On March 22, 2016 CytRx Corporation (NASDAQ: CYTR), a biopharmaceutical research and development company specializing in oncology, reported that it will present two posters with new preclinical data based on its proprietary LADR technology at the upcoming 2016 American Association of Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, April 16-20, 2016, being held at the Ernest N. Morial Convention Center in New Orleans, Louisiana (Press release, CytRx, MAR 22, 2016, View Source [SID:1234509819]). Schedule your 30 min Free 1stOncology Demo! Highlights include data on DK049, CytRx’s next albumin-binding drug conjugate nominated for clinical development, which demonstrated superior anti-tumor efficacy compared to gemcitabine in human patient-derived tumor xenograft models of non-small cell lung cancer, ovarian cancer and pancreatic cancer. DK049 decreases the clearance and drug resistance mechanisms that limit the effectiveness of gemcitabine, one of the most commonly used chemotherapy drugs. As a result, DK049’s superior anti-tumor efficacy was achieved using a significantly reduced dose compared to gemcitabine. CytRx plans to commence clinical trials with DK049 in the second half of this year.
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CytRx’s second poster details the broad capabilities of the Company’s LADRTM (Linker Activated Drug Release) technology platform. A key advantage is a suite of versatile linkers with the ability to control the release profile of potent cytotoxic agents between 1-50 hours to create personalized therapies for specific cancers. DK049 and the LADRTM technology platform were created in-house at CytRx’s drug discovery lab in Freiburg, Germany.
"The posters that will be presented highlight for the first time the uniquely tunable nature of the LADRTM platform and its ability to create novel drug candidates, like DK049, with superior anti-tumor activity," said Felix Kratz, PhD, CytRx’s Vice President of Drug Discovery.
The following CytRx abstracts have been selected for AACR (Free AACR Whitepaper) poster presentations:
Title: DK049, a novel acid-sensitive prodrug of gemcitabine: design, in vitro properties and in vivo efficacy
Date/Time: Monday, April 18, 1:00pm – 5:00pm CDT
Session Title: Drug Delivery; Poster Section 15, Abstract #2061
Title: LADR: A novel linker activated drug release technology for drug delivery
Date/Time: Wednesday, April 20, 8:00am – 12:00pm CDT
Session Title: Drug Design; Poster Section 21, Abstract #4858
Author: [email protected]
Daiichi Sankyo and ArQule Announce Continuation of METIV-HCC Phase 3 Study of Tivantinib in Second-Line Hepatocellular Carcinoma
On March 22, 2016 ArQule, Inc. (Nasdaq: ARQL) and Daiichi Sankyo reported that the independent data monitoring committee (DMC) of the METIV-HCC study conducted the planned interim assessment and it was determined the trial will continue to its final analysis (Press release, ArQule, MAR 22, 2016, View Source [SID:1234509818]). Schedule your 30 min Free 1stOncology Demo! METIV-HCC is a biomarker-selected, double-blind, placebo-controlled, pivotal phase 3 study evaluating tivantinib (2:1) versus best supportive care in previously systemically-treated patients with MET-high, inoperable HCC, with overall survival as the primary endpoint.
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The interim analysis was triggered when at least 60 percent of the target number of events occurred. The final analysis will take place when 100 percent of the target number of events occurs. The METIV-HCC trial completed patient accrual in December 2015 with more than 300 patients with MET-high HCC enrolled.
About Hepatocellular Carcinoma (HCC)
Liver cancer is the sixth most common cancer globally with 782,000 new cases in 2012 and is the second most common cause of cancer-related death with 745,000 deaths in 2012.1 HCC accounts for about 90 percent of primary liver cancers.2 Cirrhosis, chronic hepatitis B and C and smoking are recognized worldwide as factors increasing the risk of HCC.2
About MET and Tivantinib (ARQ 197)
Tivantinib is an oral MET inhibitor, currently in phase 2 and phase 3 clinical trials. In healthy adult cells, MET can be present in normal levels to support natural cellular function, but in cancer cells, MET can be inappropriately and continuously activated. When abnormally activated, MET plays multiple roles in aspects of human cancer, including cancer cell growth, survival, angiogenesis, invasion and metastasis. The activation of certain cell signaling pathways, including MET, has also been associated with the development of resistance to anti-EGFR (epidermal growth factor receptor) antibodies such as cetuximab and panitumumab.
In clinical trials to date, treatment with tivantinib has been generally well tolerated and has shown clinical activity in a number of tumors studied. Tivantinib has not yet been approved for any indication in any country.
In December 2008, ArQule and Daiichi Sankyo signed a licensing, co-development and cocommercialization agreement for tivantinib in the U.S., Europe, South America and the rest of the world, excluding Japan, China (including Hong Kong), South Korea and Taiwan. 2 In November 2015, ArQule exercised its co-commercialization option for tivantinib in the U.S. A co-commercialization agreement is expected to be finalized in 2016.
