CLRB Cellectar Biosciences Inc.

0.54
-0.05  -8%
Previous Close 0.59
Open 0.6
52 Week Low 0.5816
52 Week High 2.98
Market Cap $32,994,683
Shares 61,101,264
Float 60,817,188
Enterprise Value $-5,634,646
Volume 560,191
Av. Daily Volume 376,363
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Drug Pipeline

Drug Stage Notes
CLR 131 - (CLOVER-1)
Various lymphoma
Phase 2
Phase 2
Phase 2 Waldenstrom’s Macroglobulinemia data presented at ASCO June 4, 2021. 100% (6/6) overall response rate, 83.3% (5/6) major response rate and a 16.7% (1/6) complete response rate. Phase 2 data reported a mean overall response rate (ORR) of 45.5%, clinical benefit rate (CBR) of 72.7% and disease control rate (DCR) of 100%, noted December 13, 2021.
iopofosine I-131 (pediatric trial)
High grade gliomas (HGGs) and soft tissue sarcomas
Phase 1
Phase 1
Phase 1 data noted that an initial response and tumor uptake were confirmed by further therapeutic responses, evidenced by changes in tumor parameters. This includes patients with relapsed HGGs experiencing over 5 months of progression free survival (PFS), noted November 16, 2021.
CLR 131 (CLOVER-WaM)
Waldenstrom’s macroglobulinemia
Phase 2
Phase 2
Phase 2 trial ongoing.
CLR 131 (iopofosine) in combination with external beam radiation (EBRT)
Head & neck cancer
Phase 1
Phase 1
Phase 1 announced the completion of the part A portion of study, September 22, 2021.
CLR 131 (CLOVER-2)
Solid tumors
Phase 1
Phase 1
Phase 1 trial ongoing.
CLR 131
Multiple myeloma
Phase 1
Phase 1
Phase 1 trial has been completed - February 19, 2020.

Latest News

  1. FLORHAM PARK, N.J., Jan. 04, 2022 (GLOBE NEWSWIRE) -- Cellectar Biosciences, Inc. (NASDAQ:CLRB), a late-stage clinical biopharmaceutical company focused on the discovery, development and commercialization of targeted drugs for the treatment of cancer, today announced Jim Caruso, president and CEO and Jarrod Longcor, CBO, will participate in a fireside chat at the H.C. Wainwright Bioconnect conference taking place virtually January 10-13, 2022.

    The fireside chat will be available on demand beginning at 7:00 am ET on January 10, 2022. To access and view the event, investors are encouraged to register by clicking on this registration link.

    The event also will be available on the News & Media section of the company's website.

    About Cellectar

    FLORHAM PARK, N.J., Jan. 04, 2022 (GLOBE NEWSWIRE) -- Cellectar Biosciences, Inc. (NASDAQ:CLRB), a late-stage clinical biopharmaceutical company focused on the discovery, development and commercialization of targeted drugs for the treatment of cancer, today announced Jim Caruso, president and CEO and Jarrod Longcor, CBO, will participate in a fireside chat at the H.C. Wainwright Bioconnect conference taking place virtually January 10-13, 2022.

    The fireside chat will be available on demand beginning at 7:00 am ET on January 10, 2022. To access and view the event, investors are encouraged to register by clicking on this registration link.

    The event also will be available on the News & Media section of the company's website.

    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, a small-molecule PDC designed to provide targeted delivery of iodine-131 (radioisotope), and proprietary preclinical PDC chemotherapeutic programs and multiple partnered PDC assets. The company is currently investigating iopofosine in a global, pivotal expansion cohort in relapsed or refractory WM patients who have received at least two prior lines of therapy, including those who have failed or had a suboptimal response to Bruton tyrosine kinase inhibitors. The WM cohort will enroll up to 50 patients to evaluate the efficacy and safety of iopofosine for marketing approval. The company is also evaluating iopofosine in highly refractory multiple myeloma patients in its Phase 2 CLOVER-1 study and relapsed/refractory pediatric cancer patients with sarcomas or brain tumors in the Phase 1 CLOVER-2 study.

    The Phase 1 pediatric study is an open-label, sequential-group, dose-escalation study to evaluate the safety and tolerability of iopofosine in children and adolescents with relapsed or refractory cancers, including malignant brain tumors, neuroblastoma, sarcomas, and lymphomas (including Hodgkin's lymphoma). The Phase 1 study is being conducted internationally at seven leading pediatric cancer centers.

