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Fate Therapeutics Appoints Neely Mozaffarian, MD, PhD, FACR, to its Board of Directors

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Fate Therapeutics (NASDAQ: FATE) has appointed Dr. Neely Mozaffarian to its Board of Directors. Dr. Mozaffarian brings over 20 years of experience in immunology and autoimmunity research and drug development. This appointment comes as Fate Therapeutics expands its clinical investigation of iPSC-derived cell products for autoimmune diseases.

The company recently treated its first systemic lupus erythematosus patient with FT819, an off-the-shelf, iPSC-derived CD8αβ+ T-cell product candidate. The patient, a 27-year-old woman with refractory disease, received a single dose of 360 million cells and was discharged after three days without notable adverse events.

Dr. Mozaffarian's expertise is expected to benefit Fate Therapeutics as it advances its pipeline of cell therapies for autoimmune conditions. Her background includes leadership roles at Atomwise, GentiBio, Janssen Pharmaceuticals, and other major pharmaceutical companies.

Fate Therapeutics (NASDAQ: FATE) ha nominato Dr. Neely Mozaffarian nel suo Consiglio di Amministrazione. Il Dr. Mozaffarian porta con sé oltre 20 anni di esperienza nella ricerca sull'immunologia e sull'autoimmunità, nonché nello sviluppo di farmaci. Questa nomina arriva mentre Fate Therapeutics espande la sua indagine clinica sui prodotti cellulari derivati da iPSC per le malattie autoimmuni.

L'azienda ha recentemente trattato il suo primo paziente affetto da lupus eritematoso sistemico con FT819, un candidato prodotto CD8αβ+ T-cell derivato da iPSC. La paziente, una donna di 27 anni con malattia refrattaria, ha ricevuto una dose singola di 360 milioni di cellule ed è stata dimessa dopo tre giorni senza eventi avversi notevoli.

Si prevede che l'esperienza del Dr. Mozaffarian avvantaggi Fate Therapeutics mentre questa avanza la sua pipeline di terapie cellulari per condizioni autoimmuni. Il suo background include ruoli di leadership presso Atomwise, GentiBio, Janssen Pharmaceuticals e altre importanti aziende farmaceutiche.

Fate Therapeutics (NASDAQ: FATE) ha nombrado al Dr. Neely Mozaffarian en su Junta Directiva. El Dr. Mozaffarian aporta más de 20 años de experiencia en investigación sobre inmunología y autoinmunidad, así como en el desarrollo de medicamentos. Este nombramiento se produce mientras Fate Therapeutics expande su investigación clínica sobre productos celulares derivados de iPSC para enfermedades autoinmunitarias.

La compañía trató recientemente a su primer paciente con lupus eritematoso sistémico con FT819, un candidato a producto de células T CD8αβ+ derivadas de iPSC. La paciente, una mujer de 27 años con enfermedad refractaria, recibió una sola dosis de 360 millones de células y fue dada de alta después de tres días sin eventos adversos notables.

Se espera que la experiencia del Dr. Mozaffarian beneficie a Fate Therapeutics a medida que avanza en su cartera de terapias celulares para condiciones autoinmunitarias. Su trayectoria incluye roles de liderazgo en Atomwise, GentiBio, Janssen Pharmaceuticals y otras importantes empresas farmacéuticas.

Fate Therapeutics (NASDAQ: FATE)는 Dr. Neely Mozaffarian을 이사회에 임명했습니다. Mozaffarian 박사는 면역학 및 자가면역 연구와 약물 개발 분야에서 20년 이상의 경험을 가지고 있습니다. 이 임명은 Fate Therapeutics가 자가면역 질환에 대한 iPSC 유래 세포 제품의 임상 조사를 확장하는 시점에서 이루어졌습니다.

회사는 최근 첫 자가면역 루푸스 환자를 FT819, 즉 iPSC 유래 CD8αβ+ T세포 제품 후보로 치료했습니다. 환자는 내성과 질환을 가진 27세 여성으로 3억 6000만 세포의 단일 용량을 받고 3일 후 별다른 부작용 없이 퇴원했습니다.

Mozaffarian 박사의 전문성은 Fate Therapeutics가 자가면역 질환을 위한 세포 치료제 파이프라인을 발전시키는데 도움을 줄 것으로 기대됩니다. 그녀는 Atomwise, GentiBio, Janssen Pharmaceuticals 등 여러 주요 제약사에서 리더십 역할을 담당해왔습니다.

Fate Therapeutics (NASDAQ: FATE) a nommé Dr. Neely Mozaffarian au sein de son Conseil d'Administration. Le Dr. Mozaffarian apporte plus de 20 ans d'expérience dans la recherche sur l'immunologie et l'auto-immunité, ainsi que dans le développement de médicaments. Cette nomination intervient alors que Fate Therapeutics élargit son enquête clinique sur des produits cellulaires dérivés d'iPSC pour les maladies auto-immunes.

L'entreprise a récemment traité son premier patient atteint de lupus érythémateux systémique avec FT819, un candidat produit T-cell CD8αβ+ dérivé d'iPSC. La patiente, une femme de 27 ans atteinte d'une maladie réfractaire, a reçu une dose unique de 360 millions de cellules et a été mise en congé après trois jours sans événements indésirables notables.

L'expertise du Dr. Mozaffarian devrait profiter à Fate Therapeutics alors qu'elle fait avancer son portefeuille de thérapies cellulaires pour les conditions auto-immunes. Son parcours comprend des rôles de direction chez Atomwise, GentiBio, Janssen Pharmaceuticals et d'autres grandes entreprises pharmaceutiques.

