A Phase 1b, Open-Label, Study of a Novel Targeted Radiotherapy in Children, Adolescents and Young Adults With Inoperable Relapsed or Refractory High-Grade Glioma

The purpose of this dose finding study is to evaluate the safety and efficacy of 2 different dose levels of CLR 131 in children, adolescents and young adults with relapsed or refractory high-grade glioma (HGG).

Start Date01 Oct 2023

Sponsor / Collaborator

Cellectar Biosciences, Inc.

[+1]

NCT04105543 / Active, not recruitingPhase 1IIT

Therapeutic Combination of CLR 131 With External Beam Radiation in Head and Neck Cancer

This is a Phase 1 study of the use of an investigational drug that selectively delivers radiation to malignant tumor cells, CLR 131, in combination with external beam radiation therapy (EBRT) in subjects with locoregionally recurrent head and neck cancer. The trial will enroll up to 12 participants who are amenable to retreatment with radiation therapy. Participants who also have distant metastatic disease may be enrolled on this clinical trial, but they must have evaluable disease that will be clinically treated with radiation therapy, as per standard of care. All participants will receive a dosimetry test dose of CLR 131 to establish drug uptake by the tumor and enable Monte Carlo dose estimation based on CLR 131 SPECT/CT imaging evaluation. Participants showing uptake will receive a cumulative tumor dose of 60-70 Gy using personalized dose calculation (via Monte Carlo methods) of CLR 131 combined with external beam radiation.

Start Date20 Dec 2019

Sponsor / Collaborator

University of Wisconsin-Madison

[+2]

NCT03478462 / Active, not recruitingPhase 1

An Open-Label, Dose Escalation, Efficacy, and Safety Study of CLR 131 in Children, Adolescents, and Young Adults With Select Solid Tumors, Lymphoma, and Malignant Brain Tumors

The study evaluates CLR 131 in children, adolescents, and young adults with relapsed or refractory malignant solid tumors and lymphoma and recurrent or refractory malignant brain tumors for which there are no standard treatment options with curative potential.

Start Date30 Apr 2019

Sponsor / Collaborator

Cellectar Biosciences, Inc.

100 Clinical Results associated with CLR-131

100 Translational Medicine associated with CLR-131

100 Patents (Medical) associated with CLR-131

Literatures (Medical) associated with CLR-131

01 Sep 2023·Cancer biotherapy & radiopharmaceuticals

Targeting of Head and Neck Cancer by Radioiodinated CLR1404 in Murine Xenograft Tumor Models with Partial Volume Corrected Theranostic Dosimetry.

Article

Author: Marsh, Ian R ; Harari, Paul M ; Grudzinski, Joseph ; Li, Chunrong ; Jeffery, Justin ; Longhurst, Colin ; Adam, David P ; Hernandez, Reinier ; Bednarz, Bryan P ; Weichert, Jamey P

Background: Delivery of radiotherapeutic dose to recurrent head and neck cancer (HNC) is primarily limited by locoregional toxicity in conventional radiotherapy. As such, HNC patients stand to benefit from the conformal targeting of primary and remnant disease achievable with radiopharmaceutical therapies. In this study, the authors investigated the tumor targeting capacity of ¹³¹I-CLR1404 (iopofosine I-131) in various HNC xenograft mouse models and the impact of partial volume correction (PVC) on theranostic dosimetry based on ¹²⁴I-CLR1404 (CLR 124) positron emission tomography (PET)/computed tomography (CT) imaging. Methods: Mice bearing flank tumor xenograft models of HNC (six murine cell line and six human patient derived) were intravenously administered 6.5-9.1 MBq of CLR 124 and imaged five times over the course of 6 d using microPET/CT. In vivo tumor uptake of CLR 124 was assessed and PVC for ¹²⁴I was applied using a novel preclinical phantom. Using subject-specific theranostic dosimetry estimations for iopofosine I-131 based on CLR 124 imaging, a discrete radiation dose escalation study (2, 4, 6, and 8 Gy) was performed to evaluate tumor growth response to iopofosine I-131 relative to a single fraction of external beam radiation therapy (6 Gy). Results: PET imaging demonstrated consistent tumor selective uptake and retention of CLR 124 across all HNC xenograft models. Peak uptake of 4.4% ± 0.8% and 4.2% ± 0.4% was observed in squamous cell carcinoma-22B and UW-13, respectively. PVC application increased uptake measures by 47%-188% and reduced absolute differences between in vivo and ex vivo uptake measurements from 3.3% to 1.0 percent injected activity per gram. Tumor dosimetry averaged over all HNC models was 0.85 ± 0.27 Gy/MBq (1.58 ± 0.46 Gy/MBq with PVC). Therapeutic iopofosine I-131 studies demonstrated a variable, but linear relationship between iopofosine I-131 radiation dose and tumor growth delay (p < 0.05). Conclusions: Iopofosine I-131 demonstrated tumoricidal capacity in preclinical HNC tumor models and the theranostic pairing with CLR 124 presents a promising new treatment approach for personalizing administration of iopofosine I-131.

