This section highlights FDA-related milestones and regulatory updates for drugs developed by HOOKIPA Pharma (HOOK).
Over the past two years, HOOKIPA Pharma has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
HB-500 and HB-700. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Select a button below to view the list of FDA events for that drug.
HB-500 FDA Regulatory Events
HB-500 is a drug developed by HOOKIPA Pharma for the following indication: For the Treatment of Human Immunodeficiency Virus.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- HB-500
- Announced Date:
- January 30, 2025
- Target Action Date:
- H2 2025
- Estimated Target Date Range:
- July 1, 2025 - December 31, 2025
- Indication:
- For the Treatment of Human Immunodeficiency Virus
Announcement
HOOKIPA Pharma announced that Primary completion expected H2 2025
AI Summary
HOOKIPA Pharma has announced an important milestone in its Phase 1b clinical trial for HB-500, a next-generation therapeutic vaccine targeting HIV. The trial, conducted in collaboration with Gilead Sciences, enrolled 30 participants across five U.S. sites to study the safety, tolerability, reactogenicity, and immunogenicity of repeated vaccine doses in individuals with HIV who are on suppressive antiretroviral therapy.
The first dosing took place on July 1, 2024, and primary completion of the clinical trial is expected in the second half of 2025. This timeline marks a significant step forward for HB-500, which is designed to induce robust and durable immunity. Following the trial, Gilead will have the exclusive right to assume further development of the program, highlighting a key aspect of this promising collaboration.
Read Announcement- Drug:
- HB-500
- Announced Date:
- January 30, 2025
- Indication:
- For the Treatment of Human Immunodeficiency Virus
Announcement
HOOKIPA Pharma announced that enrollment is complete in the Phase 1b clinical trial evaluating HB-500 for the treatment of HIV, with 30 participants enrolled across five sites in the United States.
AI Summary
HOOKIPA Pharma has reached an important milestone in its HIV therapeutic vaccine program with HB-500. The Phase 1b clinical trial aimed at evaluating HB-500 for HIV treatment has successfully enrolled 30 participants across five United States sites. This next-generation vaccine is being developed in collaboration with Gilead Sciences, and it is designed to boost the immune system’s ability to fight HIV. The trial will assess the safety and tolerability of repeated HB-500 doses, along with its ability to stimulate a strong immune response in participants already on antiretroviral therapy. Primary completion of the study is expected in the second half of 2025, marking a significant step forward in the search for a potential functional cure for HIV.
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HB-700 FDA Regulatory Events
HB-700 is a drug developed by HOOKIPA Pharma for the following indication: for the Treatment of KRAS-Mutated Cancers.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- HB-700
- Announced Date:
- September 24, 2024
- Indication:
- for the Treatment of KRAS-Mutated Cancers
Announcement
HOOKIPA Pharma announced that the Company will present preclinical data related to the HB-700 program for the treatment of KRAS mutated cancers at the 6th Annual RAS-Targeted Drug Development Summit being held in Boston, Massachusetts from September 24-26, 2024.
AI Summary
HOOKIPA Pharma Inc. announced that it will present preclinical data on its HB-700 program at the 6th Annual RAS-Targeted Drug Development Summit in Boston, Massachusetts, from September 24-26, 2024. The data focuses on using HB-700 for treating KRAS mutated cancers, which are common in pancreatic, colorectal, and lung cancer patients. The preclinical study shows promising results, including a good safety profile, the activation of target-specific CD8+ T-cells, and effective killing of target cells in several animal and translational models.
Mark Winderlich, PhD, Chief Research & Development Officer, stated that HB-700 is designed to target multiple KRAS mutations with a single therapy, potentially leading to a broadly applicable treatment option for patients. With IND clearance from the FDA received in Q2 2024, HB-700 is ready to move into Phase 1 clinical trials.
Read Announcement
