BerGenBio’s bemcentinib is a selective AXL inhibitor, currently in Phase II clinical trials as a combination and single agent therapy for lung cancer and leukemia.
The US Food and Drug Administration (FDA) recently granted the candidate fast track designation for the treatment of elderly patients with acute myeloid leukemia (AML) whose disease has relapsed, an indication for which there are no approved drugs available to date.
Following the designation, the drug developer announced its plans to outsource further development and manufacturing operations to Piramal, and the latter’s ‘Xcelerate Integrated Solutions’ platform, which, according to BerGenBio’s CEO, Richard Godfrey, represents an ‘ideal’ solution.
According to Piramal, this specific service was chosen in order to meet the timelines required for fast track development.
However, Piramal’s program includes a long manufacturing journey, with the required intermediates sourced in India; subsequently, the pilot process development and validation takes place in North America; and, ultimately, the formulation development will occur in Europe.
The Xcelerate program has been successfully applied to more than eighty programs to date, according to Piramal, with the company stating that it is preferable for clients due to its streamlined services, “managed by a single point of contact who expedites the exchange of information.”
Upon the potential regulatory approval of the candidate, Piramal will also provide the commercial manufacture of the final drug product.
Financial terms of the partnership were not disclosed.