Media Release Entered into strategic collaboration with Dr. Reddy’s for commercialisation of eftilagimod alfa (efti) in all countries outside North America, Europe, Japan, and Greater ChinaIn January 2026, Immutep received ~A$30 million upfront payment from Dr. Reddy’s and is eligible to receive up to ~A$528 million in potential milestones, plus royalties on commercial sales of eftiStrong operational progress reported for TACTI-004 (KEYNOTE-F91) Phase III trial evaluating efti in first line non-small cell l ...

Data update from the ongoing Phase 1b/2 study of muzastotug + pembrolizumab in 3L+ MSS CRC patients remains on track for Q1 2026 Unaudited cash and cash equivalents of $74.5 million as of December 31, 2025 anticipated to provide sufficient runway into late 2027 SAN DIEGO and SUZHOU, China, Jan. 23, 2026 (GLOBE NEWSWIRE) -- Adagene Inc. (“Adagene”) (Nasdaq: ADAG), a company transforming the discovery and development of novel antibody-based therapies, today announced year-end unaudited cash and cash equivalen ...

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]

Core Insights - IO Biotech is focused on developing novel immune-modulatory, off-the-shelf cancer therapies targeting various tumors, including melanoma, lung, and head and neck cancers [2][15] - The IOB-013 study showed improvements in progression-free survival (PFS) but narrowly missed statistical significance on the primary endpoint, which the company believes has de-risked the program [2][5] - The company plans to discuss the next Phase 3 study design for Cylembio with the FDA in December 2025 [2][5] Recent Business Highlights - The company presented topline data from the Phase 3 clinical trial (IOB-013) at the ESMO congress, indicating clinically relevant improvements in PFS across various subgroups [5][6] - A meeting with the FDA is scheduled for December to align on the design of a potential new Phase 3 registrational trial for IO102-IO103 in advanced melanoma [5][6] - Pre-clinical data for additional candidates targeting arginase 1 and TGF-β were presented at the SITC Annual Meeting [5][6] Financial Results - For Q3 2025, total operating expenses were $19.4 million, down from $26.5 million in Q3 2024 [12][20] - Research and development expenses decreased to $13.7 million from $20.2 million year-over-year [12][20] - Cash and cash equivalents as of September 30, 2025, were approximately $31 million, expected to support operations through Q1 2026 [5][12] Clinical Trials Overview - The IOB-013/KN-D18 trial evaluated Cylembio in combination with Merck's KEYTRUDA in 407 patients with advanced melanoma, with enrollment completed by December 2023 [11][12] - The primary endpoint of the trial was progression-free survival, with secondary endpoints including overall response rate and safety [11][13] - The company is also conducting a Phase 2 basket trial (IOB-022/KN-D38) for advanced non-small cell lung cancer and head and neck cancer [14]

Core Insights - Immutep Limited announced positive results from the EFTISARC-NEO trial, demonstrating significant efficacy in treating resectable soft tissue sarcoma (STS) with a novel combination of eftilagimod alfa (efti), radiotherapy, and KEYTRUDA [1][2] Study Results - The Phase II study showed a median 51.5% tumor hyalinization/fibrosis in the evaluable patient population (N=38), significantly exceeding the prespecified pathologic response rates (p<0.001) [2] - The trial included patients with ten different STS subtypes, including aggressive tumors with poor prognosis such as myxofibrosarcoma (N=16) and undifferentiated pleomorphic sarcoma (N=10) [3] Immune Response - Early data indicated strong immune system activation, with significant increases in key cytokines and chemokines, including CXCL9 (2.5x, p<0.01), CXCL10 (1.8x, p<0.0001), IL-23 (2.2x, p<0.05), and IFN-γ (2.5x, p<0.05) [4][5] - The increase in immune response biomarkers correlated with pathologic responses, suggesting a higher probability of favorable clinical outcomes [5] Clinical Implications - The achieved tumor hyalinization/fibrosis rate is over three times greater than standard-of-care radiotherapy based on historical data, indicating potential for improved overall survival and recurrence-free survival in STS patients [6] - The findings support the hypothesis that efti's activation of antigen-presenting cells enhances both adaptive and innate immunity, which is crucial for effective cancer treatment [7][10] Future Directions - The results suggest that efti may have applications beyond advanced or metastatic cancer, potentially benefiting patients with localized and resectable tumors [10] - Ongoing translational studies aim to further explore the correlation between immune responses and clinical outcomes [6] Recognition - The EFTISARC-NEO trial received the Golden Scalpel Award in Poland, highlighting its innovation and impact in medical research and clinical practice [9][12] Company Overview - Immutep is a late-stage biotechnology company focused on developing novel immunotherapies for cancer and autoimmune diseases, leveraging its expertise in Lymphocyte Activation Gene-3 (LAG-3) [15]

Core Insights - Adagene Inc. has initiated a Phase 2 clinical trial for muzastotug in combination with KEYTRUDA for patients with microsatellite stable colorectal cancer, with the first patient dosed in October 2025 [1][2] - The trial aims to confirm the optimal dosing for a subsequent Phase 3 trial, with completion anticipated in early 2027 and potential updates expected in 2026 [1][2] Phase 2 Clinical Trial Details - The trial will randomize patients to receive either 10 mg/kg or 20 mg/kg of muzastotug, with up to 30 patients per arm [1][4] - The primary endpoint is overall response rate (ORR), while secondary endpoints include duration of response (DOR), progression-free survival (PFS), and overall survival (OS) [4] Phase 1b/2 Trial Findings - In the Phase 1b/2 trial, 67 patients were treated with muzastotug, showing an ORR of 17% for the 10 mg/kg cohort and 29% for the 20 mg/kg cohort [3][4] - The median duration of response for the 10 mg/kg cohort was 6.2 months, while the median overall survival for the 10 mg/kg cohort was 19.4 months [5] Safety Profile - Muzastotug has been safely dosed at 20 mg/kg with less than 20% Grade 3 adverse events and no discontinuations, indicating a favorable safety profile compared to first-generation anti-CTLA-4 therapies [2][5] Company Overview - Adagene Inc. is a clinical-stage biotechnology company focused on developing novel antibody-based cancer immunotherapies, utilizing computational biology and artificial intelligence [7][8] - The company's lead program, ADG126 (muzastotug), targets regulatory T cells in the tumor microenvironment and is part of a broader pipeline leveraging its SAFEbody technology [9]