On April 14, 2015 Teva Pharmaceutical and Eagle Pharmaceuticals reported that the New Drug Application (NDA) for a liquid bendamustine hydrochloride (HCl) rapid infusion product has been accepted for filing by the U.S. Food and Drug Administration (FDA) (Filing, 8-K, Eagle Pharmaceuticals, APR 14, 2015, View Source [SID:1234502996]). The Prescription Drug User Fee Act (PDUFA) goal date for a decision on this NDA by the FDA is December 2015.

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This NDA requests FDA approval of the rapid infusion bendamustine HCl product for the treatment of patients with chronic lymphocytic leukemia (CLL) and patients with indolent B-cell non-Hodgkin lymphoma (NHL) that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen. This product candidate has received Orphan Drug Designations for both CLL and indolent B-cell NHL, and therefore may be eligible for seven years of exclusivity upon approval. The NDA is supported by data from a clinical trial completed in November 2014, which demonstrated that the rapid infusion bendamustine HCl product can be administered in ten minutes in a low-volume, 50 mL admixture.

"The rapid infusion bendamustine product, if approved, will be an important new treatment option for patients with CLL or indolent B-cell NHL that has progressed and their healthcare providers," said Scott Tarriff, President and Chief Executive Officer of Eagle Pharmaceuticals. "We look forward to continuing to work closely with the FDA through the review process, and to their decision on the NDA in December of this year."

"We are very pleased the FDA has accepted the rapid infusion bendamustine NDA for review," stated Paul Rittman, Vice President and General Manager, Teva Oncology. "Teva looks forward to the opportunity to bring this product to market, if approved, and we believe it represents an important and improved benefit to both patients and healthcare providers."
In February 2015, Eagle and Teva Pharmaceutical Industries Ltd. entered into an exclusive license agreement for the rapid infusion bendamustine product. Teva will be responsible for all U.S. commercial activities for the product including promotion and distribution. Eagle has responsibility for obtaining all regulatory approvals, conducting post-approval clinical studies, if required, and initially supplying drug product to Teva.

On April 14, 2015 Argos Therapeutics and Lummy reported they have entered into a license agreement. Under the terms of the agreement, Lummy HK will license from Argos the rights to manufacture, develop and commercialize AGS-003, Argos’ investigational immunotherapy for the treatment of cancer, in China, Hong Kong, Taiwan and Macau (Filing, 8-K, Argos Therapeutics, APR 14, 2015, View Source [SID:1234502991]).

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In connection with the license agreement, Tianyi Lummy International Holdings Group Ltd., an affiliate of Lummy HK ("Tianyi Lummy"), and the China BioPharma Capital I Fund ("China BioPharma Capital") have purchased an aggregate of one million shares of Argos’ common stock at a premium of 12.5% for a purchase price of approximately $10 million. Lummy HK has agreed to pay Argos a royalty on net sales of AGS-003 at a rate in the teens and up to an aggregate of $20 million for regulatory and commercial milestones. In addition, Tianyi Lummy and China BioPharma Capital have agreed to purchase an additional $10 million of Argos’ common stock following and subject to the interim data analysis from Argos’ pivotal phase 3 ADAPT trial of AGS-003 by the Independent Data Monitoring Committee expected in late 2015 that will occur at approximately 50% of events in the trial and certain other conditions. China BioPharma Capital recently announced its first closing and is focusing on investments in pharmaceutical life science innovation in Western companies with the objective to obtain licenses for development and commercialization in China.

"We are excited about the potential for Arcelis-based products to advance the treatment of cancer throughout Greater China and in markets around the world," said Jeff Abbey, president and CEO of Argos. "Our agreement with Lummy HK is another reflection of the strong clinical data that we have observed with AGS-003 and our ability to attract outstanding partners to support commercialization in the years ahead."

Argos’ proprietary Arcelis technology platform uses a patient’s own dendritic cells and tumor sample to create a fully personalized immunotherapy. AGS-003, Argos’ lead product candidate, is currently being tested in the pivotal phase 3 ADAPT clinical trial for the treatment of metastatic renal cell carcinoma (mRCC).

Under the license agreement, Lummy HK also acquires rights to develop Arcelis-based products for additional oncology indications, potentially including pancreatic, lung, liver, stomach, rectal, gastric, and esophageal cancers. Lummy HK will be responsible, at its expense, for all development costs that are necessary for regulatory approval in all markets covered in the license agreement.

