Cellectar Biosciences Partners with MiBA, a Data Subsidiary of American Oncology Network, to Advance the Treatment of Waldenstrom's Macroglobulinemia in the Community Setting
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The partnership between Cellectar Biosciences and the American Oncology Network (AON) marks a strategic move in the oncology sector, particularly for the treatment of Waldenstrom's macroglobulinemia (WM), a rare form of cancer. The collaboration is poised to leverage AON's extensive network and the data analytics prowess of Meaningful Insights-BioTech Analytics (MiBA) to enhance the commercial strategy for Cellectar's iopofosine I 131. It's crucial to understand the significance of such alliances in improving patient access to novel treatments, especially for conditions with limited therapeutic options.
The reported overall response rate and disease control rate from the Clover WaM study are notable, as they exceed the outcomes of current therapies for relapsed or refractory WM. Such data not only bolster the therapeutic potential of iopofosine I 131 but also underscore the importance of targeted radiotherapeutic conjugates in managing complex hematologic malignancies. From a clinical perspective, the partnership could streamline the integration of new treatments into routine care, ultimately enhancing patient outcomes and setting new standards in oncology practice.
The announcement by Cellectar Biosciences regarding their partnership with AON and MiBA is a significant development within the biopharmaceutical industry, particularly for investors monitoring the commercial potential of novel cancer therapies. The focus on community-based oncology management is a strategic approach to broaden market penetration and ensure that the treatment reaches a wider patient population. By collaborating with a network that manages a substantial number of WM patients, Cellectar is positioning iopofosine I 131 for accelerated adoption following FDA approval.
The market for WM treatments is niche, given the rarity of the disease, yet the unmet medical need presents a substantial opportunity for Cellectar. The Orphan and Fast Track Designation by the FDA further enhances the potential for expedited commercialization. Investors should consider the implications of this partnership on Cellectar's market position and the possible impact on the company's revenue growth, especially as the treatment approaches regulatory approval and market entry.
The strategic collaboration between Cellectar Biosciences, AON and MiBA is a pivotal step in the advancement of WM treatment. The utilization of real-world data and advanced analytics by MiBA can significantly contribute to the understanding of treatment patterns, patient outcomes and healthcare provider needs. This data-driven approach is essential for optimizing the launch strategy of iopofosine I 131 and ensuring that the therapy meets the clinical and practical needs of both patients and providers.
It is also noteworthy that the Clover WaM study represents a landmark in WM research, targeting the most refractory patient population ever tested. The high response rates observed suggest that iopofosine I 131 could become an influential therapy in the WM treatment landscape. For stakeholders, including clinicians and patients, the implications of this partnership extend beyond immediate commercial interests and hold the promise of improved standards of care in a disease area with significant unmet needs.
Partnership to Provide Key Data on WM Treatment Landscape and Community Clinic Access to Support Iopofosine I 131 Commercialization Strategy
FLORHAM PARK, N.J., Jan. 11, 2024 (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, announced today a partnership to advance the treatment of Waldenstrom's macroglobulinemia (WM) in the community setting with American Oncology Network (AON), a leading oncology platform with an innovative model of physician-led, community-based oncology management, and its data arm subsidiary Meaningful Insights-BioTech Analytics (MiBA), a healthcare AI technology company on a mission to close the feedback loop between physicians, patients, and industry partners.
"AON is currently managing over 650 Waldenstrom’s macroglobulinemia patients,” said Dr. Fred Divers, chief medical officer of AON. “We are committed to providing promising new radiotherapies, starting with Cellectar’s iopofosine I 131, a novel phospholipid radiotherapeutic conjugate, throughout our nationwide network of clinics. It is critical for patients to have access to advances in the treatment of this rare cancer, where there is currently no standard of care for those with relapsed or refractory disease. The pivotal topline data for iopofosine demonstrating an overall response rate of
Positive topline data from the pivotal Clover WaM study for iopofosine I 131 was reported on January 8, achieving the primary endpoint with a
“We are extremely pleased to be partnering with AON and MiBA to support our collective goal to enrich the WM treatment paradigm for patients and providers,” said James Caruso, president and CEO of Cellectar. “This collaboration will provide additional insight to patients’ and health care providers’ needs across the WM treatment landscape and the learnings will be incorporated into the launch strategy for iopofosine I 131. Following achievement of the primary endpoint in the CLOVER WaM pivotal study, this partnership with AON represents another strategically important collaboration to ensure patient access and optimize outcomes with iopofosine therapy upon FDA approval.”
