MEDGENE THERAPEUTICS, INC.
PBL-T™ Therapy and RIV-8: Redefining Cancer Therapies
MedGene Therapeutics is:
Two Breakthrough Cell Therapies
MedGene Therapeutics is developing twin foundational technologies for cell therapy targeting solid tumors.
PBL-T™ is a version of Tumor Infiltrating Lymphocyte (TIL) therapy based on obtaining anti-cancer T cells from blood rather than tumor tissue. Developed by Dr. Steven A. Rosenberg, this technology was patented by NIH and is exclusively licensed to MedGene.
RIV-8™ is an anti-T cell exhaustion protocol which both prevents and reverses the problem of the persistent fading of T cell anti-tumor activity in patients, Developed by Dr. Rho H. Seong, MedGene's Chief Science Advisor, RIV-8™ is owned exclusively by MedGene.
The use of both technologies together in a patient's cancer treatment, is called AUTO-T™ therapy.
MedGene Therapeutics is based in Maryland, but also has a world class research team and company principals in South Korea, providing the best of both worlds. MedGene is closely aligned and working with NIH, FDA, and the unmatched US private and public pharmaceutical infrastructure, while utilizing the research depth and capacity of South Korea’s top immunology and oncology experts for bold new steps in cell therapies for solid tumor cancer.
A Company Built by Scientists
PBL-T™ Technology
MedGene Therapeutics seeks to harness the body's own cancer fighter, the killer (CD8+) T cell, and supercharge its effects allowing the body to develop a more powerful and durable, innate anti-cancer immune response. Cancer patients' own bodies create targeted anti-tumor killer T cells which are capable of attacking the malignancy.
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, MedGene Therapeutics is developing a less invasive, less expensive method of harvesting cancer-targeting lymphocytes. The T cells can be greatly expanded outside the body in a sterile lab. By reinfusing 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 a lower cost. Current TIL therapies require extensive tumor tissue sampling in order to obtain tumor-reactive lymphocytes. PBL-T™ therapy provides a simple alternative.
Anti-tumor T Cell Selection & Amplification
Tumor Tissue
(TIL)
Blood Draw
(PBL-T)
Disaggregation
Figure: TIL vs. PBL-T™ TIL
The PBL-T™ 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.
In conventional TIL therapies, tumor-reactive killer T cells are harvested from tumor tissue, which must be resected by invasive surgery or needle biopsy. The tissue is then disaggregated, subjected to T cell selection prior to expansion and infusion (Figure, left loop).
In MedGene's PBL-T™ therapy, tumor-reactive killer T cells are harvested from peripheral blood prior to expansion and infusion (Figure, center loop). Thus a routine blood draw is all that is needed to obtain tumor-reactive T cells, avoiding costly and potentially harmful surgery. PBL-T™ also presents an avenue of treatment to those patients whose malignancies are inoperable.
RIV-8 Technology: Full
T Cell Revitalization
TIL's Challenge: T Cell Exhaustion
Cellular anti-cancer therapies rely on strong effector T cell anti-tumor activity to find and destroy cancer cells. Maintaining the T cell’s optimum cancer cell destruction capacity is a challenge in the tumor microenvironment—a setting that mimics chronic infection causing increased expression of inhibitory receptors, poor effector function, loss of ability to express key cytokines, like IL-2 and IFN-γ, as well as unique transcription and epigenetic states that lead to progressive exhaustion and eventually cell death.
Solution: The RIV-8 Revolution
Dealing with an obstacle as complex as T cell decline in the tumor microenvironment required an equally complex solution. RIV-8 was developed over years of study and careful refinement in the lab of leading immunologist Dr. Rho H. Seong at Seoul National University. RIV-8 is a multifaceted protocol dealing with each aspect of T cell enervation in turn: rising of inhibitory receptors, replacing negative cytokine environments with positive ones, and making key epigenetic alterations, such as methylation changes.
Far more comprehensive than the checkpoint inhibitors which are now approved for over 40 cancer types,
RIV-8 has been patented and MedGene Therapeutics owns the exclusive IP rights. Research findings announcing this breakthrough were published in the journal Science Advances (11/29/2022) and can be found at the link below.
RIV-8 Protocol Reverses and
Protects Against T Cell Decline
The RIV-8
Advantage
MedGene Therapeutic's newly patented RIV-8 protocol promises a major advance for all cell therapies, including MedGene's own PBL-T™ therapy. It can be used for TIL, CAR-T, TCR and any other T cell therapy to combat the ubiquitous problem of T cell exhaustion.
