CT109

Innovation: Therapeutics—antibody pipeline backed by a platform discovery technology, targeting stromal stellate cells for the treatment of cancer and fibrotic diseases
Targeted Cancer(s): Colorectal and pancreatic cancers
Scientific Leadership: Daniel Von Hoff, M.D.; Haiyong Han, Ph.D.; Michael Pierce, Ph.D.
Stage of Project: Ready to move into clinical trials following only final set of formal pre-clinical studies

Developed and with robust intellectual property protections is a current portfolio of at least five antibodies, along with a unique platform technology that can effectively generate proprietary new ones. The leading drug candidate among the five existing proteins is CT109, a monoclonal antibody (MoAb) that targets a key molecule, CD66c, associated with cancer dissemination and disease progression. Furthermore, CT109 targets a novel, patent-protected epitope, ensuring sharp specificity. In addition to the existing antibodies portfolio, including CT109, an associated full-scale development platform has also been fully licensed. The technology enables the production of a variety of high-affinity antibodies to endogenously-expressed targets.

• CT109 has demonstrated promising pre-clinical results in colorectal and pancreatic cancer models, along with those for lung tumors.
• Initially targeted as its first indication will be patients with refractory metastatic colorectal cancer (CRC).
• In the U.S., CRC is the third most commonly diagnosed cancer in men and women, with a total of 145,000 new cases and 51,000 deaths in 2018. About 20% of patients with newly diagnosed colorectal cancer have distant metastases, with most expected to experience relapse post chemotherapy.

• CT109 targets a novel epitope, demonstrates high affinity and has potential as not only a therapeutic, but also in imaging applications
• The proprietary platform, based on years of development and know-how, has emerged as a unique tool for the identification of novel, cryptic epitopes previously beyond reach. It supports the development of other highly effective, proprietary antibody drug candidates.
• Other proprietary antibodies include:
  • MoAb37 and MoAb51, both of which are second generation, cancer-specific MoAbs to multiple carcinomas, targeting an obligatory antigen to the tumor and showing high affinity compared to marketed drugs; and
  • Novel sFRP2-specific MoAB, a newly developed antibody targeting activated stellate cells and which can restore quiescence.

• Intellectual Property: A portfolio is held of over 12 patents, issued and under review
• Clinical Development Plan: CT109 is humanized and is ready for formal pre-clinical studies; an Investigational New Drug is planned to be submitted to the U.S. Food and Drug Administration in late 2020, followed by Phase I/IIa clinical studies in colorectal patients in 2021; additionally, in 2020, a complete proof of concept in animals with the sFRP2-specific antibody is being undertaken and partnering for the development of MoABs 37 and 51 is being explored