CryoPort Supports Gradalis Inc.’s Vigil Platform In Clinical Trials For Autologous Immunotherapies For Multiple Cancers

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IRVINE, Calif., Jan. 3, 2017 /PRNewswire/ — Cryoport, Inc. (NASDAQ: CYRX, CYRXW), the world’s leading cryogenic logistics company committed to providing innovative, reliable and efficient logistics solutions to the life sciences industry, today announced that its validated cryogenic logistics solutions are supporting Gradalis, Inc.’s clinical trials to evaluate its investigational Vigil® Engineered Autologous Tumor Cell (EATC) cellular immunotherapy technology for use in cancer treatments. Cryoport is currently supporting Gradalis’ phase 2/3 trial for high risk stage III/IV ovarian cancer patients, its randomized Phase 2b trial for Ewing’s sarcoma, as well as the pilot combination studies with PD-1/PD-L1 inhibitors, all of which utilize the Vigil bi-shRNA furin and GMCSF.

According to Gradalis sources, Vigil is a fully personalized cancer immunotherapy platform that may be applied to virtually any cancer from which a surgical sample can be gathered. The purpose of the platform is to activate the patient’s T-cells against the patient’s own unique tumor neoantigens. It has been used in support of clinical trials in a variety of tumor types including ovarian cancer, breast cancer, melanoma, Ewing’s sarcoma, non-small cell lung cancer, colon cancer, and other cancers.  Gradalis’ lead product targeting ovarian cancer is in Phase 3 and is ramping up to a patient population of over 220, with each patient scheduled to receive multiple doses over the next year.

Cryoport’s global distribution network will provide the required cryogenic logistics support for multiple participating clinical sites located throughout the U.S.  Cryoport’s cryogenic cold chain logistics solutions will extend access to patients currently enrolled in the trials.

Sunil Joshi, President and Chief Executive Officer of Gradalis commented, “We rely on Cryoport’s advanced cryogenic logistics solutions to maintain the integrity of our clinical trial work as the therapies are transported between Gradalis’ manufacturing and various clinical sites. We are at a critical stage of our development and we need to ensure proper access for our clinical trial participants. With the advancements we have made thus far, we look forward to further developing our proprietary platform for additional applications. Cryoport, as with all of our partners, will play a critical supporting role in the success of our clinical programs.”

Jerrell Shelton, Chief Executive Officer of Cryoport, stated, “We are honored to support Gradalis in its efforts to develop cutting edge immunotherapy treatments for ovarian cancer, Ewing’s sarcoma and other cancers.  In 2015, the American Cancer Society estimated that more than 50% of those diagnosed with ovarian cancer would die from the disease. Gradalis’ technology has the potential to address this significant unmet medical need in this patient population.  Likewise, Ewing’s sarcoma is an ultra-orphan indication with no standard of care for patients who are progressing on or after chemotherapy treatment.  We look forward to providing Gradalis with our advanced and validated cryogenic logistics solutions including 24/7/365 support to help move it closer to managing these life-threating diseases.”

About Vigil EATC
Vigil is an investigational cellular immunotherapy technology that combines the concepts of genetic engineering with the science of immuno-oncology, to enable an immune response to cancer cells. A patient’s tumor cells are engineered with a plasmid carrying the gene vector for shRNA Furin and GMCSF to elicit a systemic T-cell directed immune response when administered to the patient through intradermal injections. By utilizing the patient’s own tumor as the antigen source, Vigil EATC is designed to elicit an immune response that is specifically targeted and broadly relevant to each patient’s unique tumor antigens. Vigil EATC is being studied in Ewing’s sarcoma and ovarian cancer as a single agent, and in breast cancer, non-small cell lung cancer and melanoma in combination with PDL1 inhibitors. More information about these studies can be found on www.vigilclinicaltrials.com.

About Gradalis, Inc.
Gradalis is a late-stage biopharmaceutical company focused on the development and commercialization of novel personalized therapeutics to treat cancer.  It is developing Vigil, a proprietary immunotherapy platform in multiple advanced cancer indications, with the lead program for the treatment of patients with advanced ovarian cancer. For more information, visit the Gradalis Incorporated website at www.gradalisinc.com.

About Cryoport, Inc.
Cryoport is the life sciences industry’s most trusted global provider of cold chain logistics solutions for temperature-sensitive life sciences commodities, serving the biopharmaceutical market with leading-edge logistics solutions for biologic materials, such as regenerative medicine, including immunotherapies, stem cells and CAR-T cells. Cryoport’s solutions are used by points-of-care, CRO’s, central laboratories, pharmaceutical companies, manufacturers, university researchers et al; as well as the reproductive medicine market, primarily in IVF and surrogacy; and the animal health market, primarily in the areas of vaccines and reproduction. Cryoport’s proprietary Cryoport Express® Shippers, Cryoportal Logistics Management Platform, leading-edge SmartPak II Condition Monitoring System and geo-sensing technology, paired with unparalleled cold chain logistics expertise and 24/7 client support, make Cryoport the end-to-end cold chain logistics partner that the industry trusts.

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