Preparations for submission of a Biologics License Application (BLA) for Cylembi o ® (imsapepimut and etimupepimut, adjuvanted) to FDA by year end 2025 remain on track. The trial completed enrollment in December 2023 ahead of plan with 407 patients.
• Findings support the development of a novel peptide vaccine targeting the immunosuppressive effects of Transforming Growth Beta (TGF- β ) in solid tumors NEW YORK, Feb. 23, 2025 (GLOBE NEWSWIRE) -- IO Biotech (Nasdaq: IOBT), a clinical-stage biopharmaceutical company developing novel, immune-modulatory, off-the-shelf therapeutic cancer vaccines, today announced details of its poster presentation at the American Association for Cancer Research (AACR)-IO conference taking place February 23-26, 2025, in Los Angeles, California. Poster Presentation Details Title: A TGF-β-directed peptide vaccine induces T cell activation & drives anti-tumor activity by modulating the architecture of the tumor microenvironment Poster number: B117 Presenter: Matteo Bocci, PhD, Senior Scientist Date and time: Tuesday, February 25, 2025, 1:45-4:00 PM PST Location: JW Marriott Los Angeles, Platinum Ballroom A-E Transforming Growth Factor Beta (TGF-β) is a key immune-suppressive factor in the tumor microenvironment (TME) of most solid tumors, often limiting the efficacy of various immune-oncology therapies.
COPENHAGEN, Denmark and NEW YORK, Dec. 20, 2024 (GLOBE NEWSWIRE) -- IO Biotech (Nasdaq: IOBT), a clinical-stage biopharmaceutical company developing novel, immune-modulating, off-the-shelf therapeutic cancer vaccines today announced that it has entered into a loan facility of up to €57.5 million from the European Investment Bank (EIB), the long-term lending institution of the European Union owned by its Member States. The debt facility includes three committed tranches totaling up to €37.5 million, which will become available if the company satisfies certain conditions, and one uncommitted accordion tranche of €20 million. The company expects the first two tranches to be available for disbursement in the first quarter of 2025.
Pivotal Phase 3 trial (IOB-013/KN-D18) evaluating off-the-shelf therapeutic cancer vaccine IO102-IO103 in combination with Merck's anti-PD-1 therapy KEYTRUDA® (pembrolizumab) in patients with advanced melanoma on track with primary endpoint of progression free survival (PFS) projected to be reached in first half of 2025 Primary endpoint met in Phase 2 basket trial (IOB-022/KN-D38) cohort evaluating IO102-IO103 in combination with pembrolizumab in the first-line treatment of advanced squamous cell carcinoma of the head and neck (SCCHN) Enrollment in Phase 2 basket trial (IOB-032/PN-E40) evaluating IO102-IO103 in combination with pembrolizumab as neoadjuvant and adjuvant treatment of patients with resectable melanoma or SCCHN is proceeding ahead of schedule Ended third quarter with approximately $80 million in cash and cash equivalents; the company continues to expect its cash position will support operations into the fourth quarter of 2025 NEW YORK, Nov. 12, 2024 (GLOBE NEWSWIRE) -- IO Biotech (Nasdaq: IOBT), a clinical-stage biopharmaceutical company developing novel, off-the-shelf, immune-modulating therapeutic cancer vaccines based on its T-win® platform, today reported financial results for the third quarter ended September 30, 2024. “We continue to add to the body of evidence that our novel investigational therapeutic cancer vaccine, IO102-IO103, has the potential to bring clinical benefit to patients with strong signals of activity now observed in patients with three types of metastatic solid tumors,” said Mai-Britt Zocca, PhD, President and CEO of IO Biotech.
