Pharmaceutical Business review

Hookipa, Merck partner for Phase II HB-200/Keytruda combination trial

Hookipa will assess HB-200/Keytruda combination for patients with advanced head and neck cancers. Credit: Colin Behrens from Pixabay.

Hookipa Pharma has signed a clinical collaboration and supply agreement with Merck to assess HB-200 in combination with Keytruda (pembrolizumab) in patients with advanced head and neck squamous cell carcinoma (HNSCC).

The partnership is based on the data obtained from the ongoing HB-200 Phase I/II trial (NCT04180215) conducted in Human Papillomavirus 16-positive (HPV16+) cancers.

This data revealed that the HB-201 monotherapy showed 18% overall response rate and median progression-free survival of 3.45 months in patients suffering with heavily pretreated head and neck cancer.

Hookipa stated that the data of the first phase conducted on 38 evaluable patients showed that HB-200 therapy has a favourable safety profile in heavily pre-treated patients with HPV16+ cancers.

Hookipa CEO Joern Aldag said: “Our collaboration with Merck & Co, a proven immuno-oncology leader, is an important step as we advance our HB-200 programme for the treatment of Human Papillomavirus 16-positive (HPV16+) cancers and seek to introduce a new class of immunotherapeutics.

“There remains considerable unmet treatment need for people with metastatic head and neck cancers, and we believe the combination of HB-200 and Keytruda may offer hope. We have seen encouraging early responses in heavily pre-treated patients with the addition of Keytruda in our ongoing HB-200 trial.

“We are excited to explore the potential benefit of HB-200 as a first-line treatment in combination with Keytruda, a leading anti-PD-1 inhibitor globally, and the possibility of making a meaningful impact on patients’ lives.”

Furthermore, the company expects to commence a Phase II trial with HB-200/Keytruda combination next year, with additional Phase II expansion cohorts planned to commence in the first quarter of the same year.