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-200, HB-500, and HB-700. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
HB-200 + KEYTRUDA (pembrolizumab) - FDA Regulatory Timeline and Events
HB-200 + KEYTRUDA (pembrolizumab) is a drug developed by HOOKIPA Pharma for the following indication: Advanced head and neck 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-200 + KEYTRUDA (pembrolizumab)
- Announced Date:
- April 25, 2024
- Indication:
- Advanced head and neck cancers
Announcement
HOOKIPA Pharma Inc announced its final pivotal Phase 2/3 trial design for HB-200 in combination with pembrolizumab.
AI Summary
HOOKIPA Pharma Inc. announced its final pivotal Phase 2/3 trial design for HB-200 in combination with pembrolizumab for first-line treatment of patients with HPV16-positive recurrent or metastatic oropharyngeal squamous cell carcinoma (OPSCC). The trial design and protocol have been fully aligned with the FDA’s feedback from a recent Type C meeting, ensuring the study meets necessary regulatory standards.
The seamless Phase 2/3 trial will enroll about 250 patients who will be randomized to receive HB-200 plus pembrolizumab or a placebo plus pembrolizumab. The primary endpoints include objective response rate in Phase 2 and overall survival in Phase 3. Patient enrollment is expected to begin in the fourth quarter of 2024. This focused design based on FDA guidance aims to expedite development and potential registration, advancing HOOKIPA’s path to providing an impactful new treatment option for OPSCC patients.
Read Announcement- Drug:
- HB-200 + KEYTRUDA (pembrolizumab)
- Announced Date:
- April 10, 2024
- Indication:
- Advanced head and neck cancers
Announcement
HOOKIPA Pharma Inc announced that members of HOOKIPA's Executive Team will host an investor call summarizing the Company's constructive regulatory interactions with the U.S.
AI Summary
HOOKIPA Pharma Inc. announced that members of the company’s Executive Team will host an investor call on April 25, 2024, at 8:00 a.m. ET. During the call, the team will summarize HOOKIPA’s positive regulatory discussions with the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). A key focus of these discussions is the agreement with the FDA on the design and protocol of the upcoming pivotal Phase 2/3 clinical trial. This trial will test HB-200 in combination with pembrolizumab, aiming to meet an unmet need in patients with certain cancers. The call is set to provide investors with more details about the clinical trial plans and the promising regulatory interactions that support the development of HOOKIPA’s innovative immunotherapy programs.
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HB-500 - FDA Regulatory Timeline and 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
- 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.
Read Announcement- Drug:
- HB-500
- Announced Date:
- January 30, 2025
- Estimated Event Date Range:
- July 1, 2025 - December 31, 2025
- Target Action Date:
- H2 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.
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HB-700 - FDA Regulatory Timeline and 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- Drug:
- HB-700
- Announced Date:
- April 24, 2024
- Indication:
- for the Treatment of KRAS-Mutated Cancers
Announcement
HOOKIPA Pharma Inc announced that the Company has received clearance from the U.S. Food and Drug Administration (FDA) for its Investigational New Drug (IND) application for HB-700, a novel arenaviral therapeutic vaccine for the treatment of KRAS-mutated cancers.
AI Summary
HOOKIPA Pharma Inc. announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for HB-700, a novel arenaviral therapeutic vaccine. HB-700 is designed to treat KRAS-mutated cancers, including lung, colorectal, and pancreatic cancers, by targeting five common KRAS mutations (G12D, G12V, G12R, G12C, and G13D). This approach could allow a single product candidate to help more patients than treatments that focus on only one mutation.
The FDA’s clearance marks an important milestone for HOOKIPA, paving the way for further clinical development of the HB-700 program. With full control over the associated intellectual property and collaboration and licensing rights now in hand, the company is poised to advance this innovative cancer immunotherapy, potentially offering new hope for patients with KRAS-mutated cancers.
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