NEW YORK, Nov. 11, 2024 (GLOBE NEWSWIRE) -- IO Biotech (Nasdaq: IOBT), a clinical-stage biopharmaceutical company developing novel, off-the-shelf, immune-modulating therapeutic cancer vaccines based on its T-win® platform, today announced that members of its senior management team will participate in the following upcoming investor conferences: Event: Jefferies London Healthcare ConferenceLocation: LondonOne-on-one meetings: Wednesday, November 20, 2024Participants: Mai-Britt Zocca, PhD, President and CEO and Amy Sullivan, CFO Event: Piper Sandler 36th Annual Healthcare ConferenceLocation: New York, New YorkFireside chat: Tuesday, December 3, 2024 at 11:00 am ETPresenter: Mai-Britt Zocca, PhD, President & CEOWebcast Link: https://event.webcasts.com/starthere.jsp?ei=1697959&tp_key=934ba9e309 A webcast replay of the Piper Sandler fireside chat will be available on IO Biotech's website at www.iobiotech.com for 90 days following the presentation. About IO102-IO103 IO102-IO103 is an investigational off-the-shelf therapeutic cancer vaccine designed to kill both tumor cells and immune-suppressive cells in the tumor microenvironment (TME) by stimulating activation and expansion of T cells against indoleamine 2,3-dioxygenase (IDO) positive and/or programmed death-ligand 1 (PD-L1) positive cells.
-- Study Meets Overall Response Rate Primary Endpoint, Encouraging Secondary Endpoint Progression-Free Survival Data in Squamous Cell Carcinoma of the Head and Neck Cohort -- -- No New Safety Signals or Added Systemic Safety Concerns Observed --
- Based on a per-protocol interim analysis of safety and efficacy data, the Independent Data Monitoring Committee (IDMC) recommended that the trial continue without modifications- No new safety signals observed at interim analysis- Primary endpoint of progression free survival projected to be reached in the first half of 2025
NEW YORK, Aug. 26, 2024 (GLOBE NEWSWIRE) -- IO Biotech (Nasdaq: IOBT), a clinical-stage biopharmaceutical company developing novel, immune-modulating therapeutic cancer vaccines based on its T-win® platform, today announced that members of its senior management team will provide a corporate update and participate in one-on-one meetings at the following upcoming investor conferences: Event: Morgan Stanley 22nd Annual Global Healthcare ConferenceLocation: New York, New YorkFireside Chat Date & Time: Wednesday, September 4, 2024 at 5:35 pm ETPresenter: Mai-Britt Zocca, PhD, CEOWebcast Link: Here Event: H.C. Wainwright 26th Annual Global Investment ConferenceLocation: New York, New YorkPresentation Time: Monday, September 9, 2024 at 10:30 am ETPresenter: Amy Sullivan, CFO Webcast Link: Here A webcast replay of the presentations will be available on IO Biotech's website at www.iobiotech.com for 90 days following the presentation.
Phase 3 interim analysis outcome still expected in Q3 2024 for the overall response rate (ORR) in the pivotal trial (IOB-013/KN-D18) of lead investigational therapeutic cancer vaccine, IO102-IO103, in combination with Merck's anti-PD-1 therapy KEYTRUDA® (pembrolizumab) in patients with advanced melanoma ; outcome of primary endpoint of progression free survival (PFS) expected in first half of 2025 Completed enrollment in Phase 2 basket trial IOB-022/KN-D38 evaluating IO102-IO103 in combination with pembrolizumab in patients with non-small cell lung cancer (NSCLC) and squamous cell carcinoma of the head and neck (SCCHN); data from SCCHN cohort has been accepted for poster presentation at the European Society for Medical Oncology (ESMO 2024) congress; abstract with data from NSCLC cohort has been submitted for poster presentation at an upcoming fall medical meeting Completed enrollment in first cohort (cohort A) of Phase 2 solid tumor basket trial (IOB-032/PN-E40) evaluating IO102-IO103 in combination with pembrolizumab as neoadjuvant and adjuvant treatment of patients with resectable solid tumors; initiated enrollment in randomized melanoma cohort Ended second quarter with approximately $100.7 million in cash and cash equivalents; the company confirms that cash position is expected to support operations into the fourth quarter of 2025 NEW YORK, Aug. 13, 2024 (GLOBE NEWSWIRE) -- IO Biotech (Nasdaq: IOBT), a clinical-stage biopharmaceutical company developing novel, immune-modulating therapeutic cancer vaccines based on its T-win® platform, today reported financial results for the second quarter ended June 30, 2024. “During the first half of this year, we've continued to execute on our mission of developing breakthrough cancer vaccines that could potentially change the treatment paradigm for people living with melanoma and other types of cancer,” said Mai-Britt Zocca, PhD, President and CEO of IO Biotech.
IO Biotech is an immunotherapy biotech in phase 3 trials. Past failures of IDO as a target cast a pall on their potential data readouts. Nevertheless, the cheap stock price and upcoming catalysts make this an interesting play.