Monte Rosa Therapeutics, Inc. (Nasdaq: GLUE), a clinical-stage
biotechnology company developing novel molecular glue degrader
(MGD)-based medicines, today announced that the first participants
have been dosed in a Phase 1, single ascending dose / multiple
ascending dose (SAD/MAD), healthy volunteer study evaluating
MRT-6160, a VAV1-directed MGD being developed for systemic and
neurological autoimmune diseases. The Company expects to obtain
initial data from the Phase 1 study in Q1 2025.
“We are very pleased to initiate our Phase 1 clinical study of
MRT-6160, a potent, highly selective, and orally bioavailable
VAV1-directed MGD, which we believe is the first rationally
designed MGD in clinical development for a non-oncology
indication,” said Markus Warmuth, M.D., Chief Executive Officer of
Monte Rosa Therapeutics. “Our MGD-based therapeutic approach is
well suited to degrade proteins that have been challenging to
address with conventional modalities, and we believe we have
opportunities to apply our technology to well-characterized targets
like VAV1 that were previously considered undruggable. By degrading
VAV1, a key regulator of T- and B-cell receptor activity, MRT-6160
could offer a differentiated approach to treat multiple autoimmune
and inflammatory diseases. The Phase 1 study of MRT-6160 is
designed to provide early insights into safety, pharmacokinetics,
VAV1 protein degradation, and key downstream pharmacodynamic
markers including CD69, IL-2, IL-6, and IL-17, helping to further
inform our clinical strategy. We look forward to sharing initial
clinical data from the study in Q1 2025, and subsequently
initiating anticipated proof-of-concept studies in ulcerative
colitis, rheumatoid arthritis, and potentially other
indications.”
The development of MRT-6160 is supported by preclinical data in
multiple models of autoimmune/inflammatory diseases and preclinical
GLP toxicology data that suggest the potential for a differentiated
therapeutic profile in T-cell, T/B-cell, and Th17-mediated systemic
and neurologic autoimmune diseases. MRT-6160 has been shown to
potently and selectively degrade VAV1 in vitro in human T and B
cells and has demonstrated encouraging results in multiple
preclinical studies of autoimmune disease, including in models of
inflammatory bowel disease, rheumatoid arthritis, and multiple
sclerosis.
About MRT-6160MRT-6160 is a potent, highly
selective, and orally bioavailable investigational molecular glue
degrader of VAV1, which in preclinical studies has shown deep
degradation of its target with no detectable effects on other
proteins. VAV1, a Rho-family guanine nucleotide exchange factor, is
a key signaling protein downstream of both the T- and B-cell
receptors. VAV1 expression is restricted to blood and immune cells,
including T and B cells. Preclinical studies have shown that
targeted degradation of VAV1 protein via an MGD modulates both T-
and B-cell receptor-mediated activity. This modulation is evident
both in vitro and in vivo, demonstrated by a significant decrease
in cytokine secretion, proteins vital for maintaining autoimmune
diseases. Moreover, VAV1-directed MGDs have shown promising
activity in preclinical models of autoimmune diseases and thus have
the potential to provide therapeutic benefits in multiple systemic
and neurological autoimmune indications, such as inflammatory bowel
disease, rheumatoid arthritis, multiple sclerosis, and
dermatological disorders. Preclinical studies have demonstrated
that MRT-6160 can inhibit disease progression in several in vivo
autoimmunity models.
About Monte RosaMonte Rosa Therapeutics is a
clinical-stage biotechnology company developing highly selective
molecular glue degrader (MGD) medicines for patients living with
serious diseases in the areas of oncology, autoimmune and
inflammatory diseases, and more. MGDs are small molecule protein
degraders that have the potential to treat many diseases that other
modalities, including other degraders, cannot. Monte Rosa’s QuEEN™
(Quantitative and Engineered Elimination of Neosubstrates)
discovery engine combines AI-guided chemistry, diverse chemical
libraries, structural biology and proteomics to identify degradable
protein targets and rationally design MGDs with unprecedented
selectivity. The QuEEN discovery engine enables access to a
wide-ranging and differentiated target space of well-validated
biology across multiple therapeutic areas. Monte Rosa has developed
the industry’s leading pipeline of MGDs, which spans oncology,
autoimmune and inflammatory disease and beyond, and has a strategic
collaboration with Roche to discover and develop MGDs against
targets in cancer and neurological diseases previously considered
impossible to drug. For more information, visit
www.monterosatx.com.
Forward-Looking Statements This communication
includes express and implied “forward-looking statements,”
including forward-looking statements within the meaning of the
Private Securities Litigation Reform Act of 1995. Forward-looking
statements include all statements that are not historical facts and
in some cases, can be identified by terms such as “may,” “might,”
“will,” “could,” “would,” “should,” “expect,” “intend,” “plan,”
“objective,” “anticipate,” “believe,” “estimate,” “predict,”
“potential,” “continue,” “ongoing,” or the negative of these terms,
or other comparable terminology intended to identify statements
about the future. Forward-looking statements contained herein
include, but are not limited to, statements about the advancement
and timeline of our MRT-6160 Phase 1 clinical study and our
expectations for obtaining and disclosing data therefrom, our plans
for our ongoing and future development of MRT-6160, our predictions
concerning the relevance of our preclinical studies for the
development of MRT-6160, and our predictions for the need and
therapeutic relevance of a VAV1-directed MGD, including for
MRT-6160. By their nature, these statements are subject to numerous
risks and uncertainties, including those risks and uncertainties
set forth in our most recent Annual Report on Form 10-K for the
fiscal year ended December 31, 2023, filed with the U.S. Securities
and Exchange Commission on March 14, 2024, and any subsequent
filings, that could cause actual results, performance or
achievement to differ materially and adversely from those
anticipated or implied in the statements. You should not rely upon
forward-looking statements as predictions of future events.
Although our management believes that the expectations reflected in
our statements are reasonable, we cannot guarantee that the future
results, performance, or events and circumstances described in the
forward-looking statements will be achieved or occur. Recipients
are cautioned not to place undue reliance on these forward-looking
statements, which speak only as of the date such statements are
made and should not be construed as statements of fact. We
undertake no obligation to publicly update any forward-looking
statements, whether as a result of new information, any future
presentations, or otherwise, except as required by applicable law.
Certain information contained in these materials and any statements
made orally during any presentation of these materials that relate
to the materials or are based on studies, publications, surveys and
other data obtained from third-party sources and our own internal
estimates and research. While we believe these third-party studies,
publications, surveys and other data to be reliable as of the date
of these materials, we have not independently verified, and make no
representations as to the adequacy, fairness, accuracy or
completeness of, any information obtained from third-party sources.
In addition, no independent source has evaluated the reasonableness
or accuracy of our internal estimates or research and no reliance
should be made on any information or statements made in these
materials relating to or based on such internal estimates and
research.
InvestorsAndrew
Funderburkir@monterosatx.com
MediaCory Tromblee, Scient
PRmedia@monterosatx.com
Monte Rosa Therapeutics (NASDAQ:GLUE)
Historical Stock Chart
From Sep 2024 to Oct 2024
Monte Rosa Therapeutics (NASDAQ:GLUE)
Historical Stock Chart
From Oct 2023 to Oct 2024