On November 9, 2023 HOOKIPA Pharma Inc. (NASDAQ: HOOK, ‘HOOKIPA’), a company developing a new class of immunotherapeutics based on its proprietary arenavirus platform, reported financial results and business highlights for the third quarter of 2023 (Press release, Hookipa Biotech, NOV 9, 2023, View Source [SID1234637368]).
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"I am pleased by the consistent and strong data within our HB-200 program; not only is our mechanism delivering powerful antigen-specific T cell responses, but it has also helped our patients continue their fight against cancer with promising objective response rate and disease control rate. With these encouraging data, we are busy finalizing plans for the randomized trial expected to begin next year," said Joern Aldag, Chief Executive Officer at HOOKIPA Pharma. "We also have significant, and achievable, upcoming milestones across our portfolio of programs, a testament to the potential of arenaviral platform technology to address unmet needs in cancer and infectious diseases."
Business Highlights and Recent Developments
Oncology
In October, HOOKIPA announced positive preliminary Phase 2 data on additional patients for HB-200 in combination with pembrolizumab, in patients with recurrent/metastatic Human Papillomavirus 16-positive (HPV16+) head and neck cancers, which was consistent with the preliminary data HOOKIPA announced in May 2023. Data from the ongoing study (NCT04180215), which was presented at the European Society for Medical Oncology Congress 2023, showed a 42 percent objective response rate for 19 evaluable checkpoint inhibitor (CPI)-naïve patients treated with HB-200 in combination with pembrolizumab. These data represent a doubling of the historical response rate (19 percent) reported for pembrolizumab alone and are consistent with previously reported data from the Phase 2 trial. HOOKIPA is preparing to start a randomized trial of HB-200 in combination with pembrolizumab in the 1st-line setting for patients with recurrent/metastatic HPV16+ head and neck cancers in mid-2024.
Enrollment continued in the ongoing Phase 1/2 study (NCT05553639) of HB-300 for the treatment of advanced prostate cancer. HB-300 is an arenaviral immunotherapy that targets two well-defined self-antigens of prostate cancer, prostatic acid phosphatase (PAP) and prostate-specific antigen (PSA). Initial safety, tolerability and immunogenicity data from the ongoing Phase 1 study of HB-300 are expected in the first half of 2024.
HOOKIPA’s HB-700 program, in collaboration with Roche, is progressing to an expected Investigational New Drug (IND) application filing in the first half of 2024. HB-700 is a novel arenaviral immunotherapy for KRAS-mutated cancers, including the five mutations that are the primary causes of lung, pancreatic and colon cancers.
Infectious disease
In August, The Journal of Infectious Disease, published peer-reviewed preclinical data on HB-400, an investigational therapeutic vaccine for chronic hepatitis B (HBV). The data show that HB-400 (NCT05770895) induced robust, HBV-specific T cell and antibody responses in non-human primates and cleared detectable serum HBV antigens in a mouse model for chronic HBV infection, with near elimination of detectable HBV antigen positive hepatocytes in the liver. HB-400 currently being evaluated in a Phase 1 trial and is one of two independent development programs in HOOKIPA’s collaboration and license agreement with Gilead Sciences, Inc. Gilead is solely responsible for further development and commercialization of the HBV product candidate.
HOOKIPA’s HB-500 program, also partnered with Gilead, is progressing towards an anticipated IND filing in the fourth quarter of 2023 and is expected to commence a Phase 1 clinical trial in 2024. HB-500 is a novel arenaviral vaccine that will be assessed as part of a potential functional curative regimen for HIV.
Anticipated Milestones
Phase 2 HB-200 in HPV16+ head and neck cancers
1st-line follow-up data in combination with pembrolizumab: H1 2024
Start of 1st-line randomized study in combination with pembrolizumab:
mid-2024 (Fast Track designation)
Phase 1 HB-300 in prostate cancer
Preliminary safety and immunogenicity data: H1 2024
HB-700 in KRAS-mutated cancers: IND filing H1 2024
HB-400 in hepatitis B: to be determined by Gilead
HB-500 in HIV: IND filing Q4 2023
Third Quarter 2023 Financial Results
Cash Position: HOOKIPA’s cash, cash equivalents and restricted cash as of September 30, 2023 was $108.1 million compared to $113.4 million as of December 31, 2022. The decrease was primarily attributable to cash used in operating activities, partly offset by funds resulting from the follow-on financing in June 2023.
Revenue: Revenue was $6.9 million for the three months ended September 30, 2023 and $2.2 million for the three months ended September 30, 2022. This increase was primarily due to higher partial recognition of the upfront and milestone payments under the Gilead and Roche collaborations, cost reimbursements for activities related to the preparation of a first human trial under the Roche collaboration, partially offset by lower cost reimbursements received under the Restated Gilead Collaboration Agreement.
Research and Development Expenses: HOOKIPA’s research and development expenses were $24.6 million for the three months ended September 30, 2023, compared to $18.3 million for the three months ended September 30, 2022. The primary drivers of the increase in research and development expenses by $6.3 million were higher clinical study expenses for our HB-200 program and increased spending for our Roche partnered program.
General and Administrative Expenses: General and administrative expenses amounted to $4.9 million for the three months ended September 30, 2023 and the three months ended September 30, 2022, respectively. General and administrative expenses remained constant.
Net Loss: HOOKIPA’s net loss was $19.1 million for the three months ended September 30, 2023, compared to a net loss of $18.3 million for the three months ended September 30, 2022. This increase was primarily due to an increase in research and development expenses.