Cellectar Biosciences (NASDAQ:CLRB) ran up 28% in premarket this morning on strong volume after the company announced positive Phase 1 Trial results from its lead PDC compound, CLR 131.
CLRB has been on a slide to the downside since mid-March, but this news could be catalyst the stock needs to make more moves to the upside.
It closed today at $1.76, up 11% from yesterday’s close.
Since the end of July, CLRB has been trading at or near its 50 Day Moving Average, and today, it finally closed well above its 50 Day Moving Average and just below its 200 Day Moving Average.
From today’s news release:
Cellectar Biosciences’ CLR 131 Achieves Overall Survival of Greater Than 22 Months in Advanced Multiple Myeloma Patients
MADISON, Wis., Aug. 08, 2017 (GLOBE NEWSWIRE) — Cellectar Biosciences, Inc. (Nasdaq:CLRB), an oncology-focused, clinical stage biotechnology company (the “company”), today announces its lead PDC compound, CLR 131 has achieved a median overall survival of 22.5 months to date after a single dose infusion of 12.5mCi/m2 in patients with multiple myeloma. Patients in the first cohort of the company’s Phase 1 clinical trial had an average of 5.8 prior lines of treatment and therefore were considered to be heavily pretreated.
It is important to note that the trial remains ongoing, and the overall survival could continue to increase over time. While there have been no head-to-head studies, for comparison, this ongoing overall survival length from the company’s Phase 1 clinical trial exceeds historic published outcomes of currently marketed second and third line treatment modalities for multiple myeloma.
Phase 1 Clinical Trial Results
The fourth cohort of the company’s Phase 1 clinical trial of CLR 131 in multiple myeloma is fully enrolled. Patients in this cohort received a single infusion providing a dose of 31.25 mCi/m2, and Cellectar expects to report initial results from this cohort by the close of the third quarter 2017, in line with previous guidance. In addition to the patients from the first cohort achieving a median overall survival (mOS) of 22.5 months to date, patients from the second and third cohorts (who received single doses of 18.75 mCi/m2 and 25 mCi/m2) have experienced mOS of 13.2 months and 6.7 months, respectively. As with Cohort One, these cohorts remain ongoing and the overall survival could continue to increase over time. As a result, the company continues to collect overall survival data on all evaluable trial participants and will provide timely updates, as appropriate.
NCI-Supported Phase 2 Trial
The company’s Phase 2 study of CLR 131 in multiple myeloma and other hematologic malignancies was initiated on March 30, 2017 and remains actively enrolling. The study is being conducted at approximately 10-15 cancer centers in the United States for patients with a variety of orphan-designated relapse or refractory hematologic cancers. The study’s primary endpoint is clinical benefit rate (CBR), with additional endpoints of overall response rate (ORR), progression free survival (PFS), median overall survival (mOS) and other markers of efficacy following a single infusion of CLR 131 providing a dose of 25.0 mCi/m2, with the option for a second 25.0 mCi/m2 dose approximately 75-180 days later.
The hematologic cancers studied in the trial include multiple myeloma (MM), chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), lymphoplasmacytic lymphoma (LPL), marginal zone lymphoma (MZL), mantle cell lymphoma (MCL), and potentially diffuse large B-cell lymphoma (DLBCL).
In addition to the CLR 131 infusion(s), MM patients will receive 40 mg oral dexamethasone weekly for up to 12 weeks. Efficacy responses will be determined by the latest International Multiple Myeloma Working Group criteria. Efficacy for all lymphoma patients will be determined according to Lugano criteria.
More information about the trial, including eligibility requirements, can be found at www.clinicaltrials.gov, reference NCT02952508.
“We continue to make meaningful progress on our CLR 131 program and are encouraged by the observed clinical outcomes to date. We look forward to reporting data from the fourth cohort of our Phase 1 trial as well as the single and multi-dose Phase 2 study when available,” said Jim Caruso, president and CEO of Cellectar Biosciences. “We also continue to make progress evaluating the clinical utility of CLR 131 in both liquid and solid tumor orphan designated cancers that have potential for accelerated regulatory pathways.”
Cellectar Biosciences (NASDAQ:CLRB) Company Overview
Cellectar Biosciences (NASDAQ:CLRB) is developing phospholipid drug conjugates (PDCs) designed to provide cancer targeted delivery of diverse oncologic payloads to a broad range of cancers and cancer stem cells.
