Press release
Compass Therapeutics Reports First Quarter 2022 Financial Results and Highlights Recent Company Progress
The FDA cleared the investigational new drug application for CTX-009 (DLL4 X VEGF-A bispecific) in January allowing the Company to expand the ongoing Phase 2
About this update from Compass Therapeutics, Inc.
[{"type":"text","content":"The FDA cleared the investigational new drug application for CTX-009 (DLL4 X VEGF-A bispecific) in January allowing the Company to expand the ongoing Phase 2 study in patients with biliary tract cancer (BTC) to a global study and initiate dosing patients in the United States in early Q3 of 2022The Company reported interim data from the ongoing Phase 2 study of CTX-009 and paclitaxel in patients with advanced BTC demonstrating a 42% overall response rate (ORR) and 92% clinical benefit rate (CBR) among the first 24 patients enrolled and dosed with interim median patient time on study of ~ 6 monthsThe Company completed enrollment in the CTX-471 (CD137 agonist) Phase 1b monotherapy study and reported 3 partial responses in patients with advanced solid tumors who were dosed with CTX-471 following progression on a prior PD-1/PD-L1 checkpoint blocker CTX-8371 GMP manufacturing campaign has begun, and the program is on track for an IND in Q1 2023$136.4 million in cash and cash equivalents at the end of the First Quarter BOSTON, May 09, 2022 (GLOBE NEWSWIRE) -- Compass Therapeutics, Inc. (Nasdaq: CMPX), a clinical-stage, oncology-focused biopharmaceutical company developing proprietary antibody-based therapeutics to treat multiple human diseases, today reported first quarter 2022 financial results. Development Pipeline CTX-009 (DLL4 and VEGF-A bispecific antibody) In January, the Company announced that the FDA cleared its IND application for CTX-009 and, in May the Company released interim results from a Phase 2 study of CTX-009 in combination with paclitaxel in patients with BTC. The data show that: CTX-009 demonstrated a 42% overall response rate (ORR) based on 10 patients with Partial Responses (PRs), including 9 PRs confirmed by RECIST 1.1 and 1 PR pending confirmationCTX-009 demonstrated anti-tumor activity in previously treated patients with a clinical benefit rate (CBR) of 92% based on 22 patients with a PR or stable disease (SD) out of 24 enrolled patientsCTX-009 was well-tolerated and preliminary safety profile is consistent with the Phase 1 studies CTX-471 (CD137 agonist) As of February 25, 2022, 49 patients with 15 different cancers have been enrolled in the study and 38 of those patients are evaluable. Of the 38 evaluable patients, 3 patients had a PR; the first two have been confirmed by RECIST 1.1 and the third PR is unconf...