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ovarian cancer

  • sam patrick posted an article
    Cancer testing innovator KIYATEC fits investor’s focus in disruptive healthcare technology see more

    KIYATEC, Inc. announced today that it secured a $2.5 million investment from Boston-based healthcare service and technology venture capital fund Seae Ventures. The fund’s focus in disruptive healthcare technologies aligns with KIYATEC’s goal to fundamentally change the way cancer drugs are selected by providing oncologists with patient-specific evidence of response, prior to treatment initiation.

    Although significant strides toward personalized medicine have been achieved in the past two decades, oncologists remain largely unable to predict treatment response for individual patients. As a result, many patients receive ineffective drug therapies, while unnecessarily experiencing toxic side effects and shouldering high cost of treatment. KIYATEC’s 3D-Predict platform and associated tests increase the patient-centric value of cancer drugs by informing oncologists’ pre-treatment cancer drug selection. Importantly, the platform also aids pharmaceutical companies by improving decision-making across drug lifecycles.

    “We are grateful for Seae Venture’s ’yes’ to KIYATEC and welcome the addition of their managing partner, Jason Robart, to our board of directors. The fund’s healthcare industry relationships coupled with Jason’s personal experience with health insurance innovation will be beneficial as we implement our strategy to impact those who need it most – cancer patients and their providers,” said Matthew Gevaert, CEO and co-founder of KIYATEC.

    The investment comes on the heels of other recent announcements of success for KIYATEC. The first release of the 3D-PREDICT clinical study data in late 2020, combined with the more recent March 2021 publication demonstrating platform expansion into immuno-oncology, highlight the rapid and disruptive nature of KIYATEC’s progress. The company’s platform has been shown to be clinically predictive for patient-specific response to chemotherapy and targeted agents, and it has been analytically validated in both ovarian cancer and high-grade gliomas.

    Robart said, “KIYATEC has the potential to significantly improve outcomes for patients and their providers, not just for one cancer type, but across many solid tumors. We’re excited about the science, the team and the potential. We welcome KIYATEC into our portfolio of companies and I’m thrilled to join its board of directors.”

     

    About KIYATEC

    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.

  • sam patrick posted an article
    Predictive platform expansion into immunotherapy testing a boon for pharma see more

    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

     

    About KIYATEC

    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.

  • sam patrick posted an article
    KIYATEC advances published in Scientific Reports see more

    KIYATEC, Inc. today announces that results from its prospective, multi-center pilot study, to investigate their assay’s predictive accuracy and correlation to outcome among newly diagnosed ovarian cancer patients, have been published in Scientific Reports. Study findings represent both a preliminary clinical validation for the company’s ovarian cancer assay and a significant developmental milestone for the assay’s technology platform, known as Ex Vivo 3D Cell Culture (EV3D).

    “For ovarian cancer patients and their physicians, this study represents an important step in demonstrating our ability to deliver a robust predictive assay with the potential to positively support therapeutic decision-making and improve patient outcomes,” said Matthew Gevaert, CEO of KIYATEC. “Our mission is to optimize and leverage our EV3D cell culture technology to develop response-predictive clinical assays across a range of solid tumor types and make a difference in the future of cancer care.”

    In the study, primary tissue from 92 newly diagnosed ovarian cancer patients were prospectively collected and tested for response to National Comprehensive Cancer Network (NCCN)-recommended frontline chemotherapy drugs at KIYATEC’s central laboratory. Assay results were successfully generated for 83 (90%) patient samples. All 92 patients received standard of care chemotherapy (80% adjuvant, 20% neoadjuvant) independent of the KIYATEC drug response prediction test result.

    A total of 44 patients (of the 83 patients tested) met minimum follow-up time of 6 months post-chemotherapy for inclusion in this publication. The KIYATEC assay successfully predicted responders (i.e. platinum sensitive) and non-responders (i.e. platinum resistant) with an accuracy of 89% (39/44, p<0.0001).

