MEDGENE THERAPEUTICS, INC.
PBTL™ Therapy: The Next Wave in Cancer Treatment
MedGene Therapeutics
MedGene Therapeutics, Inc. is a pioneering T cell therapy biotech start-up (late pre-clinical stage) based in Maryland, USA formed to build foundational new cancer treatments based on the patented breakthrough by Dr. Steven A. Rosenberg and NIH for isolating a patient’s own anti-tumor lymphocytes from peripheral blood.
Medgene is focused on developing and commercializing PD1+ peripheral blood-derived tumor-reactive T lymphocyte (PBTL™) TIL therapies as a platform for the treatment of solid tumors that are rare, orphan, or have critical unmet needs.
This differs critically from current Tumor Infiltrating Lymphocyte (TIL) therapies now being practiced by NIH and others in a series of approved clinical trials worldwide, in which patient's anti-tumor lymphocytes are isolated directly from resected tumors. PBTL™ (PD1+ PBL) is a simpler, smarter version of TIL.
MedGene’s PBTL™ Therapy TIL platform for isolating and amplifying tumor reactive T-cells from easily obtained patient blood samples rather than in difficult and invasive tumor resections promises far less costly and less arduous future TIL therapies for patients.
PBTL™ Therapy
Technology
At MedGene Therapeutics, Inc., we seek to harness the body's own omnipresent cancer fighter, the killer (CD8+) T Cell, and supercharge its effects to allow the body to develop a more powerful and durable innate anti-cancer immune response. Cancer patients' own bodies generate targeted anti-tumor killer T Cells which are capable of attacking the malignancy. However cancers are adept at evading and neutralizing these natural killer T Cell defenses over time. So, this natural T Cell defense needs help to maintain its efficacy in the patient.
MedGene Therapeutics, Inc., by utilizing patented NIH technology developed by Dr. Steven A. Rosenberg, which isolates highly specific tumor-reactive CD8+ T Cells from the patient's own peripheral blood, is developing a less expensive, less invasive way of harvesting cancer-targeting lymphocytes that can then be greatly expanded and activated outside the body. By infusing these highly effective and greatly increased tumor-reactive T-Cells back into the patient, a much stronger anti-cancer response is possible, in effect supercharging the body's own defenses, This promises easier to tolerate treatments for less cost, easily obtained from blood draws. This PBTL™ Therapy leapfrogs current TIL therapies which require extensive tumor tissue sampling in order to obtain tumor-reactive lymphocytes,
Selection & Amplification
Tumor
Blood
Figure: TIL vs. PBTL™-TIL
The PBTL™ Therapy
TIL Advantage
MedGene Therapeutic's approach to harvesting a patient's tumor-reactive killer T Cells from peripheral blood gives it a tremendous advantage over conventional TIL therapy.
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In conventional TIL therapies, tumor-reactive killer T cells are harvested from tumor tissue itself, which must be resected by invasive surgery or needle biopsy, the tissue disaggregated, then subject to T-Cell selection prior to expansion and infusion (Figure, left loop).
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In MedGene's PBTL™ Therapy, tumor-reactive killer T cells are harvested from peripheral blood prior to expansion and infusion (Figure, center loop). Thus a simple blood draw is all that is needed to obtain tumor-reactive T Cells, avoiding costly and potentially harmful surgery. It also gives avenues of treatment to those patients whose malignancies cannot be resected.
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Current Pipelines
MedGene Therapeutics has the following Clinical Development Pipelines:
Entering Pre-Clinical Phase 1
NCT-201 (Metastatic Malignant Melanoma).
NCT-301 (Metastatic Esophageal Cancer).
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Pre-IND Stage
NCT-02 (MSTS_ Metastatic Soft Tissue Sarcoma).
NCT-401 (Ovarian Cancer).
NCT-01 (MFTC_ Metastatic Follicular Thyroid Cancer).
NCT-101 (MTS_ Metastatic Thyroid Cancer).
NCT-501 (TNBC).
NCT-601 (Cervical Cancer).
NCT-701 (Endometrial Cancer).
NCT-801 (HCC).
MedGene's Principles of Cancer Treatment
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• We build on and amplify the body’s natural defense against cancer using the patient’s own T lymphocytes.
• Our product is based on multiple cell lines of anti-tumor T cells and can thus recognize diverse neoantigens. (Solid tumors are very heterogenous.)
• Our product is designed to give a long-lived anti-cancer response with just a single application. It has the potential to establish immunological memory, thus requiring no additional maintenance therapy after infusion.
The MedGene Team
Rho H. Seong, Ph.D.
Senior Scientific Advisor (SAB)
Dr. Seong is a distinguished immunologist and professor at the Department of Biological Sciences at Seoul National University, where he also serves as Director of the Institute of Molecular Biology & Genetics. He is an expert in T-cell differentiation in the thymus, biogenesis of regulatory T cells, the role of transcription factors in T-cell development and early progenitor cell differentiation. Dr. Seong received his B.S. and M.S. from SNU and a PhD from Stanford University. He has served as a Dean of Research Affiairs of Seoul National University and also as an editor-in-chief of Molecules and Cells (The official journal of Korean Molecular and Cellullar Biology).
Yong H. (Henry) Park, M.D.
CEO
Dr. Park has focused on developing clinical applications of autologous cell therapy (Stem cells, Cytotoxic T cells, NK cells) for over 20 years. He holds a Certificate for Advanced Studies in Technology Transfer at the FAES (Foundation for Advanced Education in the Sciences) Graduate School at NIH. Previous he had been in the clinical field for more than 20 years as a Board-certified Orthopedic Surgeon in South Korea. Dr. Park holds an M.D. from Chonnam National University College of Medicine, a Masters Degree in Pathology from Chonnam National University, and is a Member of American Academy of Orthopedic Surgeons.
Yong W. Moon, M.D., Ph.D.
CMO
Dr. Moon is a preeminent oncologist and Associate Professor of Medical Oncology at the Department of Internal Medicine at CHA Bundang Medical Center, CHA University in South Korea. He has conducted many important global clinical trials and his research interests are breast, gynecologic and prostate cancers as well as resistance to targeted therapies, mouse tumor models and immunotherapy. Dr. Moon holds an M.D. and Ph.D. from Yonsei University College of Medicine in South Korea. He was a research fellow at the National Cancer Institute (USA) and a clinical fellow at the University of Texas MD Anderson Cancer Center.
James Song, M.D.
Board of Director, Medical Advisor
Dr. Song has been working in the clinical field for more than 15 years. He will provide key advice on clinical trials, help with all level of issues to do with organizations, such as hospitals, and provide broad insights into critical regulatory issues such as HIPAA. Dr. Song has an B.A. from the University of Chicago and M.D. from the University of Illinois College of Medicine, Chicago and is an American board-certified Radiologist with a subspecialty in MRI. He did a residency and fellowship at the Northwestern University Medical Center.
“The wound is the place where the Light enters you.”