Treatment of Blood Cancers - Biopharma Companies Building out their Pipeline of Solutions

June 18, 2024 at 08:45 AM EDT

Vancouver, Kelowna, and Delta, British Columbia--(Newsfile Corp. - June 18, 2024) - Investorideas.com, a go-to investing platform covering biotech and medical technology stocks releases the second of a two-part series looking at developments for the treatment of blood cancers, including AML, featuring Actinium Pharmaceuticals, Inc. (NYSE American: ATNM). Actinium is a leader in the development of Antibody Radiation Conjugates (ARCs) and other targeted radiotherapies.

Read the full article on Investorideas
https://www.investorideas.com/News/2024/biotech/06180Treatment-of-Blood-Cancers.asp

Approximately every 3 minutes, one person in the US is diagnosed with leukemia, lymphoma or myeloma. Approximately every 9 minutes, someone in the US dies from a blood cancer. This statistic represents approximately 157 people each day or more than six people every hour. This data from the Leukemia and Lymphoma Society demonstrates the growing and urgent demand for solutions.

Behind the scenes and the data, biopharma stocks are developing their unique approaches to treatment and building a pipeline of potential answers.

Actinium Pharmaceuticals, Inc. (NYSE American: ATNM) is building out its pipeline and has recently announced progress on several products.

Actinium develops targeted radiotherapies to meaningfully improve survival for people who have failed existing oncology therapies.

"Our Iomab-B and Actimab-A advanced product candidates fill the major unmet medical needs in relapsed or refractory AML in a complementary fashion directed at different parts of the patient journey," they say on their website.

Actinium announced yesterday 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.

On June 14^th, Actinium announced that results from the Phase 3 SIERRA trial of Iomab-B were presented at the 2024 European Hematology Association (EHA) Hybrid Congress being held June 13 - 16, 2024, in Madrid, Spain. The two presentations at EHA highlighted outcomes in patients with active relapsed or refractory acute myeloid leukemia (r/r AML) enrolled in the SIERRA trial who had a TP53 mutation and long-term efficacy results in this older patient population.

From the news: The Phase 3 SIERRA trial enrolled 153 patients ages 55 and above with active r/r AML and compared outcomes of patients receiving an Iomab-B led bone marrow transplant (BMT) to those of patients receiving physician's choice of care in the control arm. Across all patients in SIERRA study, only patients receiving an Iomab-B led BMT achieved the trial's primary endpoint of durable complete remission with these patients having 92% 1-year survival and 69% 2-year survival with statistically significant higher event free survival. The SIERRA trial enrolled high-risk patients including those with one or more of the following: a TP53 mutation, advanced age up to 77 years old, complex cytogenetics and prior therapy including venetoclax and other targeted agents.

Actinium plans to advance Iomab-B for other blood cancers and next generation conditioning candidate Iomab-ACT to improve cell and gene therapy outcomes.

On June 11th, Actinium highlighted data from the completed Phase 1b combination trial of Actimab-A + CLAG-M in patients with relapsed or refractory acute myeloid leukemia (r/r AML) at the 2024 Society of Nuclear Medicine & Molecular Imaging (SNMMI) Annual Meeting held June 8 - 11, 2024, in Toronto, Canada. Actimab-A is an ARC comprised of a CD33 targeting monoclonal antibody conjugated with the alpha-particle emitter Actinium-225 isotope payload. Actimab-A has been studied as a single agent and in combination with chemotherapies and targeted therapies in Phase 1 and Phase 2 trials.

In mid-May, Kura Oncology, Inc. (NASDAQ: KURA), a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer, 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.

From the news: "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."

Continued: Kura announced the first patients dosed in the Phase 2 portion of KOMET-001 in February 2023. The registration-directed study is designed to assess evidence of clinical activity, safety and tolerability of ziftomenib in patients with R/R NPM1-mutant AML, with a primary endpoint of complete response. The study has completed enrollment of the 85 patients necessary to support the primary endpoint analysis.

"The rapid enrollment of this study reflects the urgent need for more effective treatment options in AML as well as the potential for ziftomenib to address this need," said Eunice Wang, M.D., Chief of the Leukemia Service at Roswell Park Comprehensive Cancer Center and principal investigator of the trial. "NPM1-mutant AML represents approximately 30% of new AML cases annually and is a disease of significant unmet need for which there is no approved targeted therapy. The favorable safety profile and encouraging clinical activity demonstrated by ziftomenib to date offer the potential to transform the standard of care for these AML patients."

