Business
Cellectar Awarded $2.0 Million Phase II NIH SBIR Grant to Support Pivotal Study of Iopofosine I-131 in Waldenstrom’s Macroglobulinemia
FLORHAM PARK, N.J., Aug. 18, 2021 (GLOBE NEWSWIRE) -- Cellectar Biosciences, Inc. (NASDAQ: CLRB), a late-stage clinical biopharmaceutical company focused on
About this update from Cellectar Biosciences, Inc.
[{"type":"text","content":"FLORHAM PARK, N.J., Aug. 18, 2021 (GLOBE NEWSWIRE) -- 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 macroglobulinemiaThe 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 cycle...