IO Biotech Announces Publication of Preclinical Data Investigating Immune-Modulatory Effects of IO112, an Arginase 1-Targeting Therapeutic Cancer Vaccine Candidate
IO Biotech (IOBT) announced the publication of preclinical study results for IO112, their second immune-modulatory therapeutic cancer vaccine candidate targeting arginase 1 (Arg1), in the Journal for ImmunoTherapy of Cancer. The study demonstrated that IO112 treatment inhibits tumor growth through changes in the tumor microenvironment (TME), showing how Arg1-specific T cells expanded by the vaccine enhance anti-tumor immunity by reprogramming tumor-associated macrophages (TAMs).
The research revealed that IO112 treatment directly impacts TAMs, completely changing their phenotype. This is particularly significant as Arg1-expressing TAMs are a major obstacle in cancer immunotherapy due to their role in creating an immunosuppressive TME. The company plans to submit an Investigational New Drug Application (IND) to the US FDA in 2025.
IO Biotech (IOBT) ha annunciato la pubblicazione dei risultati di uno studio preclinico per IO112, il loro secondo candidato vaccino terapeutico immunomodulatore contro il cancro mirato all'arginasi 1 (Arg1), sulla rivista Journal for ImmunoTherapy of Cancer. Lo studio ha dimostrato che il trattamento con IO112 inibisce la crescita tumorale attraverso cambiamenti nel microambiente tumorale (TME), mostrando come le cellule T specifiche per Arg1, amplificate dal vaccino, migliorino l'immunità antitumorale riprogrammando i macrofagi associati al tumore (TAM).
La ricerca ha rivelato che il trattamento con IO112 ha un impatto diretto sui TAM, cambiando completamente il loro fenotipo. Questo è particolarmente significativo poiché i TAM che esprimono Arg1 rappresentano un grosso ostacolo nell'immunoterapia contro il cancro a causa del loro ruolo nel creare un TME immunosoppressivo. L'azienda prevede di presentare una Richiesta di Nuovo Medicinale Sperimentale (IND) alla FDA degli Stati Uniti nel 2025.
IO Biotech (IOBT) anunció la publicación de los resultados de un estudio preclínico para IO112, su segundo candidato a vacuna terapéutica inmunomoduladora contra el cáncer dirigida a la arginasa 1 (Arg1), en la revista Journal for ImmunoTherapy of Cancer. El estudio demostró que el tratamiento con IO112 inhibe el crecimiento tumoral a través de cambios en el microentorno tumoral (TME), mostrando cómo las células T específicas para Arg1, ampliadas por la vacuna, mejoran la inmunidad antitumoral reprogramando los macrófagos asociados al tumor (TAM).
La investigación reveló que el tratamiento con IO112 impacta directamente en los TAM, cambiando completamente su fenotipo. Esto es especialmente significativo ya que los TAM que expresan Arg1 son un gran obstáculo en la inmunoterapia contra el cáncer debido a su papel en la creación de un TME inmunosupresor. La empresa planea presentar una Solicitud de Nuevo Medicamento en Investigación (IND) a la FDA de EE. UU. en 2025.
IO Biotech (IOBT)는 IO112에 대한 전임상 연구 결과를 발표했다고 전했습니다. 이는 아르기나제 1(Arg1)을 타겟으로 하는 두 번째 면역 조절 종양 백신 후보로, 암 면역 치료 저널에 게재되었습니다. 이 연구는 IO112 치료가 종양 미세환경(TME)에서의 변화를 통해 종양 성장을 억제함을 보여주었으며, 백신에 의해 확장된 Arg1 특이적 T 세포가 종양 관련 대식세포(TAM)를 재프로그래밍하여 항종양 면역을 강화한다는 사실을 밝혔습니다.
연구 결과 IO112 치료가 TAM에 직접적인 영향을 미쳐서 그 표현형을 완전히 변화시킨다는 것이 밝혀졌습니다. 이는 Arg1을 발현하는 TAM이 면역 억제 TME를 형성하는 역할로 인해 암 면역 치료에서 큰 장애물이라는 점에서 특히 중요합니다. 회사는 2025년에 미국 FDA에 임상시험용 의약품 신청(IND)을 제출할 계획입니다.
