Compass Therapeutics (NASDAQ:CMPX) CEO Thomas Schuetz said the Boston-based oncology biologics company is preparing for key regulatory and clinical updates across its antibody pipeline, led by tovecimig, a DLL4/VEGF-A bispecific antibody being developed in biliary tract cancer.
Speaking during a conference discussion hosted by H.C. Wainwright, Schuetz described Compass as a biologics discovery and development company focused on monoclonal and bispecific antibodies for cancer. He said the company currently has four drugs in the clinic, including tovecimig, a PD-1/PD-L1 bispecific antibody, a CD137 agonist antibody and a PD-1/VEGF-A bispecific antibody.
Tovecimig data in second-line biliary tract cancer
The company’s lead indication for tovecimig is second-line biliary tract cancer. Schuetz reviewed results from the pivotal Phase 2/3 COMPANION-002 trial, which randomized patients two-to-one to receive tovecimig plus paclitaxel or paclitaxel alone after one prior line of therapy. He said 111 patients were randomized to the combination arm and 57 to the paclitaxel control arm. The trial allowed patients in the control arm to cross over to the combination after central confirmation of progression.
Schuetz said the study previously met its primary endpoint of overall response rate, with responses assessed by blinded independent central review. He said the company “more than tripled” the response rate versus the control arm. He also highlighted progression-free survival, the first secondary endpoint analyzed under the statistical plan, saying the study showed a hazard ratio of 0.44 and a P value of less than 0.0001.
Overall survival was affected by crossover, according to Schuetz. He said patients who crossed over to tovecimig had a median overall survival of 12.8 months, which he characterized as similar to what is seen in the frontline setting. He also said regulatory precedent exists for oncology drug approvals based on overall response rate and progression-free survival without a demonstrated overall survival benefit.
Regulatory plans and first-line study
Compass plans to meet with the U.S. Food and Drug Administration in the late July to early August timeframe, Schuetz said, though the meeting had not yet been scheduled. He said the company expects to present its data and align with the agency on a plan to submit a biologics license application later this year.
Schuetz said the company has not observed changes in its interactions with the FDA despite broader public discussion about turmoil at the agency. “Our medical reviewer is the same, the responses to our submissions are the same,” he said.
Schuetz also discussed an investigator-sponsored frontline biliary tract cancer study at MD Anderson, which is adding tovecimig to gemcitabine, cisplatin and durvalumab. He said the study is enrolling and could help Compass evaluate tovecimig’s commercial potential if the drug is launched in the second-line setting. Citing an abstract presented at the annual Cholangiocarcinoma Foundation meeting, he said a new analysis estimated about 25,000 newly diagnosed biliary tract cancer patients annually in the United States.
Pipeline updates expected later this year
Schuetz said Compass will present data at ASCO for CTX-8371, its PD-1/PD-L1 bispecific antibody discovered through the company’s StitchMabs platform. He said the drug showed no dose-limiting toxicities in a Phase 1 dose-escalation study across five dose levels in patients who had previously received checkpoint inhibitors.
At higher dose levels, Schuetz said the company observed antitumor responses, including in patients with triple-negative breast cancer, non-small cell lung cancer and Hodgkin lymphoma after prior checkpoint therapy. Based on those findings, Compass opened cohort expansions in triple-negative breast cancer, non-small cell lung cancer and Hodgkin lymphoma in the first quarter. Schuetz said enrollment is progressing well and that additional efficacy updates could come later this year.
Compass has also begun Phase 1 testing of CTX-10726, its PD-1/VEGF bispecific antibody, in selected tumor types where Schuetz said there is evidence for both checkpoint inhibitor activity and angiogenesis blockade. The trial includes patients with gastric cancer, hepatocellular cancer, renal cell cancer and endometrial cancer. Schuetz said the company may provide an update from that study later this year.
CD137 program targets CD56-positive tumors
Schuetz said Compass is preparing to start a Phase 2 study of CTX-471, its CD137 agonist antibody, in tumors expressing NCAM, also known as CD56. He said the study has been submitted to the FDA and is expected to begin in the second half of the year.
In an earlier Phase 1 study in post-checkpoint inhibitor patients, Schuetz said Compass observed responses in melanoma, small cell lung cancer and mesothelioma. He said biopsy analyses suggested responding tumors were CD56-positive, supporting a strategy focused on NCAM-positive tumors that may attract CD56-positive natural killer cells that can be activated by a CD137 agonist antibody.
About Compass Therapeutics (NASDAQ:CMPX)
Compass Therapeutics, Inc is a clinical‐stage biotechnology company dedicated to the discovery and development of novel immuno‐oncology therapies. Headquartered in Cambridge, Massachusetts, the company focuses on engineering monoclonal antibody candidates designed to enhance T cell–mediated anti‐tumor responses. Compass leverages proprietary antibody platforms to identify and optimize biologics that modulate immune checkpoint pathways and the tumor microenvironment.
The company’s lead programs include CTX-471, a bispecific antibody targeting both PD-1 and PD-L1 checkpoints, and DSP107, a CD47‐SIRPα pathway modulator aimed at disrupting “don’t eat me” signals on cancer cells.
