On January 14, 2019 CytRx Corporation (NASDAQ: CYTR), a biopharmaceutical research and development company specializing in oncology, reported that aldoxorubicin licensee NantCell, Inc., a private subsidiary of NantWorks, LLC, has dosed the first patient in the Phase 1b portion of a Phase 1b/2 clinical trial for patients with relapsed or refractory colorectal cancer (CRC) who have been previously treated with standard of care (SOC) therapy (Press release, CytRx, JAN 14, 2019, View Source [SID1234532646]). This is the fourth trial conducted by NantCell which will investigate high-affinity natural killer (haNK) cell therapy in combination with anti-cancer agents, including aldoxorubicin, in certain high unmet need cancer indications.
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
"Among the most compelling recent medical advances has been the significant improvement in efficacy seen when immunotherapy is combined with chemotherapy, especially in high unmet medical need cancers such as non-small cell lung, pancreatic cancer and triple negative breast cancers," said Eric Curtis, CytRx’s President and Chief Operating Officer. "NantCell is leveraging this important emerging combination trend and to date has initiated four Phase 1b/2 clinical trials investigating their haNK cell therapy in combination with several anti-cancer agents, including aldoxorubicin. Aldoxorubicin targets and binds to serum albumin to concentrate drug inside solid tumors, maximizing efficacy and minimizing systemic toxicity. This newest clinical trial in relapsed or refractory CRC speaks to NantCell’s continued commitment to maximizing the clinical and commercial potential of targeting solid tumors with albumin binding aldoxorubicin for these patients with difficult to treat malignancies."
The trial titled "QUILT-3.071: NANT Colorectal Cancer (CRC) Vaccine: A Phase 1b/2 Trial of the NANT CRC Vaccine vs Regorafenib in Subjects With Metastatic CRC Who Have Been Previously Treated With Standard-of-Care Therapy," (NCT03563157) is a single-center, open-label, Phase 1b/2 clinical trial designed to evaluate the safety and efficacy of several combination therapies, including combinations with aldoxorubicin, in subjects with CRC who have progressed on or after SOC therapy. The primary endpoint for the Phase 1b portion of the trial is safety and if the study proceeds to phase 2, the primary endpoint for the Phase 2 portion of the trial is progression-free survival (PFS) and objective response rate (ORR), both by RECIST.
About Colorectal Cancer
Colorectal cancer (CRC), also known as bowel cancer, colon cancer, or rectal cancer, is any cancer that affects the colon and the rectum. According to the Colorectal Cancer Alliance, CRC is the third most common type of cancer in the U.S., and the second leading cause of cancer death. The American Cancer Society estimates that approximately 140,000 new cases of CRC are expected to be diagnosed in the U.S. in 2018 and it will cause over 50,000 deaths in the same timeframe. CRC affects men and women of all racial and ethnic groups, and is most often found in people 50 years or older, however, incidence in those younger than 50 is on the rise.