LOUISVILLE, CO and CULVER CITY, CA – GlobeImmune, Inc. today announced a number of developments in its clinical programs and licensing and manufacturing activities. The Company previously announced that NantCell, Inc., a member of the ecosystem of NantWorks companies, has acquired a controlling interest in GlobeImmune. Through this relationship, a number of programs have now advanced into multiple trials.
NantCell has licensed exclusive worldwide rights to the Company’s GI-4000 program, which targets the mutated Ras oncogene product, and which had previously completed phase 2 trials in resected pancreas cancer, non-small cell lung cancer (NSCLC) and colorectal cancer. GI-4000 will now be evaluated in combination with multiple additional agents in patients with metastatic pancreas cancer, triple negative breast cancer (TNBC), ovarian cancer, urothelial cancer, head and neck squamous cell cancer, metastatic colorectal cancer and NSCLC, whose tumors express mutations in the Ras oncogene product.
NantCell has also now acquired exclusive rights to develop, manufacture and commercialize the Company’s GI-6207 program which targets the CEA protein expressed in a number of solid tumors and the Company’s GI-6301 program targeting the Brachyury protein. In addition, NantCell has exercised an option to license the Company’s preclinical GI-6100 program targeting the MUC1 protein. GI-6207 and GI-6301 will be combined with GI-4000 and other agents in a number of the above described trials. More details on these trials can be found at www.clinicaltrials.gov by searching for “QUILT” trials.
Under the terms of each of these agreements with NantCell, GlobeImmune is entitled to receive payments on the achievement of certain product development and commercialization milestones and royalties based on net sales of products by NantCell or its affiliates or sublicensees.
In preparation for clinical trials of these products, the Company has re-started manufacturing activities at its Louisville Colorado facility and will be providing GMP product under a supply agreement with NantCell to support these trials.
“We are delighted at these developments,” stated Jeffrey Dekker, the Company’s president. “They demonstrate the progress we anticipated with our new relationship with NantCell and will allow us to continue to explore the potential of the Tarmogen platform.”
Dr. Patrick Soon-Shiong, Founder and CEO of NantCell noted, “Our goal has continued to focus on the most comprehensive path to activating the innate and adaptive immune system and through our partnership with GlobeImmune, we are able to increase the number of molecular immunotherapy options we currently have available for patients. We’re looking forward to the continued work we’re doing with this innovative company and are excited to learn from the results of the clinical trials.”
NantCell, a majority owned and controlled entity of the NantWorks, LLC family of companies, is an immuno-oncology company focused on the discovery of innovative antibody, T cell and NK cell based treatments by developing molecularly targeted therapeutics, based on the proteomic profile of the patient’s tumor, independent of the cancer’s anatomical type. Dr. Patrick Soon-Shiong, the creator of Abraxane® and the founder of the nab® technology platform established NantCell to develop a pipeline of human antibodies and inhibitors of proteins which drive tumor growth and pursue Chimeric Receptor Antigen platforms in both T and NK cells. NantCell’s mission is to make obsolete the standard method of clinical trial design of “trial and error” and replace it with a level of quantitative predictability based on both the genomic and proteomic profile performed a priori. The Company will tap into comprehensive “omic” analytic tools and “big data” generated from supercomputing to develop molecularly designed drugs in this era of genomics and proteomics and identify patients and their tumor signature at the most granular cellular, DNA and protein levels. Patients entering clinical trials would be identified after a comprehensive “omic” analysis from tissue to cell to DNA to RNA to protein to peptide to drug, and tested based on this molecular profile to maximize clinical outcome and minimize side effects. Through these integrated diagnostic methods, the Company is pursuing the vision of treating the biology of cancer rather than the anatomy, and drive the immune system inherited by all to defeat cancer. For more information please visit www.nanthealth.com and follow Dr. Soon-Shiong on Twitter @DrPatSoonShiong.
GlobeImmune is a biopharmaceutical company focused on developing products for the treatment of cancer and infectious diseases based on its proprietary Tarmogen® platform. Tarmogens activate the immune system by stimulating cellular immunity, known as T cell immunity, in contrast to traditional vaccines that predominately stimulate antibody production. To date, Tarmogen product candidates have been generally well tolerated in clinical trials for multiple disease indications and are efficient to manufacture. For additional information, please visit the Company’s website at www.globeimmune.com.
Safe Harbor Statement
This press release contains “forward-looking statements” for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, statements regarding the success of GlobeImmune and NantCell to effectively integrate operations following the transaction, the potential for Tarmogens to treat or prevent any disease, GlobeImmune and its collaborator’s abilities to successfully complete clinical trials, timing and eventual prospects for completion of clinical trials and any approval to market any of GlobeImmune’s product candidates and the prospects for GlobeImmune’s collaborations. Such statements are based on management’s current expectations and involve risks and uncertainties. Actual results and performance could differ materially from those projected in the forward-looking statements as a result of many factors, including, without limitation, the risks and uncertainties associated with: GlobeImmune’s financial resources and whether they will be sufficient to meet its business objectives and operational requirements; results of earlier studies and trials may not be predictive of future clinical trial results, the protection and market exclusivity provided by the GlobeImmune’s intellectual property; risks related to the drug discovery and the regulatory approval process; and, the impact of competitive products and technological changes. GlobeImmune’s forward-looking statements also involve assumptions that, if they prove incorrect, would cause its results to differ materially from those expressed or implied by such forward-looking statements. Forward-looking statements contained in this announcement are made as of this date, and GlobeImmune undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.
Tarmogen is a registered trademark of GlobeImmune, Inc.
GLOBEIMMUNE INVESTOR CONTACT:
C. Jeff Dekker
NANTCELL INVESTOR CONTACT: