Credit: Shutterstock photoOf late, biotechnology and pharmaceutical companies are investing in immuno-oncology research therapies as it remains a key area of focus, thanks to its vast growth potential. Last week, the immuno-oncology space grabbed investors' attention with the FDA approving Novartis AG' s NVS breakthrough gene transfer treatment, Kymriah (tisagenlecleucel) suspension for the treatment of patients up to 25 years of age with B-cell precursor acute lymphoblastic leukemia (ALL) that is refractory or in second or later relapse.
Kymriah, formerly CTL019, is the first chimeric antigen receptor T cell (CAR-T) therapy approved. A novel immunocellular therapy and one-time treatment, Kymriah uses patient's T cells to fight cancer.
While the long-term impact of the treatment is yet to be evaluated, the approval opens up new frontiers in the treatment of cancer. To start with, CAR-T uses patient's cells to identify and destroy cancer cells, thereby making it different from other small molecule or biologic therapies. During the treatment, T cells are drawn from a patient's blood. These cells are then reprogrammed in the manufacturing facility to create genetically coded cells to express a chimeric antigen receptor to recognize and fight cancer cells and other B cells expressing a specific antigen.
With the approval of Kymriah, investors have started to shift their focus on a number of companies which have been developing their pipeline candidates to remain afloat in the highly competitive environment.
4 Stocks That Warrant a Look
Kite Pharma Inc. KITE is expected to receive approval for its CAR-T therapy axicabtagene ciloleucel (axi-cel) shortly. The Biologics License Application for the candidate was submitted in March 2017. The application was gr priority review in the United States and the FDA is expected to give a decision on Nov 29, 2017. The candidate is also under review in the EU with a tentative approval expected in 2018. The candidate is being developed for the treatment of refractory aggressive non-Hodgkin lymphoma, which includes diffuse large B-cell lymphoma, transformed follicular lymphoma and primary mediastinal B-cell lymphoma.
Given the likely approval and potential in the space, Gilead Sciences Inc. GILD has inked a deal to acquire Kite Pharma for $11.9 billion. Kite Pharma's stock has moved up 297.0% year to date, which compares favorably with a 15% increase registered by the industry . The company presently carries a Zacks Rank #3 (Hold). You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here .
Juno Therapeutics, Inc. JUNO is also developing cell-based cancer immunotherapies based on its CAR and high-affinity TCR technologies to genetically engineer T cells to recognize and kill cancer cells. The company is currently conducting a phase I trial with JCAR017 in adult r/r aggressive NHL, including r/r DLBCL, and planning to file an IND in 2017 for a planned phase I/II trial with JCAR017 in r/r chronic lymphocytic leukemia (CLL). The company expects an approval in 2018. Shares of the company have rallied119.7% year to date. The company currently carries a Zacks Rank #4 (Sell).
bluebird bio, Inc. BLUE in collaboration with Celgene Corporation CELG is evaluating bb2121, a CAR-T cell product candidate for the treatment of multiple myeloma in a phase I study. The company expects to initiate a phase I study to evaluate the safety and efficacy of bb21217, the next anti-BCMA CAR-T cell product candidate. Shares of the company have gained 105.0% year to date. The company presently carries a Zacks Rank #3.
ZIOPHARM Oncology, Inc. ZIOP is developing CAR-T cell therapies for advanced lymphoid malignancies. The company is currently enroling patients for an investigator-led phase I study using second-generation CD19-specific CAR+ T cells with a revised CAR structure in patients with advanced lymphoid malignancies. Shares of the company have rallied 18% year to date. The company at present carries a Zacks Rank #3.
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Novartis AG (NVS): Free Stock Analysis Report
Gilead Sciences, Inc. (GILD): Free Stock Analysis Report
Celgene Corporation (CELG): Free Stock Analysis Report
ZIOPHARM Oncology Inc (ZIOP): Free Stock Analysis Report
Kite Pharma, Inc. (KITE): Free Stock Analysis Report
bluebird bio, Inc. (BLUE): Free Stock Analysis Report
Juno Therapeutics, Inc. (JUNO): Free Stock Analysis Report
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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
