Kite Pharma, a clinical-stage biopharma engaged in the development of novel cancer immunotherapy products, and the Experimental Transplantation and Immunology Branch (ETIB) of the National Cancer Institute signed a Cooperative Research and Development Agreement for the development of new T-cell receptor (TCR) drug candidates to treat human papillomavirus-associated cancers related to HPV-16 E6 and E7 oncoproteins.

Under the terms of the new agreement, the NCI will test a new TCR drug candidate targeting HPV-16 E7 as a monotherapy and in combination with an inhibitor for HPV-16 associated solid tumors. The clinical trial is led by Christian S. Hinrichs, M.D., of the ETIB, who is also a lead investigator of this collaboration.

The NCI will advance a newly designed TCR drug candidate for HPV-16 E6, which is in Phase 1/2, under a previous agreeemnt between Kite and the surgery branch of the NCI.

“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,” said Arie Belldegrun, M.D., Kite’s chairman, president, and CEO, adding Kite is excited about the NCI collaboration as it advances its HPV-associated cancer therapy pipeline.

HPV is a DNA virus that can infect humans. Like all papillomaviruses, HPVs establish productive infections only in keratinocytes of the skin and mucous membranes. Although the majority of HPV infections are subclinical cases and will cause no physical symptoms, sometimes subclinical infections can become clinical and cause benign papillomas, or premalignant lesions. These can develop to cause cancers of the cervix, vulva, penis, vagina, oropharynx, or anus.

HPV16 and HPV18 are known to cause around 70 percent of cervical cancer. Researchers have identified more than 170 types of HPV, more than 40 of which are typically transmitted through sexual contact and infect the anogenital region (anus and genitals).  High-risk HPV infection is a cause of nearly all cases of cervical cancer.

In the U.S., more than 33,000 cases of HPV-related tumors are diagnosed every year, and over 11,000 people die of the diseases yearly, according to the Centers for Disease Control and Prevention. HPV-associated cancer does not respond well to the current treatment, in addition to the bad response duration, requiring further therapeutic solutions.