MacroGenics Announces Achievement of $10 Million Milestone Related to Retifanlimab Collaboration with Incyte

Rhea-AI Summary

MacroGenics (Nasdaq: MGNX) announced a $10 million milestone related to the development of retifanlimab under its global collaboration with Incyte. The FDA has accepted Incyte's BLA for retifanlimab, targeting a PDUFA action date of July 25, 2021, for treating advanced squamous carcinoma of the anal canal. Incyte is conducting Phase 3 trials of retifanlimab for non-small cell lung cancer and other cancers. MacroGenics has received $65 million in milestones, with potential total milestones of $355 million and commercial royalties ranging from 15% to 24% on net sales.

Positive

• Achievement of $10 million milestone under collaboration with Incyte.
• FDA acceptance of BLA for retifanlimab with a target action date of July 25, 2021.
• Incyte's ongoing Phase 3 studies could enhance market prospects for retifanlimab.
• Potential future milestones up to $355 million and commercial royalties from 15% to 24% on sales.

Negative

• Market acceptance and competition risks for retifanlimab.
• Uncertainties regarding future clinical trials and regulatory approvals.

ROCKVILLE, MD, Feb. 11, 2021 (GLOBE NEWSWIRE) --  MacroGenics, Inc. (Nasdaq: MGNX), a biopharmaceutical company focused on developing and commercializing innovative monoclonal antibody-based therapeutics for the treatment of cancer, today announced that a $10 million milestone has been achieved related to development progress of retifanlimab outside the U.S., under its exclusive global collaboration and license agreement with Incyte. Retifanlimab is an investigational anti-PD-1 monoclonal antibody designed by MacroGenics and licensed to Incyte (as INCMGA0012).

As previously announced in January 2021, the U.S. Food and Drug Administration (FDA) has accepted for Priority Review Incyte’s Biologics License Application (BLA) for retifanlimab as a potential treatment for adult patients with locally advanced or metastatic squamous carcinoma of the anal canal (SCAC) who have progressed on, or who are intolerant of, platinum-based chemotherapy. The Prescription Drug User Fee Act (PDUFA) target action date for retifanlimab is July 25, 2021. In addition, Incyte has stated it is pursuing development of retifanlimab as monotherapy in potentially registration-enabling studies in patients with MSI-high endometrial cancer and Merkel cell carcinoma.

In 2020, Incyte initiated two Phase 3 studies of retifanlimab in combination with chemo-radiation or chemotherapy in patients with advanced or metastatic non-small cell lung cancer (NSCLC) and in patients with metastatic SCAC, known as POD1UM-304 and POD1UM-303, respectively. Incyte is also pursuing development of retifanlimab in combination with multiple product candidates from its pipeline.

MacroGenics is currently evaluating retifanlimab in combination with margetuximab, an investigational Fc-engineered, anti-HER2 monoclonal antibody (mAb), in a potentially registration-enabling study of patients with HER2-positive gastric cancer. The Company also plans to initiate a study of retifanlimab in combination with enoblituzumab, an investigational Fc-engineered, anti-B7-H3 mAb, in patients with squamous cell carcinoma of the head and neck (SCCHN).

Under the collaboration agreement with Incyte, MacroGenics has received $65 million in milestones to date and is eligible to receive up to a total of $355 million in potential remaining development and regulatory milestones and up to $330 million in potential commercial milestones. If retifanlimab is approved and commercialized, MacroGenics would be eligible to receive royalties, tiered from 15 to 24 percent, on future worldwide net sales of the molecule.

About MacroGenics, Inc.

MacroGenics is a biopharmaceutical company focused on developing and commercializing innovative monoclonal antibody-based therapeutics for the treatment of cancer. The Company generates its pipeline of product candidates primarily from its proprietary suite of next-generation antibody-based technology platforms, which have applicability across broad therapeutic domains. 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 and the MacroGenics logo 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 Company's therapeutic candidates, commercial prospects of or product revenues from MARGENZA, milestone or opt-in payments from the Company's collaborators, the Company's anticipated milestones 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: risks that MARGENZA revenue, expenses and costs may not be as expected, risks relating to MARGENZA’s market acceptance, competition, reimbursement and regulatory actions, 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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FAQ

What is the milestone achieved by MacroGenics regarding retifanlimab?

MacroGenics announced a $10 million milestone related to the development of retifanlimab under its collaboration with Incyte.

What is the FDA's target action date for the BLA of retifanlimab?

The FDA's target action date for the BLA of retifanlimab is July 25, 2021.

What are the ongoing studies for retifanlimab?

Incyte is conducting Phase 3 studies of retifanlimab for advanced non-small cell lung cancer and squamous carcinoma of the anal canal.

What are the potential financial benefits for MacroGenics from the retifanlimab collaboration?

MacroGenics is eligible for up to $355 million in future milestones and royalties ranging from 15% to 24% on worldwide net sales of retifanlimab.