Gliknik is focused on discovering and developing truly innovative biologics for people living with cancer and immune disorders. This work is based on the team’s expertise in immune modulation. Gliknik has two R&D platforms, the immunomodulator platform and the stradomer™ /stradobody™ technology platform, both of which hold the promise of producing multiple innovative biologics for patients with autoimmune diseases or cancer.

Pipeline-Q2-2014-v4

Immunomodulators – The immunomodulator platform is Gliknik’s most clinically advanced program with compounds having entered clinical testing in patients. The goal of the program is to direct the immune system to attack a specific cancer. Gliknik’s immunomodulators are cancer therapeutic vaccines that increase CD4, CD8, and antibody immune responses against targeted cancer epitopes.

Stradomers™ – Stradomers™ are recombinant compounds designed to bind to multiple targets simultaneously, for example in a manner that monoclonal antibodies cannot achieve. This is a new approach to drug discovery but is based on published clinical and preclinical literature spanning 40 years that demonstrates the importance of avid binding in modulating the immune system.

Stradobodies™ – The Stradobody™ platform represents a novel way to make antibody-mimetics, generating monoclonal antibody-like compounds that are more effective than mAbs when directed against cancer and inflammatory disease targets. Funded in part under a competitively obtained NCI contract, Gliknik has made a series of stradobodies™ with greater potency compared to the corresponding monoclonal antibody.

Pipeline programs:

  • GL-0817:  Scientific founder Dr. Strome and his research partner Dr. Lieping Chen were at the The Mayo Clinic together when they discovered the checkpoint inhibitor PD-L1 and how an antibody to it could be useful in preventing tumor-induced suppression of the normal immune system. Dr. Strome also worked with Dr. Esteban Celis at Mayo to create immunomodulatory cancer therapeutic vaccines with novel properties. GL-0817 is a patent-protected peptide immunomodulator targeted against the cancer protein MAGE-A3 which is expressed in some cases of Head and Neck cancer, multiple myeloma, Lung Cancer and others. Designed in response to previous challenges with clinical immunomodulator studies, GL-0817 has a number of built-in features that are not available in any competitive product. It was designed to enter the cell more effectively than predecessor compounds, travel intact through the cell, be cleaved to appropriate epitopes better than predecessor compounds, and stimulate CD4, CD8, and B cell responses.GL-0817 has been assessed in a dose-rising clinical study in patients with advanced Head and Neck Cancer and in combination with multiple therapies in multiple myeloma. Publications from clinical researchers working independent of Gliknik have demonstrated epitope-specific CD4 and CD8 as well as peptide-specific antibody immune responses to GL-0817. In February 2014, Carl H. June, M.D., Richard W. Vague Professor in Immunotherapy, Department of Pathology and Laboratory Medicine in the Perelman School of Medicine at the University of Pennsylvania, and Aaron P. Rapoport, M.D., Gary Jobson Professor in Medical Oncology, University of Maryland School of Medicine and Director of Lymphoma Gene Medicine, Marlene and Stewart Greenebaum Cancer Center, published an independent study incorporating GL-0817 in a complex clinical trial of patients with advanced multiple myeloma. The publication is available at Clinical Cancer Research. The safety and immunologic effects in both clinical studies support advancing these compounds in further clinical studies. The issued patents and patent applications for these two compounds were in-licensed from The Mayo Clinic and from the University of Maryland, Baltimore. GL-0817 is poised to enter a Phase IIb study in secondary prevention of high risk Squamous Cell Cancer of the Oral Cavity. Gliknik is planning to advance this program internally in Phase IIb studies and is open to discussions with interested potential partners.
  • GL-2045: GL-2045, Gliknik’s first stradomer™, was designed to mimic the efficacy of pooled human intravenous immunoglobulin in a wide range of autoimmune diseases including low platelet count (ITP), peripheral neuropathy (CIDP), and Myasthenia gravis but with lower and more convenient dosing, no supply constraints, no blood product components, no IgA, and ideally further improvements in safety and side effects. GL-2045 has shown promising results in a broad range of preclinical tests. In September 2013, Gliknik entered into a noteworthy licensing agreement with Pfizer for GL-2045.
  • GB-4542: Gliknik has generated a portfolio of compounds and has selected GB-4542 as a lead “biobetter” of rituximab that is expected to compete effectively with second- and third-generation anti-CD20 monoclonal antibodies. The company anticipates at least similar efficacy at lower doses and with additional potential advantages. This is accomplished by presenting multiple Fc portions of an antibody to Fc receptors simultaneously.