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Aeterna Zentaris Completes Patient Recruitment for ZoptEC Phase 3 Study with Zoptarelin Doxorubicin in Advanced Endometrial Cancer

On June 30, 2015 Aeterna Zentaris reported that it has reached its goal of recruiting 500 patients for its pivotal Phase 3 ZoptEC (Zoptarelin Doxorubicin in Endometrial Cancer) clinical study with zoptarelin doxorubicin in women with advanced, recurrent or metastatic endometrial cancer (Press release, AEterna Zentaris, JUN 30, 2015, View Source;q=675 [SID:1234506531]). The trial is being conducted in over 120 sites in North America, Europe and Israel. The primary efficacy endpoint is improvement in overall survival.

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Following its first pre specified interim analysis last April, a Data and Safety Monitoring Board recommended that the ZoptEC Phase 3 study continue as planned. A second interim analysis is expected during Q4, 2015 at approximately 192 events, with the final analysis planned at an anticipated 384 events. The trial is expected to be completed by the end of 2016.

David A. Dodd, Chairman and CEO of Aeterna Zentaris, commented, "We are very excited to have completed patient recruitment for our ZoptEC Phase 3 trial in endometrial cancer earlier than expected, and I would like to thank everyone involved in this project for their steadfast commitment. We believe zoptarelin doxorubicin has the potential to become the first FDA approved medical therapy for advanced, recurrent endometrial cancer. This could result in its rapid adoption as a novel core therapy for patient treatment and management, and therefore, could represent a significant market opportunity for the Company. Moving forward, we are continuing to develop our commercialization plans regarding zoptarelin doxorubicin in this indication, including establishing additional partnerships in territories that we do not intend to pursue ourselves. Furthermore, contingent on the success of the ZoptEC program, we have additional areas of interest for further therapeutic development, including ovarian, prostate and triple negative breast cancer. Our commitment is to provide therapies to patients and their physicians that can potentially improve and extend the quality of lives."

About the ZoptEC Phase 3 trial

The ZoptEC Phase 3 trial is an open-label, randomized-controlled study, comparing the efficacy and safety of zoptarelin doxorubicin, a hybrid molecule composed of a synthetic peptide carrier and a well known chemotherapy agent, doxorubicin, to doxorubicin alone. It is being conducted under a Special Protocol Assessment with the U.S. Food and Drug Administration ("FDA"). Patients are centrally randomized in a 1:1 ratio and receive either zoptarelin doxorubicin (267 mg/m2) or doxorubicin (60 mg/m2) intravenously, every 3 weeks and for up to 9 cycles. Response will be evaluated every 3 cycles during treatment, thereafter, every 12 weeks until progression. All patients will be followed for survival as the primary efficacy endpoint ("EP"). Secondary EPs include progression free survival, objective response-rate, and clinical benefit rate.

For more information on this trial, please consult (ClinicalTrials.gov Identifier: NCT01767155; EudraCT No: 2012-005546-38; ZoptEC: Zoptarelin doxorubicin in endometrial cancer).

About Zoptarelin Doxorubicin

Zoptarelin doxorubicin represents a new targeting concept in oncology using a hybrid molecule composed of a synthetic peptide carrier and a well-known chemotherapy agent, doxorubicin. Zoptarelin doxorubicin is the first intravenous drug in advanced clinical development that directs the chemotherapy agent specifically to LHRH-receptor expressing tumors, which could result in a more targeted treatment with less damage to healthy tissue. The Company is currently conducting a ZoptEC (Zoptarelin doxorubicin in Endometrial Cancer) Phase 3 trial in women with advanced, recurrent or metastatic endometrial cancer, while zoptarelin doxorubicin is also in an investigator initiated Phase 2 trial in prostate cancer. Aeterna Zentaris owns the worldwide rights to this compound except in China (including Hong Kong and Macau) where rights have been out-licensed to Sinopharm A-Think Pharmaceuticals, a subsidiary of Sinopharm, the largest medical and healthcare group in China and on Fortune’s Global 500 list. On April 16, 2015, the Company announced the filing of a patent application intended to strengthen the exclusivity of zoptarelin doxorubicin through a unique, significantly lower cost in the manufacturing process.

About Endometrial Cancer

Endometrial cancer is the most common gynecologic malignancy in developed countries and develops when abnormal cells amass to form a tumor in the lining of the uterus. It largely affects women over the age of 50 with a higher prevalence in Caucasians and a higher mortality rate among African Americans. According to the American Cancer Society, there will be approximately 55,000 new cases of endometrial cancer in the U.S. alone in 2015, with about 20% of recurring disease.

