Randomized Phase 2 trial in microsatellite stable colorectal cancer (MSS CRC) ongoing, with results expected in 1H 2027; potential registration trial expected in 2027 once recommended dose regimen has been established
Data reported at AACR from triple combination therapy in 1L hepatocellular carcinoma $(HCC)$ and late-line MSS CRC highlights muzastotug's potential as a backbone combination treatment for multiple tumor types across all lines of therapy
Initiated dosing in a global Phase 1/2 basket trial evaluating muzastotug in combination with a next-generation investigational IO agent through a clinical collaboration with Sanofi
Investigator-initiated Phase 2 trial of muzastotug in neoadjuvant setting for colorectal cancer is ongoing
Cash and cash equivalents of $127.9 million include proceeds of public offering in April 2026; provide runway into late 2028
SAN DIEGO and SUZHOU, China, Aug. 12, 2026 (GLOBE NEWSWIRE) -- Adagene Inc. ("Adagene") (Nasdaq: ADAG), a platform-driven, clinical-stage biotechnology company transforming the discovery and development of novel antibody-based therapies, today reported financial results for the six months ended June 30, 2026, and provided corporate updates.
"The first half of 2026 was a period of meaningful advances for the company, as our lead program, muzastotug, a masked, anti-CTLA-4 SAFEbody, continues to demonstrate compelling efficacy and a favorable safety profile in MSS CRC and HCC," said Peter Luo, Ph.D., CEO and President of R&D at Adagene. "The strength of muzastotug as a potential backbone therapy continues to be recognized with recent collaborations and the clinical data to date demonstrates the enhanced safety of muzastotug relative to legacy CTLA-4 therapies, even at approximately ten times higher doses. This enhanced safety allows muzastotug to be used as a potential backbone therapy in combination with pembrolizumab and/or other standard of care therapies, such as fruquintinib. We remain encouraged by the durable benefit we are seeing."
"We also welcomed Peter Lebowitz to our Scientific and Strategic Advisory Board, further strengthening the clinical expertise guiding our programs;" continued Dr. Luo. "The equity offering in April brought in new investors and extended our cash runway into late 2028, allowing us to accelerate our pipeline and deliver on our mission to transform cancer immunotherapy for patients."
PIPELINE HIGHLIGHTS
Muzastotug (ADG126) Phase 1b/2 study in combination with Merck's (known as MSD outside of the United States and Canada) anti-PD-1 therapy, KEYTRUDA$(R)$ (pembrolizumab), in patients with advanced microsatellite stable colorectal cancer (MSS CRC) with no liver metastases.
-- Updated data announced in April 2026 highlighted clinical results from
patients that have been treated with a muzastotug dose of either 10 mg/kg
or 20 mg/kg, in combination with pembrolizumab.
-- In the combined 10 mg/kg cohorts, muzastotug achieved an overall
response rate $(ORR)$ of 13%. The median progression-free survival
$(PFS)$ was 4.8 months, and median overall survival (OS) was 19.8
months.
-- In patients dosed with 10 mg/kg of muzastotug every 6 weeks
(Q6W), the ORR was 0% (0/10) and median PFS was 4.5 months.
-- In patients dosed with 10 mg/kg of muzastotug every 3 weeks
(Q3W), the ORR was 17% (5/29) and median PFS was 4.8
months.
-- In the combined 20 mg/kg cohorts, muzastotug achieved a confirmed
ORR of 31%. The median PFS was 6.7 months, and median OS was not
yet reached.
-- In patients dosed with 20 mg/kg of muzastotug every 6 weeks
(Q6W), the ORR was 25% (3/12) and median PFS was 4.9
months.
-- In the 20 mg/kg loading dose cohort (20 mg/kg, followed by
10 mg/kg Q3W), the ORR was 36% (5/14) and median PFS was
15.4 months.
-- Across 67 patients in all cohorts, a low 4% overall discontinuation rate,
no dose limiting toxicities, and no Grade 4 or 5 treatment-related
adverse events (TRAEs); Grade 3 TRAEs were 15% in the 10 mg/kg cohorts
and 38% in the 20 mg/kg cohorts, which were generally transient and
manageable.
-- Enrollment into the randomized Phase 2 trial is well on-track, and
results are expected in 1H 2027. The Phase 2 trial is enrolling patients
into two arms designed to allow dose regimen selection for the Phase 3
trial. Both arms include an induction phase to drive early efficacy and a
maintenance phase to prolong overall survival.
