On January 23, 2018 Immunomic Therapeutics, Inc. reported that Senior Director of Corporate Development Sia Anagnostou will present at Phacilitate’s Immuno-Oncology Frontiers World in Miami (Press release, Immunomics, JAN 23, 2018, View Source [SID1234523545]). The presentation, entitled "LAMP-Vax: intracellular trafficking could deliver on the promise of nucleic acid vaccines for cancer immunotherapy", will discuss the study of LAMP-based nucleic acid immunotherapy platforms. These investigational technologies have the potential to alter how we use immunotherapy for cancer, allergies and animal health. Anagnostou will be the third speaker on the panel, "Back to the future: the renaissance of cancer vaccine approaches, hope or hype?".

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Who: Immunomic Therapeutics, Inc. Senior Director of Corporate Development Sia Anagnostou

What: Presentation at Phacilitate’s Immuno-Oncology World: LAMP-Vax: intracellular trafficking could deliver on the promise of nucleic acid vaccines for cancer immunotherapy

When: Wednesday, January 24, 11:50 a.m. EST

Where: Hyatt Regency, 400 SE 2nd Ave, Miami, Florida 33131

About LAMP-Vax

ITI’s investigational LAMP-Vax platform is thought to work by encoding the Lysosomal Associated Membrane Protein, an endogenous protein in humans. In this way, ITI’s vaccines (DNA or RNA) have the potential to utilize the body’s natural biochemistry to develop a broad immune response including antibody production, cytokine release and critical immunological memory. This approach could put LAMP-Vax technology at the crossroads of immunotherapies in a number of illnesses, including cancer, allergy and infectious diseases. LAMP is currently being employed in Phase II clinical trials as a cancer immunotherapy. ITI is also collaborating with academic centers and biotechnology companies to study the use of LAMP in cancer types of high mortality, including cases where there are limited treatment options like glioblastoma and acute myeloid leukemia. ITI believes that these early clinical studies may provide a proof of concept for LAMP-Vax therapy in cancer, and if successful, set the stage for future studies, including combinations in these tumor types and others. Preclinical data is currently being developed to explore whether LAMP nucleic acid constructs may amplify and activate the immune response in highly immunogenic tumor types and be used to create immune responses to tumor types that otherwise do not provoke an immune response.

On January 23, 2018 Puma Biotechnology, Inc. (Nasdaq: PBYI) reported that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has communicated a negative trend vote after meeting with the Company today to discuss the Marketing Authorisation Application (MAA) for neratinib for the extended adjuvant treatment of early stage HER2-positive breast cancer (Press release, Puma Biotechnology, JAN 23, 2018, View Source [SID1234523492]). A negative trend vote means it is unlikely that CHMP will provide a positive opinion related to the Company’s MAA at the formal CHMP decision vote scheduled in February 2018, and that additional steps would need to be taken to gain marketing approval in Europe. CHMP indicated that, in its opinion, the benefit risk assessment is negative as the study results are based on evidence from a single pivotal trial and the 2- and 5-year invasive disease free survival (iDFS) benefits observed to-date may lack sufficient clinical relevance.

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CHMP’s opinion was based on the results from both the Phase III ExteNET trial in extended adjuvant early stage HER2-positive breast cancer and the Phase II CONTROL trial in extended adjuvant early stage HER2-positive breast cancer.

About HER2-Positive Breast Cancer

Approximately 20% to 25% of breast cancer tumors over-express the HER2 protein. HER2-positive breast cancer is often more aggressive than other types of breast cancer, increasing the risk of disease progression and death. Although research has shown that trastuzumab can reduce the risk of early stage HER2-positive breast cancer returning after surgery, up to 25% of patients treated with trastuzumab experience recurrence.

On January 23, 2018 MacroGenics, Inc. (NASDAQ:MGNX), a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer, reported completion of a pre-planned interim futility analysis of the Phase 3 SOPHIA trial (Press release, MacroGenics, JAN 23, 2018, View Source [SID1234523490]). This randomized, multi-center clinical study compares margetuximab plus chemotherapy to trastuzumab plus chemotherapy in subjects with metastatic breast cancer. Based on results from the futility analysis, an independent data safety monitoring committee (DSMC) has recommended that the SOPHIA study continue as planned without modification. This analysis was based on a pre-specified assessment of progression-free survival (PFS) as determined by independent central review. The futility analysis did not allow for early stopping due to efficacy.