12 May 2021·Leukemia & lymphoma

Targeted treatment of multiple myeloma with a radioiodinated small molecule radiopharmaceutical

Letter

Author: Marino, Roberta ; Baiu, Dana C. ; Weiss, Gerald E. ; Callander, Natalie S. ; Pula, Taner ; Otto, Mario ; Shahi, Ankita ; Bhattacharya, Saswati ; Asimakopoulos, Fotis

Despite recent advances in the therapy of multiple myeloma (MM), this blood cancer is characterized by initial response to treatment.MM is a very radiosensitive malignancy and ionizing radiation was one of the first therapeutic modalities investigated in the treatment of MM patients.However, limited by the infiltrative bone marrow distribution pattern throughout the body and toxicity associated with treatment of large areas, radiotherapy is now primarily reserved for disease palliation and prescribed in the context of emergencies.CLR 131 is a clin.-stage, radioactive isostere of CLR 127 (18-(p-iodo-phenyl) octadecyl phosphocholine), a tumor-selective alkyl phosphocholine (APC) analog that belongs to the family of anti-tumor alkyl phospholipid (APL) drugs.We determined CLR1501 uptake by flow cytometry in MM cells from 5 sep. patient bone marrow aspirate samples and compared the uptake to non-MM bone marrow cell populations from the same sample.

01 Jan 2020·Advances in experimental medicine and biologyQ4 · MEDICINE

Radiopharmaceuticals for Treatment of Osteosarcoma

Q4 · MEDICINE

Review

Author: Anderson, Peter M

Although trace amounts of radioactivity are routinely used to detect osteosarcoma, the use of larger therapeutic amounts of radiation is often an unrecognized opportunity to treat metastatic osteosarcoma. This chapter will review a number of approaches to use ionizing radiation in the form of injectable radiopharmaceuticals. Since bone metastases are a common pattern of metastatic spread of cancer in general, a number of bone-seeking radiopharmaceuticals have been developed and FDA approved for treatment of bone metastases. Although osteosarcoma, a bone-forming cancer, would seem ideally suited to be treated with bone seekers, patterns of relapse involving non-ossifying metastases remain a major problem to be overcome. Thus, this review will not only describe experience using a number of bone-seeking radiopharmaceuticals such as 153-samarium-EDTMP, 153-samarium-DOTMP, and 223-radium against osteosarcoma, but also approaches to identify patients who may benefit as well as some means to the improve overall efficacy including combination therapy with routine agents and using nuclear imaging to develop best strategy for use. These include imaging with not only ^99mTc-MDP standard bone scans, but also ^99mTc-MDP bone scans with SPECT CT, bone-specific sodium fluoride PET-CT (Na¹⁸F), and ¹⁸FDG-PET-CT. Accurate knowledge of oligometastatic active disease can facilitate more effective use of combination therapy, including radiosensitizers and local control measures, for example, stereotactic body radiotherapy (SBRT) and/or cryoablation to reduce disease burden as well as manage and prevent micrometastatic disease from growing and metastasizing. Finally, a new tumor-specific radiopharmaceutical, CLR 131, may also provide another radiopharmaceutical to treat both osteoblastic and non-ossifying areas of osteosarcoma.

