ -- The year 2024 marks a milestone year for continuous advancements in Cell and Gene Therapy (CGT). The global launch of Amtagvi, a Tumor-Infiltrating Lymphocyte (TIL) therapy, has ushered in a new era for solid tumor treatment using cell therapy. PM359, the world's first lead editing therapy, has been approved for clinical trials, signaling another leap forward in gene editing technology. Meanwhile, INT2104, the first in vivo edited CAR-T therapy, is set to enter clinical trials, greatly expanding the development pathway for CAR-T therapies... Alongside this flourishing growth, both opportunities and challenges arise. How to carve out new frontiers in the vast and promising yet risky CGT market and precisely navigate the path forward has become a key focus for the entire industry and beyond. On November 20, 2024, the "2024 GenScript Biotech Global Forum • London," themed "Unlock the Full Potential of Cell and Gene Therapies," will bring together leading global experts to discuss the future of CGT development, driving progress and transformation within the industry. This year's forum is packed with highlights, including the presence of Dr. James Wilson, a distinguished scientist in the field of gene therapy. Also making an appearance is Miguel Forte, a leading figure who spans academia, industry, and regulatory sectors. Ying Huang, CEO of Legend Biotech, will represent the industry as a featured guest. The gathering of so many esteemed experts promise not only a feast of ideas and insights but also the stimulation of innovative thinking and the promotion of cross-sector collaboration, driving the CGT industry towards robust growth. We look forward to witnessing the birth of more groundbreaking innovations and opening a new chapter in industry development at this forum. As a leader in the biotech industry, GenScript is committed to fostering dialogue and collaboration by establishing a professional global platform for exchange, with the goal of advancing innovation in the Cell and Gene Therapy (CGT) sector. GenScript has successfully hosted two previous global forums during JPM Week, and as part of the GenScript Biotech Global Forum series, the London forum will also focus on the latest developments in CGT. It will bring together global industry leaders to envision the future together. Click the link and register with the invitation code GS2024 by September 15 for free entry. James Wilson, a prominent figure in the field of gene therapy, will attend the forum and participate actively. Renowned for his groundbreaking work in Adeno-Associated Virus (AAV) vector design and application, Dr. Wilson has made significant contributions. His team developed several safe and effective AAV vectors that have successfully transitioned from the lab to clinical practice, greatly advancing gene therapy and offering new hope to patients with rare genetic diseases. Today, this industry titan has successfully transitioned from academia to the business world, with two new companies spun out from the University of Pennsylvania: GEMMA Biotherapeutics and Franklin Biolabs. GEMMA is focused on developing innovative therapies for rare diseases, with a pipeline that includes PBGM01 for GM1 gangliosidosis, PBKR03 for Krabbe disease, and PBML04 for metachromatic leukodystrophy. Franklin, on the other hand, is a contract research organization (CRO) for gene therapy companies, offering comprehensive solutions from discovery to development and distribution. At this forum, James Wilson will focus on the field of gene therapy, sharing his wealth of experience and insights. Meanwhile, for this forum, we are honored to invite Miguel Forte, a key figure in the field of Cell and Gene Therapy who spans academia, industry, and regulatory sectors. He will deliver a keynote speech focusing on the current state of CGT, analyzing future development opportunities and addressing the urgent challenges that lie ahead, providing attendees with comprehensive knowledge sharing and strategic guidance. Miguel Forte is a versatile leader in the field of Cell and Gene Therapy, with over 20 years of deep experience in academia, industry, and regulatory affairs. Dr. Forte has held significant roles at international pharmaceutical companies such as BMS and UCB, where he was deeply involved in the development, launch, and business expansion of several key products, gaining extensive experience in product development and commercialization. During his tenure as Chief Medical Officer and Chief