Clinical comparative study of lenvatinib sequential iodine-131 and traditional iodine-131 in the treatment of metastatic and locally advanced differentiated thyroid cancer

Start Date05 Aug 2024

Sponsor / Collaborator

Jiangsu Provincial People's Hospital

JPRN-UMIN000047144 / RecruitingIIT

Effect of the method of applying the iodine compound drape on its adhesiveness - iodine compound drape

Start Date30 Jun 2024

Sponsor / Collaborator-

100 Clinical Results associated with Iodine

100 Translational Medicine associated with Iodine

100 Patents (Medical) associated with Iodine

3,422

Literatures (Medical) associated with Iodine

01 Jan 2025·JOURNAL OF NUTRITIONAL BIOCHEMISTRY

Preventive and therapeutic effects of molecular iodine in a model of diabetes mellitus induced by streptozotocin

Article

Author: Rodríguez-Castelán, Julia ; Delgado-González, Evangelina ; Sánchez-Tapia, Mónica ; Anguiano, Brenda ; Torres, Nimbe ; Aceves, Carmen

Diabetes mellitus (DM) is a multifactorial condition that involves oxidative alterations and dysbiosis of the gut microbiota associated with an imbalance in glucose metabolism. Therefore, the need to develop integrative therapies that are both effective and have fewer side effects has become evident in recent years. Molecular iodine (I₂) has antioxidant effects in preclinical hyperglycemic models. The present work analyzes the preventive and therapeutic effects of oral I₂ supplementation in a DM model induced by low doses of streptozotocin (STZ). Male CD1 mice (12 weeks old) were divided into the following groups: control, STZ (20 mg/kg/day, i.p., for 5 days), I₂ (0.2 mg/Kg in drinking water), preventive (STZ + I₂), and therapeutic (I₂ supplementation from day 35 to day 90; STZ + I_2(Ther)). The supplementation with I₂ prevented and normalized hyperglycemia, hypercholesterolemia, and hypertriglyceridemia associated with STZ, preserving pancreatic, liver, muscle, and adipose tissue morphology and normalizing inflammatory gene induction (TLR2, TLR4, NFkβ, TNFα) in several tissues. Furthermore, compared to the STZ group, the presence of I₂ favored a more significant abundance of beneficial bacteria that support the integrity of the intestinal epithelial barrier and higher α-diversity. In conclusion, the I₂ supplement has preventive and therapeutic effects, reducing oxidative damage and reestablishing microbiota diversity following STZ exposure.

01 Jan 2025·CURRENT OPINION IN ONCOLOGY

Reproductive life and differentiated thyroid carcinoma in women: reciprocal influences on their respective outcome

Review

Author: Costante, Giuseppe ; Poppe, Kris ; Kyrilli, Aglaia

Purpose of review:

To analyze the reciprocal influences between female reproductive life and DTC management.

Recent findings:

Data on pregnancy outcome in DTC patients indicate that after conceiving, these women may need an increased L-T4 dose to maintain suppressed serum TSH levels. Nevertheless, this does not determine major harm in terms of pregnancy outcome. Analogously, the most recent findings obtained with the propensity score matching approach have confirmed that pregnancy does not significantly affect DTC clinical course and eventually tumor prognosis. A recent metanalysis and a large case–control study excluded a significant effect of radioactive iodine treatment (RAIT) on several reproductive variables in DTC patients, providing reassuring evidence that the current recommendations on RAIT for women of childbearing age are sufficiently well tolerated and do not affect fertility nor pregnancy rate. Nonetheless, it seems reasonable to recommend special attention for older than 35 years women requiring higher RAIT activities.

Summary:

Overall, the most recent studies have provided sufficiently reassuring evidence that the occurrence of pregnancy and DTC management are of no reciprocal harm for adverse outcome in affected women of childbearing age. Thus, female DTC patients should be managed according to the individual response to treatment before pregnancy. When DTC diagnosis is made after conception, delaying surgery does not represent a harm in most patients.

09 Dec 2024·Hellenic Journal of Nuclear Medicine

Efficacy of a fixed low dose of radioactive iodine in the treatment of Graves' disease in Sub-Saharan Africa.

