RAHWAY, N.J.--(BUSINESS WIRE)---- $MRK #MRK--KEY + WEL as Adjuvant Therapy Reduced the Risk of Disease Recurrence or Death Compared to KEYTRUDA Mono in Certain Patients With Earlier-Stage RCC. ...

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 Viewpoint - Immutep Limited has reached 50% of its patient enrollment target in the TACTI-004 Phase III trial for eftilagimod alfa (efti) in combination with KEYTRUDA and chemotherapy for advanced/metastatic non-small cell lung cancer [1][7]. Group 1: Trial Progress and Details - The TACTI-004 trial has enrolled 378 patients globally, with enrollment continuing at a robust pace [3][7]. - The trial is set to complete patient enrollment by the third quarter of 2026, with a futility analysis expected in the first quarter of the same year [2][3]. - The study aims to enroll approximately 756 patients across over 150 clinical sites in more than 25 countries, regardless of PD-L1 expression [4]. Group 2: Efti and Its Mechanism - Efti is a first-in-class MHC Class II agonist that activates antigen-presenting cells to initiate a broad anti-cancer immune response [5]. - The immunotherapy is being evaluated for various solid tumors, including non-small cell lung cancer, and has received Fast Track designation from the FDA for first-line treatments [6]. Group 3: Company Overview - Immutep is a late-stage biotechnology company focused on developing novel immunotherapies for cancer and autoimmune diseases, leveraging its expertise in LAG-3 therapeutics [8].

Core Insights - Immutep Limited has made significant progress in its immunotherapy development, particularly with eftilagimod alfa (efti), through a strategic collaboration with Dr. Reddy's Laboratories for commercialization outside key markets [3][5][6] Efti Development Program in Oncology - The strategic collaboration with Dr. Reddy's includes an upfront payment of USD 20 million (~AUD 30.2 million) and potential milestone payments of up to USD 349.5 million (~AUD 528.4 million) [5][6] - Efti is currently under evaluation in a Phase III trial (TACTI-004) for first-line non-small cell lung cancer (1L NSCLC), with strong operational progress reported [4][8] - The combination of efti with KEYTRUDA and chemotherapy has shown a 61.7% overall response rate (ORR) in patients with low and no PD-L1 expression, significantly higher than the historical control of 40.8% [14] - The EFTISARC-NEO Phase II trial met its primary endpoint with a median tumor hyalinization/fibrosis of 51.5%, indicating potential for improved survival outcomes in soft tissue sarcoma [17][20] Financial Summary - As of December 31, 2025, the company reported a strong cash position of approximately AUD 99.1 million, which will extend its cash reach into Q2 CY2027 [35][40] - The company received EUR 2.59 million (~AUD 4.6 million) in R&D tax incentives from the French government to support ongoing clinical development [36] - Total cash outflows for R&D activities during the quarter were AUD 9.9 million, a decrease from AUD 15.8 million in the previous quarter [37] Intellectual Property - Immutep was granted four patents during the quarter, including a new patent in New Zealand for a binding assay related to LAG-3 protein and three new patents for IMP761 in Brazil and Japan [32] Corporate Activities - The company successfully held its Annual General Meeting (AGM), with all resolutions approved by shareholders, reflecting strong support for its strategic objectives [33]

Core Insights - Adagene Inc. announced an update on its ongoing Phase 1b/2 study of muzastotug in combination with pembrolizumab for patients with microsatellite stable metastatic colorectal cancer (MSS CRC), with data expected in Q1 2026 [1][6] - The company reported unaudited cash and cash equivalents of $74.5 million as of December 31, 2025, which is anticipated to provide sufficient runway until late 2027 [1][3] 2025 Key Accomplishments - The company demonstrated a favorable safety profile for muzastotug at doses 10-20 times higher than first-generation CTLA-4 inhibitors, with encouraging overall response rates and durable responses [5] - Muzastotug received FDA Fast Track designation for use in combination with KEYTRUDA for adult patients with MSS CRC without current or active liver metastases [5] - Adagene secured a strategic investment of up to $25 million from Sanofi to support the randomized Phase 2 study of muzastotug [5] - Collaborations were established with Third Arc Bio for developing next-generation T cell therapies and with Exelixis for advancing a third masked ADC against a solid tumor target [5] 2026 Objectives - The company aims to provide a data update from the ongoing Phase 1b/2 study, including results from 41 patients in the 10 mg/kg cohort and 26 patients in the 20 mg/kg cohort [6] - Complete enrollment of the randomized Phase 2 dose-optimization study with muzastotug, aligned with FDA Project Optimus [6] - Share results from a clinical trial collaboration with Roche evaluating muzastotug in combination with atezolizumab and bevacizumab for liver cancer [6] Company Overview - Adagene Inc. is a clinical-stage biotechnology company focused on developing novel antibody-based cancer immunotherapies using computational biology and artificial intelligence [8] - The company's lead clinical program, muzastotug, is a masked anti-CTLA-4 SAFEbody targeting regulatory T cells in the tumor microenvironment, currently in Phase 1b/2 and Phase 2 studies [10]

