Adagene(US:ADAG)2025-09-10 12:02Summary of Adagene Inc. Conference Call Company Overview - Company: Adagene Inc. - Industry: Biotechnology, specifically focused on antibody generation and protein engineering Key Points and Arguments SAFEbody® Platform and ADG126 - Adagene utilizes AI for protein engineering and antibody generation, leading to the development of novel antibodies, including ADG126, a masked anti-CTLA-4 antibody [2][3] - ADG126 binds to a different epitope than first-generation anti-CTLA-4 antibodies (ipilimumab and tremelimumab), resulting in up to 10 times stronger antibody-dependent cellular cytotoxicity (ADCC) [2] - The proprietary masking technology of ADG126 allows for a significantly expanded therapeutic window, addressing the high dose-dependency and toxicity issues associated with anti-CTLA-4 therapies [3][4] Target Indication: Microsatellite Stable Colorectal Cancer (MSS-CRC) - MSS-CRC accounts for 95% of all colorectal cancer cases, presenting a significant unmet medical need as current immunotherapies have not been effective in this subgroup [5][6] - Adagene is focusing on patients without liver metastasis, which represent roughly one-third of MSS-CRC patients, equating to over 10,000 patients in the U.S. [26] - The combination of ADG126 with Keytruda (pembrolizumab) has shown a confirmed response rate of 29% in phase 1B trials, with a median overall survival of 19 months, outperforming standard care options [10][12][32] Clinical Development and Regulatory Path - A randomized phase 2 trial is set to begin before the end of 2023, testing two dose levels of ADG126 in combination with Keytruda [22][18] - The primary endpoint for the phase 2 trial will be the response rate, which will inform the pivotal phase 3 trial [18][19] - The FDA has indicated that a control arm may not be necessary for the phase 2 trial, recognizing the ineffectiveness of PD-1 and CTLA-4 monotherapies in the targeted setting [41][42] Financial Position and Collaborations - Adagene had approximately $63 million in cash at the end of June 2025, with a runway extending into 2027 due to a recent equity investment from SNOWPEA [27][28] - SNOWPEA has committed to invest up to $25 million, with the first tranche of $17 million already received, supporting the phase 2 trial [28] - The collaboration with SNOWPEA includes a phase 1/2 trial evaluating a novel combination involving ADG126, potentially expanding its addressable market [29] Competitive Landscape and Future Outlook - Adagene is well-positioned within the global biotech landscape, leveraging its Chinese heritage and global clinical trial capabilities [37][38] - The company is utilizing AI to enhance antibody design and decision-making processes, positioning itself as a disruptor in the biotech space [39] - Future data readouts and updates on clinical trials are anticipated, with a focus on durability and response rates from ongoing studies [30][32] Additional Important Points - The incidence of grade 3 adverse events in the high-dose cohort of ADG126 is less than 20%, with no grade 4 or 5 events reported, indicating a favorable safety profile [11][33] - The collaboration with SNOWPEA not only validates Adagene's technology but also enhances its clinical development capabilities [34]