Blueprint Medicines is cutting funding to its clinical-stage CDK2 inhibitor even as the Ayvakit-maker pushes forward with similar preclinical breast cancer-focused therapies.
The biopharma has three CDK2 inhibitors in development for breast cancer, but has decided that the most advanced of these, dubbed BLU-222, is not worthy of any more cash. Last year, Blueprint touted “promising” data from the phase 1 study of BLU-222 in combination with Novartis' Kisqali and AstraZeneca's Faslodex in patients with hormone-receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) breast cancer.
Blueprint claimed at the time that the data “validate the potency and selectivity of BLU-222, its potential as a first- and best-in-class CDK2 inhibitor, and its use as the combination partner of choice in breast cancer,” but that evidently wasn't enough to persuade the company to continue the program alone.
The biopharma revealed in a company update Sunday that once it had completed the phase 1 dose escalation study of BLU-222, it would “deprioritize further investment in this program.” Blueprint had been talking up a potential Big Pharma partnership for BLU-222 over the course of last year, but yesterday’s release didn’t bring any fresh news on that front.
The company “continues to engage strategic partners on potential opportunities to broadly advance its franchise of CDK programs,” Blueprint said in the release.
The Massachusetts-based biopharma still has two preclinical CDK2 inhibitors listed in its pipeline, and Blueprint explained that its CDK2 and CDK4-targetted candidates have “progressed faster than expected in preclinical development toward potentially best-in-class profiles.” To this end, the company is “prioritizing further investment in its CDK franchise for breast cancer and other solid tumors to these programs.”
The pipeline changes come a year after Blueprint dropped two non-small cell lung cancer programs in response to early clinical data on the EGFR tyrosine kinase inhibitors.
Blueprint has found success with Ayvakit, its FDA-approved drug for systemic mastocytosis and certain types of gastrointestinal stromal tumors (GIST) that the company now expects to reach $2 billion in annual sales by 2030. The biopharma has similar blockbuster hopes for BLU-808, a KIT inhibitor that sailed through a phase 1 trial in healthy volunteers.
"With Ayvakit growing towards a multibillion-dollar opportunity, anchoring our SM franchise, and with BLU-808, our next program with blockbuster potential coming into focus, we enter 2025 in the strongest position we have ever been in as a company,” CEO Kate Haviland said in the release. “We have a number of commercial and clinical catalysts that we expect to deliver significant near- and long-term value to both patients and shareholders.”