TRACON Pharmaceuticals, Inc. (NASDAQ:TCON) Q1 2020 Earnings Conference Call - Final Transcript

May 13, 2020 • 04:30 pm ET


TRACON Pharmaceuticals, Inc. (NASDAQ:TCON) Q1 2020 Earnings Conference Call - Final Transcript


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Charles Theuer

a 4% objective response rate. This is a clear statement as to the high unmet need.

We believe targeting a 15% response rate in UPS and MFS is reasonable, as Keytruda's Phase II trial in UPS demonstrated a 23% response rate. Furthermore, checkpoint inhibition with the combination of Opdivo and Yervoy more than doubled the Opdivo response rate in unselected sarcomas. Dual checkpoint inhibition may, therefore, result in a higher response rate as well as deeper and more durable responses than single-agent envafolimab treatment. Success in both cohorts could allow approval of envafolimab as a single agent in combination with Yervoy -- pardon me, success in both cohorts could allow approval of envafolimab as a single agent and in combination with Yervoy, which would allow physicians to determine which patients are best served by single-agent or combination therapy.

The dual-arm design also provides for risk mitigation should combination treatment be required for robust responses. Notably, BMS executed a similar dual-cohort clinical strategy for Opdivo in MSI-high tumors that resulted in Opdivo's approval as both a single agent and in combination with Yervoy based on objective response rate in MSI-high cancers.

Not surprisingly, key opinion leaders and investigators are very enthusiastic about initiating the ENVASARC trial based on addressing an unmet need and the convenience of subcutaneous dosing. We expect to open the study at approximately 20 sites in the US. Also of note is that the expected total cost of the ENVASARC trial using our CRO-independent product development platform, including paying for the Yervoy, is approximately $15 million that will be spent over the next two to three years.

We recently filed envafolimab for orphan drug designation in sarcoma. And now that the FDA meeting has been completed, we expect to file an IND that will cross-reference the existing open IND for envafolimab maintained by our partner, 3D Medicines, and initiate dosing in the ENVASARC trial in the second half of this year. Our partner, 3D Medicines, is conducting clinical trials in the US and China. And in the near future, we expect them to file envafolimab for approval in China.

We also look forward to our partner's clinical data presentation at ASCO. The ASCO presentation is abstract 3021 and is entitled "Envafolimab in Advanced Tumors With Mismatch-Repair Deficiency" and will be part of the immunotherapy developmental therapeutics session. The abstract contents are expected to be released by ASCO later today, and we expect to highlight the abstract contents in a press release tomorrow morning.

Our expected time line for the ENVASARC trial continues to include an interim response assessment in 2021, a final response assessment in 2022, and assuming positive data, submitting a BLA for accelerated approval that, if approved, would allow for a product launch in the US in 2023. Additionally, positive data from the initial trial in refractory UPS and MFS could lead to an additional new clinical trial and testing in other sarcoma patient populations. This could be accomplished by initiating a randomized trial of envafolimab