Kite Pharma Inc (NASDAQ: KITE) announced that it has submitted an Investigational New Drug (IND) application with the U.S. Food and Drug Administration(FDA) to initiate a Phase 1 trial of KITE-718, a T cell therapy engineered to express T cell receptors (TCRs) that target MAGE A3 and MAGE A6. MAGE A3/A6 are frequently found in common tumors including bladder, esophageal, head and neck, lung and ovarian cancers. KITE-718 recognizes the MAGE A3 and MAGE A6 fragments bound to a Class II HLA (DPB1*04:01) and therefore has the potential to kill tumor cells both directly and indirectly through activation of the immune system given it incorporates a class II TCR. Class II HLA (DPB1*04:01) is found in 50 percent to 70 percent of Caucasians. The trial is designed to assess the safety and anti-tumor effect of KITE-718 on these solid tumors.
“Submission of this IND is an important milestone for our solid tumor strategy utilizing engineered T cell therapy based on both TCR and CAR platform technology,” said David Chang, M.D., Ph.D., Executive Vice President of Research and Development and Chief Medical Officer of Kite. “TCRs have the potential to access a broad spectrum of tumor targets and we have incorporated our next generation cell manufacturing technologies into KITE-718 to exploit targets naturally expressed in common solid tumors for which there is a great unmet medical need.”
KITE-718 is built on the proof of concept data established by the National Cancer Institute’s (NCI) MAGE A3/A6 TCR program (NCT02111850). No off-target toxicity was observed in the NCI study, and evidence of tumor regression was seen in patients with multiple types of solid tumors. KITE-718 has been optimized from the foundational work at the NCI by streamlining the manufacturing process through advanced technologies and next-generation cell manufacturing conditions. (Original Source)
Shares of Kite Pharma are rising 1.47% to $45.50, or up $0.66 in pre-market trading Tuesday. KITE has a 1-year high of $64.30 and a 1-year low of $38.41. The stock’s 50-day moving average is $49.28 and its 200-day moving average is $52.29.
On the ratings front, Kite Pharma has been the subject of a number of recent research reports. In a report issued on December 18, Jefferies Co. analyst Biren Amin reiterated a Buy rating on KITE, with a price target of $72, which represents a potential upside of 61% from where the stock is currently trading. Separately, on December 12, Stifel Nicolaus’ Thomas Shrader reiterated a Buy rating on the stock .
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Biren Amin and Thomas Shrader have a yearly average loss of -2.5% and -4.1% respectively. Amin has a success rate of 36% and is ranked #3809 out of 4345 analysts, while Shrader has a success rate of 30% and is ranked #3793.
Sentiment on the street is mostly bullish on KITE stock. Out of 9 analysts who cover the stock, 8 suggest a Buy rating and one recommends to Hold the stock.
Kite Pharma, Inc. is a clinical stage biotechnology company, which engages in the development and commercialization of novel cancer immunotherapy products designed to target and kill cancer cells. It uses engineered autologous cell therapy, which involves the genetic engineering of T cells. Its lead product candidate, KTE-C19, a CAR-based therapy, which seeks treat patients with refractory diffuse large B-cell lymphoma, primary mediastinal large B-Cell lymphoma, and transformed follicular lymphoma.