IGM Biosciences Initiates First-in-Human Phase 1 Clinical Trial of IGM-2323 for the Treatment of Relapsed/Refractory B Cell N...
October 02 2019 - 7:00AM
IGM Biosciences, Inc. (Nasdaq: IGMS), a biotechnology company
focused on creating and developing engineered IgM antibodies for
the treatment of cancer patients, today announced that the first
patient has been dosed in its Phase 1 clinical trial evaluating
IGM-2323, the Company’s CD20 x CD3 bispecific IgM antibody, in
patients with relapsed/refractory B cell Non-Hodgkin’s lymphoma
(NHL).
This Phase 1 clinical trial represents the first in-human
application of IGM Biosciences’ engineered IgM antibody technology.
The Phase 1 multi-center, open label trial is intended to assess
the safety, pharmacokinetics and preliminary efficacy of
intravenous IGM-2323 in patients with relapsed/refractory B cell
NHL. IGM-2323 will initially be administered at a planned
fixed-dose, as part of a dose escalation protocol.
About IGM Biosciences, Inc.
Headquartered in Mountain View, California, IGM Biosciences is a
biotechnology company focused on creating and developing engineered
IgM antibodies for the treatment of cancer patients. Since 2010,
IGM Biosciences has worked to overcome the manufacturing and
protein engineering hurdles that have limited the therapeutic use
of IgM antibodies. Through its efforts, IGM Biosciences has created
a proprietary IgM technology platform for the development of IgM
antibodies for those clinical indications where their inherent
properties may provide advantages as compared to IgG
antibodies.
Cautionary Note Regarding Forward-Looking
Statements
This press release contains forward-looking statements within
the meaning of The Private Securities Litigation Reform Act of
1995. Forward-looking statements generally relate to future events
or IGMBiosciences’ future financial or operating performance. Such
forward-looking statements include, but are not limited to,
statements regarding the Company’s Phase 1 clinical trial of
IGM-2323. Such statements are subject to numerous important
factors, risks and uncertainties that may cause actual events or
results to differ materially, including but not limited to:
IGM Biosciences’ early stages of clinical drug
development; uncertainties related to the use of engineered
IgM antibodies, which is a novel and unproven therapeutic approach;
IGM Biosciences’ ability to advance product candidates into, and
successfully complete, clinical trials on the timelines it
projects; IGM Biosciences’ ability to adequately demonstrate
sufficient safety and efficacy of its product candidates; IGM
Biosciences’ ability to enroll patients in its ongoing and future
clinical trials; IGM Biosciences’ ability to successfully
manufacture and supply its product candidates for clinical trials;
IGM Biosciences’ ability to obtain additional capital to finance
its operations; uncertainties related to the projections of the
size of patient populations suffering from the diseases IGM
Biosciences is targeting; IGM Biosciences’ ability to obtain,
maintain, and protect its intellectual property rights;
developments relating to IGM Biosciences’ competitors and its
industry, including competing product candidates and therapies;
general economic and market conditions; and other risks and
uncertainties, including those more fully described in IGM
Biosciences’ filings with the Securities and Exchange Commission
(“SEC”), including IGM Biosciences’ prospectus filed pursuant to
Rule 424(b) under the Securities Act of 1933, as amended, dated
September 17, 2019 and in IGM Biosciences’ future reports to
be filed with the SEC. Any forward-looking statements
contained in this press release speak only as of the date hereof,
and IGM Biosciences specifically disclaims any obligation to update
any forward-looking statement, except as required by law.
CONTACT:
Argot Partners David Pitts 212-600-1902
igmbio@argotpartners.com
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