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Biopharma Stocks (NYSE American: ATNM) (NASDAQ: BPTH) (NASDAQ: STTK) (NASDAQ: MBRX) Quest for Solutions for Acute Myeloid Leukemia (AML)


June 17, 2024 ( Newswire), a go-to investing platform releases the first of a two-part series looking at developments for the treatment of blood cancers. Today's snapshot focuses in on acute myeloid leukemia (AML) and the companies developing innovative solutions, featuring Actinium Pharmaceuticals, Inc. (NYSE AMERICAN:ATNM). Actinium is a leader in the development of Antibody Radiation Conjugates (ARCs) and other targeted radiotherapies.

"Acute myeloid leukemia (AML) is a cancer of the bone marrow and the blood that progresses rapidly without treatment. AML mostly affects cells that aren't fully developed, leaving these cells unable to carry out their normal functions. It can be a difficult disease to treat; researchers are studying new approaches to AML therapy in clinical trials," says the Leukemia Lymphoma Society.

There is a huge market opportunity for companies that offer solutions for AML. The Acute Myeloid Leukemia Market was valued at USD 2.1 billion in 2023 and is estimated to grow at a CAGR of 10.7% between 2024, reports GMI Insights .

With breaking news on AML treatment, Actinium Pharmaceuticals, Inc. (NYSE AMERICAN:ATNM) just announced that an abstract detailing the first ever preclinical data from the combination of menin inhibitors with Actinium's ARC Actimab-A in acute myeloid leukemia (AML) models was presented at the 2024 European Hematology Association (EHA) Congress held June 13 - 16, 2024, in Madrid, Spain. Actinium studied Actimab-A in combination with the leading menin inhibitors, revumenib (Syndax Pharmaceuticals, Inc.) and ziftomenib (Kura Oncology, Inc.), which are being developed for patients with KMT2A rearrangements and NMP1 mutations, which are present in approximately 10% and 30% of AML patients, respectively.

Paid news dissemination on behalf of Actinium

Actimab-A + Menin inhibitor combination results include:

  • Actimab-A as a single agent showed potent AML cell killing activity in KMT2A harboring cells in both MV-4-11 and MOLM-13 cell lines in vitro compared to the non-radio conjugated CD33 antibody lintuzumab (p<0.0001)
  • Actimab-A enhanced AML cell death when combined with both revumenib and ziftomenib at all dose levels in difficult to treat KMT2A AML
  • The combination of Actimab-A with leading menin inhibitors triggered an acute increase in AML necrosis and cell death relative to single agent therapy within 72 hours of dosing
  • Anti-tumor effect was significantly potentiated and prolonged when combining Actimab-A with a leading menin inhibitor compared to monotherapies in xenograft leukemia models in vivo (p<0.0024 Actimab-A + menin) as shown in the exhibit below

The Actimab-A + Menin Inhibitor combination presentation can be accessed on the investor relations page of Actinium's website here.

Actimab-A targets CD33, a marker expressed ubiquitously in patients with AML, and is conjugated with the alpha-partible payload Actinium-225. The broad expression of CD33 and the differentiated mutation agnostic cell-killing mechanism of targeted radiotherapy make Actimab-A broadly applicable for combinations with chemotherapy, targeted agents including venetoclax, FLT3 and menin inhibitors, immunotherapies and cellular therapies supporting its potential backbone therapy profile across the AML patient treatment journey.

Sandesh Seth, Actinium's Chairman and CEO said, "Combining with menin inhibitors is an exciting expansion of the already broad potential of Actimab-A in AML. Across single agent and combination studies, Actimab-A has produced high rates of response, MRD negativity and improved survival in high-risk, relapsed and refractory patients including those with a TP53 mutation and venetoclax failures. The broad expression of CD33 in AML coupled with the potency of Actinium-225 make Actimab-A an ideal agent for treating radiation sensitive AML. We are encouraged by this highly promising initial data and the synergistic potential of Actimab-A with menin inhibitors, which has broad potential across the AML treatment continuum including frontline, maintenance and relapsed/refractory settings. We are eager to continue to study this combination and generate additional data that could support advancing into clinical studies of Actimab-A with menin inhibitors."

Menin inhibitors are a class of drug candidates being developed for patients with AML that have a rearrangement of the KMT2A gene, previously known as the mixed-lineage leukemia (MLL) or mutation of the NPM1 gene. There are multiple menin inhibitors in development for these patients with revumenib (Syndax Pharmaceuticals, Inc.) being most advanced having a PDUFA data of September 2024 and ziftomenib (Kura Oncology, Inc.) enrolling patients in a registration Phase 2 trial. Multiple menin inhibitors are being studied in Phase 1 clinical trials by companies including Johnson & Johnson, Sumitomo Pharma Co., Ltd., Hutchmed, Biomea Fusion, Inc. and BioNova Pharmaceuticals Pvt Ltd.

Bio-Path Holdings, Inc. (NASDAQ:BPTH), a biotechnology company leveraging its proprietary DNAbilize® liposomal delivery and antisense technology to develop a portfolio of targeted nucleic acid cancer drugs, announced it has presented interim results from the Company's Phase 2 study of prexigebersen (BP1001) in combination with decitabine and venetoclax for the treatment of acute myeloid leukemia (AML) in a poster presentation at 2024 European Hematology Association (EHA) Congress, on June 14, 2024 in Madrid, Spain.

More from the News: Jorge Cortes, M.D., Director of the Georgia Cancer Center, presented data showing prexigebersen continues to be well-tolerated and has now demonstrated compelling efficacy results in two reporting cohorts including evaluable newly diagnosed AML patients and evaluable refractory/relapsed AML patients, both of which exceeded outcomes with frontline therapy.

