Checkpoint Inhibitor Response Prediction Milestone Achieved in KIYATEC Study Detecting Ex Vivo Cancer Patient-Specific Immune ResponsePredictive 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
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.
KIYATEC Advancing Functional Ex Vivo 3D Cell Culture Models that Reveal Response Dynamics to Immuno-Oncology DrugsKey evidence to be presented at AACR 2020 see more
KIYATEC, Inc. today announced that it will present data at the 2020 American Association for Cancer Research (AACR) Annual Meeting, June 22-24, revealing how its 3D cell culture models characterize ex vivo tumor response and immunoreactivity to immune checkpoint inhibitors (i.e. PD-1, PD-L1 inhibitors) in solid tumors. These emerging capabilities address a significant unmet need in both preclinical drug development and clinical decision-making in oncology.
PD-1/L1 inhibitors have experienced meteoric growth over the last decade, offering hope to hundreds of thousands of cancer patients every year in the US alone. However, typically no more than 25-30% of eligible cancer patients who receive PD-1/L1 inhibitors actually respond to them. Given that the direct costs associated with PD-1/L1 therapy can run into the hundreds of thousands of dollars per patient, KIYATEC believes that pre-treatment, patient-specific PD-1/L1 response prediction could one day offer clinicians, patients and payers a more objective basis for determining PD-1/L1 inhibitor patient eligibility vs. today’s commonly used population-based biomarkers.
Evidence presented by KIYATEC at AACR 2020 will highlight findings of the company’s ability to detect dose-dependent response to checkpoint blockade and corresponding correlation with immune cell activation in high-throughput ex vivo 3D tumor spheroid models. KIYATEC believes these recent advances may represent key building blocks toward the eventual development and validation of clinical assays capable of accurate pre-treatment, patient-specific prediction of response to immuno-oncology drugs.
“We’re constantly innovating and expanding the capabilities of our 3D cell culture technologies to reduce the cost and risk of preclinical drug development for our immuno-oncology customers,” said Matthew Gevaert, CEO of KIYATEC. “As we continue to make these advances in immuno-oncology drug response on higher-throughput platforms, we can begin to envision a time when such capability would inform clinical decision-making for cancer patients as well.”
KIYATEC’s poster presentations at AACR 2020 are as follows:
- Abstract: 7397 / Poster: 315 / Session: 3D & Tissue Recombinant Models / June 22-24
Title: PARP inhibition in combination with pembrolizumab enhances cytotoxicity in ovarian cancer patient-derived 3D spheroids
- Abstract: 7132 / Poster: 2244 / Session: Immune Checkpoints 2 / June 22-24
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 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. 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. To learn more about KIYATEC, visit www.kiyatec.com.
KIYATEC Adds Clinical and Reimbursement Experience to Board as Clinical Testing Validation ProgressesKIYATEC adds to its Board of Directors see more
KIYATEC, Inc. today announced the appointment of Bruce Nash, MD, MBA, to its Board of Directors. Dr. Nash brings over 30 years of executive-level healthcare experience in the managed care, hospital and medical group practice settings. Currently, he serves as Chief Physician Executive and Senior Vice President at Blue Cross Blue Shield of Massachusetts, one of the nation’s leading health insurance plans. During his career, Dr. Nash has held executive leadership positions in both managed care (Kaiser Permanente, Capital District Physicians’ Health Plan) and healthcare (Northern Berkshire Health System, North Adams Regional Hospital) organizations.
Dr. Nash serves on the boards of the Blue Cross Blue Shield Foundation and the Network for Excellence in Health Innovation (NEHI), while also serving on the Board of Strategic Advisors at the Excel Venture Management Fund and the Clinical Advisory Group at the Blue Venture Fund. He is a board-certified physician who completed his residency training at Duke University. Bruce earned his MBA in Health Sector Management from Duke University's Fuqua School of Business.
“We are delighted to welcome Dr. Nash to KIYATEC’s Board of Directors,” said Robert Silverman, Chairman of the Board of Directors of KIYATEC. “Bruce’s relevant experience and vision as both a clinician and an expert in managed care will provide tremendous value as KIYATEC moves forward in the development of our predictive clinical tests to improve cancer patient care and outcomes.”
The addition of Dr. Nash to the KIYATEC Board of Directors comes as the company’s evidence development efforts continue to gain momentum:
- 3D-PREDICT Study (NCT03561207) of clinical tests to predict pre-treatment drug response to drug therapies for ovarian cancer and high-grade glioma continues to add study sites and enroll patients
- Pilot study publication entitled, “Prospective Validation of an Ex Vivo, Patient-Derived 3D Spheroid Model for Response Predictions in Newly Diagnosed Ovarian Cancer,” was recognized this spring by Scientific Reports (Nature Research) as being one of its Top 100 cancer papers of 2019 (of >1,000 published)
- Emerging evidence of I/O (immuno-oncology) drug response characterization to be presented via multiple posters at AACR in June
About KIYATEC, Inc.
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 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
Subject matter leaders from across Palmetto State to cover what businesses need to know see more
March 9, 2020 – SCBIO will host a full day program March 17 -- Life Sciences Boot Camp: Insights on SC’s Fastest-Growing Industry – to inform and update businesses and professionals from across the state on opportunities, trends and issues facing South Carolina’s fastest-growing industry segment.
