LADR™ Scientific Research Published as Cover Story in the Peer Reviewed Journal of Controlled Release, a Leading Journal for Drug Delivery
Ultra High Potency Drugs Can Be Utilized with Albumin as a Drug Carrier without the Expense and Manufacturing Complexity of Antibody Conjugation
LOS ANGELES, Feb. 13, 2019 /PRNewswire/ -- CytRx Corporation (CYTR), a biopharmaceutical research and development company specializing in oncology, and its private, wholly-owned subsidiary Centurion BioPharma Corporation, today announced the publication of peer reviewed, scientific research for LADR-7 (AE-Keto-Sulf07), one of its lead LADR™ (Linker Activated Drug Release) candidates. The article, entitled "Novel auristatin E-based albumin-binding prodrugs with superior anticancer efficacy in vivo compared to the parent compound" to be published in the Journal of Controlled Release, a leading journal for drug delivery on February 28, 2019. The abstract may be found and full article purchased online at https://www.sciencedirect.com/journal/journal-of-controlled-release/vol/296.
The manuscript was published by Felix Kratz, PhD and his team of researchers who have been pioneers in the field of albumin-based drug research. Dr. Kratz has investigated the use of albumin as a drug carrier with highly potent cytotoxic agents for over 25 years focusing on acid-sensitive and enzymatically cleavable linkers. Dr. Kratz commented, "The data published today provides convincing preclinical proof-of-concept that for the first time the body's own albumin can be used as an effective drug carrier to target and deliver highly potent auristatin E in a variety of solid tumors with outstanding efficacy."
LADR-7 is designed to release the ultra high potency auristatin E payload at the tumor site in a pH-dependent manner. Preclinical efficacy shows impressive results in a panel of patient and cell-derived human tumor xenograft models (melanoma, ovarian carcinoma, non-small-cell lung cancer and head and neck squamous cell carcinomas) in comparison with the parent compound auristatin E. While auristatin E was devoid of any antitumor efficacy except in one model, LADR-7 showed anticancer efficacy inducing statistically significant partial and/or complete tumor regressions in both small (130‒150 mm3) and large (270‒380 mm3) tumors. Of note is that long-term regressions were achieved in all tested xenograft models up to 14-week post-injection.
Auristatin E as a drug treatment experienced a resurgence with Adcetris®, an antibody drug conjugate developed by Seattle Genetics. Centurion's LADR™ platform demonstrates that such highly potent drugs can be harnessed without the expense and complex manufacturing process of antibody conjugation.
Additionally, several recent regulatory approvals for immunotherapeutic agents combined with conventional cytotoxic therapy demonstrate the revival of cytotoxic therapy to deliver added benefits over conventional therapy. The LADR mechanism targets the tumor and reduces side effects which makes it an attractive partner to study in combination with immunotherapies in solid tumors. The preclinical dossier for LADR-7 is complete and ready for transfer to a strategic partner for further development.
About the LADR™ Drug Candidates and the Albumin Companion Diagnostic
Centurion BioPharma's LADR™ (Linker Activated Drug Release) technology employs a broad portfolio of novel linker molecules that selectively bind to circulating albumin and have the ability to be linked to a wide variety of anti-cancer payloads. Centurion's LADR™ drug candidates, LADR-7, LADR-8, LADR-9 and LADR-10, utilize the anti-cancer agents maytansine and auristatin E to maximize tumor cell kill potential while minimizing systemic toxicity. Centurion believes these agents have the potential to be combined with immunotherapies to improve the efficacy and safety of treatments for cancers that have typically been difficult to treat. At the American Association for Cancer Research (AACR) 2018 Annual Meeting, scientific research was presented which described the breakthrough data supporting Centurion's selection of its current LADR assets for advancement toward Investigational New Drug-enabling studies. These targeted compounds demonstrated excellent, long-term antitumor activity across a wide range of human solid tumor cancer types, including lung, breast, ovarian, head and neck, renal cell, and melanoma.
In July 2018, Centurion filed a provisional patent application with the U.S. Patent and Trademark Office covering its unique albumin companion diagnostic (ACDx) for use alongside its albumin binding ultra-high potency LADR™ (Linker Activated Drug Release) drug candidates. The goal of ACDx is to identify patients with cancer who are most likely to benefit from treatment with LADR-7, LADR-8, LADR-9 and LADR-10.
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. In addition, CytRx's other drug candidate, arimoclomol has been out-licensed to Orphazyme A/S (Nasdaq Copenhagen exchange: ORPHA). 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). CytRx Corporation's website is www.cytrx.com.
About Centurion Corporation
CytRx's wholly owned subsidiary, Centurion BioPharma Corporation, is focused on the development of personalized medicine that is designed to 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 Centurion BioPharma to enter into strategic transactions or partnerships involving its proprietary LADR™ drug candidates; the ability of Centurion's LADR™ drug candidates to enter clinical trials or obtain regulatory approvals for any such products; the efficacy, safety and results me of any clinical trials involving Centurion's LADR™ drug candidates; the ability of Centurion to develop new ultra-high potency drug candidates based on its LADR™ technology platform and 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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