"It was a pleasure to present these compelling data to an audience of European oncologists who treat AML patients and understand the continued great need for new therapeutic options," said Peter Nielsen, Chief Executive Officer of Bio-Path. "Given that our study is being conducted in the U.S., this encore presentation is an important step towards educating global oncology leaders on the benefits of prexigebersen and its potential to be another tool in their fight against AML."

Also looking for answers for AML patients, Shattuck Labs, Inc. (Nasdaq: STTK), a clinical-stage biotechnology company pioneering the development of bifunctional fusion proteins as a potential new class of biologic medicine for the treatment of patients with cancer and autoimmune disease, recently announced updated interim data from the Phase 1B dose expansion clinical trial of SL-172154 in combination with AZA in frontline HR-MDS and TP53m AML patients. These data are to be featured in a poster presentation on June 14, 2024 at 18:00 CEST, during the European Hematology Association (EHA) 2024 Congress.

"We are pleased to present additional data from our Phase 1B dose expansion clinical trial, which further supports our differentiated mechanism of action and underscores SL-172154's emergence as the leading CD47 inhibitor in hematologic malignancies," said Taylor Schreiber, M.D., Ph.D., Chief Executive Officer of Shattuck. "This update shows that the rate of complete remission has improved since our last data release in December, with additional patients in both cohorts who continue to improve on therapy. As a result of these encouraging data, and our expectation of rapid enrollment and progress in our ongoing randomized, controlled cohort in HR-MDS, we are focusing our efforts on our opportunity in HR-MDS and TP53m AML. These are indications with high unmet need, limited competition, and potential for accelerated paths to approval."

More from the news: Dr. Lini Pandite, MBChB, M.B.A., Chief Medical Officer of Shattuck added, "We are encouraged by the maturing data that continues to underscore the therapeutic potential, and manageable safety profile, of SL-172154 for patients with previously untreated HR-MDS and TP53m AML. Accumulating clinical evidence now shows the pharmacodynamic contribution of CD40 activation in the peripheral blood, and an emerging correlation between clinical remission and CD40 mediated induction of certain cytokines. The TP53m AML and HR-MDS patients we have treated represent a high-risk group with short duration of complete remission and overall survival when treated with azacitidine alone. Median overall survival and duration of remission have not yet been achieved, and we look forward to sharing additional durability data later this year. Enrollment is now underway for our randomized, controlled expansion cohort in frontline HR-MDS patients, and we expect to engage in regulatory discussions later this year regarding the registrational strategy for SL-172154."

Moleculin Biotech, Inc., (Nasdaq:MBRX), a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting hard-to-treat tumors and viruses, last week reported additional efficacy findings from the Company's ongoing Phase 1B/2 (MB-106) 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 acute myeloid leukemia (AML). The preliminary data was presented at the European Hematology Association (EHA) 2024 Hybrid Congress. The Company also hosted a data presentation to leading AML experts as part of a KOL meeting held in conjunction with EHA 2024 Congress.

More from the news: To date, a total of 22 subjects have been enrolled (the Intent-to-Treat population, ITT), 20 (Lines 1st-7th) of whom have completed efficacy evaluations with 9 subjects (45%) achieving a composite complete remission (CRc or CR/CRi), consisting of 8 (40%) subjects with complete remission (CR) and one subject with complete remission with an incomplete recovery of peripheral blood counts (CRi), following treatment with AnnAraC. Efficacy outcomes for 2 additional subjects (enrolled and treated) are pending.

Of the 10 ITT subjects for whom AnnAraC was administered in the 2nd line setting, 5 achieved a CR (50%) and 6 achieved a CRc (60%). Of the 13 subjects in the ITT evaluable population that were 1st or 2nd line treatment, 7 achieved a CR (54%) and 8 achieved a CRc (62%). The mDOR for the 9 subjects who achieved a CRc is approximately 6 months and climbing. Additionally, the median overall survival in the 2nd line subjects (n=10) is approximately 6 months and increasing.

Continued: Additionally, 89% of the subjects included in the CRc group (n=9) had cytogenetics and/or mutations generally considered to contribute to a poor prognosis. These include FLT3, IDH2, ASXL1, KMT2A and others. While not yet statistically relevant, the Company believes such cytogenetic and mutation data are informative to clinicians.

"We continue to be highly encouraged by the positive growing body of preliminary clinical data demonstrated by Annamycin in the treatment of patients with AML," commented Walter Klemp, Chairman and Chief Executive Officer of Moleculin. "While still preliminary, we believe the efficacy to date including the climbing durability of response demonstrated by AnnAraC in 2nd line patients continues to significantly exceed the performance reported by any drug currently approved for use in 2nd line AML. We are incredibly pleased with the progress of the trial and the data and continue to advance our preparations for an End of Phase 2 meeting with FDA."

The American Cancer Society's estimates for leukemia in the United States for 2024 are: "About 62,770 new cases of leukemia (all kinds) and 23,670 deaths from leukemia (all kinds), .about 20,800 new cases of acute myeloid leukemia (AML);most will be in adults. About 11,220 deaths from AML; almost all will be in adults."

In addition to Actinium's (NYSE AMERICAN:ATNM) ARC Actimab-A, Iomab-B, their lead asset is being studied in the pivotal Phase 3 SIERRA clinical trial as an induction and conditioning agent in patients over the age of 55 with active relapsed or refractory Acute Myeloid Leukemia (AML) prior to receiving a bone marrow transplant (BMT), also known as a hematopoietic stem cell transplant or HSCT.

Actinium's ambitions expand beyond AML, with the company saying, "We are continuing to expand our drug development pipeline of targeted radiotherapies for patients with blood cancers and solid tumors. Our intellectual property portfolio includes more than 220 patents and patent applications worldwide."

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