On March 2, 2016 OncoSec Medical Incorporated ("OncoSec") (NASDAQ: ONCS), a company developing DNA-based intratumoral cancer immunotherapies, reported the completion of patient enrollment in the Company’s Phase II extension study of its investigational product ImmunoPulse IL-12 for the treatment of advanced melanoma (Press release, OncoSec Medical, MAR 2, 2016, View Source [SID:1234509333]). Schedule your 30 min Free 1stOncology Demo! The trial’s objective is to evaluate an alternate dosing frequency and additional biomarkers to provide further scientific understanding of ImmunoPulse IL-12 in an extension of the OMS-I100 Phase II melanoma trial. The Company expects to report consolidated data from the OMS-I100 and extension studies by Q3 2016.
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"We are committed to improving the lives of patients with advanced melanoma and are pleased to have completed enrollment in this Phase II study," said Punit Dhillon, President and CEO of OncoSec. "Completing enrollment in this study is an important step in the development for ImmunoPulse IL-12 as it allows us to build upon our positive Phase I and II results and inform our ongoing and future trials. There is a significant opportunity to bring forward a new generation of intratumoral immunotherapies for patients with melanoma who typically don’t respond to first-line immunotherapies due to a low-TIL (tumor-infiltrating lymphocyte) phenotype. Our intention is to use the results from this study along with data from our OMS-I100 Phase II trial to formulate a combination registration path for ImmunoPulse IL-12 in melanoma."
The objective of the extension study is to assess the safety and efficacy of a six-week treatment cycle with ImmunoPulse IL-12 in 21 patients with advanced melanoma. The protocol extension provides an opportunity to assess whether more frequent treatment with ImmunoPulse IL-12 can provide additional clinical benefit to patients. The details of the trial can be found at www.clinicaltrials.gov.
Author: [email protected]
Filing of Public Knowledge-Based Application for Anti-Cancer Agent “Xeloda®” for Additional Indication of Adjuvant Chemotherapy for Rectal Cancer
On March 2, 2016 Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) reported that it has filed public knowledge-based applications for the anti-cancer agent, capecitabine (brand name: Xeloda Tablets 300) (Xeloda) for the additional indication of "adjuvant chemotherapy for rectal cancer" with the Ministry of Health, Labour and Welfare (MHLW) (Press release, Chugai, MAR 2, 2016, View Source [SID:1234509328]). Schedule your 30 min Free 1stOncology Demo! As a result of the evaluation by the "26th Review Committee on Unapproved Drugs and Indications with High Medical Needs"* held on February 3, 2016, a "public knowledge-based application" is applicable when filing for this indication. The filing was made based on the decision at the meeting of the Second Committee on New Drugs, Pharmaceutical Affairs and Food Sanitation Council, held on February 26, 2016, which confirmed that filing through the "public knowledge-based application" was reasonable for this indication.
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Xeloda was developed by Nippon Roche K.K. (currently Chugai) and has been approved in more than 100 countries worldwide. In Japan, Xeloda is marketed by Chugai and it received approval for "inoperable or recurrent breast cancer" in June 2003. Afterward, Xeloda received approval for the indications of "postoperative adjuvant chemotherapy for colon cancer," "advanced or refractory colorectal cancer, which is not amenable to curative resection" and "gastric cancer."
Xeloda has been placed for the standard therapy of "adjuvant chemotherapy for rectal cancer" by the clinical guidelines on Europe and America and results of overseas clinical trials. In order Xeloda to be accessible for Japanese patients sooner, Chugai will continue its effort to receive an approval as soon as possible.
* The "Review Committee on Unapproved Drugs and Indications with High Medical Needs" was established for the purpose of enhancing development by the pharmaceutical companies of drugs and indications that have been approved for use in western countries but not yet approved in Japan, through activities such as evaluating medical needs and confirming the applicability of "public knowledge-based application" and investigating the need for studies that should be additionally conducted."
Advaxis Study in Head and Neck Cancer Selected for Late-Breaking Poster at the American Association for Cancer Research Annual Meeting
On March 02, 2016 Advaxis, Inc. (NASDAQ:ADXS), a clinical stage biotechnology company developing cancer immunotherapies, reported that data from a Phase 2 study of its lead Lm immunotherapy candidate in HPV-associated head and neck cancer, axalimogene filolisbac (AXAL), has been selected as a late-breaker poster presentation at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting (Press release, Advaxis, MAR 2, 2016, View Source [SID:1234509327]). According to AACR (Free AACR Whitepaper)’s selection criteria, late-breaking abstracts demonstrate highly significant and timely findings in any area of cancer research that were not available at the time of the regular abstract deadline. Additionally, only abstracts deemed to be of high scientific priority are accepted for presentation. Schedule your 30 min Free 1stOncology Demo! The Phase 2 study by Andrew G. Sikora, M.D., Associate Professor of Otolaryngology and co-director of the Head and Neck Cancer Program in the NCI Comprehensive-Designated Dan L. Duncan Cancer Center at Baylor College of Medicine, is evaluating the efficacy of axalimogene filolisbac as neoadjuvant treatment prior to robot-assisted surgery in patients with HPV-associated head and neck cancer. The poster will present data on the effect of axalimogene filolisbac in targeting and inducing a T-cell response in the tumor microenvironment. The study received a three-year $1.1 million grant from the U.S. Food and Drug Administration’s Office of Orphan Products Development, which funds research for the development of products for rare diseases.
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"Our research into the potential of AXAL in targeting HPV-related cancers continues to make remarkable progress. We are pleased to have the opportunity to share these results with the cancer research community at AACR (Free AACR Whitepaper)," said Daniel J. O’Connor, President and Chief Executive Officer of Advaxis.
