Alpha Cancer Technologies

Using Nature to Beat Cancer.

Alpha Cancer Technologies Inc. (ACT) is a private Toronto 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 calm autoimmune disease.

About ACT

Platform Technologies in Immuno-Oncology, Radiopharmaceuticals and Immunomodulation

ACT has three platforms under development, all built on ACT-101, its patented recombinant human alpha fetoprotein: Targeted Oncology — ACT-903, a protein drug conjugate (PDC) that delivers a chemotherapy payload to cancer cells. Radiopharmaceuticals — 89Zr-ACT-101 (diagnostic) and 177Lu-ACT-101 (therapeutic), targeting the same receptor. Immunomodulation — ACT-101 itself, as a treatment for autoimmune disease, available for partnering and outlicensing. ACT-101 has been studied in more than 300 patients in non-cancer clinical studies, where it demonstrated an excellent safety record with no serious adverse events and no neutralizing antibodies. ACT’s drug master file with the FDA covers manufacturing, toxicology, and human safety for ACT-101.

Lead program: ACT-903 (Targeted Oncology)

ACT-903 links ACT-101 to a proprietary maytansine payload with a glutathione-sensitive linker (drug-antibody ratio ~5.96). It is a protein drug conjugate, not an antibody drug conjugate. How it works: The receptor for AFP (AFPR) is re-expressed on most cancers — solid and liquid — and on myeloid-derived suppressor cells (MDSCs), which tumors recruit to shield themselves from the immune system. AFPRs are absent on normal adult cells in studies to date. By attaching a payload to ACT-101, ACT-903 is designed to kill cancer cells and MDSCs directly, and by taking down the MDSC shield, to let the patient’s own immune system attack the tumor as well. 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. These results show the direct effect on tumors only: the xenograft model uses immunodeficient mice, so the additional immune effect of removing MDSCs is expected to be demonstrated in clinical studies, not yet shown. ACT-903 has not yet been tested in humans, and its safety will be established in Phase I. Intellectual property: European patent claims covering ACT’s three-component combination (ACT-101 + linker + maytansine) have been granted, with coverage to 2042 and beyond. Applications in the US, China, India, and Canada are pending. Manufacturing: Absci has developed the E. coli cell line that produces ACT-101. The line transfers to a contract manufacturer for cGMP production, and Abzena performs the conjugation step. 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. Pipeline (snapshot): ACT-903 (PDC) — Targeted oncology, solid and liquid tumors — Preclinical. 89Zr-ACT-101 — Radiopharmaceutical diagnostic — Preclinical study underway (McMaster). 177Lu-ACT-101 — Radiopharmaceutical therapeutic — Preclinical study underway (McMaster). ACT-101 — Myasthenia Gravis (FDA Orphan Drug Designation) — Phase II-ready; partnering. ACT-101 — Inflammatory Bowel Disease (Crohn’s/Colitis) — Phase II-ready; partnering. ACT-101 — Multiple Sclerosis and 40+ other autoimmune diseases — Early / partnering. ACT-901 (paclitaxel) and ACT-902 (thapsigargin) were earlier non-covalent candidate assets; ACT-903 is the current lead oncology program. Immunomodulation: ACT-101 is a natural immune regulator: during pregnancy, autoimmune disease commonly goes into remission as AFP levels rise. ACT-101 is given subcutaneously once per week and is being developed as a ‘portfolio in a product’ across IgG-driven diseases. Myasthenia Gravis: FDA Orphan Drug Designation granted; pre-IND completed and a Phase II design agreed. Ready for a Phase II study with a partner. Inflammatory Bowel Disease: a Phase II-ready program with a study plan designed by Alimentiv. Note: the earlier 78-patient IBD study used wild-type AFP extracted from human fetal tissue, not ACT-101; that study is background, not ACT-101 clinical data.

LEADERSHIP

Richard Potts

A track record of management, finance, and marketing of growth companies across biotechnology, medical, and information technology, including as CEO and Chair of Lorus Therapeutics (now Aptose), a TSX/NASDAQ biotech company.

Dr. Igor Sherman

Extensive pharmaceutical and biotechnology experience, particularly in oncology, including as Director of Clinical Research and Director of Scientific Affairs at YM Biosciences and Scientific Director of Oncology at AstraZeneca Canada.

Dianne Parsons, CA

Scientific Advisory Board

Daniel D. Von Hoff, MD, FACP, FASCO, FAACR

Also Professor of Medicine at Mayo Clinic and Chair of the Early Drug Development Committee at US Oncology, most notable for his work in targeted therapies for cancer. Distinguished Professor and Executive Vice President, Molecular Medicine; Virginia G. Piper Distinguished Chair for Innovative Cancer Research and Chief Scientific Officer, HonorHealth Research Institute; Margaret Givan Larkin Endowed Chair in Developmental Cancer Therapeutics, Hoag Hospital Distinguished Professor, Department of Medical Oncology and Therapeutic Research, City of Hope.

