IO Biotech completes enrollment in its Phase 2 cancer vaccine trial, with initial data expected in 2025.
Quiver AI Summary
IO Biotech has successfully completed enrollment ahead of schedule for its Phase 2 clinical trial (IOB-032/PN-E40) studying the immune-modulatory cancer vaccine IO102-IO103 in combination with Merck's KEYTRUDA® in patients with resectable melanoma and squamous cell carcinoma of the head and neck. The trial, which involved 93 patients across multiple sites in the US, Europe, and Australia, aims to evaluate the treatment's anti-tumor activity and safety. Initial data is anticipated in 2025, with the study exploring the effectiveness of this therapy approach both before and after surgery. The company's leadership emphasized the potential impact of this research on treatment paradigms for difficult-to-treat cancers, while highlighting the encouraging past results of IO102-IO103 in various cancer indications.
Potential Positives
- Completion of enrollment in the Phase 2 trial ahead of schedule indicates strong interest and momentum for IO Biotech's investigational cancer vaccine.
- Initial data from the Phase 2 trial and data from the Phase 3 trial in advanced melanoma are expected in 2025, which could significantly advance the company's research and development efforts.
- Positive early clinical data may strengthen the company’s positioning in the immune-oncology market, particularly with its novel off-the-shelf therapeutic cancer vaccine, IO102-IO103.
- The strong enrollment across multiple international sites underscores the critical need for effective treatment options for patients with resectable melanoma and squamous cell carcinoma, potentially enhancing the company's reputation and collaboration opportunities within the oncology community.
Potential Negatives
- Dependence on timing for initial data: The press release indicates that initial data from the Phase 2 trial is not expected until 2025, which may raise concerns among investors about the company's near-term prospects and operational timelines.
- Risks associated with forward-looking statements: The inclusion of extensive caution regarding the uncertainties and unpredictability of clinical trial outcomes could signal potential volatility in the company's future performance, which might discourage investors or stakeholders.
- Potential market competition: As the press release discusses partnerships with Merck and the development of their cancer vaccine, it highlights the need for effective treatment options, implying existing competitive pressures from other companies in the same therapeutic area.
FAQ
What is the IOB-032/PN-E40 trial studying?
The IOB-032/PN-E40 trial is studying the IO102-IO103 cancer vaccine in combination with Merck's KEYTRUDA® for treating certain solid tumors.
When is initial data from the trial expected?
Initial data from the IOB-032/PN-E40 trial is expected to be available in 2025.
How many patients were enrolled in the trial?
A total of 93 patients were enrolled in the multicenter IOB-032/PN-E40 trial across various locations.
What are the primary endpoints of the study?
The primary endpoint of the study is the major pathological response (MPR) after treatment.
What stage are IO Biotech's clinical trials in?
IO Biotech's clinical trials, including the IOB-032/PN-E40, have completed enrollment.
Disclaimer: This is an AI-generated summary of a press release distributed by GlobeNewswire. The model used to summarize this release may make mistakes. See the full release here.
$IOBT Insider Trading Activity
$IOBT insiders have traded $IOBT stock on the open market 6 times in the past 6 months. Of those trades, 4 have been purchases and 2 have been sales.
Here’s a breakdown of recent trading of $IOBT stock by insiders over the last 6 months:
- MAI-BRITT ZOCCA (Chief Executive Officer) purchased 12,500 shares.
- AMY SULLIVAN (Chief Financial Officer) purchased 10,250 shares.
- DEVIN WHITTEMORE SMITH (General Counsel) purchased 12,000 shares.
- QASIM IFTIKHAR AHMAD (Chief Medical Officer) purchased 31,350 shares.
- HOLDINGS A/S NOVO has traded it 2 times. They made 0 purchases and 2 sales, selling 75,000 shares.
To track insider transactions, check out Quiver Quantitative's insider trading dashboard.
$IOBT Hedge Fund Activity
We have seen 8 institutional investors add shares of $IOBT stock to their portfolio, and 7 decrease their positions in their most recent quarter.
