TRACON Pharmaceuticals Presents Data from a Phase 1 Study of Uliledlimab (TJ004309) and Tecentriq® (Atezolizumab) at the American Society of Clinical Oncology Virtual Annual Meeting

Rhea-AI Summary

TRACON Pharmaceuticals (NASDAQ:TCON) announced updated data from its Phase 1 study of TJ004309 in combination with Tecentriq (atezolizumab) at the recent ASCO virtual annual meeting. The study involved 20 patients with advanced cancers, revealing that uliledlimab was well-tolerated without dose-limiting toxicities. Notably, clinical activity was observed, including one complete response and two partial responses. The results indicate a need for further investigation of uliledlimab with checkpoint inhibitors in lung and ovarian cancers.

Positive

• Uliledlimab showed manageable safety profiles in patients.
• One complete response, two partial responses, and three stable disease cases observed.
• Full saturation of CD73 achieved at doses ≥ 10 mg/kg.

Negative

• None.

SAN DIEGO, June 04, 2021 (GLOBE NEWSWIRE) -- TRACON Pharmaceuticals (NASDAQ:TCON), a clinical stage biopharmaceutical company focused on the development and commercialization of novel targeted therapeutics for cancer, today presented updated data from the Company’s Phase 1 study of TJ004309 and Tecentriq® (atezolizumab) at the American Society of Clinical Oncology (ASCO) virtual annual meeting.

In poster presentation 2511 entitled, “The safety, pharmacokinetics (PK), pharmacodynamics (PD) and clinical efficacy of uliledlimab (TJ004309), a differentiated CD73 antibody, in combination with atezolizumab in patients with advanced cancer,” data were presented from 20 refractory cancer patients with advanced or metastatic solid tumors treated with the combination of uliledlimab and atezolizumab.

Key results included:

• Uliledlimab was safe and well-tolerated up to 20 mg/kg every three weeks (Q3W) and 15 mg/kg once weekly (QW) as a monotherapy and in combination therapy with atezolizumab 1200 mg Q3W. No dose limiting toxicity was observed and the maximum tolerated dose was not reached.
• Full saturation of circulating and cell-bound CD73 was achieved at doses ≥ 10 mg/kg.
• Linear PK profile was observed at the doses ≥10 mg/kg following a single dose and the PK profile of uliledlimab supports Q3W dosing.
• There was evidence of clinical activity (one complete response, two partial responses and three cases of stable disease) in both PD-(L)1 treatment naïve and refractory cancer patients, following treatment with uliledlimab and atezolizumab.
• Higher tumor CD73 and PD-L1 co-expression were found in responders compared to non-responders.

“Uliledlimab was safe and refractory solid tumor patients benefitted following treatment with uliledlimab and atezolizumab,” said Francisco Robert M.D., lead author and Professor of Medicine at the University of Alabama, Birmingham. “Further evaluation of uliledlimab in combination with checkpoint inhibitors in lung and ovarian cancers is warranted.”

The poster is available on TRACON’s website at www.traconpharma.com.

About TJ004309

TJ004309 is a novel, humanized antibody discovered by I-Mab, against CD73, an ecto-enzyme expressed on stromal cells and tumors that converts extracellular adenosine monophosphate (AMP) to adenosine, which is highly immunosuppressive.  TRACON is developing TJ004309 in collaboration with I-Mab Biopharma through one of our two strategic agreements with them, whereby we are responsible for the regulatory and clinical development of TJ004309 in the U.S. and Europe for this study. TJ004309 is currently being studied in an ongoing Phase 1 trial to assess safety and preliminary efficacy as a single agent and when combined with the PD-L1 checkpoint inhibitor Tecentriq in patients with advanced solid tumors.

About TRACON

TRACON develops targeted therapies for cancer utilizing a capital efficient, CRO independent, product development platform. The Company’s clinical-stage pipeline includes: Envafolimab, a PD-L1 single-domain antibody given by rapid subcutaneous injection that is being studied in the pivotal ENVASARC trial for sarcoma; TRC102, a Phase 2 small molecule drug candidate for the treatment of lung cancer; and TJ004309, a CD73 antibody in Phase 1 development for the treatment of advanced solid tumors. TRACON is actively seeking additional corporate partnerships whereby it leads U.S. regulatory and clinical development, shares in the cost and risk of clinical development, and leads U.S. commercialization.  In these partnerships TRACON believes it can serve as a solution for companies without clinical and commercial capabilities in the U.S.  To learn more about TRACON and its product pipeline, visit TRACON's website at www.traconpharma.com.

Company Contact:	Investor Contact:
Mark Wiggins	Brian Ritchie
Chief Business Officer	LifeSci Advisors LLC
(858) 251-3492	212-915-2578
mwiggins@traconpharma.com	britchie@lifesciadvisors.com

FAQ

What were the results of the Phase 1 study for TJ004309 presented by TRACON Pharmaceuticals?

The study showed that TJ004309 (uliledlimab) was well-tolerated, with one complete response and two partial responses observed among advanced cancer patients.

What is the significance of the study results for TCON's stock?

Positive clinical results could enhance investor confidence and attract interest in TRACON's pipeline, potentially impacting TCON's stock price positively.

When were the study results for TJ004309 and Tecentriq presented?

The results were presented during the American Society of Clinical Oncology (ASCO) virtual annual meeting on June 4, 2021.

What does the study imply for future trials involving TJ004309?

The study suggests further evaluation of TJ004309 in combination with checkpoint inhibitors, particularly in lung and ovarian cancers, is warranted.