Ignyta Announces the Release for Clinical Use of a Proprietary NGS Clinical Trial Assay to Support Its STARTRK Clinical Studies

On June 30, 2015 Ignyta reported the release for clinical use of its first clinical trial assay to support patient identification and enrollment into its STARTRK ("Studies of Tumor Alterations Responsive to Targeting Receptor Kinases") clinical development program for entrectinib (Press release, Ignyta, JUN 30, 2015, View Source [SID:1234506011]). Entrectinib is the company’s proprietary oral tyrosine kinase inhibitor, targeting tumors that harbor activating alterations to NTRK1/2/3 (encoding TrkA/TrkB/TrkC), ROS1 or ALK.

"A key tenet of Ignyta’s vision to be a leading precision oncology company is our ability to seamlessly integrate Rx with Dx to detect appropriate cancer patients to treat with highly targeted agents," said Jonathan Lim, M.D., Ignyta’s Chairman and Chief Executive Officer. "Today we have taken a major step toward achieving that vision by releasing for clinical use Ignyta’s first clinical trial assay, which was co-developed with ArcherDx and validated within Ignyta’s own diagnostic labs. Ignyta’s CLIA-registered, QSR-compliant diagnostic lab in San Diego will utilize this assay in acting as the central testing lab for patient screening for the STARTRK-2 study."

STARTRK-2 is a global Phase 2 study that will further evaluate the safety and efficacy of entrectinib, and the design was recently summarized at Ignyta’s Management Presentation during the 2015 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) conference.

The NGS-based clinical trial assay will initially be performed only to identify potential patients for clinical trial enrollment and will not be offered for commercial use.

AVEO Oncology Announces Additional Biomarker Analyses from BATON-CRC Tivozanib Study to be Presented at the ESMO 17th World Congress on Gastrointestinal Cancer

On June 30, 2015 AVEO reported that additional biomarker analyses from the BATON- (Biomarker Assessment of Tivozanib in ONcology) CRC study will be presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 17th World Congress on Gastrointestinal Cancer, taking place July 1-4 in Barcelona, Spain (Press release, AVEO, JUN 30, 2015, View Source;p=RssLanding&cat=news&id=2063535 [SID:1234506008]). Tivozanib is an oral, potent, selective inhibitor of vascular endothelial growth factor (VEGF) with a long half-life and activity against all three VEGF receptors.

The BATON-CRC study is a randomized Phase 2 clinical trial of modified FOLFOX6 combined with tivozanib or bevacizumab in metastatic colorectal cancer (CRC). The presentation, titled "Neuropilin 1 (NRP1) may be Prognostic and Identify a Subgroup of Patients with Metastatic Colorectal Cancer (mCRC) who Benefit from Tivozanib + mFOLFOX6 compared to Bevacizumab + mFOLFOX6," will be presented in an oral session titled "Session X: Presentation of Selected Abstracts: Colorectal Cancer," which begins at 8:00 a.m. CEST on Friday, July 3, 2015, and in a poster session that begins at 10:25 a.m. CEST that day.

As previously announced, the additional analyses, which produced similar results to those presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Tumor Angiogenesis and Vascular Normalization Conference in March 2015 used a different NRP1 assay and were conducted as part of the Company’s ongoing effort to develop an NRP1 assay suitable for further clinical study and eventual commercialization. Al B. Benson III, MD, FACP, Professor of Medicine at the Feinberg School of Medicine, Associate Director for Clinical Investigations at the Robert H. Lurie Comprehensive Cancer Center of Northwestern University, and principal investigator of the BATON-CRC study, will present the updated findings.

A copy of the poster presentation will be available, beginning at the time of presentation, on AVEO’s website at www.aveooncology.com.

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

On June 30, 2015 CytRx reported 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 (Press release, CytRx, JUN 30, 2015, View Source [SID:1234506012]).

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.

8-K – Current report

On June 29, 2015 Cellular Biomedicine Group reported it has completed the previously announced acquisition of Blackbird Bio Finance and University of South Florida’s ("Licensor") next generation GVAX vaccine’s ("CD40LGVAX") related technologies and technical knowledge (Filing, 8-K, Cellular Biomedicine Group, JUN 29, 2015, View Source [SID:1234506026]). With the close of this acquisition, management believes that the Company will be able to offer comprehensive immuno-oncology cell therapy portfolios, as well as a broad set of options for patients.

Dr. William (Wei) Cao, Chief Executive Officer of CBMG, commented: "We are extremely pleased with this strategic acquisition which strengthens our cancer immunotherapy vaccine and vaccine combination technology platform. This inroad into the U.S. market is a significant strategic milestone for the Company and we look forward to seeking approval to conduct international clinical trials with leading medical centers."

Under the terms of the agreement, CBMG will pay an initial consideration of $2.5 million in cash and up to $1.75 million in shares of the Company’s Common Stock which is based on the 20-day volume weighted average price ("VWAP") of the Company’s Common Stock on the closing date of June 29, 2015. As a licensee of CD40LGVAX, the Company could pay potentially more than $25M in future milestone and sales royalty payments to the Licensor. Additional information can be found in the Form 8-K filed by Cellular Biomedicine Group with the Securities and Exchange Commission on June 12, 2015.