The first patient has been dosed in a Phase 1/2 trial testing Hookipa Pharma‘s experimental cancer vaccine HB-201, alone or in combination with an immune checkpoint inhibitor, in people with Human Papillomavirus 16-positive (HPV16+) cancers. This dosing marks the first test of HB-201 in humans.
The Phase 1/2 trial (NCT04180215), just launched in December, is recruiting up to 100 people with HPV16+ cancers that failed to respond to prior treatments. Enrollment information can be found here.
Four cancer centers are actively recruiting for this trial in the United States, including the Banner MD Anderson Cancer Center in Gilbert, Ariz., the Icahn School of Medicine at Mount Sinai in New York City, the University of Oklahoma Health Sciences Center in Oklahoma City, and the Providence Portland Medical Center in Portland, Ore.
It is estimated that HPV is the cause of roughly 5% of all cancers. This is due to viral DNA from the HPV infection becoming intertwined with chromosomal DNA. Once the two DNA sources fuse, the host cells will produce two key HPV proteins, E6 and E7, which disrupt the normal regulation of cell division. E6 and E7 are the key targets of HB-201.
HB-201 is a fusion protein of E6 and E7 together, generated in the laboratory to be recognized by the immune system and to work as a cancer vaccine. When examined in preclinical studies, HB-201 triggered a strong immune response, as measured by a higher amount of cancer-specific T-cells compared with other therapeutic approaches. HB-201 also showed significant anti-tumor activity in experiments using mice.
“We are excited to begin first-in-human testing with HB-201, our first clinical trial in immuno-oncology. Translating our promising preclinical data to cancer patients is an important milestone,” Joern Aldag, CEO at Hookipa, said in a press release.
“We believe Hookipa approach can supercharge the natural defence mechanisms by inducing strong T cell responses to the benefit of patients affected by cancer and infectious diseases,” Aldag said.
The primary goals of the Phase 1 trial are determining HB-201’s safety and tolerability, and the recommended dosage for future analyses. To determine the recommended dose for both intravenous (into-the-vein) and intratumoral administration of HB-201, participants will be split into two groups of 20.
The first group will be comprised of patients with HPV16-positive head and neck squamous cell carcinoma, who will receive HB-201 intravenously every month. The second group will include patients with an accessible tumor site, who will receive an initial intratumoral injection of HB-201, followed by intravenous administration every month thereafter.
Once a recommended dose has been established from the two groups in Phase 1, the Phase 2 part will investigate the anti-tumor efficiency of HB-201, either alone or in combination with a PD-1 inhibitor. PD-1 is a receptor in immune cells that, once bound to its ligand PD-L1 in cancer cells, tells the immune system to leave the cancer unharmed. Those “brakes” in the immune cells are removed by PD-1 inhibitors.
Hookipa expects to release data on the safety, recommended dose, and efficacy of HB-201 by late 2020 or early 2021.
