On May 19, 2021 Adagene Inc. (‘Adagene’) (Nasdaq: ADAG), a platform-driven, clinical-stage biopharmaceutical company committed to transforming the discovery and development of novel antibody-based immunotherapies, reported clinical data from its ADG106 NEObodyTM program (Press release, Adagene, MAY 19, 2021, View Source [SID1234580333]). Results from Phase I, open-label, dose-escalation, single center (NCT03802955) and multicenter (NCT03707093) studies of ADG106 in subjects with advanced or metastatic solid tumors and/or relapsed/refractory non-Hodgkin lymphoma were presented in an abstract at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2021 Annual Meeting . In these Phase I trials, ADG106 monotherapy exhibited a favorable safety profile and demonstrated promising clinical efficacy in biomarker positive patients. ADG106 is a fully human, ligand-blocking, agonistic anti-CD137 IgG4 antibody (mAb) engineered using Adagene’s proprietary NEObody platform technology.

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‘We are very pleased with the original finding of a predictive biomarker for our anti-CD137 agonist and its association with tumor shrinkage,’ said Peter Luo, Ph.D., Co-founder, Chief Executive Officer and Chairman of Adagene. ‘ADG106 has been well tolerated in dose escalation and extensive expansion cohorts at dosage of up to 5 mg/kg, which exceeds that of other anti-CD137 agonists. Further, this clinical data demonstrates the power of our proprietary NEObody platform designed to generate antibodies with novel mechanisms of action by targeting unique and highly conserved epitopes. We believe these results, together with analyses of PK and PD data from around 100 patient population, support the recommended dose regimen for ongoing clinical development of ADG106 as monotherapy and in combination with anti-PD-1 and other therapies. We look forward to multiple upcoming studies as we continue to advance our ADG106 clinical program.’

‘Predictive biomarkers for patient stratification are critical to advances in precision immuno-oncology. It’s compelling to identify a predictive biomarker for anti-CD137 agonism that shows a strong correlation between ADG106 treatment and tumor shrinkage,’ said Hua Gong, M.D. Ph.D., Chief Operating Officer and Head of Precision Medicine of Adagene. ‘In an upcoming global Phase Ib/II trial (ADG106-2001), we plan to enrich for populations expressing our predictive biomarker in order to demonstrate a clinical benefit to ADG106 therapy. Our predictive biomarker has the potential to optimize favorable treatment options and enable oncologists to preselect cancer patients who are likely to benefit from ADG106 treatment. In our continuing commitment to the development of precision immunotherapies, Adagene has established a center of excellence for precision medicine in San Diego with cutting-edge technologies to support biomarker-guided clinical trials.’

Interim data for the ongoing Phase 1 clinical trial includes:

·Biomarker studies: In a retrospective analysis, 75% of biomarker positive patients demonstrated more than 30% tumor shrinkage after ADG106 treatment.
oTumor shrinkage was not significant among biomarker negative patients. There was a strong negative correlation (100%) between biomarker absence and clinical response.
oA tissue microarray study confirmed biomarker expression in a variety of tumor types suggesting a broad indication for ADG106 therapy.
·Target engagement: Target engagement upon ADG106 treatment was demonstrated with dose-dependent increases in NK cells in ADG106-mediated anti-tumor activities and in dose-dependent induction of soluble CD137 over baseline.
·Safety and efficacy: ADG106 demonstrated a disease control rate of 56% and exhibited a favorable safety profile at 3mg/kg and 5mg/kg with dose escalation up to 10mg/kg.
ADG106-1001 and ADG106-1002 Phase I trials have successfully completed enrollment of nearly 100 patients with advanced solid tumors and/or non-Hodgkin’s lymphoma in the US and China, respectively. Limited TEAEs, i.e., liver toxicity or hematologic abnormalities, were observed. Following a productive end-of-phase I (EOP1) meeting about our ADG106 biomarker-stratified trial design with the FDA, Adagene made a new submission (ADG106-2001) to stratify patients using the predictive biomarker prior to treatment with ADG106 as monotherapy and its combination with anti-PD-1 therapy. In March 2021, Adagene initiated patient enrollment in China for ADG106-1008 (NCT04775680) a multicenter, open-label, Phase Ib/II study of ADG106 in combination with PD-1 antibody in advanced solid tumors and relapsed/refractory non-Hodgkin lymphoma. Preparations are underway for the ADG106-1003 trial in Australia to evaluate ADG106 in combination with other therapies in advanced solid tumors and hematological malignancies.