Compass Therapeutics Announces That the Phase 2 Data for CTX009 in Combination With Paclitaxel in Patients With Biliary Tract Cancers will be presented at the ASCO GI Cancers Symposium, January 20, 2023
Compass to host Investor Event Monday 23 Januaryrd At 8:30 AM ET
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Compass has launched a Phase 2/3 randomized trial of CTX009 and paclitaxel (U.S.) in patients with BTC. Based on the study results, this study could support a Biologics License Application (BLA) submission by Compass in 2024
BOSTON, Jan. 19, 2023 (GLOBE NEWSWIRE) — Compass Therapeutics, Inc.Today,, a biopharmaceutical company that focuses on the treatment of multiple diseases, announced that data from a Phase II study of CTX009 and paclitaxel in patients suffering from biliary tract cancers (BTC) was presented by. These data will be presented at ASCO GI Symposium 2023 in San Francisco, CA (January 20, 2023).
Highlights of the poster presentation are:
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CTX009 with paclitaxel showed a 37.5%ORR based on 9 patients who had partial responses (PRs). This was confirmed by RECIST 1.1. It is important to note that 7 of 11 patients who had previously received systemic treatment achieved a PR. This resulted in an ORR of 63.66% in this sub-group.
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The median follow up was approximately 12 months. The median PFS was 9.4 month and the median OS was 12.5 month. FOLFOX is a regimen that has been evaluated in patients with advanced BTC. This regimen is recommended by the National Comprehensive Cancer Network (NCCN), for patients with BTC who are being treated in the second line setting. FOLFOX showed a median PFS time of 4.0 months, and an OS time of 6.2 months in a randomized study against the best supportive treatment.
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The safety and tolerability for CTX-009 when combined with paclitaxel will continue to improve as the data mature. Treatment emergent adverse events (TEAEs) were observed in all patients, including those TEAEs related to the patients’ disease and the two study drugs in the treatment regimen, paclitaxel and/or CTX-009. 95.8% of patients reported TEAEs at grade 3 or higher, including anemia (12.5%), hypertension (16.7%), and hypotension (16.7%).
The poster presentation will be posted to the Pipeline section on the Compass Therapeutics website. www.compasstherapeutics.com.
“We are very pleased to see the maturing data from this study, particularly the median progression free survival of greater than 9 months and median overall survival of 12.5 months supporting the durable effect of CTX-009 in this patient population,” said Thomas Schuetz, M.D., Ph.D., Chief Executive Officer and Scientific Founder of Compass. “Given that patients with advanced BTC have a poor prognosis, have been heavily pre-treated, and have few treatment options, we are particularly enthused with these results.”
“The results from the Phase 2 trial in BTC continue to show the potential of CTX-009, which has demonstrated activity in a broad range of solid tumors. We are presently enrolling patients in two clinical studies of CTX-009 in the United States and expect to report initial data from the colorectal study in the second half of this year,” added Vered Bisker-Leib Ph.D., President and Chief Operating Officer of Compass.
Investor Event Details
Compass will host a Webcast Monday, January 23rd at 8:30 AM ET. Registration for the webcast or access to a replay of the call is available on the Company’s website or by clicking here.
CTX-009 Phase 2 BTC Study Design
The Phase 2 study will be conducted at four of the most prestigious medical centers in Korea.
Twenty-four patients had been enrolled as of the November 9th, 2022 data cut-off date. At least one cycle of CTX009 and/or paclitaxel had been administered to them. 22 of these patients were evaluated for potential response. Nearly all of the patients (23/24) received gemcitabine and cisplatin first-line treatments. The study included 45.8% patients who had received one therapy prior to the study and 54.2% who received at least two therapies prior. All four types of BTC were included in the study. These were intrahepatic, extrahepatic, gallbladder and ampullary. Patients had a median of 62.1 years of age and an ECOG status of 0 (54.2%) and 1 (45.8%).
