HOOKIPA announces positive preliminary Phase 1 immunogenicity data for its immunotherapy candidates to treat advanced HPV16+ cancers

• Preliminary data demonstrate a robust increase in HPV16+-specific T cells, including up to 8% of circulating CD8+ T cells, after one dose of HB-201 or HB-202
  
  
• Early data on HB-201 monotherapy show an increase in interferon-gamma and other immune stimulatory cytokines after a single dose, highlighting immune system activation
  
  
• Late-breaker data at AACR Annual Meeting reinforce promising anti-tumor activity reported in 2020 and underscore the potential of HOOKIPA’s novel arenavirus platform to deliver transformational cancer therapies

NEW YORK and VIENNA, Austria, April 10, 2021 (GLOBE NEWSWIRE) -- HOOKIPA Pharma Inc. (NASDAQ: HOOK, ‘HOOKIPA’), a company developing a new class of immunotherapeutics based on its proprietary arenavirus platform, today announced positive preliminary Phase 1 immunogenicity data for its lead oncology candidates, HB-201 and HB-202, to treat Human Papillomavirus 16-positive (HPV16+) cancers. The results are from an ongoing Phase 1/2 study (NCT04180215) currently investigating HB-201 as a single-vector therapy and HB-201 and HB-202 as an alternating two-vector therapy for the treatment of advanced metastatic HPV16+ cancers. The data were presented today at a late-breaker poster session at the virtual American Association for Cancer Research Annual Meeting.

“We’re excited to see the quantity and quality of a targeted immune response, particularly the directly measured increase in HPV16+-specific CD8+ T cells, generated by a single dose of our lead oncology candidates, HB-201 or HB-202. As we are still exploring optimal dosing, these early responses are particularly encouraging,” said Joern Aldag, Chief Executive Officer of HOOKIPA. “We believe our novel arenavirus platform has the potential to introduce a new class of immunotherapeutics that could considerably advance how physicians care for people with HPV16+ cancers. Building on the early clinical results reported on HB-201 in December, we look forward to additional data read-outs from our first clinical oncology program in the coming months.”

Preliminary data showed a strong antigen-specific T cell response after one dose of HB-201 or HB-202, based on direct Enzyme-Linked ImmunoSpot (ELISpot) T cell analysis. (ELISpot is used to quantify antigen-specific T cells in the blood.) All 5 patients who received a single dose of HB-201 or HB-202 had a strong induction of T cells specific to HPV16+ cancer 2 weeks after administration. An up to 250-fold increase in antigen-specific T cells was observed 2 weeks after a single dose of HB-201 in 4 patients. One patient who received a single dose of HB-202 showed a 150-fold increase in antigen-specific T cells 2 weeks after administration. Importantly, the results are based on direct ELISpot without ex vivo expansion of T cells, underscoring the magnitude of T cell response generated by one dose of HB-201 or HB-202. (Ex vivo expansion is often used to amplify responses so that they are more easily measured.) The data are derived from dose level 2 of ongoing dose escalation, and the recommended Phase 2 doses for HB-201 and HB-202 have not been reached.