KIYATEC, Inc. today announced that research published in the March 2021 Cancer Immunology, Immunotherapy journal solidifies the foundation to characterize predictive accuracy in immune-oncology. By using a patient’s own tumor cells and infiltrating immune cells to model patient-specific biological complexity, KIYATEC’s platform achieves a fundamental requirement bridging drug discovery through post-approval clinical use. The future ability to accurately predict which patients respond to immunotherapy agents, prior to treatment, will spare non-responders from financial toxicity and drug-induced side effects.
Immune checkpoint inhibitors that target programmed cell death protein 1 (PD-1) and programmed death-ligand 1 (PD-L1) have only shown modest activity as monotherapies for the treatment of ovarian cancer. Approval for a patient’s use of these immunotherapies is based on the current paradigm of cancer drug selection, spanning genetic sequencing, gene expression and biomarkers. For many checkpoint inhibitor indications, only 10-30% of patients treated with these premium-cost drugs respond. The importance of checkpoint inhibitors meeting key clinical endpoints has recently been brought into focus in more than one cancer indication.
Tessa DesRochers, PhD, KIYATEC Chief Scientific Officer said, “Our research highlights the significant steps that we have defined and those we have met to ultimately validate immune-oncology response prediction. While clinical prediction is still in progress pharmaceutical companies can today utilize our technology to make meaningful decisions during their drug development process.”
The company has defined the four critical steps necessary to successfully predict immunotherapy response in the clinic. The latest research from KIYATEC demonstrates achievement of the first three: 1) development of a live cell co-culture test with patient-matched cells, 2) demonstration of sustained functionality of key infiltrating immune cells, and 3) characterization of dose-dependent and patient-specific cellular responses to immunotherapies. These three steps deliver what drug developers need today, strengthening KIYATEC’s basis for high value-added preclinical services. The fourth step will be to correlate the test results with patient immunotherapy endpoints in the clinic, enabling the prediction of patient-specific response to immunotherapies prior to treatment.
KIYATEC’s platform is already predictive for chemotherapy and targeted agents. In December 2020, the company announced that unblinded use of KIYATEC’s test results to inform drug selection for recurrent brain cancer patients approximately doubled the expected clinical outcome. An earlier blinded clinical study, published in 2019, demonstrated that progression-free survival doubled for newly diagnosed ovarian cancer patients if they had received a drug treatment to which KIYATEC’s test results had predicted a response.
“We are optimistic about the growing need for more effective pairing of immunotherapies and patients, particularly given recent developments in this multi-billion-dollar market,” said Matthew Gevaert, PhD, CEO and Founder of KIYATEC. “The expansion of our predictive platform beyond chemotherapy and targeted agents has the potential to change how patients are selected for life-saving treatments.”
Appleton, K.M., Elrod, A.K., Lassahn, K.A. et al. PD-1/PD-L1 checkpoint inhibitors in combination with olaparib display antitumor activity in ovarian cancer patient-derived three-dimensional spheroid cultures. Cancer Immunol Immunother 70, 843–856 (2021). https://doi.org/10.1007/s00262-021-02849-z
KIYATEC leverages its proprietary ex vivo 3D cell culture platforms to accurately model and predict response to approved and investigational cancer drugs targeting a spectrum of solid tumors. The platforms are positioned to address the gap-defining limitations of current cancer drug selection. The company’s Clinical Services business is currently engaged in the validation of clinical assays as well as investigator-initiated studies in ovarian cancer, breast cancer, glioblastoma and rare tumors, in its CLIA-certified laboratory. The company’s Drug Development Services business works in partnership with leading biopharmaceutical companies to unlock response dynamics for their investigational drug candidates across the majority of solid tumor types.