Novel Cancer Therapy Phase 3 Trial Expects To Be Completed Shortly

The following post was written and/or published as a collaboration between Benzinga’s in-house sponsored content team and a financial partner of Benzinga.

As science advances in terms of finding new treatments for unmet medical needs, certain approaches are not appropriate for specific types of patients. For example, when it comes to older patients, often certain treatments can be counterproductive, leaving them vulnerable and without a way to combat the disease.

In the biotech world, many are racing to give people solutions and hope for a better future. While we are ages from having prompt answers, companies like Fortress Biotech, Inc. FBIO, Viking Therapeutics VKTX, Onconova Therapeutics ONTX, Fusion Pharmaceuticals Inc FUSN, Gilead Sciences, Inc. GILD and Bristol-Myers Squibb BMY, among others, are on the front lines of this race.

Also, another company to highlight is Actinium Pharmaceuticals, Inc ATNM. The company is a leader in the targeted radiotherapy field, pursuing several hematology targets with late-stage clinical programs. It provides treatment options for cancer patients who can’t tolerate chemotherapy or radiation.

Actinium’s targeted radiotherapies are intended to be focused missiles that hits cancer directly as opposed to a broader chemo-radiation therapy that can hit many other areas that do not need to be attacked with such harsh treatments. The company is currently in Phase 3 trials of its lead product candidate, Iomab-B, and soon its results will be released.

Here’s what you need to know.

Actinium Pharmaceuticals Iomab-B: Innovative Cancer Approach And Research

Actinium’s novel approach may benefit patients with a broad range of hematologic malignancies, including acute myeloid leukemia (AML), Myelodysplastic Syndrome, and Multiple Myeloma.

The company is advancing the Iomab-B pivotal Phase 3 SIERRA (study of Iomab-B in elderly relapsed or refractory AML) trial, a 150-patient, randomized, controlled clinical trial in patients with relapsed or refractory AML who are age 55 and above.

The SIERRA trial is being conducted at preeminent transplant centers in the U.S. with the primary endpoint of durable complete remission (dCR) at six months and a secondary endpoint of overall survival. 

Upon approval, Iomab-B is intended to prepare and condition patients for a bone marrow transplant, also referred to as a hematopoietic stem cell transplant. It offers a potentially safer and more efficacious option than intensive chemotherapy conditioning, the current standard of care in bone marrow transplant conditioning. A bone marrow transplant is often considered the only potential cure for patients with certain blood-borne cancers and blood disorders.

What Is Acute Myeloid Leukemia?

Acute myeloid leukemia (AML) is an aggressive cancer involving myeloid cells. Myeloid cells include red blood cells (RBCs), non-lymphocyte white blood cells (WBCs), and platelets. 

According to The National Cancer Institute, 20,240 people will be diagnosed in the U.S. in 2021 with AML — it is the 2nd most common form of leukemia. AML is commonly diagnosed around the age of 68 and is rare to be diagnosed before the age of 45. 

The most common treatments are radiation and chemotherapy. However, patients above 60 years old often have trouble tolerating intensive treatment and can experience chromosome changes in leukemia cells, affecting noncancerous cells.
In a Phase 2 clinical study in 58 patients of Iomab-B with advanced AML or high-risk myelodysplastic syndrome (MDS) age 50 and older, Iomab-B produced complete remissions in 100% of patients, and these patients experienced transplant engraftment at day 28. The overall survival rate of the 36 relapsed or refractory AML patients in the proof-of-concept study was 30% at 1 year and approximately 20% at 2 years. 

Other Corporate Highlights

Recently, the company announced the start of patient enrolment in the Phase I study of Iomab-ACT for targeted conditioning before treatment with Memorial Sloan Kettering Cancer Center’s (MSK) CD19 targeted CAR T-cell 19-28z and the completion of enrollment of second dose cohort in Actimab-A Venetoclax combination trial for patients with R/R AML. 

Photo by Yassine Khalfalli

The preceding post was written and/or published as a collaboration between Benzinga’s in-house sponsored content team and a financial partner of Benzinga. Although the piece is not and should not be construed as editorial content, the sponsored content team works to ensure that any and all information contained within is true and accurate to the best of their knowledge and research. This content is for informational purposes only and not intended to be investing advice.