    Investigators also assessed assay accuracy and correlation to outcome among the 35 of 44 (80%) patients who received adjuvant chemotherapy. In this cohort, the KIYATEC assay correctly predicted responders and non-responders with 89% accuracy (31/35, p=0.0004). From date of surgical debulk, progression free survival (PFS) among test subjects predicted to respond to the first line chemotherapy they received was over 20 months v. 9 months for patients predicted not to respond (p=0.01).

    “At present, clinicians have no way of knowing, prior to treatment, which of our newly diagnosed or relapsed ovarian cancer patients will respond or not to approved drug therapies,” said Larry Maxwell, MD, Chairman of Obstetrics and Gynecology and co-director of Inova’s Women’s Health Integrated Research Center (WHIRC), and an author of the study. “To predict a complex future result with very high accuracy is a meaningful achievement, especially given that sometimes these outcomes take months to define. Similar test performance in larger, follow-on studies would establish this as a go-to tool in cancer drug selection that should help improve patient outcomes in ovarian cancer.”

    Based on these promising findings, KIYATEC has opened a prospective, pivotal clinical study, 3D-PREDICT (NCT03561207), in 500 patients to further validate EV3D-enabled clinical assays for newly diagnosed and recurrent ovarian cancer (8-drug panel) and glioblastoma (12-drug panel). The study is currently open to enrollment.

    About KIYATEC, Inc.

    KIYATEC leverages its proprietary ex vivo 3D cell culture technology platforms to accurately model and predict response to approved and investigational cancer drugs targeting a spectrum of solid tumors.  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.

  • sam patrick posted an article
    KIYATEC and OHSU initiate patient enrollment into key oncology clinical trial. see more

    GREENVILLE, S.C.-- KIYATEC, Inc., today announced that Oregon Health & Science University (OHSU) Knight Cancer Institute has initiated patient enrollment into KIYATEC’s clinical study, 3D-PREDICT, to validate the company’s test as a patient-specific predictor of response to cancer therapies for solid tumors.

    In this clinical study, the test analyzes a patient’s live cancer cells, grown in KIYATEC’s laboratory within a biologically-relevant 3D microenvironment, to determine whether or not those cells respond to guideline-recommended cancer drugs. Evidence from the company’s earlier pilot study established a correlation between patient-specific predicted tumor response and actual patient clinical response to cancer therapy. The 3D-PREDICT study is a fully prospective, multi-institutional effort to validate the predictive accuracy of the test and correlate response predictions to clinical outcomes among patients with newly diagnosed and relapsed ovarian cancer, glioblastoma and certain rare tumors.

    At present, the OHSU Knight Cancer Institute is enrolling newly diagnosed and relapsed ovarian cancer patients into the 3D-PREDICT Study.

    “As a pioneer in personalized cancer care, the OHSU Knight Cancer Institute is deeply committed to optimizing appropriate therapy for our patients as early as possible following diagnosis, when the disease is most treatable,” said Dr. Koen De Geest, lead investigator of the clinical trial at OHSU. “Five-year survival among high-grade ovarian cancer patients is 30%, and we believe this test has the potential to help improve outcomes in the clinic.”

    “With cancer treatment, and especially ovarian cancer, time is of the essence and being able to measure patient-specific evidence of response and non-response before treatment begins can truly change the future of cancer care,” said Matthew Gevaert, CEO of KIYATEC. “We welcome OHSU to our clinical study and their participation will be integral as we work to deliver accurate predictions of patient response to cancer therapies, reducing the need for patients to undergo treatments that may not work.”

    The 3D-PREDICT study is anticipated to continue through 2022. Details on the trial can be found on https://clinicaltrials.gov/ct2/show/NCT03561207.

    About KIYATEC, Inc.
    KIYATEC is changing the future of cancer care by accurately predicting patient-specific response and non-response to therapies before treatment begins. Wasted time is the enemy of cancer patients and there is currently no way to accurately predict which cancer patients will respond to standard oncology treatments. KIYATEC has developed a validated process to use a cancer patient’s own live cells to 
    accurately predict treatment response prior to beginning treatment.