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TRACON Pharmaceuticals advancing development of envafolimab to treat soft tissue sarcoma

The company, which closed 2019 with more than $16 million in cash, has a financial runway that extends into 2021

TRACON Pharmaceuticals - TRACON Pharmaceuticals advancing the development of envafolimab to treat soft tissue sarcoma
The San Diego company plans to meet with the FDA to discuss potential pivotal trial design for envafolimab

TRACON Pharmaceuticals (NASDAQ:TCON) announced Thursday it ended 2019 with cash, cash equivalents and short-term investments of $16.4 million as it advances the development of envafolimab to treat soft tissue sarcoma. 

The company also noted that in December and January it sold shares through its ATM facility with JonesTrading for gross proceeds of $5.3 million, helping to extend the company’s cash runway into 2021.

TRACON noted that in December it entered into a collaborative partnership agreement with 3D Medicines Co Ltd and Jiangsu Alphamab Biopharmaceuticals Co Ltd for the North American development of envafolimab -- a PD-L1 single-domain antibody administered by subcutaneous injection without an adjuvant, in soft tissue sarcoma. 

WATCH: TRACON Pharmaceuticals reveals platform milestones and most recent pipeline update

The company said it expects to meet with the US Food and Drug Administration to discuss a potential pivotal trial design and apply for orphan drug designation in the second quarter. In addition, TRACON anticipates beginning patient enrollment in the study during the second half of this year.

“We are pleased to have entered into this recent promising collaboration with 3D Medicines and Alphamab for the development and commercialization of envafolimab, a potentially best in class PD-L1 single domain antibody that may offer a much needed new treatment option for sarcoma patients,” said CEO Dr Charles Theuer. 

“Envafolimab has now become our lead asset. We are focused on beginning a pivotal trial as quickly as possible so we can address the high unmet medical need that exists for sarcoma patients, and have the opportunity to become a commercial company in the US in approximately three years with envafolimab.”

The San Diego-based company said it plans to meet with the FDA to discuss a potential pivotal trial design for envafolimab, followed by the submission of an application for orphan drug designation, in the first half of 2020.

It also has a goal to enroll the first patient in a pivotal trial of envafolimab for sarcoma during the second half of 2020.

Other expected 2020 milestones for the company: 

  • Top-line data from the fully enrolled randomized Phase 2 AVANTE trial of DE-122 in patients with wet AMD.
  • Top-line data from the Phase 1 dose-escalation study of TJ004300 to treat advanced tumors.
  • Phase 2 proof-of-concept data from the fully enrolled Phase 1/2 clinical trial of TRC253 in metastatic castrate-resistant prostate cancer expected in the first half of 2020. 
  • Nomination and IND filing of the initial bispecific antibody (BsAb) from the I-Mab pipeline expected in the second half of 2020.

The company’s shares recently traded up 19% to $3.50 a share in after-hours trading.

Contact the author: [email protected]

Follow him on Twitter @PatrickMGraham

Quick facts: TRACON Pharmaceuticals

Price: 1.7 USD

Market: NASDAQ
Market Cap: $14.45 m

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