Operating Officer at TxCell, Dr. Forte demonstrated exceptional strategic development skills, leading the company through a successful IPO and multiple funding rounds, significantly advancing the development of CGT products. Subsequently, Dr. Forte served as CEO of Zelluna Immunotherapy and Bone Therapeutics, where he not only led Zelluna through critical financing and initiated an allogeneic CGT development strategy for solid tumors but also directed Bone through strategic restructuring, multiple financings, and important acquisitions. Notably, his previous roles at the Portuguese and European Medicines Agency (EMA) have provided Dr. Forte with a wealth of experience in drug approval and regulatory policy development. Currently, Miguel Forte serves as the CEO and Co-Founder of Kiji Therapeutics, a company focused on offering new treatment options for patients with refractory diseases using advanced gene editing technologies and cell engineering. Its pipeline primarily concentrates on CGT therapies for solid tumors. His extensive experience and insights will provide a comprehensive, multidimensional perspective on the industry, offering valuable inspiration. This forum also features several thematic discussions that delve deeply into hot topics across the entire industry chain, including technological innovations and breakthroughs in cell therapy, advances in gene therapy and mRNA vaccines, challenges in CGT manufacturing, and future pathways for CGT from an investment perspective. In the roundtable discussion on technological innovations and breakthroughs in cell therapy, leaders from major CGT companies, such as Ying Huang, CEO of Legend Biotech, Pascal Touchon, President and CEO of Atara Biotherapeutics, Biao Zheng, CEO of Bangio Biotech, and Jason Foster, CEO of Ori Biotech, will participate. Cilta-cel, a cell therapy product from Legend Biotech, has recently received approvals from the FDA and the European Commission for use in second-line treatment of multiple myeloma. Also, it has been approved for market release in China, promising to benefit more patients. Atara Biotherapeutics has launched Ebvallo, the world's first off-the-shelf T cell therapy, marking the dawn of the off-the-shelf cell therapy era. BRL Medicine's new-generation allogeneic CAR-T therapy, TyU19, has been successfully applied to refractory autoimmune diseases, enriching the application scenarios of CAR-T therapies. The proprietary fully automated and standardized CGT manufacturing platform from Ori Biotech is set to significantly reduce production costs, bringing the goal of increased patient accessibility closer. During the roundtable, industry leaders from the pioneering companies will discuss how CAR-T therapies are transcending boundaries, transitioning from hematological malignancies to new frontiers in solid tumor treatments. They will analyze the latest advancements and challenges in TIL therapies, CAR-T therapies, and allogeneic cell therapies, while also forecasting the breakthroughs and urgent challenges in the CGT field. Their insights will provide strategic guidance for high-level industry development, aiming to extend the benefits of CGT therapies to a broader patient population. In addition, there are numerous compelling highlights that you simply cannot afford to miss: Cutting-edge Technology Sharing: Leading biotech companies will present their latest research achievements focused on the entire CGT industry chain. Attendees will gain profound insights into innovative technologies and explore how to achieve breakthroughs for successful clinical application. Engage with International Experts: Renowned international experts will gather to discuss hot topics in the CGT field, including cutting-edge technological innovations and breakthroughs, as well as industrialization challenges and opportunities. Attendees will have the opportunity to interact and engage in in-depth discussions with global industry leaders. Investment & Financing Collaboration Opportunities: The forum provides a global stage for exchange and collaboration, where investors, researchers, and executives from around the world will explore future trends and potential opportunities in the CGT industry, uncovering collaborative prospects and charting a grand blueprint for synergistic development. Further exciting content will be updated continuously. The "2024 GenScript Biotech Global Forum•London" will offer profound inspiration and reflection for professionals, scholars, and entrepreneurs in the CGT field. Let us join top global thought leaders to address the potential challenges of the next decade in CGT, and drive the industry towards new heights through innovation and collaboration. Click the link and register with the invitation code GS2024 by September 15 for free entry. Contact us: [email protected] SOURCE GenScript Biotech Corporation WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

