Item 7.01 Regulation FD Disclosure.
On June 22, 2020, HOOKIPA Pharma Inc. (the "Company") announced positive Phase 2
interim safety and immunogenicity results for its cytomegalovirus, or CMV,
vaccine candidate HB-101. A copy of the press release is attached hereto as
Exhibit 99.1.
The information in this Item 7.01 of Form 8-K, including the accompanying
Exhibit 99.1, shall not be deemed "filed" for purposes of Section 18 of the
Securities Exchange Act of 1934 (the "Exchange Act"), or otherwise subject to
the liability of such section, nor shall such information be deemed incorporated
by reference in any filing under the Securities Act of 1933 or the Exchange Act,
regardless of the general incorporation language of such filing, except as shall
be expressly set forth by specific reference in such filing.
Item 8.01 Other Events.
On June 22, 2020, the Company announced positive interim results on its
prophylactic CMV vaccine candidate HB-101. HB-101 is being investigated in a
double-blind Phase 2 clinical trial to assess safety, immunogenicity and
efficacy in patients receiving a kidney transplant from a live donor. The
Company reported that HB-101 was observed to be well tolerated with fewer
adverse events in patients with end-stage kidney disease than in the Company's
previous Phase 1 clinical trial of HB-101 in healthy volunteers. Patients who
received three doses of HB-101 showed comparable immunogenicity to healthy
volunteers in the Company's Phase 1 clinical trial of HB-101. In addition, in
available samples, patients who received three doses of HB-101 had a
CMV-specific cellular immune response.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.
Exhibit
Number Description
99.1 Press release issued by HOOKIPA Pharma Inc. on June 22, 2020
1
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