Cellectar Biosciences, Inc. (Nasdaq: CLRB) Breaking News - November 28, 2016

Cellectar Biosciences Announces Partnership with Radiopharmaceutical Specialists, CPDC, to Establish Manufacturing Capacity in Anticipation of CLR 131 Pivotal Trial and Commercial Production

Madison, WI - (November 28, 2016) -- Cellectar Biosciences, Inc. (Nasdaq: CLRB) (the “company”), an oncology-focused, clinical stage biotechnology company, today announced it has selected Hamilton, Ontario-based Centre for Probe Development and Commercialization (CPDC), a well-respected GMP manufacturing organization specializing in radiopharmaceuticals, as a supplier of the company’s lead phospholipid drug conjugate (PDC), CLR 131.

The company believes that CPDC will provide a cost-effective and long-term manufacturing solution. The partnership establishes manufacturing capacity at a level sufficient for both a pivotal trial and future large-scale commercial production. CPDC’s development of further production capability for CLR 131 will significantly enhance the company’s ability to support the anticipated clinical trial activity as it progresses through 2017 while also preparing for a pivotal study and, ultimately, commercialization.

“This partnership with CPDC signals an important milestone in the development of CLR 131; it reflects our confidence in the potential clinical utility of our lead compound and establishes an additional supply source as well as pivotal trial and commercial scale production,” said Jim Caruso, president and CEO of Cellectar Biosciences. “As we prepare to initiate our NCI-supported Phase II trial of CLR 131 in multiple myeloma and other hematologic malignancies, it is imperative that we continue to identify optimal pathways to accelerate and further support its development.”

About CLR 131
CLR 131 is an investigational compound under development for a range of hematologic malignancies. It is currently being evaluated in a Phase I clinical trial in patients with relapsed or refractory multiple myeloma. The company plans to initiate a Phase II clinical study to assess efficacy in a range of B-cell malignancies in the first quarter of 2017. Based upon preclinical and interim Phase I study data, treatment with CLR 131 provides a novel approach to treating hematological diseases and may provide patients with therapeutic benefits, including overall response rate (ORR), an improvement in progression-free survival (PFS) and overall quality of life. CLR 131 utilizes the company’s patented PDC tumor targeting delivery platform to deliver a cytotoxic radioisotope, iodine-131 directly to tumor cells. The FDA has granted Cellectar an orphan drug designation for CLR 131 in the treatment of multiple myeloma.

About Phospholipid Drug Conjugates (PDCs)
Cellectar’s product candidates are built upon its patented cancer cell-targeting delivery and retention platform of optimized phospholipid ether-drug conjugates (PDCs). The company deliberately designed its phospholipid ether (PLE) carrier platform to be coupled with a variety of payloads to facilitate both therapeutic and diagnostic applications. The basis for selective tumor targeting of our PDC compounds lies in the differences between the plasma membranes of cancer cells compared to those of normal cells. Cancer cell membranes are highly enriched in lipid rafts, which are glycolipoprotein microdomains of the plasma membrane of cells that contain high concentrations of cholesterol and sphingolipids, and serve to organize cell surface and intracellular signaling molecules. PDCs have been tested in over 70 different xenograft models of cancer.

About Relapsed or Refractory Multiple Myeloma
Multiple myeloma is the second most common blood or hematologic cancer with approximately 30,000 new cases in the United States every year. It affects a specific type of blood cells known as plasma cells. Plasma cells are white blood cells that produce antibodies to help fight infections. While treatable for a time, multiple myeloma is incurable and almost all patients will relapse or the cancer will become resistant/refractory to current therapies.

About Cellectar Biosciences, Inc.
Cellectar Biosciences 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. Cellectar's PDC platform is based on the company's proprietary phospholipid ether analogs. These novel small-molecules have demonstrated highly selective uptake and retention in a broad range of cancers. Cellectar's PDC pipeline includes product candidates for cancer therapy and cancer diagnostic imaging. The company's lead therapeutic PDC, CLR 131, utilizes 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 plans to initiate a Phase II clinical study to assess efficacy in a range of B-cell malignancies in the first quarter of 2017. The company 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. For more information please visit www.cellectar.com.

About CPDC
CPDC discovers, develops, and distributes radiopharmaceuticals. The CPDC was founded in 2008 as a Centre of Excellence for Commercialization and Research (CECR) in Canada, specializing in radiopharmaceutical research, development and commercialization. Since its inception, CPDC has gained recognition as one of a select few R&D centres that has the full range of scientific, technical, regulatory and business expertise combined with the full specialized infrastructure required to translate radiopharmaceuticals to the clinic and provide them to the marketplace. Through its outstanding staff, and working with academic and industry partners, CPDC has completed over 50 radiopharmaceutical discovery, development, and manufacturing programs. It has brought over a dozen radiopharmaceuticals into clinical development, and currently supports more than 25 clinical trials that are being run in Canada, the United-States, and Europe.

