– 89% of CRc's were subjects with "poor
prognosis" cytogenetics and/or mutations
– Current median durability of response (mDOR)
of CRc's = 6 months and increasing (n=9)
– In 2nd line subjects (n=10)
Annamycin in combination with Cytarabine (AnnAraC) achieved an
estimated median overall survival (mOS) of 6 months and increasing
plus 5 CR's (50%) and 6 CRc's (60%)
– Recruitment increased to 22 subjects and
CRc's in all subjects evaluable for efficacy (n=20) was 45%
– Annamycin continues to demonstrate no
cardiotoxicity
– Data presented at European Hematology
Association (EHA) 2024 Hybrid Congress and Company KOL Meeting in
Madrid
HOUSTON,
June 14,
2024 /PRNewswire/ -- Moleculin Biotech, Inc.,
(Nasdaq: MBRX) ("Moleculin" or the "Company"), a clinical stage
pharmaceutical company with a broad portfolio of drug candidates
targeting hard-to-treat tumors and viruses, today reported
additional efficacy findings from the Company's ongoing Phase
1B/2 (MB-106) clinical trial
evaluating Annamycin in combination with Cytarabine (also known as
"Ara-C" and for which the combination of Annamycin and Ara-C is
referred to as AnnAraC) for the treatment of subjects with acute
myeloid leukemia (AML). The preliminary data was presented at the
European Hematology Association (EHA) 2024 Hybrid Congress. The
Company also hosted a data presentation to leading AML experts as
part of a KOL meeting held in conjunction with EHA 2024
Congress.
To date, a total of 22 subjects have been
enrolled (the Intent-to-Treat population, ITT), 20 (Lines
1st-7th) of whom have completed efficacy
evaluations with 9 subjects (45%) achieving a composite complete
remission (CRc or CR/CRi), consisting of 8 (40%) subjects with
complete remission (CR) and one subject with complete remission
with an incomplete recovery of peripheral blood counts (CRi),
following treatment with AnnAraC. Efficacy outcomes for 2
additional subjects (enrolled and treated) are pending.
Of the 10 ITT subjects for whom AnnAraC was
administered in the 2nd line setting, 5 achieved a CR
(50%) and 6 achieved a CRc (60%). Of the 13 subjects in the ITT
evaluable population that were 1st or 2nd
line treatment, 7 achieved a CR (54%) and 8 achieved a CRc (62%).
The mDOR for the 9 subjects who achieved a CRc is approximately 6
months and climbing. Additionally, the median overall survival in
the 2nd line subjects (n=10) is approximately 6 months
and increasing.
Additionally, 89% of the subjects included in the
CRc group (n=9) had cytogenetics and/or mutations generally
considered to contribute to a poor prognosis. These include FLT3,
IDH2, ASXL1, KMT2A and others. While not yet statistically
relevant, the Company believes such cytogenetic and mutation data
are informative to clinicians.
"We continue to be highly encouraged by the
positive growing body of preliminary clinical data demonstrated by
Annamycin in the treatment of patients with AML," commented
Walter Klemp, Chairman and Chief
Executive Officer of Moleculin. "While still preliminary, we
believe the efficacy to date including the climbing durability of
response demonstrated by AnnAraC in 2nd line patients
continues to significantly exceed the performance reported by any
drug currently approved for use in 2nd line AML. We are
incredibly pleased with the progress of the trial and the data and
continue to advance our preparations for an End of Phase 2 meeting
with FDA."
"There remains a significant unmet need for safe
and effective therapies for R/R AML. These data are exciting, and I
believe further underscore the potential of Annamycin to provide
patients and physicians with a promising treatment option in AML,"
concluded Mr. Klemp.
Currently, the median age of subjects in MB-106
is 69 years. Not including the two most recent subjects, a total of
17 subjects had relapsed/refractory AML and 3 subjects were first
line treatment. Two subjects discontinued early due to allergic
reactions. All subjects who completed treatment had undergone
post-therapy bone marrow assessment (Day 15 or later). No
clinically significant signs of cardiotoxicity were noted during or
after treatment in any of the subjects enrolled. The combination
was well tolerated with myelosuppression and infections being the
main adverse events (AEs). All data from MB-106 is preliminary and
subject to change.
