The Promise of M2T™

About Leukogene

Leukogene Therapeutics is a Charleston, SC based oncology focused biotech company, a spin-out from the Medical University of South Carolina (MUSC). Our mission is to deliver innovative immunotherapies for hard-to-treat cancers with emphasis on immunologically “cold” tumors.

Leukogene’s MHC class II targeted M2T™ immunotherapy directs and mobilizes the immune system to trigger a robust, tumor antigen specific immune response and eliminate tumor cells. Our lead candidates in acute myeloid leukemia (AML) and pancreatic ductal adenocarcinoma (PDAC) have already demonstrated preclinical proof of concept.

Leukogene is an NCI and SCRA SC Launch portfolio company.

Blazing a trail in cancer immunotherapy

Cancer immunotherapy has revolutionized oncology. However, cures are still rare and survival rates for most cancer patients have improved only marginally over the past several decades.

Existing immunotherapies selectively activate T cells or utilize monoclonal antibodies in isolation, but they fail to coordinate all components of the immune system or direct them to specific molecular destinations in tumors.

Leukogene is in the driver’s seat of a revolutionary new approach that activates the immune system through Major Histocompatibility Complex II (MHCII).

Major Histocompatibility Complexes (MHC) play a crucial role in the immune response by presenting foreign antigens to T cells. MHC is divided into two classes, MHC class I (MHCI) and MHC class II (MHCII), each of which presents antigens to different subsets of T cells.

MHCI directly interacts with CD8+ T cells, whereas MHCII activates CD4+ helper T cells.

Much of the cancer immunotherapy field has focused on the MHCI-CD8+ axis, given the cytotoxic phenotype of CD8+ T cells and their ability to recognize and eliminate tumor cells directly. However, recent evidence has demonstrated that CD4+ T cells are essential for orchestrating an effective cancer immunotherapy response.

CD4+ T cells “help” by supporting activation and proliferation of CD8+ T cells along with other immune cells, such as macrophages, dendritic cells, B cells, and NK cells, and skew the immune system toward a tumor-suppressive phenotype.

Promise of M2T™

M2T™ is a recombinant protein that conjugates tumor associated antigens (TAA) to an MHCII targeting protein that mimics MHCII binding motifs found in nature. It harnesses the potent immunogenicity of MHCII presentation to trigger a robust tumor antigen specific immune response.

Increase immunogenicity– High affinity binding to MHCII targets antigens directly to antigen presenting cells and drives a response independent of human leukocyte antigen (HLA) polymorphisms.

Bypass tolerance – Non-classical presentation of antigens breaks immune tolerance.

Combination Synergy – Act synergistically with other cancer immunotherapies to provide greater efficacy.

Antigen Presentation to T Lymphocytes

Antigen Presenting Cells (APC) present peptide antigens to CD4 and CD8 T cells via MHC class II and MHC class I molecules, respectively. CD4+ cells “help” cytotoxic CD8+ cells by secreting pro-inflammatory cytokines such as IFN𝛾. This collaborative effort between CD4+ and CD8+ T cells mediates cellular immunity against pathogens and malignant cells. 

The Executive Team

Sandeep Gupta, Ph.D.
Chief Executive Officer

Dr. Gupta has a distinguished career spanning 25+ years in large pharma and biotech. He founded Asana BioSciences and was its CEO and President, where he raised >$250M in private financing and monetized/out-licensed multiple oncology and immunology assets.

Recently, Dr. Gupta was the CEO of Kashiv BioSciences LLC, a fully integrated biopharmaceutical company developing and manufacturing biosimilars.

Previously, he was Senior Vice President of Discovery and Early Development at Endo Health Solutions, and Head of Discovery and Pharmacology at Forest Laboratories.

Dr. Gupta also held academic positions at the University of Pennsylvania and Boston University Schools of Medicine. Dr. Gupta is an inventor on >20 patents and has authored >50 scientific papers and book chapters. He is a member of ASCO and AACR and was a member of The CEO Roundtable on Cancer.

Nathan Dolloff, Ph.D.
Co-Founder and Chief Scientific Officer

The M2T cancer immunotherapy platform was developed by Dr. Dolloff and his research team. He is the co-inventor on patents protecting the platform’s candidates and has raised over $5M in dilutive and non-dilutive funding for Leukogene.