This news release contains forward-looking statements. You can identify these statements by our use of words such as "may," "expect," "believe," "anticipate," "intend," "could," "estimate," "continue," "plans," or their negatives or cognates. These statements are only estimates and predictions and are subject to known and unknown risks and uncertainties that may cause actual future experience and results to differ materially from the statements made. These statements are based on our current beliefs and expectations as to such future outcomes. Drug discovery and development involve a high degree of risk. Factors that might cause such a material difference include, among others, uncertainties related to the ability to raise additional capital, uncertainties related to the ability to attract and retain partners for our technologies, the identification of lead compounds, the successful preclinical development thereof, the completion of clinical trials, the FDA review process and other government regulation, our pharmaceutical collaborators' ability to successfully develop and commercialize drug candidates, competition from other pharmaceutical companies, product pricing and third-party reimbursement. A complete description of risks and uncertainties related to our business is contained in our periodic reports filed with the Securities and Exchange Commission including our Form 10-K/A for the year ended December 31, 2015. These forward-looking statements are made only as of the date hereof, and we disclaim any obligation to update any such forward-looking statements.

CONTACT:
Jules Abraham
JQA Partners
917-885-7378
jabraham@jqapartners.com

INVESTOR CONTACT:
Stephanie Prince
Managing Director
PCG Advisory Group
646-762-4518
sprince@pcgadvisory.com

Source: Cellectar Biosciences, Inc.
 

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Recent Cellectar Biosciences News:

Cellectar Biosciences Announces Successful Conjugation of Multiple Pierre Fabre Cytotoxic Compounds to PDC Delivery Platform; Initiates In Vivo Studies for Solid Tumors

Madison, WI - (November 17, 2016) -- Cellectar Biosciences, Inc. (Nasdaq: CLRB) (the “company”), an oncology-focused, clinical stage biotechnology company, today announces that following the successful conjugation of multiple, natural product cytotoxic molecules developed by Pierre Fabre to Cellectar’s PDC delivery platform, it has initiated in vivo studies for a variety of solid tumors.

Harnessing a selection of linkers to attach the cytotoxic molecules to the PDC platform, the company has constructed a series of novel compounds specifically designed for improved tumor targeting. This research collaboration falls under the company’s CLR CTX programs, geared to convert non-targeted cytotoxic agents into targeted cancer treatments when combined with Cellectar’s proprietary delivery system. The drug’s targeting enhancement is designed to further improve efficacy and reduce adverse events.

As part of the Pierre Fabre research collaboration, Cellectar has already completed a series of in vitro studies with the newly created compounds, and is currently compiling early efficacy data. Cellectar will then initiate additional in vitro and in vivo studies in melanoma, lung, and colon cancers, as well as in additional solid tumors.
“We are excited by the rapid advancement of these programs and look forward to sharing data from our development work with Pierre Fabre,” said Jim Caruso, president and CEO of Cellectar Biosciences. “This partnership is an excellent example of the power of our business model, a cost-efficient system with the potential to generate high-yielding assets. In parallel, we continue to make significant progress on our lead radiotherapeutic PDC, CLR 131 for the treatment of relapsed/refractory multiple myeloma, including our ongoing Phase I and our impending NCI-supported Phase II clinical trial in selected hematologic malignancies.”

About Phospholipid Drug Conjugates (PDCs)
Cellectar’s product candidates are built upon its patented cancer cell-targeting delivery and retention platform of optimized phospholipid ether-drug conjugates (PDCs). The company deliberately designed its phospholipid ether (PLE) carrier platform to be coupled with a variety of payloads to facilitate both therapeutic and diagnostic applications. The basis for selective tumor targeting of our PDC compounds lies in the differences between the plasma membranes of cancer cells compared to those of normal cells. Cancer cell membranes are highly enriched in lipid rafts, which are glycolipoprotein microdomains of the plasma membrane of cells that contain high concentrations of cholesterol and sphingolipids, and serve to organize cell surface and intracellular signaling molecules. PDCs have been tested in over 70 different xenograft models of cancer.

About CLR 131
CLR 131 is an investigational compound under development for a range of hematologic malignancies. It is currently being evaluated in a Phase I clinical trial in patients with relapsed or refractory multiple myeloma. The company plans to initiate a Phase II clinical study to assess efficacy in a range of B-cell malignancies in the first quarter of 2017. Based upon preclinical and interim Phase I study data, treatment with CLR 131 provides a novel approach to treating hematological diseases and may provide patients with therapeutic benefits, including overall response rate (ORR), an improvement in progression-free survival (PFS) and overall quality of life. CLR 131 utilizes the company’s patented PDC tumor targeting delivery platform to deliver a cytotoxic radioisotope, iodine-131 directly to tumor cells. The FDA has granted Cellectar an orphan drug designation for CLR 131 in the treatment of multiple myeloma.

About Relapsed or Refractory Multiple Myeloma
Multiple myeloma is the second most common blood or hematologic cancer with approximately 30,000 new cases in the United States every year. It affects a specific type of blood cells known as plasma cells. Plasma cells are white blood cells that produce antibodies to help fight infections. While treatable for a time, multiple myeloma is incurable and almost all patients will relapse or the cancer will become resistant/refractory to current therapies.