To be held at the SC Hospital Association’s Yates Conference Center in Columbia, the program will run from 8:30 a.m. until 1 p.m. and will feature a light breakfast followed by presentations from over 15 noted life sciences industry leaders. Confirmed topics and speakers include:
- Best Practices in Life Sciences Recruiting & Retention – addressing how the state’s life sciences leaders are attracting, training and retaining top talent will be Lou Kennedy, CEO of Nephron Pharmaceuticals; Shawn Regan, CEO of Rhythmlink; Andrew Lee, Founder of IMCS, and Matt Vaadi, CEO of ERG
- Partnering Effectively with Higher Education & Research Universities – ways to tap into the wealth of resources, knowledge and experience prevalent in the state’s higher education and research universities will be explained by a panel comprised of Anthony Herrera, Executive Director of Furman University Entrepreneurship & Innovation; Angela Lockman, Director of Partnerships and Strategic Initiatives for Clemson University; Chad Hardaway, Assoc. Director of the University of South Carolina Office of Economic Engagement; Carol Moore, President of Columbia College; and Michael Rusnak, Executive Director, MUSC Foundation for Research Development
- Accessing Capital to Grow Your Life Sciences Organization – the secrets to finding capital to grow and expand your organization, from start-up to growth company, will be unveiled by John Osborne, Principal with Good Growth Capital; Jill Sorensen, Executive Director of SC Launch; and Tyler Tatum of 3Phase SC
- Attracting & Retaining Life Sciences Organizations – three economic development experts will share how the Palmetto State is going about growing the life sciences industry here, and what plans are to make it even more attractive tomorrow. Speaking will be Stephanie Few, Partner with Womble Bond Dickinson; Jeremy Migliara, Shareholder with Elliott Davis; and Will Clarke, Manager with Elliott Davis
- Protecting Your Life Sciences Organization from Cybercrime – will be addressed by cybersecurity expert Delano Collins, Vice President of Cybersecurity with Corsica Technologies. He’ll address how planning defense in depth -- from network and systems security to industry compliance and employee training -- can set organizations up for security and success.
SCBIO Investor Organizations receive one registration at no charge, and additional attendees from Investor organizations as well as SCBIO registered Members pay only $50 for the program. The general public and Non-Members can attend for just $100. Fees include the full program, plus a light breakfast and lunch. To register or for more details, visit the Events page at www.SCBIO.org/. Interested students and media members are invited to attend, with advance registration, at no cost.
SCBIO is South Carolina’s investor-driven public/private economic development organization exclusively focused on building, advancing, and growing the life sciences industry in the state. The industry has an $11.4 billion annual economic impact in the Palmetto State, with more than 675 firms directly involved and 43,000 professionals employed in the research, development and commercialization of innovative healthcare, medical device, industrial, environmental and agricultural biotech and products. The state-wide nonprofit has offices in Greenville, Columbia, and Charleston, and represents companies in the advanced medicines, medical devices, equipment, diagnostics, IT, and healthcare outcome industries. Life sciences is recognized as the fastest-growing segment of South Carolina’s knowledge economy.
Spartanburg Regional's Gibbs Cancer Center to open expanded facility see more
With a seven-story, $72 million expansion set to open on March 16, Spartanburg Regional Healthcare System’s Gibbs Cancer Center plans to offer patients treatment beyond traditional chemotherapy and radiation.
At a ribbon-cutting held Thursday, staff unveiled the 191,000-square-foot expansion. The center includes a new physical therapy gym, patient accessible-kitchen, retail shop featuring wigs and prosthesis-fitting services and an on-site outpatient pharmacy. The facility offers radiation, medical and surgical oncology along with cyber knife technologies, centralized lab services, genetic counseling and an integrative medicine center.
“We’re blessed in the Upstate to have a world-class cancer center here that enables patients not to have to travel far,” said Tony Kouskolekas, Pelham Medical Center’s president. “They are able to get first-quality opinions and recommendations on cancer care, and what makes us a little different is that our doctors are committed to what we call multi-disciplinary care. Historically, they have gotten together to discuss someone’s case once someone was diagnosed with cancer. Now, the design of this building will allow them to come together while patients are in the building for multidisciplinary clinics, so that patients can get opinions from multiple providers while they are here for one visit.”
Kouskolekas expects that the center will bring 80 jobs to the area in its first stages, but notes that there is plenty of room to grow as needed.
“To be involved with the planning of this and working with our cancer team has just been another great facet, Kouskolekas said. “Our campus is poised for growth: we have plenty of land and so if we need to do something, we certainly can.”
According to Dr. Michael Starnes, Gibbs Cancer Center’s radiation oncology director, 36 exam rooms have been reserved for the March 16 opening, bringing the center to 75% capacity. Starnes said the center prioritizes clinical research and holistic care alongside traditional treatment measures. The integrative medicine center will allow patients a bridge to recovery through massage and art therapy, tai chi and cooking classes recorded for outpatient survivors to follow.
The new space raises the center’s capacity from less than 10 infusion treatment beds to 40 treatment rooms.
Dr. Heather Allen, a radiology oncologist at Gibbs Cancer Center, noted that the new facility streamlines and strengthens collaborative treatment opportunities spearheaded by oncologists Drs. James Bearden and Julian Josey when they founded the Gibbs Cancer Center 40 years ago.
“They were ahead of the game. This is the model that works, but it wasn’t in place 40 years ago. It was their vision to take a new paradigm shift in cancer treatment and bring it home to the local area,” Allen said.