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MacroGenics also announced today that the U.S. FDA has granted Fast Track designation for the investigation of margetuximab for treatment of patients with metastatic or locally advanced HER2 positive breast cancer who have previously been treated with anti-HER2-targeted therapy. Fast Track designation is designed to facilitate the development and expedite the review of new therapies for serious conditions and unmet medical needs. With Fast Track designation, early and frequent communications between the FDA and the sponsor are encouraged to help enable rapid development of the candidate molecule.

"We are encouraged with the DSMC’s determination that there were no safety concerns and that the analysis of PFS data support continuation of the Phase 3 SOPHIA trial. Recruitment of patients into the SOPHIA study is progressing well. We remain on track to complete enrollment by the end of 2018 and we look forward to sharing top-line results after the trial has read out in 2019," commented Scott Koenig, M.D., Ph.D., President and Chief Executive Officer of MacroGenics. "Also, we are very pleased to receive Fast Track designation for margetuximab, as this may potentially expedite future regulatory interactions on this product candidate. Furthermore, the gastric cancer data recently presented at ASCO (Free ASCO Whitepaper) GI for margetuximab in combination with anti-PD-1 may provide additional opportunities to address unmet medical needs in other HER2+ indications."

About the SOPHIA Study

MacroGenics continues to enroll patients in the pivotal Phase 3 SOPHIA clinical study of margetuximab at approximately 200 trial sites across North America, Europe and Asia. The 530-patient study is designed to evaluate the efficacy of margetuximab plus chemotherapy compared to that of trastuzumab plus chemotherapy in relapsed/refractory HER2-positive metastatic breast cancer patients. This registration study has sequential primary endpoints, which include PFS and overall survival. For additional information on the ongoing SOPHIA trial, visit www.clinicaltrials.gov.

About Margetuximab

Margetuximab is an Fc-optimized monoclonal antibody that targets the human epidermal growth factor receptor 2, or HER2, oncoprotein. HER2 is expressed by tumor cells in breast, gastric, and other forms of solid tumor cancers, making it a key marker for biologic therapy. In addition to being studied in metastatic breast cancer, margetuximab is also being studied in combination with an anti-PD-1 agent in a Phase 1b/2 clinical trial in gastric cancer, for which data was recently presented at the recent ASCO (Free ASCO Whitepaper) Gastrointestinal Symposium.

On January 23, 2018 Tmunity Therapeutics, Inc., a private clinical-stage biotherapeutics company focused on saving and improving lives by delivering the full potential of next-generation T cell immunotherapy, reported the closing of a $100 million Series A financing (Press release, Tmunity Therapeutics, JAN 23, 2018, View Source [SID1234523496]). Syndicate investors, which include Ping An Ventures, Parker Institute for Cancer Immunotherapy, Gilead Sciences, Inc. and Be The Match BioTherapies, join seed round investors, the University of Pennsylvania and Lilly Asia Ventures. Tmunity is developing a diversified portfolio of novel treatments that exhibit best-in-class control over T cell activation and direction in the body. The proceeds from the Series A will be used to advance and expand the business and operational structure of Tmunity to support the rapid translation, development and manufacture of its portfolio of novel T cell based immunotherapies, first for the treatment of cancer.

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"Tmunity was created to integrate and advance proprietary, novel approaches to cell and gene therapies and we have pursued an equally unique approach to the selection of our visionary funding partners," said Usman "Oz" Azam, M.D., President and Chief Executive Officer of Tmunity. "Our mix of investors brings together global leaders in healthcare services and biopharmaceuticals in Ping An Ventures and Gilead, the visionary philanthropy of the Parker Institute for Cancer Immunotherapy, and Be The Match BioTherapies. Together, they share a common passion to work together to drive the next-generation of personalized therapies for patients. We appreciate their confidence in – and vision for – Tmunity to deliver on that potential. This is a very exciting time for us."

Pursuing Integrated Approaches to Engineered T Cell Therapies Leveraging Proprietary and External Technologies and Scientific Insight from the University of Pennsylvania

Tmunity was founded on an exclusive collaboration and license agreement with the University of Pennsylvania, offering proprietary technologies and unparalleled expertise in first-in-patient cell and gene therapies of its scientific founders, led by Carl H. June, M.D. Today, Tmunity is uniquely positioned to integrate the best technologies and pursue multiple approaches to engineered T cell therapies simultaneously in order to advance treatments into the clinic rapidly, optimize and scale manufacturing, pursue regulatory approvals aggressively, and thus deliver them effectively to patients.

