Palm Beach, FL – June 17, 2024 – Acute Myeloid Leukemia (AML) is a type of cancer that affects the blood and bone marrow. It is characterized by the rapid growth of abnormal myeloid cells, which are immature blood cells that normally develop into red blood cells, white blood cells, and platelets. In AML, these abnormal cells accumulate in the bone marrow and interfere with the production of normal blood cells. According to Global Market Insights 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 and 2032. High market growth can be attributed to factors such as advancement in research and technology, surging government initiatives and policies, early diagnosis coupled with efforts to implement screening programs. Also, increasing prevalence of acute myeloid leukemia (AML) is a significant factor driving the growth of the market. The report said: “For instance, according to the American Cancer Society, in 2023, there were about 20,380 new cases of acute myeloid leukemia (AML) in the U.S. alone. Hence, as the population ages, the incidence of AML tends to rise, contributing to a larger patient pool seeking diagnosis and treatment, thereby fostering the market growth. Surging government initiatives and polices play a pivotal role in driving the acute myeloid leukemia industry. Also, increased government funding for medical research, including acute myeloid leukemia research, drive advancements in understanding the molecular basis of AML, leading to the development of innovative therapies and treatment modalities.” Active biotech and pharma companies in the markets this week include Actinium Pharmaceuticals, Inc. (NYSE AMERICAN: ATNM), Syndax Pharmaceuticals (NASDAQ: SNDX), Kura Oncology, Inc. (NASDAQ: KURA), Biomea Fusion, Inc. (NASDAQ: BMEA), Johnson & Johnson (NYSE: JNJ).
Global Market Insights continued: “Based on treatment type, the global acute myeloid leukemia market is classified into chemotherapy, targeted therapy, immunotherapy, and other treatment types. The chemotherapy segment held the largest market revenue of USD 1.3 billion in 2023. Chemotherapy works by killing rapidly dividing cells, including acute myeloid leukemia cells. This ablation of abnormal cells is crucial for resetting the bone marrow environment. Thus, it has been the choice of treatment for the patients suffering from AML. Hence, driving the growth of the market. Further, due to its efficacy and success rate in the treatment of AML, it has attained a notable position in the market. For instance, according to the National Cancer Institute, in 2023, approximately 60 – 70% of adults with AML can be expected to attain complete remission status after appropriate therapy. Therefore, chemotherapy agents can be combined with targeted therapies or other novel agents in evolving treatment strategies. As combinations are designed to improve efficacy and reduce the risk of relapse. Thus, all these factors contribute to the growth of the segment.”
Actinium Presents First Ever Data Demonstrating Statistically Significant Anti-Tumor Control and Potent Leukemic Cell Killing with Actimab-A in Combination with Leading Menin Inhibitors in Preclinical Acute Myeloid Leukemia Models at the 2024 EHA Congress –
- Actimab-A enhances dose-dependent acute myeloid leukemia cell death in KMT2A sensitive acute myeloid leukemia blasts in combination with leading menin inhibitors
- Combination with leading menin inhibitor demonstrates acute myeloid leukemia cell death and significant tumor elimination not achieved with monotherapy
- Menin combination expands backbone potential of Actimab-A in acute myeloid leukemia that already includes chemotherapy, venetoclax and FLT3 inhibitors
– Actinium Pharmaceuticals, Inc. (NYSE AMERICAN: ATNM) (Actinium or the Company), a leader in the development of Antibody Radiation Conjugates (ARCs) and other targeted radiotherapies, today 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.
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)
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. CONTINUED… Read these full press releases and more news for Actinium Pharmaceuticals at: https://www.financialnewsmedia.com/news-atnm/
Other recent developments in the biotech industry of note for cancer events include:
Syndax Pharmaceuticals (NASDAQ: SNDX), a clinical stage biopharmaceutical company developing an innovative pipeline of cancer therapies, recently announced updated data from multiple combination trials of revumenib, the Company’s potent, selective, small molecule menin inhibitor, in patients with acute leukemias. The updated data are being presented at the European Hematology Association (EHA) 2024 Congress, being held June 13-16 in Madrid, Spain and virtually.
