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.

On January 23, 2018 Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) reported that it will report its fourth quarter and full year 2017 financial and operating results on Thursday, February 8, 2018, before the U.S. financial markets open (Press release, Regeneron, JAN 23, 2018, View Source [SID1234523493]). The Company will host a conference call and simultaneous webcast at 8:30 AM Eastern Time that day.

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Conference Call Information
To access this call, dial (800) 708-4539 (U.S.) or (847) 619-6396 (International). A link to the webcast may be accessed from the ‘Events and Presentations’ page of Regeneron’s website at www.regeneron.com. A replay of the conference call and webcast will be archived on the Company’s website and will be available for 30 days.

On January 23, 2018 Astellas Pharma Inc. (TSE: 4503, President and CEO: Yoshihiko Hatanaka, "Astellas" ) reported that it has completed the acquisition of Mitobridge, Inc. ("Mitobridge"), and Mitobridge has become a wholly owned subsidiary of Astellas as of January 23, 2018 (U.S. Eastern Time) (Press release, Astellas Pharma US, JAN 23, 2018, View Source [SID1234523489]).

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Astellas and Mitobridge

By exercising the option right to acquire Mitobridge, Astellas paid $225 million1 to acquire 100% of the equity in Mitobridge. In addition, Mitobridge shareholders will be eligible for additional payments from Astellas that total up to $225 million2 depending on the progress of various programs in clinical development.

The transaction accelerates Astellas’ research and development in diseases associated with mitochondrial dysfunctions and will enable the delivery of innovative new treatment options to patients. At this point, Astellas will maintain the organization in Cambridge, MA, and retain the Mitobridge name as a division of Astellas.

Astellas is still reviewing the impact of the completion of the acquisition on its financial results for the fiscal year ending March 31, 2018.

(1) As Astellas is a shareholder in Mitobridge, the actual payment by Astellas to Mitobridge shareholders after adjustment based on the estimate of cash and cash equivalents etc. held by Mitobridge is $161.7 million. The amount is subject to further true-up based on actual numbers as of the closing date.

(2) As Astellas is a shareholder in Mitobridge, the actual payment by Astellas to Mitobridge shareholders will be $165.5 million.