NKore News
We are on the brink of groundbreaking advancements in cancer immunotherapy. Keep an eye on our page for the latest news and developments that could change the landscape of treatment for patients of all ages.
FDA Grants NKore BioTherapeutics, Inc. a Type B Pre-IND Meeting for Lead Supercharged NK Cell Therapy Candidate NK101
LOS ANGELES, CA, UNITED STATES, July 29, 2026
NKore BioTherapeutics, Inc. ("NKore" or the "Company"), a biotechnology company developing next-generation Supercharged Natural Killer (sNK™) cell therapies for cancer, announced that the U.S. Food and Drug Administration (FDA) has granted the Company's request for a Type B pre-Investigational New Drug (pre-IND) meeting for its lead product candidate, NK101.
The Company submitted its meeting request on June 24, 2026, received a pre-IND number, has been granted a formal meeting with the FDA. NKore and also completed and submitted its pre-IND briefing package, marking the Company's first formal regulatory interaction with the agency and an important milestone toward a planned U.S. IND submission for NK101.
NK101 is an allogeneic Supercharged Natural Killer (sNK™) cell therapy built upon more than three decades of immunology research led by Dr. Anahid Jewett at UCLA. The Company's proprietary platform is designed to enhance the innate cancer-fighting capabilities of Natural Killer cells while supporting scalable, potentially off-the-shelf cellular immunotherapies for multiple oncology indications.
"Reaching this milestone reflects the coordinated efforts of our clinical, regulatory, manufacturing, quality, product development, and executive teams. It demonstrates that NKore has established the strategic infrastructure necessary to advance a complex cellular immunotherapy program through the U.S. regulatory pathway," stated Dr. Aaron U. Levy, Chairman and Chief Executive Officer of NKore BioTherapeutics, Inc.
The FDA's pre-IND process enables sponsors to obtain regulatory feedback before submitting an IND application. The Company's briefing package requests FDA input on key aspects of the NK101 development program, including manufacturing and product characterization, nonclinical pharmacology and safety, available human clinical experience, planned IND-enabling toxicology studies, dose selection, and the proposed design of NKore's first U.S. clinical trial.
Dr. Aneel Paulus, Medical Advisor to NKore and a member of the Company's Board of Directors, commented, "This meeting represents the beginning of an important regulatory dialogue with the FDA rather than an endpoint. Under Dr. Levy's leadership, NKore has strengthened its regulatory, manufacturing, and operational capabilities while consolidating manufacturing, nonclinical, and clinical information into a comprehensive submission. We believe this disciplined approach positions the Company well as it advances toward an IND filing."The Company believes the pre-IND process provides an important opportunity to identify and address regulatory considerations early in development.
NKore intends to incorporate the FDA's feedback into its ongoing development plans and wishes to acknowledge the contributions of its scientific advisors, employees, consultants, Board of Directors, shareholders, and research collaborators whose efforts supported this milestone.
Disclaimer: NK101 is an investigational product and has not been approved by the U.S. Food and Drug Administration or any other regulatory authority. The safety and effectiveness of NK101 have not been established. The submission of a pre-IND briefing package and the granting of a pre-IND meeting do not constitute FDA review, acceptance, or endorsement of NK101 or of any clinical data generated to date.
About NKore BioTherapeutics, Inc.
NKore BioTherapeutics, Inc. is a biotechnology company developing proprietary Supercharged Natural Killer (sNK™) cell therapies for the treatment of cancer. Built upon more than three decades of immunology research led by Dr. Anahid Jewett at UCLA, the Company's lead product candidate, NK101, is an allogeneic Supercharged NK cell therapy designed to enhance the natural cancer-fighting capabilities of Natural Killer cells. NKore's proprietary platform is designed to amplify NK cell cytotoxic activity while supporting the development of scalable, potentially off-the-shelf cellular immunotherapies across multiple oncology indications.
Forward-Looking Statements
This press release contains forward-looking statements regarding NKore BioTherapeutics' development programs, regulatory activities, clinical plans, and future business objectives. These statements are based on current expectations and involve risks and uncertainties that could cause actual results to differ materially from those expressed or implied. Completion of a pre-IND submission or receipt of FDA feedback does not guarantee acceptance of an IND application, initiation of clinical trials, regulatory approval, or commercial success. FDA feedback is advisory and non-binding, and the Company cannot predict when or whether it will submit an IND application. NKore undertakes no obligation to update these forward-looking statements except as required by applicable law.
May 22, 2026:
Dr. Jason Chiang (M.D., Ph.D), officially accepts an invitation to join NKore’s Medical Advisory Board
I am very pleased to announce that Jason Chiang, M.D., Ph.D., a physician-scientist at UCLA, specializing in image-guided therapies for solid tumors, has officially accepted an invitation to join our Medical Advisory Board of NKore BioTherapeutics, Inc.
As part of the continued transformation of NKore from an early-stage startup into its next phase of scientific and clinical advancement, Dr. Chiang will play an important role in supporting the transformation and continue advancement of Supercharged NK (sNK) technology toward future clinical development and clinical trials.
An interventional radiologist specializing in minimally invasive, image-guided cancer therapies, Dr. Chiang’s research focuses on improving the precision and efficacy of cell-based immunotherapies while minimizing side effects for patients. His work integrates medical imaging, engineering, and immunology to optimize the delivery of energy-based therapies and immunotherapies targeting solid tumors, particularly liver cancer.
