ACT-101 is under clinical development by Alpha Cancer Technologies and currently in the Phase I in clinical pathway. The characteristics of the clinical trial as well as other attributes related to the drug, regulations, and company play a fundamental role in ensuring the likelihood of transition that the drug moves from its current development stage to next.

According to GlobalData, the latest event to affect ACT-101’s likelihood of approval (LoA) and phase transition for Hashimoto Thyroiditis took place on 16 Dec 2022, which increased the likelihood that the drug progresses to the next phase in its clinical pathway and increased the likelihood of final approval for this indication.

In addition, the same event on 16 Dec 2022 increased ACT-101’s LoA and PTSR for Ulcerative Colitis.

GlobalData uses proprietary data and analytics to provide a complete picture of this assessment in their ACT-101 Likelihood of Approval (LoA) and Phase Transition Success Rate (PTSR) Report.

ACT-101 overview

ACT-101 is under development for the treatment of myasthenia gravis, multiple sclerosis, cancers, Crohn's disease, Hashimoto thyroiditis, ulcerative colitis and other IgG-driven diseases. The drug candidate is administered by subcutaneous route. ACT-101 is a genetically engineered recombinant version of a naturally occurring protein known as alpha fetoprotein (AFP) which acts by targeting neonatal Fc receptor (FcRn) and is an immunomodulatory agent. It was also under development for uveitis, rheumatoid arthritis, chronic plaque psoriasis and systemic lupus erythematosus.

Alpha Cancer Technologies overview

Alpha Cancer Technologies (ACT) is a clinical stage biotechnology company that offers development in oncology and auto-immune disease indications. The company products include alpha fetoprotein, immunology platform and targeted chemotherapy platform. It manufACTures products using its proprietary recombinant human alpha fetoprotein with immuno-oncology properties. ACT include drug master file with FDA manufACTuring, toxicology and human safety. The company provides treatment for myasthenia gravis, multiple sclerosis and autoimmune encephalitis and lupus. It also include chemotherapy platform for the treatment of solid and liquid tumors. The company collaborates with healthcare university, cancer and polytherics institution. ACT is headquartered in Toronto, Ontario, Canada.

Quick View ACT-101 LOA Data

Report Segments
  • Innovator
Drug Name
  • ACT-101
Administration Pathway
  • Subcutaneous
Therapeutic Areas
  • Central Nervous System
  • Gastrointestinal
  • Hormonal Disorders
  • Immunology
  • Oncology
  • Ophthalmology
Key Developers
Highest Development Stage
  • Phase I

GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.

GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in its clinical pathway (PTSR), as well as how likely the drug will be approved (LoA). This is based on a proprietary algorithm built from the drugs’ sales forecast, regulatory milestones, cost forecasts, WACC rate and other proprietary data sources found on GlobalData’s Pharmaceutical Intelligence Center.