“The growing body of data supports the potential for revumenib to have a meaningful impact in combination with current standard of care therapies,” said Joshua F. Zeidner, M.D., Chief, Leukemia Research at the University of North Carolina, Lineberger Comprehensive Cancer Center. “Based on the BEAT AML data in the newly diagnosed setting which showed a high rate of MRD-negative responses coupled with a safety profile that enables combination use, revumenib has the potential to become a cornerstone of treatment as front-line therapy for newly diagnosed KMT2Ar and mNPM1 AML.”
Kura Oncology, Inc. (NASDAQ: KURA), a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer, recently announced that it has completed enrollment of 85 patients in the Phase 2 portion of KOMET-001, a registration-directed clinical trial of the Company’s menin inhibitor, ziftomenib (KO-539), in patients with relapsed or refractory (R/R) NPM1-mutant acute myeloid leukemia (AML). The Company expects to report topline data from the trial in early 2025.
“We are thrilled to announce this critical milestone, which brings us one step closer to delivering ziftomenib as a potentially best-in-class treatment for patients with genetically defined acute leukemias,” said Troy Wilson, Ph.D., J.D., President and Chief Executive Officer of Kura Oncology. “Our confidence is supported by our recently announced Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA), which recognizes ziftomenib’s potential as an innovative medicine for patients with R/R NPM1-mutant AML and is intended to expedite review as we prepare for submission of a New Drug Application. We are grateful for the KOMET-001 investigators, patients and their families, and we look forward to sharing topline data from this pivotal study early next year.”
Biomea Fusion, Inc. (NASDAQ: BMEA), a clinical-stage biopharmaceutical company dedicated to discovering and developing oral covalent small molecules to treat and improve the lives of patients with metabolic diseases and genetically defined cancers, recently announced the completion of enrollment of the first three dose expansion arms of COVALENT-111, with a total of over 260 type 2 diabetes patients enrolled.
The COVALENT-111 study is a multi-site, randomized, double-blind, placebo-controlled Phase I/II study. Phase II consists of multiple dose escalation and dose expansion cohorts including adult patients with type 2 diabetes uncontrolled by standard of care medicines. The dose escalation phase is evaluating BMF-219 dosed over 4 weeks with 22 weeks follow-up off treatment. The first three arms (A, B, C) of the expansion phase are evaluating BMF-219 dosed over 8 and 12 weeks at 100 mg and 200 mg with up to 40 weeks of follow-up off treatment. Additional information about the Phase I/II clinical trial of BMF-219 in type 2 diabetes can be found at ClinicalTrials.gov using the identifier NCT05731544.
Johnson & Johnson (NYSE: JNJ) recently announced patients treated with nipocalimab demonstrated statistically significant (P=0.002) and clinically meaningful improvement in ClinESSDAIa score versus placebo at 24 weeks compared to baseline (primary endpoint) in the Phase 2 DAHLIAS dose-ranging study of nipocalimab in adult patients living with Sjögren’s disease (SjD). Response was demonstrated as early as Week 4 and continued to increase throughout the 24-week treatment period compared with patients receiving placebo. These data represent the first positive results in SjD for nipocalimab. The study results were featured in a late-breaking presentation (LBA0010) and are among 30 abstracts that the Company is presenting at the European Alliance of Associations for Rheumatology (EULAR) 2024 Congress.
Experience the full interactive Multichannel News Release here: https://www.multivu.com/players/English/9273851-johnson-and-johnson-nipocalimab-results-sjd-eular-2024/
“These data establish proof of concept for nipocalimab in Sjögren’s disease and support further clinical development, which is welcome news for the approximately four million people worldwide living with this chronic, debilitating disease,” said Prof. Jacques-Eric Gottenberg, M.D., Ph.D., Department of Rheumatology, Strasbourg University Hospital, National Centre for Rare Systemic Autoimmune Diseases and study investigator. “SjD patients need approved advanced therapies that can help address the serious health consequences of the disease, and I am encouraged by these results and the positive impact on disease measures that are clinically meaningful.”
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