– Poster Presented at the 2023 Connective
Tissue Oncology Society (CTOS) Annual Meeting
– Annamycin continues to be 100%
non-cardiotoxic
– Annamycin has Fast Track Status and Orphan
Drug Designation from FDA for the treatment of soft tissue
sarcoma
HOUSTON, Nov. 6, 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 tumors and viruses, today announced the
presentation of preliminary efficacy findings from the Phase 2
portion of the Company's ongoing U.S. Phase 1B/2 clinical trial evaluating Annamycin for the
treatment of soft tissue sarcoma lung metastases (MB107).
The abstract titled, "A Phase 1b/2
Study of Liposomal Annamycin (ANN) in Subjects with Previously
Treated Soft-Tissue Sarcomas (STS) with Pulmonary
Metastases," was presented by Brian
Andrew Van Tine, MD, PhD, Professor of Medicine,
Washington University School of
Medicine in a poster presentation at the 2023 CTOS Annual Meeting
being held November 1-4, 2023 in
Dublin, Ireland.
"Our growing body of preliminary data demonstrated by Annamycin
in the treatment of patients with STS lung mets continues to be
encouraging and bolsters our confidence in its potential to be a
meaningful option for patients," commented Walter Klemp, Chairman and Chief Executive
Officer of Moleculin. "While still preliminary, the rates of the
median progression free response and the trend being established
for overall survival despite the patients in this study having
received multiple prior chemotherapy regimens continues to exceed
our expectations. We look forward to further data readouts from
this trial and understanding the full potential of Annamycin for
the treatment of STS lung mets."
19 subjects were enrolled in the Phase 1B portion of the MB107 study. The median number
of cycles administered was 2. There were no significant safety
concerns or unexpected serious adverse events (SAEs) up to the 390
mg/m2 dose. The recommended Phase 2 dose (RP2D) was
defined as 330 mg/m2. The most frequently reported
adverse events (AEs) related to Annamycin were in the system organ
class of Investigations (decreased platelet counts). There was no
evidence of cardiotoxicity as measured by ejection fraction, strain
analyses, ECGs, and cardiac biomarkers including Troponin-I and T.
In Phase 2, 14 subjects (median # of prior therapies = 3) received
at least 2 cycles of Annamycin at 330 mg/m2.
Of the 14 subjects enrolled in the Phase 2 portion of the trial,
9 (64%) showed stable disease (SD) through 2 cycles, 5 (36%) of
whom continued to show SD through 4 cycles, and 2 (14%) showed SD
through 6 cycles. Of these 2, one subject maintained SD through the
end of 6 cycles prior to progressing ~6.2 months after initiating
treatment with Annamycin. The other subject maintained SD through 8
cycles prior to progressing ~6.9 months after initiating treatment
with Annamycin. 3 subjects continue to be followed for progression
free survival (PFS), and 12 of 14 subjects in the Phase 2 efficacy
population continue to be followed for overall survival (OS).
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 therapy (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) – are
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
continue the Phase 2 portion of the clinical trial on a timely
basis. 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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