Item 8.01 Other Events.
On April 25, 2023, HilleVax, Inc. (the "Company") announced that it completed
enrollment of its NEST-IN1 clinical trial (Norovirus Efficacy and Safety Trial
for INfants), with over 3,000 subjects enrolled in six countries. NEST-IN1 is
the Company's ongoing Phase 2b trial for HIL-214, its investigational virus-like
particle (VLP) based vaccine candidate for the prevention of moderate-to-severe
norovirus-related acute gastroenteritis (AGE) in infants. Topline safety and
clinical efficacy data from NEST-IN1 are expected in the first quarter of 2024.
NEST-IN1 is a randomized, double-blind, placebo-controlled trial in infants of
approximately 5 months of age at time of initial vaccination at sites in the
United States and Latin America. Subjects were randomized 1:1 to receive either
HIL-214 or placebo. In the vaccine arm, subjects received HIL-214 (50/150 µg
GI.1/GII.4 VLP combination with 500 µg alum) in a two-dose regimen delivered 28
to 56 days apart. In the control arm, subjects received saline placebo at the
corresponding timepoints. The primary objective of NEST-IN1 is to evaluate the
protective efficacy of HIL-214 against moderate or severe AGE events associated
with GI.1 or GII.4 norovirus strains (excluding certain co-infections) during a
pre-determined surveillance period that begins one month after the
administration of the second dose of HIL-214. A key secondary endpoint is the
evaluation of the protective efficacy of HIL-214 against any GI or GII norovirus
strain. Other secondary endpoints include the evaluation of safety and
immunogenicity of HIL-214.
Forward Looking Statements
The Company cautions you that statements contained in this report regarding
matters that are not historical facts are forward-looking statements. The
forward-looking statements are based on the Company's current beliefs and
expectations and include, but are not limited to, the expected timing of data
readouts from the NEST-IN1 clinical trial. Actual results may differ from those
set forth in this report due to the risks and uncertainties inherent in the
Company's business, including, without limitation: the Company currently depends
entirely on the success of HIL-214, and the Company has not yet completed any
clinical trials of HIL-214; potential delays in the commencement, enrollment,
and completion of clinical trials and preclinical studies; the Company's
dependence on third parties in connection with manufacturing, research and
clinical and preclinical testing; unexpected adverse side effects or inadequate
immunogenicity or efficacy of HIL-214 or any future vaccine candidates that may
limit their development, regulatory approval, and/or commercialization;
unfavorable results from clinical trials; results from prior clinical trials and
studies not necessarily being predictive of future results; the Company's
ability to maintain undisrupted business operations due to the COVID-19 pandemic
or other epidemic diseases, including delaying or disrupting the Company's
clinical trials, manufacturing and supply chain; unstable market and economic
conditions and adverse developments with respect to financial institutions and
associated liquidity risk may adversely affect the Company's business and
financial condition and the broader economy and biotechnology industry;
regulatory developments in the United States and foreign countries; any future
impacts to the Company's business resulting from the conflict between Russia and
Ukraine or other geopolitical developments outside the Company's control; the
Company's reliance on intellectual property rights under the Company's license
agreement with Takeda Vaccines, Inc.; the Company's ability to obtain, maintain
and enforce intellectual property protection for the Company's vaccine
candidates; the Company may use its capital resources sooner than the Company
expects; and other risks described in the Company's prior press releases and the
Company's filings with the Securities and Exchange Commission (SEC), including
under the heading "Risk Factors" in the Company's annual report on Form 10-K and
any subsequent filings with the SEC. You are cautioned not to place undue
reliance on these forward-looking statements, which speak only as of the date
hereof, and the Company undertakes no obligation to update such statements to
reflect events that occur or circumstances t-hat exist after the date hereof.
All forward-looking statements are qualified in their entirety by this
cautionary statement, which is made under the safe harbor provisions of the
Private Securities Litigation Reform Act of 1995.
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