Article

Author: Pillay, Venesen ; Nxasana, Thembelihle ; Masikane, Sphelele ; Patel, Maryam ; Hadebe, Bawinile ; Ndlovu, Nontobeko ; Nyakale, Nozipho ; Harry, Lerwine ; Gabela, Lerato ; Mkhiz, Thokozani ; Vorster, Mariza

OBJECTIVE:

Graves' disease represents 60%-90% of all causes of thyrotoxicosis in different regions of the world. Thyrotoxicosis contributes approximately 66% to thyroid disorders in South Africa and of those Graves' disease contributes about 34%. In most Sub-Saharan African countries, Graves' disease is managed mainly with medical treatment, due to a lack of or poor access to other means of treatment. Despite the primary use of anti-thyroid drugs (ATD) in the management of Graves' disease, the use of radioactive iodine (RAI) is required in many patients, especially in cases where ATD are contraindicated, or in patients who have failed ATD treatment and are poor surgical candidates. There is no consensus on the best method for deciding on how much activity of radioiodine to administer to patients with Graves' disease, that is, whether to use a calculated dose, or an empirical or fixed dose for RAI. The standardized fixed dose is particularly helpful in under-resourced areas or centres with few nuclear physicians and high patient loads. However, little is known about the efficacy of the fixed dose compared to the calculated or empirical dose methods. The purpose of this retrospective observational study was to assess the efficacy of a fixed low dose of radioiodine-131 (¹³¹I) in the treatment of Graves' disease.

SUBJECTS AND METHODS:

Patients treated with a fixed dose of 10mCi between the periods of 2014 to 2017 were evaluated for treatment response after each dose of RAI. Outcome of therapy was evaluated at 3 monthly follow-up using biochemical markers: thyroid stimulating hormone (TSH), total free thyroxine (fT4), and or triiodothyronine (T3), and the presence or absence of clinical symptoms of thyrotoxicosis. According to their response to RAI therapy, patients were classified as responders (if they became euthyroid or hypothyroid), non-responders (if they failed to achieve euthyroidism or hypothyroidism at 6 months) and complete treatment failure (if no response was present within 18 months after two or three fixed low doses of RAI). Percentage uptake, baseline fT4 and patient age were compared according to treatment response.

RESULTS:

Our cohort included 111 patients, 95 (86%) females and 16 (14%) males, with a mean age of 41.9 years. Treatment was successful after the first dose in 89.2% of cases (27.0% euthyroid; 62.2% hypothyroid), with 10.8% requiring a second dose, and only a single patient who remained hyperthyroid after that second empiric dose. Statistical analysis demonstrated that a high percentage thyroid uptake was associated with treatment failure, whereas a low percent thyroid uptake was associated with a good treatment response (P=0.0048). We found no significant difference in FT4 levels or age, between hyperthyroid and non-hyperthyroid (euthyroid or hypothyroid) groups post initial RAI therapy (P=0.5 and P=0.96, respectively).

CONCLUSION:

The use of a low fixed/empiric radioiodine activity for hyperthyroidism due to Graves' disease performed well in our setting with a nearly 90% response rate achieved after a single dose of 10mCi. Justification for higher activity should be specified, and this method of determining the optimal dose of RAI therapy may be beneficial in resource constrained settings with high patient volumes.

News (Medical) associated with Iodine

10 Dec 2024

·www.globenewswire.com

Cellectar Biosciences Provides Strategic Update on Clinical Development, Pipeline Programs and Corporate Restructuring