News (Medical) associated with CLR-131

18 Aug 2021

·www.globenewswire.com

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 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 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 . About Waldenstrom’s macroglobulinemiaWaldenstrom’s macroglobulinemia is a rare and incurable disease defined by specific genotypic subtypes that defines patient responses and long-term outcomes. The annual incidence is 6,500 with prevalence of approximately 60,000 patients globally. WM is a lymphoma, or cancer of the lymphatic system. The disease occurs in a type of white blood cell called a B-lymphocyte or B-cell, which normally matures into a plasma cell whose job is to manufacture immunoglobulins (antibodies) to help the body fight infection. In WM, there is a malignant change to the B-cell in the late stages of maturing, and it continues to proliferate into a clone of identical cells, primarily in the bone marrow but also in the lymph nodes and other tissues and organs of the lymphatic system. These clonal cells over-produce an antibody of a specific class called IgM. WM cells have characteristics of both cancerous B-lymphocytes (NHL) and plasma cells (multiple myeloma), and they are called lymphoplasmacytic cells. For that reason, WM is classified as a type of non-Hodgkin’s lymphoma called lymphoplasmacytic lymphoma (LPL). About 95% of LPL cases are WM; the remaining 5% do not secrete IgM and consequently are not classified as WM.There is no standard treatment for WM. Several drugs have demonstrated activity either alone or in combinations, but only a single drug has received regulatory approval. Treatment is mainly focused on the control of symptoms and the prevention of organ damage. Front-line treatments for WM include rituximab alone or in combination with other agents. In the salvage therapy (second line or later) setting, ibrutinib, combinations of proteosome inhibitors and immunomodulatory drugs and stem cell transplantation are considered. Ibrutinib is the only drug to receive regulatory approval (2015) as a salvage therapy; in late 2019, it was approved for front-line treatment in combination with rituximab. Factors such as long-term cytopenias, age, hyper viscosity, the need for quick disease control, lymphadenopathy, co-morbidities, and IgM-related end-organ damage are key consideration in the choice of treatment. About Cellectar Biosciences, Inc.Cellectar Biosciences is focused on the discovery and development of drugs for the treatment of cancer. The company is developing proprietary drugs independently and through research and development collaborations. The company’s core objective is to leverage its proprietary Phospholipid Drug Conjugate™ (PDC) delivery platform to develop PDCs that specifically target cancer cells, delivering improved efficacy and better safety as a result of fewer off-target effects. The company’s PDC platform possesses the potential for the discovery and development of the next-generation of cancer-targeting treatments, and it plans to develop PDCs independently and through research and development collaborations. The company’s product pipeline includes iopofosine I-131, a small-molecule PDC designed to provide targeted delivery of iodine-131 (radioisotope), and proprietary preclinical PDC chemotherapeutic programs and multiple partnered PDC assets. For more information, please visit and or join the conversation by liking and following us on the company’s social media channels: Twitter, LinkedIn, and Facebook. Forward-Looking Statement DisclaimerThis 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 including our expectations of the impact of the COVID-19 pandemic. 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 disruptions at our sole source supplier of iopofosine I-131, the ability to attract and retain partners for our technologies, the identification of lead compounds, the successful preclinical development thereof, patient enrollment and the completion of clinical studies, the FDA review process and other government regulation, our ability to maintain orphan drug designation in the United States for iopofosine I-131, the volatile market for priority review vouchers, 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 for the year ended December 31, 2020. These forward-looking statements are made only as of the date hereof, and we disclaim any obligation to update any such forward-looking statements Contacts Investors:Monique KosseManaging DirectorLifeSci Advisors212-915-3820monique@lifesciadvisors.com

AntibodyOrphan DrugPriority ReviewFast TrackCollaborate

15 Jul 2021

·www.biospace.com

Advaxis Announces Initiation of Phase 1 Clinical Trial of ADXS-504 for the Treatment of Early Prostate CancerStudy in biochemically recurrent prostate cancer expands off-the-shelf ADXS-HOT program to second indication

