News | June 30, 2015

CytRx Unveils Novel LADR™ (Linker Activated Drug Release) Technology Platform

  • Next Generation Linker Technology Designed to Improve the Safety and Efficacy of Oncology Therapies, Including Immunotherapies and High Potency Chemotherapeutics up to 1,000 Times More Powerful than Traditional Drugs
  • First Drugs Derived from CytRx's LADR™ Platform Expected to Enter Clinical Development in 2016

Los Angeles, CA /PRNewswire/ - CytRx Corporation (NASDAQ: CYTR), a biopharmaceutical research and development company specializing in oncology, today unveiled its proprietary LADR™ (Linker Activated Drug Release) technology platform, a discovery engine designed to leverage the Company's expertise in albumin biology and linker technology for the development of a new class of anti-cancer therapies. CytRx expects the LADR™ platform to rapidly expand its pipeline of oncology drug candidates, providing an avenue for the development of propriety drug candidates that complement its global Phase 3 aldoxorubicin program. Among the cancers being pursued are liver, pancreatic, and non-small cell lung cancer.

"LADR™ is a creative, novel approach to the development of next-generation therapeutic drug conjugates, which we have rationally designed to control release in tumors of high-potency chemotherapeutics that are attached to either albumin or anti-cancer antibodies," stated Dr. Felix Kratz, Vice President of Drug Discovery at CytRx. "These therapies have release properties that minimize their toxic effects on non-cancerous cells, may substantially reduce drug resistance and maximize their anti-cancer potency. With the first drug candidates from this platform expected to enter the clinic in 2016, we look forward to further validating the great potential of this platform in the near future. Our LADR™ Technology can also be easily combined with immunotherapies to potentially improve outcomes."

"CytRx is committed to improving and extending the lives of patients with cancer through the development of new and innovative therapies," said Steven A. Kriegsman, Chairman and CEO of CytRx. "LADR™ is an important platform, one that combines our deep knowledge of albumin biology with cutting-edge chemistry and linker technology to deliver a highly potent next-generation albumin and antibody drug conjugate (ADC) drug candidates for cancer treatment. We believe this platform provides us with a number of avenues for near- and long-term value creation."

LADR™ Platform Mechanism

LADR™ technology was invented and developed by CytRx at its laboratories in Freiberg, Germany. The platform employs a portfolio of novel linker molecules that bind to albumin in the blood and could also be tied to a variety of antibodies, including antibodies directed at cancer targets. Because of the linker's ability to modulate release of the highly potent chemotherapy drugs attached to them at the site of cancer cells, it may be possible to reduce toxicity and increase efficacy using these conjugates.

As Dr. Kratz has previously demonstrated, these drug conjugates can form a covalent bond to albumin, the most abundant protein in the blood stream, almost instantaneously. The cytotoxic drug is then held inactive while it circulates throughout the body. Due to highly dysfunctional vasculature surrounding tumors, macromolecules like albumin are able to leak out of the blood vessel and into the tumor itself. This allows for the albumin-bound drug conjugate to accumulate at the tumor but avoid concentration in less permeable normal tissues. The linkers then allow the controlled release of selected payload agents under a variety of conditions that are present in tumors, such as low pH levels. Cleaving of the linker occurs within specific compartments in the cancer cells or can occur in the acidic conditions in and around the tumor. Since most normal tissues are not acidic, the linker does not release the drug, thereby minimizing toxicity to healthy tissues.

Once released in the tumor, the payload induces cell death based on the selected molecule. In current candidates under preclinical development, CytRx has bound very high potency drugs (10-1,000x more potent than standard chemotherapeutics), as well as modified standard chemotherapeutics that are able to avoid drug resistance mechanisms. The first group of these drugs are expected to enter the clinic in 2016.

Broad Intellectual Property Portfolio Covering LADR™ Technology

CytRx has filed a patent application including comprehensive claims directed to the LADR™ (Linker Activated Drug Release) technology platform, and compositions of matter and methods related to the technology.

About CytRx Corporation
CytRx Corporation is a biopharmaceutical research and development company specializing in oncology. CytRx currently is focused on the clinical development of aldoxorubicin (formerly known as INNO-206), its improved version of the widely used chemotherapeutic agent doxorubicin. CytRx has initiated under a special protocol assessment a pivotal Phase 3 global trial with aldoxorubicin as a therapy for patients with soft tissue sarcomas whose tumors have progressed following treatment with chemotherapy, and has announced that it has received approval from the FDA to continue dosing patients with aldoxorubicin until disease progression in that clinical trial. CytRx is currently evaluating aldoxorubicin in a global Phase 2b clinical trial in small cell lung cancer, a Phase 2 clinical trial in HIV-related Kaposi's sarcoma, a Phase 2 clinical trial in patients with late-stage glioblastoma (brain cancer), a Phase 1b trial in combination with ifosfamide in patients with soft tissue sarcoma, and a Phase 1b trial in combination with gemcitabine in subjects with metastatic solid tumors. CytRx has completed a global Phase 2b clinical trial with aldoxorubicin as a first-line therapy for soft tissue sarcomas, a Phase 1b/2 clinical trial primarily in the same indication, a Phase 1b clinical trial of aldoxorubicin in combination with doxorubicin in patients with advanced solid tumors and a Phase 1b pharmacokinetics clinical trial in patients with metastatic solid tumors. CytRx is expanding its pipeline of oncology candidates at its laboratory facilities in Freiburg, Germany, through its LADR™ (Linker Activated Drug Release) linker technology platform, a discovery engine designed to leverage the Company's expertise in albumin biology and linker technology for the development of a new class of anti-cancer therapies. For more information about CytRx Corporation, visit www.cytrx.com.

Forward-Looking Statements
This press release contains forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended. 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 relating to the outcome, timing and results of CytRx's preclinical testing of its LADR™ linker technology platform, the outcome, timing or results of CytRx's clinical testing of aldoxorubicin, the risk that any future pre-clinical or human testing of compounds based on the LADR™ technology platform might not show efficacy or reduced side effects of those compounds, risks related to CytRx's ability to manufacture its drug candidates in a timely fashion, cost-effectively or in commercial quantities in compliance with stringent regulatory requirements, risks related to CytRx's need for additional capital or strategic partnerships to fund its ongoing working capital needs and development efforts, including the Phase 3 clinical development of aldoxorubicin and the preclinical and clinical development of compounds based on the LADR™ technology platform, risks related to lawsuits that have been brought against the Company and its officers and/or directors for alleged violations of the securities laws, and the 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.

Source: CytRx Corporation

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