About Cellectar Biosciences, Inc.
Cellectar Biosciences 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. Cellectar's PDC platform is based on the company's proprietary phospholipid ether analogs. These novel small-molecules have demonstrated highly selective uptake and retention in a broad range of cancers. Cellectar's PDC pipeline includes product candidates for cancer therapy and cancer diagnostic imaging. The company's lead therapeutic PDC, CLR 131, utilizes 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 plans to initiate a Phase II clinical study to assess efficacy in a range of B-cell malignancies in the first quarter of 2017. The company 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. For more information please visit www.cellectar.com.

About Pierre Fabre
Pierre Fabre is a privately-owned French health and beauty care company created in 1961 by Mr. Pierre Fabre. In 2015, global sales reached €2.2 billion across 130 countries. The company is structured around two divisions: Pharmaceuticals (Prescription drugs, Consumer Health Care) and Dermo-cosmetics (including the European and Asian market leader Eau Thermale Avène brand). Pierre Fabre employs some 13,000 people worldwide and owns subsidiaries in 43 countries. In 2015, the company allocated 17 percent of its pharmaceuticals sales to R&D with a focus on 4 therapeutic areas: oncology, dermatology, central nervous system and consumer healthcare.

Pierre Fabre’s oncology know-how is based on three decades of experience in the discovery, development and global commercialization of innovative cancer drugs including monoclonal antibodies and natural cytotoxic agents. The company performs its oncology R&D in two major research centres: the Pierre Fabre Immunology Centre (CIPF) based in Saint-Julien-en-Genevois, and the Pierre Fabre Research- Centre (CRPF) located on the Toulouse Oncopole campus. The latter is officially recognized as a “National Center of Excellence” for cancer research by the French government. For more information on Pierre Fabre, please visit www.pierre-fabre.com.

# # #

This news release contains forward-looking statements. You can identify these statements by our use of words such as "may," "expect," "believe," "anticipate," "intend," "could," "estimate," "continue," "plans," or their negatives or cognates. These statements are only estimates and predictions and are subject to known and unknown risks and uncertainties that may cause actual future experience and results to differ materially from the statements made. These statements are based on our current beliefs and expectations as to such future outcomes. Drug discovery and development involve a high degree of risk. Factors that might cause such a material difference include, among others, uncertainties related to the ability to raise additional capital, uncertainties related to the ability to attract and retain partners for our technologies, the identification of lead compounds, the successful preclinical development thereof, the completion of clinical trials, the FDA review process and other government regulation, our pharmaceutical collaborators' ability to successfully develop and commercialize drug candidates, competition from other pharmaceutical companies, product pricing and third-party reimbursement. A complete description of risks and uncertainties related to our business is contained in our periodic reports filed with the Securities and Exchange Commission including our Form 10-K/A for the year ended December 31, 2015. These forward-looking statements are made only as of the date hereof, and we disclaim any obligation to update any such forward-looking statements.

CONTACT:
Jules Abraham
JQA Partners
917-885-7378
jabraham@jqapartners.com

INVESTOR CONTACT:
Stephanie Prince

Source: Cellectar Biosciences, Inc.
 

Cellectar Biosciences Announces INC Research as the CRO for the Phase II Trial of CLR 131 in Hematologic Malignancies; $2M NCI Grant Covers Half of Study Cost, with Potential Option to Pursue Additional $3M for Pivotal Trial

Madison, WI - (November 15, 2016) -- Cellectar Biosciences, Inc. (Nasdaq: CLRB) (the “company”), an oncology-focused, clinical stage biotechnology company, today announced it has selected INC Research (Nasdaq:INCR), a leading global Phase I to IV contract research organization, to oversee its NCI-supported Phase II clinical trial of CLR 131 in patients with multiple myeloma and select hematologic malignancies. The company anticipates that its $2M NCI grant will cover approximately 50 percent of the study’s cost, and the terms of the grant allow Cellectar to pursue an additional $3M for a pivotal Phase III trial of the company’s lead radiotherapeutic compound.

Cellectar plans to leverage the results of its 80-patient, Phase II study to optimally design its pivotal trial of CLR 131 in multiple myeloma and other hematologic malignancies. The multi-armed study will include relapse/refractory patients with 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), who have been treated with standard therapy for their underlying malignancies. The company recently accelerated its guidance and announced plans to initiate the trial during the first quarter of 2017.
“INC Research has outstanding experience in cancer clinical research and a strong reputation within the hematology community. With strong investigator relationships, proven operational expertise and a commitment to high-quality data, they are the ideal partner for this important trial,” said Jim Caruso, president and CEO of Cellectar. “Given the accelerated initiation of our Phase II study to the first quarter of 2017 and that we will utilize as many as 15 participating sites, we can confidently plan on providing initial efficacy data in the second half of 2017.”

