First-in-Human Clinical Trial to Prevent Acute Graft-versus-Host Disease and Severe Infections Planned for 2016
Poster Presentations to Highlight Preclinical Findings and Potential Therapeutic and Pharmacoeconomic Value Propositions in HCT
SAN DIEGO, Nov. 5, 2015 (GLOBE NEWSWIRE) -- Fate Therapeutics, Inc. (NASDAQ:FATE), a biopharmaceutical company dedicated to the development of programmed cellular immunotherapeutics for the treatment of cancer and immune disorders, announced today that it will present preclinical data for ProTmune™, its product candidate for patients undergoing hematopoietic cell transplantation (HCT) using mobilized peripheral blood (mPB), at the American Society of Hematology (ASH) 2015 Annual Meeting being held December 5-8 in Orlando, Florida. The Company expects to initiate a first-in-human clinical trial in 2016 to investigate the potential of ProTmune to prevent the life-threatening complications of acute graft-versus-host-disease (GvHD) and severe infections.
Acute GvHD and severe infections are life-threatening complications affecting allogeneic HCT patients, and are leading causes of morbidity and mortality. The Company is pursuing a fundamentally novel strategy to prevent acute GvHD and severe infections in patients undergoing allogeneic HCT with its development of ProTmune – by using small molecules to first program the therapeutic properties of the donor cells ex vivo, the immune tolerance and anti-infective activity of the donor cells administered to the patient may be significantly enhanced. New preclinical data to be presented show that a single administration of programmed cells result in a statistically-significant reduction in GvHD score and improvement in survival as compared to vehicle-treated cells in preclinical models. Pharmacoeconomic data will also be presented demonstrating that mean healthcare costs per patient are increased by approximately $170,000 and length of hospital stay is extended by 19 days for patients experiencing one or more infections after HCT compared to those that do not develop any infection.
Presentations at ASH 2015 include the following:
Saturday, December 5, 2015, 5:30 p.m. – 7:30 p.m. EST (poster presentation)
Title: Ex Vivo Modulation of Donor Cells Results in Enhanced Survival and Reduced GVHD Mortality
Session Name: 702. Experimental Transplantation: Immune Function, GVHD and Graft-versus-Tumor Effects: Poster I
Abstract Number: 1884
Lead Author: Lisa Guerrettaz, Ph.D., Senior Scientist, Immunology, Fate Therapeutics
Location: Orange County Convention Center, Hall A
Monday, December 7, 2015, 6:00 p.m. – 8:00 p.m. EST (poster presentation)
Title: Economic Burden of Infections Following Allogeneic Hematopoietic Cell Transplant for Hematologic Malignancies
Session Name: 902. Health Services and Outcomes Research – Malignant Diseases: Poster III
Abstract Number: 4500
Lead Author: Ariel Berger, MPH, Evidera
Location: Orange County Convention Center, Hall A
About ProTmune
ProTmune is a programmed cellular immunotherapeutic undergoing preclinical investigation for the prevention of acute graft-versus-host disease (GvHD) and severe infections in patients undergoing allogeneic hematopoietic cell transplantation (HCT). GvHD and severe infections are major complications that significantly impair the quality of life and survival of many patients. To date, preventative strategies are limited and treatment strategies involve toxic medications that can cause systemic side effects. ProTmune is produced by modulating donor mobilized peripheral blood (mPB) ex vivo using two small molecules, and the resulting programmed mPB cells are adoptively transferred to a patient through a single administration. Fate Therapeutics has shown that programmed T cells within mPB are functionally less allo-reactive, with a reduced capacity to produce Interferon Gamma (IFN-ɣ) and an increased capacity to produce Interleukin 4 (IL-4) and 10 (IL-10).
About Fate Therapeutics, Inc.
Fate Therapeutics is a biopharmaceutical company dedicated to the development of programmed cellular immunotherapeutics for the treatment of cancer and immune disorders. The Company's cell-based product pipeline is comprised of off-the-shelf immuno-oncology therapeutics, including NK- and T-cell-based candidates derived from induced pluripotent cells, and immuno-regulatory therapeutics, including hematopoietic cell-based candidates for protecting the immune system of patients undergoing hematopoietic cell transplantation and for suppressing auto-reactive T cells of patients with auto-immune disorders. Its adoptive cell therapy candidates are based on the Company's novel ex vivo cell programming approach, which it applies to modulate the therapeutic function and direct the fate of immune cells. 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 Company's intention to initiate a clinical trial for ProTmune during 2016, the therapeutic potential of ProTmune, and the Company's plans and ability to develop programmed cellular immunotherapeutics, including ProTmune. 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 of cessation or delay of planned development and clinical activities for a variety of reasons (including any adverse events or other results that may be observed during development), any inability to develop programmed cellular immunotherapeutics which are suitable for therapeutic applications, the risk that results observed in prior preclinical studies of ProTmune may not be replicated in subsequent studies or clinical trials, and the risk that ProTmune or programmed cellular immunotherapeutics that the Company may develop 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 Form 10-Q for the quarter ended September 30, 2015, and from time to time the Company's other investor communications. The Company 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.