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Fate (FATE) Surges on Favorable Phase I Data on FT596 at ASH
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Shares of clinical-stage biopharmaceutical company Fate Therapeutics, Inc. (FATE - Free Report) jumped 37.8% after it presented an encouraging patient case study update.
The data was released from its phase I study of FT596, its universal, off-the-shelf, CD19-targeted chimeric antigen receptor (CAR) natural killer (NK) cell product candidate, at the 62nd Annual Society of Hematology Annual Meeting and Exposition.
The open-label, multi-center phase I study is designed to assess the safety and activity of a single-dose treatment cycle of FT596 in up to four dose cohorts 30, 90, 300 and 900 million cells) as a monotherapy and in combination with CD20-targeted monoclonal antibody therapy for the treatment of relapsed / refractory B-cell malignancies.
Per the case study, a heavily pretreated patient with diffuse large B-cell lymphoma (DLBCL) 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. In addition, the patient subsequently received a second single-dose treatment cycle of FT596, which led to a better response as evidenced by a further decrease in both tumor size and metabolic activity.
This particular patient had previously received seven prior treatment regimens including five rituximab-containing regimens as well as an autologous stem cell transplantation and was most recently refractory to an experimental cellular therapy.
Fate continues to enroll patients in dose escalation with FT596 as a monotherapy and in combination with rituximab. Per the clinical protocol, the company may seek the FDA nod for administration of a second single-dose treatment cycle.
A couple of days ago, Fate announced positive interim data from the company’s dose escalation phase I study of FT516 in combination with rituximab for patients with relapsed / refractory B-cell lymphoma. FT516 is its universal, off-the-shelf NK cell product candidate derived from a clonal master induced pluripotent stem cell (iPSC) line engineered with a novel high-affinity, non-cleavable CD16 Fc receptor. As of Nov 16, 2020 data cutoff, 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. All these patients were heavily pretreated, having received at least two prior rituximab-containing regimens. Each patient received two 30-day treatment cycles with each cycle consisting of fludarabine and cyclophosphamide lympho-conditioning followed by three once-weekly doses of FT516, IL-2 cytokine support and rituximab.
Three of four patients evaluable for efficacy in dose-escalation cohorts 2 and 3 showed an objective response while two achieved a complete response. Six doses of FT516 were well-tolerated without any FT516-related Grade 3 or greater adverse events.
The successful development of these innovative cell therapies will be a significant boost to Fate.
Shares of the company have soared 330.4% so far this year compared with the industry’s growth of 5.9%
To develop its pipeline, Fate entered into a number of collaborations. It has a collaboration and option agreement with Janssen Biotech, Inc., a unit of Johnson & Johnson (JNJ - Free Report) , to develop iPSC-derived CAR NK and CAR T-cell product candidates for the treatment of cancer.
Cellular immunotherapies promise huge potential. Hence, companies like Gilead Sciences, Inc. (GILD - Free Report) and Bristol-Myers Squibb Company (BMY - Free Report) are currently focusing on developing cellular immunotherapies to treat cancer.
Be among the early investors in the new type of device that experts say could impact society as much as the discovery of electricity. Current technology will soon be outdated and replaced by these new devices. In the process, it’s expected to create 22 million jobs and generate $12.3 trillion in activity.
A select few stocks could skyrocket the most as rollout accelerates for this new tech. Early investors could see gains similar to buying Microsoft in the 1990s. Zacks’ just-released special report reveals 8 stocks to watch. The report is only available for a limited time.
Image: Bigstock
Fate (FATE) Surges on Favorable Phase I Data on FT596 at ASH
Shares of clinical-stage biopharmaceutical company Fate Therapeutics, Inc. (FATE - Free Report) jumped 37.8% after it presented an encouraging patient case study update.
The data was released from its phase I study of FT596, its universal, off-the-shelf, CD19-targeted chimeric antigen receptor (CAR) natural killer (NK) cell product candidate, at the 62nd Annual Society of Hematology Annual Meeting and Exposition.
The open-label, multi-center phase I study is designed to assess the safety and activity of a single-dose treatment cycle of FT596 in up to four dose cohorts 30, 90, 300 and 900 million cells) as a monotherapy and in combination with CD20-targeted monoclonal antibody therapy for the treatment of relapsed / refractory B-cell malignancies.
Per the case study, a heavily pretreated patient with diffuse large B-cell lymphoma (DLBCL) 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. In addition, the patient subsequently received a second single-dose treatment cycle of FT596, which led to a better response as evidenced by a further decrease in both tumor size and metabolic activity.
This particular patient had previously received seven prior treatment regimens including five rituximab-containing regimens as well as an autologous stem cell transplantation and was most recently refractory to an experimental cellular therapy.
Fate continues to enroll patients in dose escalation with FT596 as a monotherapy and in combination with rituximab. Per the clinical protocol, the company may seek the FDA nod for administration of a second single-dose treatment cycle.
A couple of days ago, Fate announced positive interim data from the company’s dose escalation phase I study of FT516 in combination with rituximab for patients with relapsed / refractory B-cell lymphoma. FT516 is its universal, off-the-shelf NK cell product candidate derived from a clonal master induced pluripotent stem cell (iPSC) line engineered with a novel high-affinity, non-cleavable CD16 Fc receptor. As of Nov 16, 2020 data cutoff, 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. All these patients were heavily pretreated, having received at least two prior rituximab-containing regimens. Each patient received two 30-day treatment cycles with each cycle consisting of fludarabine and cyclophosphamide lympho-conditioning followed by three once-weekly doses of FT516, IL-2 cytokine support and rituximab.
Three of four patients evaluable for efficacy in dose-escalation cohorts 2 and 3 showed an objective response while two achieved a complete response. Six doses of FT516 were well-tolerated without any FT516-related Grade 3 or greater adverse events.
The successful development of these innovative cell therapies will be a significant boost to Fate.
Shares of the company have soared 330.4% so far this year compared with the industry’s growth of 5.9%
To develop its pipeline, Fate entered into a number of collaborations. It has a collaboration and option agreement with Janssen Biotech, Inc., a unit of Johnson & Johnson (JNJ - Free Report) , to develop iPSC-derived CAR NK and CAR T-cell product candidates for the treatment of cancer.
Cellular immunotherapies promise huge potential. Hence, companies like Gilead Sciences, Inc. (GILD - Free Report) and Bristol-Myers Squibb Company (BMY - Free Report) are currently focusing on developing cellular immunotherapies to treat 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.
Biggest Tech Breakthrough in a Generation
Be among the early investors in the new type of device that experts say could impact society as much as the discovery of electricity. Current technology will soon be outdated and replaced by these new devices. In the process, it’s expected to create 22 million jobs and generate $12.3 trillion in activity.
A select few stocks could skyrocket the most as rollout accelerates for this new tech. Early investors could see gains similar to buying Microsoft in the 1990s. Zacks’ just-released special report reveals 8 stocks to watch. The report is only available for a limited time.
See 8 breakthrough stocks now>>