Here are some of the largest recent moves:
- ARMISTICE CAPITAL, LLC removed 1,545,000 shares (-100.0%) from their portfolio in Q3 2024
- NOVO HOLDINGS A/S removed 1,075,000 shares (-24.3%) from their portfolio in Q3 2024
- FMR LLC removed 314,600 shares (-100.0%) from their portfolio in Q3 2024
- MORGAN STANLEY added 229,742 shares (+11.6%) to their portfolio in Q3 2024
- UBS GROUP AG added 104,626 shares (+3189.8%) to their portfolio in Q3 2024
- CITADEL ADVISORS LLC removed 86,894 shares (-100.0%) from their portfolio in Q3 2024
- RENAISSANCE TECHNOLOGIES LLC removed 83,800 shares (-46.3%) from their portfolio in Q3 2024
To track hedge funds' stock portfolios, check out Quiver Quantitative's institutional holdings dashboard.
Full Release
-- Enrollment Completed Ahead of Schedule --
-- Initial Data Expected in 2025 --
NEW YORK, Jan. 09, 2025 (GLOBE NEWSWIRE) -- IO Biotech (Nasdaq: IOBT), a clinical-stage biopharmaceutical company developing novel, immune-modulatory, off-the-shelf therapeutic cancer vaccines, completed enrollment in its neoadjuvant/adjuvant Phase 2 basket trial (IOB-032/PN-E40). The trial is studying IO102-IO103, the company’s lead investigational therapeutic cancer vaccine candidate, in combination with Merck’s (known as MSD outside of the US and Canada) anti-PD-1 therapy, KEYTRUDA
®
(pembrolizumab), given before (neoadjuvant) and after (adjuvant) surgery with curative intent in patients with resectable melanoma or squamous cell carcinoma of the head and neck (SCCHN).
“We are pleased to have completed enrollment early in this study, as it signifies an important step in exploring the potential of our investigational therapeutic cancer vaccine, IO102-IO103, across a range of solid tumors at an earlier stage of disease progression,” said Mai-Britt Zocca, PhD, President and CEO of IO Biotech. “Our off-the-shelf cancer vaccine is designed to be a readily available option for patients and has demonstrated encouraging clinical activity without significant systemic toxicity across three first line advanced cancer indications – melanoma, lung cancer and head and neck cancer. With data from our Phase 3 trial in patients with advanced melanoma expected in the first half of 2025 and initial data from this Phase 2 basket trial also expected in 2025, we hope to add to the accumulating evidence of potential benefit of this combination therapy across a range of difficult-to-treat cancers.”
IOB-032/PN-E40, a multicenter, multi-cohort clinical trial, has enrolled 93 patients at sites in the United States, Europe, and Australia to evaluate anti-tumor activity, safety, and biomarker data of IO102-IO103 in combination with pembrolizumab as neoadjuvant and adjuvant treatment in patients with resectable tumors. The primary endpoint is major pathologic response (MPR), which refers to reduction in viable tumor cells after treatment, defined as pCR (0% residual viable tumor) or near pCR (≤10% residual viable tumor) in the resected tumor tissue after neoadjuvant treatment (by central assessment). Secondary endpoints include pathological complete response (pCR), ORR, disease-free survival (DFS), event-free survival (EFS), and safety.
Qasim Ahmad, MD, Chief Medical Officer of IO Biotech, added, “The importance of systemic immunotherapy in the perioperative setting and its potential to change early treatment paradigms for a variety of cancers cannot be understated. This approach is being recognized as a critical opportunity to improve outcomes for patients by reducing the risk of recurrence and improving long-term survival. The interest we received from physicians and the rapid enrollment rate for this trial signifies the need for effective treatment options for patients with resectable melanoma and SCCHN. We are grateful to patients, families and investigators for their participation in this trial and for advancing the body of research for the oncology community.”