    For more information, please visit www.cellectar.com and www.wmclinicaltrial.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 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, 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 for the year ended December 31, 2020, and our Form 10-Q for the quarter ended September 30, 2021. 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 Kosse

    Managing Director

    LifeSci Advisors

    212-915-3820



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  2. Poster highlighted data from 11 patients with at least triple class refractory multiple myeloma

    Mean ORR of 45.5%, CBR of 72.7% and DCR of 100% and the subset of quad/penta drug refractory patients had an ORR of 80% and CBR of 100%

    FLORHAM PARK, N.J., Dec. 13, 2021 (GLOBE NEWSWIRE) -- Cellectar Biosciences, Inc. (NASDAQ:CLRB), a late-stage clinical biopharmaceutical company focused on the discovery, development and commercialization of targeted drugs for the treatment of cancer, presented data from 11 multiple myeloma patients from the company's ongoing Phase 2 CLOVER-1 study of iopofosine I-131 in a poster at the American Society of Hematology (ASH) Annual Meeting and Exposition.

    The multiple myeloma patients were at least triple class…

    Poster highlighted data from 11 patients with at least triple class refractory multiple myeloma

    Mean ORR of 45.5%, CBR of 72.7% and DCR of 100% and the subset of quad/penta drug refractory patients had an ORR of 80% and CBR of 100%

    FLORHAM PARK, N.J., Dec. 13, 2021 (GLOBE NEWSWIRE) -- Cellectar Biosciences, Inc. (NASDAQ:CLRB), a late-stage clinical biopharmaceutical company focused on the discovery, development and commercialization of targeted drugs for the treatment of cancer, presented data from 11 multiple myeloma patients from the company's ongoing Phase 2 CLOVER-1 study of iopofosine I-131 in a poster at the American Society of Hematology (ASH) Annual Meeting and Exposition.

    The multiple myeloma patients were at least triple class refractory (defined as refractory to an immunomodulatory agent, proteasome inhibitor and monoclonal antibody) with data current as of the end of May 2021. Patients had a median of greater than 7 prior therapies with 50% classified as high risk. Initial results in these patients showed an overall response rate (ORR) of 45.5%, a clinical benefit rate (CBR) of 72.7% and a disease control rate (DCR) of 100%. Median progression free survival (PFS) was 3.4 months. In a subset of 5 quad/penta drug refractory patients, efficacy increased, demonstrating an ORR of 80% and CBR of 100% in this highly treatment refractory group. The most commonly observed treatment emergent adverse events were cytopenias that included Grade 3 or 4 thrombocytopenia (62.5%), anemia (62.5%), neutropenia (62.5%) and decreased white blood cell count (50%). Treatment emergent adverse events were mostly limited to bone marrow suppression in line with prior observations. No patients experienced a treatment emergent adverse event of neuropathy, arrhythmia, cardiovascular event, bleeding, ocular toxicities, renal function, alterations in liver enzymes, or infusion-site reactions or adverse events.

    "These results in heavily pre-treated, highly refractory patients are very encouraging, and show that iopofosine I-131 has the potential to be a meaningful part of the treatment regimen in multiple myeloma," said Dr. Sikander Ailawadhi, professor of medicine, Lead, International Cancer Center, Division of Hematology/Oncology, Departments of Medicine and Cancer Biology at Mayo Clinic Jacksonville, Florida and principal investigator of the Phase 2 CLOVER-1 study.

    James Caruso, president and CEO of Cellectar, said, "Unfortunately, there remains a need for additional therapies and treatment options for patients with refractory multiple myeloma. We believe iopofosine I-131's demonstrated ability to specifically target cancer cells potentially represents an important advancement in cancer-targeting treatments. We look forward to sharing additional data as the Phase 2 CLOVER-1 study matures. In parallel, we continue to execute on our ongoing pivotal study in Waldenstrom's macroglobulinemia where we anticipate announcing results of a futility analysis in the first quarter of 2022."

    Patients in the study received up to 4, approximately 20 minute IV infusions of iopofosine I-131 over 3 months, with doses given 14 days apart in each cycle and a maximum of 2 cycles. Low dose dexamethasone 40mg weekly (20mg in patients ≥ 75), was provided for up to 12 weeks. Following treatment with iopofosine I-131, approximately 91% of patients experience a reduction in tumor marker with approximately 73% experiencing greater than 37% reduction.

    A copy of the poster will be available after the presentation on the Posters and Presentations section of the company's website.

