Fate Therapeutics Announces Leadership Transition
Fate Therapeutics announced a leadership transition as Scott Wolchko will retire as President and CEO on December 31, 2024, after 10 years of leading the company's iPSC-derived cellular immunotherapies development. Bob Valamehr, current President of R&D, will become President and CEO on January 1, 2025. Under Wolchko's leadership, the company treated over 300 patients with engineered NK cell and T-cell product candidates. The company reported progress with FT819, their off-the-shelf CAR T-cell product, in treating systemic lupus erythematosus (SLE), with promising initial results in the first three patients with lupus nephritis, showing no dose-limiting toxicities.
Fate Therapeutics ha annunciato un cambiamento nella leadership, poiché Scott Wolchko si ritirerà dalla carica di Presidente e CEO il 31 dicembre 2024, dopo 10 anni alla guida dello sviluppo delle terapie immunologiche cellulari derivate da iPSC dell'azienda. Bob Valamehr, attuale Presidente della Ricerca e Sviluppo, assumerà il ruolo di Presidente e CEO il 1 gennaio 2025. Sotto la guida di Wolchko, l'azienda ha trattato oltre 300 pazienti con candidati a prodotti cellulari NK e T-cell ingegnerizzati. L'azienda ha riportato progressi con FT819, il loro prodotto CAR T-cell pronto all'uso, nel trattamento del lupus eritematoso sistemico (LES), con risultati iniziali promettenti nei primi tre pazienti con nefrite lupica, mostrando nessuna tossicità limitante alla dose.
Fate Therapeutics anunció una transición en la dirección, ya que Scott Wolchko se retirará como Presidente y CEO el 31 de diciembre de 2024, tras 10 años liderando el desarrollo de las terapias inmunitarias celulares derivadas de iPSC de la empresa. Bob Valamehr, actual Presidente de I+D, se convertirá en Presidente y CEO el 1 de enero de 2025. Bajo el liderazgo de Wolchko, la empresa trató a más de 300 pacientes con candidatos a productos celulares NK y T-cell diseñados. La empresa informó avances con FT819, su producto CAR T-cell de uso inmediato, en el tratamiento del lupus eritematoso sistémico (LES), con resultados iniciales prometedores en los primeros tres pacientes con nefritis lúpica, mostrando ninguna toxicidad limitante de dosis.
Fate Therapeutics는 리더십 전환을 발표했으며, Scott Wolchko는 2024년 12월 31일 CEO이자 회장직에서 은퇴할 예정입니다. 그는 10년 동안 회사의 iPSC 유래 세포 면역 요법 개발을 이끌어 왔습니다. Bob Valamehr는 현재 R&D 부사장으로, 2025년 1월 1일부터 회장 겸 CEO로 취임할 것입니다. Wolchko의 지도 하에 이 회사는 조작된 NK 세포 및 T 세포 제품 후보를 사용하여 300명 이상의 환자를 치료했습니다. 회사는 FT819, 즉시 사용 가능한 CAR T 세포 제품이 전신성 루푸스 에리테마토수스(SLE) 치료에서 진전을 보였으며, 루푸스 신염 환자 3명에서 유망한 초기 결과를 보여주었고, 용량 제한 독성을 나타내지 않았습니다.
Fate Therapeutics a annoncé une transition de leadership, alors que Scott Wolchko prendra sa retraite en tant que Président et CEO le 31 décembre 2024, après 10 ans à la tête du développement des immunothérapies cellulaires dérivées de l'iPSC de l'entreprise. Bob Valamehr, l'actuel Président de la R&D, deviendra Président et CEO le 1er janvier 2025. Sous la direction de Wolchko, l'entreprise a traité plus de 300 patients avec des candidats de produits cellulaires NK et T-cell modifiés. L'entreprise a signalé des progrès avec FT819, leur produit CAR T-cell prêt à l'emploi, dans le traitement du lupus érythémateux systémique (LES), avec des résultats initiaux prometteurs chez les trois premiers patients atteints de néphrite lupique, montrant aucune toxicité limitante de dose.
Fate Therapeutics hat einen Führungswechsel angekündigt, da Scott Wolchko am 31. Dezember 2024 nach 10 Jahren als Präsident und CEO, in denen er die Entwicklung der iPSC-abgeleiteten zellulären Immuntherapien des Unternehmens leitete, in den Ruhestand gehen wird. Bob Valamehr, der derzeitige Präsident für Forschung und Entwicklung, wird am 1. Januar 2025 Präsident und CEO. Unter Wolchkos Führung behandelte das Unternehmen über 300 Patienten mit entwickelten NK-Zell- und T-Zell-Produktkandidaten. Das Unternehmen berichtete über Fortschritte mit FT819, ihrem sofort einsetzbaren CAR T-Zell-Produkt, bei der Behandlung von systemischem Lupus erythematodes (SLE), mit vielversprechenden ersten Ergebnissen bei den ersten drei Patienten mit Lupusnephritis und ohne dosislimitierende Toxizität.