Core Insights - CytomX Therapeutics is advancing its clinical programs, particularly focusing on Varsetatug masetecan (Varseta-M) and CX-801, with significant milestones expected in 2026 [1][2][3] Clinical Program Updates - Varseta-M Phase 1 expansion data is on track for release in Q1 2026, with a combination study with bevacizumab in colorectal cancer (CRC) set to begin in Q1 2026 [1][4] - The total enrollment for the Varseta-M Phase 1 study is projected to reach approximately 100 patients by the planned update in Q1 2026 [6] - The company aims to align with the FDA in 2026 regarding a potential registrational study design for Varseta-M monotherapy in advanced CRC [6] - CX-801 Phase 1 study is ongoing, focusing on advanced melanoma, with monotherapy dose escalation having reached the fourth dose level [6] - Initial clinical data for CX-801 in combination with KEYTRUDA is anticipated by the end of 2026 [6] Strategic Focus - The company is committed to advancing Varseta-M towards a registrational trial in late-line CRC and aims to move it into earlier lines of treatment to address high unmet medical needs [2][3] - CytomX is leveraging its PROBODY therapeutic platform to progress a broader pipeline of therapeutics, including CX-801 [3][8] Upcoming Events - CytomX will present at the 44th Annual JP Morgan Healthcare Conference on January 14, 2026 [1][7]

Core Insights - Immutep Limited reports significant operational progress in the TACTI-004 Phase III trial for eftilagimod alfa (efti) in combination with KEYTRUDA and chemotherapy for advanced non-small cell lung cancer [1][5] Group 1: Trial Progress - The TACTI-004 trial has enrolled 289 patients, which is over 38% of the targeted 756 patients, with recruitment continuing at a strong pace [2][8] - More than 120 clinical sites have been activated across 27 countries, all of which have received full regulatory approvals [2][8] - The first clinical site in the United States has received regulatory clearance following the FDA's Project Optimus initiative [3] Group 2: Future Milestones - The trial has already enrolled the necessary 170 patients for a futility analysis, which is expected to be conducted in the first quarter of CY2026 [4] - Completion of patient enrollment is anticipated in the third quarter of CY2026 [4] Group 3: Efti Overview - Efti is a first-in-class MHC Class II agonist that activates antigen-presenting cells to initiate a broad anti-cancer immune response [7] - Efti is being evaluated for various solid tumors, including non-small cell lung cancer, head and neck squamous cell carcinoma, soft tissue sarcoma, and breast cancer [8][9] Group 4: Company Background - Immutep is a late-stage biotechnology company focused on developing novel immunotherapies for cancer and autoimmune diseases, leveraging its expertise in LAG-3 therapeutics [10]

Core Insights - MDNA11 demonstrates durable anti-tumor activity in difficult-to-treat populations, exceeding objective response rate (ORR) benchmarks in immune checkpoint resistant melanoma, MSS endometrial cancer, MSI-H, and TMB-H cancers [1] - The monotherapy expansion cohorts show an ORR of 42% and a disease control rate (DCR) of 83% for patients treated with MDNA11 after progression on immune checkpoint inhibitors [1] - Combination therapy with KEYTRUDA shows an ORR of 50% and a DCR of 75% in MSS endometrial cancer, while MSS TMB-H tumors show an ORR of 25% and a DCR of 88% [1] Clinical Data - In monotherapy cohorts, ORR is 38% in melanoma and 22% in MSI-H tumors, with corresponding DCRs of 75% and 78% respectively [1] - Patients with disease control in monotherapy cohorts had a median overall survival (mOS) of 120.2 weeks compared to 28.6 weeks for those without disease control [7] - In combination cohorts, patients with disease control had a median OS that was not yet reached, compared to 26 weeks for those without disease control [10] Safety Profile - MDNA11 shows a manageable safety profile, with over 90% of treatment-related adverse events being Grade 1-2 and transient, resolving typically within 48 hours [4] - No dose-limiting toxicities were observed at doses up to 120 µg/kg in monotherapy or in combination with KEYTRUDA [4] Recommended Dose - The preliminary recommended dose for expansion for both monotherapy and combination arms is established at 90 µg/kg Q2W, with a biological effective dose range set at 60 to 120 µg/kg [5] Future Developments - Medicenna plans to share new and mature data from the ABILITY-1 study and additional studies in the coming weeks and months [3]