About IOB-032/PN-E40 Phase 2 Solid Tumor Basket Trial
IOB-032/PN-E40 (NCT05280314) is a multicenter Phase 2 basket trial investigating the IO102-IO103 immuno-modulatory therapeutic cancer vaccine in combination with Merck’s anti-PD-1 therapy, KEYTRUDA
®
(pembrolizumab) as neo-adjuvant/adjuvant treatment of patients with solid tumors at sites in Australia, the United States, France, Germany, Spain, and Denmark. The study completed enrollment in all cohorts: 18 patients with melanoma in cohort A and 16 patients with SCCHN in cohort B, both as single arm cohorts receiving combination of IO102-IO103 with pembrolizumab. In cohort C, 59 melanoma patients were randomized 1:1 to either the combination of IO102-IO103 with pembrolizumab or pembrolizumab alone, with some patients still in screening, who, if they pass the entry criteria, will be allowed to join the study. In the neo-adjuvant period, for all cohorts, treatment is every 3 weeks (Q3W) for 3 cycles (melanoma) or 2-3 cycles (SCCHN). Patients entering the study will be scheduled for surgery and begin neoadjuvant treatment 4-9 weeks prior. Surgery will be followed by adjuvant treatment with the same regimen for 15 cycles. Cohort C patients with poor pathological response to pembrolizumab alone in the neo-adjuvant phase (>10% residual viable tumor) may cross over to combination treatment post-surgery. The primary endpoint is major pathological response at surgery (≤10% residual viable tumor; central assessment). IO Biotech is sponsoring the Phase 2 trial and Merck is supplying pembrolizumab.
About IO102-IO103
IO102-IO103 is an investigational, immune-modulatory, 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 (IDO1) positive and/or programmed death-ligand 1 (PD-L1) positive cells. The company is currently conducting a pivotal Phase 3 trial (IOB-013/KN-D18; NCT05155254) investigating IO102-IO103 in combination with Merck’s anti-PD-1 therapy, KEYTRUDA
®
(pembrolizumab) versus pembrolizumab alone in patients with advanced melanoma, a Phase 2 basket trial (IOB-022/KN-D38; NCT05077709) investigating IO102-IO103 in combination with pembrolizumab as first line treatment in patients with advanced solid tumors, and a Phase 2 basket trial (IOB-032/PN-E40; NCT05280314) investigating IO102-IO103 in combination with pembrolizumab as neo-adjuvant/adjuvant treatment of patients with solid tumors. Enrollment in the three ongoing company-sponsored clinical trials is now complete.
The clinical trials are sponsored by IO Biotech and conducted in collaboration with Merck, which is supplying pembrolizumab. IO Biotech maintains global commercial rights to IO102-IO103.
KEYTRUDA
®
is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.
About IO Biotech
IO Biotech is a clinical-stage biopharmaceutical company developing novel, immune-modulatory therapeutic cancer vaccines based on its T-win
®
platform. The T-win platform is based on a novel approach to cancer vaccines designed to activate and expand T cells to target both tumor cells and the immune-suppressive cells in the tumor microenvironment. IO Biotech is advancing its lead cancer vaccine candidate, IO102-IO103, in clinical trials, and additional pipeline candidates through preclinical development. Based on positive Phase 1/2 first line metastatic melanoma data, IO102-IO103, in combination with Merck’s anti-PD-1 therapy, KEYTRUDA
®
(pembrolizumab), has been granted a Breakthrough Therapy Designation for the treatment of advanced melanoma by the US Food and Drug Administration. IO Biotech is headquartered in Copenhagen, Denmark and has US headquarters in New York, New York.
For further information, please visit
www.iobiotech.com
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and X (
@IOBiotech
).
Forward-Looking Statement
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements, including regarding the timing or outcome of initial data from the IOB-032/PN-E40 study, the primary analysis of the company’s Phase 3 trial, other current or future clinical trials, their progress, enrollment or results, or the company’s financial position or cash runway, are based on IO Biotech’s current assumptions and expectations of future events and trends, which affect or may affect its business, strategy, operations or financial performance, and actual results and other events may differ materially from those expressed or implied in such statements due to numerous risks and uncertainties. Forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified. Because forward-looking statements are inherently subject to risks and uncertainties, you should not rely on these forward-looking statements as predictions of future events. These forward-looking statements speak only as of the date hereof and should not be unduly relied upon. Except to the extent required by law, IO Biotech undertakes no obligation to update these statements, whether as a result of any new information, future developments or otherwise.
Contact:
Investors
Maryann Cimino, Director of Investor Relations
IO Biotech, Inc.
617-710-7305
mci@iobiotech.com
Media
Julie Funesti
Salutem
917-498-1967
Julie.Funesti@salutemcomms.com
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