MONMOUTH JUNCTION, N.J., July 15, 2021 (GLOBE NEWSWIRE) -- Advaxis, Inc. (Nasdaq: ADXS), a clinical-stage biotechnology company focused on the development and commercialization of immunotherapy products, today announced the initiation of its Phase 1 clinical study evaluating ADXS-504 in patients with biochemically recurrent prostate cancer. The study, being conducted at Columbia University Irving Medical Center, is the first clinical evaluation of ADXS-504, Advaxis’ off-the-shelf neoantigen immunotherapy drug candidate for early prostate cancer. Mark Stein, M.D., associate professor of medicine in the Division of Hematology/Oncology at Columbia University Vagelos College of Physicians and Surgeons, is the study’s principal investigator. “Evaluating ADXS-504 in patients with biochemically recurrent prostate cancer is the first step in testing whether Lm-based immunotherapies may have a role in the adjuvant setting in cancer patients who have undergone radical therapy and who have no detectable primary tumor or metastatic disease at enrollment,” said Dr. Andres Gutierrez, Chief Medical Officer of Advaxis. “This Phase 1 study will evaluate the safety, tolerability, immunogenicity and clinical activity of ADXS-504 in men who have undergone radical prostatectomy or radiotherapy and whose prostate specific antigen (PSA) levels in the blood are rising, which we believe are ideal patients to evaluate with this approach. Moreover, we believe our multi-neoantigen vector has the potential to drive T cell responses against both hormone-sensitive and hormone-resistant cancer cells, which could result in disease control and may delay the start of androgen blockade therapy and its associated long-term complications. This study will also examine our lowest dose of an Lm-based immunotherapy to date, which could enhance the risk/benefit ratio that we have previously observed in our ADXS-HOT program.” Kenneth A. Berlin, President and Chief Executive Officer of Advaxis stated, “We are pleased to be launching the first clinical evaluation of ADXS-504, expanding the reach of our off-the-shelf neoantigen immunotherapy program to a second potential indication. Our strong foundation of clinical data generated across both prostate cancer and non-small cell lung cancer suggest Lm-based immunotherapy may bring meaningful clinical benefit to patients and we look forward to continued momentum across the ADXS-HOT program.” The Phase 1 open-label dose escalation study will evaluate the safety and tolerability of two dose levels (1e7 and 1e8 CFU) of ADXS-504 monotherapy, administered via infusion every four weeks for six total doses in 9-18 patients with biochemically recurrent prostate cancer (i.e., those with elevation of prostate-specific antigen (PSA) in the blood after radical prostatectomy or radical radiotherapy (external beam or brachytherapy) and who are not currently receiving androgen ablation therapy). The study will also evaluate preliminary clinical and immune responses following treatment with ADXS-504 monotherapy. ADXS-504 is a novel Lm-based immunotherapy, bioengineered to elicit T cell responses against 24 tumor antigens that include 14 peptide antigens derived from frequently occurring and commonly shared hotspot mutations in patients with prostate cancer and 10 peptide antigens derived from sequence-optimized tumor-associated antigens (TAAs) that are differentially expressed or overexpressed in prostate cancer. ADXS-504 is designed to express multiple tumor antigen targets to which patients may generate a broad set of effector T cells for tumor control. Similar to Advaxis’s other Lm-based immunotherapies, ADXS-504 is expected to induce an innate immune response followed by the adaptive response and modification of the immunosuppressive tumor microenvironment (TME) by reducing regulatory T cells (Tregs) and myeloid-derived suppressor cell (MDSC) frequencies in the TME. About Advaxis Advaxis, Inc. is a clinical-stage biotechnology company focused on the development and commercialization of proprietary Lm-based antigen delivery products. These immunotherapies are based on a platform technology that utilizes live attenuated Listeria monocytogenes (Lm) bioengineered to secrete antigen/adjuvant fusion proteins. These Lm-based strains are believed to be a significant advancement in immunotherapy as they integrate multiple functions into a single immunotherapy and are designed to access and direct antigen presenting cells to stimulate anti-tumor T cell immunity, activate the immune system with the equivalent of multiple adjuvants, and simultaneously reduce tumor protection in the tumor microenvironment to enable T cells to eliminate tumors. Forward Looking Statements This press release contains forward-looking statements that are made pursuant to the safe harbor provisions within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements are any statements that express the current beliefs and expectations of management. Any statements contained herein that do not describe historical facts are forward-looking statements that are subject to risks and uncertainties that could cause actual results, performance and achievements to differ materially from those discussed in such forward-looking statements. Such risks include, but are not limited to: the success and timing of the Company’s clinical trials, including patient accrual; the Company’s ability to develop and commercialize its products; the Company’s ability to identify license and collaboration partners and to maintain existing relationships; the Company’s available cash and its ability to obtain additional funding; and any outcomes from the Company’s review of strategic transactions. These and other risks are discussed in the Company’s filings with the SEC, including, without limitation, its Annual Report on Form 10-K, filed on January 22, 2021, as amended, and its periodic reports on Form 10-Q and Form 8-K. The Company cautions readers not to place undue reliance on any forward-looking statements, which speak only as of the date they were made. The Company undertakes no obligation to update or revise forward-looking statements whether as a result of new information, future events or otherwise, except as otherwise required by law. Contact: Tim McCarthy, LifeSci Advisors, LLC 212.915.2564 tim@lifesciadvisors.com

AntibodyImmunotherapy

14 Jun 2021

·www.globenewswire.com

Advaxis Reports Second Quarter Ended April 30, 2021 Financial Results and Provides a Business Update