-- Arm A: Patients receive 10 mg/kg induction dose of muzastotug plus
200 mg pembrolizumab Q3W for 4 doses followed by one 200 mg dose
of pembrolizumab; the maintenance phase doses 10 mg/kg muzastotug
Q6W plus 400 mg of pembrolizumab Q6W.
-- Arm B: Patients receive 20 mg/kg induction dose of muzastotug Q6W
plus 400 mg pembrolizumab Q6W for 2 doses; the maintenance phase
doses muzastotug at 15 mg/kg Q6W plus 400 mg pembrolizumab Q6W.
-- A potential registration trial is expected to begin once the recommended
dose regimen has been established, supported by the Fast Track
Designation and FDA alignment under Project Optimus.
Triple combination Phase 1b/2 study of muzastotug, atezolizumab and bevacizumab, in patients with first-line HCC:
-- Data presented at the American Association for Cancer Research (AACR)
annual meeting in April 2026 included results from the study which is
evaluating the triple combination of muzastotug, atezolizumab and
bevacizumab compared to atezolizumab and bevacizumab as an active control
arm. Interim results from six patients in the muzastotug arm (18.8 months
median duration of follow-up) demonstrated a 66.7% ORR (4/6) using
HCC-specified modified RECIST v1.1 criteria. ORR was 50.0% (3/6) using
RECIST v1.1 criteria. The median PFS was 8.2 months (same for both RECIST
criteria) and the median OS was not yet reached at the data cut but was
greater than 22 months.
-- These results compared favorably to the 40 patients in the active control
arm (17.2 months median duration of follow-up) that demonstrated an ORR
of 32.5% (13/40) using HCC-specified modified RECIST v1.1 criteria,
median PFS of 5.5 months, and median OS of 17.5 months. Using RECIST v1.1
criteria, the ORR was 17.5% (7/40) and the median PFS was 4.3 months.
-- The triplet regimen of muzastotug, atezolizumab and bevacizumab was
well-tolerated with safety data comparable to the doublet active control
arm of atezolizumab and bevacizumab. Grade 3 or greater TRAEs were 50%
(3/6) in the muzastotug arm and 45% (18/40) in the active control arm,
which supports the potential for continuous dosing with
muzastotug. Ongoing muzastotug plus atezolizumab treatment after
bevacizumab discontinuation suggests potential flexibility to modify
individual agents during safety-related interruptions while preserving
durable clinical benefit from the muzastotug and atezolizumab doublet for
an extended period of time.
Triple combination Phase 1b/2 study of muzastotug, pembrolizumab and fruquintinib in patients with advanced or metastatic MSS CRC:
-- In data presented at AACR, interim results from the study demonstrated a
25% confirmed ORR (1/4) among patients at a dose of 10 mg/kg every 6
weeks (Q6W) of muzastotug (6.7 months median follow-up), and a 40% ORR
(2/5) among patients at a dose of 15 mg/kg Q6W of muzastotug (5.9 months
median follow-up). The triplet regimen was well-tolerated with no new
safety signals, relative to known CTLA-4, PD-1, and fruquintinib
monotherapy and combination safety data. There were no dose-limiting
toxicities, 25 -- 60% Grade 3 TRAEs, and no Grade 4 or Grade 5 TRAEs.
Investigator-initiated Phase 2 trial of muzastotug in the neoadjuvant setting, in combination with pembrolizumab, for the treatment of MSS CRC:
-- Patients in this study received muzastotug up to 20 mg/kg in combination
with pembrolizumab prior to surgery. Using paired tumor biopsies
collected before and after treatment, the study evaluates muzastotug's
pharmacokinetic profile in tumor tissue and its pharmacodynamic effects
on the immune landscape of the tumor microenvironment. These analyses are
designed to further elucidate muzastotug's unique mechanism of action and
its potential to deliver an enhanced therapeutic index.
-- Additionally, the trial's primary endpoint is the rate of Major
Pathologic Response (MPR), defined as <=10% residual viable tumor in the
surgical specimen, and is being evaluated in up to 20 patients. Secondary
endpoints include complete pathological response, disease-free survival,
and safety/tolerability. Preliminary clinical data will inform future
development of muzastotug in the neoadjuvant setting.
Comments