MIPS Project Detail:
Company
Company Description:
Gliknik is a privately held biopharmaceutical company working to ease human suffering by creating new therapies for people living with cancer and immune disorders. Stradomers™ are the company’s first core innovative discovery; this technology was advanced under the MIPS project. MIPS Project Challenge Intravenous immunoglobulin (IVIG) is used therapeutically in dozens of autoimmune diseases and is in chronic short supply. This project was designed to identify and advance a recombinant human protein that is one of the most active fractions of IVIG, a blood product that was already known to be safe and effective but which currently comes from the pooled blood of tens of thousands of people. The most active component of this product, the Fc portion of aggregates, had been identified in publications. Gliknik invented the concept of treating autoimmune diseases with recombinant products containing multiple Fc, and selected GL-2045 as its first internally generated drug candidate, which it provided to Strome’s lab for in vitro function testing and confirmation of binding affinity to its cognate receptors. The product was later tested by Gliknik for in vivo activity in mouse models of autoimmunity. The result would be the defining of a lead pre-clinical compound to address autoimmune diseases.
MIPS Project
Recombinant IgG Fc for treatment of Autoimmunity
Project #
4007
|
MIPS Round
40
|
Starting Date:
Aug 2007
Project Scope:
The goal of these projects was to build adequate proof-of-concept data around the lead product for moving the drug through clinical pharmacokinetics into pivotal clinical trials. Phase 2 addressed the final preparatory work to advance the drug into patients. The research resulted in a potential drug candidate.
Results:
The MIPS project enabled initial proof of concept for the underlying technology. As a result of the project, GL-2045 advanced in preclinical development. The product to be commercialized, GL-2045, is a recombinant IgG1 Fc fusion protein that multimerizes yet retains full Fc functionality, presenting polyvalent Fc to more than one Fc receptor simultaneously. IVIG is indicated for numerous autoimmune diseases, including chronic inflammatory demyelinating polyneuropathy, a peripheral nerve disease, and idiopathic thrombocytopenic purpura, a bleeding disorder in which the immune system destroys platelets. GL-2045 is anticipated to be developed in these types of autoimmune diseases. Because IVIG has been used for decades, its efficacy and safety are well established, decreasing the riskiness of GL-2045 compared to a novel recombinant drug candidate that does not have a predecessor blood product.
In October, 2011, the National Cancer Institute (NCI) awarded the company a Small Business Innovation Research (SBIR) Phase II contract for up to $1.5 million. With the funding, Gliknik advanced its lead compounds from its first-in-class Stradobody™ platform towards the clinic. In October, 2012, the company raised $4.9 million in Series B Financing, supported by Baxter Ventures, LifeTech Development Partners, Brace Pharma, and the Maryland Health Care Product Development Corporation. In September, 2013, Gliknik announced a significant license of GL-2045 to Pfizer Inc. Pfizer has received orphan drug status from the FDA for the development of the product. Gliknik received an upfront payment of $25 million and is eligible to receive development, regulatory and commercial milestone payments.
Gliknik also has a peptide cancer drug, GL-0817, currently enrolling a Phase IIb clinical study in seven countries for oral cavity cancer. Gliknik is conducting research on numerous drug candidates from its Stradomer™ technology platform.
Principal Investigator:
Scott
Strome
Professor and Chair, Department of Otorhinolaryngology, Head & Neck Surgery
Project Manager:
David
Block
President
Technologies:
Biotechnology / Genetic Engineering