ADXS-503 Phase 1/2 trial data presented at ASCO demonstrate disease control rate of 44% with durable clinical benefit observed beyond one year in patients with disease progression on KEYTRUDA® Expansion of off-the-shelf ADXS-HOT program with planned Phase 1 study in early prostate cancer with biochemical recurrence Cash runway anticipated into fiscal 3rd quarter of 2023 PRINCETON, N.J., June 14, 2021 (GLOBE NEWSWIRE) -- Advaxis, Inc. (Nasdaq: ADXS), a clinical-stage biotechnology company focused on the development and commercialization of immunotherapy products today announces its financial results for the second quarter ended April 30, 2021 and provides a business update. Second Quarter Ended April 30, 2021 Financial Results and Recent Key Accomplishments: Management Commentary “Our recent presentation at ASCO adds to the strong foundation of data which suggest treatment with ADXS-503 has the potential provide durable clinical benefit in patients with certain clinical characteristics and early T cell responses,” said Kenneth A. Berlin, President and Chief Executive Officer of Advaxis. “Achieving clinical benefit in patients with immediate prior progression on KEYTRUDA® is particularly meaningful, suggesting that ADXS-503 has the potential to enhance and/or restore sensitivity to checkpoint inhibitors. These encouraging data, combined with our expanded set of translational data which show on-mechanism innate and adaptive immune stimulation, leave us confident that our off-the-shelf neoantigen immunotherapy may be an important new treatment option to expand the reach of immunotherapies in diverse treatment settings and indications. We will continue our progress with ADXS-503 in NSCLC and will expand our ADXS-HOT program to additional indications, with our planned study of ADXS-504 in early stage prostate cancer, and look forward to providing additional study updates in the coming months.” Second Quarter Ended April 30, 2021 Financial Results Research and development expenses for the second quarter of fiscal year 2021 were $4.34 million, compared with $3.92 for the second quarter of fiscal year 2020. The increase of $0.42 million was primarily attributable to winding down some legacy studies and losses on disposal of research-related property and equipment in connection with the termination of the office lease at the Company’s former location. General and administrative expenses for the three months ended April 30, 2021 were at $3.35 million, compared to $2.65 million in the same three-month period in fiscal 2020. The increase of $0.7 million primarily relates to increases in sub-license fees and legal fees, amounts paid in settlement of shareholder demand letters and losses on disposal of other property and equipment in connection with the termination of the Company’s office lease at its former location. As of April 30, 2021, the Company had approximately $48.1 million in cash and cash equivalents. The Company believes this is sufficient capital to fund its obligations, as they become due, in the ordinary course of business into the 3rd fiscal quarter of 2023. About Advaxis, Inc.Advaxis, Inc. is a clinical-stage biotechnology company focused on the development and commercialization of proprietary Lm-based antigen delivery products. These immunotherapies are based on a platform technology that utilizes live attenuated Listeria monocytogenes (Lm) bioengineered to secrete antigen/adjuvant fusion proteins. These Lm-based strains are believed to be a significant advancement in immunotherapy as they integrate multiple functions into a single immunotherapy and are designed to access and direct antigen presenting cells to stimulate anti-tumor T cell immunity, activate the immune system with the equivalent of multiple adjuvants, and simultaneously reduce tumor protection in the tumor microenvironment to enable T cells to eliminate tumors. To learn more about Advaxis, visit and connect on Twitter, LinkedIn, Facebook and YouTube. Forward-Looking StatementsThis press release contains forward-looking statements that are made pursuant to the safe harbor provisions within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements are any statements that express the current beliefs and expectations of management, including but not limited to statements related to the expected clinical development of the Company’s drug product candidates, statements about the Company’s balance sheet position, including the sufficiency of the Company’s cash and cash equivalents to fund its obligations into the future, and statements related to the goals, plans and expectations for the Company’s ongoing clinical studies. These and other risks are discussed in the Company’s filings with the SEC, including, without limitation, its Annual Report on Form 10-K, filed on January 22, 2021, and its periodic reports on Form 10-Q and Form 8-K. Any statements contained herein that do not describe historical facts are forward-looking statements that are subject to risks and uncertainties that could cause actual results, performance and achievements to differ materially from those discussed in such forward-looking statements. The Company cautions readers not to place undue reliance on any forward-looking statements, which speak only as of the date they were made. The Company undertakes no obligation to update or revise forward-looking statements, except as otherwise required by law, whether as a result of new information, future events or otherwise. KEYTRUDA® is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, N.J., USA. Contact:Tim McCarthy, LifeSci Advisors, LLC212.915.2564tim@lifesciadvisors.com