Data presented at the European Hematology
Association (EHA) 2024 Hybrid Congress:
As previously announced, the poster titled
"LIPOSOMAL ANNAMYCIN (L-ANN) IN COMBINATION WITH CYTARABINE FOR
TREATMENT OF PATIENTS WITH ACUTE MYELOID LEUKAEMIA (AML) REFRACTORY
TO OR RELAPSED (R/R) AFTER INDUCTION THERAPY (MB-106 STUDY),"
was presented as part of the "Acute myeloid leukemia –
Clinical" session by Wolfram C. M. Dempke, MD, PhD, MBA,
European Chief Medical Officer of Moleculin. The poster
presentation mentioned above will be posted on the Company's
website and filed on Form 8-K with the Securities and Exchange
Commission.
Annamycin currently has Fast Track Status and
Orphan Drug Designation from the U.S. Food and Drug Administration
for the treatment of relapsed or refractory acute myeloid leukemia,
in addition to Orphan Drug Designation for the treatment of soft
tissue sarcoma. Furthermore, Annamycin has Orphan Drug Designation
for the treatment of relapsed or refractory acute myeloid leukemia
from the European Medicines Agency (EMA). For more information
about the ongoing MB-106 Phase 1B/2
trial, visit clinicaltrialsregister.eu and reference EudraCT
2020-005493-10 or clinicaltrials.gov and reference NCT05319587.
About Moleculin Biotech, Inc.
Moleculin Biotech, Inc. is a clinical stage
pharmaceutical company with a growing pipeline, including Phase 2
clinical programs, for hard-to-treat tumors and viruses. The
Company's lead program, Annamycin is a next-generation
anthracycline designed to avoid multidrug resistance mechanisms and
to eliminate the cardiotoxicity common with currently prescribed
anthracyclines. Annamycin is currently in development for the
treatment of acute myeloid leukemia (AML) and soft tissue sarcoma
(STS) lung metastases. All interim and preliminary data related to
its active clinical trials are subject to change.
Additionally, the Company is developing WP1066,
an Immune/Transcription Modulator capable of inhibiting p-STAT3 and
other oncogenic transcription factors while also stimulating a
natural immune response, targeting brain tumors, pancreatic and
other cancers. Moleculin is also engaged in the development of a
portfolio of antimetabolites, including WP1122 for the potential
treatment of viruses, as well as certain cancer indications.
For more information about the Company, please
visit www.moleculin.com and connect on Twitter, LinkedIn and
Facebook.
Forward-Looking Statements
Some of the statements in this release are
forward-looking statements within the meaning of Section 27A of the
Securities Act of 1933, Section 21E of the Securities Exchange Act
of 1934 and the Private Securities Litigation Reform Act of 1995,
which involve risks and uncertainties. Although Moleculin believes
that the expectations reflected in such forward-looking statements
are reasonable as of the date made, expectations may prove to have
been materially different from the results expressed or implied by
such forward-looking statements. Moleculin has attempted to
identify forward-looking statements by terminology including
'believes,' 'estimates,' 'anticipates,' 'expects,' 'plans,'
'projects,' 'intends,' 'potential,' 'may,' 'could,' 'might,'
'will,' 'should,' 'approximately' or other words that convey
uncertainty of future events or outcomes to identify these
forward-looking statements. These statements are only predictions
and involve known and unknown risks, uncertainties, and other
factors, including those discussed under Item 1A. "Risk Factors" in
our most recently filed Form 10-K filed with the Securities and
Exchange Commission (SEC) and updated from time to time in our Form
10-Q filings and in our other public filings with the SEC. Any
forward-looking statements contained in this release speak only as
of its date. We undertake no obligation to update any
forward-looking statements contained in this release to reflect
events or circumstances occurring after its date or to reflect the
occurrence of unanticipated events.
Investor Contact:
JTC Team, LLC
Jenene Thomas
(833) 475-8247
MBRX@jtcir.com
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SOURCE Moleculin Biotech, Inc.