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ADAGENE Adagene Reports Financial Results for the Six Months Ended June 30 , 2021 and Provides Corporate Updates August 26 , 2021 - Established three clinical collaborations with Merck to conduct global combination trials with pembrolizumab for three clinical - stage oncology candidates - - Evidence of ADG 106 efficacy with favorable safety profile shown in monotherapy trials ; combination trials ramping up to target biomarker - enriched indications and PD - 1 resistant patients - - Strong potential for differentiated profile of novel NEObody ™ anti - CTLA - 4 candidate , ADG116 , demonstrated in ongoing phase 1 trial - - First SAFEbody ™ program , ADG126 , advancing in phase 1 dose - escalation - - Continued execution of multiple preclinical programs towards IND , leveraging the company's powerful antibody - based technology platforms · -- - Further strengthened leadership team and expanded network of scientific and strategic advisors to develop best - in - class pipeline - SAN FRANCISCO and SUZHOU , China , Aug. 26 , 2021 ( GLOBE NEWSWIRE ) Adagene Inc. ( " Adagene " ) ( Nasdaq : ADAG ) , a platform - driven , clinical - stage biopharmaceutical company committed to transforming the discovery and development of novel antibody - based immunotherapies , today reported financial results for the six months ended June 30 , 2021 , and provided corporate updates . " During the first half of 2021 , we advanced our clinical pipeline of three highly differentiated immuno - oncology candidates , while building a robust pipeline of novel preclinical programs that leverage our unique computational biology and artificial intelligence ( AI ) powered technology platforms , " said Peter Luo , Ph.D. , Co - founder , Chief Executive Officer and Chairman of Adagene . " With three Merck collaborations now in place , we've refined our global clinical development strategies to enhance efficiency and optimize our plans moving forward , while we anticipate key upcoming data from ongoing trials . Our pipeline aims to transform cancer therapy with the first of a new class of agonist antibodies targeting CD137 , as well as new modalities and novel combinations to unlock the value of CTLA - 4 as a proven target and the backbone of future immunotherapies . Applying our unique technology platforms and translational expertise , our goal is to strike a balance between safety and efficacy , addressing the core challenge of oncology drug development . " Recent Highlights and Upcoming Milestones ADG106 : This NEObody ™ program is a fully human ligand - blocking , agonistic anti - CD137 IgG4 monoclonal antibody ( mAb ) that is being evaluated in patients with advanced solid tumors and / or non - Hodgkin's lymphoma . • Evaluated ADG106 in 98 patients in phase 1 monotherapy dose escalation trials in U.S. ( ADG106-1001 ) and China ( ADG106-1002 ) : • ADG106 monotherapy was well tolerated at doses of 3 mg / kg and 5 mg / kg . Limited treatment emergent adverse events were observed ( i.e. , limited liver toxicity or hematologic abnormalities ) . Results showed evidence of efficacy with a 56 % disease control rate , and more than 30 % tumor shrinkage was observed in 75 % of patients with positive biomarker expression ( via retrospective analysis ) , including a partial response evaluated by RECIST v1.1 in a patient with a solid tumor who failed multiple prior therapies . o Data from these trials were published at the ASCO 2021 Annual Meeting . • Continued dose escalation in a phase 1b / 2 trial ( ADG106-1008 ) evaluating safety and preliminary efficacy of ADG106 in combination with toripalimab , an approved anti - PD - 1 in China . This trial is targeting biomarker - enriched tumors in patients who failed prior standard and / or immuno - oncology therapies . • Preliminary data from this trial demonstrate target engagement as shown by a dose - dependent pharmacodynamic biomarker , consistent with the monotherapy trials . • Implementing a biomarker - enriched tumor targeting strategy for a phase 1b / 2 trial of ADG106 in combination with pembrolizumab ( ADG106 - P2001 ; KEYNOTE - D12 ) in the U.S. and Asia Pacific ( APAC ) , integrating earlier plans for the ADG106-2001 trial . Data from this trial are expected in 2022 . • Upcoming ADG106 milestones : • H2 2021 。 2022 ■ Results from ongoing trial in combination with toripalimab ( ADG106-1008 ) ■ Complete patient follow up in monotherapy trials in the U.S. ( ADG106-1001 ) and China ( ADG106-1002 ) ■ Results from combination trial with pembrolizumab ( ADG106 - P2001 ) ADG116 : This NEObody program , targeting a unique epitope of CTLA - 4 , is being evaluated in patients with advanced / metastatic solid tumors . ADG116 is designed to enhance efficacy by potent Treg depletion in the tumor microenvironment ( TME ) and to maintain its physiological function by soft ligand blocking in order to address safety concerns associated with existing CTLA - 4 therapeutics .