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.

On April 9, 2015 Exelixis reported that the U.S. Food & Drug Administration (FDA) has granted Fast Track designation to cabozantinib for treatment of patients with advanced renal cell carcinoma (RCC) who have received one prior therapy (Press release, Exelixis, APR 9, 2015, View Source [SID:1234502971]). Cabozantinib is the company’s lead compound and inhibits the activity of multiple tyrosine kinases including MET, VEGFRs and RET. The FDA created the Fast Track process to facilitate the development and expedite the review of drugs to treat serious diseases and address unmet medical needs. Fast Track designation confers important benefits, including the potential eligibility for Priority Review of a New Drug Application, if relevant criteria are met.1

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Cabozantinib is the subject of METEOR, an ongoing phase 3 pivotal trial in patients with metastatic RCC who have experienced disease progression following treatment with at least one VEGFR tyrosine kinase inhibitor. Patients are randomized 1:1 to receive 60 mg of cabozantinib daily or 10 mg of everolimus daily. The primary endpoint of METEOR is progression-free survival, and secondary endpoints include overall survival and objective response rate. Exelixis expects to release top-line results from the trial in the second quarter of 2015. In addition to the metastatic RCC development program, Exelixis is also evaluating cabozantinib in CELESTIAL, a phase 3 pivotal trial in second-line hepatocellular carcinoma (HCC).

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About Metastatic Renal Cell Carcinoma

The American Cancer Society’s 2015 statistics cite kidney cancer as among the top ten most commonly diagnosed forms of cancer among both men and women in the United States.2 Clear cell renal cell carcinoma is the most common type of kidney cancer in adults.3 If detected in its early stages, the five-year survival rate for RCC is high; however, the five-year survival rate for patients with advanced or late-stage metastatic RCC is under 10 percent, with no identified cure for the disease.4

Treatments for metastatic RCC had historically been limited to immunotherapy (e.g., interleukin-2 and interferon) until the introduction of targeted therapies into the RCC setting a decade ago. In the second-line setting, which encompasses approximately 11,000 drug-eligible patients in the U.S. and 37,000 globally, four new therapies have been approved in the past five years.5 Despite the availability of several therapeutic options, however, currently approved agents have shown little differentiation in terms of efficacy and have demonstrated only modest PFS benefit in patients refractory to sunitinib, a commonly-used first-line therapy.

About Cabozantinib

Cabozantinib inhibits the activity of tyrosine kinases including MET, VEGFRs and RET. These receptor tyrosine kinases are involved in both normal cellular function and in pathologic processes such as oncogenesis, metastasis, tumor angiogenesis, and maintenance of the tumor microenvironment.

COMETRIQ (cabozantinib) is currently approved by the U.S. Food and Drug Administration for the treatment of progressive, metastatic medullary thyroid cancer (MTC).

The European Commission granted COMETRIQ conditional approval for the treatment of adult patients with progressive, unresectable locally advanced or metastatic MTC. Similar to another drug approved in this setting, the approved indication states that for patients in whom Rearranged during Transfection (RET) mutation status is not known or is negative, a possible lower benefit should be taken into account before individual treatment decisions.

Important Safety Information, including Boxed WARNINGS

WARNING: PERFORATIONS AND FISTULAS, and HEMORRHAGE

Serious and sometimes fatal gastrointestinal perforations and fistulas occur in COMETRIQ-treated patients.
Severe and sometimes fatal hemorrhage occurs in COMETRIQ-treated patients.
COMETRIQ treatment results in an increase in thrombotic events, such as heart attacks.
Wound complications have been reported with COMETRIQ.
COMETRIQ treatment results in an increase in hypertension.
Osteonecrosis of the jaw has been observed in COMETRIQ-treated patients.
Palmar-Plantar Erythrodysesthesia Syndrome (PPES) occurs in patients treated with COMETRIQ.
The kidneys can be adversely affected by COMETRIQ. Proteinuria and nephrotic syndrome have been reported in patients receiving COMETRIQ.
Reversible Posterior Leukoencephalopathy Syndrome has been observed with COMETRIQ.
Avoid administration of COMETRIQ with agents that are strong CYP3A4 inducers or inhibitors.
COMETRIQ is not recommended for use in patients with moderate or severe hepatic impairment.
COMETRIQ can cause fetal harm when administered to a pregnant woman.
Adverse Reactions – The most commonly reported adverse drug reactions (≥25%) are diarrhea, stomatitis, palmar-plantar erythrodysesthesia syndrome (PPES), decreased weight, decreased appetite, nausea, fatigue, oral pain, hair color changes, dysgeusia, hypertension, abdominal pain, and constipation. The most common laboratory abnormalities (≥25%) are increased AST, increased ALT, lymphopenia, increased alkaline phosphatase, hypocalcemia, neutropenia, thrombocytopenia, hypophosphatemia, and hyperbilirubinemia.

Please see full U.S. prescribing information, including Boxed WARNINGS, at www.COMETRIQ.com/downloads/Cometriq_Full_Prescribing_Information.pdf. Please refer to the full European Summary of Product Characteristics for full European Union prescribing information, including contraindication, special warnings and precautions for use at www.sobi.com once posted.