November 8, 2016
By Alex Keown, BioSpace.com Breaking News Staff
SANTA MONICA, Calif. – Since Friday, shares of Kite Pharma have jumped more than 7 percent, increasing by more than $5 per share. Although Kite has yet to have an approved drug, analysts suggest the company should be watched closely as it nears regulatory approval of its CAR-T therapy.
According to Press Telegraph, eight analysts rank Kite Pharma stock as a “buy” and one as a “hold.” What seems to be driving investor excitement around Kite is the company’s preparation for marketing its first commercial product -- KTE-C19, a treatment for patients with of Non-Hodgkin’s Lymphoma. The company is aiming at the end of the year to file for regulatory approval of the CAR-T therapy. During an investors conference last month, Kite Chief Executive Officer Arie Belldegrun told investors and members of the media that he has scheduled a pre-application meeting with the U.S. Food and Drug Administration (FDA), which will “provide the clarity Kite is looking for on submitting the data.”
Kite believes the interim data of the Phase II trial released in September will be strong enough to lead regulators at the U.S. Food and Drug Administration to ultimately give its approval – making KTE-C19 the first CAR-T therapy to reach the market ahead of rivals Juno Therapeutics and Novartis. Kite said it plans to seek regulatory approval of KTE-C19 in diffuse large B-cell lymphoma (DLBCL), transformed follicular lymphoma (TFL) and primary mediastinal B-cell lymphoma (PMBCL) based upon the combined data of multiple trial cohorts. Kite anticipates commercial launch of KTE-C19 in 2017.
The question is – will the FDA approve the drug, or will it demand more data given some concerns around the trial, such as the small-trial size and two deaths that occurred during the trial. There is also the lack of a placebo arm in the mid-stage trial that could raise an issue. Another question that may need to be clearly addressed is the sliding response rate of patients on KTE-C19.
Kite remains optimistic though and said if the FDA does want more data, Kite could have an additional six months’ worth by February, which would push back the New Drug Application to the third quarter of 2017. Even with the delay, Belldegrun was optimistic that it would give Kite Pharma a lead of about one year over other CAR-T competitors.
While Kite has been focused on its lead CAR-T therapy, the company has not placed all of its eggs in one basket. Last month, the company unveiled four new near-term clinical development programs, along with projected timelines for Investigational New Drug Applications, including two planned for this year. Kite said it will file the IND for KITE-196 for the treatment of acute myeloid leukemia and KITE-718 for non-small cell lung cancer and bladder cancer this year. In 2017, the company plans to file an IND for KITE-585 targeting multiple myeloma and in 2018 will file an IND for KITE-439 for cervical cancer and head and neck cancer.
are selling this morning at $45.30 as of 10:48 a.m.