IO Biotech (IOBT) a annoncé la publication des résultats d'une étude préclinique sur IO112, leur deuxième candidat vaccin thérapeutique immunomodulateur visant l'arginase 1 (Arg1), dans le Journal for ImmunoTherapy of Cancer. L'étude a démontré que le traitement par IO112 inhibe la croissance tumorale par des changements dans le microenvironnement tumoral (TME), montrant comment les cellules T spécifiques à Arg1, élargies par le vaccin, améliorent l'immunité antitumorale en reprogrammant les macrophages associés aux tumeurs (TAM).
La recherche a révélé que le traitement par IO112 a un impact direct sur les TAM, changeant complètement leur phénotype. Cela est particulièrement significatif car les TAM exprimant Arg1 représentent un obstacle majeur dans l'immunothérapie contre le cancer en raison de leur rôle dans la création d'un TME immunosuppresseur. La société prévoit de soumettre une Demande de Médicament Expérimental (IND) à la FDA américaine en 2025.
IO Biotech (IOBT) gab die Veröffentlichung der Ergebnisse einer präklinischen Studie zu IO112, ihrem zweiten immunmodulatorischen therapeutischen Krebsimpfstoffkandidaten, der auf Arginase 1 (Arg1) abzielt, im Journal for ImmunoTherapy of Cancer bekannt. Die Studie zeigte, dass die Behandlung mit IO112 das Tumorwachstum durch Veränderungen im Tumormikroenvironment (TME) hemmt, wobei gezeigt wird, wie Arg1-spezifische T-Zellen, die durch den Impfstoff expandiert wurden, die antitumorale Immunität durch Umprogrammierung der tumorspezifischen Makrophagen (TAMs) verstärken.
Die Forschung ergab, dass die Behandlung mit IO112 direkte Auswirkungen auf TAMs hat und deren Phänotyp vollständig verändert. Dies ist besonders bedeutend, da Arg1-exprimierende TAMs ein großes Hindernis in der Krebsimmuntherapie darstellen, da sie eine Rolle bei der Schaffung eines immunsuppressiven TME spielen. Das Unternehmen plant, 2025 einen Antrag auf ein Prüfpräparat (IND) bei der US-amerikanischen FDA einzureichen.
- Successful preclinical results showing IO112's effectiveness in inhibiting tumor growth
- Publication in a respected journal (Journal for ImmunoTherapy of Cancer) validating research
- Clear development timeline with IND submission planned for 2025
- Product still in preclinical stage, years away from potential commercialization
- No clinical data available yet to confirm efficacy in humans
Insights
The publication of IO112's preclinical data marks a significant milestone in cancer immunotherapy development. The research reveals a sophisticated dual-action mechanism that could potentially overcome one of the most challenging aspects of cancer treatment - the immunosuppressive tumor microenvironment.
The study's findings are particularly noteworthy for three key reasons:
- IO112's ability to reprogram tumor-associated macrophages (TAMs) represents a novel approach to cancer treatment, as TAMs are typically associated with poor prognosis and treatment resistance
- The targeting of Arginase 1 (Arg1) is strategically important, as this enzyme is overexpressed in multiple cancer types and plays a central role in immune suppression
- The data supports IO Biotech's T-win® platform technology, which uniquely targets both tumor cells and immune-suppressive cells
With an IND submission planned for 2025, IO Biotech is positioning itself in the rapidly growing cancer immunotherapy market. The company's approach through their T-win® platform technology differentiates them from traditional checkpoint inhibitors and CAR-T therapies. For investors, this represents a potential value inflection point, as successful IND acceptance could accelerate the company's clinical development timeline.
However, it's important to note that while preclinical data is promising, the path to clinical validation remains long and complex. The true test will be translating these laboratory findings into human clinical trials, where many promising cancer therapies have historically faced challenges.
– 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
mci@iobiotech.com
Media
Julie Funesti
Edelman
917-498-1967
julie.funesti@edelman.com
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