Evaluating strategic options for iopofosine I 131 a late-stage clinical program with compelling Phase 2 data and a substantial market opportunity Focusing on advancing radiotherapeutic assets including alpha- and Auger-emitting radioconjugates into Phase 1 solid tumor studies FLORHAM PARK, N.J., Dec. 10, 2024 (GLOBE NEWSWIRE) -- Cellectar Biosciences, Inc. (NASDAQ: CLRB), a late-stage clinical biopharmaceutical company focused on the discovery, development and commercialization of drugs for the treatment of cancer, today announces a strategic update on its clinical development programs for its proprietary phospholipid ether drug conjugate platform that delivers a broad array of therapeutic modalities to target cancers. Due to recent communications with the U.S. Food and Drug Administration (FDA, or the Agency) regarding a confirmatory study to support accelerated approval and the regulatory submission for iopofosine I 131, the Company has decided to pursue strategic options for the further development and commercialization of this product candidate. The CLOVER-WaM study was conducted in accordance with earlier FDA communications from an end of Phase 2 meeting and from a meeting in early 2024, during which the Company was informed that positive results for major response rate (MRR) as the primary endpoint could be acceptable to support accelerated approval of iopofosine I 131 as a treatment for Waldenstrom’s macroglobulinemia (WM). Based upon a recent Type-C meeting with the FDA, the Company now believes that a submission seeking accelerated approval would need to be based on the MRR data from CLOVER-WaM and enrollment in a randomized, controlled confirmatory study that is designed to generate data on progression-free survival (PFS). “While iopofosine I 131’s positive WM data along with the high unmet medical need for these patients support further investment, we have determined that such a program may best be brought to market by a larger organization with greater resources. Importantly, partnering or divesting this program supports our commitment to providing this potentially life-saving drug to the patients who need it as quickly as possible,” stated James Caruso, president and CEO of Cellectar. “We believe iopofosine I 131 represents a compelling opportunity as it has shown strong efficacy and good tolerability based on our clinical studies. Moreover, the commercial work we conducted demonstrates iopofosine I 131’s substantial market opportunity based upon the product profile, which includes off-the-shelf global distribution, orphan pricing and existing unmet medical need.” Cellectar remains confident in the potential of its phospholipid ether drug conjugate platform and the targeted radiotherapies in its development pipeline. Iopofosine I 131’s clinical success validates the platform’s ability to target cancers and Cellectar will leverage its experience to focus on the development of its earlier clinical programs. Specifically, Cellectar will focus on those assets it believes have the highest therapeutic potential and opportunity for value creation. As highlighted by recent acquisitions and collaborations within the radiopharmaceutical sector, precision isotopes like alpha- and Auger-emitters have emerged as the leading therapeutics of interest. Consequently, the Company will now focus its resources on targeting solid tumors by advancing CLR 121225, its actinium-225 based program, and CLR 121125, its iodine-125 Auger-emitting program into the clinic. Cellectar expects to file Investigational New Drug applications in the first half of 2025 for both CLR-121225 and CLR-121125, which will allow the initiation of Phase 1 clinical studies in solid tumor cancers. Both programs have demonstrated robust in vivo activity, tolerability, excellent targeting and uptake in preclinical solid tumor models. The Company believes this approach will provide an expedited timeframe to achieve safety and proof-of-concept data in patients. The Company’s strategic reprioritization will impact all departments and result in an immediate reduction in headcount of approximately 60%, which should be complete by the end of the fourth quarter 2024. The Company anticipates that the implementation of the restructuring will extend its cash runway into the third quarter of 2025. “We are being methodical in our efforts to reorganize the company with the goal of conserving cash while maintaining the flexibility to execute immediate priorities and build for long-term growth and value creation. This reorganization is difficult but necessary for the future growth potential of Cellectar,” said Mr. Caruso. “I want to extend my deepest gratitude to our departing employees for their significant contributions to our work and their dedication to making a difference in the lives of patients.” About Cellectar Biosciences, Inc. Cellectar Biosciences is a late-stage clinical biopharmaceutical company focused on the discovery and development of proprietary drugs for the treatment of cancer, independently and through research and development collaborations. The company’s core objective is to leverage its proprietary Phospholipid Drug ConjugateTM (PDC) delivery platform to develop the next-generation of cancer cell-targeting treatments, delivering improved efficacy and better safety as a result of fewer off-target effects. The company’s product pipeline includes lead asset, iopofosine I 131, a small-molecule PDC designed to provide targeted delivery of iodine-131 (radioisotope), CLR 121225, an actinium-225 based program being targeted to several solid tumors with significant unmet need, such as pancreatic cancer, CLR 121125, an iodine-125 Auger-emitting program targeted in other solid tumors, such as triple negative breast, lung and colorectal, proprietary preclinical PDC chemotherapeutic programs and multiple partnered PDC assets. In addition, iopofosine I 131 is under evaluation in Phase 2b studies for relapsed or refractory multiple myeloma (MM) and central nervous system (CNS) lymphoma, alongside the CLOVER-2 Phase 1b study, targeting pediatric patients with high-grade gliomas, for which Cellectar is eligible to receive a Pediatric Review Voucher from the FDA upon approval. The FDA has also granted iopofosine I 131 Orphan Drug and Fast Track Designations for various cancer indications. New data from the CLOVER-WaM Phase 2 clinical trial were recently presented in an oral presentation at the 66th American Society of Hematology Annual Meeting and Exposition (ASH 2024). For more information, please visit www.cellectar.com or join the conversation by liking and following us on the company’s social media channels: Twitter, LinkedIn, and Facebook. Forward-Looking Statement Disclaimer 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 disruptions at our sole source supplier of iopofosine, 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 obtain regulatory exclusivities, the availability of priority review vouchers, our 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, 2023, and our Form 10-Q for the quarter ended September 30, 2024. 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 MEDIA: Christy MaginnBliss Bio Health 703-297-7194 cmaginn@blissbiohealth.com INVESTORS: Anne Marie FieldsPrecision AQ212-362-1200annemarie.fields@precisionaq.com

