Clinical-stage biopharmaceutical company Fate Therapeutics Inc. (FATE:NASDAQ), which is focused on the development of programmed cellular immunotherapies for cancer and immune disorders, last Friday announced "positive interim data from the company's dose escalation Phase 1 study of FT516 in combination with rituximab for patients with relapsed / refractory B-cell lymphoma."
Fate Therapeutics advised that FT516 is a universal, off-the-shelf natural killer (NK) cell product candidate that was developed using its proprietary induced pluripotent stem cell (iPSC) product platform. The product has been designed and engineered to maximize antibody-dependent cellular cytotoxicity allowing NK cells to recognize, bind and kill antibody-coated cancer cells.
The company's President and CEO Scott Wolchko commented, "We are highly encouraged by these Phase 1 data, which clearly demonstrate that off-the-shelf, iPSC-derived NK cells can drive complete responses for cancer patients and that our proprietary hnCD16 Fc receptor can effectively synergize with and enhance the mechanism of action of tumor-targeted antibodies...Importantly, the safety profile of FT516 continues to suggest multiple doses of iPSC-derived NK cells can be administered in the outpatient setting, and supports potential use across multiple lines of therapy, including as part of early-line CD20-targeted monoclonal antibody regimens, for the treatment of B-cell lymphoma."
The firm indicated that thru November 16, 2020, "three patients in the second dose cohort of 90 million cells per dose and one patient in the third dose cohort of 300 million cells per dose were available for assessment of safety and efficacy and that all four patients were heavily pre-treated, having received at least two prior rituximab-containing regimens."
In a separate announcement yesterday, Fate Therapeutics released data from a patient case study in its Phase 1 clinical trial of FT596, a CD19-targeted chimeric antigen receptor (CAR) natural killer (NK) cell product candidate. The firm noted that the study data was presented to the 62nd Annual Society of Hematology Annual Meeting and Exposition.
The firm highlighted and discussed the results observed in one previously heavily treated patient with diffuse large B-cell lymphoma (DLBCL). The company indicated that that this patient had successfully achieved a partial response following administration of a single-dose treatment cycle of FT596 as a monotherapy in the first dose cohort of 30 million cells. The firm noted that when the patient was later given a second single-dose of FT596, an even greater response was recorded as evidenced by further decrease in both tumor size and metabolic activity.
Fate Therapeutics' Senior Vice President of Clinical Development Dr. Wayne Chu remarked, "The safety, pharmacokinetics and clinical activity observed following both the first and second single-dose treatment cycles of FT596 are compelling, especially when considering that the administered cell dose was significantly lower than the recommended cell dose of FDA-approved autologous CD19-targeted CAR T-cell therapies and that the heavily pre-treated patient was refractory to last prior therapy...We are excited the CAR component of FT596 has shown clinical activity at this low dose level, and we continue to enroll patients in dose escalation with FT596 as a monotherapy and in combination with rituximab. Our recent Phase 1 clinical data with FT516 in combination with rituximab, which demonstrate the potential of our novel hnCD16 Fc receptor to potentiate ADCC and drive complete responses, support our belief that the multi-antigen targeting functionality of FT596 may offer best-in-class potential for patients with B-cell malignancies."
The company described FT596 as "an investigational, universal, off-the-shelf natural killer (NK) cell cancer immunotherapy derived from a clonal master induced pluripotent stem cell (iPSC) line engineered with three anti-tumor functional modalities." These include a proprietary chimeric antigen receptor, a novel high-affinity 158V, non-cleavable CD16 (hnCD16) Fc receptor and an IL-15 receptor fusion (IL-15RF) that promotes enhanced NK cell activity.
Fate Therapeutics is a clinical-stage biopharmaceutical company headquartered in San Diego, Calif. The firm uses its proprietary induced pluripotent stem cell (iPSC) product platform to develop universal off the shelf cellular immunotherapies for cancer and immune disorders. 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™, which it describes a pharmacologically modulated, donor cell graft 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 $5.3 billion with approximately 87.24 million shares outstanding and a short interest of about 16.4%. FATE shares opened nearly 13% higher today at $68.485 (+$7.695, +12.66%) over Friday's $60.79 closing price and reached a new 52-week high this morning of $89.92. The stock has traded today between $68.165 and $89.92 per share and is currently trading at $83.43 (+$22.64, +37.24%).[NLINSERT]
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