Phil Gold, CC, OQ, MD, PhD, FRSC, DSc (Hon), MACP, FRCP(C)

Discovered the carcinoembryonic antigen (CEA), the first clinically useful human tumor marker, found in 70% of cancer patients, and credited with developing the field of Human Tumor Marker Biology. His subsequent demonstration that CEA was found in embryonic and fetal tissue initiated the field of Oncodevelopmental Biology.

Michael Julius, PhD

Formerly Vice-President, Research, Sunnybrook Health Sciences Centre and Sunnybrook Research Institute; Senior Scientist, Biological Sciences, Odette Cancer Research Program. His work on the biochemistry of lymphocyte activation and the cellular and molecular interactions culminating in protective immunity has supported his continuing interest in autoimmune diseases and ailments involving dysregulated immune function.

Ingmar Bruns, MD, PhD

Instrumental in the sale of Trillium to Pfizer for $2.2 billion, which closed in November 2021. About 20 years of experience in hematology and oncology as a physician and scientist; formerly Senior Vice President and Head of Clinical Development at Pieris Pharmaceuticals, led clinical development of several high-priority oncology assets at Bayer Pharmaceuticals from 2013 to 2017, and served as an attending hematologist and oncologist and physician-scientist at Albert Einstein College of Medicine in New York and previously the University Hospital of Dusseldorf in Germany.

Sam Sadeghi, PhD

His lab develops molecular imaging agents that enable in vivo visualization of biological mechanisms of disease and targeted radiotherapeutics to treat cancer.

News

European patent claims granted on ACT’s three-component combination (ACT-101 + linker + maytansine).

Radiopharmaceutical study underway at McMaster University under peer-reviewed grants from NSERC and the Ontario Centre of Innovation, evaluating 89Zr-ACT-101 as a companion diagnostic and 177Lu-ACT-101 as a therapeutic.

Executive Summary, Q1 2026 — available on request.

FAQ

What is alpha fetoprotein?

Alpha fetoprotein (AFP) is a human protein produced during fetal development. It protects the embryo from the mother’s immune system and carries nutrients to rapidly growing embryonic cells via AFP receptors (AFPRs). After birth, AFP production and AFPR expression recede — and AFPRs reappear on most cancer cells and on myeloid-derived suppressor cells (MDSCs).

What is ACT-101?

ACT-101 is ACT’s recombinant human AFP, differing from natural human AFP by a single amino acid substitution at position 233 (glutamine for asparagine). It is non-glycosylated, has 16 disulphide bridges, and is now produced from an E. coli cell line developed by Absci. ACT-101 has been studied in over 300 patients in non-cancer clinical studies with an excellent safety record and no neutralizing antibodies.

What is ACT-903?

ACT-903 is ACT’s lead oncology program: a protein drug conjugate (PDC) that links ACT-101 to a proprietary maytansine payload with a glutathione-sensitive linker. It targets AFPRs on cancer cells and MDSCs. ACT-903 is preclinical — it has not been tested in humans. In an ovarian cancer xenograft study it eliminated tumors completely with no regrowth to day 62; that study used immunodeficient mice, so the immune effect of removing MDSCs remains to be demonstrated in clinical studies.

What stage is ACT-903 at?

Preclinical. IND-enabling work is ongoing, and a Phase Ia/b multiple-ascending-dose basket study is planned, enriched to an orphan indication such as platinum-resistant ovarian cancer or testicular germ cell cancer. No IND has been filed yet.

What is the PDC rationale?

Because AFPRs are present on most cancers and on MDSCs but absent on normal adult cells in studies to date, attaching a potent payload to ACT-101 is designed to concentrate treatment in tumors while sparing normal tissue — and, by removing the MDSC shield, to let the immune system attack the tumor as well. The receptor has not yet been clinically validated; that is what the planned clinical studies are for.

What about autoimmune disease?

ACT-101 is Phase II-ready in Myasthenia Gravis (FDA Orphan Drug Designation granted) and in Inflammatory Bowel Disease, and is being positioned for partnering and outlicensing. Note: the earlier 78-patient IBD study used wild-type AFP from human fetal tissue, not ACT-101.

Why was maytansine selected?

Maytansine is roughly 1,000-fold more potent than first-generation toxins such as doxorubicin, and the maytansinoid class is clinically validated in approved conjugates such as Kadcyla (DM1) and Elahere (DM4). ACT-903 uses a proprietary maytansine with a glutathione-sensitive linker created for ACT.

Is ACT-101 immunogenic?

In clinical studies in over 300 patients, no neutralizing antibodies were found. In animal toxicology studies, neutralizing antibodies to AFP were detected in rodents, and low titers in about 50% of marmosets dosed every 72 hours for 26 weeks.