Shares of Alderley Park-based Redx Pharma rose about 5% on Wednesday after the US Food and Drug Administration (FDA) cleared the investigational new drug (IND) application for JZP815, a “pan-RAF inhibitor for the treatment of solid tumors and hematologic malignancies that contain mutations in the MAPK pathway.”
The FD clearance enables Jazz Pharmaceuticals to proceed with initiating a clinical trial for JZP815.
As a result, a milestone payment of $5 million from Jazz payable to Redx has been triggered.
“The milestone payment was triggered under the agreement in which Jazz acquired Redx’s pan-RAF inhibitor programme, announced on 10 July 2019,” said Redx.
“Redx carried out development activities up to the completion of IND-enabling studies.
“Today’s milestone is on top of USD $6.5 million already received under the collaboration and Redx remains entitled to development, regulatory and commercial milestone payments as well as incremental tiered royalties in mid-single digit percentages, based on any future net sales.
“Preclinical data from this pan-RAF programme was recently presented at the American Association for Cancer Research (AACR) conference in March. JZP815 is a precision pan-RAF inhibitor with a differentiated mechanism of action, and Jazz expects to assess its utility in treating several types of difficult-to-treat solid tumours where there remains significant unmet patient needs.
“Jazz expects to advance JZP815 into a Phase 1 clinical programme and, when initiated, JZP815 will be the fifth compound discovered by Redx to enter the clinic.”
Redx Pharma’s biggest shareholders are San Francisco investment firm Redmile Group LLC with a 79% stake and European venture capital firm Sofinnova Partners with about 9%.
Redx CEO Lisa Anson said: “I am delighted that the IND application for the pan-RAF inhibitor, JZP815, has been accepted.
“When Jazz commence the clinical programme this will become the fifth drug candidate discovered by Redx to enter the clinic, further validating our world-class research and development capabilities.
“We value the strong relationship we have built with Jazz Pharmaceuticals and look forward to continuing our work together.”
Jazz Pharmaceuticals Global Head of Research Rob Iannone said: “We’re excited to advance JZP815, a precision pan-RAF inhibitor with a differentiated mechanism of action, into a clinical trial programme.
“JZP815 may represent a significant advancement in the pan-RAF inhibitor class by not inducing paradoxical pathway activation that can stimulate the growth of certain cancers.
“The JZP815 programme exemplifies our continued progress in expanding our early-stage oncology pipeline, and in developing therapies with the potential to address unmet patient need.
“Redx has an exceptional team of research and development scientists and together we have formed an outstanding collaboration, leveraging the strengths of both companies.”