- First lupus nephritis patient treated with FT819 achieved drug-free clinical remission
- Initial clinical trial data shows favorable safety profile for FT819
- Company holds over 500 issued patents
- Successful treatment of over 300 patients with cell therapy products
- None.
Bob Valamehr, Ph.D. MBA, To Become President and CEO January 1, 2025
Scott Wolchko To Retire as President and CEO after 10 years of Leadership in Pioneering iPSC-derived Cellular Immunotherapies
SAN DIEGO, Nov. 29, 2024 (GLOBE NEWSWIRE) -- Fate Therapeutics, Inc. (NASDAQ: FATE) (“Fate Therapeutics” or the “Company”), a clinical-stage biopharmaceutical company dedicated to bringing first-in-class induced pluripotent stem cell (iPSC)-derived cellular immunotherapies to patients with cancer and autoimmune disorders, today announced that Scott Wolchko, the Company’s President and CEO, will retire effective December 31, 2024. Fate’s current President of Research and Development (R&D), Bob Valamehr, Ph.D. MBA, will assume the role of President and CEO as of January 1, 2025. Fate Therapeutics will passionately continue its mission to develop novel off-the-shelf cellular immunotherapies to broadly treat patients in need.
Since 2015, Mr. Wolchko has guided the Company to become a leading biopharmaceutical company in the field of off-the-shelf natural killer (NK) cell and T-cell immunotherapies for patients with cancer and autoimmune diseases. During his tenure, the Company pioneered the development of a versatile and powerful iPSC product platform and treated over 300 patients with first-of-kind, multiplexed-engineered NK cell and T-cell product candidates. The Company’s innovative platform enables the generation of clonal master iPSC lines and the scaled manufacture of off-the-shelf product candidates uniquely designed and engineered to perform disease fighting roles. Mr. Wolchko will continue as a strategic advisor to the Company.
“I would like to thank Scott for his leadership and contributions since the Company’s founding and his vision in establishing Fate as a leader in creating multiplexed-engineered living drugs to tackle complex diseases and delivering them as safe and cost-effective medicines that are available on-demand,” said Bill Rastetter, Fate’s Chairman of the Board of Directors. “I have learned from Scott and admired his unique insights on building strategic differentiation into our product platform and product candidates.”
For nearly 15 years, Dr. Valamehr has led the development of the Company’s iPSC platform and is a leader in the field of cellular therapeutics. Under his direction, the Company has established a world class R&D organization yielding numerous high-tier journal publications, over 500 issued patents, and a pipeline of highly innovative cellular products. Dr. Valamehr’s pursuit to treat patients in need with novel cellular therapeutics includes the allowance of thirteen Investigational New Drug applications, spanning the treatment of hematological malignancies, solid tumors and autoimmune disorders.
Included in the Company’s product candidate pipeline is FT819, the Company’s off-the-shelf, CD19-targeted, 1XX CAR T-cell product candidate comprised of CD8αβ+ T cells. FT819 is currently in an ongoing multi-center, Phase 1 clinical trial for patients with moderate-to-severe systemic lupus erythematosus (SLE) where the trial is designed to evaluate the safety, pharmacokinetics, and anti-B cell activity of FT819 (NCT06308978). The first three patients, all of whom presented with active lupus nephritis, received fludarabine-free conditioning followed by a single dose of FT819. All three patients remain on-study, and there have been no dose-limiting toxicities. (Goulding et al., American College of Rheumatology Annual Conference 2024).
“The initial data from our use of FT819, where we have observed a favorable safety profile, first in the treatment of aggressive B cell lymphoma, and now in the initial stages of our SLE clinical trial, provide support for the potential of the company’s iPSC platform across different diseases,” said Dr. Valamehr. “The first lupus nephritis patient treated with a single dose of FT819 and fludarabine-free conditioning has achieved drug-free clinical remission and continues free of all immunosuppressive therapy. We will continue the trial of FT819 in SLE as we gather insights to implement an approval strategy for this novel off-the-shelf cellular immunotherapy. We also continue to push forward our other clinical programs, including FT825 / ONO-8250 CAR T-cell product candidate for treatment of advanced solid tumors pursued in collaboration with our partner Ono Pharmaceutical.”
