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QBI-139: Oncology Lead

'RNA Clearance': Immune/Inflammation

EVade™ RNase Payloads

EVade RNase™ QBI-139 Oncology Lead

More than thirty EVade™ RNases were manufactured and tested in vivo against a variety of cancers. QBI-139 is a variant of human pancreatic RNase 1 that retains 95% sequence identity to the native protein, yet is able to kill cancer cells. QBI-139 was selected because of its broad efficacy and excellent safety profile. In xenograft models, QBI-139 causes significant (>50%) tumor growth inhibition in breast, colorectal, non-small cell lung, ovarian, pancreatic and prostate cancers. The efficacious doses were generally well tolerated in the models, and the safety profile of QBI-139 appeared improved relative to the chemotherapy comparators.

Following large scale GMP production, IND-enabling toxicology studies were completed, which again showed a safety profile different than traditional chemotherapy. The Investigational New Drug (IND) application to the Food and Drug Administration (FDA) allowed for a first in human Phase 1 clinical trial at University of Texas M. D. Anderson Cancer Center and University of Wisconsin Carbone Cancer Center. Dose escalation of QBI-139 in a Phase I clinical trial for solid tumors has recently been completed. As in the model systems, QBI-139 did not show myelosuppression or other adverse effects commonly associated with drug that target rapidly dividing cells. Based on encouraging signs of clinical impact (increased rate of stable disease as well as changes in the serum cancer marker prostate specific antigen), partners are being sought for expansion cohorts to demonstrate efficacy of QBI-139 in a defined patient population (non-small cell lung, ovarian or prostate cancers). The safety profile of this broadly active drug provides particular benefit in combination therapy, including immunooncology drugs.

The benefits of QBI-139 as a cancer therapeutic include:

  • Distinct mechanism of action
  • Strong pre-clinical in vivo activity against multiple tumors as a single agent
  • Clinically differentiated safety profile relative to traditional cancer drugs
  • Signs of activity in first in human dose escalation Phase I
  • Data supporting range of combination therapies

The current opportunity is for partners and funders to work with Quintessence on a proof of efficacy trial in defined patient population.

'RNA Clearance': Immune/Inflammation

A role for RNA has been demonstrated in processes ranging from adhesion to coagulation to the innate immune system, and cleavage of RNA by wild type RNase 1 disrupts these activities. Our technologies related to RNase 1 variants will allow development of leads with optimal activity, such as extending serum residence or changing cell specificity. Application of the RNases to autoimmune disease or anti-coagulation therapy will benefit from the data from the clinical trial of oncology lead, QBI-139.

EVade™ Ribonuclease Payloads

A role for RNA has been demonstrated in processes ranging from adhesion to coagulation to the innate immune system, and cleavage of RNA by wild type RNase 1 disrupts these activities. Our technologies related to RNase 1 variants will allow development of leads with optimal activity, such as extending serum residence or changing cell specificity. Application of the RNases to autoimmune disease or anti-coagulation therapy will benefit from the data from the clinical trial of oncology lead, QBI-139.