Imago BioSciences, Inc. (“Imago” or the “company”) (Nasdaq: IMGO),
a clinical stage biopharmaceutical company discovering and
developing new medicines for the treatment of myeloproliferative
neoplasms (MPNs) and other bone marrow diseases, today presented
updated positive data from its ongoing global Phase 2 clinical
study evaluating bomedemstat in patients with advanced
myelofibrosis (MF).
The data were presented in a poster session
during the 30th European Hematology Association Annual Meeting and
Congress (EHA), taking place 9-12 June 2022. Previously, a Phase 2
data set with a cut-off of 31 October 2021 was presented at the
63rd American Society of Hematology (ASH) Annual Meeting and
Exposition in December 2021.
Updated Highlights (as of 29 April 2022
data cutoff):
- Of the evaluable patients at 24
weeks,
- 55% (28/51) showed a decrease in
Total Symptom Score (TSS).
- 22% (11/51) showed a ≥50% decrease
in TSS.
- 64% (32/50) showed spleen volume
reductions.
- 52% (36/69) of patients had a
decrease in mutant allele frequencies (MAFs) including driver
mutations (e.g., JAK2) with the greatest reduction in ASXL1, a high
molecular risk (HMR) mutation.
- 90% (37/41) of
transfusion-independent patients had stable or improved hemoglobin
at Week 12.
- 85% (50/59) of patients had an
improved (19/59) or stable (31/59) bone marrow fibrosis score
post-baseline.
- No new mutations or transformation
to acute myeloid lymphoma (AML) in patients with high risk of
progression.
“The potential of bomedemstat to be a unique and
differentiated monotherapy for patients living with advanced
myelofibrosis is underscored by the data presented at EHA today,”
said Hugh Young Rienhoff, Jr., M.D., CEO of Imago. “The data
continue to show improvements across multiple hallmarks of disease,
such as symptom scores, spleen volume, fibrosis, and anemia, while
at the same time demonstrating a favorable safety and tolerability
profile relative to the current available therapies. Of particular
interest is the effect on patients with ASXL1 mutations, a mutation
that confers an increased risk of leukemia. Importantly, these data
also point to the potential utility of bomedemstat in other
myeloproliferative diseases, such as polycythemia vera and
essential thrombocythemia, with similar mutation profiles. Patients
in this study will continue to be treated in an extension study
while we further explore these patient responses and evaluate the
added value of bomedemstat combined with ruxolitinib.”
Safety & Tolerability
- Bomedemstat was generally safe and
well-tolerated in patients with myelofibrosis.
- The most common non-hematologic
adverse event (AE) related to bomedemstat was dysgeusia (altered
taste), which occurred in 36% of patients and dysgeusia led to
discontinuation in 1 patient
- There were 14 serious adverse
events (SAEs) deemed related to bomedemstat per the
Investigator
Details on the Imago EHA
Presentation
Poster Presentation Title: A
Phase 2 Study of IMG-7289 (Bomedemstat) in Patients With Advanced
Myelofibrosis Session: 16. Myeloproliferative
neoplasms – ClinicalPresenter: Harinder Gill,
M.D., study investigator and presenter of the data, Department
of Medicine, University of Hong Kong, Queen Mary
Hospital, Pok Fu Lam, Hong Kong Date &
Time: Friday, June 10, 2022, at 10:30 AM ET
For further details, please see the EHA 2022
abstract and presentation on the Imago website here.
Virtual Investor Event
Details
Individuals interested in listening to the event
at 10:30 a.m. ET on Saturday, June 11, 2022 may do so by dialing
(844) 348-6880 for domestic callers, or +1 (914) 800-3944 for
international callers, and reference conference ID: 3493998; or
from the webcast link in the investor relations section of the
company’s website at: www.imagobio.com. The webcast will be
available in the investor relations section on the company’s
website for 90 days following the completion of the call.
About the Imago Phase 2 Advanced
Myelofibrosis Program
Myelofibrosis (MF) is a progressive cancer in
which the bone marrow is gradually replaced by fibrous, scar-like
tissue. There is a significant unmet need for a disease-modifying
therapy. The need is greatest in patients with MF whose disease is
not adequately managed with current JAK inhibitors, the current
standard of care.
This Phase 2 multi-center, open-label study is
designed to assess the safety, efficacy, pharmacodynamics, and
spleen volume reduction of bomedemstat, an oral inhibitor of
lysine-specific demethylase 1 (LSD1). Eligible patients aged 18 or
older with MF who were refractory or resistant to, intolerant of,
were inadequately controlled by or ineligible for approved
therapies were considered for the study. Exploratory assessments
include symptom reduction, changes in cytokine profiles, changes in
the frequency of mutant alleles and bone marrow fibrosis. The trial
was conducted in the United States, the United
Kingdom, European Union, Australia, and Hong Kong.
This 24-week study completed enrollment in May 2021 with
a total of 89 patients.