    About iopofosine I-131

    Iopofosine is a small-molecule Phospholipid Drug Conjugate™ designed to provide targeted delivery of iodine-131 (radioisotope) directly to cancer cells, while limiting exposure to healthy cells. We believe this profile differentiates iopofosine from many traditional on-market treatments. Iopofosine is currently being evaluated in the CLOVER-WaM Phase 2 pivotal study in patients with relapsed/refractory (r/r) Waldenstrom's macroglobulinemia (WM), a Phase 2b study in r/r multiple myeloma (MM) patients and the CLOVER-2 Phase 1 study for a variety of pediatric cancers. The U.S. Food and Drug Administration granted iopofosine Fast Track Designation for WM patients having received two or more prior treatment regimens, as well as r/r MM and r/r diffuse large B-cell lymphoma (DLBCL). Orphan Drug Designations (ODDs) have been granted for WM, MM, neuroblastoma, rhabdomyosarcoma, Ewing's sarcoma and osteosarcoma. Iopofosine was also granted Rare Pediatric Disease Designation (RPDD) for the treatment of neuroblastoma, rhabdomyosarcoma, Ewing's sarcoma and osteosarcoma. The European Commission granted an ODDs for r/r MM and WM.

    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, a small-molecule PDC designed to provide targeted delivery of iodine-131 (radioisotope), and proprietary preclinical PDC chemotherapeutic programs and multiple partnered PDC assets. The company is currently investigating iopofosine in a global, pivotal expansion cohort in relapsed or refractory WM patients who have received at least two prior lines of therapy, including those who have failed or had a suboptimal response to Bruton tyrosine kinase inhibitors. The WM cohort will enroll up to 50 patients to evaluate the efficacy and safety of iopofosine for marketing approval. The company is also evaluating iopofosine in highly refractory multiple myeloma patients in its Phase 2 CLOVER-1 study and relapsed/refractory pediatric cancer patients with sarcomas or brain tumors in the Phase 1 CLOVER-2 study.

    The Phase 1 pediatric study is an open-label, sequential-group, dose-escalation study to evaluate the safety and tolerability of iopofosine in children and adolescents with relapsed or refractory cancers, including malignant brain tumors, neuroblastoma, sarcomas, and lymphomas (including Hodgkin's lymphoma). The Phase 1 study is being conducted internationally at seven leading pediatric cancer centers.

    For more information, please visit www.cellectar.com and www.wmclinicaltrial.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 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, 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 for the year ended December 31, 2020, and our Form 10-Q for the quarter ended September 30, 2021. 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 Kosse

    Managing Director

    LifeSci Advisors

    212-915-3820



    Primary Logo

    View Full Article Hide Full Article
  3. FLORHAM PARK, N.J., Dec. 08, 2021 (GLOBE NEWSWIRE) -- Cellectar Biosciences, Inc. (NASDAQ:CLRB), a late-stage clinical biopharmaceutical company focused on the discovery, development and commercialization of targeted drugs for the treatment of cancer, today announced a poster presentation featuring data from the company's ongoing Phase 2 CLOVER-1 study of iopofosine I-131 at the American Society of Hematology (ASH) Annual Meeting and Exposition being held virtually December 11-14, 2021.

    The poster will highlight data from eleven multiple myeloma patients who were at least triple class refractory (immunomodulatory agent, proteasome inhibitor and monoclonal antibody) that were treated with iopofosine I-131 in the company's Phase 2 CLOVER-1…

    FLORHAM PARK, N.J., Dec. 08, 2021 (GLOBE NEWSWIRE) -- Cellectar Biosciences, Inc. (NASDAQ:CLRB), a late-stage clinical biopharmaceutical company focused on the discovery, development and commercialization of targeted drugs for the treatment of cancer, today announced a poster presentation featuring data from the company's ongoing Phase 2 CLOVER-1 study of iopofosine I-131 at the American Society of Hematology (ASH) Annual Meeting and Exposition being held virtually December 11-14, 2021.

    The poster will highlight data from eleven multiple myeloma patients who were at least triple class refractory (immunomodulatory agent, proteasome inhibitor and monoclonal antibody) that were treated with iopofosine I-131 in the company's Phase 2 CLOVER-1 study, with data current as of the end of May 2021.