About CLR 131
CLR 131 is an investigational compound under development for a range of hematologic malignancies. It is currently being evaluated in a Phase I clinical trial in patients with relapsed or refractory multiple myeloma. The company plans to initiate a Phase II clinical study to assess efficacy in a range of B-cell malignancies in the first quarter of 2017. Based upon preclinical and interim Phase I study data, treatment with CLR 131 provides a novel approach to treating hematological diseases and may provide patients with therapeutic benefits, including overall response rate (ORR), an improvement in progression-free survival (PFS) and overall quality of life. CLR 131 utilizes the company’s patented PDC tumor targeting delivery platform to deliver a cytotoxic radioisotope, iodine-131 directly to tumor cells. The FDA has granted Cellectar an orphan drug designation for CLR 131 in the treatment of multiple myeloma.

About Phospholipid Drug Conjugates (PDCs)
Cellectar’s product candidates are built upon its patented cancer cell-targeting delivery and retention platform of optimized phospholipid ether-drug conjugates (PDCs). The company deliberately designed its phospholipid ether (PLE) carrier platform to be coupled with a variety of payloads to facilitate both therapeutic and diagnostic applications. The basis for selective tumor targeting of our PDC compounds lies in the differences between the plasma membranes of cancer cells compared to those of normal cells. Cancer cell membranes are highly enriched in lipid rafts, which are glycolipoprotein microdomains of the plasma membrane of cells that contain high concentrations of cholesterol and sphingolipids, and serve to organize cell surface and intracellular signaling molecules. PDCs have been tested in over 70 different xenograft models of cancer.

About Relapsed or Refractory Multiple Myeloma
Multiple myeloma is the second most common blood or hematologic cancer with approximately 30,000 new cases in the United States every year. It affects a specific type of blood cells known as plasma cells. Plasma cells are white blood cells that produce antibodies to help fight infections. While treatable for a time, multiple myeloma is incurable and almost all patients will relapse or the cancer will become resistant/refractory to current therapies.

About Cellectar Biosciences, Inc. Cellectar Biosciences 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. Cellectar's PDC platform is based on the company's proprietary phospholipid ether analogs. These novel small-molecules have demonstrated highly selective uptake and retention in a broad range of cancers. Cellectar's PDC pipeline includes product candidates for cancer therapy and cancer diagnostic imaging. The company's lead therapeutic PDC, CLR 131, utilizes 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 plans to initiate a Phase II clinical study to assess efficacy in a range of B-cell malignancies in the first quarter of 2017. The company 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. For more information please visit www.cellectar.com.

About INC Research
INC Research (Nasdaq:INCR) is a leading global contract research organization ("CRO") providing the full range of Phase I to Phase IV clinical development services for the biopharmaceutical and medical device industries. Leveraging the breadth of our service offerings and the depth of our therapeutic expertise across multiple patient populations, INC Research connects customers, clinical research sites and patients to accelerate the delivery of new medicines to market. The Company was named “Best Contract Research Organization” in December 2015 by an independent panel for Scrip Intelligence, and ranked “Top CRO to Work With” among large global CROs in the 2015 CenterWatch Global Investigative Site Relationship Survey. INC Research is headquartered in Raleigh, NC, with operations across six continents and experience spanning more than 110 countries. For more information, please visit www.incresearch.com and connect with us on LinkedIn and Twitter @inc_research.

This news release contains forward-looking statements. You can identify these statements by our use of words such as "may," "expect," "believe," "anticipate," "intend," "could," "estimate," "continue," "plans," or their negatives or cognates. These statements are only estimates and predictions and are subject to known and unknown risks and uncertainties that may cause actual future experience and results to differ materially from the statements made. These statements are based on our current beliefs and expectations as to such future outcomes. Drug discovery and development involve a high degree of risk. Factors that might cause such a material difference include, among others, uncertainties related to the ability to raise additional capital, uncertainties related to the ability to attract and retain partners for our technologies, the identification of lead compounds, the successful preclinical development thereof, the completion of clinical trials, the FDA review process and other government regulation, our pharmaceutical collaborators' ability to successfully develop and commercialize drug candidates, competition from other pharmaceutical companies, product pricing and third-party reimbursement. A complete description of risks and uncertainties related to our business is contained in our periodic reports filed with the Securities and Exchange Commission including our Form 10-K/A for the year ended December 31, 2015. These forward-looking statements are made only as of the date hereof, and we disclaim any obligation to update any such forward-looking statements.

CONTACT:

Jules Abraham
JQA Partners
917-885-7378
jabraham@jqapartners.com

INVESTOR CONTACT:
Stephanie Prince
Managing Director
PCG Advisory Group
646-762-4518
sprince@pcgadvisory.com

Source: Cellectar Biosciences, Inc

 

UPDATE -- Cellectar Biosciences Announces Recent Key Accomplishments and Third Quarter 2016 Financial Results

Madison, WI - (November 11, 2016) -- Cellectar Biosciences, Inc. (Nasdaq: CLRB) (the “company”), an oncology-focused, clinical stage biotechnology company, today announces key accomplishments and its financial results for the third quarter of 2016, which ended September 30, 2016.

