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5 CAR-T Stocks in Focus as NVS Drug Wins FDA Advisory Panel Vote

Arpita Dutt
Updated

The CAR-T (chimeric antigen receptor T cells) space got a significant boost recently with an FDA advisory panel issuing a positive recommendation for an experimental treatment in this corner of the immune-oncology market. Last week, Swiss pharma giant, Novartis’ NVS experimental CAR-T therapy, CTL019, got a unanimous (10-0) vote of approval from the FDA’s Oncologic Drugs Advisory Committee (ODAC). Novartis is looking to get CTL019 approved for the treatment of relapsed or refractory (r/r) pediatric and young adult patients with B-cell acute lymphoblastic leukemia (ALL). CTL019 is currently under priority review and timely approval would make it the first CAR-T cell therapy to be available.

How Does CAR-T Cell Therapy Work?

CAR-T falls under the ambit of cellular immunotherapy which involves using a patient’s own immune cells to attack and get rid of harmful disease cells in the body.

The CAR-T approach involves -- the collection of a patient’s T cells, their genetic modification outside the body, the incorporation of specific receptors which target cancer cells and finally, the re-infusion of the modified T cells back into the patient.

There is a lot of enthusiasm for CAR-T as early stage studies have shown that it can help achieve durable complete responses in some leukemias and lymphomas, including in patients who have suffered multiple relapses. But, CAR-T therapy comes with its own set of challenges including a high level of R&D investment as well as safety issues like serious immune toxicity (CRS) or neurotoxicity. Pricing could be an issue as well as these treatments will not come cheap.

However, these treatments have huge commercial potential and could well change the treatment paradigm.

5 CAR-T Stocks in Focus

Given the increased focus on this corner of the immune-oncology market and the possibility that a CAR-T drug could enter the market by year end, here is a look at 5 companies that are working on CAR-T cell treatments.

Kite Pharma, Inc. KITE: Santa Monica, CA-based Kite is a cell therapy company engaged in the development of innovative cancer immunotherapies with the goal of providing rapid, long-term durable response and eliminating the burden of chronic care. The company’s focus is on CAR and T cell receptor (TCR) engineered cell therapies.

Kite is following close on the heels of Novartis where FDA approval of a CAR-T treatment is concerned. Lead pipeline candidate, axicabtagene ciloleucel, is currently under priority review in the U.S. for the treatment of patients with refractory aggressive non-Hodgkin lymphoma (NHL). A response from the FDA is expected by Nov 29, 2017. The company will be filing for EU approval in the third quarter. Axicabtagene ciloleucel targets the antigen CD19, a protein expressed on the cell surface of B-cell lymphomas and leukemias.

According to the company, the initial market opportunity for axicabtagene ciloleucel includes about 7,400 and 7,000 addressable CAR-T patients in the U.S. and Europe, respectively, while 7,800 new cases are diagnosed in Japan every year and 25,000 in key urban/eastern rural coastal areas of China.

Kite has had a strong run so far in 2017 with shares skyrocketing 128.1%, outperforming the Zacks-categorized Medical-Biomedical/Genetics industry which is up about 9%.

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