    Details for the poster presentation are as follows:

    Title:CLR 131 (Iopofosine I-131) Treatment in Triple Class Refractory and Beyond Multiple Myeloma Patients: Preliminary Efficacy and Safety Results from the Phase 2 CLOVER-1 Trial
    Session/Title:653/Myeloma and Plasma Cell Dyscrasias: Clinical-Prospective Therapeutic Trials: Poster I
    Abstract:1652
    Authors:Sikander Ailawadhi; Patrick Stiff; Emad Ibrahim; Damian J. Green; Brea Lipe; Elizabeth H. Cull; Natalie S. Callander; John Friend; Jarrod Longcor, and Kate Oliver
    Date/Time:Saturday, December 11, 2021 at 5:30 pm – 7:30 pm

    A copy of the poster will be available after the presentation on the News and Events section of the company's website.

    About iopofosine (also known as CLR 131)

    Iopofosine is a small-molecule Phospholipid Drug Conjugate™ designed to provide targeted delivery of iodine-131 (radioisotope) directly to cancer cells, while limiting exposure to healthy cells. We believe this profile differentiates iopofosine from many traditional on-market treatments. Iopofosine is currently being evaluated in the CLOVER-WaM Phase 2 pivotal study in patients with relapsed/refractory (r/r) Waldenstrom's macroglobulinemia (WM), a Phase 2b study in r/r multiple myeloma (MM) patients and the CLOVER-2 Phase 1 study for a variety of pediatric cancers. The U.S. Food and Drug Administration granted iopofosine Fast Track Designation for WM patients having received two or more prior treatment regimens, as well as r/r MM and r/r diffuse large B-cell lymphoma (DLBCL). Orphan Drug Designations (ODDs) have been granted for WM, MM, neuroblastoma, rhabdomyosarcoma, Ewing's sarcoma and osteosarcoma. Iopofosine was also granted Rare Pediatric Disease Designation (RPDD) for the treatment of neuroblastoma, rhabdomyosarcoma, Ewing's sarcoma and osteosarcoma. The European Commission granted an ODDs for r/r MM and WM.

    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, a small-molecule PDC designed to provide targeted delivery of iodine-131 (radioisotope), and proprietary preclinical PDC chemotherapeutic programs and multiple partnered PDC assets. The company is currently investigating iopofosine in a global, pivotal expansion cohort in relapsed or refractory WM patients who have received at least two prior lines of therapy, including those who have failed or had a suboptimal response to Bruton tyrosine kinase inhibitors. The WM cohort will enroll up to 50 patients to evaluate the efficacy and safety of iopofosine for marketing approval. The company is also evaluating iopofosine in highly refractory multiple myeloma patients in its Phase 2 CLOVER-1 study and relapsed/refractory pediatric cancer patients with sarcomas or brain tumors in the Phase 1 CLOVER-2 study.

    The Phase 1 pediatric study is an open-label, sequential-group, dose-escalation study to evaluate the safety and tolerability of iopofosine in children and adolescents with relapsed or refractory cancers, including malignant brain tumors, neuroblastoma, sarcomas, and lymphomas (including Hodgkin's lymphoma). The Phase 1 study is being conducted internationally at seven leading pediatric cancer centers.

    For more information, please visit www.cellectar.com and www.wmclinicaltrial.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 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, 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 for the year ended December 31, 2020, and our Form 10-Q for the quarter ended September 30, 2021. 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 Kosse

    Managing Director

    LifeSci Advisors

    212-915-3820



    Primary Logo

    View Full Article Hide Full Article
  4. FLORHAM PARK, N.J., Nov. 16, 2021 (GLOBE NEWSWIRE) -- Cellectar Biosciences, Inc. (NASDAQ:CLRB), a late-stage clinical biopharmaceutical company focused on the discovery, development and commercialization of targeted drugs for the treatment of cancer, today announced that patients in a Phase 1 study of iopofosine I-131 ("iopofosine") in children and adolescents with relapsed and refractory high grade gliomas (HGGs) and soft tissue sarcomas, exhibited positive changes in various tumor parameters. The Phase 1 study is an international, open-label, dose escalation, safety study of iopofosine in children and adolescents with relapsed or refractory cancers, specifically HGGs, high risk neuroblastoma and select soft tissue sarcomas.

    The independent…

    FLORHAM PARK, N.J., Nov. 16, 2021 (GLOBE NEWSWIRE) -- Cellectar Biosciences, Inc. (NASDAQ:CLRB), a late-stage clinical biopharmaceutical company focused on the discovery, development and commercialization of targeted drugs for the treatment of cancer, today announced that patients in a Phase 1 study of iopofosine I-131 ("iopofosine") in children and adolescents with relapsed and refractory high grade gliomas (HGGs) and soft tissue sarcomas, exhibited positive changes in various tumor parameters. The Phase 1 study is an international, open-label, dose escalation, safety study of iopofosine in children and adolescents with relapsed or refractory cancers, specifically HGGs, high risk neuroblastoma and select soft tissue sarcomas.