Dr. Chiang’s research focuses on optimizing image-guided, energy-based therapies to eliminate tumors of the lung, liver, and kidney, with a particular emphasis on hepatocellular carcinoma (liver cancer). His work utilizes advanced imaging techniques to guide needles and catheters precisely to tumors and targeted blood vessels, enabling localized therapy delivery while minimizing damage to healthy tissue. These minimally invasive approaches often allow patients to return home shortly after treatment.
Dr. Chiang credited his involvement in the NK cell therapy field to the mentorship and scientific influence of the late Dr. Jewett. He stated: “Supercharged NK cells are a legacy of Dr. Jewett’s work and one of the reasons I got into the field. Its efficacy on a variety of solid tumors and favorable safety profile stands on its own in the rapidly growing field of allogeneic cell-based immunotherapies. I look forward to helping move sNK from bench to bedside to improve patient health, especially in those that have failed standard-of-care systemic therapies.”
Dr. Chiang also shared his experience working alongside Dr. Jewett during the early stages of his academic career. He recalled regularly collaborating with her laboratory, reviewing experimental data together, and co-mentoring postdoctoral researchers, graduate students, and undergraduate students. Their combined expertise in translational medicine and NK cell immunotherapy resulted in multiple peer-reviewed publications, external research funding, and donor-supported initiatives. Today, his laboratory remains one of the few radiology-based programs with a dedicated focus on cell-based immunotherapies.
His research additionally explores aggressive liver cancers through the study of cancer stem cell markers and tumor metabolism. By leveraging clinically relevant large-animal tumor models, Dr. Chiang aims to bridge laboratory discoveries with clinical applications and accelerate the translation of novel NK cell-based therapies into patient care.
Looking ahead, I am enthusiastic and confident that Dr. Chiang will be an outstanding addition to NKore’s Medical Advisory Board and will help guide the Company’s scientific and clinical direction as we continue advancing Dr. Jewett’s legacy and working to bring innovative cancer therapies to patients worldwide.
Please join me in warmly welcoming Dr. Jason Chiang, to the NKore BioTherapeutics Medical Advisory Board.
May 12, 2026:
Dr. Aneel Paulus joins NKore BioTherapeutics, Inc.’s Board of Directors
As part of the continued restructuring, and transformation of NKore BioTherapeutics, Inc. into its next phase of growth and clinical advancement, I am very pleased to formally announce that Dr. Aneel Paulus has accepted my invitation to join the Board of Directors of NKore,
Dr. Paulus has already served as a trusted medical advisor to NKore for more than two years and has made meaningful contributions to the organization during a critical stage of our development. He personally undertook the due diligence and medical review associated with approving NKore’s first patients' treatments, coordinated with external clinicians to assist in the design of future clinical trial strategies, and helped establish important criteria for patient qualification, oversight, and care.
Aneel Paulus, MD, MS, is a highly accomplished physician-scientist, biotech executive, and inventor, served on the faculty of Mayo Clinic, and has more than 17 years of experience translating laboratory discoveries into clinical-stage therapies for cancer patients. His drug development experience spans the full spectrum from preclinical research through early-stage clinical development across small molecules, therapeutic antibodies, bispecific NK-cell engagers, and lipid nanoparticle therapeutics.
For more than a decade, Dr. Paulus served on the faculty of Mayo Clinic Florida, most recently as Associate Professor of Medicine and Head of Translational Research in Mature B-Cell Cancers. There, he led multidisciplinary teams of physicians, laboratory scientists, and clinical research professionals focused on advancing innovative therapies for multiple myeloma, chronic lymphocytic leukemia, Waldenström macroglobulinemia, mantle cell lymphoma, and other hematologic malignancies.
Throughout his career, Dr. Paulus has contributed to the scientific rationale, design, endpoints, and translational strategy of multiple Phase I and Phase II oncology clinical trials. He has also maintained scientific advisory and sponsored research relationships with several leading oncology and biotechnology organizations, including AbbVie, Janssen, Pharmacyclics, Bristol Myers Squibb, Bayer, Genentech, Roche, Ascentage, Affimed, Xencor, and Millennium Pharmaceuticals.
Dr. Paulus is also a named inventor on four patents involving novel cancer therapeutic approaches, including proteasome inhibitors, dual BTK/PI3K inhibitors, methods for identifying proteasome inhibitor resistance, and individualized cancer vaccines.
His scientific accomplishments include more than 55 peer-reviewed publications, four book chapters, an H-index of 26, more than 2,100 scientific citations, and dozens of invited national and international lectures. In addition to his oncology and translational medicine work, Dr. Paulus is also a founder of West Eastern Health, an integrative mental health and human optimization center focused on advancing holistic approaches to patient wellness and performance.
Dr. Paulus earned his BS/MD from Windsor University and his Master of Science in Interdisciplinary Sciences through the State University of New York at Buffalo in collaboration with Roswell Park Cancer Institute.
Dr. Paulus stated "Having had the opportunity to closely observe Aaron’s leadership during this transition, I have developed strong confidence in both the direction of the Company and the strategic vision now guiding NKore forward. As a result, I was honored to accept Aaron’s personal invitation to join the NKore Board of Directors and partner with him in helping guide the Company through this important next phase of clinical and organizational growth."
Looking ahead, I am confident that Dr. Paulus will be an outstanding addition to our Board of Directors and will play an important role in helping guide NKore’s scientific, clinical, and strategic direction as we work to advance Dr. Jewett’s legacy and bring innovative cancer therapies to patients worldwide.
Please join me in warmly welcoming Dr. Paulus to the NKore's Board of Directors.
