Adagene FY Conference Summary Company Overview - **Company**: Adagene (NasdaqGM:ADAG) - **Focus**: Development of immuno-oncology drugs, specifically targeting microsatellite stable colorectal cancer (MSS-CRC) with low response rates to current therapies [2][3] Key Points and Arguments Drug Development and Efficacy - **Lead Compound**: ADG126, a masked anti-CTLA-4 antibody, is being developed in combination with KEYTRUDA (pembrolizumab) for late-line MSS-CRC without liver metastases [3][4] - **Response Rates**: ADG126 has shown a response rate between 15% and 30% depending on dosage, with a median overall survival of 20 months in the lowest dose cohort [3][5] - **Safety Profile**: The discontinuation rate is less than 10%, with no grade 4 or 5 adverse events reported, indicating a favorable safety margin [5][15] Market Opportunity - **Target Population**: Approximately 10,000 patients in the U.S. represent the MSS-CRC without liver metastases, a challenging tumor type for immuno-oncology agents [12] - **Historical Context**: Current standard of care has a median overall survival of 10-14 months, highlighting the need for more effective treatments [2][11] Collaboration and Funding - **Sanofi Investment**: Sanofi committed to an equity investment of up to $25 million, with the first tranche of $17 million received at $2 per share. This funding supports the ongoing phase 2 trial of ADG126 [6][7] - **Trial Collaboration**: Sanofi will evaluate ADG126 in combination with their bispecific PD-1 IL-15 in over 100 patients with solid tumors [6][7] Competitive Landscape - **CTLA-4 Mechanism**: CTLA-4 therapies like Yervoy (ipilimumab) and Imjudo (tremelimumab) generate close to $4 billion in revenues, indicating a robust market for effective CTLA-4 inhibitors [8][9] - **Differentiation**: ADG126 is positioned as a safer alternative with a better safety margin compared to existing CTLA-4 therapies, which have shown high toxicity [10][76] Future Developments - **Upcoming Data**: Updates on ADG126's efficacy and safety are expected in the coming months, including data from triplet combinations and a phase 2 trial in neoadjuvant colorectal cancer patients [20][23] - **Regulatory Pathway**: Plans for a randomized phase 3 trial focusing on overall survival as the primary endpoint are in discussion with the FDA [62][73] Additional Important Insights - **Combination Potential**: ADG126 is seen as a versatile partner for various combinations beyond PD-1, including potential combinations with VEGF and TGF inhibitors [36][38] - **Strategic Partnerships**: The company aims to pursue more licensing deals and trial collaborations to expand its market reach and evaluate novel regimens [23][24] This summary encapsulates the critical insights from the Adagene FY Conference, highlighting the company's strategic direction, drug development progress, and market potential in the oncology space.

Core Insights - The European Commission has approved the subcutaneous formulation of Opdivo (nivolumab) for multiple solid tumor indications, making it the first PD-1 inhibitor approved for subcutaneous use in the EU [1][3]. Approval Details - The approval applies to all 27 EU member states, as well as Iceland, Norway, and Liechtenstein [1]. - Nivolumab for subcutaneous use is co-formulated with recombinant human hyaluronidase and is indicated for various adult solid tumors, either as monotherapy or in combination with other therapies [2][4]. Clinical Study Findings - The approval was supported by data from the CheckMate -67T clinical study, which demonstrated that the subcutaneous formulation has a pharmacokinetics and safety profile comparable to the intravenous version [4]. - The study showed that the subcutaneous formulation met primary pharmacokinetic noninferiority endpoints, with a geometric mean ratio for Cavgd28 of 2.10 and for Cminss of 1.77 [7]. - The objective response rate was 24% in the subcutaneous group compared to 18% in the intravenous group, indicating comparable efficacy [7]. Market Performance - Bristol Myers' shares have declined by 17% year to date, while the industry has seen a decline of 5.4% [3].

Core Viewpoint - Bristol Myers Squibb (BMY) has received a positive recommendation from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) for the approval of Opdivo (nivolumab) for additional indications in treating non-small cell lung cancer (NSCLC) and for a subcutaneous formulation across multiple solid tumor indications [1][10]. Group 1: Opdivo Approval and Clinical Trials - The CHMP recommended Opdivo in combination with platinum-based chemotherapy as neoadjuvant treatment, followed by Opdivo as monotherapy after surgical resection for high-risk resectable NSCLC patients with PD-L1 expression ≥1% [2]. - The positive CHMP opinion was based on the CheckMate-77T trial, which showed significant improvement in event-free survival compared to neoadjuvant chemotherapy and placebo [3]. - The CheckMate-77T study also demonstrated improvements in secondary efficacy endpoints, including pathologic complete response and major pathologic response (MPR) [4]. Group 2: Market Performance and Growth - BMY's shares have increased by 21.4% over the past year, contrasting with a 7.1% decline in the industry [9]. - The approval of Opdivo Qvantig for subcutaneous use is expected to enhance the immuno-oncology franchise's impact into the next decade [12]. - BMY's growth portfolio, including drugs like Reblozyl, Breyanzi, Camzyos, and Opdualag, has stabilized revenue amid generic competition [13]. Group 3: Recent Acquisitions and New Approvals - BMY recently acquired 2seventy bio, Inc. for $286 million, with plans to close the acquisition in the second quarter of 2025 [15]. - The approval of Cobenfy for schizophrenia represents a new pharmacological approach, with initial sales of $10 million in 2024 expected to contribute significantly to BMY's revenue [14].