“Following the submission in 2019 of our first BLA with the
The Company’s research and development priorities for its investigational molecules in 2020 are highlighted below.
Margetuximab is an Fc-engineered, anti-HER2 monoclonal antibody being evaluated for the treatment of patients with advanced HER2-positive cancers.
- Biologics Licensing Application (BLA) for Metastatic Breast Cancer. Pending acceptance and review of the BLA submitted in
December 2019to the Food and Drug Administration( FDA) based on the Phase 3 SOPHIA study results, the Company anticipates a Prescription Drug User Fee Act (PDUFA) date by the end of 2020. MacroGenicsexpects a Standard Review process in which the FDAwill likely require an Oncologic Drugs Advisory Committee(ODAC) meeting in the second half of 2020.
- Phase 2/3 MAHOGANY Study in Advanced Gastric and Gastroesophageal Junction Cancer.
MacroGenicsis enrolling patients in this front-line study designed to evaluate the combination of margetuximab with anti-PD-1 based therapies. Initial safety and efficacy data are expected in the second half of 2020 from Module A of this study, which is evaluating a chemotherapy-free regimen. Module A has been designed to support a potential accelerated approval in the U.S. based on evaluation of objective response rate in a single-arm study.
Flotetuzumab is a bispecific CD123 x CD3 DART® molecule being evaluated for the treatment of patients with relapsed or refractory acute myeloid leukemia (AML).
MGA012 (INCMGA0012) is an anti-PD-1 monoclonal antibody that has been exclusively licensed to
MGD013 is a first-in-class, bispecific PD-1 x LAG-3 DART molecule being evaluated in a Phase 1 dose expansion study.
Enoblituzumab is an Fc‐engineered, anti‐B7‐H3 monoclonal antibody. To further inform the development of this molecule,
MGC018 is an antibody-drug conjugate (ADC) targeting B7-H3 and MGD019 is a bispecific PD-1 x CTLA-4 DART molecule. The Company expects to complete dose escalation for each of these molecules in early 2020 and then initiate a focused dose expansion in select tumor types.
MGD009 is a B7-H3 x CD3 DART molecule and MGD007 is a gpA33 x CD3 DART molecule. In connection with its strategic prioritization, the Company will discontinue development of these programs.
Cash Balance and Cash Runway
The Company’s estimated cash, cash equivalents and marketable securities balance as of
A slide presentation describing these corporate priorities, research and development goals and other information will be available on the Investors page on the Company's website at www.macrogenics.com after the market close on
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 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
1 Clinicaltrials.gov and MacroGenics’ website as of
Anna Krassowska, Ph.D., Vice President, Investor Relations & Corporate Communications Jim Karrels, Senior Vice President, CFO 1-301-251-5172, firstname.lastname@example.org
Source: MacroGenics, Inc.