Preclinical studies show ACT-903 demonstrates tumor suppression, increased survival, maytansine and metabolite accumulation in the tumor, and no signs of toxicity

TORONTO, Canada I September 16, 2021 I Alpha Cancer Technologies Inc. (ACT) a biopharmaceutical company focused on developing and commercializing targeted immuno-oncology and immunology therapies based on its proprietary recombinant human Alpha Fetoprotein (AFP) platform, today announced the presentation of new preclinical data from the Company’s investigational therapy, ACT-903 at the European Society of Medical Oncology (ESMO) Annual Meeting being held virtually September 16-21, 2021.

“We are excited by the promise of ACT-903, our novel protein drug conjugate developed though our AFP platform, which we believe has the potential to overcome the shortcomings of traditional immuno-oncology therapies,” said Dr. Igor Sherman, CEO of ACT. “Unlike healthy cells, cancer and suppressor cells express AFP receptors, which allows for our conjugates to selectively deliver chemotherapy payloads to these cancer cells while bypassing normal cells, leading to greater efficacy in a broad range of tumor-specific targets, and reduced off-target toxicity. The preclinical findings we have reported with ACT-903 validates our approach and we look forward to advancing this program into the clinic.”

The poster titled, “AFP-Maytansine Conjugate – a Novel Targeted Cancer Immunotherapy,” highlights preclinical data from an animal study conducted with Southern Research Institute (SRI) evaluating ACT-903, a novel protein drug conjugate using a proprietary version of recombinant human AFP, combined with a proprietary chemical linker and maytansine toxin.

During the study, four novel AFP-maytansine conjugates of differing drug-protein ratios and slightly different linker structures were administered intravenously (IV) to mice bearing human colon carcinoma (COLO-205) xenografts, at doses previously determined to be safe. Seven days after implantation, mice with tumors greater than 150 mm3 were randomized to receive control or one of the four conjugates (10 animals/ group). Animals were treated daily for two weeks with two days of rest after five doses and tumor volume was assessed twice weekly for 60 days following implantation. In a separate study, the biodistribution of an earlier version of AFP-maytansine conjugate in the COLO-205 model was investigated after a single IV dose.

Highlights from the study are below:

  • Statistically significant reduction in tumor volume was observed in all treatment groups compared to control beginning at Day 17. In one of the conjugate groups, tumor reduction continued following treatment discontinuation with tumor volumes falling below the limit of detection in 9 of 10 animals
  • 100% survival in ACT-903 group at day 60, compared to 0% survival in the control group by day 38
  • After a single IV dose, biodistribution study of conjugate showed excellent tumor targeting with maytansine and metabolite accumulation and undetectable bone marrow toxicity
  • No signs of toxicity were observed in treated mice

ACT has identified the ACT-903 conjugate with the strongest efficacy profile and will advance the program into further studies to support a Phase 1 clinical trial.

Poster Details:

Title: AFP-Maytansine Conjugate – a Novel Targeted Cancer Immunotherapy
Abstract Number: 523P
Authors: I. Sherman, R. Boohaker, K. Stinson, P. Griffin, W. Hill

For more information about the Annual Meeting, please visit: https://www.esmo.org/meetings/esmo-congress-2021

About ACT-903

ACT-903 (AFP+linker+maytansine) is a novel protein drug conjugate using a proprietary version of recombinant human alpha-fetoprotein (AFP), combined with a proprietary chemical linker and maytansine toxin. ACT-903 has been shown to selectively target AFP receptors found on the surface of solid and liquid cancers as well as myeloid derived suppressor cells and deliver the toxic maytansine payload to these cells.

About Alpha Cancer Technologies, Inc.

Alpha Cancer Technologies, Inc. is an emerging biotechnology company with products under development in immunotherapy (Inflammatory Bowel Disease, Multiple Sclerosis, Myasthenia Gravis, Hashimoto) and immuno-oncology. ACT’s immuno-oncology products target AFP receptors expressed on almost all solid and liquid tumors and immune suppressor cells but absent on normal cells. This approach offers the benefits of much lower toxicity and greater efficacy compared to conventional chemotherapy and other targeted therapies. ACT is based in Toronto, Ontario, Canada. For more information, please visit www.alpha-cancer.com.

SOURCE: Alpha Cancer Technologies