Novartis' (NVS) CTL109 BLA Gets Breakthrough Therapy Status

Novartis (NYSE:NVS) announced that the FDA has granted Breakthrough Therapy Designation to its pipeline candidate, CTL019.

The company is evaluating CTL01, an experimental chimeric antigen receptor T cell (CAR-T) therapy, for the treatment of adult patients with relapsed and refractory (r/r) diffuse large B-cell lymphoma (DLBCL), who have failed in two or more prior therapies.

Novartis’ share price shows that the company has outperformed the Zacks classified industry year to date. The stock has increased 0.1% compared with the Large Cap Pharmaceuticals industry’s gain of 5.5%.

In fact, CAR-T is a novel therapy as it is personalized for each individual patient. It reprograms a patient's own T cells to look for cancer cells and other B-cells expressing a particular antigen, called CD19. Once reprogrammed, these T cells (called CTL019 after reprogramming) are released into the patient's blood to proliferate and bind to the targeted CD19+ cancer cells, thereby destroying them.

CTL019 was first developed by the University of Pennsylvania. In 2012, the university signed an exclusive global agreement with Novartis to research, develop and commercialize personalized CAR-T cell therapies for the treatment of cancers.

The Breakthrough Therapy Designation is based on data from phase II JULIET study (NCT02445248), which is assessing the efficacy and safety of CTL019 in adult patients with r/r DLBCL. By the end of 2017, Novartis expects to file for regulatory submissions for r/r DLBCL, which is an aggressive cancer with limited options. While about 10% to 15% DLBCL patients fail to respond to this initial therapy or relapse within three months of treatment, additional 20% to 25% relapse after initial response to it.
Breakthrough Therapy Designation from the FDA will expedite the development and review of drugs that are intended to treat serious diseases and should provide access of the drug to patients as soon as possible.

Notably, the FDA granted Breakthrough Therapy designation to CTL019 for the treatment of r/r B-cell acute lymphoblastic leukemia (ALL) in pediatric and young adult patients. Last month, it also granted and accepted priority review designation to its biologics license application (BLA) for CTL019 for the treatment of pediatric and adult patients suffering from r/r ALL.

In addition, we remind investors that Kite Pharma, Inc. (NASDAQ:KITE) had also filed a BLA for its CAR-T candidate, KTE-C19 for treatment DLBCL in December 2016.

Further, Novartis has collaborated with Intellia Therapeutics Inc. (NASDAQ:NTLA) for the discovery and development of treatments using CAR-T with the latter’s CRISPR genome editing technology. Juno Therapeutics Inc. (NASDAQ:JUNO) is also using CRISPR to improve its CAR-T and TCR platforms.

Zacks Rank

Novartis currently carries a Zacks Rank #5 (Strong Sell). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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