Pipeline at a glance

ACT-903
Targeted oncology
Preparing for clinic

⁸⁹Zr-ACT-101
Diagnostic
Preclinical study underway (McMaster)

¹⁷⁷Lu-ACT-101
Therapeutic
Preclinical study underway (McMaster)

ACT-101
Myasthenia Gravis
Phase II-ready

FDA Orphan Drug Designation granted.

ACT-101
Inflammatory Bowel Disease (Crohn’s/Colitis)
Phase II-ready

About ACT

Alpha Cancer Technologies Inc. (ACT) is a private biotechnology company developing targeted therapies from recombinant human alpha fetoprotein (ACT-101) — a protein the body itself uses during fetal development, now engineered to deliver treatment to cancer cells and to modulate autoimmune diseases.

Platform Technologies in Immuno-Oncology, Radiopharmaceuticals and Immunomodulation

ACT-101 differs from natural human AFP by a single amino acid substitution at position 233 (glutamine for asparagine). It is non-glycosylated, has 16 disulfide bridges, and is now produced from an E. coli cell line developed using AI by Absci. ACT-101 was studied by our licensor, who spent over US$100 million in Phase I and II rheumatoid arthritis clinical studies in over 300 patients, with no serious adverse events at doses up to 100 mg per week and with no neutralizing antibodies. ACT’s drug master file with the FDA covers manufacturing, toxicology, and human safety for ACT-101 which are all now owned by ACT.

ACT-903: ACT-101 (recombinant human AFP) carrying six maytansine payloads on cleavable linkers

Lead program: ACT-903 (Targeted Oncology)

ACT-903 links ACT-101 to a proprietary chemotherapy payload with a cleavable linker (drug-to-protein ratio ~6). It targets AFP receptors found on cancer cells and MDSCs. AFP receptors are absent on normal adult cells in studies to date.

Preclinical data: In an ovarian cancer xenograft study (A2780, Southern Research), ACT-903 eliminated tumors completely in all treated animals, with no regrowth to day 62, while all control animals had died by day 34. That study used immunodeficient mice, so the immune effect of removing MDSCs remains to be demonstrated in clinical studies.

Clinical plan: A Phase Ia/b multiple-ascending-dose basket study is planned, enriched to an orphan cancer indication such as platinum-resistant ovarian cancer or testicular germ cell cancer, at Princess Margaret Cancer Centre and one US centre. The study has not yet begun; IND-enabling work is ongoing.

Intellectual property: Patent applications covering ACT’s three-component combination (ACT-101 + linker + maytansine) are pending in Europe, the US, China, India, and Canada, with coverage, if granted, to 2042 and beyond.

Manufacturing: Our partner absci, an AI drug creation company, developed the E. coli cell line that produces ACT-101.

Oncology Pre Clinical Studies

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