None  Welcome to this week's Chutes & Ladders, our roundup of hirings, firings and retirings throughout the industry. Please send the good word—or the bad—from your shop to Max Bayer or Gabrielle Masson, and we will feature it here at the end of each week.  Gilead taps Roche exec to be Shaw replacement at Kite Kite Pharma Gilead Sciences has landed a new leader for cell-therapy-focused subsidiary Kite Pharma, naming Cindy Perettie as executive vice president of the company. Her appointment comes three months after Christi Shaw announced her departure.  Perettie joins after a wide-ranging career at Roche and Genentech, most recently leading the Swiss pharma’s molecular diagnostics team, which includes molecular labs, sequencing labs and blood screening. It’s just the tip of the iceberg, as her tenure began almost 20 years when she joined in 2004 as the project team leader for immunotherapy Avastin. It’s a product she helped oversee for the following six years before becoming VP of global regulatory operations and clinical/safety documentation in 2010. Since then, she’s had a hand in leading a number of other of oncology focuses for Genentech, including hematology and the HER2 franchise.  Perettie said in a LinkedIn post that she was “humbled” by the progress Kite has made and looks forward to advancing the company’s portfolio. Kite’s lymphoma franchise is buoyed by Yescarta and Tecartus, which helped rake in $1.5 billion in revenue for Gilead’s cell therapies in 2022, a 68% increase from 2021. Fierce Pharma FDA’s revolving door with industry spits out Billy Dunn  Prothena No, Billy Dunn, M.D., will not be headed to Biogen. The former head of the FDA’s Office of Neuroscience will instead join the board of directors at Prothena, a biotech building out a pipeline focused on protein dysregulation with therapies aimed at neurodegenerative diseases and amyloidosis.  Dunn’s appointment comes a little less than three months after he called it quits on an 18-year career at the agency, helping launch the neuroscience office under the Center for Drug Evaluation and Research. Prior to launching the office, Dunn took on increasing roles in the agency’s Division of Neurology Products.  But his tenure was marred in his last two years after investigations from both Stat News and congressional leaders found that Dunn and the FDA maintained a too-cozy relationship with Biogen as it developed its Alzheimer’s med Aduhelm. A congressional report detailed how portions of Biogen’s briefing document submitted ahead of a critical advisory meeting were drafted by the FDA. Advisers voted against Aduhelm’s risk benefit profile, but the FDA granted accelerated approval anyway. Release Recursion brings on Mauro as CMO    Recursion Recursion has named David Mauro, M.D., Ph.D., as chief medical officer, a serial clinical development executive who’s now held five CMO roles in less than nine years.  Mauro was most recently chief medical officer at Codiak BioSciences, which filed for bankruptcy earlier this year. Before that, he lead clinical development at Checkmate Pharmaceuticals before it was acquired by Regeneron. He had the same role at Advaxis and Prelude Therapeutics. Recursion says that Mauro has had a hand in guiding 25 candidates into phase 1 trials over the course of his career.  His hiring at Recursion comes as the AI-focused drugmaker is progressing five assets through clinical development spanning cancer, rare diseases and other indications. Four other cancer treatments are in the preclinical or late discovery stage, with more than a dozen other programs waiting in the wings. Recursion previously culled one clinical-stage asset in October, ending work on a treatment for infantile GM2 gangliosidosis after delaying trial enrollment earlier in the year. Source > President Joe Biden has confirmed his intent to nominate the current head of the National Cancer Institute and former cancer surgeon Monica Bertagnolli, M.D., to lead the National Institutes of Health (NIH). Bertagnolli will be the second woman ever to fill the NIH director role