IO Biotech published preclinical results for its cancer vaccine IO112 and plans to submit an IND to the FDA in 2025.
Quiver AI Summary
IO Biotech has announced the publication of preclinical study results for its immune-modulatory therapeutic cancer vaccine candidate, IO112, which targets arginase 1 (Arg1), in the Journal for ImmunoTherapy of Cancer. The study shows that IO112 treatment enhances anti-tumor immunity by expanding Arg1-specific T cells and reprogramming tumor-associated macrophages (TAMs), addressing the challenge posed by TAMs in creating an immunosuppressive tumor microenvironment. The company plans to submit an Investigational New Drug Application (IND) for IO112 to the US FDA in 2025 as part of its ongoing commitment to develop innovative cancer treatments. IO112 is designed to activate T cells against Arg1, an enzyme linked to immune suppression in various hard-to-treat cancers.
Potential Positives
- Publication of preclinical study results in a reputable journal enhances the credibility and visibility of IO112 and highlights the company's innovative approach to cancer treatment.
- Demonstration of how IO112 impacts tumor-associated macrophages could provide a competitive edge in cancer immunotherapy by addressing immunosuppressive mechanisms.
- Drug candidate IO112 is set for an Investigational New Drug Application submission to the FDA in 2025, indicating the company's progress toward clinical development and potential market entry.
- Supportive data from the study reinforces IO Biotech's T-win® platform's potential to transform cancer treatment paradigms, which could attract investor interest and partnerships.
Potential Negatives
- The expectation to submit the IND for IO112 in 2025 indicates a delayed timeline for clinical development, which may raise concerns about the pace of the company's progress compared to competitors.
- The press release's emphasis on future regulatory submissions and clinical trials suggests ongoing risks and uncertainties, possibly indicating challenges within the development pipeline.
- The reliance on forward-looking statements may foster skepticism among investors regarding the company's ability to deliver on its commitments and achieve projected milestones.
FAQ
What is the main focus of IO Biotech's research?
IO Biotech focuses on developing immune-modulatory, therapeutic cancer vaccines targeting specific immune pathways to enhance anti-tumor immunity.
When is IO Biotech planning to submit its IND application?
IO Biotech expects to submit its Investigational New Drug (IND) application for IO112 to the US FDA in 2025.
What role does Arginase 1 (Arg1) play in cancer?
Arginase 1 is an immunoregulatory enzyme that contributes to immune suppression in the tumor microenvironment and is overexpressed in several cancers.
What is the T-win® platform developed by IO Biotech?
The T-win® platform is designed to activate T cells to target both tumor cells and immune-suppressive cells within the tumor microenvironment.
What are the potential benefits of the IO112 vaccine candidate?
IO112 aims to enhance anti-tumor immunity by targeting Arg1-specific T cells, potentially transforming treatment for various hard-to-treat cancers.
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 4 times in the past 6 months. Of those trades, 4 have been purchases and 0 have been sales.
Here’s a breakdown of recent trading of $IOBT stock by insiders over the last 6 months:
- QASIM IFTIKHAR AHMAD (Chief Medical Officer) purchased 31,350 shares for an estimated $26,553
- MAI-BRITT ZOCCA (Chief Executive Officer) purchased 12,500 shares for an estimated $10,120
- DEVIN WHITTEMORE SMITH (General Counsel) purchased 12,000 shares for an estimated $9,720
- AMY SULLIVAN (Chief Financial Officer) purchased 10,250 shares for an estimated $8,482
To track insider transactions, check out Quiver Quantitative's insider trading dashboard.
$IOBT Hedge Fund Activity
We have seen 9 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, for an estimated $1,622,250
- NOVO HOLDINGS A/S removed 1,075,000 shares (-24.3%) from their portfolio in Q3 2024, for an estimated $1,128,750
- FMR LLC removed 314,600 shares (-100.0%) from their portfolio in Q3 2024, for an estimated $330,330
- MORGAN STANLEY added 229,742 shares (+11.6%) to their portfolio in Q3 2024, for an estimated $241,229
- UBS GROUP AG added 104,626 shares (+3189.8%) to their portfolio in Q3 2024, for an estimated $109,857
- CITADEL ADVISORS LLC removed 86,894 shares (-100.0%) from their portfolio in Q3 2024, for an estimated $91,238
- RENAISSANCE TECHNOLOGIES LLC removed 83,800 shares (-46.3%) from their portfolio in Q3 2024, for an estimated $87,990
To track hedge funds' stock portfolios, check out Quiver Quantitative's institutional holdings dashboard.
Full Release
– Submission of Investigational New Drug Application (IND) to US FDA expected in 2025 –
NEW YORK, Feb. 04, 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 publication of results from a preclinical study of its second immune-modulatory therapeutic cancer vaccine candidate, IO112, targeting arginase 1 (Arg1), in the Journal for ImmunoTherapy of Cancer .
These preclinical data further expand upon previously reported data that IO112 treatment inhibits tumor growth through dynamic changes in the tumor microenvironment (TME). The present study showed how Arg1-specific T cells expanded by the vaccine enhance anti-tumor immunity by reprogramming tumor-associated macrophages (TAMs) and promote a proinflammatory TME. Arg1 plays a central role in immune suppression, and its overexpression has been reported in several cancers.
“Arg1-expressing TAMs remain a major hurdle in cancer immunotherapy due to their role in creating an immunosuppressive TME,” said Ayako Wakatsuki Pedersen, PhD, Senior Vice President of Translational Research at IO Biotech. “TAMs represent one of the most abundant immune cell subsets found within the TME and it’s really exciting to learn that IO112 treatment directly impacts TAMs, changing the phenotype of TAMs completely. These findings further support the continued clinical development of Arg1-based immune-modulatory vaccines.”
“These data published in the Journal of ImmunoTherapy of Cancer add to the strong body of evidence that the unique approach of our T-win ® platform, designed to kill both tumor cells and immune-suppressive cells in the TME, could potentially change the treatment paradigm in the management of a number of cancers,” said Mai-Britt Zocca, Ph.D., President and CEO of IO Biotech. “We look forward to submitting an IND for IO112 in 2025 and advancing into clinical development as part of our commitment to transform the treatment of cancer patients.”
About IO112
IO112 is the company’s fully-owned, novel investigational product candidate containing a single Arginase 1-derived peptide designed to engage and activate Arginase 1-specific human T cells. IO112 is designed to target T cells that recognize epitopes derived from Arginase 1, which is an immunoregulatory enzyme highly expressed in difficult-to-treat tumors associated with high levels of myeloid-derived suppressor cells (MDSCs) including renal cell carcinoma, head and neck, breast, pancreatic, ovarian, colorectal and prostate cancers. Arginase overexpression is a well-documented tumor escape mechanism. IO112 has been studied in a single arm first-in-human Phase 1 trial in patients with arginase-positive solid tumors, conducted in an investigator-initiated trial at the University of Copenhagen. The company anticipates filing an IND for IO112 in 2025.
About IO Biotech
IO Biotech is a clinical-stage biopharmaceutical company developing novel, immune-modulatory, off-the-shelf 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 T cells to target both tumor cells and the immune-suppressive cells in the tumor microenvironment. IO Biotech is advancing its lead investigational cancer vaccine candidate, Cylembio™ (imsapepimut and etimupepimut, adjuvanted) 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 . Follow us on our social media channels on LinkedIn and X ( @IOBiotech ).
Cylembio is a trademark of IO Biotech ApS.
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 of submission of an IND for IO112, other current or future regulatory submissions or 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
[email protected]
Media
Julie Funesti
Edelman
917-498-1967
[email protected]