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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 Inc. (NASDAQ: HOOK) announced significant leadership changes on July 22, 2024. Dr. Malte Peters was appointed as CEO and Terry Coelho as EVP and CFO, replacing Jörn Aldag and Reinhard Kandera respectively. Both new executives will retain their Board positions. The company is initiating a review of its business strategy and operations to maximize the potential of HB-200 and create shareholder value.
HOOKIPA has recently received PRIME designation from the EMA for HB-200 and aligned with the FDA on a clinical development strategy with potential for accelerated approval. The company is also advancing other programs, including a collaboration with Gilead for HB-500 in HIV treatment. Sean Cassidy, former CFO of Arvinas, has been appointed to HOOKIPA's Board of Directors and will chair the Audit Committee.
HOOKIPA Pharma has announced a 1-for-10 reverse stock split effective July 9, 2024, to comply with Nasdaq's minimum bid price requirement. The stock will trade on a split-adjusted basis from July 10, 2024, under the symbol 'HOOK' with the new CUSIP number 43906K209. The reverse split will combine every 10 outstanding shares into one, reducing the total number of issued and outstanding shares from 96.6 million to 9.7 million, and proportionately adjusting authorized shares from 400 million to 40 million. Stockholders will receive cash for fractional shares, and adjustments will be made for stock options and convertible preferred stock.
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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