CytRx Highlights Use of Aldoxorubicin in Phase 2 Clinical Trials Yielding Positive Interim Data on Survival Rates in Metastatic Pancreatic Cancer Patients

LOS ANGELES--(BUSINESS WIRE)--CytRx Corporation (OTCQB:CYTR) (“CytRx” or the “Company”), a specialized biopharmaceutical company focused on research and development for the oncology and neurodegenerative disease categories, today highlighted that NantKwest, Inc. (NASDAQ: NK) (“NantKwest”) and ImmunityBio, Inc. (“ImmunityBio”) have announced that their ongoing Phase 2 clinical trials of a novel combination immunotherapy – which include CytRx’s licensed drug aldoxorubicin – for locally advanced or metastatic pancreatic cancer have produced early indications of increased survival rates for patients with no other approved treatment options. Interim results of the three-cohort trials, known as QUILT 88, show median survival rates more than doubled that of the historic rate in patients with advanced metastatic pancreatic cancer (for which no other FDA approved treatment exists).

According to NantKwest and ImmunityBio, the current trials were based on the original Cancer Moonshot hypothesis and exploratory QUILT trials initiated in 2017. The companies announced this week that the trials appear to validate the theory that by orchestrating natural killer and T-cell therapy, survival rates for individuals afflicted with advanced metastatic pancreatic cancer could be improved without high-dose chemotherapy. The interim trial results disclosed by the companies are as follows:

• In the Cancer Moonshot QUILT trials of haNK combined with PD-L1 inhibitor avelumab, which were completed in 2019, the median overall survival rate more than doubled (three months historic control versus 8 months in the treatment arm) in the 12-patient trial.

• A complete remission was achieved when replacing haNK and PD-L1 inhibitor avelumab with PD-L1 t-haNK and four out of five patients who had not yet reached median survival time (three months) are alive 8-16 months since beginning treatment on these expanded protocols.

• A single-arm Phase 2 trial (QUILT 88, Cohort C) was initiated in October 2020, for which the primary endpoint is overall survival and 15 out of 18 (83%) patients enrolled with second-line or greater pancreatic cancer remain alive to date.

• Randomized Phase 2 trials (QUILT 88, Cohorts A and B) for first- and second-line metastatic pancreatic cancer are actively enrolling at three sites with more than 50 patients enrolled or being evaluated in QUILT 88 to date.

Additional information pertaining to QUILT 88 trial details:

According to NantKwest and ImmunityBio, QUILT 88 is intended to evaluate 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. Each treatment setting, as well as each first- and second-line or later maintenance treatment, will be evaluated independently as Cohort A, Cohort B, and Cohort C, respectively, with A and B having independent experimental and control arms. The trial will initially enroll 298 subjects across all three cohorts. The primary objective of Cohorts A and B is progression-free survival and the objective of Cohort C is overall survival per RECIST V1.1. Secondary objectives include initial safety and additional efficacy measures, including overall response rate, complete response rate, durability of response, disease control rate, and overall survival.

Cancer Moonshot QUILT trial numbers include QUILT 3.039, 3.060, 3.070, and 3.080.

Additional information pertaining to QUILT 88 trial sites and enrollment:

According to NantKwest and ImmunityBio, there are currently three trial sites that have been activated: Hoag Memorial Hospital Presbyterian in Orange County, Calif.; The Chan Soon-Shiong Institute for Medicine in Los Angeles County, Calif.; and Avera McKennan Hospital and University Health Center in Sioux Falls, South Dakota. The latter site will serve patients in the tri-state area (Iowa, Nebraska, and South Dakota). More than 50 patients are currently enrolled in or being evaluated for the trial.

Additional information pertaining to pancreatic cancer:

Pancreatic cancer is the fourth leading cause of cancer-related deaths in the U.S., with an estimated 47,050 deaths and 57,600 new cases expected in 2020. It is the 12th most common cancer worldwide, with around 338,000 new cases diagnosed in 2012 (2% of all cancer diagnoses). Pancreatic cancer continues to increase today with no standard of care available for patients beyond second line. A clear unmet medical need exists in these patients facing anticipated survival times that are brief and high levels of existing comorbidities.

Patrick Soon-Shiong, M.D., Chairman, and Chief Executive Officer of ImmunityBio, issued the following statements earlier this week:

“For five patients for whom no other treatment was available, we replaced haNK and avelumab with the investigational NK cell therapy PD-L1 t-haNK and were pleased to observe a complete remission in the first patient to receive this combo therapeutic. To date, four out of five of these patients remain alive since beginning treatment. These observations confirmed the promise of our hypothesis that activating the patient’s own immune system with low-dose chemo immunomodulation therapy could improve outcomes. On the basis of our initial studies, we initiated our QUILT 88 randomized trials in metastatic pancreatic cancer and are pleased to present today those findings, including Cohort C survival rates. While this data is still early, a doubling of the survival rate is encouraging and warrants further confirmation through QUILT 88.”

Steven A. Kriegsman, CytRx’s Chairman and Chief Executive Officer, commented:

“We are very encouraged to see that Aldoxorubicin is helping to deliver positive outcomes for pancreatic cancer patients participating in the ongoing QUILT 88 trials. In our view, the interim results announced by NantKwest and ImmunityBio reflect the significant potential of the novel combination immunotherapy being studied. We look forward to monitoring the continuation of QUILT 88 and remain optimistic about the role Aldoxorubicin can play in combating aggressive cancers.”

About CytRx Corporation

CytRx Corporation (OTCQB: CYTR) is a biopharmaceutical company with expertise in discovering and developing new therapeutics principally to treat patients with cancer and neurodegenerative diseases. CytRx's most advanced drug conjugate, aldoxorubicin, is an improved version of the widely used anticancer drug doxorubicin and has been out-licensed to ImmunityBio, Inc. In addition, CytRx's other drug candidate, arimoclomol, was sold to Orphazyme (Nasdaq: ORPH) Orphazyme A/S (Nasdaq Copenhagen exchange: ORPHA.CO) in exchange for milestone payments and royalties. Orphazyme is testing arimoclomol in four indications including amyotrophic lateral sclerosis (ALS), Niemann-Pick disease Type C (NPC), Gaucher disease and sporadic Inclusion Body Myositis (sIBM) and have filed an NDA for NPC with a PDUFA date of June 17, 2021. CytRx Corporation’s website is www.cytrx.com.

Forward-Looking Statements

This press release contains forward-looking statements, including statements relating to the success of the QUILT 88 trial and other types of combination immunotherapy in improving the treatment and outcomes of cancer patients. Such statements involve risks and uncertainties that could cause actual events or results to differ materially from the events or results described in the forward-looking statements, such as the risks and uncertainties relating to the ability of NantKwest and ImmunityBio to obtain regulatory approval for their products that use aldoxorubicin; the ability of NantKwest or ImmunityBio to continue their planned preclinical and clinical development of their respective development programs and the timing and success of any such continued preclinical and clinical development and planned regulatory submissions; the ability of NantKwest and ImmunityBio to manufacture and commercialize products or therapies that use aldoxorubicin; the amount, if any, of future milestone and royalty payments that we may receive from NantKwest and ImmunityBio; the final results of the QUILT 88 trial and other studies and trials of cancer treatments and therapies that include aldoxorubicin, including combination immunotherapies; and other risks and uncertainties described in the most recent annual and quarterly reports filed by CytRx with the Securities and Exchange Commission and current reports filed since the date of CytRx's most recent annual report. All forward-looking statements are based upon information available to CytRx on the date the statements are first published. CytRx undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.