Fast TrackPhase 2ASHOrphan DrugPhase 1

18 Nov 2024

·www.globenewswire.com

Cellectar Biosciences Reports Financial Results for Q3 2024 and Provides a Corporate Update

Phase 2 CLOVER-WaM pivotal study data selected for oral presentation at 66th Annual American Society of Hematology Meeting and Exposition Raised approximately $19.4 million with potential to raise up to an additional $73.3 million Company to hold webcast and conference call at 8:30 AM ET today FLORHAM PARK, N.J., Nov. 18, 2024 (GLOBE NEWSWIRE) -- Cellectar Biosciences, Inc. (NASDAQ: CLRB), a late-stage clinical biopharmaceutical company focused on the discovery, development, and commercialization of drugs for the treatment of cancer, today announced financial results for the quarter ended September 30, 2024, and provided a corporate update. “We achieved important clinical, operational and commercial corporate objectives during the quarter. We reported topline results from the CLOVER-WaM pivotal study in WM and look forward to filing our NDA submission with a request for accelerated regulatory approval in the coming months,” said James Caruso, president and CEO of Cellectar Biosciences. “In addition to our lead iopofosine I 131 program, we plan to further advance the value of our phospholipid radioconjugate pipeline and are preparing alpha and Auger PRCs for initiation of solid tumor clinical studies as business conditions allow.” Third Quarter and Recent Corporate Highlights Reported positive results from the Phase 2 CLOVER-WaM pivotal study evaluating iopofosine I 131, the company’s potentially first-in-class, targeted radiotherapeutic candidate, for the treatment of relapsed/refractory Waldenstrom’s macroglobulinemia (WM). These results support the company’s planned filing of the New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) in the near term.Selected to present data from the CLOVER-WaM study evaluating iopofosine I 131 in patients with WM at the upcoming 66th Annual American Society of Hematology Meeting and Exposition (ASH), in an oral presentation session. Details of the oral presentation are as follows: Abstract Title: Iopofosine I 131 in Previously Treated Patients with Waldenström Macroglobulinemia (WM): Efficacy and Safety Results from the International, Multicenter, Open-Label Phase 2 Study (CLOVER-WaM™)Session Name: 623. Mantle Cell, Follicular, Waldenstrom’s, and Other Indolent B Cell Lymphomas: Clinical and Epidemiological: Clinical Trials for Marginal Zone Lymphoma, Waldenstrom's Macroglobulinemia and Hairy Cell LeukemiaSession Date: Monday, December 9, 2024Presentation Time: 3:15 PM PST Delivered oral and poster presentations at the 12th International Workshop on Waldenstrom’s Macroglobulinemia (IWWM) in October 2024 that highlighted the activity of iopofosine I 131 in WM. Oral presentation: Session XXII Clinical Trials in Progress for WM: Multi-center trial of iopofosine I-131 in relapsed/refractory WMPoster presentation: Treatment With iopofosine I 131 in a Patient With Bing-Neel Syndrome, A Rare Manifestation of Waldenström Macroglobulinemia: A Case Report Advanced sales, marketing and medical planning activities to support iopofosine I 131 commercializationPartnered with key national and regional community cancer networks to better understand the WM disease landscape, to advance iopofosine I 131 for WM patients in the community settingEstablished collaboration with the City of Hope Cancer Center to evaluate iopofosine I 131 in mycosis fungoides, a cutaneous T-cell lymphomaExecuted supply and manufacturing agreements, further strengthening our multi-sourced