and the first permanent replacement for the federal institute since Francis Collins, M.D., Ph.D., retired in December 2021. Release  > Sangamo Therapeutics has tapped Lisa Rojkjaer, M.D., to serve as chief medical officer, taking the spot of Bettina Cockroft, M.D., who is leaving the genomic medicine company to pursue other opportunities. Rojkjaer joins Sangamo from her CMO role at Viracta Therapeutics and has held previous positions at Nordic Nanovector, Novartis, MorphoSys and Novo Nordisk. Release   > Replay has selected Arun Balakumaran, M.D., Ph.D., to be the DNA writing company’s chief medical officer. Balakumaran joins from Allogene Therapeutics, where he was CMO and SVP, and has clocked in time at Merck, Amgen and the National Institutes of Health. Release    > Amy Broidrick is resigning from her role as Qualigen Therapeutics' president, chief strategy and operating officer and director. She's set to depart June 16. Release    > Novartis has approved eight board members for its biosimilars business Sandoz that were recommended by the spinoff’s chair Gilbert Ghostine. The group includes Nestle Chief Financial Officer Francois-Xavier Roger; former Eli Lilly Chief Information and Digital Officer Aarti Shah, Ph.D.; Swiss dairy company Emmi’s former CEO Urs Riedener; Deutsche Lufthansa’s CFO Remco Steenbergen; former Procter & Gamble exec Yannis Skoufalos; former Danaher VP of Medical Affairs and Policy Shamiram Feinglass, M.D.; British consumer goods company Unilever’s chief legal officer Maria Varsellona; and former Novartis exec and CEO at Swiss CDMO Solvia Karen Huebscher, Ph.D. Fierce Pharma > Zymeworks President and Chief Operating Officer Neil Klompas will be leaving the company June 30. Klompas has been with the clinical-stage biotech across several roles since 2007. Release    > German VC MIG Capital has four new leaders to guide investment strategy, naming Fei Tian, M.D., Ph.D., Frederick Michna and Oliver Kahl, Ph.D., as principals. Andreas Kastenbauer has also been hired as a partner at the firm. Release   > Leon-Nanodrugs, the Munich-based maker of a nanoparticle-producing platform, tapped Setu Kasera, Ph.D., to serve as its chief scientific officer starting May 15. Kasera, formerly the company’s head of science and engineering, replaces Frank Stieneker, Ph.D., who will stay on as an exclusive adviser to Leon. Release  > Gina Ford is the new executive director of Women in Bio. Her nearly two-decade career in life sciences has included leadership roles at Ipsen, AcelRx, Crinetics and NephroSant, among others, and she’s also the principal owner and founder of biopharma consulting firm One Joule. Release  > Fulcrum Therapeutics is back in balance after spending the first half of this year under an interim CEO. Effective July 1, Alex Sapir will take the reins of the rare disease drugmaker as CEO, president and a member of the board. The GSK and United Therapeutics alum previously led Dova Pharmaceuticals and, most recently, was CEO of U.K. biotech ReViral from 2019 until its acquisition by Pfizer last year. Release  > Healthcare-focused Sofinnova Investments has found a new executive partner in Jakob Dupont, M.D. The oncologist’s resume includes stints as chief medical officer of Gossamer Bio and OncoMed Pharmaceuticals as well as leadership roles in the R&D teams at Atara Biotherapeutics and Genentech. He’s also on the boards of Apexigen and Imugene and is a scientific adviser to Ambrx. Release  > Senisca, a spinout of the U.K.’s University of Exeter tackling age-related diseases, added three new members to its leadership team. Sarah Cole, Ph.D., a veteran of Takeda and Transine Therapeutics, has been named chief operating officer, and Tim Schmidt, Ph.D., who hails from GSK, UCB, TxCell and Sitryx, will serve as chief development officer. Meanwhile, Adam Clauss, Ph.D., will come aboard as VP of dermatology, following stints at Bioglan and Leo Pharma. Release

