Cellectar Biosciences is laying off 60% of its employees and halting work on its sole clinical-stage radiotherapy after the company received feedback from the FDA that a fresh study would be required before approval.
The New Jersey-based biotech had been working on the assumption that it had already accrued the data needed to submit the phospholipid drug conjugate, called iopofosine I 131, for approval to treat a rare cancer of the bone marrow called Waldenström macroglobulinemia (WM).
Cellectar had run its phase 2 CLOVER-WaM study “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 WM,” the biotech explained in a post-market release Dec. 10.
However, those plans were thrown into doubt after a recent meeting with the FDA, from which Cellectar left now believing that an accelerated approval submission would also require a confirmatory study to generate data on progression-free survival (PFS).
Having mulled this feedback, the company has decided to “pursue strategic options for the further development and commercialization” of iopofosine I 131, it said in the release.
“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,” Cellectar CEO James Caruso said.
“We believe iopofosine I 131 represents a compelling opportunity as it has shown strong efficacy and good tolerability based on our clinical studies,” Caruso added. “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.”
Despite having no other candidates in the clinic, the biotech said it would “focus on those assets it believes have the highest therapeutic potential and opportunity for value creation.” Pointing to the sector’s newfound interest in alpha- and Auger-emitters, Cellectar said it would focus its resources on its solid tumor-targetting actinium-225 based program, as well as its iodine-125 Auger-emitting program.
The plan is to secure the green light in the first half of next year to launch trials of both programs, which the company noted have “demonstrated robust in vivo activity, tolerability, excellent targeting and uptake in preclinical solid tumor models.”
This new strategy will involve laying off around 60% of the company’s staff. The impact will be felt across “all departments,” with the force reduction due for completion by the end of the year.
“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,” Caruso said. “This reorganization is difficult but necessary for the future growth potential of Cellectar.”
Investors appeared unconvinced by the new direction, sending the biotech’s shares down 52% in pre-market trading Wednesday to 61 cents, from a Tuesday closing price of $1.28.