Previously, Dr. Dolloff led projects that delivered multiple cancer drug candidates, including olaratumab/LARTRUVO, CDK9 inhibitors, dual CDK1/GSK3beta inhibitors, and PDI inhibitors. He has held leadership positions in entrepreneurship and technology development at the MUSC Hollings Cancer Center and the Zucker Institute for Innovation Commercialization.

Dr. Dolloff is a previous Research Scholar of the American Cancer Society, MUSC Innovator of the Year, inventor on numerous issued and pending patents, and author of >50 peer reviewed journal articles and book chapters.

Born and raised outside of Philadelphia, Dr. Dolloff trained in cancer therapeutics at Drexel College of Medicine and the University of Pennsylvania; and held prior faculty appointments at the Penn State Hershey Cancer Institute.

Reeder Robinson, Ph.D.
Principal Scientist

Reeder Robinson is the Principal Scientist of protein biochemistry at Leukogene and was a postdoctoral scholar and staff scientist at MUSC. He was one of the first recipients of Small Business Transition Grant for Early Career Scientists from the National Cancer Institute. Dr. Robinson’s research focuses on protein engineering and biochemistry in the area of cancer biotherapeutics. He received his PhD in Biochemistry from Virginia Tech and trained in experimental cancer therapeutics at MUSC.

Scott Thompson, Ph.D.
Program Director

Scott Thompson is leading CMC and project management at Leukogene. Dr. Thompson has over 33 years of pharmaceutical industry experience at Asana BioSciences, Endo Health Solutions and Glaxo SmithKline. In those roles, he worked across multiple areas of drug discovery and development, including project leadership and management, API and drug product development and manufacturing, as well as medicinal chemistry. Dr. Thompson has conducted research in multiple therapeutic areas including oncology and immunology and led multiple projects that delivered clinical development candidates.

Board of Directors

Lawrence Olanoff, MD, Ph.D.
Chairman of the Board

Dr. Lawrence Olanoff is the Chairman of the Board of Directors at Leukogene. He is also an Adjunct Assistant Professor and Executive in Residence at the Medical University of South Carolina (MUSC).

Previously, Dr. Olanoff served as the President and COO for Forest Laboratories, Inc., CEO of Celsion Corporation, and held Senior Clinical Research roles at Sandoz and Upjohn. His contributions have led to 30 New Drug Approvals over a range of therapeutic areas. He serves on the boards of Ichnos Glenmark Innovation, Tevard Biosciences, and several non-profit organizations.

He is the author of over 40 publications on controlled drug delivery, pharmacokinetics, drug metabolism and clinical toxicology.

Frank Marcoux, Ph.D.
Co-Founder and former CEO

Previously, Dr. Marcoux was CEO and Chief Scientific Officer of Portage Pharmaceuticals, Ltd, and CEO of Portage Glasgow, Ltd. Currently he is a Director of Opsidio Pharmaceuticals.

Dr. Marcoux has been a member of the Scientific and Business Advisory Committee for Indivumed, GmbH. Prior to that, he was the Vice President of Clinical, Quantitative and Innovative Medicine at Pfizer.

Dr. Marcoux held research positions prior to industry at Harvard Medical School, University of Alabama and the University of Vermont.

Sandeep Gupta, Ph.D.
Chief Executive Officer

Dr. Gupta has a distinguished career spanning 25+ years in large pharma and biotech. He founded Asana BioSciences and was its CEO and President, where he raised >$250M in private financing and monetized/out-licensed multiple oncology and immunology assets.

Recently, Dr. Gupta was the CEO of Kashiv BioSciences LLC, a fully integrated biopharmaceutical company developing and manufacturing biosimilars.

Previously, he was Senior Vice President of Discovery and Early Development at Endo Health Solutions, and Head of Discovery and Pharmacology at Forest Laboratories.

Dr. Gupta also held academic positions at the University of Pennsylvania and Boston University Schools of Medicine. Dr. Gupta is an inventor on >20 patents and has authored >50 scientific papers and book chapters. He is a member of ASCO and AACR and was a member of The CEO Roundtable on Cancer.

Nathan Dolloff, Ph.D.
Co-Founder and Chief Scientific Officer

The M2T cancer immunotherapy platform was developed by Dr. Dolloff and his research team. He is the co-inventor on patents protecting the platform’s candidates and has raised over $5M in dilutive and non-dilutive funding for Leukogene.

