Our Pipeline

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

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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)

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

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