supply network: Commercial finished product supply of iopofosine I 131 with SpectronRxPre-clinical and clinical supply of alpha-emitting actinium 225 isotope with Northstar Medical Radioisotopes Raised $19.4 million through warrant exercises and issued new milestone-based warrants with the potential to raise up to an additional $73.3 million. Funds generated from the execution of these new warrants will further advance the company’s commercialization plans for iopofosine I 131 in the treatment of WM and support future clinical development. Third Quarter 2024 Financial Highlights Cash and Cash Equivalents: As of September 30, 2024, the company had cash and cash equivalents of $34.3 million, including 19.4 million ($17.5 million, net) raised through investor exercises of Tranche B warrants and the purchase of new warrants in July 2024, compared to $9.6 million as of December 31, 2023. The company believes its cash balance as of September 30, 2024, is adequate to fund its basic budgeted operations into the second quarter of 2025.Research and Development Expenses: R&D expenses for the three months ended September 30, 2024, were approximately $5.5 million, compared to approximately $7.0 million for the three months ended September 30, 2023. The overall decrease was primarily a result of the conclusion of patient enrollment in our WM pivotal study having occurred earlier in the year, partially offset by increased activity in our ongoing pediatric trial and an increase in personnel.General and Administrative Expenses: G&A expenses for the three months ended September 30, 2024, were approximately $7.8 million, compared to approximately $2.4 million for the same period in 2023. The increase was primarily driven by costs associated with the development of infrastructure necessary to support commercialization upon anticipated NDA approval, including the related marketing and personnel cost. Conference Call & Webcast DetailsCellectar management will host a conference call and webcast today, November 18, 2024, at 8:30 AM Eastern Time to discuss these results and answer questions. Stockholders and other interested parties may participate in the conference call by dialing 1-800-717-1738. A live webcast of the conference call can be accessed in the “Events & Presentations” section of Cellectar’s website at www.cellectar.com. A recording of the webcast will be available and archived on the Company’s website for approximately 90 days. About Cellectar Biosciences, Inc.Cellectar Biosciences is a late-stage clinical biopharmaceutical company focused on the discovery, development, and commercialization of proprietary drugs for the treatment of cancer, 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 the next-generation of cancer cell-targeting treatments, delivering improved efficacy and better safety as a result of fewer off-target effects. The company’s product pipeline includes lead asset iopofosine I 131, a small-molecule PDC designed to provide targeted delivery of iodine-131 (radioisotope), proprietary preclinical PDC chemotherapeutic programs and multiple partnered PDC assets. For more information, please visit www.cellectar.com or join the conversation by liking and following us on the company’s social media channels: X, LinkedIn, and Facebook. Forward Looking Statements Disclaimer 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 including our expectations regarding the CLOVER-WaM pivotal trial. 