"Tmunity is unlike any other cell-based immunotherapy ‘start-up’ because of the unrivaled expertise of its scientific founders and leadership team in cell and gene therapy and its proven translational and manufacturing success in T cell medicine," said Jiang Zhang, Managing Partner of Ping An Ventures. "We were also attracted to the global potential of the pipeline, especially the T cell therapies in oncology in China, as well as the scope beyond oncology into autoimmune and infectious diseases, as we begin to expand our investment portfolio."

About Series A Round Investors

Ping An Ventures

Ping An Ventures is the direct investment arm under Ping An Insurance (Group) Company of China, Ltd., one of the largest and most valuable financial service conglomerates in the world, ranked No. 39 on the Global Fortune 500. Ping An Ventures invests in healthcare industry in all stages with a specific focus on both growth-stage and PIPE investment. With multi-billion dollars asset under management in multiple funds, the investment team has invested in over 50 companies globally, covering all sectors in healthcare: Biotech, Diagnostics, Medical Device, Services, Healthcare IT, etc. The investment team includes many industry and financial veterans, and commits to discovering and helping fast-growing and leading healthcare companies in their sectors. For more information, visit www.pinganventures.com.

Parker Institute for Cancer Immunotherapy

The Parker Institute for Cancer Immunotherapy brings together the best scientists, clinicians and industry partners to build a smarter and more coordinated cancer immunotherapy research effort. The Parker Institute is an unprecedented collaboration between the country’s leading immunologists and cancer centers. The program started by providing institutional support to six academic centers, including Memorial Sloan Kettering Cancer Center, Stanford Medicine, the University of California, Los Angeles, the University of California, San Francisco, the University of Pennsylvania and The University of Texas MD Anderson Cancer Center. Recently, the institute also initiated programmatic support for top immunotherapy investigators, including a group of researchers at Dana-Farber Cancer Institute, Robert Schreiber, Ph.D., of Washington University School of Medicine in St. Louis, Nina Bhardwaj, M.D., Ph.D., of the Icahn School of Medicine at Mount Sinai and Phil Greenberg, M.D., of the Fred Hutchinson Cancer Research Center. The Parker Institute network also includes more than 40 industry collaborations, more than 60 labs and more than 300 of the nation’s top researchers focused on treating the deadliest cancers. The goal is to accelerate the development of breakthrough immune therapies capable of turning most cancers into curable diseases. The institute was created through a $250 million grant from The Parker Foundation. For more information, visit www.parkerici.org.

Gilead Sciences

Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company’s mission is to advance the care of patients suffering from life-threatening diseases. Gilead has operations in more than 30 countries worldwide, with headquarters in Foster City, California. For more information, visit www.gilead.com.

Be The Match

Be The Match BioTherapies partners with organizations pursuing life-saving cellular therapies in every stage of development – from discovery through commercialization. The organization is built on the foundation established over the last 30 years by the National Marrow Donor Program (NMDP)/Be The Match, with unparalleled experience managing cellular therapies. Be The Match BioTherapies offers customizable solutions, such as cell therapy supply chain delivery for autologous or allogeneic therapies, enabled by high-touch, personalized case management and a robust, customizable technology platform, MatchSourceSM. Experience in cell sourcing and collection allows Be The Match BioTherapies to provide cells consented for research, clinical or commercial use. Researchers have access to clinical trial services through a partnership with the CIBMTR (Center for International Blood and Marrow Transplant Research). In addition, Be The Match BioTherapies has the infrastructure in place to collect, store and analyze patient samples post-cell or gene therapy treatment at the time points required by regulatory authorities. For more information, visit BeTheMatchBioTherapies.com.

On January 23, 2018 Sanofi reported that its Pre-Quarterly Results Communication document is available on the "Investors" page of the company’s corporate website (Press release, Sanofi, JAN 23, 2018, View Source [SID1234523494]):

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View Source

As for each quarter, Sanofi prepared this document to assist in the financial modeling of the Group’s quarterly results. This document includes a reminder on various non-comparable items and exclusivity losses as well as the foreign currency impact and share count. Sanofi’s fourth quarter results will be published on February 7, 2018.