Clinical-stage biopharmaceutical company Fate Therapeutics Inc. (FATE:NASDAQ), which is focused on the development of programmed cellular immunotherapies for cancer and immune disorders, yesterday announced that "the first patient has been treated in the company's first-in-human Phase 1 clinical trial evaluating FT596, the first cell therapy product candidate engineered with three active anti-tumor modalities, in patients with B-cell malignancies and chronic lymphocytic leukemia."
The company described FT596 as "an off-the-shelf chimeric antigen receptor (CAR) natural killer (NK) cell cancer immunotherapy derived from a clonal master induced pluripotent stem cell (iPSC) line engineered to express a proprietary CD19-targeting CAR, a novel high-affinity 158V, non-cleavable CD16 (hnCD16) Fc receptor, and a unique interleukin-15 receptor fusion (IL-15RF)."
The company's President and CEO Scott Wolchko commented, "We are pleased to have worked with the Masonic Cancer Center, University of Minnesota to treat the first patient with FT596...The COVID-19 pandemic presents unprecedented challenges for clinical trial conduct worldwide, and we anticipate there will be delays across our studies. We are committed to the health and safety of our employees and partners, and have implemented a remote work program to the greatest extent possible while continuing certain activities that can only be completed on-site. We are also working closely with our clinical sites and principal investigators so that we are well positioned to accelerate clinical trial execution when pressures on the health system ease."
The company also used the opportunity to provide an operational update on its response to the global COVID-19 pandemic. The firm stated that it has taken steps commensurate with CDC and the State of California guidelines to protect the health and safety of its employees and the community. The company added that it has implemented a work from home policy, and restricted on-site activities to certain manufacturing and necessary laboratory and support activities.
The company noted that it remains committed to its clinical programs and development plans though it does expect that the timelines of its ongoing clinical trials will be impacted somewhat by potential delays or disruptions due to the COVID-19 situation.
The firm indicated that "it continues to engage the U.S. Food and Drug Administration (FDA) and remains on-track to submit Investigational New Drug applications to the FDA for FT538, its off-the-shelf, iPSC-derived NK cell product candidate for multiple myeloma and for FT819, the company's first off-the-shelf, iPSC-derived CAR T-cell product candidate for B-cell malignancies in Q2/20."
The company explained that its proprietary induced pluripotent stem cell (iPSC) product platform, which is supported by more than 300 issued and 150 pending patents, "enables mass production of off-the-shelf, engineered, homogeneous cell products that can be administered with multiple doses to deliver more effective pharmacologic activity, including in combination with cycles of other cancer treatments." The firm stated in the report that "human iPSCs possess the unique dual properties of unlimited self-renewal and differentiation potential into all cell types of the body."
Fate Therapeutics is a clinical-stage biopharmaceutical company headquartered in San Diego, Calif., that specializes in developing cellular immunotherapies for cancer and immune disorders utilizing its using its proprietary induced pluripotent stem cell (iPSC) product platform. The company's listed that its immuno-oncology product candidates include natural killer (NK) cell and T-cell cancer immunotherapies and its immuno-regulatory product candidates include ProTmune™ that is currently being evaluated in a Phase 2 clinical trial for the prevention of graft-versus-host disease.
Fate Therapeutics has a market capitalization of around $1.8 billion with approximately 75.94 million shares outstanding and a short interest of about 13.7%. FATE shares opened 18% higher today at $24.90 (+$3.83, +18.189%) over yesterday's $21.07 closing price. The stock has traded today between $22.89 and $25.00 per share and is currently trading at $23.10 (+$2.03, +9.63%).
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