MacroGenics Enters Collaboration and License Agreement with Janssen to Develop MGD011 for Multiple B-Cell Malignancies
- MacroGenics licenses MGD011 (CD19 x CD3 DART®)
to Janssen
- $50 million upfront license fee paid to MacroGenics,
and a $75 million equity investment by Johnson
& Johnson Innovation - JJDC, Inc.
- MacroGenics may elect to fund a portion of late-stage
development costs in exchange for a U.S. and Canada profit
share
- MacroGenics may elect to co-promote in the United
States
Rockville, Maryland, Dec. 22, 2014 (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 various autoimmune disorders and infectious
diseases, today announced a global collaboration and license
agreement for MGD011 with Janssen Biotech, Inc. This product
candidate incorporates MacroGenics' proprietary platform for
Dual-Affinity Re-Targeting (DART®) to simultaneously target CD19
and CD3 for the potential treatment of B-cell malignancies.
Under the terms of the agreement and subject to the termination
or expiration of any applicable waiting periods under
Hart-Scott-Rodino Act, MacroGenics will receive a $50 million
upfront license fee and Johnson & Johnson Innovation - JJDC,
Inc. will invest $75 million to purchase 1,923,077 new shares of
MacroGenics common stock at a price of $39.00 per share.
Janssen will be fully responsible for developing MGD011 following
submission of the IND, which is planned for 2015. Assuming
successful development and commercialization, MacroGenics could
receive up to an additional $575 million in clinical, regulatory
and commercialization milestone payments. MacroGenics may
elect to fund a portion of late-stage clinical development in
exchange for a profit share in the U.S. and Canada. If
commercialized, MacroGenics would be eligible to receive
double-digit royalties on any global net sales and has the option
to co-promote the molecule with Janssen in the U.S.
"MGD011 is a promising product candidate and one that we believe
is meaningfully differentiated from competing CD19-directed
therapies," said Scott Koenig, M.D., Ph.D., President and CEO of
MacroGenics. "Janssen represents the ideal partner for this
product candidate, given their track record of successfully
developing and commercializing transformative oncology therapies
and their experience in the B-cell malignancy area. We look
forward to working with Janssen to significantly expand the
development of MGD011 and maximize its value."
About MGD011
MGD011, a humanized CD19 x CD3 bispecific DART protein, is being
developed for the treatment of B-cell hematological
malignancies. CD19, a lymphocyte-specific marker expressed
from early B-lymphocyte development through mature memory B cells,
is highly represented in B-cell malignancies. This makes it
attractive for targeted interventions. MGD011 is designed to
redirect T cells, via their CD3 component, to eliminate
CD19-expressing cells found in many hematological
malignancies. MGD011 has been engineered to address half-life
challenges posed by other programs targeting CD19 and CD3. This
product candidate has an Fc domain, which allows for extended
pharmacokinetic properties and convenient dosing at a once-a-week
or longer interval. In addition, MGD011 and the Company's
other DART molecules that redirect T cells against cancer targets
are manufactured using a conventional antibody platform without the
complexity of having to genetically modify T cells from individual
patients as required by approaches such as chimeric antigen
receptor (CAR) T-cells.
About the JJDC Financing
The closing of the financing is subject to certain closing
conditions.
The shares of Common Stock sold in the private placement have
not been registered under the Securities Act of 1933, as amended,
or state securities laws and may not be offered or sold in the
United States absent registration with the Securities and Exchange
Commission or an applicable exemption from the registration
requirements. MacroGenics, at the request of JJDC, will be
obligated to file a resale registration statement covering the
shares of Common Stock issued in the private placement following
the expiration of a pre-specified lock-up period.
This news release is not an offer to sell or the solicitation of
an offer to buy the shares of Common Stock or any other securities
of MacroGenics.
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 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 and DART are 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, milestone or opt-in payments from
the Company's collaborators, the Company's future expectations and
plans and prospects and other statements containing the words
"anticipate," "believe," "estimate," "expect," "intend," "may,"
"plan," "predict," "project," "target," "potential," "will,"
"would," "could," "should," "continue," and similar expressions,
constitute forward-looking statements within the meaning of The
Private Securities Litigation Reform Act of 1995. 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 risk factors described in the
Company's filings with the Securities and Exchange Commission,
including those discussed in the "Risk Factors" section of the
Company's Annual Report on Form 10-K filed with the Securities and
Exchange Commission on March 20, 2014 and the subsequent Quarterly
Reports on Form 10-Q. In addition, the forward-looking statements
included in this press release represent the Company's views 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. These forward-looking statements
should not be relied upon as representing the Company's views as of
any date subsequent to the date hereof.
CONTACT: CONTACT:
Jim Karrels, Vice President, CFO
MacroGenics, Inc.
1-301-251-5172, info@MacroGenics.com
Karen Sharma, Vice President
MacDougall Biomedical Communications on behalf of MacroGenics, Inc.
1-781-235-3060, ksharma@macbiocom.com
Source:
MacroGenics, Inc.
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