The Key Features: RIV-8
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Comprehensive, breakthrough T cell reinvigoration technology
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Patents filed in South Korea, PCT and USA
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MedGene holds sole ownership
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RIV-8 enhances CD8 T cell effector function and promotes the differen-tiation into a transitory effector subset
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Partly based on ex-vivo epigenetic reprogramming
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Surpasses current PD-1 checkpoint inhibitor treatments
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Can be used for any adoptive cell therapy using T cells
Our Vision: AUTO-T™ Program
Combining the technologies of PBL-T™ and RIV-8, our AUTO-T™ utilizes the two innovative therapies working in tandem to bring the patient to better health. Patients will get the benefits of PBL-T™ over TIL (no surgery, better quality T cells), as well as the benefit of RIV-8 (overcoming T cell exhaustion) to allow their body's immune system to overcome solid tumor cancers.
PBL-T ™
AUTO-T ™
Changing the game in cancer immunotherapy
Current Pipeline
MedGene has robust breakthrough pipeline ready for clinical study, with three INDs in preparation:
• Two for PBL-T™ (Liquid TIL)
• One for AUTO-T™ (PBL-T™ + RIV-8 )
Pre-IND Stage PBL-T™
NCT-01 (Metastatic Follicular Thyroid Cancer).
NCT-02 (Metastatic Soft Tissue Sarcoma).
NCT-011 (MFTC) Plus Special X Product
NCT-021 (MSTS) Plus Special X Product
Pre-IND Stage AUTO-T™
RCT-401 (Metastatic Ovarian Cancer)
RCT-501 (Metastatic Triple Neg Breast Cancer)
RCT-701 (Metastatic Endometrial Cancer)
MedGene's Principles of Cancer Treatment
Redefining Cancer Therapies
• 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, thus can recognize diverse neoantigens. (Solid tumors are very heterogenous.)
• Our product uses a breakthrough proprietary protocol to revive, recharge and protect CD8 effector T cells and their anti-tumor activity.
• 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.
Executive SAB, Scientific Cofounder
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 Affairs of Seoul National University and also as an editor-in-chief of Molecules and Cells (The Official Journal of the Korean Society for Molecular and Cellular Biology).
Yong H. (Henry) Park, M.D.
Chief Executive Officer (CEO)
Dr. Park has focused on clinical applications of autologous cell therapy 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.
Chief Medical Officer (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.
Steve Yoo
Chief Financial Officer (CFO)
Steve Yoo joined MedGene in 2022 as CFO. Prior to MedGene, he developed extensive sellside and buyside investment research analyzing therapeutics companies at firms such Sofinnova, Surveyor Capital (Citadel), UBS, and Leerink Partners. He has performed scientific, commercial, financial and regulatory due diligence on both public and private companies. Steve graduated from Keck Graduate Institute with a Masters of Business and Science and MIT with a BS in biology.
Robin E. Fontenot, DDS
VP, Strategic Development
Dr. Fontenot joined the company after serving 25 years in the US Air Force. He rose to senior USAF management ultimately overseeing preparedness activities of 2800 Air Force dental personnel. He simultaneously represented the AF Dental Corps on the NATO Dental Service Panel headquartered in Brussels. Prior to this he oversaw medical requirements for all AF medical operations in the Pacific Air Forces—a region covering 4 nations with 9 fixed facilities, caring for 45,000 Airmen and their families. He commanded 3 dental squadrons and served on the Executive Committee at the Air Force’s largest inpatient hospital. He completed a 2-year Advanced Education in General Dentistry and is certified with the American Board of General Dentistry.
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.
Eu Chang Hwang, M.D., and Ph.D.
Advisory Board (Scientific)
Currently a Professor of Urology at Chonnam National University Medical School in South Korea with over 20 years of clinical experience. Dr. Hwang specializes in urological cancers. He performs a variety of uro-oncological surgeries including robot-assisted laparoscopic radical prostatectomy and minimally invasive procedures, with a particular interest in kidney and upper tract urothelial cancers. He is currently contact editor of the Cochrane Urology group and an associate editor of ICUrology. He is a director of guideline committee of Korean Urological Oncologic Society. Dr. Hwang has conducted large numbers of clinical trials in oncology.
Young Jae Ryu, M.D.
Advisory Board (Scientific)
Dr. Ryu is a general surgeon, specializing in both thyroid and breast cancer, and an assistant professor and surgical supervisor at Chonnam National University’s Cancer Specialty Center with over 15 years of clinical experience. Current research interests include ultrasound imaging and the molecular diagnosis of thyroid cancer. Dr. Ryu was a military surgeon, including a stint with the UN Peacekeeping Force in Lebanon in 2008. As a surgical oncologist, Dr Ryu is focused on building survival outcomes and quality of life.
“The wound is the place where the Light enters you.”