CLRB’s PDC platform is based on the company’s proprietary phospholipid ether analogs which are novel small-molecules that have demonstrated highly selective uptake and retention in a broad range of cancers.
The PDC pipeline includes product candidates for cancer therapy and cancer diagnostic imaging.
The company’s lead therapeutic PDC – CLR 131 – uses iodine-131, a cytotoxic radioisotope, as its payload.
CLR 131 is currently being evaluated under an orphan drug designated Phase I clinical study in patients with relapsed or refractory multiple myeloma.
In addition, the company has initiated a Phase II clinical study to assess efficacy in a range of B-cell malignancies.
CLRB is also developing PDCs for targeted delivery of chemotherapeutics such as paclitaxel (CLR 1602-PTX), a preclinical stage product candidate, and plans to expand its PDC chemotherapeutic pipeline through both in-house and collaborative R&D efforts.
Recent CLRB Milestones
CLRB has been focused on moving its products through various research and development stages including FDA Phase 1 trials:
- August 2017 – Announced collaboration with Avicenna Oncology to develop new PDCs for solid tumors (see news release)
- May 2017 – Announced dosing regimens of CLR 131 in different tumor types published in the 2017 ASCO annual meeting proceedings (see news release)
- May 2017 – Reports first quarter 2017 financial results (see news release)
CLRB Management Team
NVAX is led by a seasoned management team experienced in leading pharmaceutical research and development and bringing new products to market.
President, CEO and Director
Mr. Caruso was appointed Cellectar Biosciences’ President and Chief Executive Officer and a director in June 2015. A life sciences executive with twenty seven years of professional success with multinational and specialty pharmaceutical companies, mid-tier biotechnology and medical device start-ups, Mr. Caruso has an established track record of enhancing value through a clear focus on strategic corporate value drivers and operational excellence; fostering high performance cultures and advancing product development and commercialization programs through internal execution and corporate collaborations. He comes to Cellectar Biosciences from Hip Innovation Technology, a successful private medical device company where he was a founder and served as Executive Vice President and Chief Operating Officer.
Chad J. Kolean
Vice President, Chief Financial Officer
Mr. Kolean has over 25 years of experience in finance management, and most recently served as CFO and Treasurer for Pioneer Surgical Technology, Inc., a global manufacturer and distributor of spinal, biological and orthopedic implants acquired by RTI Biologics in July 2013. From 2010 until its merger in 2011 with Accuray, Inc., Mr. Kolean served as Corporate Controller for Tomotherapy, Inc., a publicly traded global leader in developing and manufacturing innovative radiation oncology equipment.
Senior V.P. Corporate Development and Operations
Mr. Longcor brings to Cellectar Biosciences, Inc over 20 years of pharmaceutical and biotech experience and was previously the Chief Business Officer for Avillion LLP. In this role, he was responsible for executing the company’s unique co-development partnership strategy. Prior to Avillion, Jarrod was the Vice President of Corporate Development for Rib-X Pharmaceuticals, Inc (now Melinta Therapeutics) where he was responsible for identifying and concluding several critical collaborations for the company, including a major discovery collaboration with Sanofi Aventis valued over $700M.
Dr. John Friend
Chief Medical Officer
Dr. Friend, age 47, brings 15 years of global drug development expertise and general management experience in oncology, inflammation, endocrine/metabolism, and pain management to Cellectar. Prior to joining the company, John spent more than seven years at Helsinn Therapeutics leading its research and development division. Most recently he served as senior vice president of Medical and Scientific Affairs at Helsinn, building the non-clinical, clinical, medical and regulatory affairs teams to lead multiple global franchises from early product development to market commercialization. Prior to his time at Helsinn, Dr. Friend held executive responsibility for clinical research, medical affairs, pharmacovigilance and risk management at various pharmaceutical companies including Akros Pharma, Actavis, Alpharma, Hospira and Abbott.
CLRB’s chart appears to be showing signs of strength, and this latest news is a positive sign its making progress on its CLR 131 trials.
The stock may be potentially undervalued and investors will be paying close attention to further results from the Phase 1 Trials.
Keep watching CLRB as it continues to execute its business plan to bring cancer therapies and diagnostic imaging to market.
Disclosure: We have no position in CLRB and have not been compensated for this article.