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oncology

  • sam patrick posted an article
    Expanded use of test builds on previous month’s publication of successful interim clinical data see more

    Functional precision oncology innovator Kiyatec announced today that it is initiating use of the 3D Predict™ Glioma test outside of its 3D-PREDICT clinical study. Recently published peer-reviewed data demonstrated successful use of this test for patients with either newly diagnosed or recurrent high-grade gliomas, which includes glioblastoma (GBM).

    In choosing July 21, 2021, to announce the expanded use of its test, KIYATEC joins the country in shining a light on glioblastoma, which is the most common, treatment-resistant, and deadliest type of brain cancer. A recent bipartisan U.S. Senate resolution declared today as Glioblastoma Awareness Day in order to highlight the severity of GBM, and show support for individuals who are currently living with GBM, as well as caregivers and families. Additionally, the resolution encourages continued investment into glioblastoma research and treatments.

    “At the core of KIYATEC’s mission is the desire to improve cancer patients’ lives. We’re excited to take the next step in fulfilling this mission by expanding the use of our testing for patients with GBM, which is such an aggressive cancer with few treatment options,” said Lillia Holmes, Chief Operations Officer at KIYATEC.

    In a patient, the biological interaction between their live cancer cells and the administered therapy drives treatment outcomes. Measurement of this interaction, before prescribing a treatment plan, is not typically part of today’s cancer treatment paradigm. KIYATEC’s test results add this measurement into the information that informs oncologists’ treatment decisions for a given patient. This approach translated to patient benefit while demonstrating clinically relevant accuracy, as documented in the June Neuro-Oncology Advances publication.

    The 3D Predict™ Glioma test is designed to work within the current framework of standard of care for high-grade glioma patients. Since live cells are required for the test, a patient’s oncologist must sync sample submission with the timing of the first surgery for newly diagnosed patients, or recurrent surgeries for relapsed patients. Oncologists interested in the potential use of the test to inform their decision-making, or requesting test kits to provide samples, should contact the company at medical.affairs@kiyatec.com.

    “Our goal is to provide oncologists with a more effective decision-making tool, by combining individual patient’s cancer cells with potential treatment drugs,” said Stephen Shuford, first author on the company’s recent Neuro-Oncology Advances publication.

    The Senate resolution recognizes that:

    • The five-year survival rate for GBM patients is 7%,
    • The median length of survival is 8 months,
    • Approximately 13,000 Americans will be diagnosed with GBM in 2021,
    • Brain cancer has the highest per-patient initial cost of care, and
    • Despite being first described over a century ago, there are only four FDA approved drugs and one device for GBM.

    KIYATEC aims to make a meaningful impact for patients who are facing this challenging cancer.

    About KIYATEC

    KIYATEC is a functional precision oncology company that measures the response of each patient’s live cancer cells to inform oncologists’ treatment selection decisions. The company’s Clinical Services business offers or is developing clinical tests for high-grade glioma, ovarian, breast, and non-small cell lung cancers, and rare tumors in its CLIA-certified lab. 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
    Goal to develop innovative products focused on improving the health of state residents see more

    Compliments of Charleston Regl. Business Journal

    The Medical University of South Carolina’s Department of Surgery Human-Centered Design Program and The Citadel Tommy and Victoria Baker School of Business Innovation Lab will collaborate on a joint effort.

    The program will create a core team of medical students, residents and Citadel cadets and students who will develop innovative products focused on improving the health of state residents, MUSC said in a news release.

    Both programs similarly promote innovative thinking. The BSB Innovation Lab focuses on teaching students the value of ground-breaking thinking and offers then the chance and guidance to invent and helm business ideas, build out a business plan and pitch ideas to investors.

    MUSC’s HCD program was founded to develop original ways to solve unmet surgical and medical needs. The program is led by Joshua Kim and was established under the leadership of chief of surgical oncology Dr. David Mahvi and vice chair of research Michael Yost, Ph.D.

    The two programs were brought together in March 2020 when the country faced protective mask shortages, particularly N-95 versions, as the pandemic picked up pace.

    During that time, Kim’s team of biomedical engineers and medical professionals developed plans for 3D-printed masks. The BSB Innovation Lab then collaborated with MUSC to print more than 500 masks to help to resolve the region’s shortage.

    “Through this new partnership, we can seamlessly innovate a design, develop a business plan and produce products that improve patient care,” said Mahvi.

    By coming together, the partnership promotes collaboration, academic growth and learning opportunities students may not have experienced in their respective schools. Residents and medical students are immersed in business training and entrepreneurship skills, while business students are exposed to the health care system.

    By working together, Capt. James Bezjian, director of the Innovation Lab and an assistant professor of strategy and entrepreneurship in the Baker School of Business, said the schools are able to work on projects that have “life-changing” capabilities.

    “The relationship the BSB Innovation Lab built with MUSC during the height of the pandemic provided an opportunity for us to partner and continue working toward improving the lives of medical professionals and the patients they take care of,” Bezjian said.

  • 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
    Clinical trials are saving lives in South Carolina see more

    When he was diagnosed with stage 4 lung cancer in 2011, Jimmy Alexander wasn’t expected to live more than a year.

    So doctors enrolled him in a clinical trial of a new chemotherapy cocktail hoping it might make a difference.

    Eight years later, the Simpsonville man is still enjoying Clemson football and time with his family, including two daughters, five grandchildren and six great-grandchildren.

    And now the program that helped Alexander is being expanded into the Midlands with an $8.2 million grant awarded Friday by the National Cancer Institute’s Community Oncology Program, or NCORP.

    “People just don’t realize what clinicals may be able to do,” Alexander said. “They can be a lifesaver.”

