Colorectal Drug Success

Preclinical Validation

Tumor Reduction and Survival Impact

Tumor Reduction and Survival Impact

Existing Results in Animal Models

Existing Results in Animal Models

Figure 1

Figure 1

Studies revealed NP/A83B4C63, Onco's novel nanoparticle formulation, demonstrated a noticeable increase in median survival time of 60 days, compared to 23 days in untreated mice with PTEN-deficient colorectal cancer (CRC).¹

Studies revealed NP/A83B4C63, Onco's novel nanoparticle formulation, demonstrated a noticeable increase in median survival time of 60 days, compared to 23 days in untreated mice with PTEN-deficient colorectal cancer (CRC).¹

Studies revealed NP/A83B4C63, Onco's novel nanoparticle formulation, demonstrated a noticeable increase in median survival time of 60 days, compared to 23 days in untreated mice with PTEN-deficient colorectal cancer (CRC).¹

Figure 2

Figure 2

Compared to placebo, NP/A83B4C63 showcased solid performance, reducing tumor growth.²

Compared to placebo, NP/A83B4C63 showcased solid performance, reducing tumor growth.²

Compared to placebo, NP/A83B4C63 showcased solid performance, reducing tumor growth.²

Path to Regulatory Approval

A regulatory roadmap for PKNP drug candidates

A regulatory roadmap for PKNP drug candidates

A regulatory roadmap for PKNP drug candidates

Validated Preclinical Data

Preclinical studies confirm both safety and efficacy, establishing a strong foundation for regulatory submissions and clinical trials.

Validated Preclinical Data

Preclinical studies confirm both safety and efficacy, establishing a strong foundation for regulatory submissions and clinical trials.

Validated Preclinical Data

Preclinical studies confirm both safety and efficacy, establishing a strong foundation for regulatory submissions and clinical trials.

Validated Preclinical Data

Preclinical studies confirm both safety and efficacy, establishing a strong foundation for regulatory submissions and clinical trials.

Regulatory Milestones

FDA submission targeted for 2025/26, with Phase I trials anticipated to begin in 2026, focusing on safety and dosage.

Regulatory Milestones

FDA submission targeted for 2025/26, with Phase I trials anticipated to begin in 2026, focusing on safety and dosage.

Regulatory Milestones

FDA submission targeted for 2025/26, with Phase I trials anticipated to begin in 2026, focusing on safety and dosage.

Regulatory Milestones

FDA submission targeted for 2025/26, with Phase I trials anticipated to begin in 2026, focusing on safety and dosage.

Fast-Track Eligibility

Oncology therapies addressing high unmet needs increase the likelihood of expedited regulatory reviews, such as Fast-Track Designation.

Fast-Track Eligibility

Oncology therapies addressing high unmet needs increase the likelihood of expedited regulatory reviews, such as Fast-Track Designation.

Fast-Track Eligibility

Oncology therapies addressing high unmet needs increase the likelihood of expedited regulatory reviews, such as Fast-Track Designation.

Fast-Track Eligibility

Oncology therapies addressing high unmet needs increase the likelihood of expedited regulatory reviews, such as Fast-Track Designation.

Global Multi-Region Strategy

Plans include submissions to the FDA, EMA, and Asia-Pacific regulatory agencies to maximize international market reach.

Global Multi-Region Strategy

Plans include submissions to the FDA, EMA, and Asia-Pacific regulatory agencies to maximize international market reach.

Global Multi-Region Strategy

Plans include submissions to the FDA, EMA, and Asia-Pacific regulatory agencies to maximize international market reach.

Global Multi-Region Strategy

Plans include submissions to the FDA, EMA, and Asia-Pacific regulatory agencies to maximize international market reach.

References


  1. Sadat et al. A synthetically lethal nanomedicine delivering novel inhibitors of polynucleotide kinase 3′-phosphatase (PNKP) for targeted therapy of PTEN-deficient colorectal cancer. J Control Release. 2021 Jun 10;334:335-352. doi:10.1016/j.jconrel.2021.04.034. https://www.sciencedirect.com/science/article/pii/S016836592100208X?via%3Dihub

  2. Sadat et al. A synthetically lethal nanomedicine delivering novel inhibitors of polynucleotide kinase 3′-phosphatase (PNKP) for targeted therapy of PTEN-deficient colorectal cancer. J Control Release. 2021 Jun 10;334:335-352. doi:10.1016/j.jconrel.2021.04.034. https://www.sciencedirect.com/science/article/pii/S016836592100208X?via%3Dihub

Onco-Innovations pioneers cancer research, developing

cutting-edge therapies to treat cancer.

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Calgary, Alberta, Canada
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© 2025 Onco-Innovations Limited | All Rights Reserved

Onco-Innovations pioneers cancer research, developing

cutting-edge therapies to treat cancer.

Reach Us

1309 – 7th Street SW
Calgary, Alberta, Canada
T2R 1A5

investors@oncoinnovations.com

+1 (888) 261–8055

© 2025 Onco-Innovations Limited | All Rights Reserved

Onco-Innovations pioneers cancer research, developing

cutting-edge therapies to treat cancer.

Reach Us

1309 – 7th Street SW
Calgary, Alberta, Canada
T2R 1A5

investors@oncoinnovations.com

+1 (888) 261–8055

© 2025 Onco-Innovations Limited | All Rights Reserved

Onco-Innovations pioneers cancer research, developing

cutting-edge therapies to treat cancer.

Reach Us

1309 – 7th Street SW
Calgary, Alberta, Canada
T2R 1A5

investors@oncoinnovations.com

+1 (888) 261–8055

© 2025 Onco-Innovations Limited | All Rights Reserved