Previously, Dr. Dolloff led projects that delivered multiple cancer drug candidates, including olaratumab/LARTRUVO, CDK9 inhibitors, dual CDK1/GSK3beta inhibitors, and PDI inhibitors. He has held leadership positions in entrepreneurship and technology development at the MUSC Hollings Cancer Center and the Zucker Institute for Innovation Commercialization.

Dr. Dolloff is a previous Research Scholar of the American Cancer Society, MUSC Innovator of the Year, inventor on numerous issued and pending patents, and author of >50 peer reviewed journal articles and book chapters.

Born and raised outside of Philadelphia, Dr. Dolloff trained in cancer therapeutics at Drexel College of Medicine and the University of Pennsylvania; and held prior faculty appointments at the Penn State Hershey Cancer Institute.

Scientific Advisors

Michael Varney, Ph.D.

Michael Varney, PhD, is a pioneer drug discoverer and biotech leader with deep expertise in diverse drug platform types, including cellular therapies. As one of the original employees at Agouron, a San Diego-based biotech, Dr. Varney built a team that developed protein-structure based design, a novel approach to drug discovery used globally today. His team launched Viracept, an HIV protease inhibitor that achieved the highest first year launch sales of any biotech product in 1997. His leadership at Agouron resulted in the discovery of many anti-cancer agents, including Xalkori and Inlyta, a drug that won the American Chemical Society’s Heroes of Chemistry Award in 2018.

Most recently, he served as Genentech’s Executive Vice President and the Head of Research and Early Development (gRED) in addition to serving as a member of the Roche Corporate Executive Committee in Basel. Under his leadership, gRED teams discovered and developed successful medicines that include Venclexta with AbbVie, the first bcl-2 inhibitor and Polivy, an antibody drug conjugate for the treatment of DLBCL. Pioneering molecules in the clinic include Mosunetuzumab, a bispecific antibody targeting CD20, and GDC-9545, a next generation estrogen receptor degrader, and the marketed anticancer agents Erivedge and Cotellic.

Dr. Varney retired from Genentech in July 2020, leaving a diversity of drug platform types that includes personalized therapeutic vaccines and cellular therapies. He is currently an advisor to the Biotech and Pharma world and is a Board member of both public and private companies.

Anthony Tolcher, MD

Anthony Tolcher, M.D., is founder and CEO of NEXT Oncology, one of the most successful and respected Phase 1 programs in oncology research.

Prior to founding NEXT Oncology, Dr. Tolcher was President and Co-Founder of START LLC, one of the world’s largest Clinical Phase I and early drug development operations in cancer medicine.

Dr. Tolcher is a medical oncologist with over 25 years’ experience in early drug development and clinical trials and has been involved in more than 21 of the initial Phase 1 studies of new oncology agents that subsequently were FDA approved, including PD-(L)1 inhibitors, antibody-drug conjugates, anti-tumor-associated antigen antibodies, and numerous targeted therapies, and he is currently the principal investigator of over 20 Phase 1 studies.

He has over 130 peer‐reviewed publications in scientific journals and has chaired the Developmental Therapeutics Review Committee for ASCO. Dr. Tolcher obtained his M.D. degree from the University of British Columbia and then completed Internal Medicine Residency at the University of Toronto, Oncology Fellowship at the University of British Columbia and a research fellowship at the NCI, Bethesda.

Patrick Mayes, Ph.D.

Dr. Patrick Mayes is an experienced biopharmaceutical executive with a background in oncology and immunology.

He joined Incyte in 2017 where he is currently serving as Group Vice President and Head of Biology, and previously held roles including Vice President of Biotherapeutic Research and Executive Director of I-O Antibody Research.
Prior to joining Incyte, Patrick worked at GSK from 2010 to 2017, where he held roles including, Director of Biology and Early Development Leader within Immuno-Oncology DPU.

Patrick holds a PhD in Pharmacological Sciences from the University of Pennsylvania School of Medicine and a BS/BA in Biochemistry and Chemistry from Virginia Tech.

Praneeth Baratam, MD

Dr. Praneeth Baratam is a Hematologist and an Oncologist, Director of Leukemia at MUSC in Charleston, South Carolina.

Dr. Praneeth Baratam received his M.D. from Andhra Medical College and trained in internal medicine at Saint Joseph Hospital, Chicago. He initially worked as an academic oncology hospitalist at Thomas Jefferson University, Philadelphia.

He recently completed a fellowship in hematology/oncology at Drexel, where he served as chief fellow. His interest is in the treatment of acute leukemia and myelodysplastic disorders and clinical research and teaching.

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