CytRx Corporation
CytRx Corporation (CYTR) is a biopharmaceutical company specializing in oncology. Its focus is on the discovery, research and clinical development of novel anti-cancer drug candidates that employ linker technologies to enhance the accumulation and release of drug at the tumor. Aldoxorubicin, it slead clinical candidate, has been tested in over 600 patients with various types of cancer.1
CytRx's lead product candidate is aldoxorubicin, a conjugate of the commonly prescribed chemotherapeutic agent doxorubicin that binds to circulating albumin in the bloodstream and is believed to concentrate the drug at the site of the tumor. Specifically, it is comprised of (6-maleimidocaproyl) hydrazine, an acid-sensitive molecule that is conjugated to doxorubicin. Its lead indication for aldoxorubicin is for patients with advanced soft tissue sarcomas (STS). It met with the FDA in March 2017 to discuss a regulatory pathway for a New Drug Application (NDA) for aldoxorubicin in STS.
Aldoxorubicin has received Orphan Drug Designation (ODD) by the U.S. FDA for the treatment of STS. ODD provides several benefits including seven years of market exclusivity after approval, certain R&D related tax credits, and protocol assistance by the FDA. European regulators granted aldoxorubicin Orphan designation for STS which confers ten years of market exclusivity among other benefits.
On July 27, 2017, CytRx entered into an exclusive worldwide license with NantCell, Inc. ("NantCell"), granting them rights to develop, manufacture and commercialize aldoxorubicin in all indications. As part of the license, NantCell made a strategic investment of $13 million in CytRx common stock at a premium to the market price. CytRx is entitled to receive up to $343 million in milestones related to regulatory approvals and commercial milestones. CytRx is entitled to receive ascending double-digit royalties for net sales for soft tissue sarcomas and mid to high single digit royalties for other indications. NantCell will take over the development and commercialization responsibility for aldoxorubicin including the NDA.
CytRx has an active drug discovery and research operation at the company’s laboratory facilities in Freiburg, Germany, focusing on the creation of novel drug anti-cancer candidates by combining its proprietary linker technologies with ultra-high potency cytotoxic drugs. It is expanding pipeline of ultra-high potency oncology candidates through its LADR™ (Linker Activated Drug Release) technology platform, a discovery engine designed to leverage CytRx's expertise in albumin biology and next generation linker technologies for the development of a new class of potential breakthrough anti-cancer therapies.
The company created a "toolbox" of linker technologies that have the ability to significantly increase the therapeutic index of ultra-high potency drugs (10-1,000 times more potent than traditional chemotherapies) by controlling the release of the drug payloads and improving drug-like properties. After infusion, these ultra-high potency drug conjugates bind to circulating albumin for transport of the drug to the tumor. Subsequently, due to specific conditions within the tumor, the linkers are cleaved and release the anti-cancer drug payload.
CytRx current efforts are focused on two classes of ultra-high potency drug conjugates. CytRx strategy across these programs is to generate additional data that will inform decisions regarding the possible selection for one or both programs for moving into human clinical trials either independently or on a partnered basis.
Milestone
- 1Q16: Enrollment in Phase 3 STS trial - Completed ahead of schedule in Q4 2015
- 2Q16: Presented data on DK049 at the AACR Annual Meeting in April
- 2Q16: Presented clinical trial updates at ASCO on GBM, Kaposi’s sarcoma and gemcitabine combination with aldoxorubicin
- July 2016: Interim Phase 3 STS PFS data
- 2H16: GBM OS data reported at ASCO
- 4Q16: Presented Phase 1b/2 results of aldoxorubicin with ifosfamide in advanced sarcomas at ESMO and CTOS
- 4Q16: Announced updated Phase 3 STS data
- 1Q17: Met with the FDA for aldoxorubicin as a treatment for STS
- 2Q17: Oral presentation of aldoxorubicin Phase 3 STS data at ASCO
- 2Q17: Present updated Phase 1b/2 results from combination trial of aldoxorubicin and ifosfamide in advanced sarcomas at ASCO
Future Timeline
- 2017: Select ultra-high potency drug conjugate for clinical development
- 3Q17: Potential global strategic alliance with aldoxorubicin
- 4Q17: Initiate rolling NDA with FDA for aldoxorubicin in STS
- 2H18: Commercialization of aldoxorubicin in STS projected
