Aldoxorubicin Is Part of the NANT Cancer Vaccine Combinations Which Include Immunotherapy and Cell-based Therapy
Early Safely Data Are Encouraging and There Are Emerging Positive Signals of Clinical Activity
LOS ANGELES, Nov. 8, 2018 /PRNewswire/ -- CytRx Corporation (CYTR), a biopharmaceutical research and development company specializing in oncology, today highlighted two poster presentations by its licensee NantCell, Inc. at the Society for Immunotherapy of Cancer's (SITC) 33rd Annual Meeting, taking place November 7-11, 2018 in Washington, DC. The abstracts describe early safety and efficacy data from the Phase 1b portion of Phase 1b/2 clinical trials evaluating NantCell's high-affinity natural killer (haNK) cell therapy in combination with anti-cancer agents, including aldoxorubicin, in patients with third-line or greater triple negative breast cancer (TNBC), fourth-line or greater head and neck squamous cell carcinoma (HNSCC) or recurrent metastatic pancreatic cancer.
Preliminary Phase 1b Results in TNBC and HNSCC
In this Phase 1b, single-arm, open-label trial, treatment was administered in 3-week cycles of low-dose chemotherapy (aldoxorubicin, cyclophosphamide, cisplatin, nab-paclitaxel, 5-FU/L), antiangiogenic therapy (bevacizumab), engineered allogeneic high affinity CD-16 NK-92 cells (haNK), IL-15RαFc (N803), adenoviral vector-based CEA, MUC1, Brachyury, HER2 vaccine, yeast vector-based RAS, Brachyury and CEA vaccine, and an IgG1 PD-L1 inhibitor, avelumab plus cetuximab. All patients in both trials received aldoxorubicin. The primary endpoint is incidence of treatment-related adverse events (AEs). Secondary endpoints include overall response rate (ORR), disease control rate (DCR), progression-free survival (PFS), and overall survival (OS).
The abstract includes data from three patients with third-line or greater TNBC and two patients with fourth-line or greater HNSCC. All treatment was completed in the outpatient setting, with no immune-related AEs. Four hematologic dose limiting toxicities (DLTs) were observed and managed with a planned dose reduction of cisplatin. Of the three patients with TNBC, two (67%) experienced a partial response (PR). Of the two patients with HNSCC, both (100%) experienced objective tumor response (100% and 47% decrease, respectively). Overall, four out of the five TNBC and HNSCC patients (80%) had confirmed overall responses, including one patient (20%) with fifth-line metastatic disease who demonstrated a complete response (CR). All responding patients are still undergoing therapy. These preliminary data suggest that the NANT Cancer Vaccine (NCV), comprised of low-dose chemo-radiation combined with innate and adaptive immunotherapy, can be administered safely in an outpatient setting without any observed increase in immune-related AEs.
Preliminary Phase 1b Results in Metastatic Pancreatic Cancer
In this Phase 1b, single-arm, open-label trial, treatment was administered in 3-week cycles of low-dose chemotherapy (aldoxorubicin, cyclophosphamide, oxaliplatin, nab-paclitaxel, 5-FU/L), antiangiogenic therapy (bevacizumab), engineered allogeneic high affinity CD-16 NK-92 cells (haNK), IL-15RαFc (N-803), adenoviral vector-based CEA vaccine, yeast vector-based RAS vaccine, and an IgG1 PDL1 inhibitor, avelumab. All metastatic pancreatic cancer patients received aldoxorubicin. The primary endpoint is incidence of treatment-related AEs. Secondary endpoints include ORR, DCR, PFS, and OS.
The abstract includes data from ten patients with third-line or greater metastatic pancreatic cancer. All treatment was safely administered in the outpatient setting. AEs were primarily hematologic which were managed by appropriate planned chemo dose reductions. No DLTs have occurred and no haNK-related AEs have occurred to date. Of the ten evaluable patients, nine have achieved stable disease (SD) for ≥ 8 weeks for a DCR of 90%. Median PFS was 5.8 months (95% confidence interval: 3.3 - 8.8) and OS was 9.5 months (95% CI: 5.0 – upper limit not yet reached) with patients continuing treatment. One patient demonstrated resolution of a metastatic lung tumor within 8 weeks of initiating NCV therapy. These preliminary results suggest that the NCV treatment regimen was well tolerated and support the safety and tolerability of the regimen. These preliminary efficacy results are encouraging and the overall survival of 9.5 months currently exceeds all standards of care for patients at this advanced stage of disease.
