HOOKIPA Pharma is advancing HB-201 to Phase II to be evaluated in combination with pembrolizumab as first or second-line treatment for Human Papillomavirus Positive 16 (HPV16+) squamous cell head and neck cancers (HNSCC).
Interim Phase I data in heavily pre-treated patients continue to show HB-200 monotherapy (both HB-201 alone and HB-202/HB-201) is highly effective at expanding T cells, has a favourable tolerability profile and promising, early anti-tumour activity.
As of November 1, 2021, among 28 patients dosed intravenously, HB-200 resulted in a 75% disease control rate and shrinkage of target lesions in 53% of patients. In these patients, HOOKIPA has observed three partial responses (including one confirmed and one unconfirmed in an ongoing patient) and one ongoing patient with a near partial response (29% tumour shrinkage). Based on the strength of the HB-200 data, HOOKIPA has prioritised its oncology portfolio and plans further development of its infectious disease programmes to be done in partnership with other companies.
“We are incredibly excited about our Phase I HB-200 data, especially the demonstrated tumour-specific T cell responses and tumour shrinkage in heavily pre-treated HNSCC patients, which we believe are highly differentiated from other active immunization technologies,” said Joern Aldag, Chief Executive Officer at HOOKIPA. “Based on these data, we’re excited to advance our promising HB-200 programme into Phase II, initially with the HB-201 and pembrolizumab combination for head and neck cancer patients, while accelerating the development of our earlier stage immuno-oncology candidates HB-300 and HB-700 in prostate and KRAS-mutated cancers, respectively, and focusing our efforts on exploring the potential of our novel arenaviral technology to address unmet needs in cancer.”
HB-200 continued to demonstrate a favourable tolerability profile in heavily pre-treated patients with HPV16+ cancers, highlighting its potential in possible combination with checkpoint inhibitors and other agents. Treatment-related adverse events were reported in 66% of 62 evaluable patients, with only 8% experiencing treatment-related adverse events rated grade 3 or higher.
Image credit: Teslariu Mihai