    Clinical trials are conducted to determine whether a treatment works while offering patients a shot at experimental therapies that aren’t otherwise available through normal channels.

    They provide physicians with new weapons in the battle against cancer, said Dr. Larry Gluck, medical director of Prisma Health-Upstate’s Cancer Institute in Greenville, which was awarded the grant.

    “Because of our NCI designation and support,” he said, “we can offer hundreds of leading-edge clinical trials that can provide treatments to patients years before approval by the FDA for general use.”

    More than 300 clinical trials are underway at Prisma’s Cancer Institute at any time and the hospital has been awarded more than $30 million in NCI grants since 1995, according to Prisma, formerly Greenville Health System.

    “What we learn from one patient helps that patient – but also many many more,” said Dr. Jeff Giguere, a Prisma oncologist.

    “A unique aspect of research via the NCORP grant is that it interrogates every point on the cancer continuum from diagnosis, treatment, supportive care," he said, "as well as proactively evaluates cancer prevention and more effective and efficient ways of delivering cancer care.”

    The latest six-year grant will enable trials for lymphoma, leukemia and solid tumors to begin in the Midlands this fall. 

    “Our goal ... is to continue to serve our Upstate patients with strengthened options here and extend our reach and expertise to the legacy Palmetto Health institutions via Prisma Health,” said Giguere. “We hope to meet an unmet need for our state.”

    There was no guarantee when Alexander was enrolled in the trial that he would benefit from the drugs. But the 78-year-old said he would have participated anyway in case it would help others.

    “If whatever I am doing helps other people, I was glad to do it,” he said. “But here I am eight years later.”

    Alexander said his cancer is stable, thanks to a weekly infusion of a drug called Erbitux, which is provided through the trial.

    Fortunately, the retired engineer was able to live to see a great-granddaughter born seven months ago.

    “I’m doing pretty good. The only problem I have is old age,” he says with a chuckle. “I’m still around to play with her. It’s a great, great thing.”

  • sam patrick posted an article
    KIYATEC closes on new round of financing see more

    GREENVILLE, SC. – May 1, 2019 – KIYATEC, Inc. today announced the initial $3 million closing of the company’s series B2 financing round. The round was led by VentureSouth and included LabCorp® (NYSE: LH).

    “This validation and confidence by our investors, coupled with the exciting progress of our clinical trials, puts us on the path toward the next phase of growth and development,” said Matthew Gevaert, CEO of KIYATEC. “We are particularly excited to welcome LabCorp as a new investor because of the depth and breadth of their expertise in oncology.  With the preclinical and clinical development strengths of LabCorp’s Covance Drug Development business, and their corporate position as a world leader in clinical testing, there is great potential synergy across the many ways KIYATEC’s technology can be used to improve cancer care.”

    Proceeds from the financing will go toward KIYATEC’s ongoing clinical study, 3D-PREDICT, to validate KIYATEC’s proprietary assay as a patient-specific predictor of response to cancer therapies for solid tumors. The test analyzes a patient’s live cancer cells, grown in KIYATEC’s laboratory within a biologically relevant 3D microenvironment, to determine whether those cells respond to guideline-recommended cancer drugs. 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.

    The company has gained significant momentum in 2019.  Recently, at the 110th Annual Meeting of the American Association for Cancer Research (AACR), KIYATEC demonstrated leading capabilities in modeling and predicting response to immuno-oncology therapies including checkpoint inhibitors. On April 10, KIYATEC was one of 20 companies recognized nationally on Capitol Hill as part of the 2019 University Innovation & Entrepreneurship Showcase.  In the first quarter of 2019, KIYATEC added three clinical sites to its 3D-PREDICT study and expects to continue its momentum by adding additional sites in the second and third quarters.

     

    About KIYATEC, Inc.

    KIYATEC is dedicated to accurately modeling and predicting cancer patient response to drug therapies, using ex vivo 3D cell culture technology, in order to inform clinical decision making and drive drug development. Our predictive clinical tests provide oncologists with patient-specific response profiles to current standard of care drugs prior to treatment selection. Our predictive 3D models are being used by leading biopharmaceutical companies to increase the success of their preclinical and clinical drug development programs as they develop the cancer therapies of the future. www.kiyatec.com.

  • sam patrick posted an article
    MUSC, Cumberland Emerging Technologies collaborate to develop biomedical products see more

    The technology transfer organization for the Medical University of South Carolina, the MUSC Foundation for Research Development, and Cumberland Emerging Technologies Inc. have entered into a collaboration agreement to develop new biomedical products.

    Consistent with their longstanding commitment to biomedical innovation and translational research, CET and the MUSC Foundation for Research Development have agreed to collaborate on future co-development programs that combine the strengths of each institution with the goal of advancing new technology to clinical practice.  Under the agreement, CET will evaluate MUSC discoveries, license intellectual property rights to promising technologies, and partner with MUSC research scientists to advance product development toward commercialization.  CET will pursue new sources of funding for these projects through the Small Business Technology Transfer and Small Business Innovation Research and other grant programs. New development programs are expected to span a variety of therapeutic areas including oncology, inflammatory diseases, and cardiovascular disease. 

    "Our office receives over 100 product ideas a year, most of which require an industry partner to be further developed," said Michael Rusnak, the executive director of the MUSC Foundation for Research Development. "We are very enthusiastic about having Cumberland as a collaborator to aid in getting technologies to market and ultimately to the patient."

    "We are very pleased to have the opportunity to partner with the MUSC Foundation for Research Development to develop technologies invented at MUSC, a nationally-recognized biomedical research institution," said A.J. Kazimi, chief executive officer of Cumberland Pharmaceuticals and CET. "We are excited to facilitate the introduction of promising new products by combining our expertise in drug development and commercialization with the MUSC's research initiatives."