– Data readouts expected before year
end
– Previously reported preliminary efficacy
data on its Phase 1B/2 clinical trial
with Annamycin in monotherapy treatment of STS lung mets with
>60% of the subjects exhibiting stable disease after two cycles
of treatment
– Annamycin has Fast Track Status and Orphan
Drug Designation from FDA for the treatment of soft tissue
sarcoma
HOUSTON, Sept. 21,
2023 /PRNewswire/ -- Moleculin Biotech, Inc.,
(Nasdaq: MBRX) (Moleculin or the Company), a clinical stage
pharmaceutical company with a growing pipeline, including Phase 2
clinical programs, for hard-to-treat cancers and viruses, today
announced the completion of enrollment in the Phase 2 portion of
the Company's U.S. Phase 1B/2
clinical trial evaluating Annamycin for the treatment of soft
tissue sarcoma lung metastases (MB107). Subjects who had stable
disease at time of study discontinuation will continue to be
followed for progression free response and overall survival.
"The completion of enrollment for our MB107 study marks an
important milestone for our STS clinical development program. We
remain very encouraged by the preliminary data we have seen in the
MB107 trial and look forward to gaining additional insight in
Annamycin's ability to treat STS lung mets as the opportunity now
shifts to data readouts," commented Walter
Klemp, Chairman and Chief Executive Officer of Moleculin.
"Since many of the patients enrolled into this trial have not yet
completed all of their scheduled follow-up examinations, the data
from this trial are not complete. However, based on the data
demonstrated to date, we believe that the median progression free
response of greater than 60%, despite the patients in this study
having received multiple prior chemotherapy regimens, exceeds what
one would expect. Importantly, we believe this level of progression
free response exceeds that of existing approved second line
therapies and that Annamycin has the potential to be a meaningful
treatment option for the treatment of STS lung mets. We look
forward to further additional updates on this trial in the fourth
quarter of this year."
The Company plans to present a more in-depth review of
the topline data on progression free survival, progression
free response, overall survival, and other data on this study prior
to this year-end. Additionally, the Company expects to report this
and further data, as previously announced, in the Company's poster
presentation and in related meetings at the 2023 CTOS (Connective
Tissue Oncology Society) Annual Meeting, which is being
held November 1-4, 2023 in
Dublin, Ireland.
Annamycin currently has Fast Track Status and Orphan Drug
Designation from the U.S. Food and Drug Administration for the
treatment of soft tissue sarcoma, in addition to Orphan Drug
Designation for the treatment of relapsed or refractory acute
myeloid leukemia. For more information about the U.S. Phase
1B/2 clinical trial evaluating
Annamycin for the treatment of soft tissue sarcoma lung metastases
(MB107) visit clinicaltrials.gov and reference identified
NCT04887298.
Study Design
In Phase 2, Annamycin was administered as an intravenous
(IV) infusion over 2 hours on Day 1, followed by 20 days off (1
cycle = 21 days). Subjects visit the study site every 21 days (±3
days) at which time safety monitoring – including for adverse
events (AEs), as well as a physical examination, laboratory
evaluations (clinical chemistry, complete blood count), vital
signs, weight measurements, Eastern Cooperative Oncology Group
(ECOG) performance status, and electrocardiograms (ECGs) – is
performed, followed by an IV infusion of study drug. Cardiac
function is followed by echocardiogram (ECHO) scans at screening,
at the end of the first two cycles and then following every other
cycle thereafter, at the End of Treatment visit, and if feasible,
during follow up at 6 months (±1 month) and 1 year (±1 month) after
study drug discontinuation. As long as the Investigator considers
that the benefits of treatment with Annamycin continue to outweigh
the risks, treatment will continue every 21 days until tumor
progression is observed or unacceptable toxicity occurs.
Tumor response is monitored every 6 weeks (±1 week) from Cycle 1
Day 1 during treatment, at the End of Treatment visit, and then
every 3 months (±1 month) until disease progression
using RECIST 1.1 criteria. Those subjects who leave the study
after a maximum response is achieved and who do not start another
therapy will be followed every 3 months (±1 month) for
progression-free survival (PFS). If a subject receives further
therapy after discontinuing from the study, they will be followed
only for overall survival (OS) and if feasible, follow-up ECHO
scans at 6 months (±1 month) and 1 year (±1 month) will be
conducted after study drug discontinuation.
About Annamycin
Annamycin is the Company's next-generation anthracycline that
has been shown in animal models to accumulate in the lungs at up to
30-fold the level of doxorubicin. Importantly, Annamycin has also
demonstrated a lack of cardiotoxicity in multiple early-stage human
clinical trials, including ongoing trials for the treatment of
acute myeloid leukemia (AML) and STS lung metastases. For that
reason, although additional data will be necessary, the Company
believes Annamycin may not face the same usage limitations imposed
on doxorubicin, one of the most common currently approved
anthracyclines. Annamycin is currently in development for the
treatment of AML and STS lung metastases and the Company believes
the drug may have the potential to treat additional
indications.
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 with little to no
cardiotoxicity. Annamycin is currently in development for the
treatment of relapsed or refractory acute myeloid leukemia (AML)
and soft tissue sarcoma (STS) lung metastases.
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, and WP1220, an analog to WP1066, for the topical
treatment of cutaneous T-cell lymphoma. Moleculin is also engaged
in the development of a portfolio of antimetabolites, including
WP1122 for the potential treatment of COVID-19 and other viruses,
as well as cancer indications including brain tumors, pancreatic
and other cancers.
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. Forward-looking statements in this press
release include, without limitation, Moleculin's ability to
provide additional updates on this trial in the fourth quarter of
this year. 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.