Core Insights - Pyxis Oncology is making significant progress in its Phase 1 clinical trials for micvotabart pelidotin (MICVO), targeting recurrent and metastatic head and neck squamous cell carcinoma (R/M HNSCC) with preliminary data expected in the second half of 2025 and first half of 2026 [1][6] - The company has a cash runway that is expected to last through data milestones and into the second half of 2026, with cash and cash equivalents totaling $90.4 million as of June 30, 2025 [1][6] Pipeline Updates - The Phase 1/2 combination study of MICVO and KEYTRUDA® (pembrolizumab) is progressing well, with preliminary data anticipated in the second half of 2025 [5][6] - Preliminary data from the Part 2 monotherapy expansion cohorts of the ongoing Phase 1 clinical trial for R/M HNSCC patients is expected in the second half of 2025, with additional data from patients who have received prior EGFRi and PD-1 inhibitor therapy anticipated in the first half of 2026 [6] Financial Results - For the quarter ended June 30, 2025, Pyxis Oncology reported revenues of $2.8 million, a significant increase from $0 in the same quarter of 2024, primarily due to milestone revenue from the approval of suvemcitug in China [6][10] - Research and development expenses increased to $17.1 million for the quarter ended June 30, 2025, compared to $14.0 million for the same period in 2024, driven by increased manufacturing and clinical trial-related expenses [10] - The net loss for the quarter was $18.4 million, or ($0.30) per common share, compared to a net loss of $17.3 million, or ($0.29) per common share, for the same quarter in 2024 [10][12]

SAFEbody option exercised and up to US$25 million strategic investment by Sanofi, with cash runway extended into 2027 Sanofi will conduct a Phase 1b/2 trial in combination with ADG126 in over 100 patients Strengthened leadership team with key additions Partnered with ConjugateBio for development of bispecific ADCs Muzastotug (ADG126) Phase 1b/2 in MSS CRC shows 19.4-month median OS (mOS) in 10 mg/kg dose cohorts; mOS for 20 mg/kg cohorts has not yet been reached Alignment with FDA on Phase 2 and Phase 3 tri ...

NEW YORK, Aug. 11, 2025 (GLOBE NEWSWIRE) -- IO Biotech (Nasdaq: IOBT) today announces topline results from the pivotal Phase 3 trial of its investigational, immune-modulatory, off-the-shelf therapeutic cancer vaccine, Cylembio (imsapepimut and etimupepimut, adjuvanted). The trial evaluated Cylembio in combination with Merck's anti-PD-1 therapy, KEYTRUDA (pembrolizumab), vs. pembrolizumab alone as a first-line treatment in 407 patients with unresectable or metastatic (advanced) melanoma. In the study, Cylemb ...

Core Insights - IO Biotech will hold a conference call and webcast on August 11, 2025, to disclose topline results from the pivotal Phase 3 trial of its cancer vaccine Cylembio [1][2] - Cylembio is being tested in combination with pembrolizumab for the treatment of unresectable or metastatic melanoma [1][3] - The company is advancing its lead candidate Cylembio and has received Breakthrough Therapy Designation from the FDA for another candidate in combination with KEYTRUDA [3] Company Overview - IO Biotech is a clinical-stage biopharmaceutical company focused on developing immune-modulatory, off-the-shelf therapeutic cancer vaccines using its T-win® platform [3] - The T-win platform aims to activate T cells to target tumor cells and immune-suppressive cells in the tumor microenvironment [3] - The company is headquartered in Copenhagen, Denmark, with a US office in New York [3]

Core Insights - Cue Biopharma, Inc. has reported promising results from its Phase 1 trial of CUE-101, showing an overall response rate (ORR) of 50% in treatment-naïve patients with recurrent metastatic HPV+ head and neck squamous cell carcinoma (HNSCC) [3] - The 12-month overall survival (OS) rate is 88%, indicating a significant reduction in the risk of death compared to historical data [3] - The median overall survival (mOS) is currently estimated at 32 months [3] Company Overview - Cue Biopharma is a clinical-stage biopharmaceutical company focused on developing a novel class of therapeutic biologics aimed at selectively engaging and modulating disease-specific T cells for treating autoimmune diseases and cancer [2][7] - The company's proprietary platform, Immuno-STAT™, is designed to harness the body's immune system without the adverse effects associated with broad systemic immune modulation [7] Product Details - CUE-101 is the most advanced clinical stage drug candidate from the CUE-100 series, designed to activate and expand HPV16 tumor-specific T cells [6] - The mechanism of action involves presenting two signals to T cells: one from the HPV E7 protein and another from an engineered IL-2 variant [6] - The CUE-100 series consists of Fc-fusion biologics that selectively target and activate tumor-specific T cells while minimizing systemic activation and potential toxicities [5] Clinical Trial Insights - The Phase 1 trial of CUE-101 is fully enrolled and evaluates the drug as a monotherapy and in combination with pembrolizumab (KEYTRUDA) for HPV16+ driven recurrent/metastatic HNSCC [6] - The trial results indicate that CUE-101 may represent a breakthrough therapeutic approach for patients battling HNSCC, as stated by the company's chief medical officer [4]

