On December 21, 2021 CytRx Corporation (OTCQB:CYTR) ("CytRx" or the "Company"), a specialized biopharmaceutical company focused on research and development in oncology and neurodegenerative diseases, highlighted ImmunityBio, Inc.’s (NASDAQ: IBRX) ("ImmunityBio") reported that recent clinical developments in the study of aldoxorubicin to treat various cancers (Press release, CytRx, DEC 21, 2021, View Source [SID1234597551]).

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CytRx out-licensed global development, manufacturing and commercialization rights for aldoxorubicin to ImmunityBio in 2017. The Company has an agreement with ImmunityBio that can yield up to $343 million in potential milestone payments as well as prospective royalties on sales of aldoxorubicin.

Pancreatic Cancer

ImmunityBio’s QUILT 88 study is a randomized, three-cohort, open-label study that evaluates the comparative efficacy and overall safety of standard-of-care chemotherapy versus standard-of-care chemotherapy in combination with PD-L1 t-haNK, Anktiva (N-803), and aldoxorubicin in subjects with locally advanced or metastatic pancreatic cancer.

On October 13, ImmunityBio announced that the third cohort ("Cohort C") in the QUILT 88 study, which includes patients with third-line or greater disease, is fully enrolled and of the evaluable patients, 90% (43/48) have exceeded the historical survival rates of approximately two months with standard-of-care chemotherapy. Based on the strength of this early data and the significant unmet medical need, ImmunityBio submitted an amendment to the U.S. Food and Drug Administration to increase enrollment in Cohort C, and enrollment is actively ongoing.

The interim results of Cohort C in the QUILT 88 study have been selected for presentation at the ASCO (Free ASCO Whitepaper) Gastrointestinal Cancers Symposium in January 2022 and the data to date continues to show that the historical overall survival in patients who have enrolled with 3rd, 4th, 5th and even 6th line metastatic pancreatic cancer exceeds any historical overall survival rate for this advanced stage of disease, for which there are no further treatment options available.

Triple Negative Breast Cancer and Head and Neck Cancer

ImmunityBio continues to study the effectiveness of N-803 and aldoxorubicin in combination with PD-L1 t-haNK in Phase 1 / 2 clinical trials to treat triple negative breast cancer and head and neck cancer.

Glioblastoma

A Phase 1 / 2 trial has been submitted for the study of N-803 and aldoxorubicin in Glioblastoma. Further updates will be provided in 2022.