Fate's IND Application for CAR T Cell Therapy Gets FDA Nod

Clinical-stage biopharmaceutical company, Fate Therapeutics, Inc. FATE, announced that the FDA has cleared its Investigational New Drug (IND) application for pipeline candidate, FT819.

FT819 is an off-the-shelf allogeneic chimeric antigen receptor (CAR) T-cell therapy targeting CD19+ malignancies. It has been derived from a clonal master induced pluripotent stem cell (iPSC) line.

Fate plans to initiate a study on FT819 for the treatment of patients with relapsed/refractory B-cell malignancies, including chronic lymphocytic leukemia (CLL), acute lymphoblastic leukemia (ALL) and non-Hodgkin lymphoma (NHL).

The multi-center phase I study of FT819 will determine the maximum tolerated dose of FT819. The study will assess its safety and clinical activity in up to 297 adult patients across these three types of B-cell malignancies.

The company will enroll independently for each indication. The candidate will be evaluated in three dose-escalating treatment regimens — Regimen A as a single dose of FT819, Regimen B as a single dose of FT819 with IL-2 cytokine support and Regimen C as three fractionated doses of FT819. Additionally, dose-expansion cohorts of up to 15 patients may be enrolled to further evaluate the clinical activity of FT819 for each indication and regimen.

We note that Fate’s immuno-oncology product candidates include natural killer (NK) cell and T-cell cancer immunotherapies, which are designed to synergize with well-established cancer therapies, including immune checkpoint inhibitors and monoclonal antibodies, and target tumor-associated antigens with CARs. The immuno-regulatory product candidates include ProTmune, a pharmacologically modulated, donor cell graft that is currently being evaluated in a phase II study for the prevention of graft-versus-host disease, and a myeloid-derived suppressor cell immunotherapy for promoting immune tolerance in patients with immune disorders.

To develop its pipeline, Fate has entered into collaborations with other companies.

The company has entered into a collaboration and option agreement with Ono Pharmaceutical Co. Ltd. for the joint development and commercialization of two off-the-shelf iPSC-derived CAR T-cell product candidates.

In April 2020, Fate entered into a collaboration and option agreement with Janssen Biotech, Inc., a unit of Johnson & Johnson JNJ, to develop iPSC-derived CAR NK and CAR T-cell product candidates for the treatment of cancer. Shares surged on the collaboration news.

The company’s shares have soared 85.8% so far this year compared with the industry’s growth of 12.3%

Cellular immunotherapies promise huge potential. Hence, companies like Gilead Sciences, Inc. GILD and Bristol-Myers Squibb Company BMY are currently focusing on the development of cellular immunotherapies for the treatment of cancer.

Fate currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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