Corporate highlights for the quarter include:

Announcement that an 18.75 mCi/m2 single-dose infusion of CLR 131 achieved efficacy data that was equivalent or superior to drugs recently approved for relapsed/refractory (R/R) multiple myeloma (MM) from Cohort 2 of our Phase I study of CLR 131 for relapsed/refractory multiple myeloma
Completion of Cohort 2 and announcement of a positive adverse event (AE) profile; no observed neuropathies, cardiotoxicities, deep vein thrombosis or gastrointestinal AEs to date
Advancement and initiation of Cohort 3 in Phase I study of CLR 131 in R/R MM at 25mCi/m2 single-dose infusion
Awarded non-dilutive NCI - Fast Track SBIR Grant of $2M to support Phase II study of CLR 131 in multiple myeloma and other selected orphan-designated hematologic malignancies
Selection of CLR 131 for non-dilutive research & development to be studied in combination with external beam radiation for head and neck cancers as part of a $12M NCI SPORE Grant awarded to the University of Wisconsin
USPTO granted Patent Allowance for CLR 1603 covering method of use in key solid tumors: breast, prostate, lung, pancreatic and colorectal
Appointment of Jarrod Longcor as senior vice president, Corporate Development and Operations
“We continue to effectively operate the company and achieve significant clinical development progress with CLR 131 as demonstrated by impressive Cohort 2 data and advancement to the third cohort of our Phase I clinical trial for multiple myeloma. In addition, we plan to initiate our NCI supported Phase II clinical trial in multiple myeloma and selected hematologic malignancies in the first quarter of 2017,” said Jim Caruso, president and CEO of Cellectar Biosciences. “We remain focused on closing 2016 strong and communicating near-term, meaningful milestones that further demonstrate the clinical and financial value of our patented PDC delivery platform.”

Financial Results for 3Q 2016

The company incurred research and development expenses of $1.3 million during the third quarter of 2016, which was $0.1 million higher than the third quarter of 2015. The primary driver was increased investment to support our upcoming Phase II Study of CLR 131 in Multiple Myeloma and other orphan-designated hematologic malignancies.

Cellectar’s general and administrative expenses for third quarter 2016 totaled $1.2 million, an increase of $0.3 million from the same period in the prior year. This increase was a result of increased costs for consulting services related to financial reporting, investor outreach and executive recruitment. Loss from operations was $2.5 million, an increase of $0.4 million from the third quarter of 2015.

The Company ended the third quarter with $5.6 million in cash and cash equivalents, compared to $3.9 million in cash and cash equivalents on December 31, 2015. The company continues to estimate that its available cash and cash equivalents will fund its planned operations into the first quarter of 2017. The company expects that additional capital will be required to complete its planned clinical and preclinical development.

Cellectar will be holding a conference call at 8:30 AM ET on Friday, November 11, 2016 to review the company’s performance, as well as these financial results. The call can be accessed by calling (888) 646-8293 (US domestic) or (973) 453-3065 (international) or investors may participate via webcast at http://edge.media-server.com/m/p/y8yf2dg7. Replays will be available via the Investor Relations section of the company’s website: http://www.cellectar.com.

About CLR 131
CLR 131 is an investigational compound under development for a range of hematologic malignancies. It is currently being evaluated in a Phase I clinical trial in patients with relapsed or refractory multiple myeloma. The company plans to initiate a Phase II clinical study to assess efficacy in a range of B-cell malignancies in the first quarter of 2017. Based upon preclinical and interim Phase I study data, treatment with CLR 131 provides a novel approach to treating hematological diseases and may provide patients with therapeutic benefits, including overall response rate (ORR), an improvement in progression-free survival (PFS) and overall quality of life. CLR 131 utilizes the company’s patented PDC tumor targeting delivery platform to deliver a cytotoxic radioisotope, iodine-131 directly to tumor cells. The FDA has granted Cellectar an orphan drug designation for CLR 131 in the treatment of multiple myeloma.

About Phospholipid Drug Conjugates (PDCs)
Cellectar’s product candidates are built upon its patented cancer cell-targeting delivery and retention platform of optimized phospholipid ether-drug conjugates (PDCs). The company deliberately designed its phospholipid ether (PLE) carrier platform to be coupled with a variety of payloads to facilitate both therapeutic and diagnostic applications. The basis for selective tumor targeting of our PDC compounds lies in the differences between the plasma membranes of cancer cells compared to those of normal cells. Cancer cell membranes are highly enriched in lipid rafts, which are glycolipoprotein microdomains of the plasma membrane of cells that contain high concentrations of cholesterol and sphingolipids, and serve to organize cell surface and intracellular signaling molecules. PDCs have been tested in over 70 different xenograft models of cancer.

About Relapsed or Refractory Multiple Myeloma
Multiple myeloma is the second most common blood or hematologic cancer with approximately 30,000 new cases in the United States every year. It affects a specific type of blood cells known as plasma cells. Plasma cells are white blood cells that produce antibodies to help fight infections. While treatable for a time, multiple myeloma is incurable and almost all patients will relapse or the cancer will become resistant/refractory to current therapies.

About Cellectar Biosciences, Inc. Cellectar Biosciences 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. Cellectar's PDC platform is based on the company's proprietary phospholipid ether analogs. These novel small-molecules have demonstrated highly selective uptake and retention in a broad range of cancers. Cellectar's PDC pipeline includes product candidates for cancer therapy and cancer diagnostic imaging. The company's lead therapeutic PDC, CLR 131, utilizes 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 plans to initiate a Phase II clinical study to assess efficacy in a range of B-cell malignancies in the first quarter of 2017. The company 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. For more information please visit www.cellectar.com.

