Moleculin Reports Higher AML Complete Remission (CR) Rates and Significant Durability with Additional Interim Subject Data
- Annamycin in combination with Cytarabine (AnnAraC) achieves CRc rate of 62% (54% CR) in 1st and 2nd line AML subjects (N=13)
- Full MB-106 trial reaches 20 subjects with CRc of 45% in 1st – 7th line, with median durability at 4.9 months and climbing
- Interim data supports advancement to development of Phase 2 registration-directed clinical trial (MB-108) to further provide data for efficacy to support an eventual application for New Drug Approval (NDA)
-
Virtual AML Clinical Day featuring internationally renowned clinician,
Martin S. Tallman , MD, today,May 7 th at11:00 AM ET - Register Here
"Adding the latest two subjects in MB-106 AML trial with AnnAraC brings the composite complete remission (CRc) rate up from 37% to 45% for all of the 20 subjects with prior therapies ranging from none to six. This adds to our growing body of positive data which continues to provide a clear line of sight for our clinical and regulatory strategies towards registration for Annamycin in AML," commented
"We continue to progress our preparations for an End of Phase 2 meeting with FDA and believe following this meeting we will be in a position to commence a pivotal registration study as a 2nd line therapy in AML early next year," added Mr. Klemp.
Ongoing AML Clinical Trial Overview
The Company is currently conducting its Phase 1B/2 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 AML as both first line therapy and for subjects who are refractory to or relapsed after induction therapy (MB-106). clinicaltrialsregister.eu: EudraCT 2020-005493-10 or clinicaltrials.gov: NCT05319587.
During 2023, Moleculin commenced its MB-106 clinical trial with AnnAraC for the treatment of AML in an all-comers trial, accepting subjects without regard to the number of prior therapies in the Phase 1 portion with a limit of two prior therapies in the Phase 2 portion. Nine clinical sites in
To date, 20 subjects have been enrolled in the full MB-106 Phase 1B/2 study. The median durability of remission (DoR) is 4.9 months and climbing. DoR is defined as the time from initiation of treatment to the point of disease relapse or death. At the end of
Moleculin's current planned pathway for initial NDA approval indication for Annamycin in combination with Cytarabine for the treatment of AML is as a 2nd line therapy. Therefore, the focus is primarily on securing an accelerated approval pathway for the treatment of 2nd line subjects (those who were relapsed from or refractory to a 1st line AML therapy, regardless of whether the subject was deemed "fit" or "unfit" for intensive chemotherapy). Moleculin continues to recruit 1st line subjects into MB-106 to provide data for a possible future confirmatory Phase 3 clinical trial in 1st line patients.
Summary of MB-106 Data
A summary table of the MB-106 preliminary results is shown below. These subjects had 0-6 prior therapies. The preliminary data for MB-106 demonstrate a CRc rate of 45% and an overall remission rate (ORR) of 55% for all subjects, regardless of the number of prior treatments (N=20). Segmenting the MB-106 subject population for 1st line (N=3) and, most notably, 2nd line (N=10) therapies in the trial, yields a CRc rate of 67% and 60% and an ORR of 67% and 70%, both respectively.
Median durability for MB-106 is 4.9 months and climbing with one death (suspected to be related to pneumonia) and one relapse to date out of the 9 CRcs. The first subject with a CRc (and who has yet to relapse) was treated in
The trial continues recruitment for treatment as 1st line and 3rd line therapy. Since Moleculin intends to position AnnAraC for initial approval as a 2nd line therapy, the Company believes that the most important data from this trial are the results in 2nd line subjects (excluding subjects who are either 1st line or 3rd line and beyond). All data from MB-106 are interim, preliminary, and subject to change until a clinical trial report is published.
Table 1
- Summary of Annamycin Remissions in MB-106 as of
Study MB-106 Combination Therapy – Phase 1B/2 with |
All Lines (Range 1-7) |
1st Line |
2nd Line |
1st and 2nd Line Combined |
All Subjects |
|
|
|
|
Recruited and Evaluable |
20 |
3 |
10 |
13 |
Subjects Evaluable Not Dosed Per Protocol |
2 |
0 |
1 |
1 |
Median Prior Therapies |
1 |
0 |
1 |
1 |
Median Age - Years (Range) |
69 (19-78) |
49 (19-69) |
71 (53 - 78) |
67 (19-78) |
Complete Remissions (CR) |
8 |
2 |
5 |
7 |
CR with incomplete recovery (CRi) |
1 |
0 |
1 |
1 |
Total Composite Complete Remission (CRc) |
9 |
2 |
6 |
8 |
Complete Remission (CR) Rate |
40 % |
67 % |
50 % |
54 % |
Complete Remission Composite (CRc) Rate |
45 % |
67 % |
60 % |
62 % |
Partial Remissions (PRs) |
2 |
0 |
1 |
1 |
Overall Response Rate (CRc's + PRs) or ORR |
55 % |
67 % |
70 % |
69 % |
CRc Relapsed or Death to Date |
2 |
0 |
2 |
2 |
BMT To Date (in CR's) |
2 |
0 |
1 |
1 |
See Note 1 below |
|
|
|
|
Notes for Table 1: Data from MB-106 is for Intent To Treat (ITT) subjects and is preliminary and subject to change.
Expected Milestones for Annamycin AML Development Program
- H1 2024: Complete MB-106 Phase 1B/2 clinical trial.
- H1 2024: MB-106 End of Phase 2 Meeting with FDA.
- H1 2025: Initiate pivotal trial.
- H2 2026 Conclude pivotal trial.
- 2027: Potential NDA submission.
Virtual AML Clinical Day Details
As previously announced, Moleculin will host a virtual AML Clinical Day today,
A live video webcast of the event will be available on the Events page under the Investors section of the Company's website (moleculin.com). A webcast replay will be available two hours following the live event and will be accessible for 90 days.
About Moleculin Biotech, Inc.
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 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, the timing of the commencement of a pivotal registration study of Annamycin as a 2nd line therapy in AML in the first half of 2025. 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
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