This year’s meeting will focus on "Delivering Cures through Cancer Science," and will take place in New Orleans, Louisiana April 16-20 at the Ernest N. Morial Convention Center. Once confirmed, the time and date of the Advaxis poster presentation will be available on Advaxis.com.
HPV-Associated Head and Neck Cancers
More than 90 percent of head and neck squamous cell oropharyngeal cancers originate from the mucosal linings of the oral cavity, pharynx, or larynx. Currently, 60 to 80 percent of these cancers are caused by HPV. Head and neck cancers are treated by surgical removal of the cancer and lymph nodes, often followed by radiation and chemotherapy based on the extent of the disease. While patients may achieve good long-term survival, standard treatments can change their physical appearance and are associated with significant short and long-term toxicities which may interfere with salivary gland function, taste, smell, and the ability to swallow.
The incidence of HPV-associated head and neck cancers has been increasing at an epidemic rate, while head and neck cancers from other causes have been decreasing. According to the World Health Organization, approximately 15 to 20 percent of the 400,000 new cases of head and neck cancer are HPV-related. In the US, there are about 12,000 new cases of HPV-associated head and neck cancer per year and it affects men about 3 times more frequently than women. HPV-associated head and neck cancer is growing fastest in developed countries like the U.S.
About Axalimogene Filolisbac
Axalimogene filolisbac (ADXS-HPV) is Advaxis’ 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. Axalimogene filolisbac has Orphan Drug Designation in the U.S. for the treatment of anal cancer.
10-K
In December 2006, we entered into a license agreement with Halozyme Therapeutics, Inc. (Halozyme), under which we granted Halozyme a worldwide, limited exclusive license to certain of our proprietary PEGylation technology to develop, manufacture and commercialize particular products that use our proprietary PEGylation materials linked only with certain qualifying hyaluronidase protein molecules including PEGPH20 (Filing, 10-K, Nektar Therapeutics, MAR 1, 2016, View Source [SID:1234513765]).
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According to Halozyme, certain cancers, including pancreatic, breast, colon and prostate, have been shown to accumulate high levels of hyaluronan (HA). Halozyme’s FDA-approved, HYLENEX recombinant human hyaluronidase, rHuPH20, is administered subcutaneously and temporarily and reversibly degrades HA to facilitate the absorption and dispersion of other injected drugs or fluids and for subcutaneous fluid administration. However, rHuPH20 acts only locally at the injection site, is rapidly inactivated in the body, and does not survive in the blood. PEGPH20 is an investigational PEGylated form of rHuPH20, under development by Halozyme to increase the half-life of the compound in the blood and allow for intravenous administration.
Halozyme is currently evaluating PEGPH20 in a Phase 2 multicenter, randomized clinical trial evaluating PEGPH20 as a first-line therapy for patients with stage IV metastatic pancreatic cancer. Halozyme is also evaluating PEGPH20 in an on-going Phase 1b/2 multi-center, randomized clinical trial evaluating PEGPH20 as a second-line therapy for patients with locally advanced or metastatic non-small cell lung cancer. On October 2, 2014, the FDA granted Orphan Drug designation for PEGPH20 for the treatment of pancreatic cancer.
We are entitled to future development milestones and royalties on net sales subject to reduction in the absence of patent coverage. Our right to receive royalties in any particular country will expire upon the later of twelve years after first commercial sale of the product or expiration of patent rights in the particular country. We also manufacture and supply Halozyme with clinical and future commercial supply of our proprietary PEGylation materials used in the manufacture of PEGPH20.
Nuvo Research® Inc. Completes Reorganization into Two Publicly Traded Companies
On March 1, 2016 Nuvo Pharmaceuticals Inc. (TSX:NRI) (Nuvo Pharma or the Company), formerly known as Nuvo Research Inc. and Crescita Therapeutics Inc. (TSX:CTX) (Crescita), reported the completion of the reorganization of Nuvo Research Inc. into two separate publicly traded companies (the Reorganization) (Press release, Nuvo Research, MAR 1, 2016, View Source [SID:1234512698]). As a result of the Reorganization, the shareholders of what was formerly Nuvo Research Inc., now own 100% of Nuvo Pharma, a revenue and EBITDA generating commercial healthcare company, and 100% of Crescita, a drug development company. The Reorganization was approved by the shareholders of Nuvo Research Inc. at a special shareholders meeting on February 18, 2016 and by the Ontario Superior Court of Justice on February 24, 2016.
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"This transaction gives both businesses greater flexibility to focus on, and pursue, their respective growth strategies," said John London, President and CEO of Nuvo Pharma. "Nuvo Pharma is a profitable business with significant revenue and EBITDA growth potential." "We are very excited about the launch of Crescita," added Dan Chicoine, Chairman and CEO of Crescita. "We have exciting technologies, a proven management team that has obtained FDA approval for four topical pharmaceutical products and a strong balance sheet to support our growth."
Under the Reorganization, existing Nuvo Research Inc. share certificates now represent common shares of Nuvo Pharma and the right to receive a share certificate representing an equal number of Crescita common shares. The distribution record date (the Record Date) for certificates representing Crescita common shares is Thursday March 3, 2016. However, the TSX has implemented due bill trading for the Nuvo Pharma common shares (TSX: NRI) until the close of trading on Friday March 4, 2016. Accordingly, shareholders who purchase Nuvo Pharma common shares through the facilities of the TSX prior to the close of trading on Friday March 4, 2016 will automatically receive one Crescita common share for each Nuvo Pharma common share purchased. Crescita common shares (TSX:CTX) are expected to commence trading on the TSX on Monday March 7, 2016. Nuvo Pharma and Crescita shareholders are encouraged to contact their brokers for additional information.
As part of the Reorganization, Nuvo has changed its name from "Nuvo Research Inc." to "Nuvo Pharmaceuticals Inc."