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, 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, 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/A for the year ended December 31, 2023, and our Form 10-Q for the quarter ended September 30, 2024. These forward-looking statements are made only as of the date hereof, and we disclaim any obligation to update any such forward-looking statements. MEDIA:Claire LaCagninaBliss Bio Health315-765-1462clacagnina@blissbiohealth.com INVESTORS:Anne Marie FieldsPrecision AQ212-362-1200annemarie.fields@precisionaq.com +++ TABLES TO FOLLOW +++ CELLECTAR BIOSCIENCES, INC.CONDENSED CONSOLIDATED BALANCE SHEETS(Unaudited) September 30, December 31, 2024 2023 ASSETS CURRENT ASSETS: Cash and cash equivalents $34,263,371 $9,564,988 Prepaid expenses and other current assets 1,635,818 888,225 Total current assets 35,899,189 10,453,213 Property, plant & equipment, net 910,131 1,090,304 Operating lease right-of-use asset 454,166 502,283 Other long-term assets 29,780 29,780 TOTAL ASSETS $37,293,266 $12,075,580 LIABILITIES AND STOCKHOLDERS’ EQUITY (DEFICIT) CURRENT LIABILITIES: Accounts payable and accrued liabilities $8,304,311 $9,178,645 Warrant liability 11,929,242 16,120,898 Lease liability, current 80,821 58,979 Total current liabilities 20,314,374 25,358,522 Long-term lease liability, net of current portion 431,929 494,003 TOTAL LIABILITIES 20,746,303 25,852,525 COMMITMENTS AND CONTINGENCIES MEZZANINE EQUITY: Series D preferred stock, 111.11 shares authorized, issued and outstanding as of September 30, 2024 and December 31, 2023 1,382,023 1,382,023 STOCKHOLDERS’ EQUITY (DEFICIT): Series E-2 preferred stock, 1,225.00 shares authorized; 149.60 and 319.76 shares issued and outstanding as of September 30, 2024 and December 31, 2023, respectively 2,188,434 4,677,632 Series E-3 preferred stock, 2,205.00 shares authorized; 202.50 and 0 shares issued and outstanding as of September 30, 2024 and December 31, 2023, respectively 4,369,317 — Series E-4 preferred stock, 1,610.00 shares authorized; 714.00 and 0 shares issued and outstanding as of September 30, 2024 and December 31, 2023, respectively 7,057,793 — Common stock, $0.00001 par value; 170,000,000 shares authorized; 40,566,534 and 20,744,110 shares issued and outstanding as of September 30, 2024 and December 31, 2023, respectively 406 207 Additional paid-in capital 246,536,080 182,924,210 Accumulated deficit (244,987,090) (202,761,017)Total stockholders’ equity (deficit) 15,164,940 (15,158,968)TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY (DEFICIT) $37,293,266 $12,075,580 CELLECTAR BIOSCIENCES, INC.CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS(Unaudited) Three Months Ended September 30, Nine Months Ended September 30, 2024 2023 2024 2023 OPERATING EXPENSES: Research and development $5,493,496 $7,034,656 $19,927,019 $19,528,898 General and administrative 7,834,181 2,378,804 19,105,853 6,883,866 Total operating expenses 13,327,677 9,413,460 39,032,872 26,412,764 LOSS FROM OPERATIONS (13,327,677) (9,413,460) (39,032,872) (26,412,764) OTHER INCOME (EXPENSE): Warrant issuance expense (7,743,284) (470,000) (7,743,284) (470,000)Gain (loss) on valuation of warrants 6,088,355 (7,688,028) 3,583,440 (8,254,649)Interest income 317,887 51,110 966,643 247,925 Total other income (expense) (1,337,042) (8,106,918) (3,193,201) (8,476,724)NET LOSS $(14,664,719) $(17,520,378) (42,226,073) $(34,889,488)NET LOSS PER SHARE — BASIC $(0.37) $(1.55) (1.21) $(3.09)NET LOSS PER SHARE — DILUTED $(0.40) $(1.55) (1.39) $(3.09)WEIGHTED-AVERAGE COMMON SHARES OUTSTANDING — BASIC 39,335,924 11,308,738 34,850,441 11,277,231 WEIGHTED-AVERAGE COMMON SHARES OUTSTANDING — DILUTED 39,794,220 11,308,738 35,545,500 11,277,231

