Hookipa Pharma Inc. (NASDAQ: HOOK) is not a household name, or even well-known within the biotech industry, but it is making waves on Friday after the firm announced an update from the U.S. Food and Drug Administration (FDA).
Specifically, the firm said that its Investigational New Drug (IND) application for a Phase 1/2 clinical trial of HB-201, a TheraT-based immunotherapy, for the treatment of Human papilloma virus (HPV)-positive cancers is now effective following clearance by the FDA.
Hookipa intends to start the Phase 1/2 clinical trial in the second half of 2019 with preliminary safety and efficacy data expected in late 2020 or early 2021. Note that this will be the firm’s first clinical trial in immuno-oncology.
The approach to this trial is designed to directly reprogram the patient’s immune system with an off-the-shelf systemic administration. This eliminates the need for any ex vivo (growing cells outside the living body and then returning them) logistics that burden adoptive cell therapy and any related ex vivo cellular approaches.
Joern Aldag, CEO, commented:
With the FDA’s clearance of our IND application we have achieved an important milestone advancing HB-201 into clinical development. We aim to prove that our technology platform can effectively super-charge the natural defense mechanisms in humans and deliver prevention or cure for the benefit of seriously ill patients.
For some quick background: HPV is estimated to cause about 5% of the worldwide burden of cancer, including approximately 99% of cervical cancers, 25% to 60% of head and neck cancers, 70% of vaginal cancers and 88% of anal cancers.
Shares of Hookipa were last seen up about 30% at $8.66, in a 52-week range of $6.06 to $14.76.