Financial StatementImmunotherapyASCO

100 Deals associated with CLR-131

External Link

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Hematologic Neoplasms	Phase 2	US	Cellectar Biosciences, Inc.	24 Mar 2017
Recurrent Glioma	Phase 2	US	Cellectar Biosciences, Inc.	01 May 2014
Non-Small Cell Lung Cancer	Phase 2	US	-	22 Feb 2012
Head and Neck Neoplasms	Phase 1	US	Cellectar Biosciences, Inc.	20 Dec 2019
Diffuse Intrinsic Pontine Glioma	Phase 1	US	Cellectar Biosciences, Inc.	30 Apr 2019
Diffuse Intrinsic Pontine Glioma	Phase 1	AU	Cellectar Biosciences, Inc.	30 Apr 2019
Diffuse Intrinsic Pontine Glioma	Phase 1	CA	Cellectar Biosciences, Inc.	30 Apr 2019
Ewing Sarcoma	Phase 1	US	Cellectar Biosciences, Inc.	30 Apr 2019
Ewing Sarcoma	Phase 1	AU	Cellectar Biosciences, Inc.	30 Apr 2019
Ewing Sarcoma	Phase 1	CA	Cellectar Biosciences, Inc.	30 Apr 2019

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02952508 (CLOVER-WaM, Corporate Publications) Manual	Phase 2	Waldenstrom Macroglobulinemia	50	Iopofosine I 131	mnelzjbcye(ooeszgdfwe) = lmlzljcrnj ipqzhcvsce (sjztisxodf, 44.5 ~ 75.8) Met View more	Positive	08 Jan 2024
NCT02952508 (CLOVER-1, Literature) Manual	Phase 2	Relapse multiple myeloma Last line	7	CLR-131+dexamethasone (total dose ≥60 mCi)	liitnwsjzq(vcklnoiuid) = mqudffipqw uzutmkenke (gcndmfjjot ) View more	Positive	06 Sep 2022
NCT02952508 (CLOVER-1, Literature) Manual	Phase 2	Relapse multiple myeloma Last line	7	CLR-131+dexamethasone (total dose <60 mCi)	-	Positive	06 Sep 2022
NCT02952508 (CLOVER-1, ASCO2021)	Phase 2	Lymphoplasmacytic Lymphoma \| Mantle-Cell Lymphoma \| Chronic Lymphocytic Leukemia ... View more	6	CLR 131	ubcickbzzo(tdanwssrne) = anaemia (66%) fmczlcrgud (pkxxvuxlvh ) View more	-	28 May 2021
NCT02952508 (ESMO2019) Manual	Phase 2	Diffuse large B-cell lymphoma recurrent	6	CLR-131	nhoaeaycsq(wqnqnynafy) = wlgcrhwjhq ltxdpzplpl (egkcmdojdz ) View more	Positive	28 Sep 2019
NCT01540513 (CTgov)	Not Applicable	Glioblastoma Multiforme \| Brain metastases	12	NM404	xltrmunaew(trntajauek) = hrungtjecg syobvsxule (ghesowgslt, zimjsabjud - tlvphiwxag) View more	-	11 Dec 2017
NCT02278315 (ASH2016) Manual	Phase 1	Multiple Myeloma	8	dexamethasone+I-131-CLR1404	yrvqqeynlz(jlzdszyffb) = tlcpbbyckv xleettbitr (xoqgovdarr )	Positive	02 Dec 2016
NCT02278315 (ASH2016) Manual	Phase 1	Multiple Myeloma	8	dexamethasone+I-131-CLR1404	ovtrccbveh(yoxqaigtqd) = fyxamsjrgk mkzdtjptmf (lakarqomjh ) View more	Positive	02 Dec 2016
NCT01495663 (ASCO2014)	Phase 1	HR-positive/HER2-low Solid Tumors	12	Phospholipid ether [<sup>131</sup>I]-CLR1404	jjxdiftkqj(aqacgajnkv) = nmupxqokgh drgvonqfut (baxrdjxhoj )	-	20 May 2014
NCT00925275 (Pubmed \| PLoS One)	Phase 1	Advanced Malignant Solid Neoplasm	8	131I-CLR1404	luyjwydode(prkkuwtghy) = ypnbbytkig pffeotcxdx (aavogxvubc ) View more	-	01 Jan 2014
AACR2013	Not Applicable	Squamous Cell Carcinoma of Head and Neck	-	131I-CLR1404	wthojfszem(fpdnxljmpx) = gsbegyowsr nsgomrsoxy (vpjwqxwyst ) View more	-	15 Apr 2013

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