Clinical ResultASHPhase 2Financial StatementOrphan Drug

14 Nov 2024

·www.globenewswire.com

Cellectar Biosciences and NorthStar Medical Radioisotopes Announce Partnership for Supply of Actinium-225

NorthStar to provide Cellectar with non-carrier-added Ac-225 for its expanded portfolio of clinical programs FLORHAM PARK, N.J., Nov. 14, 2024 (GLOBE NEWSWIRE) -- Cellectar Biosciences, Inc. (NASDAQ: CLRB) a late-stage clinical biopharmaceutical company focused on the discovery, development and commercialization of drugs for the treatment of cancer, today announced the signing of a strategic supply agreement with NorthStar Medical Radioisotopes, LLC, for the procurement of NorthStar’s non-carrier added (n.c.a.) Ac-225. The Company’s CLR 121225 development program combines its proprietary Phospholipid Ether (PLE) delivery platform and actinium 225 for the treatment of solid tumors. Existing supply chains for medical radioisotopes are often strained, posing a challenge to patient care, clinical trials, and ongoing drug development. Actinium-225 (Ac-225) is considered a rare radioisotope and is in short supply for clinical development and commercialization. “Our PLE platform provides a unique ability to optimize delivery of any radioisotope and can be designed for the treatment of specific tumor types. Our leading alpha emitter program, CLR 121225, utilizes Ac-225 and has demonstrated promising preclinical results in pancreatic, triple negative breast and other solid tumors, justifying the progression to clinical development,” said James Caruso, president and CEO of Cellectar. “We plan to advance CLR 121225 into human clinical trials in 2025 as part of a broader strategy to bring first-and best-in-class radiotherapeutics to market. This agreement with NorthStar provides a reliable source of Ac-225, which is a critical to our clinical development strategy.” NorthStar is a global innovator in the development, production, and commercialization of radiopharmaceuticals used for therapeutic applications and medical imaging including non-carrier added (n.c.a) Ac-225. “Recent years have seen increased interest in alpha-emitting radiotherapies like Cellectar’s novel TAT compounds, including CLR 121225 and others, but development activities have been hampered by the relative scarcity of Ac-225 supply,” said Frank Scholz, president and CEO of NorthStar. “Our passion is to reduce technological and operational barriers to give companies like Cellectar a reliable source of environmentally preferred, high purity (n.c.a) Ac-225 that will help make these new therapies possible.” The agreement provides supply of Ac-225 from NorthStar for 10 years, and initiation is expected to occur in 2025. CLR 121225 is an investigational therapy and not yet approved by any regulatory authority. About NorthStar Medical Radioisotopes, LLC (NorthStar) NorthStar Medical Radioisotopes is a commercial-stage radiopharmaceutical company at the forefront of advancing patient care by utilizing novel technologies to produce commercial-scale radioisotopes that, once attached to a molecule, have the ability to detect and treat cancer and other serious diseases. NorthStar’s expanding industry-leading position in the emerging field of radiopharmaceutical therapy is supported by its unique capabilities in the sophisticated production of radioisotopes, proven management team, and state-of-the-art, environmentally preferable technologies. NorthStar routinely produces copper-67 (Cu-67) and is poised to be the first commercial-scale producer of non-carrier-added (n.c.a.) actinium-225 (Ac-225). The Company’s Radiopharmaceutical Contract Development and Manufacturing Organization (CDMO) services unit provides customized service offerings and specialized radiopharmaceutical expertise to help biopharmaceutical companies rapidly advance their development and commercial programs. For more information about NorthStar’s comprehensive portfolio and patient-focused services, visit: www.northstarnm.com. About Cellectar Biosciences, Inc. Cellectar Biosciences is a late-stage clinical biopharmaceutical company focused on the discovery, development and commercialization of novel drugs for the treatment of cancer, 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 the next-generation of cancer cell-targeting treatments, delivering improved efficacy and better safety as a result of fewer off-target effects. The company’s product pipeline includes lead asset iopofosine I 131, a small-molecule PDC designed to provide targeted delivery of iodine-131 (radioisotope), proprietary preclinical PDC chemotherapeutic programs and multiple partnered PDC assets. For more information, please visit www.cellectar.com or join the conversation by liking and following us on the company’s social media channels: Twitter, LinkedIn, and Facebook. Forward-Looking Statement Disclaimer 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 including our expectations regarding the CLOVER WaM pivotal trial. 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, 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, 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/A for the year ended December 31, 2023, and our Form 10-Q for the quarter ended June 30, 2024. 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 MEDIA: Christy MaginnBliss Bio Health 703-297-7194 cmaginn@blissbiohealth.com INVESTORS:Anne Marie FieldsPrecision AQ (formerly Stern IR)annemarie.fields@precisionaq.com

100 Deals associated with Iodine

External Link

KEGG	Wiki	ATC	Drug Bank
D00108	-	D08AG03	DB05382

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Pressure Ulcer	JP	Teikoku Seiyaku Co. Ltd.	02 Mar 2005
Skin Ulcer	JP	Teikoku Seiyaku Co. Ltd.	02 Mar 2005
Disinfectants	JP	Maruishi Pharmaceutical Co., Ltd.	05 Nov 1985
Infectious Diseases	CN	Mayinglong Pharmaceutical Group Co., Ltd.	01 Jan 1981