Phase 2/3 BTC Study Design for CTX-009
Compass initiated a Phase 2/3 randomized study of CTX009 in combination to paclitaxel in the United States for patients with advanced BTC. Patients with BTC will be recruited from up to 150 patients who have not received any prior systemic therapies. In a 2:1 ratio, patients will either receive CTX-009 with or without paclitaxel. This study could potentially support a biologics license application (BLA), depending on regulatory feedback and the study results. ORR is measured using RECIST 1. This is the primary endpoint. Secondary endpoints of this study include PFS and OS as well as Quality of Life and other measures.
Details about the study are available www.clinicaltrials.gov Identifier: NCT05506943
About CTX-009
CTX-009 is a bispecific anti-tumor antibody that simultaneously blocks Delta -like ligand4/Notch (DLL4) as well as vascular endothelial grow factor A (VEGFA) signaling pathways. These pathways are crucial for tumor vascularization and angiogenesis. The strong anti-tumor effect of CTX009 on solid tumors is evident from both preclinical and clinical data. It blocks both the gastric, colorectal and cholangiocarcinoma pathways. Partially effective monotherapy of CTX-009 has been seen in patients with advanced cancers who had previously received anti-VEGF therapy.
Compass has the global rights for CTX-009 (also called ABL001), with the exception of rights that are held by Handok, Inc. in Korea.https://www.handok.co.kr/eng/) and rights in China, which were out-licensed to Elpiscience Biopharma, Ltd. (https://www.elpiscience.com/).
About Biliary Tract Cancers
Biliary tract cancers (BTC) are a group of aggressive gastrointestinal (GI) cancers that form in the cells of the bile ducts (cholangiocarcinoma), gallbladder, or ampulla of Vater (where the bile duct and pancreatic duct connect to the small intestine).
In the United States approximately 18,400 cases of BTC are diagnosed annually,¹ including cholangiocarcinoma, gallbladder, and ampullary subtypes. Only 10% of these patients are at an advanced stage that would allow them to be candidates for surgery resection. The vast majority present with locally advanced or metastatic BTC, for which there are very few therapeutic options.²
¹ seer.cancer.gov/statfacts/html/livibd.html
² cancer.gov/types/liver/patient/bile-duct-treatment-pdq#_66
About Compass Therapeutics
Compass Therapeutics, Inc., a biopharmaceutical company that focuses on cancer, is developing its own antibody-based therapies to treat multiple diseases. Compass’s scientific focus is on the relationship between angiogenesis, the immune system, and tumor growth. Compass’s pipeline of novel product candidates is designed to target multiple critical biological pathways required for an effective anti-tumor response. These include modulation of the microvasculature via angiogenesis-targeted agents, induction of a potent immune response via activators on effector cells in the tumor microenvironment, and alleviation of immunosuppressive mechanisms used by tumors to evade immune surveillance. Compass will develop its product candidates via clinical development. This includes standalone therapies as well as combinations with proprietary pipeline antibodies, based on supporting clinical and nonclinical evidence. Compass was established in 2014 in Boston, Massachusetts. You can find more information on the Compass Therapeutics, Incorporate website. https://www.compasstherapeutics.com.
Forward-Looking Statements
Forward-looking statements can be found in this press release. Forward-looking statements include statements that are not purely historical. Such forward-looking statements include, among other things, references to Compass’s product candidate, CTX-009, its development, regulatory plans with respect thereto and therapeutic potential thereof. Many factors could cause actual results to differ from the ones projected in forward-looking statement. Such factors include, among others, Compass’s ability to raise the additional funding it will need to continue to pursue its business and product development plans, the inherent uncertainties associated with developing product candidates and operating as a development stage company, Compass’s ability to identify additional product candidates for development, Compass’s ability to develop, complete clinical trials for, obtain approvals for and commercialize any of its product candidates, competition in the industry in which Compass operates and market conditions. These forward-looking statement are made as of the date and time of this press release. Compass is not required to revise or update any forward-looking statement. Investors should consult all of the information set forth herein and should also refer to the risk factor disclosure set forth in the reports and other documents Compass files with the SEC available at www.sec.gov, including without limitation Compass’s latest Form 10-Q and subsequent filings with the SEC.
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