This news release contains forward-looking statements. You can identify these statements by our use of words such as "may," "expect," "believe," "anticipate," "intend," "could," "estimate," "continue," "plans," or their negatives or cognates. These statements are only estimates and predictions and are subject to known and unknown risks and uncertainties that may cause actual future experience and results to differ materially from the statements made. These statements are based on our current beliefs and expectations as to such future outcomes. Drug discovery and development involve a high degree of risk. Factors that might cause such a material difference include, among others, uncertainties related to the ability to raise additional capital, uncertainties related to the ability to attract and retain partners for our technologies, the identification of lead compounds, the successful preclinical development thereof, the completion of clinical trials, the FDA review process and other government regulation, our pharmaceutical collaborators' ability to successfully develop and commercialize drug candidates, competition from other pharmaceutical companies, product pricing and third-party reimbursement. A complete description of risks and uncertainties related to our business is contained in our periodic reports filed with the Securities and Exchange Commission including our Form 10-K/A for the year ended December 31, 2015. These forward-looking statements are made only as of the date hereof, and we disclaim any obligation to update any such forward-looking statements.

CONTACT:
Jules Abraham
JQA Partners
917-885-7378
jabraham@jqapartners.com

INVESTOR CONTACT:
Stephanie Prince
Managing Director
PCG Advisory Group
646-762-4518
sprince@pcgadvisory.com

Source: Cellectar Biosciences, Inc.

Cellectar Biosciences Announces Recent Key Accomplishments and Third Quarter 2016 Financial Results

Madison, WI - (November 10, 2016) -- Cellectar Biosciences, Inc. (Nasdaq: CLRB) (the “company”), an oncology-focused, clinical stage biotechnology company, today announces key accomplishments and its financial results for the third quarter of 2016, which ended September 30, 2016.

Corporate highlights for the quarter include:

Announcement that an 18.75 mCi/m2 single-dose infusion of CLR 131 achieved efficacy data that was equivalent or superior to drugs recently approved for relapsed/refractory (R/R) multiple myeloma (MM) from Cohort 2 of our Phase I study of CLR 131 for relapsed/refractory multiple myeloma
Completion of Cohort 2 and announcement of a positive adverse event (AE) profile; no observed neuropathies, cardiotoxicities, deep vein thrombosis or gastrointestinal AEs to date
Advancement and initiation of Cohort 3 in Phase I study of CLR 131 in R/R MM at 25mCi/m2 single-dose infusion
Awarded non-dilutive NCI - Fast Track SBIR Grant of $2M to support Phase II study of CLR 131 in multiple myeloma and other selected orphan-designated hematologic malignancies
Selection of CLR 131 for non-dilutive research & development to be studied in combination with external beam radiation for head and neck cancers as part of a $12M NCI SPORE Grant awarded to the University of Wisconsin
USPTO granted Patent Allowance for CLR 1603 covering method of use in key solid tumors: breast, prostrate, lung, pancreatic and colorectal
Appointment of Jarrod Longcor as senior vice president, Corporate Development and Operations
“We continue to effectively operate the company and achieve significant clinical development progress with CLR 131 as demonstrated by impressive Cohort 2 data and advancement to the third cohort of our Phase I clinical trial for multiple myeloma. In addition, we plan to initiate our NCI supported Phase II clinical trial in multiple myeloma and selected hematologic malignancies in the first quarter of 2017,” said Jim Caruso, president and CEO of Cellectar Biosciences. “We remain focused on closing 2016 strong and communicating near-term, meaningful milestones that further demonstrate the clinical and financial value of our patented PDC delivery platform.”

Financial Results for 3Q 2016

The company incurred research and development expenses of $1.3 million during the third quarter of 2016, which was $0.1 million higher than the third quarter of 2015. The primary driver was increased investment to support our upcoming Phase II Study of CLR 131 in Multiple Myeloma and other orphan-designated hematologic malignancies.

Cellectar’s general and administrative expenses for third quarter 2016 totaled $1.2 million, an increase of $0.3 million from the same period in the prior year. This increase was a result of increased costs for consulting services related to financial reporting, investor outreach and executive recruitment. Loss from operations was $2.5 million, an increase of $0.4 million from the third quarter of 2015.

The Company ended the third quarter with $5.6 million in cash and cash equivalents, compared to $3.9 million in cash and cash equivalents on December 31, 2015. The company continues to estimate that its available cash and cash equivalents will fund its planned operations into the first quarter of 2017. The company expects that additional capital will be required to complete its planned clinical and preclinical development.

Cellectar will be holding a conference call at 8:30 AM ET on Friday, November 11, 2016 to review the company’s performance, as well as these financial results. The call can be accessed by calling (888) 646-8293 (US domestic) or (973) 453-3065 (international) or investors may participate via webcast at http://edge.media-server.com/m/p/y8yf2dg7. Replays will be available via the Investor Relations section of the company’s website: http://www.cellectar.com.

