Caladrius snags heart disease stem cell therapy from Shire

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Caladrius has cell therapies for diabetes, critical limb ischemia and coronary microvascular dysfunction in its pipeline. (Image: Gerd Altmann)

Caladrius Biosciences picked up the worldwide rights to Shire’s late-stage CD34+ stem cell therapy for refractory angina, while the big pharma will receive an undisclosed upfront fee, milestones and a royalty on product sales.

The New Jersey-based biotech now has its hands on preclinical and clinical data through phase 3 for the therapy as a treatment for refractory angina, as well as the relevant regulatory filings, according to a statement. It could become a treatment for patients with angina who have run out of therapeutic options.

“This transaction offers an ideal opportunity for Caladrius to obtain a promising late-stage development asset complementary to our existing pipeline of CD34+ cell therapy development programs in ischemic repair,” said David Mazzo, Caladrius CEO.  “This program represents a large potential commercial opportunity as refractory angina afflicts approximately one million people in the U.S. alone, with an incidence rate of 50,000 to 100,000 annually.”

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Caladrius’ new asset will boost a pipeline where the lead candidate, a T regulatory cell (Treg) treatment for Type 1 diabetes, is in phase 2. The biotech is working on a CD34 treatment for critical limb ischemia in Japan, under the country’s regenerative medicine law, as well as a CD34+ therapy for coronary microvascular dysfunction. Both candidates have been cleared for phase 2.

“We believe that the growing body of clinical data in support of CD34+ cell therapy as a treatment for refractory angina is very encouraging and we believe that Caladrius is uniquely positioned to advance this late-stage program through to potential regulatory approval,” said Douglas Losordo, Caladrius’ chief medical officer and SVP of clinical, medical and regulatory affairs.

Losordo joined Caladrius in 2013 from Baxter, where he led the phase 1 and 2 trials of the CD34+ therapy. He also kicked off the phase 3 study before the treatment found its way to Shire via Baxalta’s spinoff and eventual acquisition by the big pharma.