CTX-009 (ABL001/ES104) Clinical Data Presented Today at the New Drugs on the Horizon Plenary Session of the 2021 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics
- CTX-009 was well tolerated and demonstrated single agent activity in heavily pre-treated patients with solid tumor who are resistant to anti-VEGF therapies, mostly of colorectal and gastric origins
- The structural differences between CTX-009 and other bispecifics targeting these pathways, as well as the affinities and avidities to their targets, may be the drivers for the differentiated safety and efficacy data observed
- The maximum tolerated dose (MTD) was not reached, and the recommended Phase 2 doses (RP2D) of CTX-009 were determined to be 10.0 and 12.5 mg/kg biweekly
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Overall response rate (ORR) of CTX-009 as a monotherapy across all doses tested (0.3 - 17.5 mg/kg) was
8% and the disease control rate (DCR) was62% in patients treated at the 3rd and 4th line settings -
Treatment with CTX-009 at the RP2D (10.0 mg/kg and 12.5 mg/kg) led to
19% (n=3/16) ORR, not including an additional unconfirmed partial response, and a69% DCR (n=11/16) - A Phase 1b study of CTX-009 in combination with chemotherapy and a Phase 2 study are underway
The first in human Phase 1 single agent dose escalation and expansion study evaluated CTX-009 across nine dose levels. The study enrolled 45 heavily pre-treated patients with cancers primarily of colorectal and gastric origin. CTX-009 was well tolerated across all doses evaluated, with no dose-limiting toxicities reported. The most frequent treatment related adverse event was hypertension, observed in 17 patients of the 45 patients enrolled. Among those, 7 patients reported Grade 3 hypertension and the rest had Grade 1 or Grade 2 (
“This is a significant clinical result because current approved anti-angiogenic drugs have little efficacy as a monotherapy. Furthermore,
“The responses to CTX-009 as a monotherapy in this refractory patient population combined with the excellent tolerability profile suggests that CTX-009 can become an important drug for a broad range of solid tumors” said
“We are pleased to present the clinical data of CTX-009 (ABL001) for the first time at a prominent international conference,” said
“We are happy to see the next frontier of anti-angiogenic therapies, CTX-009 (ES104) showing promising anti-tumor activity in a Phase 1 study as monotherapy,” said
About CTX-009
CTX-009 (ABL001/ES104) is a bispecific antibody that simultaneously blocks Delta-like ligand 4/Notch (DLL4) and vascular endothelial growth factor A (VEGF-A) signaling pathways, which are critical to angiogenesis and tumor vascularization. Pre-clinical and early clinical data of CTX-009 suggests that blockade of both pathways provides robust anti-tumor activity across several solid tumors, including colorectal, gastric, cholangiocarcinoma, pancreatic and non-small cell lung cancer. Partial responses to CTX-009 as a monotherapy have been observed in heavily pre-treated cancer patients, who were resistant to currently approved anti-VEGF therapies. CTX-009 has completed a Phase 1 monotherapy dose escalation and expansion study. Phase 1b and Phase 2 combination studies are ongoing.
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About ABL Bio
About Elpiscience BioPharma
Elpiscience is a clinical stage biopharmaceutical company focusing on innovating and developing the next generation of cancer immunotherapy. Elpiscience has developed a pipeline of globally innovative molecules, covering a wide range of targets with a particular focus on turning “cold” tumors “hot”. The company has four assets in clinical stage (ES101, ES102, ES104 and ES002). Elpiscience’s sustainable pipeline forms a strong cornerstone for developing the next generation and more effective immunotherapies. Founded and managed by seasoned executives in the biopharma industry, Elpiscience is backed by renowned investors such as
Forward-Looking Statement
This press release contains forward-looking statements. Statements in this press release that are not purely historical are forward-looking statements. Such forward-looking statements include, among other things, references to our product candidate, CTX-009, and the development and therapeutic potential thereof. Actual results could differ from those projected in any forward-looking statements due to numerous factors. Such factors include, among others, our ability to raise the additional funding we will need to continue to pursue our business and product development plans, the inherent uncertainties associated with developing product candidates and operating as a development stage company, our ability to identify additional product candidates for development, our ability to develop, complete clinical trials for, obtain approvals for and commercialize any of our product candidates, and competition in the industry in which we operate and market conditions. These forward-looking statements are made as of the date of this press release, and Compass assumes no obligation to update the forward-looking statements, or to update the reasons why actual results could differ from those projected in the forward-looking statements, except as required by law. Investors should consult all the information set forth herein and should also refer to the risk factor disclosure set forth in the reports and other documents we file with the
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