MacroGenics, Inc. (NASDAQ: MGNX), a biopharmaceutical company
focused on discovering, developing, manufacturing and
commercializing innovative antibody-based therapeutics for the
treatment of cancer, today announced a poster (display)
presentation of clinical data from the TAMARACK Phase 2 study of
vobramitamab duocarmazine (vobra duo) at the upcoming European
Society for Medical Oncology (ESMO) Congress 2024 taking place in
Barcelona, Spain on September 13-17, 2024.
The abstract submitted to ESMO was based on an April 12 data cut
off, and the poster will report additional data from a July 9 data
cut-off, including safety, efficacy and landmark 6-month
radiographic progression-free survival (rPFS) data. The poster is
titled:
1654P; TAMARACK: Randomized Phase 2
trial of the B7-H3 targeting antibody drug conjugate (ADC)
vobramitamab duocarmazine (vobra duo) in metastatic
castration-resistant prostate cancer (mCRPC)
“We are pleased to have the opportunity to present updated
safety and efficacy data from our TAMARACK trial at the upcoming
ESMO Congress in September," said Scott Koenig, M.D., Ph.D.,
President and CEO of MacroGenics. “We believe that these data will
give us valuable insights to inform potential next steps for the
vobra duo program in mCRPC, and we look forward to providing
additional perspective to the investment community following our
ESMO presentation.”
In accordance with ESMO’s embargo policy, the poster will be
published under "Events & Presentations" in the Investor
Relations section of MacroGenics’ website at
http://ir.macrogenics.com/events.cfm on or around September 15,
2024. Given the embargoed TAMARACK data, the Company’s management
has entered a quiet period and will not be hosting a conference
call to discuss its financial results or corporate progress for the
quarter ended June 30, 2024. The Company expects to issue a release
detailing its financial results and corporate progress on or around
August 6, 2024, and plans to host an investor conference call
following the ESMO presentation to discuss the TAMARACK data and
potential next steps for the vobra duo program.
TAMARACK Study Update
MacroGenics completed enrollment of the TAMARACK study in the
fourth quarter of 2023, and plans to present at ESMO the study’s
landmark primary endpoint of 6-month rPFS rate, which represents
the proportion of study participants who remain alive and
progression-free at 6 months.
In late July 2024, after a review of accumulated study data,
MacroGenics agreed with the study’s Independent Data Monitoring
Committee’s (IDMC) recommendation that study treatment should be
discontinued for the remaining mCRPC study participants who
potentially could have received additional doses. Most of these
remaining study participants had already received 8-12 cycles of
vobra duo. Participants continue to be monitored for adverse
events, disease progression and survival.
“Patient safety is our top priority, and having reached the
study’s primary endpoint, we decided to discontinue additional
dosing for the remaining TAMARACK participants who had not yet
completed treatment. We expect to have the data necessary to
determine next steps for the vobra duo program later this year and
will provide further updates on an investor call following our ESMO
presentation,” continued Dr. Koenig. “We are committed to fully
assessing the potential of vobra duo in mCRPC through rigorous
evaluation of the data, including the mature median rPFS and OS. We
look forward to completing follow-up for the TAMARACK trial before
year-end and presenting final data at a future conference.”
The Company expects to have the mature efficacy findings,
including median rPFS, later in the second half of 2024 and plans
to present the data at a subsequent medical conference. The data to
be presented at ESMO will be used to inform how future potential
studies could be designed.
About Vobra Duo and the TAMARACK Study
Vobra duo is an antibody-drug conjugate (ADC) that targets
B7-H3, an antigen with broad expression across multiple solid
tumors and a member of the B7 family of molecules involved in
immune regulation. The TAMARACK Phase 2 study of vobra duo is being
conducted in participants with metastatic castration-resistant
prostate cancer (mCRPC) who were previously treated with one prior
androgen receptor axis-targeted therapy (ARAT). Participants may
have received up to one prior taxane-containing regimen, but no
other chemotherapy agents. The TAMARACK study is designed to
evaluate vobra duo at two different doses: 2.0 mg/kg or 2.7 mg/kg
every four weeks (q4W).
About MacroGenics, Inc.
MacroGenics (the Company) is a biopharmaceutical company focused
on discovering, developing, manufacturing 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, the
MacroGenics logo, MARGENZA 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 MacroGenics (“Company”), including
statements about the Company’s strategy, future operations,
clinical development of the Company’s therapeutic candidates,
including initiation and enrollment in clinical trials, expected
timing of results from clinical trials, discussions with regulatory
agencies, commercial prospects of or product revenues from MARGENZA
and the Company’s product candidates, if approved, manufacturing
services revenue, 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, as well as
future global net sales of TZIELD and the Company’s ability to
achieve the milestone payments set forth under the terms of the
agreement with DRI (or its successors or assigns with respect to
such agreement), and other statements containing the words “subject
to”, "believe", “anticipate”, “plan”, “expect”, “intend”,
“estimate”, “potential,” “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 TZIELD, vobramitamab
duocarmazine, lorigerlimab, ZYNYZ, MARGENZA or any other product
candidate’s revenue, expenses and costs may not be as expected,
risks relating to TZIELD, vobramitamab duocarmazine, lorigerlimab,
ZYNYZ, MARGENZA or any other product candidate’s market acceptance,
competition, reimbursement and regulatory actions; future data
updates, especially with respect to vobramitamab duocarmazine; our
ability to provide manufacturing services to our customers; the
uncertainties inherent in the initiation and enrollment of future
clinical trials; the availability of financing to fund the internal
development of our product candidates; expectations of expanding
ongoing clinical trials; availability and timing of data from
ongoing clinical trials; expectations for the timing and steps
required in the regulatory review process; expectations for
regulatory approvals; expectations of future milestone payments;
the impact of competitive products; our ability to enter into
agreements with strategic partners and other matters that could
affect the availability or commercial potential of the Company's
product candidates; business, economic or political disruptions due
to catastrophes or other events, including natural disasters,
terrorist attacks, civil unrest and actual or threatened armed
conflict, or public health crises such as the novel coronavirus
(referred to as COVID-19 pandemic); 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.
###
CONTACTS:
Jim Karrels, Senior Vice President, CFO
1-301-251-5172
info@macrogenics.com
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