About CLR 131
CLR 131 is an investigational compound under development for a range of hematologic malignancies. It is currently being evaluated in a Phase I clinical trial in patients with relapsed or refractory multiple myeloma. The company plans to initiate a Phase II clinical study to assess efficacy in a range of B-cell malignancies in the first quarter of 2017. Based upon preclinical and interim Phase I study data, treatment with CLR 131 provides a novel approach to treating hematological diseases and may provide patients with therapeutic benefits, including overall response rate (ORR), an improvement in progression-free survival (PFS) and overall quality of life. CLR 131 utilizes the company’s patented PDC tumor targeting delivery platform to deliver a cytotoxic radioisotope, iodine-131 directly to tumor cells. The FDA has granted Cellectar an orphan drug designation for CLR 131 in the treatment of multiple myeloma.

About Phospholipid Drug Conjugates (PDCs)
Cellectar’s product candidates are built upon its patented cancer cell-targeting delivery and retention platform of optimized phospholipid ether-drug conjugates (PDCs). The company deliberately designed its phospholipid ether (PLE) carrier platform to be coupled with a variety of payloads to facilitate both therapeutic and diagnostic applications. The basis for selective tumor targeting of our PDC compounds lies in the differences between the plasma membranes of cancer cells compared to those of normal cells. Cancer cell membranes are highly enriched in lipid rafts, which are glycolipoprotein microdomains of the plasma membrane of cells that contain high concentrations of cholesterol and sphingolipids, and serve to organize cell surface and intracellular signaling molecules. PDCs have been tested in over 70 different xenograft models of cancer.

About Relapsed or Refractory Multiple Myeloma
Multiple myeloma is the second most common blood or hematologic cancer with approximately 30,000 new cases in the United States every year. It affects a specific type of blood cells known as plasma cells. Plasma cells are white blood cells that produce antibodies to help fight infections. While treatable for a time, multiple myeloma is incurable and almost all patients will relapse or the cancer will become resistant/refractory to current therapies.

About Cellectar Biosciences, Inc. Cellectar Biosciences 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. Cellectar's PDC platform is based on the company's proprietary phospholipid ether analogs. These novel small-molecules have demonstrated highly selective uptake and retention in a broad range of cancers. Cellectar's PDC pipeline includes product candidates for cancer therapy and cancer diagnostic imaging. The company's lead therapeutic PDC, CLR 131, utilizes 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 plans to initiate a Phase II clinical study to assess efficacy in a range of B-cell malignancies in the first quarter of 2017. The company 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. For more information please visit www.cellectar.com.

This news release contains forward-looking statements. You can identify these statements by our use of words such as "may," "expect," "believe," "anticipate," "intend," "could," "estimate," "continue," "plans," or their negatives or cognates. These statements are only estimates and predictions and are subject to known and unknown risks and uncertainties that may cause actual future experience and results to differ materially from the statements made. These statements are based on our current beliefs and expectations as to such future outcomes. Drug discovery and development involve a high degree of risk. Factors that might cause such a material difference include, among others, uncertainties related to the ability to raise additional capital, uncertainties related to the ability to attract and retain partners for our technologies, the identification of lead compounds, the successful preclinical development thereof, the completion of clinical trials, the FDA review process and other government regulation, our pharmaceutical collaborators' ability to successfully develop and commercialize drug candidates, competition from other pharmaceutical companies, product pricing and third-party reimbursement. A complete description of risks and uncertainties related to our business is contained in our periodic reports filed with the Securities and Exchange Commission including our Form 10-K/A for the year ended December 31, 2015. These forward-looking statements are made only as of the date hereof, and we disclaim any obligation to update any such forward-looking statements.

CONTACT:
Jules Abraham
JQA Partners
917-885-7378
jabraham@jqapartners.com

INVESTOR CONTACT:
Stephanie Prince
Managing Director
PCG Advisory Group
646-762-4518
sprince@pcgadvisory.com

Source: Cellectar Biosciences, Inc.
 

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About Cellectar Biosciences:

Cellectar Biosciences 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. Cellectar’s PDC platform is based on the company’s proprietary phospholipid ether analogs. These novel small-molecules have demonstrated highly selective uptake and retention in a broad range of cancers. Cellectar’s PDC pipeline includes product candidates for cancer therapy and cancer diagnostic imaging.

Mission

Cellectar’s commitment to research and development of an innovative pipeline through collaboration and manufacturing of quality drug products motivates us daily. The potential to diagnose and treat cancer patients by providing the highest quality specialized treatments creates a rewarding environment for its employees.
Vision

Cellectar‘s goal is to improve the lives of cancer patients through innovation, collaboration, and the manufacturing of our targeted drug delivery technologies.
Corporate Governance

The Board of Directors of Cellectar Biosciences (the “ Company”) sets high standards for the Company’s employees, officers and directors. Implicit in this philosophy is the importance of sound corporate governance. It is the duty of the Board of Directors to serve as a prudent fiduciary for shareholders and to oversee the management of the Company’s business. To fulfill its responsibilities and to discharge its duty, the Board of Directors follows the procedures and standards that are set forth in these guidelines. These guidelines are subject to modification from time to time as the Board of Directors deems appropriate in the best interests of the Company or as required by applicable laws and regulations.

