Preliminary efficacy updated to 80% overall
response rate (ORR) demonstrated in single agent AML trial
following database lock
Next generation anthracycline, Annamycin, has
demonstrated both safety and promising early activity across
multiple clinical studies with potential to be an effective
treatment across multiple oncology indications
Recent independent report from cardiology
expert concluded Annamycin has no evidence of cardiotoxicity to
date in a total of 42 subjects across three of the Company's
Annamycin clinical trials
Granted FDA Fast Track and Orphan Drug
designation for AML and STS lung mets
HOUSTON, Dec. 15,
2022 /PRNewswire/ -- Moleculin Biotech,
Inc., (Nasdaq: MBRX) ("Moleculin" or the "Company"), a
clinical stage pharmaceutical company with a broad portfolio of
drug candidates targeting highly resistant tumors and viruses,
today provided an update on its clinical programs evaluating
Annamycin for the treatment of relapsed or refractory acute myeloid
leukemia (AML) and soft tissue sarcoma (STS) lung metastases. These
updates were recently presented during a reception for potential
investigators held outside of the 64th American Society
of Hematology (ASH) Annual Meeting in New
Orleans.
Key updates made during the presentation were as follows:
- Announced 80% overall response rate (ORR) in final cohort (n=5)
of the European trial of Annamycin as a single agent for the
treatment of relapsed/refractory acute myeloid leukemia (R/R AML)
with one CRi (complete response with incomplete recovery of
peripheral blood count) and three PRs (Partial Response).
- Of a total of 42 subjects in three of the Company's Annamycin
clinical trials, 100% demonstrated no signs of cardiotoxicity as
confirmed by independent expert. All expert reviews included
analysis of ejection fraction, echo strain and certain troponin
levels intended to assess the potential for both acute and chronic
heart damage.
- In two of the Company's Annamycin clinical trials, 32 subjects
have been, as allowed by the trial protocol, safely treated above
the current FDA lifetime maximum anthracycline dose (550
mg/m2) with up to 1800 mg/m2 of Annamycin
treatment with no evidence of cardiotoxicity as confirmed by an
independent expert.
- Data so far have resulted from treatment with Annamycin as a
single agent, however, based on additional preclinical animal data
from sponsored research, Annamycin in combination with Cytarabine
demonstrated a 68% improvement in the median overall survival (OS)
compared to Annamycin as a single agent and a 241% increase in OS
compared to Cytarabine alone. These data were recently presented at
the 62nd Annual Meeting & Exposition of the American
Society for Hematology (ASH) under the title: "High Efficacy of
Liposomal Annamycin (L-ANN or Annamycin) in Combination with
Cytarabine in Syngeneic p53-null AML Mouse
Model."1
- Annamycin has been in two single agent Phase 1 clinical trials
treating R/R/AML, one in the US and one in Europe. Annamycin is currently in two Phase
1b/2 clinical trials for the
treatment of soft tissue sarcoma metastasized to the lungs, again
one in the US and one in Europe.
Furthermore, based on the preclinical and clinical data discussed
above, the Company has begun screening in Poland for a Phase 1b/2 clinical trial using Annamycin in
combination with Cytarabine for the treatment of R/R AML. The
Company is looking to expand this trial into other countries in
Europe to potentially improve
recruitment rates.
"Annamycin is the Company's next-generation anthracycline that
has been designed to be non-cardiotoxic. We have continued to make
significant progress across our clinical trial programs evaluating
Annamycin in STS lung mets and AML. Based on the encouraging data
seen to date, we are optimistic in Annamycin's potential to treat a
number of indications and remain committed to furthering its
development," commented Walter
Klemp, Chairman and CEO of Moleculin. "Additionally, we
continue to receive encouraging feedback from our clinical staff
and recently had the opportunity to meet with our current and
potential investigators during the ASH Annual Meeting. We
intend to expand our Phase 1b/2
clinical trial using Annamycin in combination with Cytarabine for
the treatment of R/R AML beyond the borders of Poland. We
have gained valuable insight in all of our ongoing development
programs, and I believe we are well-positioned to successfully
execute on our clinical development initiatives moving
forward."
Annamycin currently has Fast Track Status and Orphan Drug
Designation from the FDA for the treatment of STS lung metastases
and the treatment of relapsed or refractory AML.
About Moleculin Biotech,
Inc.
Moleculin Biotech, Inc. is a clinical stage pharmaceutical
company focused on the development of a broad portfolio of drug
candidates for the treatment of highly resistant 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, whether the results of
Moleculin's preclinical animal models can be replicated in human
trials and Moleculin's ability to expand its Phase 1b/2 clinical trial using Annamycin in
combination with Cytarabine for the treatment of R/R AML into other
countries in Europe to potentially
improve recruitment rates. 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.
1 Zal T, Zielinski R, Grela K, Cardenas-Zuniga R,
Skora S, Fokt I, Zal A, Andreeff M, Gil L Shephard R, Priebe W,
High Efficacy of Liposomal Annamycin (L-ANN) in Combination with
Cytarabine in Syngeneic p53-Null AML Mouse Model, Blood (2020) 136
(Supplement 1): 6-7. https://doi.org/10.1182/blood-2020-143344
Investor Contact:
JTC Team, LLC
Jenene Thomas
(833) 475-8247
MBRX@jtcir.com
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SOURCE Moleculin Biotech, Inc.