CytRx Corporation Announces Conclusion of Pre-Clinical Phase for Its Albumin Binding Ultra High Potency LADR™ Drug Candidates and Accompanying Companion Diagnostic

In In The News by Barbara Jacoby

Source: CytRx Corporation

From: prnewswire.com

CytRx Corporation (NASDAQ: CYTR), a biopharmaceutical research and development company specializing in oncology, today announced that its private, wholly-owned subsidiary Centurion BioPharma Corporation (the Company) has concluded the pre-clinical phase of its development for its albumin binding ultra high potency LADR™ (Linker Activated Drug Release) drug candidates, LADR-7, LADR-8, LADR-9 and LADR-10, and for its unique albumin companion diagnostic (ACDx).  As a result of completing this work, operations taking place at the pre-clinical laboratory located in Freiburg, Germany will no longer be needed.

The LADR™ platform combines Centurion’s proprietary linker chemistry with albumin biology to create anti-cancer molecules that the Company believes will deliver highly potent agents directly to the tumor, while avoiding unacceptable systemic toxicity.  The pre-clinical laboratory synthesized and evaluated over 75 rationally-designed drug conjugates across two distinct classes of compounds, the auristatins and maytansinoids. In vitro, in vivo, stability and manufacturing feasibility testing is now complete for all four lead LADR candidates as well for ACDx.  The pre-clinical stage dossiers for all of these assets are now complete and are ready for transfer to a strategic partner.

“Our investment in the Freiburg pre-clinical laboratory has yielded a platform of personalized medicine assets, including a highly unique companion diagnostic for use alongside four albumin binding drug conjugates,” said Eric Curtis, CytRx’s President and Chief Operating Officer.  “The world-class pre-clinical team has achieved the critical steps and each of these pipeline assets are now eligible for IND-enabling studies.  As a result of the completion of this project, CytRx will have reduced its cash burn and will utilize its financial resources for other opportunities while we work to secure a strategic transaction for the LADR and ACDx assets, with the goal of executing such a transaction as soon as possible.  The company remains under CDA with several big pharma companies and is continuing discussions regarding a potential partnership.”

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 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.

About CytRx Corporation

CytRx Corporation (NASDAQ: 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). 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).

Forward-Looking Statements

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 the LADR™ drug candidates LADR‑7, LADR-8, LADR-9 and LADR-10, and the companion diagnostic ACDx, and to enter clinical trials or obtain regulatory approvals for any such products; the efficacy and safety of such products; 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.; risks and uncertainties relating to the ability of Orphazyme A/S to obtain regulatory approval for its products that use arimoclomol; the ability of Orphazyme A/S to manufacture and commercialize products or therapies that use arimoclomol; the amount, if any, of future milestone and royalty payments that we may receive from Orphazyme A/S; 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 and Centurion BioPharma undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.