"Our agreement with Argos to develop AGS-003 in China, Hong Kong, Taiwan and Macau is another example of our ongoing commitment to develop and market new therapies that can address serious unmet needs in the treatment of cancer in China and throughout Asia," said Mr. Qiu Yu, chairman of Lummy HK. "The Arcelis technology platform also holds great promise for automating the manufacturing and commercialization of a portfolio of fully personalized immunotherapies and we look forward to working with Argos to initiate our own development programs to bring products based on this innovative technology to the patients we serve."

About the Arcelis Technology Platform

Arcelis is a fully personalized immunotherapy technology that captures mutated and variant antigens that are specific to each patient’s disease. It is designed to overcome immunosuppression by producing a durable memory T-cell response without adjuvants that may be associated with toxicity. The technology is potentially applicable to a wide range of different cancers, and is designed to overcome many of the manufacturing and commercialization challenges that have impeded other personalized cancer immunotherapies. The Arcelis process uses only a small tumor or blood sample and the patient’s own dendritic cells, which are collected and optimized following a single leukapheresis procedure. The proprietary process uses RNA isolated from the patient’s disease sample to program dendritic cells to target disease specific antigens. The activated, antigen-loaded dendritic cells are then formulated into the patient’s plasma and administered via intradermal injection.

On April 9, 2015 Inovio Pharmaceuticals reported preliminary data showing that its INO-3112 DNA-based immunotherapy generated strong CD8+ T cell responses in 3 of 4 patients with head and neck cancer associated with human papillomavirus (HPV) types 16 and 18 (Press release, Inovio, APR 9, 2015, View Source;Neck-Cancer-Patients/default.aspx [SID:1234502974]). INO-3112, an active immunotherapy that targets HPV 16 and 18 and simultaneously expresses IL-12, is designed to activate in vivo (in the body) immune responses to antigens from high risk HPV types and eliminate precancerous and cancerous cells displaying these antigens. The data, which are T cell measurements from the first four treated patients of this phase I/IIa study, are being presented today at the World Vaccine Congress 2015 by Inovio’s COO, Dr. Niranjan Y. Sardesai.

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These positive results represent the first study and first report of T cell immune responses generated in cancer patients after treatment with an Inovio DNA immunotherapy. The magnitude and characteristics of these interim immune response data mirror immune responses previously observed in human studies of VGX-3100 for HPV-associated cervical dysplasia; in a placebo-controlled phase II study, strong T cell immune responses were positively correlated with achievement of primary and secondary efficacy endpoints.

Dr. J. Joseph Kim, Inovio’s President and CEO, said, "This initial data set from Inovio’s first cancer study provides encouraging evidence that we are on an important path to better optimized immunotherapy products. Regardless of whether it is an infectious disease, a precancer, or a cancer: the immune system uses the same mechanism to eliminate infected or mutated cells. In immune-oncology, it’s all about the T cells. Here we show in cancer patients that we can generate antigen-specific CD8+ killer T cell responses, which are essential to an effective immunotherapy.

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"We look forward to completing our currently enrolling studies for HPV-associated head & neck and cervical cancers, completing the preparations for our planned phase III study for cervical precancer, and launching new studies for hepatitis B and prostate cancer that all rely on the same targeted T-cell-based killing activity."

This open label study of HPV-caused head and neck cancer is intended to assess the safety, tolerability, and immunogenicity of INO-3112 in up to twenty adults with HPV-positive head and neck squamous cell carcinoma. The study (NCT02163057) includes patients who are being treated with INO-3112 before and after resection of their tumor as well as patients being treated with INO-3112 after completion of chemotherapy and radiation therapy.

About HPV-Caused Head & Neck Cancer

Human papillomavirus (HPV) is the most common sexually transmitted disease in the United States, infecting 79 million Americans. HPV is known to play a major role in the development of head and neck cancers, which include cancers of the oral cavity, oropharynx, nose/nasal passages and larynx. Head and neck cancers associated with HPV account for nearly 3 percent of all cancers in the United States and are twice as prevalent in men as in women. Incidence rates of HPV-caused head and neck cancers have been on the rise, especially HPV-associated oropharyngeal cancer in men, and are expected to continue growing. By 2025, researchers believe that HPV will be the causative factor of 90% of all head/neck cancers.