Cellectar’s product candidates are built upon a cancer cell-targeting delivery and retention platform of optimized phospholipid ether-drug conjugates (PDCs). Cellectar’s proprietary PLE carrier platform was deliberately designed to be coupled with multiple payloads to facilitate both therapeutic and diagnostic applications. Several payloads have been conjugated to provide/allow for the targeted delivery of radiotherapeutics, chemotherapeutics, and molecular diagnostics.

After systemic administration, our PDCs bind to lipid rafts in tumor cell membranes and enter the tumor cells in a clathrin-independent manner. Research has shown that Cellectar’s PDCs feature a number of unique attributes that make them a compelling and scalable oncology delivery platform:

Excellent safety and tolerability profile of the delivery vehicle, which has not shown any toxicities in clinical studies
Selective uptake and prolonged retention of PDCs by cancer cells and cancer stem cells

Broad-spectrum targeting of liquid and solid cancers
The capacity to deliver large payload molecules allows for a wide spectrum of therapeutic or diagnostic agents to be attached

Clinical translation into humans: To date, CLR 131 and CLR 124 have been administered to more than 100 patients and has been well tolerated. Clinical data support the selective uptake and prolonged retention see in vitro and in pre-clinical models.
Cellectar has based the development of our proprietary compounds on the key discovery that selective retention by malignant tumor cells depends on specific properties of the PLEs. These properties include the structure and length of the molecule’s ‘backbone’, the structure of the molecule’s head group, and the overall charge on the molecule. By performing extensive structure-activity relationship (SAR) studies in which multiple PLEs were synthesized and key molecular features that are critical for both increased malignant tumor uptake and selective retention were identified.

Selective Uptake And Retention Of PDCs In Malignant Cells And Tumors

The basis for selective tumor targeting of our PDC compounds lies in differences between the plasma membranes of cancer cells as compared to those of most normal cells. Specifically, cancer cell membranes are highly enriched in lipid rafts. Lipid rafts are glycolipoprotein microdomains of the plasma membrane of cells that contain high concentrations of cholesterol and sphingolipids and serve to organize cell surface and intracellular signaling molecules. In vitro studies using fluorescent PDCs (CLR 1501 and CLR 1502) suggest that lipid rafts serve as portals of entry for PDCs. Furthermore, disruption of the lipid raft architecture significantly reduces the uptake of our PLEs into cancer cells. These experiments have also demonstrated the selective uptake and prolonged retention in cancer cells versus non-cancerous cells. This selectivity of our compounds for cancer cells is attributed to the high affinity of the PLE carrier for cholesterol and the abundance of cholesterol-rich lipid rafts in cancer cells as compared to non-cancer cells. Cellectar’s PDCs transported into the cytoplasm via clathrin-independent endocytosis.

PDC Product Pipeline

Cellectar’s product candidates are built upon a cancer cell-targeting delivery and retention platform of optimized phospholipid ether-drug conjugates (PDCs). Cellectar’s proprietary PLE carrier platform was deliberately designed to be coupled with multiple payloads to facilitate both therapeutic and diagnostic applications. Several payloads have been conjugated to provide/allow for the targeted delivery of radiotherapeutics, chemotherapeutics, and molecular diagnostics.

CLR 131
There is a preponderance of scientific data supporting the sensitivity of hematologic malignancies to radiotherapeutics. Ideally, a cancer-targeted radiopharmaceutical would deliver a cytotoxic radiation dose to all tumor cells while sparing critical normal tissues from consequential radiation dose. Cellectar’s isotope delivery technology is coming closer to this ideal by selectively depositing cytotoxic radiation.

CLR 131 is a small-molecule, cancer-targeted radiopharmaceutical that Cellectar believes has the potential to be the first therapeutic agent to use PLEs to target cancer cells. CLR 131 is comprised of our proprietary PLE, acting as a cancer-targeted delivery and retention vehicle, covalently labeled with iodine-131, a cytotoxic radioisotope that is commonly used to treat thyroid and other cancer types. Iodine-131 has an eight day radioactive half-life which matches well with the pharmacokinetic profile of CLR 1404. The half-life also makes global distribution of CLR 131 possible from a central manufacturing facility.


CLR 131 represents a unique and highly attractive development opportunity because, unlike many early stage oncology therapeutics:
CLR 131 utilizes a new cancer cell-selective delivery mechanism to deliver a proven radiotherapeutic to hematologic malignancies (, which generally respond well to radiation?)
CLR 131 leverages a unique mechanism of action distinct from other therapeutic approaches; it does not rely on the inhibition of specific cellular pathways; it works by exposing cancer cells to sustained cytotoxic radiation.
CLR 131’s delivery vehicle is a small molecule, meaning that synthesis, physicochemical characterization, and scale-up manufacturing are less involved than similar steps for larger molecules such as monoclonal antibodies and – as a results – are more economical and associated with fewer risks

.SOURCE: http://cellectar.com/

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