Syros Pharmaceuticals (NASDAQ: SYRS) is developing tamibarotene, an oral selective RARα agonist in frontline patients with higher-risk myelodysplastic syndrome and acute myeloid leukemia with RARA gene overexpression.

Syros announced earlier this year that the United States Food and Drug Administration (USFDA) has granted Fast Track Designation to tamibarotene in combination with azacitidine and venetoclax for the treatment of newly diagnosed acute myeloid leukemia (AML) with RARA overexpression as detected by an FDA approved test in adults who are over age 75 years or who have comorbidities that preclude the use of intensive induction chemotherapy. Tamibarotene, an oral first-in-class selective retinoic acid receptor alpha (RARα) agonist, is currently being evaluated in combination with venetoclax and azacitidine for the treatment of newly diagnosed AML patients with RARA gene overexpression.

"We are pleased to receive Fast Track designation for tamibarotene for the treatment of AML. This designation reflects the tremendous need for a safe and effective therapy, which can improve the clinical outcomes and prognosis among people diagnosed with AML, many of whom cannot tolerate intensive treatment," said David A. Roth, M.D., Chief Medical Officer of Syros Pharmaceuticals. "We are particularly encouraged to secure Fast Track designation following initial randomized data from a prespecified interim analysis of our ongoing SELECT-AML-1 clinical trial, in which treatment with our RARα agonist, tamibarotene, in combination with venetoclax and azacitidine resulted in a 100% CR/CRi rate compared with a 70% CR/CRi rate for the comparator of venetoclax and azacitidine. Additionally, tamibarotene in combination with venetoclax and azacitidine demonstrated no added toxicity relative to venetoclax and azacitidine alone. We look forward to sharing additional data from SELECT-AML-1 later this year, and to potentially accelerate the delivery of tamibarotene as a new frontline option for the approximately 30% of AML patients who are positive for RARA overexpression."

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, announced on June 10^th 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).

From the news: "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."

Continued: Dr. Stergiou continued: "In addition, we are excited to share very promising initial data from this Phase 2a trial. Efficacy was demonstrated across all cohorts far exceeding the targeted ORR of 20% and median overall survival (mOS) of 3 months. The results also showed that SLS009 was well-tolerated across all doses. These data give us increased confidence in SLS009 as a potential new treatment for AML. We remain committed to advancing the treatment landscape for this underserved patient population and we look forward to continuing the trial, mainly the expansion cohorts, and reporting additional study updates and data in Q3 of this year."

AML is one of the most common types of leukemia and its incidence is rising globally, including in the Asia-Pacific region, says DataBridgeInsights.

They also reported, "According to a survey by Bristol-Myers Squibb, approximately 1.85 million new cases of blood cancer will be diagnosed worldwide in 2040, with 918,872 cases of lymphoma, 656,345 cases of leukaemia, and 275,047 cases of myeloma. Furthermore, the survey predicted that by 2040, there will be around 1,100,000 fatalities worldwide owing to blood cancer."

Biopharmaceutical stocks like Actinium Pharmaceuticals, Inc. (NYSE American: ATNM) are on the hunt for solutions. Iomab-B was developed at the Fred Hutchinson Cancer Research Center where it was studied in several Phase 1 and Phase 2 trials in almost 300 patients in multiple blood cancer indications, including acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), chronic myeloid leukemia (CML), acute lymphoblastic leukemia (ALL), chronic lymphocytic leukemia (CLL), Hodgkin's disease (HD), Non-Hodgkin lymphomas (NHL) and multiple myeloma (MM) and is currently being studied in several ongoing physician trials. Iomab-B has been granted Orphan Drug Designation for relapsed or refractory AML in patients 55 and above by the US Food and Drug Administration (USFDA) and the European Medicines Agency.

Read part one of the series on Investorideas.com
https://www.investorideas.com/news/2024/biotech/06171Biopharma-Stocks.asp

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Treatment of Blood Cancers - Biopharma Companies Building out their Pipeline of Solutions

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