Core Insights - Adagene Inc. announced updated data from its Phase 1b/2 study of ADG126 in advanced microsatellite stable colorectal cancer (MSS CRC) with promising efficacy and safety results [1][2][3] Efficacy - ADG126 in combination with pembrolizumab achieved a 29% confirmed overall response rate (ORR) in the 20 mg/kg cohorts, while the 10 mg/kg cohorts had an ORR of 17% [1][3] - The median overall survival (OS) for the 10 mg/kg cohorts was reported at 19.4 months, with the median OS for the 20 mg/kg cohorts not yet reached [3][4] - All six responders in the 20 mg/kg cohorts remain on treatment, with four patients on study for over forty weeks [1] Safety - The 20 mg/kg Q6W dosing regimen demonstrated fewer than 20% Grade 3 adverse events, with no treatment discontinuations [2][4] - The study indicated a significant reduction in treatment-related toxicities while maintaining a near 30% ORR [2] Study Design - A total of 67 MSS CRC patients with no liver metastases were treated with ADG126 at either 10 mg/kg or 20 mg/kg, in combination with pembrolizumab [2] - The dosing regimens included a loading dose of 20 mg/kg followed by either 10 mg/kg every three weeks or 20 mg/kg every six weeks [2] Future Plans - As data continue to mature, the company plans to discuss the dosing regimen with regulatory bodies for the next phase of clinical development [4]

Core Insights - IO Biotech is a clinical-stage biopharmaceutical company focused on developing immune-modulatory, off-the-shelf therapeutic cancer vaccines [5] - The company will participate in the TD Cowen 6th Annual Oncology Summit and the Jefferies Global Healthcare Conference, showcasing its leadership and ongoing clinical trials [1][2] Company Overview - IO Biotech is headquartered in Copenhagen, Denmark, with a US office in New York, New York [5] - The company is advancing its lead cancer vaccine candidate, Cylembio, through various clinical trials, including a pivotal Phase 3 trial in combination with Merck's KEYTRUDA [3][5] - Cylembio is designed to target both tumor cells and immune-suppressive cells in the tumor microenvironment [3] Clinical Trials - IO Biotech is conducting three ongoing clinical trials for Cylembio, with enrollment now complete [3] - The pivotal Phase 3 trial (IOB-013/KN-D18) is investigating Cylembio in combination with KEYTRUDA for patients with advanced melanoma [3] - Additional Phase 2 trials are exploring Cylembio's efficacy in various treatment settings for advanced solid tumors [3] Collaborations - The clinical trials are sponsored by IO Biotech in collaboration with Merck, which supplies KEYTRUDA [4] - IO Biotech retains global commercial rights to Cylembio, indicating a strong position in the market [4]

Core Insights - IO Biotech is advancing its pipeline of immune-modulatory cancer vaccines, with a pivotal Phase 3 trial expected to read out in Q3 2025 [1][5][6] - The company aims to submit a Biologics License Application (BLA) for its lead candidate, Cylembio, in 2025, with a potential launch in the US in 2026 [2][6] - IO Biotech was recognized as one of the most innovative biotechnology companies by Fast Company, ranking 9th in the biotechnology category [5][6] Financial Performance - For Q1 2025, the company reported a net loss of $22.4 million, compared to a net loss of $19.5 million in Q1 2024 [13] - Research and development expenses increased to $16.4 million in Q1 2025 from $14.3 million in Q1 2024 [13] - Cash and cash equivalents decreased to $37.1 million as of March 31, 2025, down from $60.0 million at the end of 2024 [13] Clinical Trials and Developments - The pivotal Phase 3 trial (IOB-013/KN-D18) is evaluating Cylembio in combination with Merck's KEYTRUDA for advanced melanoma, with 407 patients enrolled [11] - Initial data from the perioperative Phase 2 trial (IOB-032/PN-E40) is expected in the second half of 2025 [6][13] - The company completed enrollment in its ongoing clinical trials, which include studies for various solid tumors [9][14][15] Upcoming Events - IO Biotech will participate in TD Cowen's 6th Annual Oncology Innovation Summit on May 27, 2025, and the Jefferies Global Healthcare Conference on June 4, 2025 [5][6]

Core Insights - Medicenna Therapeutics Corp. presented updated clinical data for MDNA11, a long-acting IL-2 super-agonist, at the 2025 AACR Annual Meeting, highlighting its potential in treating advanced solid tumors, particularly in patients resistant to immune checkpoint inhibitors [1][2][10] Clinical Activity - Ten patients achieved an objective response (5 confirmed) with MDNA11 alone or in combination with KEYTRUDA, showing an objective response rate (ORR) of 36% (5 of 14) in all tumor types and 31% (4 of 13) in cancers planned for the Phase 2 combination expansion cohort [1][5] - In the monotherapy dose expansion, patients treated at ≥ 60 µg/kg had an ORR of 29.4% (5 of 17) across all tumor types and 40% (4 of 10) in the Phase 2 monotherapy expansion cohort [1][7] - The highest ORR of 50% was observed among MSI-H patients receiving MDNA11 monotherapy and endometrial cancer patients receiving the combination treatment [1][6] Safety Profile - MDNA11 demonstrated an acceptable safety profile, with over 90% of treatment-related adverse events being Grade 1-2 and transient, and no dose-limiting toxicities observed at doses up to 120 µg/kg [3][5] Immunodynamics - The study showed robust expansion of immune effector cells in both monotherapy and combination settings, with notable increases in critical T cell populations necessary for sustained anti-tumor responses [6][9] Future Directions - Enrollment in the Phase 2 combination dose expansion arm is ongoing, with the recommended dose for expansion established at 90 µg/kg every 2 weeks alongside KEYTRUDA [1][10] - Additional clinical data from the ABILITY-1 study is expected to be shared at future medical conferences throughout the year [2][8]