    The independent data monitoring committee (DMC) had previously determined that doses up to 60 mCi/m2 were safe and tolerable and to initiate the 75 mCi/m2 dosing cohort. The DMC advised, based upon the initial data, to enrich the 60 mCi/m2 dose level for patients over the age of 10 with HGG and Ewing sarcoma. The initial response and tumor uptake were confirmed by further therapeutic responses, evidenced by changes in tumor parameters. This includes patients with relapsed HGGs experiencing over 5 months of progression free survival (PFS).

    "Initial responses to iopofosine I-131 in relapsed pediatric brain tumors are most encouraging. Current treatment paradigms typically result in only 2-3 months1 of PFS and while there is no comparator in this study, iopofosine data to date have demonstrated nearly double the PFS versus historical data," said Laurence Reilly interim chief medical officer of Cellectar. "Based upon these data we will continue to enroll patients with high grade gliomas and soft tissue sarcomas, and we look forward to engaging with the FDA in order to outline a potential registrational pathway."

    Pediatric HGGs are a collection of aggressive brain and central nervous system tumor subtypes including diffuse intrinsic pontine gliomas, glioblastomas, astrocytomas and ependymomas. Children with these tumors have a poor prognosis and 5-year survival of less than 30%.

    About iopofosine (also known as CLR 131)

    Iopofosine is a small-molecule Phospholipid Drug Conjugate™ designed to provide targeted delivery of iodine-131 (radioisotope) directly to cancer cells, while limiting exposure to healthy cells. We believe this profile differentiates iopofosine from many traditional on-market treatments. Iopofosine is currently being evaluated in the CLOVER-WaM Phase 2 pivotal study in patients with relapsed/refractory (r/r) Waldenstrom's macroglobulinemia (WM), a Phase 2b study in r/r multiple myeloma (MM) patients and the CLOVER-2 Phase 1 study for a variety of pediatric cancers. The U.S. Food and Drug Administration granted iopofosine Fast Track Designation for WM patients having received two or more prior treatment regimens, as well as r/r MM and r/r diffuse large B-cell lymphoma (DLBCL). Orphan Drug Designations (ODDs) have been granted for WM, MM, neuroblastoma, rhabdomyosarcoma, Ewing's sarcoma and osteosarcoma. Iopofosine was also granted Rare Pediatric Disease Designation (RPDD) for the treatment of neuroblastoma, rhabdomyosarcoma, Ewing's sarcoma and osteosarcoma. The European Commission granted an ODDs for r/r MM and WM.

    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, a small-molecule PDC designed to provide targeted delivery of iodine-131 (radioisotope), and proprietary preclinical PDC chemotherapeutic programs and multiple partnered PDC assets. The company is currently investigating iopofosine in a global, pivotal expansion cohort in relapsed or refractory WM patients who have received at least two prior lines of therapy, including those who have failed or had a suboptimal response to Bruton tyrosine kinase inhibitors. The WM cohort will enroll up to 50 patients to evaluate the efficacy and safety of iopofosine for marketing approval. The company is also evaluating iopofosine in highly refractory multiple myeloma patients in its Phase 2 CLOVER-1 study and relapsed/refractory pediatric cancer patients with sarcomas or brain tumors in the Phase 1 CLOVER-2 study.

    The Phase 1 pediatric study is an open-label, sequential-group, dose-escalation study to evaluate the safety and tolerability of iopofosine in children and adolescents with relapsed or refractory cancers, including malignant brain tumors, neuroblastoma, sarcomas, and lymphomas (including Hodgkin's lymphoma). The Phase 1 study is being conducted internationally at seven leading pediatric cancer centers.

    For more information, please visit www.cellectar.com and www.wmclinicaltrial.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 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, 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 for the year ended December 31, 2020, and our Form 10-Q for the quarter ended September 30, 2021. 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 Kosse

    Managing Director

    LifeSci Advisors

    212-915-3820

    1. Narayana A, Kunnakkat S, Chacko-Mathew J, Gardner S, Karajannis M, Raza S, Wisoff J, Weiner H, Harter D, Allen J. Bevacizumab in recurrent high-grade pediatric gliomas. Neuro Oncol. 2010 Sep;12(9):985-90. doi: 10.1093/neuonc/noq033. Epub 2010 Apr 2. PMID: 20363768; PMCID: PMC2940690.





