NEW YORK - HOOKIPA Pharma Inc. (NASDAQ: HOOK), a clinical-stage biopharmaceutical company, has reported encouraging results from a Phase 2 clinical trial for its lead oncology candidate, HB-200, in combination with pembrolizumab. The study targets patients with HPV16+ recurrent/metastatic head and neck cancer.
The trial results, presented at the ASCO 2024 Annual Meeting, showed a 37% confirmed objective response rate (ORR) among 35 evaluable patients, with an 11% complete response (CR) rate and a 69% disease control rate (DCR). Notably, in a subset of 17 patients with a PD-L1 combined positive score (CPS) of 20 or higher, the confirmed ORR was 53%, with an 18% CR rate and an 82% DCR.
Preliminary progression-free survival (PFS) for this subgroup was 16.3 months, which is a significant increase compared to the historical PFS of 3.4 months for pembrolizumab alone. Additionally, the overall survival (OS) rate was 88% at 9 months, with a median OS not yet reached; 16 out of 19 patients were still alive at the time of the analysis.
Dr. Alan Ho, a trial investigator and Head and Neck Oncologist at Memorial Sloan Kettering Cancer Center, commented on the potential of the immunotherapy combination to improve response rates and durability. Joern Aldag, CEO of HOOKIPA, also highlighted the combination's consistent positive outcomes and the company's alignment with the U.S. Food and Drug Administration on a clinical development strategy that could lead to accelerated approval.
The trial's promising data has set the stage for a planned pivotal Phase 2/3 trial, which is expected to begin enrolling patients in the fourth quarter of 2024. HB-200, utilizing HOOKIPA's proprietary arenavirus platform, has received Fast Track Designation from the U.S. FDA and PRIME designation from the European Medicines Agency for the treatment of first-line HPV16+ recurrent/metastatic oropharyngeal squamous cell carcinoma.
The company plans to host a conference call today at 4:15 p.m. ET to discuss the ASCO data update. This announcement is based on a press release statement.
InvestingPro Insights
As HOOKIPA Pharma Inc. (NASDAQ: HOOK) continues to make strides in the oncology field with its promising HB-200 clinical trial results, investors are keeping a keen eye on the company's financial health and market performance. According to InvestingPro data, HOOKIPA's market capitalization stands at a modest $80.34 million, reflecting the size and speculative nature of this clinical-stage biopharmaceutical company.
InvestingPro data also reveals a significant revenue growth of 235.12% over the last twelve months as of Q1 2024, indicating the company's rapid increase in sales, which may align with analysts' anticipation of further sales growth in the current year. This is a critical metric for investors to consider, as revenue growth can be a harbinger of future profitability and company success.
Despite the company's impressive clinical results and potential for future growth, it's important to note that HOOKIPA is not yet profitable, with a negative gross profit margin of -57.44% over the last twelve months. This underlines the company's current stage in the biopharmaceutical development cycle, where investment in research and development often precedes profit.
For potential investors looking for a deeper dive into HOOKIPA's financials and future prospects, there are additional InvestingPro Tips available. These tips include insights such as the company's cash burn rate and analysts' earnings revisions, which are crucial for evaluating the sustainability of HOOKIPA's operations and its ability to continue funding its promising clinical trials. There are 11 more tips listed on InvestingPro for those interested in a more comprehensive analysis.
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