On March 28, 2016 Puma Biotechnology, Inc. (NYSE: PBYI), a biopharmaceutical company, reported that based on its recent meetings with the U.S. Food and Drug Administration (FDA), the Company now plans to submit its New Drug Application (NDA) for the approval of neratinib for the treatment of extended adjuvant breast cancer that has previously been treated with a trastuzumab-containing regimen in mid-2016 (Press release, Puma Biotechnology, MAR 28, 2016, View Source [SID:1234510117]).

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Puma has recently conducted a series of meetings and communications with the FDA. The purpose of these communications was to provide the FDA with the data from neratinib’s non-clinical and clinical development programs that will form the basis of the Company’s NDA for neratinib for the treatment of extended adjuvant breast cancer that has previously been treated with a trastuzumab-containing regimen. The data discussed with the FDA included preclinical data (pharmacology, toxicology, reproductive toxicity, carcinogenicity) and clinical trial data, including the data from the Phase III trial of neratinib in the extended adjuvant treatment of HER2-positive early stage breast cancer (ExteNET trial) and the Phase II trial of neratinib monotherapy in the extended adjuvant treatment of HER2-positive early stage breast cancer where patients received loperamide prophylaxis in order to prevent the neratinib-related diarrhea. Following its review of this material, the FDA requested that Puma amend the current statistical analysis plan for the ExteNET trial to incorporate the FDA’s recommendations with regard to rules for censoring the data for recurrent disease events or death.

For the primary endpoint of the ExteNET trial (Invasive Disease Free Survival), the analysis was based on all recurrent disease events and deaths occurring within 2 years and 28 days post randomization. The FDA has requested that events (disease recurrence or deaths) observed after missing 2 or more scheduled disease assessments be censored at the last available disease assessment time prior to the event occurrence. The FDA’s requested approach was a sensitivity analysis used in the ExteNET trial’s original statistical analysis plan but will now be the primary analysis approach used in the trial’s updated statistical analysis plan. In order to accommodate this change, Puma expects to delay filing its NDA for neratinib for the treatment of extended adjuvant breast cancer that has previously been treated with a trastuzumab-containing regimen until mid-2016.

The primary analysis results of the trial do not appear to be altered materially by the updated analysis approach. Provided below are the results of the original and updated analyses of the primary endpoint of invasive disease-free survival (iDFS) for the intent to treat (ITT) population:

1. ITT population applying the original event and censoring rule:
– 179 iDFS events
– 33% reduction in risk of iDFS vs. placebo (hazard ratio=0.67 (0.50, 0.91), 1-sided P=0.005)
– iDFS rates 93.9% (neratinib arm) vs. 91.6% (placebo arm)

2. ITT population applying the revised event and censoring rule per FDA:
– 173 iDFS events
– 34% reduction in risk of iDFS vs. placebo (hazard ratio=0.66 (0.49, 0.90), 1-sided P=0.004)
– iDFS rates 94.2% (neratinib arm) vs. 91.9% (placebo arm)

On March 28, 2016 Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) reported it has entered into a worldwide license agreement with ABBA Therapeutics AG, a Swiss biotechnology company developing innovative immuno-oncology therapies (Press release, Ligand, MAR 28, 2016, View Source [SID:1234510060]).

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Under the license, ABBA will be able to use the OmniRat, OmniMouse and OmniFlic platforms to generate fully human mono- and bispecific antibodies. Ligand is to receive an initial access payment, and will be eligible to receive clinical milestone payments and royalties for each successful OmniAb antibody. ABBA will be responsible for all costs related to the program.

"OmniAb will provide ABBA with industry-leading technology for generation of novel antibody therapeutics to further their therapeutic strategy," said John Higgins, Chief Executive Officer of Ligand. "This is the third OmniAb license deal since the close of the OMT acquisition and the 19th overall OmniAb Ligand partner, and continues to show the licensing power that the OmniAb franchise brings to Ligand."

About OmniAb

OmniAb includes three transgenic animal platforms for producing mono- and bispecific human therapeutic antibodies. OmniRat is the industry’s first human monoclonal antibody technology based on rats. It has a complete immune system with a diverse antibody repertoire and generates antibodies with human idiotypes as effectively as wild-type animals make rat antibodies. OmniMouse is a transgenic mouse that complements OmniRat and expands epitope coverage. OmniFlic is an engineered rat with a fixed light chain for development of bispecific, fully human antibodies. The three platforms use patented technology, have broad freedom to operate and deliver fully human antibodies with high affinity, specificity, expression, solubility and stability.