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Pain	Phase 3	US	Symbollon Pharmaceuticals, Inc.	01 Jul 2005
Fibrocystic Breast Disease	Phase 3	US	Symbollon Pharmaceuticals, Inc.	-
Oral Ulcer	Phase 1	CN	Beijing Humanwell Junwei Healthcare Technology Development Co Ltd	21 Dec 2020
Conjunctivitis, Bacterial	Preclinical	DE	Novaliq GmbH	11 Jun 2024
Conjunctivitis, Viral	Preclinical	DE	Novaliq GmbH	11 Jun 2024
Bacterial Infections	Preclinical	US	Symbollon Pharmaceuticals, Inc.	15 Sep 2009

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04625517 (CTgov)	Phase 4	Breast Cancer	6	Low Osmolar Contrast Material, 300-399 Mg/Ml Iodine Concentration, Per Ml+Digital Mammography	xtdiwwazxp(ygdgxlmkje) = nbwcuxjnfn ohoyoabfsy (jvxmibwuny, rvoinfqcgq - nlsutrmlvd) View more	-	12 Oct 2023
SNMMI2023	Not Applicable	Hyperthyroidism	-	iodine-131 (Patients with Plummer's disease)	ffnbpofbwh(abbyejqsjs) = mccsmeivlv yrzswuisoc (hpoavcfczn )	-	28 Aug 2023
				iodine-131 (Patients with Graves' disease)	ffnbpofbwh(abbyejqsjs) = xyxelxiehq yrzswuisoc (hpoavcfczn )
ASTRO	Not Applicable	Differentiated Thyroid Gland Carcinoma Adjuvant	151	Iodine-131 (Thyroid Hormone Withdrawal)	xzeqvsfccr(gszwwpthhz) = dycawunqqx ilctivwyfx (vivnuaefli )	Positive	01 Nov 2020
				Thyrotropin-Alpha	xzeqvsfccr(gszwwpthhz) = qgaowcwcpl ilctivwyfx (vivnuaefli )
SNMMI2018	Not Applicable	Differentiated Thyroid Gland Carcinoma	-	Iodine-131 (Pediatric patients)	jbkzguvqfg(mugxolnlow) = zvwummstsc gbglxorcrm (alqnugfaxe, 43.70) View more	-	23 May 2018
				Iodine-131 (Young adult patients)	jbkzguvqfg(mugxolnlow) = inyeouxles gbglxorcrm (alqnugfaxe, 39.58) View more
AHNS2016	Not Applicable	-	-	5% Lugol's iodine solution	qhlwhmxyae(zuwerfkasx) = No serious side effects noted other than bad taste gfvpmicszr (yofsxcxxjq ) View more	Positive	18 Jul 2016
LIHNCS (AHNS2016)	Not Applicable	Mouth Diseases	10	Lugol's Iodine (Patients with oral and oropharyngeal dysplasia)	icdnvqqglt(ekcqnwdntr) = krsrkemvtx kittpcpeam (zewzrowoaa )	-	16 Jul 2016
SNMMI2016	Not Applicable	-	327	Low-dose radioiodine (1850 MBq)	xhmylziqjb(zonayvshze) = hkdhjfyusq itpxnhafry (kgpsegjwan )	Positive	24 May 2016
				High-dose radioiodine (3700 MBq)	xhmylziqjb(zonayvshze) = rwzacytnor itpxnhafry (kgpsegjwan )
SNMMI2016	Not Applicable	Thyroid Nodule	-	High dose (30 mCi) Iodine-131 therapy	agpvsmfwmq(ggyfjjlxax) = zqvvuxcgci jspdimxyxt (jjnvfycxyi )	-	24 May 2016
1578/2013 (ASCO2016)	Not Applicable	Differentiated Thyroid Gland Carcinoma Adjuvant	45	Radioactive Iodine 30 mci	vdlszaosnq(tzlljgaolc) = The 80 mci arm patients had longer hospital admission compared to the 30 mci arm (p 0.008) tkhocllbgn (difinptvvo ) View more	Positive	20 May 2016
				Radioactive Iodine 80 mci
ASCO_GU2016	Not Applicable	-	18	Whole prostate sPPI	ngivuwaqqv(hbstbnozti) = drpqnskttn xhbeyidxij (chgpdcuclm ) View more	-	10 Jan 2016
				Focal sPPI	(loquqkpzvu) = kkaqkmvpka pbimovrizn (hghrcvgekf, Gy^2)

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