Findings provide scientific insights into the contributions of IDO1 and PD-L1 vaccination to PD-1 blockade for the treatment of metastatic melanomaFive-year analysis of median progression free survival was 25.5 monthsThese results reinforce the potential of immune-modulatory vaccination NEW YORK, Dec. 15, 2025 (GLOBE NEWSWIRE) -- IO Biotech (Nasdaq: IOBT), a clinical-stage biopharmaceutical company developing novel, immune-modulatory, off-the-shelf therapeutic cancer vaccines, today announced the publicatio ...

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]

Group 1: Reviva Pharmaceuticals Holdings Inc. (RVPH) - RVPH experienced a significant after-hours rally, increasing 18.27% to $0.58 after a 35.1% surge during regular trading, with a trading volume of over 40.5 million shares, nearly nine times its daily average [2][3] - The company has a market cap of $47 million and is focused on its lead candidate brilaroxazine, which targets neuropsychiatric and respiratory conditions [3] Group 2: Penumbra Inc. (PEN) - PEN surged 7.97% in after-hours trading to $273.69, following a 1.55% gain during the regular session, with a market cap nearing $9.9 billion [4][5] - The company has increased its revenue guidance for FY25 to a range of $1.355 billion - $1.370 billion, indicating a growth of 13% to 15% over 2024 [6] Group 3: Palisade Bio Inc. (PALI) - PALI jumped 10% in after-hours trading to $1.87, extending a 29.8% surge during the regular session, driven by a $138 million public offering [7][8] - The company has a market cap of $15.8 million and is gaining attention due to recent clinical updates and licensing agreements [8] Group 4: IO Biotech Inc. (IOBT) - IOBT rose 5.08% in after-hours trading to $0.4571, following a 22.3% surge during the regular session, with heavy trading volume of 16.7 million shares [9] - The company announced plans to design a new registrational study for its cancer vaccine candidate Cylembio after receiving regulatory feedback from the FDA [10] Group 5: Rallybio Corp. (RLYB) - RLYB increased 11.2% in after-hours trading to $0.5688, reversing a modest dip during the regular session, with a market cap of $21.4 million [11][12] - The company recently completed dosing in its Phase 1 study for RLYB116 and received a $12.5 million milestone payment for progress on the REV102 program [12] Group 6: Vor Biopharma Inc. (VOR) - VOR rose 3.6% in after-hours trading to $38.00, recovering from a 6.6% decline during the regular session, with a market cap of $251 million [13][14] - The company is focusing on its trem-cel platform and CD33-directed therapies for acute myeloid leukemia, alongside new executive appointments [14]

Company Performance - MoonLake Immunotherapeutics (NASDAQ:MLTX) experiences a drastic decrease in its stock price to $6.24, about 89.93% [1][6] - KALA BIO, Inc. (NASDAQ:KALA) sees its stock decline sharply to $2.13, translating to an 88.82% decrease [2][6] - IO Biotech, Inc. (NASDAQ:IOBT) experiences a 77.31% decrease in its stock price, falling to $0.35 [3][6] - Maris-Tech Ltd. (NASDAQ:MTEKW) sees its stock price decrease to $0.22, a 71.16% drop [4] Industry Insights - The recent market movements highlight the volatile nature of the stock market, where companies across various sectors can experience significant fluctuations [5] - Factors such as market sentiment, industry trends, and company-specific developments play crucial roles in influencing stock prices [5]

Core Viewpoint - IO Biotech's Cylembio (imsapepimut and etimupepimut) will not proceed with a Biologics License Application (BLA) based on the current clinical trial data, as recommended by the FDA, despite showing improved progression-free survival (PFS) in the IOB-013 trial [1][6] Regulatory Update - The FDA advised against submitting a BLA for Cylembio based on IOB-013 trial data, which narrowly missed statistical significance for PFS [1][6] - IO Biotech plans to engage in further discussions with the FDA to design a new registrational study for Cylembio [2][6] Clinical Trials - Cylembio is currently being evaluated in multiple clinical trials, including a pivotal Phase 3 trial (IOB-013/KN-D18) in combination with Merck's KEYTRUDA (pembrolizumab) for advanced melanoma [3][5] - The IOB-013 trial enrolled 407 patients across over 100 centers globally, with topline results reported in Q3 2025 [5][7] Financial and Operational Strategy - The company is implementing a restructuring plan to conserve capital, which includes a workforce reduction of approximately 50% and expects a non-recurring charge of $1.0 - $1.5 million in Q3 2025 [2][6] - IO Biotech has sufficient capital to sustain operations into Q1 2026 while pursuing regulatory approval for Cylembio [2] 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 [8]

Core Insights - IO Biotech is set to present significant findings from its clinical trials at the 2025 ESMO Congress in Berlin, focusing on its cancer vaccine candidates [1][2][5] Group 1: Clinical Trials and Presentations - The company will present results from a randomized Phase 3 trial of the IO102-IO103 cancer vaccine in combination with pembrolizumab for first-line advanced melanoma [2][5] - A poster session will feature final data from a Phase 2 basket trial assessing the same vaccine in combination with pembrolizumab for various advanced solid tumors [3][5] - The pivotal Phase 3 trial (IOB-013/KN-D18) enrolled 407 patients across over 100 centers globally, with the primary endpoint being progression-free survival [8] Group 2: Vaccine Development and Mechanism - Cylembio, the lead candidate, is designed to target both tumor cells and immune-suppressive cells in the tumor microenvironment by activating T cells against IDO1 and PD-L1 positive cells [4][10] - The company is conducting multiple trials, including a Phase 2 basket trial for non-small cell lung cancer (NSCLC) and squamous cell carcinoma of the head and neck (SCCHN) [9][10] Group 3: Company Overview - IO Biotech is a clinical-stage biopharmaceutical company headquartered in Copenhagen, Denmark, with a focus on developing immune-modulatory cancer vaccines [10]

Core Insights - IO Biotech announced topline results from the pivotal Phase 3 trial of its investigational cancer vaccine Cylembio, showing clinical improvement in progression-free survival (PFS) when combined with Merck's KEYTRUDA compared to KEYTRUDA alone [1][2][5] Study Results - The trial involved 407 patients with unresectable or metastatic melanoma, with 203 receiving Cylembio plus KEYTRUDA and 204 receiving KEYTRUDA alone [2][8] - The primary endpoint of PFS showed a hazard ratio of 0.77, with a median PFS of 19.4 months for the combination group versus 11.0 months for the control group [2][5] - A trend towards improved overall survival (OS) was observed, with a hazard ratio of 0.79, although OS data is not yet mature [2][5] Subgroup Analysis - Improvement in PFS was noted across nearly all subgroups, particularly in patients with PD-L1 negative tumors, achieving a median PFS of 16.6 months compared to 3.0 months for the control group [3][5] - In patients without prior anti-PD-1 treatment, the combination therapy resulted in a median PFS of 24.8 months versus 11.0 months for the control group [3][5] Safety and Tolerability - The combination therapy was well tolerated, with no new safety signals reported; the most common adverse events were transient injection site reactions, reported by 56% of patients in the combination arm [4][5] Future Plans - IO Biotech plans to engage with the FDA to discuss the data and potential regulatory submission for Cylembio [2][6][12] - The company will present more detailed results at an upcoming medical meeting [6][12]

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 - 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]