IGM Biosciences Announces Strategic Pipeline Prioritization and Cash Runway Extension
December 05 2023 - 4:01PM
IGM Biosciences, Inc. (Nasdaq: IGMS), a clinical-stage
biotechnology company creating and developing engineered IgM
antibodies, today announced that it will focus its resources in two
strategic areas: (i) treating colorectal cancer using IgM death
receptor 5 (DR5) agonist antibodies, and (ii) treating autoimmune
diseases using IgM T cell engager antibodies. As an expansion of
its autoimmune efforts, the Company also announced today that it
plans to file an Investigational New Drug (IND) application to
begin the clinical development of IGM-2644, its CD38 x CD3 T cell
engager antibody, for the treatment of autoimmune diseases. As part
of its strategic refocus, the Company is halting all hematologic
oncology clinical development as well as the clinical development
of its targeted cytokine product candidate. The Company will
continue to focus on the development of oncology and immunology and
inflammation product candidates under its collaboration with
Sanofi. In conjunction with this strategic refocusing, the Company
will be reducing its workforce by approximately 22 percent. As a
result of these actions, IGM expects to extend its cash runway into
the second quarter of 2026.
“IGM continues to have a tremendous opportunity
to transform a variety of disease areas using an entirely new class
of antibody medicines,” said Fred Schwarzer, Chief Executive
Officer of IGM Biosciences. “Although we are very encouraged by the
clinical and preclinical data that we have generated for the
programs we are halting, given the difficult conditions in the
capital markets for our industry, we have decided to focus our
capital resources on those opportunities that we believe have the
most potential to produce significant near-term value. We are very
sorry that some of our dedicated and talented employees will be
leaving IGM as part of this strategic refocusing, and we wish to
extend our sincere thanks and assistance to them in this difficult
transition.”
Pipeline Update:
Aplitabart (DR5 agonist)
- Clinical development of
aplitabart in colorectal cancer prioritized.
- Enrollment continues in
randomized colorectal cancer clinical trial. The Company
continues to enroll patients in a randomized clinical trial of
aplitabart, a death receptor 5 agonist, plus FOLFIRI and
bevacizumab in second-line metastatic colorectal cancer, with a
goal of enrolling approximately 110 patients by the end of the
first quarter of 2024. In addition to clinical trial sites in the
United States, this trial includes multiple clinical trial sites in
Asia and Europe.
- Treatment at 10 mg/kg
ongoing in the single arm colorectal cancer clinical trial
continues. The Company also continues to treat later line
colorectal cancer patients in its single arm combination clinical
trial of 10 mg/kg of aplitabart and FOLFIRI. The Company expects to
complete enrollment of patients in this 10 mg/kg single arm
combination study in the first half of 2024.
Imvotamab (CD20 x CD3)
- Clinical development of
imvotamab in autoimmune diseases prioritized. The Company
is prioritizing the clinical development of imvotamab, an IgM-based
CD20 x CD3 bispecific T cell engaging antibody in autoimmune
diseases. The Company currently has two Phase 1b clinical trials
underway, one in severe systemic lupus erythematosus (SLE) and one
in severe rheumatoid arthritis (RA). These clinical trials are
being expanded to include multiple U.S. and international clinical
trial sites. The Company also recently received clearance from the
FDA of its IND application for the use of imvotamab in treating
idiopathic inflammatory myopathies (myositis), and preparations are
underway to move this clinical trial forward.
IGM-2644 (CD38 x CD3)
- Clinical development of
IGM-2644 in autoimmune diseases prioritized. The Company
is prioritizing the clinical development of IGM-2644, a CD38 x CD3
T cell engager antibody, in the treatment of autoimmune diseases,
and it plans to file an IND for these purposes in 2024.
As a part of this strategic refocusing, the
Company will halt the following clinical development
activities:
- Aplitabart in acute myeloid
leukemia and in combination with birinapant
- IGM-2644 (CD38 x CD3) in multiple
myeloma
- IGM-2537 (CD123 x CD3)
- IGM-7354 (IL-15 x PD-L1)
About IGM Biosciences, Inc.IGM
Biosciences is a clinical-stage biotechnology company
committed to developing and delivering a new class of medicines to
treat patients with cancer and autoimmune and inflammatory
diseases. IGM’s pipeline of clinical and preclinical assets is
based on the IgM antibody, which has 10 binding sites compared to
conventional IgG antibodies with only 2 binding sites. IGM also has
an exclusive worldwide collaboration agreement with Sanofi to
create, develop, manufacture, and commercialize IgM antibody
agonists against oncology and immunology and inflammation targets.
For more information, please visit www.igmbio.com.
Cautionary Note Regarding
Forward-Looking StatementsThis press release contains
forward-looking statements. Such forward-looking statements are not
based on historical fact and include, but are not limited to: the
potential of, and expectations regarding, IGM’s technology platform
and its IgM antibodies and product candidates, including
aplitabart, imvotamab, and IGM-2644; IGM’s plans and expectations
regarding its clinical development efforts and activities;
statements regarding the clinical development of aplitabart,
imvotamab, and IGM-2644, including the timing of clinical trial
initiation, patient enrollment and IND submissions; IGM’s
expectations regarding its financial position and projected cash
runway; and statements by IGM’s Chief Executive Officer. 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’s early stages of
clinical drug development; risks related to the use of engineered
IgM antibodies, which is a novel and unproven therapeutic approach;
IGM’s ability to demonstrate the safety and efficacy of its product
candidates; IGM’s ability to successfully and timely advance its
product candidates through clinical trials; IGM’s ability to enroll
patients in its clinical trials; the potential for the results of
clinical trials to differ from preclinical, preliminary, initial or
expected results; the risk of significant adverse events,
toxicities or other undesirable side effects; IGM’s ability to
successfully manufacture and supply its product candidates for
clinical trials; the potential impact of continuing or worsening
supply chain constraints; the risk that all necessary regulatory
approvals cannot be obtained; the potential market for IGM’s
product candidates, and the progress and success of alternative
therapeutics currently available or in development; IGM’s 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 is targeting; IGM’s
ability to obtain, maintain and protect its intellectual property
rights; developments relating to IGM’s competitors and its
industry, including competing product candidates and therapies; any
potential delays or disruptions resulting from catastrophic events,
including epidemics or other outbreaks of infectious disease;
general economic and market conditions, including inflation;
uncertainties related to IGM’s ability to realize the contemplated
benefits of its pipeline prioritization efforts and related
reduction in force; and other risks and uncertainties, including
those more fully described in IGM’s filings with the Securities and
Exchange Commission (SEC), including IGM’s Quarterly Report on Form
10-Q filed with the SEC on November 13, 2023 and in IGM’s 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 specifically disclaims any obligation to update any
forward-looking statement, except as required by law.
Contact:Argot PartnersDavid
Pitts212-600-1902igmbio@argotpartners.com
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