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HOOKIPA Pharma Inc. (symbol: HOOK) is a clinical-stage biopharmaceutical company dedicated to the development of immunotherapeutics aimed at preventing and treating infectious diseases and cancer. Leveraging its proprietary arenavirus platform, HOOKIPA has created VaxWave® and TheraT®, groundbreaking technologies that reprogram and stimulate the immune system.
VaxWave® is a replication-deficient viral vector, while TheraT® is an attenuated replicating vector. Both technologies are designed to induce strong pathogen-neutralizing antibodies and CD8+ T cells. Remarkably, these vectors can be administered repeatedly without losing efficacy. TheraT® has shown the ability to stimulate CD8+ T cell responses to tumor antigens, achieving frequencies and potencies comparable to or surpassing those seen in adoptive T cell therapy.
HOOKIPA's viral vectors are administered systemically and target dendritic cells in vivo, effectively activating the immune system. This capability is particularly beneficial in the field of immuno-oncology, where it allows for the systemic combating of both primary and metastatic solid tumors.
In recent achievements, HOOKIPA has successfully completed a Phase 1 clinical trial, demonstrating the potential and safety of its innovative approaches. The company continues to focus on advancing its pipeline, which includes the development of an arenavirus-based immunotherapy for KRAS mutant cancer and a neoadjuvant HPV16-specific immunotherapy combined with chemotherapy for HPV16-positive oropharyngeal cancer.
As of December 31, 2023, the company maintains a robust financial position. HOOKIPA remains committed to pioneering immune-based treatments that offer hope for patients with infectious diseases and cancer, positioning itself at the forefront of biopharmaceutical innovation.
HOOKIPA Pharma (NASDAQ: HOOK) announced the first participant has been dosed in the Phase 1b clinical trial of HB-500, a novel arenaviral therapeutic vaccine for HIV developed in collaboration with Gilead Sciences. This milestone has triggered a $5 million non-dilutive payment under their collaboration agreement. The trial, which began on July 1, 2024, will assess the safety, tolerability, reactogenicity, and immunogenicity of HB-500 in HIV patients on suppressive antiretroviral treatment. The Phase 1b trial includes two dose escalation cohorts randomized to receive either HB-500 or a placebo. HOOKIPA is responsible for advancing the HIV program through this trial, after which Gilead has the exclusive right to continue development.
HOOKIPA Pharma announced updated Phase 2 clinical data for HB-200 combined with pembrolizumab in treating recurrent/metastatic HPV16+ head and neck cancer at the ASCO 2024 Annual Meeting. Out of 35 evaluable patients, results showed a 37% confirmed objective response rate (ORR), 11% complete response (CR) rate, and 69% disease control rate (DCR). Notably, in a subset of 17 patients with a PD-L1 CPS of 20 or higher, the ORR was 53%, CR rate 18%, and DCR 82%. Preliminary progression-free survival (PFS) for this subset was 16.3 months, with a 9-month overall survival (OS) rate of 88%. The treatment was generally well-tolerated, with Grade ≥3 treatment-related adverse events reported in 15% of patients. The pivotal Phase 2/3 trial is set to begin in Q4 2024.
HOOKIPA Pharma (NASDAQ: HOOK) will host an investor call on June 4, 2024, at 4:15 p.m. ET to discuss promising preliminary results from its Phase 2 clinical trial of HB-200 in combination with pembrolizumab.
The data, presented at the American Society of Clinical Oncology 2024 Annual Meeting, focuses on progression-free survival and overall survival for patients with a Combined Positive Score (CPS) ≥20, targeting human papillomavirus 16 positive head and neck cancer.
The company's proprietary arenavirus platform underpins this new class of immunotherapeutics.
HOOKIPA Pharma announced positive results from its Phase 1/2 trial of HB-200 for HPV16+ head and neck cancers, to be presented at ASCO 2024. The study, which involved 42 patients, showed an objective response rate (ORR) of 53% and a disease control rate (DCR) of 82% among patients with PD-L1 CPS of 20 or higher. HB-200 combined with pembrolizumab exhibited a favorable safety profile, with no treatment-related deaths and low treatment discontinuation rates. Additional data, including preliminary progression-free survival and overall survival, will be presented on June 4, 2024. Preliminary findings from an investigator-initiated trial for HB-200 with chemotherapy in non-metastatic HPV16+ cancers showed promising results, with an 81% deep response rate. Preclinical data for HB-700, targeting KRAS mutations, demonstrated effective T-cell responses and tumor cell killing in mice.
HOOKIPA Pharma Inc. reported its first quarter 2024 financial results and business highlights, focusing on its pivotal trial design for HB-200 in combination with pembrolizumab for HPV16+ recurrent or metastatic OPSCC. The company received FDA clearance for its IND application for HB-700 for KRAS mutated cancers. Financially, HOOKIPA saw total revenues of $36.6 million, driven by milestone payments, resulting in a profitable quarter.
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