CLR-131

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

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