Core Insights - MDNA11 demonstrates durable anti-tumor activity in difficult-to-treat populations, exceeding objective response rate (ORR) benchmarks in immune checkpoint resistant melanoma, MSS endometrial cancer, MSI-H, and TMB-H cancers [1] - The monotherapy expansion cohorts show an ORR of 42% and a disease control rate (DCR) of 83%, indicating the potential of MDNA11 in earlier lines of treatment [1] - Combination treatment with KEYTRUDA shows promising results, with an ORR of 50% and a DCR of 75% in MSS endometrial cancer [1][9] Clinical Data - In monotherapy expansion cohorts, ORRs are 38% in melanoma and 22% in MSI-H tumors, with corresponding DCRs of 75% and 78% respectively [1] - Patients treated with MDNA11 as the next treatment after immune checkpoint inhibitors had an ORR of 42% [8] - In MSS endometrial cancers, the ORR was 50% with a DCR of 75%, while TMB-H tumors showed an ORR of 25% and a DCR of 88% [9] Safety Profile - MDNA11 exhibits a manageable safety profile, with over 90% of treatment-related adverse events being Grade 1-2 and transient [4] - No dose-limiting toxicities were observed at doses up to 120 µg/kg, and Grade 3-4 events were mainly laboratory abnormalities without clinical sequelae [4] Overall Survival - In monotherapy cohorts, patients with disease control had a median overall survival (mOS) of 120.2 weeks compared to 28.6 weeks for those without disease control [7] - In combination cohorts, patients with disease control had a median OS that was not yet reached, compared to 26 weeks for those without disease control [10] Future Developments - Medicenna plans to share new and mature data from the ABILITY-1 study and additional studies in the coming weeks and months [3] - The NEO-CYT trial provides external validation of MDNA11's approach, suggesting its potential as a de-risked drug candidate for earlier stage cancer patients [3]

Core Insights - Immutep Limited is set to present new data from the AIPAC-003 trial at the 2025 San Antonio Breast Cancer Symposium, highlighting its late-stage immunotherapy targeting cancer and autoimmune diseases [1] Study Overview - The Phase II AIPAC-003 trial involved 66 female participants with HR+ and HER2-negative/HER2-low metastatic breast cancer resistant to endocrine therapy or metastatic triple-negative breast cancer not eligible for PD-(L)1 therapy [2] - Participants were randomized to receive either 30 mg or 90 mg of eftilagimod alfa in combination with paclitaxel to determine the optimal biological dose [2] Efficacy Results - The study reported strong objective response rates (ORR) of 41.9% for the 30 mg dose and 48.5% for the 90 mg dose, with disease control rates (DCR) of 87.1% and 78.8%, respectively [3] - Time to onset of response was similar at 2.0 months for the 30 mg dose and 1.9 months for the 90 mg dose [3] Pharmacodynamic Response - Both dosing levels showed significant increases in immune activation biomarkers, including absolute-lymphocyte count and interferon-gamma, aligning with the mechanism of action of eftilagimod alfa [4] Clinical Implications - The study's findings support the selection of 30 mg as the optimal biological dose, which is crucial for meeting FDA's Project Optimus requirements and advancing Immutep's oncology pipeline [6] - The ongoing Phase III TACTI-004 trial will evaluate eftilagimod alfa in combination with KEYTRUDA and chemotherapy for advanced or metastatic non-small cell lung cancer [6] Presentation Details - The presentation at SABCS 2025 will be led by Dr. Nuhad Ibrahim and will focus on the optimal biological dose of eftilagimod alfa in metastatic breast cancer patients [7][8]