TRACON Pharmaceuticals Presents Positive Updated Phase 1b Results for TRC105 in Combination With Inlyta® at the 2015 Kidney Cancer Association Meeting

TRACON Pharmaceuticals

, a clinical stage biopharmaceutical company focused on the development and commercialization of novel targeted therapeutics for cancer, wet age-related macular degeneration and fibrotic diseases, today announced updated positive results from a Phase 1b clinical trial combining TRC105 with Inlyta® (axitinib) in patients with advanced or metastatic renal cell carcinoma (RCC). Data were presented at the 2015 Kidney Cancer Association meeting in Miami, Florida. The open-label dose escalation and expansion Phase 1b study enrolled patients who had received at least one prior line of therapy with a VEGF receptor tyrosine kinase inhibitor (VEGFR TKI). The median number of prior therapies was three (range of one to six). All patients in the trial received a combination of TRC105 and Inlyta. Data are summarized in the table below. Summary of Phase 1b Results for TRC105-Inlyta Combination Patients ORR Stable Disease Overall Disease Control Median PFS Median PFS in Clear Cell RCC Subset N = 17 29 % 59 % 88 % 8.4 months 9.6 months (5/17) (10/17) (15/17) For comparison, the objective response rate seen in the large subgroup of VEGFR TKI-refractory patients treated with Inlyta (n=194) in the Inlyta AXIS Phase 3 study in second line clear cell RCC patients (a separate trial) was 11.3%, and median progression-free survival (PFS) was 4.8 months. All patients in TRACON's Phase 1b study have now completed treatment and the randomized Phase 2b TRAXAR clinical trial of TRC105 in combination with Inlyta is currently enrolling patients with advanced or metastatic RCC. The poster presentations will be available on the Publications page under the News section of the TRACON website at www.traconpharma.com. "These Phase 1b data underscore the potential value of simultaneously targeting endoglin with TRC105 in combination with a VEGF inhibitor to improve outcomes in patients with metastatic renal cell carcinoma," said Charles Theuer, M.D., Ph.D, president and CEO of TRACON. "The addition of TRC105 may provide meaningful improvement in response rate, and most importantly, progression-free survival as compared to treatment with Inlyta alone, and we look forward to sharing data from the Phase 2b TRAXAR study when they become available, which is expected in late 2016." The following key additional data from the study were also presented at the meeting: The recommended Phase 2 dose of TRC105 of 10 mg/kg dosed weekly was well-tolerated with Inlyta and no dose limiting toxicities were observed. The most common adverse events were low grade epistaxis, headache, fatigue, diarrhea, and gingival bleeding. Common adverse reactions expected with Inlyta treatment as a single agent such as diarrhea, hypertension, palmar-plantar erythrodysesthesia, and proteinuria, did not increase in frequency or severity when combined with TRC105. None of the partial responding patients had previously responded to first line treatment with a VEGFR TKI: One fourth line patient received previous treatment with high dose IL-2, pazopanib and an immune checkpoint inhibitor. This patient's best response to their last line of treatment was stable disease for 3.7 months. This patient received treatment with TRC105 in combination with Inlyta for 14 months. One fourth line patient received previous treatment with sunitinib and two lines of everolimus treatment. This patient's best response to their last line of treatment was stable disease for 34 months. This patient received treatment with TRC105 in combination with Inlyta for 16.9 months. One fourth line patient received previous treatment with sunitinib, pazopanib and an immune checkpoint inhibitor. This patient's best response to their last line of treatment was stable disease for 7.4 months. This patient received treatment with TRC105 in combination with Inlyta for 11.3 months. One second line patient received previous treatment with sunitinib. This patient's best response to their last line of treatment was progressive disease after 5.7 months. This patient received treatment with TRC105 in combination with Inlyta for 11.3 months. One fourth line patient received previous treatment with temsirolimus, sunitinib and pazopanib. This patient's best response to their last line of treatment was progressive disease after 3.5 months. This patient received treatment with TRC105 in combination with Inlyta for 9.6 months.