On September 14, 2015 Advaxis, Inc. (NASDAQ:ADXS), a clinical-stage biotechnology company developing cancer immunotherapies,reported that the U.S. Food and Drug Administration’s (FDA) Office of Orphan Products Development (OOPD) awarded a grant totaling $1.1 million over three years to Baylor College of Medicine in support of an ongoing Phase 2 trial of Advaxis’s lead Lm Technology immunotherapy, axalimogene filolisbac (ADXS-HPV), in HPV-associated oropharynx (throat) cancer, a type of head and neck cancer (Press release, Advaxis, SEP 14, 2015, View Source [SID:1234507466]). Schedule your 30 min Free 1stOncology Demo! The grant was administered through the FDA’s Orphan Products Grants Program, created more than 30 years ago by the Orphan Drug Act to promote the development of products for rare diseases. It is a competitive program that receives approximately 100 applications per year, from which typically 10 to 15 applications are selected for funding each fiscal year.
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"Applications to the Orphan Products Grants Program undergo rigorous review for scientific and technical merit by a panel of experts to compete for funding," said Daniel J. O’Connor, President and Chief Executive Officer of Advaxis. "We are encouraged to see axalimogene filolisbac recognized as viable by being awarded a grant for its clinical research that could ultimately contribute to market approval."
The Phase 2 study will be led by Andrew G. Sikora, M.D., Associate Professor of Otolaryngology at BCM and co-director of the Head and Neck Cancer Program in the NCI Comprehensive-Designated Dan L. Duncan Cancer Center at Baylor, and is supported by key investigators Brett Miles, M.D. and Marshall Posner, M.D. at the Icahn School of Medicine at Mount Sinai. The study is designed to evaluate the efficacy of axalimogene filolisbac as neoadjuvant treatment prior to robot-assisted surgery in patients with HPV-associated oropharyngeal cancer.
"We hope to improve outcomes in HPV-associated head and neck cancer by exploring axalimogene filolisbac in this indication, where existing treatment options are associated with risk of long-term morbidity," said Dr. Sikora. "If successful, this trial could pave the way for immunotherapy to become a standard treatment for HPV-associated cancers."
HPV-Associated Oropharynx (Throat) Cancer
Human papillomavirus (HPV) is an important cause of cancers worldwide, including cancers of the oropharynx (throat), cervical cancer, and other cancers. HPV-related throat cancer is currently the fastest-growing type of head and neck cancer, with an incidence of approximately 15,500 new cases of HPV-associated oropharynx cancer in the U.S. per year.
About Axalimogene Filolisbac
Axalimogene filolisbac (ADXS-HPV) is Advaxis’s lead Lm Technology immunotherapy candidate for the treatment of HPV-associated cancers and is in clinical trials for three potential indications: invasive cervical cancer, head and neck cancer, and anal cancer. In a completed randomized Phase 2 study in recurrent/refractory cervical cancer, axalimogene filolisbac showed apparent prolonged survival, objective tumor responses, and a manageable safety profile alone or in combination with chemotherapy, supporting further development of the company’s Lm Technology.
Author: [email protected]
EISAI TO PRESENT LATEST CLINICAL DATA ON LENVIMA(R) (LENVATINIB) AND HALAVEN(R) (ERIBULIN) AT EUROPEAN CANCER CONGRESS
On September 14, 2015 Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") reported that a series of abstracts highlighting the latest clinical data on Lenvima (generic name: lenvatinib mesylate; selective inhibitor of receptor tyrosine kinases with a novel binding mode, "lenvatinib") and Halaven (generic name: eribulin mesylate; halichondrin class microtubule dynamics inhibitor, "eribulin") will be presented during the European Cancer Congress (ECC) 2015, taking place in Vienna, Austria, from September 25 to 29 (Press release, Eisai, SEP 13, 2015, View Source [SID:1234507464]).
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For lenvatinib, four abstract presentations are to take place at the meeting including an oral presentation highlighting an updated analysis on overall survival gain in a Phase III clinical study on radioiodine-refractory differentiated thyroid cancer (the SELECT study), and a poster presentation on correlative analyses of serum biomarkers and clinical outcomes in a Phase II study in patients with metastatic renal cell carcinoma, as key presentations. Lenvatinib has been approved and launched as a treatment for refractory thyroid cancer in the United States, Japan and Europe. Meanwhile, Eisai has received a Breakthrough Therapy Designation from the U.S. Federal Drugs Administration for lenvatinib regarding the indication of advanced or metastatic renal cell carcinoma.
For eribulin, a poster presentation on an analysis of quality-of-life (QOL) results from a Phase III clinical study on soft tissue sarcoma (Study 309) will be conducted at the meeting. Currently, applications seeking approval of an additional indication for eribulin as a treatment for soft tissue sarcoma are undergoing regulatory review in Japan, the United States and Europe.
Eisai positions oncology as a key franchise area. The company will continue to create innovation in the development of new drugs based on cutting-edge cancer research, and in doing so seeks to make further contributions to address the diversified needs of, and increase the benefits provided to, patients and their families as well as healthcare providers.
10-K – Annual report [Section 13 and 15(d), not S-K Item 405]
(Filing, 10-K, CellCeutix, SEP 11, 2015, View Source [SID:1234507462])
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10-Q – Quarterly report [Sections 13 or 15(d)]
(Filing, 10-Q, Advaxis, SEP 11, 2015, View Source [SID:1234507461])
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TMRC Enters into License Agreement with Syros Pharmaceuticals for Development and Commercialization of TM-411 in North America and Europe for Cancer
On September 11, 2015 TMRC Co., Ltd. ("TMRC" Hisao Ekimoto, President & CEO, Tokyo, Japan) reported that it has entered into an exclusive license agreement with Syros Pharmaceuticals Inc. ("Syros" Nancy Simonian, CEO, Massachusetts, USA) for the U.S. biopharmaceutical company to develop and commercialize TM-411 (tamibarotene) in North America and Europe for cancer (Press release, TMRC, SEP 11, 2015, View Source [SID:1234512621]).
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Syros plans to initiate a Phase 2 clinical trial of TM-411 (which Syros refers to as SY-1425) in 2016 in a genomically defined subset of patients with acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS).
Syros’ proprietary gene control platform is designed to systematically analyze patient tissue to identify crucial genes that become dysregulated in diseased cells in order to create medicines that return cells to a non-diseased state.
Using its platform, Syros discovered a biomarker associated with RARα dependency in subsets of AML and breast cancer patients based on analysis of their tumors. Syros observed the elevated biomarker in approximately 25% of AML patient samples analyzed. Syros then demonstrated in patient-derived xenograft models of AML that tumors with the biomarker for RARα dependency responded to TM-411 while tumors without the biomarker did not respond to the therapy.
Treatment with TM-411 extended survival in animals carrying patient-derived tumors with the biomarker.
Syros plans to research the potential role of this biomarker in other cancers, including breast cancer.
›Tamibarotene
The retinoic acid derivative invented by Dr. Koichi Shudo at Faculty of Pharmacy at University of Tokyo exhibits stronger differentiation activity with improved stability and safety than the retinoid agents currently available. Tamibarotene was developed by Toko Pharmaceuticals and approved (Amnolake Tablet 2 mg) for relapsed/refractory acute promyelocytic leukemia (APL) in Japan on April 11, 2005.