UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
___________________
FORM 8-K
___________________
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
Date of Report: December 14, 2016
(Date of earliest event reported)
CELLECTAR BIOSCIENCES, INC.
(Exact name of registrant as specified in its charter)
|
Delaware |
1-36598 |
04-3321804 |
|
(State or other jurisdiction of incorporation) |
(Commission File Number) |
(IRS Employer Identification Number) |
3301 Agriculture Drive
Madison, WI 53716
(Address of principal executive offices)
(608) 441-8120
(Registrant's telephone number, including area code)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
| ¨ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
| ¨ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| ¨ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| ¨ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
| ITEM 7.01 | REGULATION FD DISCLOSURE |
On December 14, 2016, we issued a press release announcing that the United States Patent and Trademark Office has issued patent allowances covering method of use for radiotherapy with the company’s lead compound, CLR 131, as well as CLR 125, another of the company’s pipeline products using its proprietary phospholipid drug conjugate (“PDC”) to deliver a radiotherapeutic for use in solid tumors. A copy of the press release is furnished as Exhibit 99.1 and is incorporated by reference herein.
| ITEM 9.01 | FINANCIAL STATEMENTS AND EXHIBITS |
(d) Exhibits
| Number | Title | |
| 99.1 | Press release dated December 14, 2016, entitled “Cellectar Biosciences Announces USPTO Grants Patent Allowances for Radiotherapeutic PDCs for A Variety of Solid Tumor Types” | |
| 2 |
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| Dated: December 14, 2016 | CELLECTAR BIOSCIENCES, INC. | ||
| By: | /s/ Chad J. Kolean | ||
| Name: Chad J. Kolean | |||
| Title: Vice President and Chief Financial Officer | |||
| 3 |
Exhibit 99.1
Cellectar Biosciences Announces
USPTO Grants Patent Allowances for
Radiotherapeutic PDCs for A Variety of Solid Tumor Types
MADISON, Wis., (December 14, 2016) -- Cellectar Biosciences, Inc. (Nasdaq: CLRB) (the “company”), an oncology-focused clinical stage biotechnology company, today announced that the United States Patent and Trademark Office (“USPTO”) has issued patent allowances covering method of use for radiotherapy with the company’s lead compound, CLR 131, as well as CLR 125, another of the company’s pipeline products using its proprietary phospholipid drug conjugate (“PDC”) to deliver a radio therapeutic.
The allowance covers radiotherapy applications for a broad range of solid tumors, specifically: lung, adrenal, intestinal, colon, colorectal, ovarian, cervical, prostate, liver, breast, subcutaneous and pancreatic cancers, as well as melanoma, retinoblastoma, glioma, carcinosarcoma, squamous cell carcinoma and hepatocellular carcinoma. These claims are a continuation of US Patent No. 8,877,159, which provides patent protection into 2025.
“This patent allowance further expands the intellectual property protection of our lead radiotherapeutic candidate beyond the hematologic cancers we are currently researching,” said Jim Caruso, president and CEO of Cellectar. “The expanded patent estate provides us and any potential partners with the option to advance CLR 131 clinical development into a wide variety of solid tumor applications.”
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 pre-clinical 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 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.
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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