AON is one of the fastest growing networks of community oncology practices with 85 sites of care across the U.S. focused on delivering high-quality cancer care. The partnership with AON and MiBA is a key addition to Cellectar’s planned collaborations with leading U.S. community-based cancer care networks to identify unmet WM patient needs and opportunities to optimize the potential commercial launch for iopofosine I 131.
“We are very excited to be able to support the efforts of all involved in this project with MiBA’s technical and analytical capabilities,” said Mark Moch, Executive Manager at MiBA. “Data identification, curation and advanced analytics are essential in moving treatments forward. Keeping our patient at the center and working in close association with AON and Cellectar, gives us the ability to positively affect outcomes and contribute to future standards of care.”
The U.S. Food and Drug Administration (FDA) has granted Cellectar’s iopofosine I 131, a small-molecule Phospholipid Drug Conjugate™ (PDC) designed to provide targeted delivery of iodine-131 (radioisotope), Orphan and Fast Track Designation for relapsed/refractory WM patients.
WM is a rare type of B-cell lymphoma that originates from the bone marrow lymphocytes. It is estimated that 26,000 people are living with WM in the U.S. and greater than 10,000 are in a second-line plus stage of treatment. Currently there are limited treatment options with only one approved class of drugs and no established standard of care beyond second-line therapy.
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 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 and www.wmclinicaltrial.com or join the conversation by liking and following us on the company’s social media channels: Twitter, LinkedIn, and Facebook.
About American Oncology Network
Since its inception in 2018, American Oncology Network, Inc. (Nasdaq: AONC) has offered an innovative model of physician-led, community-based oncology management. AONC preserves and elevates community oncology by helping its physicians navigate the complex healthcare landscape, providing them an efficient platform to work autonomously and thrive, and most importantly, improving the quality of patient care that is being delivered. The network is an alliance of physicians and veteran healthcare leaders partnering to ensure the long-term success and viability of oncology diagnosis and treatment in community-based settings. As of September 30, 2023, AONC has more than 200 providers across 85 locations in 19 states and the District of Columbia. AONC’s robust platform provides oncology practices with comprehensive support, access to revenue- diversifying adjacent services and practice management expertise to empower physicians to make cancer care better for every patient.
About MiBA
MiBA is a healthcare AI technology company on a mission to close the feedback loop between physicians, patients and industry partners. The technology and data insights that MiBA generates will support pharmaceutical companies, research organizations, payers, biotech, health systems and providers to advance the quality of patient care.
MiBA’s culture is one of empathy. The heart of the mission is every patient deserves the best care possible- period. Putting the power of data into the hands of industry stakeholders to enable to drive informed decisions.
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 WM 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 for the year ended December 31, 2022, and our Form 10-Q for the quarter ended September 30, 2023. 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:
Claire LaCagnina
Bliss Bio Health
315-765-1462
clacagnina@blissbiohealth.com
INVESTORS:
Chad Kolean
Chief Financial Officer
investors@cellectar.com
FAQ
What is the partnership announced by Cellectar Biosciences (NASDAQ: CLRB)?
What was the major response rate (MRR) achieved in the pivotal Clover WaM study for iopofosine I 131?
What is the goal of the partnership between Cellectar Biosciences, AON, and MiBA?
What is the FDA designation granted to Cellectar's iopofosine I 131?
How many people are estimated to be living with WM in the U.S.?
