NEW YORK - HOOKIPA Pharma Inc. (NASDAQ: HOOK), a clinical-stage biopharmaceutical company, has announced the final design for its Phase 2/3 trial of HB-200 in combination with pembrolizumab, a therapy aimed at treating HPV16+ recurrent or metastatic oropharyngeal squamous cell carcinoma (OPSCC). The trial design, which aligns with U.S. Food and Drug Administration (FDA) feedback, is set to begin enrolling patients in the fourth quarter of 2024.
The study will investigate the efficacy of HB-200, an arenavirus-based immunotherapy, plus pembrolizumab in approximately 250 patients with HPV16+ recurrent/metastatic PD-L1 CPS ≥ 20 OPSCC. Patients will be randomized in a one-to-one ratio to receive either HB-200 plus pembrolizumab or a placebo plus pembrolizumab.
The primary endpoints will be the objective response rate for the Phase 2 portion and overall survival for the Phase 3 portion. The trial may seek accelerated approval based on Phase 2 data, with primary analysis expected in 2026.
HOOKIPA will present data from approximately 40 patients treated with the combination therapy at the American Society of Clinical Oncology (ASCO) 2024 Annual Meeting on June 4, 2024. Two additional abstracts related to HB-200 and HB-700, another investigational therapy, have been accepted for presentation at the same meeting.
HB-200 has received both Fast Track Designation from the FDA and PRIME designation from the European Medicines Agency for the treatment of HPV16+ recurrent/metastatic OPSCC in the first-line setting. These designations are based on preliminary clinical evidence from an ongoing Phase 1/2 trial, which showed promising results doubling the objective response rate compared to pembrolizumab alone.
The company will host an investor call today at 8:00 a.m. ET to discuss the trial design and clinical development strategy for oncology. This announcement is based on a press release statement from HOOKIPA Pharma Inc.
InvestingPro Insights
As HOOKIPA Pharma Inc. (NASDAQ: HOOK) gears up for its pivotal Phase 2/3 trial of HB-200, investors are closely monitoring the company’s financial health and market performance. According to InvestingPro data, HOOKIPA holds a market capitalization of $84.11 million, signaling a relatively small player within the biopharmaceutical landscape.
The company's revenue growth has been impressive over the last twelve months as of Q4 2023, with an increase of 41.27%, yet it has experienced a quarterly revenue dip of -5.38% in Q4 2023. These figures suggest a dynamic revenue situation that investors should watch closely.
InvestingPro Tips indicate that HOOKIPA is not expected to be profitable this year, which is consistent with many clinical-stage biopharmaceutical companies that are investing heavily in research and development.
The company's gross profit margin stands at a staggering negative 322.66%, reflecting significant costs associated with its ongoing clinical trials. Despite this, HOOKIPA has experienced a substantial price uptick over the last six months, with a total return of 86.0%, highlighting a potential investor optimism for its future prospects, especially as it approaches key clinical milestones.
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