Complete responses observed in two patients with angiosarcoma in TRC105 + Votrient sarcoma study
Four partial responses observed in TRC105 + Nexavar liver cancer study
SAN DIEGO, June 1, 2015 (GLOBE NEWSWIRE) -- TRACON Pharmaceuticals (Nasdaq:TCON), a clinical stage biopharmaceutical company focused on the development and commercialization of novel targeted therapeutics for cancer, age-related macular degeneration and fibrotic diseases, today reported positive results from two separate clinical trials combining TRC105 with approved VEGF inhibitors. Data were presented at the American Society of Clinical Oncology (ASCO) 2015 Annual Meeting in Chicago.
The first study was the dose escalation Phase 1b portion of a Phase 1b/2 study of TRC105 in combination with Votrient® (pazopanib) in 18 patients with advanced soft tissue sarcomas. All patients in the Phase 1b study received at least one prior chemotherapy regimen, and prior treatment with Votrient was allowed. The median number of prior therapies for patients in the Phase 1b study was two, and ranged from one to seven. All patients were treated with the combination of TRC105 given once weekly (8 or 10 mg/kg) and Votrient at its approved dose of 800 mg per day. The combination was well-tolerated without the development of dose limiting toxicity. Six of 18 patients (33%) had tumor reductions of greater than 10% by RECIST, and median progression-free survival for patients to date is 5.9 months. One patient with angiosarcoma, a tumor type known to express high levels of endoglin, has an ongoing complete response by RECIST and remains on treatment at week 30. In addition, in the ongoing Phase 2 portion of the study, a patient with angiosarcoma also demonstrated a complete response to treatment that is ongoing at this time. The Phase 1b portion of the study has completed enrollment, and the Phase 2 portion of the study combining TRC105 with Votrient continues to enroll patients.
The National Cancer Institute (NCI) presented updated data for the dose escalation Phase 1b portion of a Phase 1b/2 study of TRC105 in combination with Nexavar® (sorafenib) in 20 patients with liver cancer. Eligible patients had compensated liver dysfunction and had not received prior treatment with Nexavar. All 20 patients enrolled in the clinical trial were treated with the combination of TRC105 given once every two weeks (3, 6, 10 or 15 mg/kg) and Nexavar at its approved dose of 400 mg given twice daily. Overall, the combination was well-tolerated; one patient developed dose limiting toxicity (liver enzyme elevation). Four of 10 patients (40%) treated at the top two dose levels of TRC105 had partial responses by RECIST, and two of these patients remain progression free for more than six months. For comparison, in separate Phase 3 clinical trials where Nexavar was given as a single agent, the partial response rate in first-line liver cancer patients was 2%. The Phase 1b portion of the study has completed enrollment, and the Phase 2 portion combining TRC105 with Nexavar continues to enroll patients.
"We continue to see encouraging data for TRC105 in combination with VEGF inhibitors that support targeting the endoglin and VEGF pathways simultaneously to deliver improved patient outcomes," said Charles Theuer, M.D., Ph.D, President and CEO of TRACON. "We look forward to completing enrollment in the ongoing Phase 2 clinical trial of TRC105 and Votrient by the end of the year, and working with our investigators to determine the next steps in the development of TRC105 in sarcoma. We also plan to initiate a Phase 2 trial of TRC105 in combination with Nexavar in liver cancer patients later this year."
Both posters are available on TRACON's website at: http://www.traconpharma.com/publications.php
About the Sarcoma Phase 2 Clinical Trial
The Phase 2 clinical trial is a multicenter, open-label, nonrandomized clinical trial of TRC105 in combination with Votrient in patients with soft tissue sarcoma. The primary endpoint of the Phase 2 study is progression-free survival. TRACON hopes to establish a correlation between progression-free survival and overall response rate with endoglin expression on sarcoma tissue in order to assess whether endoglin expression on sarcoma cells may serve as a biomarker that identifies responsive sarcoma subtypes. Approximately 63 patients who have failed prior anthracycline chemotherapy are expected to enroll in the study. For additional information on this clinical trial, please visit www.clinicaltrials.gov, identifier NCT01975519.
About TRC105
TRC105 is a novel, clinical stage antibody to endoglin, a protein overexpressed on proliferating endothelial cells that is essential for angiogenesis, the process of new blood vessel formation. TRC105 is currently being studied in clinical trials sponsored by both TRACON and the National Cancer Institute for the treatment of multiple solid tumor types in combination with VEGF inhibitors. TRC105 is also being developed in combination with VEGF inhibitor treatments in age‐related macular degeneration. For more information about the clinical trials, please visit TRACON's website at http://www.traconpharma.com/clinical_trials.php.
About TRACON
TRACON develops targeted therapies for cancer, age-related macular degeneration and fibrotic diseases. TRACON's current pipeline includes two clinical stage product candidates: TRC105, an anti-endoglin antibody that is being developed for the treatment of renal cell carcinoma, soft tissue sarcoma, hepatocellular carcinoma, glioblastoma and choriocarcinoma, and TRC102, a small molecule that is being developed for the treatment of lung cancer and glioblastoma. To learn more about TRACON and its product candidates, visit TRACON's website at www.traconpharma.com.
Forward-Looking Statements
This press release contains forward-looking statements, including statements regarding the timing of enrollment in the Phase 2 study of TRC105 and Votrient, further development plans for TRC105 in sarcoma, TRACON's plans to initiate a Phase 2 trial of TRC105 in combination with Nexavar, the possible correlation between clinical trial endpoints and endoglin expression on sarcoma tissue, and expected parameters of future clinical studies. Forward-looking statements speak only as of the date of this press release and TRACON does not undertake any obligation to update or revise these statements, except as may be required by law. These forward-looking statements are based on management's expectations and assumptions as of the date of this press release and actual results may differ materially from those in these forward-looking statements as a result of various factors. These factors include, but are not limited to, the fact that results of subsequent studies may not be consistent with results of prior studies, TRACON's and NCI's ability to identify and enroll patients in on-going and planned Phase 2 studies, potential delays in completing on-going Phase 2 studies and initiating new studies, whether TRC105 will be shown to be safe and effective in subsequent studies, whether TRACON will be able to establish a correlation between endoglin expression on sarcoma tissue and clinical endpoints, and TRACON's and NCI's ability and willingness to fund additional clinical development of TRC105. For a further description of these and other risks facing TRACON, please see the risk factors described in TRACON's filings with the United States Securities and Exchange Commission, including those factors discussed under the caption "Risk Factors" in those filings. Forward-looking statements speak only as of the date of this press release and TRACON undertakes no obligation to update or revise these statements, except as may be required by law.