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Our Pipeline

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Our pipeline assets range from a cell therapy targeting the root cause of many autoimmune diseases, to a  monoclonal antibody for a new immuno-oncology target, and to a clinical diagnostic assay.

Our current pipeline consists of assets with the potential to diagnose, prevent, treat and even “cure” as disease modifying therapies:

  • AVT001 – A clinical stage autologous dendritic cell-based vaccine for AID and transplant rejection

  • AVT-Dx001 – A potency molecular/cellular assay to assess the functional status of Q/E CD8+ Treg pathway, a potential tool for early diagnosis of AID which could also precisely guide clinical treatments

  • AVT002 – A monoclonal antibody (mAb), as a potential cancer therapy directed at a novel immuno-oncology target, to prevent cancer from recurring

  • The unique specificity of the regulation by the Q/E CD8+ Treg pathway presents a rarely seen therapeutic advantage to target a wide spectrum of autoimmune diseases and other immunologically relevant conditions without the necessity to identify the disease specific pathogenic antigens, which is an extremely challengeable task currently

Lead Asset, AVT001, Showcases Strong “Evidence Chain” From Research to Drug Development

  • Clinical proof of concept demonstrating safety/tolerability and efficacy in a new onset Type 1 Diabetes (T1D) Phase I/II clinical trial with statistically significant reduction in C-peptide decline vs. placebo

  • Biological proof of concept with AVT-Dx001 successfully identifying the pathway defect and predicting response of AVT001

  • Completed the T1D Phase I/II clinical trial and is engaging an End of Phase II pre-IND meeting with FDA to initiate a T1D Phase III trial

  • Initial FDA feedback supporting entering a phase IIb proof of concept study (PoC) for multiple sclerosis (MS)

  • Supporting preclinical evidence from human ex vivo studies in nearly 300 patients with >20 distinct autoimmune diseases and 3 mouse models **(NOD1, EAE2 and ATT3)

      **NOD - non-obese diabetic, EAE - Experimental Autoimmune Encephalomyelitis, ATT – Adult transplantation tolerance

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