- CR rate of 36% in Intent to Treat or ITT
(n=11) subjects with durability
- CR rate of 44% in subjects treated with
Annamycin (n=9)
- Durability of CR's up to 8 months &
climbing (no relapses to date)
- Recruitment in MB-106 Phase 1B/2 clinical trial reaches 59%
- Announces Publication for 65th
ASH Annual Meeting and Exposition
- Annamycin continues to be 100%
non-cardiotoxic
HOUSTON, Dec. 11,
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 Company's ongoing European Phase 1B/2 clinical trial evaluating Annamycin for the
treatment of acute myeloid leukemia or AML (MB-106) to key opinion
leaders and current investigators at a meeting held in conjunction
with the 65th American Society of Hematology Meeting and
Exposition (ASH) in San Diego on
December 10, 2023. Additionally, the
Company will have a paper published on its MB-106 clinical trial as
part of ASH. A link will be provided on the Company's website once
this publication is available online.
The KOL presentation included an update to the positive
preliminary efficacy findings previously reported on MB-106. To
date, among patients who had an evaluable post treatment bone
marrow biopsy, or who dropped out due to an adverse event (AE),
there have been 4 complete responses (CR's) or 36% of the intent to
treat (ITT) subjects (n=11) and 44% of the subjects treated (dosed
with Annamycin) (n=9). Two subjects experienced adverse events and
were not dosed with one being an allergic reaction to Annamycin,
the first the Company has seen in over 70 subjects dosed in the
Company's multiple Annamycin clinical trials; the second dropout
was due to an allergic reaction to cytarabine. There continues to
be no evidence of cardiotoxicity as measured by ejection fraction,
strain analyses, ECGs, and cardiac biomarkers including Troponin-I
and T in MB-106.
"We believe that our growing body of preliminary clinical data
demonstrated by Annamycin in the treatment of patients with AML
continues to be highly 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
complete response rate we are seeing continues to reflect what we
believe is an efficacy level greater than we need for eventual
approval of Annamycin. Our recruitment rate continues to exceed
expectations and we are optimistic that we will be fully recruited
within the next few months."
Currently, the median age of subjects in MB-106 is 69 years with
a median number of prior therapies for AML of one. While two of the
Company's complete responders are too recent to measure durability,
the Company is seeing durability as high as 8 months and climbing,
and the Company has yet to see any relapses of CR's experienced to
date in the trial. The Company has recruited 16 subjects to date
with 2 subjects withdrawing from the trial due to adverse events
and 3 other subjects having received treatment and not having the
bone marrow aspirate fully evaluated.
Additionally, one of the subjects treated but not evaluated
experienced a grade 4 serious adverse event (SAE) with septic shock
caused by Escherichia coli (E. coli) and was reported on a Suspect
Adverse Reaction Report to the appropriate regulatory bodies and
ethics committees. The subject was treated for the infection, the
SAE is still reported as "ongoing," and the subject is recovering.
This subject will be evaluated until resolution of the SAE and will
be assessed for efficacy per protocol.
The presentation to the KOL's 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. For more information about the MB-106 Phase
1B/2 trial, visit
clinicaltrialsregister.eu and reference EudraCT 2020-005493-10 or
clinicaltrials.gov and reference NCT05319587.
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 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 "Complete Remission"
Per the American Cancer Society, the goal of treatment for acute
myeloid leukemia is to put the leukemia into complete remission
(the bone marrow and blood cell counts return to normal),
preferably a complete molecular remission (no signs of leukemia in
the bone marrow, even using sensitive lab tests), and to keep it
that way. Source:
https://www.cancer.org/cancer/types/acute-myeloid-leukemia/treating/response-rates.html
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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SOURCE Moleculin Biotech, Inc.