By Chris Wack
Imunon shares rose after the company received clearance from the U.S. Food and Drug Administration to begin a Phase 1 clinical trial with a seasonal Covid-19 booster vaccine.
Shares were up 8% to $1.23 in recent trading. The stock hit its 52-week high of $2 on March 28.
The company filed an investigational new drug application for IMNN-101 in late February, and pending resolution of limited comments from the FDA, expects to begin patient enrollment in the second quarter of 2024.
The primary objectives of the Phase 1 study are to evaluate safety, tolerability, neutralizing antibody response, and the vaccine's durability in healthy adults.
Secondary objectives of the study include evaluating the ability of the IMNN-101 vaccine to elicit binding antibodies and cellular responses and their associated durability.
The phase 1 study will enroll 24 subjects evaluating three escalating doses of IMNN-101 at two U.S. clinical trial sites.
Write to Chris Wack at chris.wack@wsj.com
(END) Dow Jones Newswires
April 18, 2024 10:23 ET (14:23 GMT)
Copyright (c) 2024 Dow Jones & Company, Inc.
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