Gamma Delta T-Cells

(NYB101)

Immune System

TRIAL PHASE
MECHANISMINDICATION(S)PRODUCT NAMEPreclinicalPhase 1Phase 2Phase 3
Gamma Delta T-Cells
Immuno-Oncology, Pancreatic Cancer
Nybo
(Proprietary*)

Immune System

Gamma Delta T-Cells
INDICATION(S):Immuno-Oncology, Pancreatic Cancer
NAME:Nybo (Proprietary*)
STAGE:Preclinical
Gamma Delta T-Cells

We are developing first-in-class monoclonal antibodies targeting immunosuppressive gamma delta T-cells, galectin-9 and related mechanisms in pancreatic cancer and other solid tumors, including colorectal cancer. Nybo’s therapeutic candidates are designed to address cancers that are suboptimally treated with currently available immunotherapies because the body’s natural defenses are compromised by persistent tumor immune evasion.


  • Patient Need & Market Potential
    • Globally, approximately 400,000 people are diagnosed with pancreatic cancer each year, with more than 90 percent diagnosed at an advanced/metastatic stage.
    • With a five-year survival rate at less than seven percent, pancreatic cancer is the third leading cause of cancer death.
    • Colorectal cancer (CRC) is among the largest cancer burdens in the world today with approximately 700,000 people being diagnosed globally each year. Median survival of patients with unresectable metastatic CRC remains less than three years. Death from CRC is expected to nearly double within the next 20 years. Current immunotherapies are only efficacious in a small proportion of CRC patients (less than 15 percent) whose tumors demonstrate mismatch repair deficiency. Hence novel, more broadly effective therapeutic strategies to engage the patients' immune system are needed.
    • Currently approved immunotherapies have been generally unsuccessful in this disease setting due to a highly immunosuppressive environment that wards off the body’s natural defenses.
    • Our gamma delta T-cell/galectin-9 program aims to address this great unmet need in malignancies, particularly those with dismal prognoses that derive little benefit from current standards of care.
  • Our Approach to Solving the Problem
    • Pre-clinical models validating our therapeutic concept show survival extensions in gold-standard animal models of pancreatic cancer that are superior to those previously observed in literature using approved treatments.
    • Our approach is differentiated from traditional checkpoint inhibitors in immuno-oncology, yet it has potential synergies with existing immunotherapies and current standards-of care.
    • It may also have broader applicability in the immuno-oncology space, with research underway expanding this initial work in pancreatic cancer and other solid tumors, including colorectal cancer.
  • Team
    • The team includes leading experts in immuno-oncology and pancreatic cancer.
    • Key advisors include:

      Erin Adams, Ph.D., Professor at the Department of Biochemistry and Molecular Biology, and on the Committees of Immunology and Cancer Biology at the University of Chicago; Steven Leach, M.D., Director of the David M. Rubenstein Center for Pancreatic Cancer Research of Memorial Sloan-Kettering;

      George Miller, M.D., Director of S. Arthur Localio Laboratories, vice chair for research in NYU, Langone’s Department of Surgery and the leader of Perlmutter Cancer Center’s Immunology Program; and

      Diane M. Simeone, M.D., Director of the Pancreatic Cancer Center at the NYU School of Medicine and the Associate Director of Translational Research, Perlmutter Cancer Center, NYU Langone Medical Center.

    • Dr. Aleksandra Filipovic, Dr. Eric Elenko, and Dr. Joseph Bolen lead the Nybo team.
  • Milestones Achieved
    • In April 2017, we publicly disclosed the Nybo program concurrent with a publication in Nature Medicine.
    • We are developing monoclonal antibodies to target newly discovered immunosuppressive mechanisms in pancreatic cancer and other solid tumors. Proof-of-concept data has been generated in both mouse and human cancer pre-clinical models.
  • Collaborations
    • Our gamma delta T-cells/galectin-9 technology is exclusively licensed from the NYU School of Medicine and is based on the work of Dr. George Miller, Director of S. Arthur Localio Laboratories and Director of the Cancer Immunology Program at NYU School of Medicine. Part of the body of data supporting this approach was published in Nature Medicine and builds upon Dr. Miller’s work previously published in Cell.
  • Expected Milestones and Timing
    • We expect to file an IND for our lead candidate in 2019.

We are developing an innovative set of therapeutics to attack difficult to treat cancers by targeting these newly identified mechanisms of immunosuppression in solid tumors as well as certain leukemias, such as acute myeloid leukemia (AM).


Key data: PoC animal models of PDA, PoC in human cancers, developed lead therapeutic mAb clones to ∂1 Chain and Galectin-9

Human proof of concept pre-clinical data