Kite Pharma ($KITE) has extended its research into HPV cancers using its T-cell receptor therapies after it penned a new deal with the National Cancer Institute (NCI).
Specifically, Kite has signed a pact with the R&D unit of the NCI for the research and clinical development of T-cell receptor (TCR) candidates directed against human papillomavirus (HPV)-16 E6 and E7 oncoproteins for the treatment of HPV-associated cancers.
The NCI will under the deal research a new TCR therapy candidate targeting HPV-16 E7 as a both a monotherapy and in combination with a (as yet unnamed) checkpoint inhibitor in HPV-16 associated solid tumors.
This Phase I/II study will be led by Christian Hinrichs from the Experimental Transplantation and Immunology Branch of the NCI.
The NCI will also continue to advance a separately designed TCR therapy candidate targeting HPV-16 E6, also currently in a Phase I/II study, under an existing deal between Kite and the Surgery Branch of the NCI, led by Steven Rosenberg. Financial details were not disclosed.
TCR treatments rely on rewiring the body's immune cells to home in on cancers, and builds on the work Kite is doing with CAR-T tech in a number of blood cancers.
Arie Belldegrun, Kite's chairman, president, and CEO, said: "TCR therapies allow targeting of viral oncoproteins that are not effectively addressed with other existing therapeutic modalities. HPV-16 E6 and E7 TCR therapies hold the potential to address the significant unmet medical need that exists in HPV-associated cancers.
“We are excited to collaborate with the network of talented investigators at the NCI as we advance our HPV-associated cancer therapy pipeline.”
This comes exactly one year to the day that Kite joined forces with gene therapy luminary bluebird bio ($BLUE) to craft new treatments for HPV-related cancers, combining two high-profile technologies in hopes of developing targeted therapies.
Under that deal, Kite brings its expertise in T cell receptors while bluebird provides its know-how in using harmless viruses to deliver corrective genes and its experience in gene editing. Combined, the partners hope to produce second-generation TCRs that use bluebird's genetic engineering platform to better attack their target cancers, particularly those related to a particular strain of HPV, or human papillomavirus.
Kite is largely known for its work on CAR-T therapies, a cousin technology to TCR. In CAR-T, the California biotech is in a race with Novartis ($NVS) and Juno Therapeutics ($JUNO), among a growing list of others, to be the first to market this new class of cancer therapy.
But less often discussed is Kite's TCR pipeline, which features a growing number of National Cancer Institute-partnered therapies in the early stages of development, and the company is pursuing both paths in tandem with the goal of churning out therapies for tumors liquid and solid.
HPV has a causal role in nearly all cervical cancers, and in many head and neck, and anogenital malignancies. HPV-16 is the most commonly found strain in these cancers, with more than 33,000 cases of HPV-associated cancers are diagnosed each year in the U.S., and more than 11,000 annual deaths are attributed to the diseases, according to the Centers for Disease Control and Prevention.
Kite says that current therapies for advanced HPV-associated tumors have low response rates and poor response duration--something it will hope to better with its new candidates.
Kite has also opened its new commercial manufacturing facility in El Segundo, California. Over 300 employees, investors and company partners attended the unveiling of the 43,500-square-foot, state-of-the-art plant this week.
The facility has been designed to produce chimeric antigen receptor (CAR) and TCR product candidates for clinical trials, as well as for the potential launch and commercialization of Kite’s lead CAR T-cell product candidate, KTE-C19.
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