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Press Release

MacroGenics to Present Phase 1 Data on Flotetuzumab, a CD123 x CD3 DART® Molecule, at 59th Annual ASH Meeting


Posted on: 01 Nov 17

ROCKVILLE, MD, Nov. 01, 2017 (GLOBE NEWSWIRE) -- – MacroGenics, Inc. (NASDAQ: MGNX), a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer, as well as autoimmune disorders and infectious diseases, today announced that Phase 1 data on flotetuzumab, MacroGenics’ CD123 x CD3 bispecific DART® molecule, will be featured in three presentations, including an oral session, at the 59th Annual Meeting of the American Society of Hematology (ASH), taking place in Atlanta on December 9-12, 2017.

The details of the presentations are as follows:

Session:613. Acute Myeloid Leukemia: Clinical Studies: Novel Therapies for AML and APL 
Date:Monday, December 11, 2017
Time:10:30 AM – 12:00 PM (10:30 AM oral session) 
Location:Georgia World Congress Center, Building B, Level 5, Murphy BR 1-2
Title:Preliminary Results of a Phase 1 Study of Flotetuzumab, a CD123 x CD3 Bispecific DART Protein, in Patients with Relapsed/Refractory Acute Myeloid Leukemia and Myelodysplastic Syndrome
  
Session: 616. Acute Myeloid Leukemia: Novel Therapy, excluding Transplantation: Poster I
Date: Saturday, December 9, 2017
Time: 5:30 – 7:30 PM (poster presentation)
Location: Georgia World Congress Center, Building A, Level 1, Hall A2
Title: Preliminary Translational Results from an Ongoing Phase 1 Study of Flotetuzumab, a CD123 x CD3 DART, in AML/MDS: Rationale for Combining Flotetuzumab and Anti-PD-1/PD-L1 Immunotherapies
  
Session:613. Acute Myeloid Leukemia: Clinical Studies: Poster III
Date:Monday, December 11, 2017
Time:6:00 PM – 8:00 PM (poster presentation)
Location:Georgia World Congress Center, Building A, Level 1, Hall A2
Title: Lead-in Dose Optimization to Mitigate Cytokine Release Syndrome in AML and MDS Patients Treated with Flotetuzumab, a CD123 x CD3 DART Molecule for T-Cell Redirected Therapy

About Flotetuzumab

Flotetuzumab (also known as MGD006 and S80880) is a clinical-stage molecule that recognizes both CD123 and CD3. CD123, the interleukin-3 receptor alpha chain, has been reported to be over-expressed on neoplastic cells in a wide range of hematological malignancies, including AML and MDS. The primary mechanism of action of flotetuzumab is believed to be its ability to redirect T lymphocytes to kill CD123-expressing cells. To achieve this, the DART molecule combines a portion of an antibody recognizing CD3, an activating molecule expressed by T cells, with an arm that recognizes CD123 on the target cancer cells.

Flotetuzumab is currently being evaluated in the U.S. and Europe in a Phase 1 dose-escalation study designed to assess the safety, tolerability, and initial anti-leukemic activity of the molecule in patients with relapsed/refractory AML or intermediate-2/high risk MDS. MacroGenics retains full development and commercialization rights to flotetuzumab in the U.S., Canada, Mexico, Japan, South Korea and India. Servier participates in the development of flotetuzumab and has rights to this molecule in all other countries. The U.S. Food and Drug Administration has granted orphan drug designation to flotetuzumab for the treatment of AML.

About MacroGenics, Inc.

MacroGenics is a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer, as well as autoimmune disorders and infectious diseases. The company generates its pipeline of product candidates primarily from its proprietary suite of next-generation antibody-based technology platforms. The combination of MacroGenics' technology platforms and protein engineering expertise has allowed the Company to generate promising product candidates and enter into several strategic collaborations with global pharmaceutical and biotechnology companies. For more information, please see the Company's website at www.macrogenics.com. MacroGenics, the MacroGenics logo, and DART are trademarks or registered trademarks of MacroGenics, Inc.

Cautionary Note on Forward-Looking Statements

Any statements in this press release about future expectations, plans and prospects for the Company, including statements about the Company's strategy, future operations, clinical development of the Any statements in this press release about future expectations, plans and prospects for the Company, including statements about the Company's strategy, future operations, clinical development of the Company's therapeutic candidates, milestone or opt-in payments from the Company's collaborators, the Company's anticipated milestones and future expectations and plans and prospects for the Company and other statements containing the words "subject to", "believe", "anticipate", "plan", "expect", "intend", "estimate", "project", "may", "will", "should", "would", "could", "can", the negatives thereof, variations thereon and similar expressions, or by discussions of strategy constitute forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the uncertainties inherent in the initiation and enrollment of future clinical trials, expectations of expanding ongoing clinical trials, availability and timing of data from ongoing clinical trials, expectations for regulatory approvals, other matters that could affect the availability or commercial potential of the Company's product candidates and other risks described in the Company's filings with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent the Company's views only as of the date hereof. The Company anticipates that subsequent events and developments will cause the Company's views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so, except as may be required by law. These forward-looking statements should not be relied upon as representing the Company's views as of any date subsequent to the date hereof.

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CONTACT: Contacts: Jim Karrels, Senior Vice President, CFO MacroGenics, Inc. 1-301-251-5172, info@macrogenics.com Karen Sharma MacDougall Biomedical Communications 1-781-235-3060, ksharma@macbiocom.com GlobeNewswire
globenewswire.com

Last updated on: 01/11/2017

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