Bellicum Pharmaceuticals, Inc. (NASDAQ:BLCM) Q2 2018 Earnings Conference Call - Final Transcript
Aug 07, 2018 • 05:00 pm ET
Good afternoon, ladies and gentlemen. Thank you for standing by. Welcome to the Bellicum Pharmaceuticals Second Quarter 2018 Earnings Conference Call. (Operator Instructions) As a reminder, this conference will be recorded and available for replay.
I would like to introduce you to our host today, Alan Musso, Bellicum's CFO. Please go ahead.
Thank you, Roya. Good afternoon everyone and thank you for joining the call. With me today is Rick Fair, Bellicum's President and CEO; and Bill Grossman, Chief Medical Officer.
Earlier this afternoon, Bellicum released financial results for the second quarter ended June 30, 2018. If you have not received this release or if you would like to be added to the distribution list, you can do so on the IR's page of the company's website.
(Forward-Looking Cautionary Statements) And now I'll turn the call over to Rick.
Thanks, Alan. Good afternoon, everyone. Overall, we've made substantial progress with our lead programs this quarter. BPX-501, our allogeneic T-cell therapy in development for patients with leukemias, lymphomas and genetic blood diseases, continues to advance on its path to market in Europe. BPX-601, the first controllable CAR-T cell therapy to enter clinical development, is on track to report initial data later this year. We also made important advances with the balance of our pipeline, including the development of 2 GoCAR-T candidates with our dual switch technology, which we expect to enter the clinic in 2019.
I'd like to give a little more color on our progress, starting with BPX-501. As you may have read in our press release today, we completed prospective enrollment in the BP-004 and C-004 studies in pediatric patients with hematologic cancers and orphan inherited blood disorders. We expect that these studies will serve as the basis for filing in Europe.
C-004 is a multicenter observational trial of pediatric patients receiving a matched unrelated donor or MUD transplant. We're conducting this trial to serve as comparator for our lead BP-004 study. The primary analysis will be a comparison of event-free survival at 6 months in patients receiving BPX-501 following a haploidentical transplant versus those receiving a MUD transplant. The goal of the study is to demonstrate non-inferiority. MUD transplants are currently the preferred option for the approximately 70% of patients who do not have an HLA-matched sibling donor. If we can demonstrate that BPX-501 enables patients without a matched donor to achieve outcomes at least as good as a MUD transplant, that would be very clinically meaningful and would bode well for commercial success.
We're looking forward to the American Society of Hematology Annual Meeting in December as a forum to present a comprehensive update on BPX-501. We have submitted abstracts, including interim event-free survival results from both BP-004 and C-004, disease outcomes from some patient subsets of interest and clinical experience of the patients who receive rimiducid to treat steroid-refractory GvHD.
Final results from both the BP-004 and C-004 studies are expected to be available in early 2019, with the goal of filing marketing authorization applications for both