Adagene Announces 2024 Mid-Year Financial Results and Corporate Update

Adagene Inc., a clinical-stage biotechnology company, reported its financial results for the six months ending June 30, 2024, reflecting its ongoing efforts to develop innovative antibody-based therapies. The company, leveraging its proprietary technology platforms, focuses on combining its lead candidate ADG126 with Merck’s KEYTRUDA (pembrolizumab) to potentially create a best-in-class immunotherapy doublet.

ADG126, a masked anti-CTLA-4 SAFEbody, targets a unique epitope of CTLA-4 on regulatory T cells in tumor tissue, showing promise when combined with pembrolizumab. The combination aims to enhance efficacy while maintaining safety, potentially positioning ADG126 as a new cornerstone in cancer immunotherapy.

Key Developments and Data:

ESMO Congress Presentation:
Adagene plans to present further data from a phase 1b/2 trial at the European Society of Medical Oncology (ESMO) Congress in September 2024. The presentation will cover longer-term data on metastatic microsatellite-stable (MSS) colorectal cancer (CRC) patients treated with ADG126 in combination with pembrolizumab. Highlights will include additional follow-up data on doses of ADG126 and initial overall survival (OS) metrics.

Previous Data from ASCO GI 2024:
In an earlier phase 1b/2 trial, ADG126 demonstrated a differentiated safety profile, even at higher doses, when combined with pembrolizumab in patients with advanced or metastatic solid tumors. The combination showed a comparable safety profile to pembrolizumab monotherapy, with notable efficacy signals. In MSS CRC patients without liver metastases, ADG126 combined with pembrolizumab resulted in a 22% overall response rate and a median progression-free survival (PFS) of seven months.

Expanded Patient Cohorts:
Adagene has extended its research to include additional MSS CRC patients, exploring different dosing regimens of ADG126 in combination with pembrolizumab. This includes expanding studies to the US and Asia Pacific regions, with initial results anticipated later this year.

Greater China Expansion:
The company has initiated studies of ADG126 in combination with pembrolizumab in Greater China, aiming to broaden dose expansion cohorts for MSS CRC and potentially other tumor types. A separate cohort is evaluating higher-dose monotherapy to identify the maximum tolerated dose.

Clinical Activity in PD-1 Experienced and PD-L1 Low Patients:
Data presented at ASCO-GI 2024 indicated clinical activity in patients previously treated with PD-1 therapies. Notably, two patients with refractory cervical and endometrial cancer showed sustained partial responses with repeat dosing of ADG126 combined with pembrolizumab, maintaining robust safety profiles.

Collaborations and Future Directions:
Adagene continues its strategic collaborations with companies like Exelixis, Sanofi, and Roche to develop novel therapies utilizing its SAFEbody technology. These partnerships aim to explore the potential of masked antibody-drug conjugates and other innovative treatments.

Financial Overview:
As of June 30, 2024, Adagene's cash and cash equivalents stood at approximately $95.7 million, projected to fund operations into 2026. The company reported no net revenue for the first half of 2024, a decrease from $17.3 million in the same period of 2023. Research and development expenses decreased to $14.7 million, reflecting a strategic focus on ADG126. Administrative expenses also saw a reduction to $3.6 million due to cost-control measures.

Despite a net loss of $17.0 million, Adagene remains focused on advancing its clinical programs, with multiple readouts expected at major medical conferences. The company’s commitment to developing safe and effective immunotherapies continues to drive its innovative research and strategic collaborations.

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