About Fate Therapeutics’ iPSC Product Platform
Human induced pluripotent stem cells (iPSCs) possess the unique dual properties of unlimited self-renewal and differentiation potential into all cell types of the body. The Company’s proprietary iPSC product platform combines multiplexed-engineering of human iPSCs with single-cell selection to create clonal master iPSC lines. Analogous to master cell lines used to mass produce biopharmaceutical drug products such as monoclonal antibodies, the Company utilizes its clonal master iPSC lines as a starting cell source to manufacture engineered cell products which are well-defined and uniform in composition, can be stored in inventory for off-the-shelf availability, can be combined and administered with other therapies, and can potentially reach a broad patient population. As a result, the Company’s platform is uniquely designed to overcome numerous limitations associated with the manufacture of cell therapies using patient- or donor-sourced cells. Fate Therapeutics’ iPSC product platform is supported by an intellectual property portfolio of over 500 issued patents and 500 pending patent applications.
About Fate Therapeutics, Inc.
Fate Therapeutics is a clinical-stage biopharmaceutical company dedicated to bringing a first-in-class pipeline of induced pluripotent stem cell (iPSC)-derived cellular immunotherapies to patients with cancer and autoimmune diseases. Using its proprietary iPSC product platform, the Company has established a leadership position in creating multiplexed-engineered master iPSC lines and in the manufacture and clinical development of off-the-shelf, iPSC-derived cell products. The Company’s pipeline includes iPSC-derived natural killer (NK) cell and T-cell product candidates, which are selectively designed, incorporate novel synthetic controls of cell function, and are intended to deliver multiple therapeutic mechanisms to patients. Fate Therapeutics is headquartered in San Diego, CA. For more information, please visit www.fatetherapeutics.com.
Forward-Looking Statements
This release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 including statements regarding the safety and therapeutic potential of the Company’s iPSC-derived CAR NK and T-cell product candidates, the advancement of and plans related to the Company's product candidates, clinical studies and preclinical research and development programs, the Company’s progress, plans and timelines for the clinical investigation of its product candidates, the initiation and continuation of enrollment in the Company’s clinical trials, the initiation of additional clinical trials and additional dose cohorts in ongoing clinical trials of the Company’s product candidates, the timing and availability of data from the Company’s clinical trials, the therapeutic and market potential of the Company’s research and development programs and product candidates, the Company’s clinical and product development strategy, the Company’s expectations regarding progress, plans, and timelines, and Mr. Wolchko’s continued service as a strategic advisor to the Company. These and any other forward-looking statements in this release are based on management's current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to, the risk that the Company’s research and development programs and product candidates, including those product candidates in clinical investigation, may not demonstrate the requisite safety, efficacy, or other attributes to warrant further development or to achieve regulatory approval, the risk that results observed in prior studies of the Company’s product candidates, including preclinical studies and clinical trials, will not be observed in ongoing or future studies involving these product candidates, the risk of a delay or difficulties in the initiation and conduct of, or enrollment of patients in, any clinical trials, the risk that the Company may cease or delay preclinical or clinical development of any of its product candidates for a variety of reasons (including requirements that may be imposed by regulatory authorities on the initiation or conduct of clinical trials, changes in the therapeutic, regulatory, or competitive landscape for which the Company’s product candidates are being developed, the amount and type of data to be generated or otherwise to support regulatory approval, difficulties or delays in patient enrollment and continuation in the Company’s ongoing and planned clinical trials, difficulties or delays in manufacturing or supplying the Company’s product candidates for clinical testing, failure to demonstrate that a product candidate has the requisite safety, efficacy, or other attributes to warrant further development, and any adverse events or other negative results that may be observed during preclinical or clinical development), and the risk that its product candidates may not produce therapeutic benefits or may cause other unanticipated adverse effects. For a discussion of other risks and uncertainties, and other important factors, any of which could cause the Company’s actual results to differ from those contained in the forward-looking statements, see the risks and uncertainties detailed in the Company’s periodic filings with the Securities and Exchange Commission, including but not limited to the Company’s most recently filed periodic report, and from time to time in the Company’s press releases and other investor communications. Fate Therapeutics is providing the information in this release as of this date and does not undertake any obligation to update any forward-looking statements contained in this release as a result of new information, future events or otherwise.
Contact:
Christina Tartaglia
Precision AQ
212.362.1200
christina.tartaglia@precisionaq.com
FAQ
When will Bob Valamehr become CEO of Fate Therapeutics (FATE)?
What are the initial results of Fate Therapeutics' (FATE) FT819 trial in lupus patients?
How many patients has Fate Therapeutics (FATE) treated with their cell therapy products?
When is Scott Wolchko retiring from Fate Therapeutics (FATE)?
