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Phase I/II Data from Hookipa is Unveiled for the First Time

Hookipa Pharma Inc., a clinical-stage biopharmaceutical company, recently unveiled the Phase I/II data for its lead product candidate, HB-101, for the first time. The data was presented at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting.

HB-101 is a novel immunotherapy that uses a proprietary platform technology called VaxWave® to stimulate the immune system to fight cancer. The therapy is designed to target cancers that express the human papillomavirus (HPV) antigen, which is present in many types of cancer, including head and neck cancer and cervical cancer.

The Phase I/II trial evaluated the safety and efficacy of HB-101 in patients with advanced HPV16-positive cancers. The trial enrolled 62 patients across three dose levels, with the highest dose being 5×10^8 viral particles.

The data showed that HB-101 was well-tolerated, with no dose-limiting toxicities observed. The most common adverse events were mild to moderate flu-like symptoms, which are typical of immunotherapies.

In terms of efficacy, the data showed promising results. The overall response rate (ORR) was 33%, with two complete responses and 18 partial responses observed. The disease control rate (DCR) was 68%, with 42% of patients achieving stable disease.

The median duration of response was not reached at the time of data cutoff, indicating that the responses were durable. Additionally, the median progression-free survival (PFS) was 6.9 months, which is encouraging for patients with advanced cancer.

“These data demonstrate the potential of our VaxWave® platform to generate a robust and durable anti-tumor immune response in patients with HPV16-positive cancers,” said Joern Aldag, CEO of Hookipa. “We are excited to continue advancing HB-101 through clinical development and look forward to exploring its potential in other HPV-associated cancers.”

The data presented at ASCO is a significant milestone for Hookipa, as it validates the company’s approach to developing immunotherapies using its VaxWave® platform. The positive results from the Phase I/II trial provide a strong foundation for further clinical development of HB-101 and other product candidates in Hookipa’s pipeline.

In conclusion, the Phase I/II data from Hookipa’s HB-101 trial is a promising development in the field of cancer immunotherapy. The data shows that HB-101 is well-tolerated and has the potential to induce durable responses in patients with advanced HPV16-positive cancers. This is an exciting time for Hookipa and the broader oncology community, as the company continues to advance its innovative platform technology to develop new treatments for cancer patients.

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