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  5. SYDNEY, Nov. 15, 2021 /PRNewswire/ -- Kazia Therapeutics Limited (NASDAQ:KZIA, ASX: KZA))), an oncology-focused drug development company, is pleased to announce the appointment of John Friend, MD, as Chief Medical Officer.

    Kazia Therapeutics Limited Logo (PRNewsfoto/Kazia Therapeutics Limited)

    In this role, Dr. Friend will be responsible for overseeing the development and commercialization of Kazia's pipeline drug candidates, and for collaborating with clinicians and scientists to advance the company's research programs. Dr. Friend is based in New Jersey in the United States.

    Kazia CEO, Dr. James Garner, commented, "We are delighted to welcome John to the Kazia team. With paxalisib moving rapidly towards potential commercialization, and EVT801 now in the clinic, this appointment is very timely. John is a highly…

    SYDNEY, Nov. 15, 2021 /PRNewswire/ -- Kazia Therapeutics Limited (NASDAQ:KZIA, ASX: KZA))), an oncology-focused drug development company, is pleased to announce the appointment of John Friend, MD, as Chief Medical Officer.

    Kazia Therapeutics Limited Logo (PRNewsfoto/Kazia Therapeutics Limited)

    In this role, Dr. Friend will be responsible for overseeing the development and commercialization of Kazia's pipeline drug candidates, and for collaborating with clinicians and scientists to advance the company's research programs. Dr. Friend is based in New Jersey in the United States.

    Kazia CEO, Dr. James Garner, commented, "We are delighted to welcome John to the Kazia team. With paxalisib moving rapidly towards potential commercialization, and EVT801 now in the clinic, this appointment is very timely. John is a highly experienced oncology and haematology drug developer who brings to Kazia a wealth of expertise, as well as a passion for improving the lives of patients with cancer."

    Dr. Friend gained his medical degree at Rutgers University (UMDNJ-Robert Wood Johnson) and also holds a BA in chemistry from Southern Methodist University. In a career spanning more than 25 years, he has worked across a wide range of therapeutic areas in roles spanning early clinical research through to medical affairs. Of note, he spent seven years with the US business unit of Helsinn Therapeutics, a leading European specialty pharmaceutical company, leaving as Senior Vice President of Medical and Scientific Affairs. Prior to joining Kazia, he was Chief Medical Officer at Cellectar Biosciences, Inc (NASDAQ:CLRB), a clinical-stage, oncology-focused biotech company based in Florham Park, NJ.

    Dr. Friend commented, "I look forward to working with Kazia colleagues to drive the company's pipeline forward toward its full potential.  Both paxalisib and EVT801 have enormous scope to address unmet needs in a number of different tumor types and I am pleased to be working with world-renowned cancer centers and their leading clinicians to develop these promising new therapies. I am delighted to join Kazia at such an exciting and pivotal time for the company."

    About Kazia Therapeutics Limited

    Kazia Therapeutics Limited (NASDAQ:KZIA, ASX: KZA))) is an oncology-focused drug development company, based in Sydney, Australia.

    Our lead program is paxalisib, a brain-penetrant inhibitor of the PI3K / Akt / mTOR pathway, which is being developed to treat glioblastoma, the most common and most aggressive form of primary brain cancer in adults. Licensed from Genentech in late 2016, paxalisib commenced recruitment to GBM AGILE, a pivotal study in glioblastoma, in January 2021. Eight additional studies are active in various forms of brain cancer. Paxalisib was granted Orphan Drug Designation for glioblastoma by the US FDA in February 2018, and Fast Track Designation for glioblastoma by the US FDA in August 2020. In addition, paxalisib was granted Rare Pediatric Disease Designation and Orphan Designation by the US FDA for DIPG in August 2020.

    Kazia is also developing EVT801, a small-molecule inhibitor of VEGFR3, which was licensed from Evotec SE in April 2021. Preclinical data has shown EVT801 to be active against a broad range of tumour types and has provided compelling evidence of synergy with immuno-oncology agents. A phase I study commenced recruitment in November 2021.

    For more information, please visit www.kaziatherapeutics.com or follow us on Twitter @KaziaTx.

    This document was authorized for release to the ASX by James Garner, Chief Executive Officer, Managing Director.

    Cision View original content to download multimedia:https://www.prnewswire.com/news-releases/kazia-therapeutics-appoints-john-friend-md-as-chief-medical-officer-301423685.html

    SOURCE Kazia Therapeutics Limited

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