After bagging Shire’s cell therapy castoff, Caladrius stock climbs

After Shire’s $32 billion buyout of Baxalta back in 2016, the company has been purging its unwanted assets to biotechs with barren pipelines. Now, one of those programs is landing in familiar hands.

Caladrius Biosciences $CLBS, a biopharma that killed its lead drug two years ago, has snatched an exclusive license to a late-stage cell therapy program being tossed by Shire. The program is a CD34+ cell therapy for refractory angina, and it’s a treatment Caladrius’ CMO knows quite well.

Douglas Losordo

“Prior to joining Caladrius, I designed and was principal investigator of the Phase I and Phase II studies of this CD34+ therapy that were conducted with the support of Baxter,” Douglas Losordo, who heads up clinical programs at Caladrius, said in a statement. “I also designed and launched the Phase III study at Baxter prior to its spinoff of Baxalta and Baxalta’s subsequent merger with Shire. Given my intimate knowledge of this clinical program, I am very excited by our acquisition of this data license and remain positive about the prospects for this therapy as a treatment for patients suffering with refractory angina.”

As part of the deal, Caladrius got its hands on quite a lot of data. The deal includes preclinical, Phase I, Phase II, and Phase III study data of the drug, along with regulatory filings. In return, Shire gets undisclosed upfront payments, milestones, and a royalty on product sales.

David Mazzo

“This program represents a large potential commercial opportunity as refractory angina afflicts approximately one million people in the US alone, with an incidence rate of 50,000 to 100,000 annually,” Caladrius’ CEO David Mazzo said in a statement. “We look forward to discussing with the FDA the most expeditious regulatory path aimed at registration for this CD34+ cell therapy program and to bringing this potentially restorative therapy to patients in need.”

The new product candidate gives Caladrius investors something to bet on, which is likely a relief for those disappointed by the company’s recent past. Back in 2016, the company scrapped its Phase III study for a metastatic melanoma drug after deciding the opportunity had shrunk thanks to checkpoint inhibitors in the space. Caladrius axed 40 employees, and its stock sank nearly 50%.

Then, last year, the company sold off its remaining interest in Caladrius’ revenue-generating subsidiary PCT to Hitachi Chemical Co America for $75 million.

Investors seem heartened by the news of this latest asset acquisition. The company’s stock is up 29% in pre-market trading.

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Research Scientist - Immunology
Recursion Pharmaceuticals Salt Lake City, UT
Director of Operations
Atlas Venture Cambridge, MA

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