Fate Therapeutics Announces Additional Clinical Data from Phase 1 Stage of PROTECT Clinical Trial of ProTmune™
No Events of Cancer Relapse
No ProTmune-related Serious Adverse Events Reported by Investigators
“The primary objective of hematopoietic cell transplantation for cancer patients is disease-free survival. We are very encouraged that no events of cancer relapse have occurred with ProTmune in the Phase 1 stage of PROTECT,” said
Seven adult subjects with hematologic malignancies undergoing matched unrelated donor hematopoietic cell transplantation (HCT) received ProTmune as the hematopoietic cell graft in the Phase 1 stage of PROTECT. As of a
Day 100 clinical data from the Phase 1 stage of PROTECT were previously presented at the 59th
Three subjects with acute lymphoblastic leukemia (ALL), three subjects with acute myeloid leukemia (AML) and one subject with myelodysplastic syndrome (MDS) received ProTmune as the hematopoietic cell graft in the Phase 1 stage. All subjects are being followed for a period of up to two years post-HCT. Non-relapse mortality deemed not attributable to ProTmune occurred in two subjects (Subject 1 on Day 228 from pulmonary edema; Subject 3 on Day 151 from atrial fibrillation). The remaining five of seven Phase 1 subjects are alive and relapse-free.
|PROTECT Clinical Data – Time on Study *|
|Age / Gender||66 / F||56 / F||66 / F||34 / F||48 / M||56 / M||69 / F|
|CD34+ cell dose (x106/kg)||10.3||4.6||10.9||4.8||3.2||3.0||9.4|
|CD3+ cell dose (x108/kg)||3.1||1.8||2.6||2.8||2.0||1.2||2.8|
|Time on Study (Days)||228||343||151||251||243||208||195|
|* Data is based on a February 26, 2018 data cut-off. The database is not locked, and final data are subject to change.|
PROTECT Phase 2 Clinical Trial
The ongoing Phase 2 stage of PROTECT is a randomized, controlled and double-blinded clinical trial assessing the safety and efficacy of ProTmune in up to 60 adult subjects with hematologic malignancies undergoing matched unrelated donor HCT following myeloablative conditioning. Subjects are being randomized, in a 1:1 ratio, to receive either ProTmune as the hematopoietic cell graft or a conventional matched unrelated donor mobilized peripheral blood cell graft. The primary efficacy endpoint of PROTECT is cumulative incidence of Grades 2-4 acute GvHD by Day 100 following HCT, where prospective clinical studies have shown that 40% to 80% of patients undergoing matched unrelated donor HCT experience Grades 2-4 acute GvHD. Additional key endpoints, including rates of chronic GvHD, cancer relapse, and disease-free and overall survival, are also being assessed.
ProTmune™ is an investigational next-generation hematopoietic cell graft for the prevention of acute GvHD in patients undergoing allogeneic HCT. ProTmune is manufactured by pharmacologically modulating an allogeneic donor-sourced, mobilized peripheral blood graft ex vivo with two small molecules (FT1050 and FT4145) to decrease the incidence and severity of acute GvHD while maintaining the anti-leukemia activity of the graft. ProTmune has been granted Orphan Drug and Fast Track Designations by the
About Allogeneic HCT
There are approximately 30,000 allogeneic HCT procedures performed globally each year according to the
About Acute GvHD
Acute GvHD is a severe immunological disease that commonly arises in patients during the first weeks following allogeneic HCT when newly-transplanted donor immune cells attack the patient’s tissues and organs, resulting in a potentially fatal immune system reaction. Prospective clinical studies have shown that 40% to 80% of patients undergoing matched unrelated donor HCT experience Grades 2-4 acute GvHD, with most incidents occurring by Day 60 following HCT despite the use of standard prophylaxis regimens. Mortality directly attributable to acute GvHD or its treatment occurs in 10% to 20% of patients.
This release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 including statements regarding the therapeutic and market potential of ProTmune™, the Company’s advancement of and plans for its clinical investigation of ProTmune, including the Company’s ability to assess key one-year outcomes from the Phase 1 stage of PROTECT and continue the ongoing Phase 2 stage of PROTECT, the ability of ProTmune to prevent, or reduce the occurrence of, graft-versus-host disease, disease relapse or mortality, the potential safety of ProTmune in the treatment of diseases, the timing for receipt of clinical data and success of the Company’s PROTECT clinical trial, and the Company’s development and product registration strategy for ProTmune, including its ability to pursue accelerated registration. 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 difficulties or delay in enrolling subjects in clinical trials or in manufacturing or supplying ProTmune for clinical testing, the occurrence of any adverse events or other results that may be observed during development, or any requirements that may be imposed by regulatory authorities on the manufacture or conduct of clinical trials of ProTmune including those necessary to support product registration), the risk that results observed in prior preclinical studies and early-stage clinical trials of ProTmune may not be observed in ongoing or future studies or clinical trials, the risk that ProTmune may not produce therapeutic benefits or may cause other unanticipated adverse effects, the risk that the Company’s expenditures may exceed current expectations for a variety of reasons, and the risk that the Company may allocate its financial and other resources to programs or product candidates that ultimately have less therapeutic or commercial potential than other product opportunities. 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
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Source: Fate Therapeutics, Inc.