Fate Therapeutics (NASDAQ: FATE) hat Dr. Neely Mozaffarian in seinen Vorstand berufen. Dr. Mozaffarian bringt über 20 Jahre Erfahrung in der Immunologie und der Forschung zu Autoimmunität sowie in der Arzneimittelentwicklung mit. Diese Ernennung erfolgt, während Fate Therapeutics seine klinische Untersuchung von iPSC-abgeleiteten Zellprodukten für Autoimmunerkrankungen ausweitet.

Das Unternehmen hat kürzlich seinen ersten Patienten mit systemischem Lupus erythematodes mit FT819, einem Lagerprodukt mit iPSC-abgeleiteten CD8αβ+ T-Zellen, behandelt. Die Patientin, eine 27-jährige Frau mit refraktärer Erkrankung, erhielt eine Einzeldosis von 360 Millionen Zellen und wurde nach drei Tagen ohne nennenswerte Nebenwirkungen entlassen.

Die Expertise von Dr. Mozaffarian wird voraussichtlich Fate Therapeutics zugutekommen, während es seine Pipeline von Zelltherapien für Autoimmunerkrankungen vorantreibt. Ihr Hintergrund umfasst Führungspositionen bei Atomwise, GentiBio, Janssen Pharmaceuticals und anderen großen Pharmaunternehmen.

Positive
  • Appointment of Dr. Neely Mozaffarian brings 20+ years of industry experience in immunology and autoimmunity
  • Successful treatment of first systemic lupus erythematosus patient with FT819 without notable adverse events
  • Expansion of clinical investigation into autoimmune diseases with iPSC-derived cell products
Negative
  • None.

SAN DIEGO, July 31, 2024 (GLOBE NEWSWIRE) -- Fate Therapeutics, Inc. (NASDAQ: FATE), 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, today announced the appointment of Neely Mozaffarian, MD, PhD, FACR, to its Board of Directors effective immediately. Dr. Mozaffarian brings to the Company medical and scientific leadership in the field of immunology and autoimmunity, with over 20 years of research and industry experience in the discovery, development, and commercialization of novel small and large molecule therapeutics.

“Dr. Mozaffarian is a strategic physician-scientist and rheumatologist with a long-standing and deep interest in systemic lupus erythematosus, and we are delighted to welcome her to our Board of Directors,” said Scott Wolchko, President and Chief Executive Officer of Fate Therapeutics. “Neely’s extensive industry experience and R&D leadership, which spans across multiple autoimmune disease areas and all phases of drug development, will be of great benefit as we continue to expand clinical investigation of our off-the-shelf, iPSC-derived cell product pipeline in autoimmunity.”

In May, the Company announced that the first patient with systemic lupus erythematosus had been treated in its Phase 1 autoimmunity study of FT819 (NCT06308978), the Company’s off-the-shelf, iPSC-derived CD8αβ+ T-cell product candidate that incorporates a novel CD19-targeted 1XX chimeric antigen receptor (CAR) construct into the T-cell receptor alpha constant locus. The first patient, a 27 year-old woman with refractory disease despite having been treated with multiple standard-of-care therapies, received conditioning chemotherapy followed by a single dose of FT819 at 360 million cells and was discharged after a three-day hospital stay without any notable adverse events.

“Initial clinical proof-of-concept with CAR T-cell therapies for autoimmunity is exceptionally promising, and I am excited to work with the team at Fate Therapeutics to drive innovation and maximize the potential of investigational disease-transforming cell products for patients,” said Dr. Mozaffarian. “The Company’s iPSC product platform and off-the-shelf cell product pipeline are positioned to be highly-differentiated, with therapeutic application across a broad spectrum of autoimmune indications, and I look forward to collaborating with the executive leadership team and the other Board members to chart novel clinical development strategies and maximize patient reach.”

Dr. Mozaffarian currently serves as Chief Medical Officer of Atomwise Inc., where she leads the company’s clinical development, operations, regulatory, and quality teams to progress AI-driven pipeline assets to first-in-human studies. Prior to Atomwise, Dr. Mozaffarian served as Chief Medical Officer of GentiBio, Inc., where she advanced novel autologous and allogenic T-regulatory cell programs aiming to restore immune homeostasis in patients with inflammatory diseases; as Vice President, Autoantibody Pathway Area Leader at Janssen Pharmaceuticals / Johnson & Johnson; as Senior Vice President at Ichnos Sciences Inc.; and held R&D leadership positions in clinical development at Gilead, Eli Lilly, and AbbVie.

Dr. Mozaffarian graduated with honors from the Albert Einstein College of Medicine in New York, and completed Internal Medicine residency and Rheumatology research fellowship at the University of Washington in Seattle.

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 advancement of, plans related to, and the therapeutic potential of the Company’s product candidates, the Company’s clinical development and manufacturing strategies, and the Company’s plans for the clinical investigation and manufacture of its product candidates. 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 manufacturing of the Company’s product candidates or 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 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

Who is the new Board of Directors member at Fate Therapeutics (FATE)?

Dr. Neely Mozaffarian, MD, PhD, FACR, has been appointed to Fate Therapeutics' Board of Directors, effective immediately.

What is FT819 and how is it being used by Fate Therapeutics (FATE)?

FT819 is Fate Therapeutics' off-the-shelf, iPSC-derived CD8αβ+ T-cell product candidate. It's being used in a Phase 1 autoimmunity study for treating systemic lupus erythematosus.

What was the outcome of the first patient treated with FT819 by Fate Therapeutics (FATE)?

The first patient, a 27-year-old woman with refractory systemic lupus erythematosus, received a single dose of 360 million FT819 cells and was discharged after three days without any notable adverse events.

What is Fate Therapeutics (FATE) focusing on in terms of product development?

Fate Therapeutics is focusing on developing induced pluripotent stem cell (iPSC)-derived cellular immunotherapies for cancer and autoimmune diseases.

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Biotechnology
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