On March 28, 2016 The University of California (UC) Berkeley, in collaboration with Aduro Biotech, Inc. (Nasdaq:ADRO), reported the launch of an innovative Immunotherapeutics and Vaccine Research Initiative (IVRI) (Press release, Aduro BioTech, MAR 28, 2016, View Source [SID:1234510057]).

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IVRI is UC Berkeley’s first-ever immunotherapy-focused initiative and, in partnership with Aduro, will combine UC Berkeley’s extensive research capabilities with the company’s expertise in immunotherapy discovery and development to identify and advance new treatment options and preventive modalities for cancer, infectious disease and autoimmune disease.

IVRI is designed to explore the unique synergy between cancer and infectious disease research and to accelerate breakthrough discoveries in both areas. IVRI researchers are working closely with collaborators and sponsors with the shared goal of discovering and advancing immunotherapeutics and vaccine strategies.

"In the last several years, we have learned so much about the role of the immune system in treating disease, and we look forward to harnessing that information across both research and industry to develop innovative new treatment options to improve patient care," said David Raulet, Faculty Director of the IVRI and a Professor of Immunology and Pathogenesis at University of California, Berkeley. "Through this initiative, we will leverage our powerful research networks to understand how we can better engage the immune system in treating cancer, infectious disease and autoimmune disease. By doing this, we hope to develop new methods for targeting and effectively controlling many different cancers, autoimmune and infectious diseases. Our goal is for these findings to pave the way for the development of innovative new treatment options."

Aduro Biotech, a leading immunotherapy company focused on the discovery, development and commercialization of therapies that transform the treatment of challenging diseases, is IVRI’s founding partner. Aduro will provide UC Berkeley with $7.5 million in research funding over the next three years, with an option for Aduro to increase and extend funding for up to an additional three years. As part of research projects, researchers at UC Berkeley will also have the opportunity to access the company’s novel technology platforms including LADD, STING Pathway Activators and B-select monoclonal antibodies, which are designed to harness the body’s natural immune system.

"Through this unique collaboration, there is tremendous opportunity to improve our understanding of the immune system’s potential to serve as an important weapon in treating cancer and infectious disease," said Stephen T. Isaacs, chairman, president and CEO of Aduro Biotech. "By combining UC Berkeley’s leading research and academic resources with innovative technology platforms, such as those developed by Aduro, we are confident that this initiative will lead to an improved understanding of, and potential treatments for, some of the most devastating diseases."

The IVRI officially launched with a reception on March 24, 2016 at the UC Berkeley campus, which featured remarks from James P. Allison, Chair of Immunology, MD Anderson Cancer Center, David Raulet, Faculty Director, IVRI, as well as Stephen Isaacs of Aduro. On March 25, 2016, a full day symposium on the topic "Harnessing the Immune System to Fight Cancer and Infectious Diseases" was hosted on the campus. The symposium featured a dynamic list of invited speakers from around the country, including Lasker Award winner James P. Allison, Director of the Emory University Vaccine Center, Rafi Ahmed, and Aduro’s Chief Scientific Officer, Thomas J. Dubensky, Jr. The symposium also featured a scientific poster session including presentations of basic and translational science in infectious diseases, immunology or immuno-oncology.

About Immunotherapeutics and Vaccine Research Initiative (IVRI)

The immune system is nature’s most powerful weapon against disease. Whether introduced to the host from the environment, arising endogenously or stemming from a dysfunction of the immune system itself, diseases are impacted by immune functions, and the immune response can be targeted for therapy. It is our vision that a fundamental understanding of immune recognition, cellular interactions and other elements of the immune system has high potential to lead to meaningful advancements in the treatment of many diseases.

The IVRI is envisioned as a center for research to develop mechanistic understanding and application of immunology, pathogenesis and vaccinology with the potential to profoundly impact the treatment of human disease. The initiative is founded on the principle that research that uncovers how the immune system controls infectious disease yields new approaches for treating cancer, and conversely, that studies of cancer immunology yield approaches for vaccines and therapies targeting infectious disease. UC Berkeley has an impressive record in this endeavor including advances that have led to cancer immunotherapeutics and novel vaccines. The IVRI will expand on and accelerate these advances by coordinating and directing the efforts of UC Berkeley researchers, their collaborators and sponsors towards ground-breaking discoveries, and the development of creative new applications in disease prophylaxis and treatment. The IVRI will facilitate communication and collaboration among researchers, streamline access to scientific and financial resources and promote not only the vision, ideas and accomplishments of its scientists, but also the translation of these ideas and findings for the development of new therapies for human diseases. By targeting synergies in the expertise and capabilities of its scientists and unifying their ingenuity with the objectives of its sponsors, the IVRI seeks to maximize the potential of its UC Berkeley researchers and accelerate the pace of discovery and translation.