About Imago BioSciences
Imago BioSciences is a clinical-stage
biopharmaceutical company discovering and developing novel small
molecule product candidates that target lysine-specific demethylase
1 (LSD1), an enzyme that plays a central role in the production of
blood cells in the bone marrow. Imago is focused on improving the
quality and length of life for patients with cancer and bone marrow
diseases. Bomedemstat, an orally available, small molecule
inhibitor of LSD1, is the lead product candidate discovered by
Imago for the treatment of certain myeloproliferative neoplasms
(MPNs), a family of related, chronic cancers of the bone marrow.
Imago is evaluating Bomedemstat as a potentially disease-modifying
therapy in two Phase 2 clinical trials for the treatment of
essential thrombocythemia (NCT04254978) and myelofibrosis
(NCT03136185). Bomedemstat has U.S. FDA Orphan Drug and Fast Track
Designation for the treatment of ET and MF, European Medicines
Agency (EMA) Orphan Designation for the treatment of ET and MF, and
PRIority MEdicines (PRIME) Designation by the EMA for the treatment
of MF. The company is based in South San Francisco, California. To
learn more, visit www.imagobio.com,
www.myelofibrosisclinicalstudy.com,
www.etclinicalstudy.com and follow us on Twitter
@ImagoBioRx, Facebook and LinkedIn.
Forward Looking Statements
This press release contains forward looking
statements within the meaning of the Private Securities Litigation
Reform Act of 1995. Words such as “anticipates,” “may,” “will,”
“should,” “expect,” “believe” and similar expressions (as well as
other words or expressions referencing future events, conditions,
or circumstances) are intended to identify forward-looking
statements.
These statements may relate to, but are not
limited to, the results, conduct, progress and timing of Imago
clinical trials, the regulatory approval path for bomedemstat,
plans for future operations, and the impact of the ongoing COVID-19
pandemic and the development of new variants of COVID-19, such as
the delta or omicron variant, on enrollment of our clinical trials,
as well as assumptions relating to the foregoing. Forward looking
statements are inherently subject to risks and uncertainties, some
of which cannot be predicted or quantified. Important factors that
could affect future results and cause those results to differ
materially from those expressed in the forward-looking statements
include: our limited operating history and lack of products for
commercial sale; our significant losses since inception and for the
foreseeable future; our need for substantial additional financing;
our unpredictable operating results; our business’s dependence on
development, regulatory approval and commercialization of our
product candidates; difficulties in enrolling patients and risks of
substantial delays in our clinical trials; our minimal control over
product candidates in investigator-initiated clinical trials;
uncertainties in the outcomes of our clinical studies;
uncertainties in the regulatory review and approval of our product
candidates if our pivotal studies are positive; potentially
material changes to the interim, top-line and preliminary data from
our clinical trials; potential undesirable effects of our product
candidates and safety or supply issues with combination-use
products; our potential inability to obtain and maintain orphan
drug designation and delays in approvals despite Fast Track
designation; risks related to clinical trials outside of the United
States; our need to manufacture multiple batches of bomedemstat
using a commercial current Good Manufacturing Process; risks
related to COVID-19 or other pandemics, natural disasters and wars;
risks related to competition; difficulties in expanding our
organization and managing growth, attracting and retaining senior
management and key scientific personnel and establishing sales and
other commercialization functions; risks related to information
technology system and cybersecurity; risks related to misconduct of
our employees and independent contractors; risks related to
hazardous materials and our compliance with environmental laws and
regulations; risks related to litigation and other claims; risks
related to reliance on third parties to conduct and support
preclinical studies and clinical trials, and to manufacture our
product candidates; risks related to third-party intellectual
property infringement claims and our ability to protect our own
intellectual property; risks related to governmental policies and
regulations including with respect to drug prices and
reimbursement, and changes thereof; risks related to our common
stock; risks related to our public company, “emerging growth
company” and “smaller reporting company” status; risks related to
internal control over financial reporting; and other risks and
uncertainties, including those listed in the section titled “Risk
Factors” in our Annual Report on Form 10-K for the year ended
December 31, 2021 and our subsequent quarterly reports. You should
not put undue reliance on any forward-looking statements. Forward
looking statements should not be read as a guarantee of future
performance or results and will not necessarily be accurate
indications of the times at, or by, which such performance or
results will be achieved, if at all.
Except as required by law, Imago does not
undertake any obligation to publicly update or revise any
forward-looking statement, whether as a result of new information,
future developments or otherwise.
INVESTORSLaurence WattsGilmartin Group,
LLC.laurence@gilmartinir.com
MEDIAIan StoneEvoke
Canaleian.stone@evokegroup.com
Source: Imago BioSciences
Imago BioSciences (NASDAQ:IMGO)
Historical Stock Chart
From Jun 2024 to Jul 2024
Imago BioSciences (NASDAQ:IMGO)
Historical Stock Chart
From Jul 2023 to Jul 2024