UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
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Item 7.01 Regulation FD Disclosure.
On June 4, 2024, HOOKIPA Pharma Inc. (the “Company”) issued a press release entitled “HOOKIPA Pharma Announces Updated Phase 2 Clinical Data at the American Society for Clinical Oncology 2024 Annual Meeting.” A copy of the press release is attached to this Current Report on Form 8-K as Exhibit 99.1 and is incorporated by reference into this Item 7.01. An updated presentation summarizing the data referenced in the press release is also available on the investor relations section of the Company’s corporate website at www.ir.hookipapharma.com.
The information in this Item 7.01 and Exhibit 99.1 attached hereto is furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”) or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such filing.
Item 8.01 Other Events.
On June 4, 2024, the Company announced updated results from its Phase 2 clinical trial of HB-200 in combination with pembrolizumab in patients with recurrent/metastatic human papillomavirus 16 positive (“HPV16+”) head and neck cancer.
Data were presented as of March 29, 2024, and included 46 first line patients with HPV16+, PD-L1 positive, recurrent or metastatic head and neck squamous cell carcinoma. The updated data continue to demonstrate a favorable safety profile of HB-200 in combination with pembrolizumab and promising clinical activity as a first line treatment.
HB-200 + pembrolizumab was generally well tolerated. Grade ≥3 treatment-related adverse events (“TRAEs”) were reported in 7 (15%) patients, serious TRAEs in 2 (4%) patients, and TRAEs leading to treatment discontinuation of HB-200 in 2 (4%) patients. No treatment-related deaths were reported.
Among 35 evaluable patients, 4 confirmed complete responses, 9 confirmed partial responses, and 11 confirmed stable disease were observed. Notably, among patients with PD-L1 CPS ≥20 (N=17), objective response rate was 53% (9/17), complete response rate was 18% (3/17), and disease control rate was 82% (14/17). All responses were confirmed per RECIST 1.1. Preliminary progression free survival for the CPS 20 or higher subgroup was 16.3 months. The preliminary overall survival (“OS”) rate was 88% at 9 months, and median OS was unreached as of the cutoff date, with 16 of 19 patients still alive. Median follow-up for these patients was 8.4 months.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
Exhibit No. |
Description | |
99.1 | Press Release, dated June 4, 2024. | |
104 | Cover Page Interactive Data File (embedded within the Inline XBRL document). |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
Date: June 4, 2024 |
HOOKIPA Pharma Inc. | |
By: | /s/ Joern Aldag | |
Name: | Joern Aldag | |
Title: | Chief Executive Officer |