Eric Curtis, CytRx's President and Chief Operating Officer, stated, "The data presented by NantCell at SITC's 33rd Annual Meeting are optimistic. We are pleased to see that these NCV regimens including aldoxorubicin are well tolerated and support the overall thesis being investigated. These data may ultimately lead to more combinations of aldoxorubicin with cutting edge therapies being studied in tumor types with high unmet needs. We look forward to seeing more data as these clinical trials progress."
"In the oncology marketplace, we have seen clear treatment trends by Big Pharma and recent regulatory approvals moving toward combining the category of potential Centurion drug candidates such as LADR 7, 8, 9 and 10 with immunotherapy."
Aldoxorubicin is a rationally-engineered cytotoxic which employs a linker bound to albumin to deliver doxorubicin directly into the tumor. CytRx out-licensed global development, manufacturing, and commercialization rights for aldoxorubicin to NantCell, Inc., a private subsidiary of NantWorks, LLC, in July 2017.
These data were highlighted at SITC's 33rd Annual Meeting in a presentation titled, "First in Human Data in Advanced Solid Tumors of NANT Cancer Vaccine: A Novel Temporospatial Orchestration of the Innate (NK) & Adaptive Immune System to Induce Antigen Cascade & Immunogenic Cell Death" which took place on Wednesday, November 7, 2018 from 5:45-6:00pm ET.
About the Society for Immunotherapy of Cancer
The Society for Immunotherapy of Cancer (SITC) is the world's leading member-driven organization specifically dedicated to improving cancer patient outcomes by advancing the science and application of cancer immunotherapy. Established in 1984, SITC, a 501(c)(3) not-for-profit organization, serves scientists, clinicians, academicians, patients, patient advocates, government representatives and industry leaders from around the world. Currently, SITC has more than 2,000 members who represent 22 medical specialties in 42 countries around the world. Through emphasis on high-caliber scientific meetings; dedication to education and outreach activities; focus on initiatives of major importance in the field; and commitment to collaborations with like-minded domestic and international organizations, government and regulatory agencies, associations and patient advocacy groups, SITC brings together all aspects of the cancer immunology and immunotherapy community. Through educational programs that foster scientific exchange and collaboration, SITC aims to one day make the word "cure" a reality for cancer patients everywhere.
About CytRx Corporation
CytRx Corporation (CYTR) is a biopharmaceutical company with expertise in discovering and developing new therapeutics to treat patients with cancer. CytRx's most advanced drug conjugate, aldoxorubicin, is an improved version of the widely used anti-cancer drug doxorubicin and has been out-licensed to NantCell, Inc. CytRx Corporation's website is www.cytrx.com.
About Centurion BioPharma Corporation
CytRx's wholly owned subsidiary, Centurion BioPharma Corporation, is focused on the development of personalized medicine that will transform solid tumor treatment. This transformational strategy combines a portfolio of novel, anti-cancer drug candidates that employ LADR™ (Linker Activated Drug Release) technology, a discovery engine designed to leverage Centurion's expertise in albumin biology and linker technology for the development of a new class of breakthrough anti-cancer therapies with a unique albumin companion diagnostic (ACDx) that can help identify patients who are most likely to benefit from treatment with the LADR™-derived therapies. A critical element of the LADR™ platform is its ability to bind anti-cancer molecules to circulating albumin, the most ubiquitous protein in human blood plasma, and then to release the highly potent cytotoxic payload at the tumor site. This technology allows for the delivery of higher doses of drug directly to the tumor, while avoiding much of the off-target toxicity observed with the parent molecules. Centurion BioPharma Corporation's website is www.centurionbiopharma.com.
This press release contains forward-looking statements. 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, including risks and uncertainties relating to the ability of NantCell, Inc., to obtain regulatory approval for its products that use aldoxorubicin; the ability of NantCell, Inc., 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 NantCell, Inc.; the safety and efficacy of the NANT Cancer Vaccine; the results of clinical trials involving the NANT Cancer Vaccine; Centurion BioPharma Corporation's ability to develop new ultra-high potency drug candidates based on its LADR™ technology platform; our ability to attract potential licensees; 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.
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