Smart Immune Bolsters Management Team with Medical and Technical Appointments Dr Frederic Lehmann, MD, appointed Chief Medical Officer and Dr Pierre Heimendinger, PharmD, appointed Chief Technical Officer Dr Pierre Heimendinger and Dr Frederic Lehmann, CTO and CMO of Smart Immune. PARIS, France, September 13, 2022 – Smart Immune SAS, a clinical-stage biotechnology company developing ProTcell™, a thymus-empowered T-cell therapy platform to fully and rapidly re-arm the immune system, announced today that it has appointed Dr Frederic Lehmann as Chief Medical Officer and Dr Pierre Heimendinger as Chief Technical Officer. They bring extensive experience and strong industrial track records in the fields of immune-oncology and cell and gene therapy. Karine Rossignol, PharmD, Co-founder and Chief Executive Officer of Smart Immune, said: "I am thrilled to be expanding our management team with such seasoned and respected executives. Dr Frederic Lehmann and Dr Pierre Heimendinger have both made impressive contributions to the field of allogeneic T-cell medicine, bringing innovation from bench to bedside. Frederic’s experience in clinical trial design and Pierre’s in cell therapy process development will be instrumental in getting the Company ready for the registration phase. I am confident that their knowledge and commitment will raise the development of our ProTcell™ platform to a new level and expedite patient access to our technology. We are excited to welcome them to Smart Immune!" As the former Head of Clinical Development and Medical Affairs and Vice President of Celyad Oncology, Dr Frederic Lehmann defined the strategic vision and contributed to securing a number of autologous and allogeneic engineered T-cell therapy IND candidates. He also spent 12 years at GSK in several roles including Head of the Early Clinical Development Business Unit for Cancer Immunotherapeutics in the company’s Vaccine Division. Frederic takes over as Chief Medical Officer from Smart Immune’s Co-founder Marina Cavazzana, MD, PhD, who will transition to the role of Strategic Clinical Development Advisor. Dr Frederic Lehmann, Chief Medical Officer of Smart Immune, commented: “I am honored to be joining such an outstanding organization and its founding team, true pioneers in T-cell progenitors, to give rise to long-lasting cellular therapy fighting cancer and infection. I strongly believe in Smart Immune’s potential, and I am very pleased to be appointed Chief Medical Officer at this exciting time. I am fully committed to help enable delivery of this unique therapeutic approach to patients with unmet need.” As Chief Technical Officer, Dr Pierre Heimendinger will oversee the development of Smart Immune’s ProTcell™ platform, most notably ensuring the stability and safety of the ProTcell™ products as they progress through Phase I/II clinical trials. Pierre brings over 30 years of experience in process automation of allogeneic and autologous CAR-Treg, Treg, viral vectors and vaccines. Prior to joining Smart Immune, he held key managerial roles overseeing production, pharmaceutical development and quality control departments at multiple pharma and biotech companies such as Aventis-Pasteur (Sanofi), Octapharma, Transgene, TxCell, and most recently, Sangamo Therapeutics. Pierre holds a PharmD from the Mérieux Institute in France. Dr Pierre Heimendinger, Chief Technical Officer of Smart Immune, commented: “Smart Immune’s developments in T-cell therapy will be completely transformative to the field as we strive to re-arm the immune system for patients fighting cancer and infection, enabling a truly off-the-shelf approach, and making the ProTcell™ cell therapy accessible for patients when it is needed and wherever it is needed. I am delighted to be working with such a groundbreaking and innovative company at a pivotal time in its growth and development and am thankful to Karine and the rest of the Smart Immune team for such a warm welcome.” Ends About Smart Immune Smart Immune is a clinical-stage biotechnology company developing ProTcell™, a thymus-empowered T-cell therapy platform to fully and rapidly re-arm the immune system, enabling next-generation allogeneic T-cell therapies for all. The company was founded in 2017 to help patients with life-threatening diseases such as high-risk blood cancers and primary immunodeficiencies. Smart Immune’s ProTcell™ platform, which is already in Phase I/II clinical trials, enables the recovery of a complete immune repertoire in patients fighting cancer and infection. ProTcell™ introduces potent, allogeneic T-cell progenitors which are then differentiated by the thymus into fully functional T-cells – an ‘off the shelf’ T-cell medicine. Smart Immune’s partners include Memorial Sloan Kettering in New York and Greater Paris University Hospitals (AP-HP). The company is headquartered at Paris Biotech Santé, 29 rue du Faubourg St Jacques, France. https://www.smart-immune.com/ LinkedIn | Twitter Media contact: Consilium Strategic Communications smartimmune@consilium-comms.com Attachment Smart Immune pic