Radiopharma biotech Cellectar Biosciences is seeking strategic alternatives, opening the door to further opportunities after looking to partner off its sole clinical-stage asset to no avail this winter.
The New Jersey-based business is open to numerous options, such as mergers, acquisitions, partnerships, joint ventures, licensing arrangements or other strategic transactions, in the name of maximizing shareholder value, according to an April 30 release.
Cellectar didn’t set a timeline for the process and doesn’t plan on sharing further details until deemed necessary, the company said in the release.
The biotech’s stock has sunk 15%, from 29 cents per share at market close yesterday to 24 cents at 10:40 a.m. ET today.
The move follows 60% layoffs in mid-December and discontinued development on the biotech’s sole clinical-stage radiotherapy. The scale-back came after the company received feedback from the FDA that a new study would be required before a possible approval.
The cancer company had been working under the assumption that it already had the data needed to submit the phospholipid drug conjugate, called iopofosine I 131, for approval in a rare cancer of the bone marrow called Waldenström macroglobulinemia (WM).
Cellectar had run a phase 2 trial “in accordance with earlier FDA communications” during which the company “was informed that positive results for major response rate as the primary endpoint could be acceptable to support accelerated approval of iopofosine I 131 as a treatment for WM,” the biotech said in a Dec. 10 release.
However, the FDA later let Cellectar know that an accelerated approval submission would also require a confirmatory study to generate data on progression-free survival. Given that feedback, the biotech began pursuing strategic options “for the further development and commercialization” of iopofosine I 131.
Now, the biotech continues to search for a partner with the resources to continue developing the asset, Cellectar CEO James Caruso said in today’s release.
“In addition to iopofosine I 131, our platform provides exciting opportunities, including our alpha- and Auger-emitting radioconjugates, CLR 225 and CLR 125, respectively, in multiple solid tumor indications as well as our small molecule and oligonucleotide conjugates,” said Caruso.
In December, the biotech had laid out plans to launch clinical trials this year for the preclinical programs CLR 225 and CLR 125. Over the last few months, those intentions have dissipated.