JOINT PROMOTION AGREEMENT ON ANTIEMETIC AGENT WITH HELSINN THERAPEUTICS INC. IN THE UNITED STATES REVISED Eisai to Return All Rights to Promote and Distribute AKYNZEO(R) (netupitant/palonosetron) to Helsinn Therapeutics Inc.
On March 22, 2016 Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") reported that its U.S. subsidiary Eisai Inc. has agreed to revise the joint promotion agreement with Helsinn Healthcare S.A. (Headquarters: Lugano, Switzerland, Group Vice Chairman and CEO: Riccardo Braglia, "Helsinn") for their chemotherapy-induced nausea and vomiting (CINV) franchise (Press release, Eisai, MAR 22, 2016, View Source [SID:1234509811]). Schedule your 30 min Free 1stOncology Demo! Under the new arrangement, from April 1, 2016, Helsinn Therapeutics Inc., the U.S. affiliate of Helsinn ("Helsinn U.S."), will obtain exclusive rights to promote and sell AKYNZEO (netupitant/palonsetron), its oral fixed dose combination product for the prevention of CINV. AKYNZEO had previously been co-promoted in the United States by both Helsinn U.S. and Eisai Inc. As part of the revised agreement, Eisai and Helsinn U.S. will continue to co-promote ALOXI (palonosetron HCl) injection in the United States for CINV.
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Moving forward, Eisai Inc. will focus on further contributing to patients with ALOXI through this revised joint promotion agreement with Helsinn U.S., along with Eisai’s in-house anticancer agents Halaven and Lenvima.
1. About AKYNZEO
AKYNZEO is a new oral fixed combination that targets two critical signaling pathways associated with CINV, by combining netupitant, an NK1 receptor antagonist, with palonosetron, a 5-HT3 receptor antagonist. Marketing authorization applications for AKYNZEO are currently being submitted in countries throughout the world.
20-F – Annual and transition report of foreign private issuers [Sections 13 or 15(d)]
(Filing, Annual, Cellectis, 2015, MAR 21, 2016, View Source [SID:1234509777])
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Survival Results with Advaxis HER2 Targeted Immunotherapy in Canine Osteosarcoma Published in Clinical Cancer Research
On March 21, 2016 Advaxis, Inc. (NASDAQ:ADXS), a clinical stage biotechnology company developing cancer immunotherapies, reported that data from a dose-escalation study of ADXS-HER2 in canine osteosarcoma (OSA) was published online March 18, 2016 in Clinical Cancer Research, a journal of the American Association for Cancer Research (AACR) (Free AACR Whitepaper) (Press release, Advaxis, MAR 21, 2016, View Source [SID:1234510047]).
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The study by Nicola Mason, PhD, BVetMed, Associate Professor of Medicine at the University of Pennsylvania School of Veterinary Medicine, evaluated the immunogenicity, safety, and impact of attenuated, recombinant Listeria monocytogenes (Lm) transformed with a HER2/Neu fusion protein (ADXS-HER2) on survival in 18 dogs with surgically treated osteosarcoma. The research is part of Advaxis’ ongoing ADXS-HER2 clinical program.
"This is promising and important research both for dogs and humans," said Dr. Mason. "We were able to use the Advaxis Lm Technology to induce an antigen-specific T-cell response against HER2/Neu which is expressed in both canine and pediatric osteosarcoma, with only low-grade, transient side-effects. I am very excited about these results and the potential this technology holds for treatment of cancer patients of either species."
In the study, 18 dogs received either 2×108, 5×108, 1×109 or 3.3×109 CFU of ADXS–HER2 post-completion of surgery and adjuvant chemotherapy with 15 dogs showing an induced antigen-specific response within 6 months of immunotherapy administration. Additionally, treatment with ADXS-HER2 reduced the incidence of metastatic disease and prolonged survival relative to a historical control group. The median survival time for the ADXS-HER2 treated dogs was 956 days which was significantly longer than the 423 day median survival time of the historical control group (p=0.014, HR 0.33; 95% CI 0.136-0.802).
Osteosarcoma is the most common primary bone tumor in dogs, with more than 10,000 dogs annually diagnosed. Osteosarcoma is also the most common bone cancer in children and teens. It is the third most common cancer in teens after lymphomas and brain tumors. HER2 is expressed in approximately 40 to 60 percent of pediatric and canine osteosarcomas and in pulmonary metastatic disease, providing strong rationale for HER2 targeted immunotherapy in these cancers.
About ADXS-HER2
ADXS-HER2 is an Lm Technology immunotherapy product candidate being developed by Advaxis to target HER2 expressing cancers. ADXS-HER2 has received orphan drug designation by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for the treatment of osteosarcoma. Advaxis is developing ADXS-HER2 for both human and animal health, and has seen encouraging data in canine osteosarcoma, which is considered a model for human osteosarcoma. Advaxis has licensed ADXS-HER2 to Aratana Therapeutics, Inc. for animal health therapeutics. Aratana expects to receive a conditional USDA license by the end of 2016 to market and sell ADXS-HER2 for dogs with canine osteosarcoma.