Adagene Receives FDA Guidance On Future Clinical Development Of Experimental Cancer Drug: Retail Turns Optimistic

Adagene Inc. (ADAG) on Tuesday said that it received directions from the U.S. Food and Drug Administration on further clinical development of its investigational drug Muzastotug in combination with Merck’s (MRK) cancer drug Keytruda in patients with microsatellite stable colorectal cancer (MSS CRC).

ADAG shares were trading 2% lower in the pre-market session at the time of writing.

Adagene had a meeting with the FDA and received written feedback, the company said.  

During the meeting, it was decided that future trials will enroll late-line patients with MSS CRC that has not spread to the liver. Mid-stage trials will randomize patients to either 10 mg/kg or 20 mg/kg of the drug in combination with Keytruda, aiming to identify which of the two doses will be used in the late-stage trial.

Approximately 30 patients will be enrolled in each arm of the mid-stage study and will seek to evaluate overall response rate, duration of response, progression-free survival, and overall survival.

In a late-stage study, the company stated that it will observe whether the drug primarily leads to an improvement in overall survival.

Neither the mid-stage nor the late-stage trial needs an arm studying the drug as a monotherapy without Keytruda, the company added.

Microsatellite stable colorectal cancer refers to colorectal tumors that do not exhibit microsatellite instability, meaning their DNA is relatively stable.

Adagene CEO Peter Luo thanked Merck for supplying Keytruda for the trials.

“Our Phase 1b/2 trial has produced robust dose-dependent efficacy data with a potential best-in-class safety profile, identifying two optimized dose levels for the Phase 2, consistent with Project Optimus,” he added.

On Stocktwits, retail sentiment around jumped from ‘neutral’ to ‘extremely bullish’ over the past 24 hours while message volume increased from ‘low’ to ‘high’ levels.

ADAG stock is down by 8% this year and by about 33% over the past 12 months.

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