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Kite Pharma (KITE) to Advance Cancer Candidate into Phase I

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Kite Pharma, Inc. announced that it has filed a Investigational New Drug (IND) application with the FDA to initiate phase I studies on KITE-718, a TCR candidate targeting MAGE in a solid tumor.

Kite Pharma’s shares have declined 12.8% in the past six months, which compares unfavorably with a decrease of 3.5% registered by the Zacks classified Biomedical/Genetics industry.

Kite Phrama is looking to revolutionize cancer treatments by engaging the body’s own immune system to treat cancer. The company uses its engineered autologous cell therapy (eACT) to genetically modify T cells to express either chimeric antigen receptors (CARs) or T cell receptors (TCRs). These modified T cells are designed to recognize and destroy cancer cells.

Kite Pharma has a Cooperative Research and Development Agreement (CRADA) with the U.S. Department of Health and Human Services’ National Cancer Institute (NCI), under which the company is funding the development of eACT-based candidates utilizing CARs and TCRs for the treatment of advanced solid and hematological malignancies.

The NCI collaboration allows it to selectively identify and advance additional pipeline candidates. Candidates are selected on the basis of human proof-of-concept data rather than preclinical animal data alone — this significantly reduces the risks of development programs. Note that KITE-718 is part of the NCI program.

KITE-718 is the first of the four new INDs for TCR/CAR T candidates that Kite Pharma expects to file in the 2016–2018 timeframe. KITE-718 targets cancer antigens MAGE A3 and MAGE A6, which are frequently found in common tumors including bladder, esophageal, head and neck, lung and ovarian cancers.

The company expects to report data on a number of these candidates from 2017 through 2018.

We note that the development of CAR T cell therapies has been attracting a lot of attention lately with several companies eyeing to enter this field. Juno Therapeutics Inc. is also working on developing therapies utilizing the CAR T cell technology. In fact, interest in immunotherapy is building up fast. The basic concept of cancer immunotherapy or immuno-oncology is to utilize certain parts of the immune system to fight the disease. This can be done by stimulating the immune system to attack cancer cells or by introducing immune system components into the body.

Merck & Co., Inc.’s (MRK - Free Report) anti-PD-1 therapy, Keytruda, is being studied for more than 30 types of cancers. Amgen Inc.’s (AMGN - Free Report) Blincyto, a BiTE antibody, gained earlier-than-expected FDA approval in Dec 2014. Blincyto has the potential to be developed for other hematologic malignancies as well.

Kite Pharma has 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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