Benzinga | Aug 18, 2021 08:31AM EDT

Cellectar Awarded $2.0M Phase II NIH SBIR Grant To Support Pivotal Study Of Iopofosine I-131 In Waldenstrom's Macroglobulinemia

Cellectar Biosciences, Inc. (NASDAQ:CLRB), a late-stage clinical biopharmaceutical company focused on the discovery and development of drugs for the treatment of cancer, today announced it has been awarded a peer-reviewed National Institutes of Health (NIH) Phase II Small Business Innovation Research (SBIR) grant of approximately $2 Million from the National Cancer Institute (NCI).



The company is currently conducting a global pivotal study of iopofosine I-131 (also known as CLR 131) in Waldenstrom's macroglobulinemia (WM) patients who have received at least two prior lines of therapy, including Bruton tyrosine kinase inhibitor failed or suboptimal response patients. The study was initiated in January of 2021 and is expected to take approximately 18 months to fully enroll.

"We appreciate the recognition and funding that the NIH and NCI have chosen to provide Cellectar for our pivotal iopofosine program. WM is an incurable disease with existing treatment options restricted to one approved drug and various unapproved salvage therapies," said James Caruso, president and CEO of Cellectar. "This $2 million non-dilutive grant will be used to support and accelerate the ongoing pivotal study. With the addition of this grant and over $46.8 million in cash and cash equivalents as of June 30, 2021, we are well capitalized with a forecasted cash runway into Q3 2023 which we believe will take us through top-line data and submission of the NDA."

The company has received FDA Fast Track Designation and was granted Orphan Drug Designation in the U.S. and EU for WM. At ASCO this year, compelling iopofosine I-131 data were presented on six WM patients, which demonstrated a 100% overall response rate. A copy of the abstract, entitled: Treatment Free Remission (TFR) and Overall Response Rate (ORR) Results in Patients with Relapsed/Refractory Waldenstrom's Macroglobulinemia (WM) Treated with iopofosine I-131 is available on ASCO's website here.

About the Pivotal Study of iopofosine I-131 in Waldenstrom's macroglobulinemia

The pivotal study is designed as a global, non-comparator, single arm, expansion cohort of the currently ongoing Phase 2 CLOVER-1 study of iopofosine I-131. The study will enroll 50 WM patients. Patients in the study will receive up to four doses of iopofosine I-131 over two cycles (cycle one days 1, 15, and cycle two days 57, 71). The primary endpoint of the study is response rate as defined as a partial response (a minimum of a 50% reduction in the biological marker IgM) or better in patients that receive a minimum total body dose of 60 mCi with secondary endpoints of treatment free survival, duration of response and progression free survival. An independent data monitoring committee (iDMC) will perform an interim safety and futility evaluation on the first 10 patients enrolled. The assessment will occur patient by patient and will conclude after the tenth patient is evaluated; there is no planned study stoppage. The study will include WM patients who have received at least two prior lines of therapy, including Bruton tyrosine kinase inhibitor failed or suboptimal response patients. To learn more about the clinical study please visit www.wmclinicaltrial.com.