Palm Beach, FL – June 17, 2024 – According to a report from Mordor Intelligence the Acute Myeloid Leukemia Market size is estimated at USD 1.83 billion in 2024, and is expected to reach USD 2.97 billion by 2029, growing at a CAGR of 10.15% during the forecast period (2024-2029).  The report said: “Key factors propelling the growth of this market are the high incidence and prevalence of acute myeloid leukemia, advancements in pharmacology and molecular biology to promote drug development and increasing investments in research and development by pharmaceutical companies. According to the American Cancer Society, it is estimated that there will be 60,650 new leukemia cancer cases, of which 24,000 are expected to die in 2022 in the US. In addition, according to the same source, 20,050 new cases of acute myeloid leukemia (AML) are estimated in 2022 in the US. It will lead to increased adoption of AML therapies. The rising prevalence of AML in developed countries such as the US is expected to drive this market’s growth.  Furthermore, with the rising investment in research and development, there is an increasing number of clinical trials conducted to demonstrate the effectiveness of the drugs. It is expected to drive the market over the forecast period.”  Active biotech and pharma companies in the markets this week include Actinium Pharmaceuticals, Inc. (NYSE AMERICAN: ATNM), Bio-Path Holdings, Inc., (NASDAQ: BPTH), Longeveron (NASDAQ: LGVN), SELLAS Life Sciences Group, Inc. (NASDAQ: SLS), Bristol Myers Squibb (NYSE: BMY).

Mordor Intelligence continued: “For Instance, according to the United States National Library of Medicine, a study titled ‘Daunorubicin or Idarubicin With Cytarabine Plus Quizartinib vs. Physician’s Choice in Newly Diagnosed FLT3-ITD+ AML (Q-SOC) is in Phase III of clinical trials. The study was estimated to start in November 2021 and be complete in March 2025.  Thus, the abovementioned factors are impacting the market growth of the Acute myeloid leukemia market. However, stringent regulations on drugs and complications related to chemotherapy are the factors expected to restrain the market growth.  North America currently dominates the market for acute myeloid leukemia and is expected to continue its stronghold over the forecast period. The rising prevalence of acute myeloid leukemia cases in the US is expected to drive the growth of this market in this region… North America currently dominates the market for acute myeloid leukemia and is expected to continue its stronghold over the forecast period. The rising prevalence of acute myeloid leukemia cases in the US is expected to drive the growth of this market in this region.”

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:

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, recently 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.

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.”

Longeveron (NASDAQ: LGVN) recently reminded the market of the recent string of positive developments, (saying)  we are becoming more encouraged that the company will be able to help parents desperate for a treatment for an often-fatal condition. Hypoplastic Left Heart Syndrome (HLHS) is a rare and life-threatening congenital heart defect affecting approximately 1,000 babies per year according to the company. Infants born with HLHS have an underdeveloped or absent left ventricle. Current standard-of-care is comprised of three reconstructive heart surgeries (Stage 1 – 3) to reconfigure the right ventricle to provide all cardiac output. These three surgeries must be performed within the first five years of life. The Stage 1 surgery (the Norwood procedure) is conducted within 2 weeks of birth and the Stage 2 (the Glenn procedure) is typically conducted by 4-5 months of age. A Stage 3 surgery (the Fontan procedure) is typically performed when the children are 4-5 years of age. Without surgical treatment, the condition is always fatal, and even with reconstructive surgical reconstruction, patients often die or require heart transplantation by 15 years of age.

The company believes that Lomecel-B can improve these patients’ outcomes and is currently involved in a Phase 2b clinical trial in an attempt to verify this belief. This trial is to evaluate the safety and efficacy of intramyocardial injection of Lomecel-B in infants with HLHS undergoing the Glenn Procedure.

SELLAS Life Sciences Group, Inc. (NASDAQ: SLS), a late-stage clinical biopharmaceutical company focused on the development of novel therapies for a broad range of cancer indications, recently announced the completion of enrollment as well as positive initial data from the ongoing Phase 2a trial of SLS009, a highly selective CDK9 inhibitor, in relapsed/refractory acute myeloid leukemia (r/r AML).

“We are pleased to announce the completion of enrollment in the initial portion of our Phase 2a trial representing a significant milestone in the development of SLS009 in AML,” said Angelos Stergiou, MD, ScD h.c., President and Chief Executive Officer of SELLAS. “There has been a high level of enthusiasm from the clinical sites, trial investigators, and patients, reflecting the significant unmet need in the AML patient population previously treated with venetoclax-based regimens. We are extremely grateful to everyone who has helped us achieve this important milestone ahead of schedule.”

Bristol Myers Squibb (NYSE: BMY) recently announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval of Augtyro (repotrectinib) for the treatment of adult and pediatric patients 12 years of age and older with solid tumors that have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion, are locally advanced or metastatic or where surgical resection is likely to result in severe morbidity, and have progressed following treatment or have no satisfactory alternative therapy. The approval is based on results from the Phase 1/2 TRIDENT-1 study, which evaluated Augtyro in adult patients with NTRK-positive solid tumors. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

“NTRK fusion-positive tumors can present challenges in the clinical setting, which is why it is important that we have additional treatment options for these patients,” said Alexander Drilon, MD, TRIDENT-1 global trial lead and Chief of the Early Drug Development Service at Memorial Sloan Kettering Cancer Center. “The FDA approval of repotrectinib adds an important tool to our toolbox, offering oncologists a next-generation TKI that can be used across a broad range of NTRK fusion-positive solid tumors for both TKI-naïve and TKI-pretreated patients.”

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