leadf
logo-loader
viewTRACON Pharmaceuticals

TRACON Pharmaceuticals announces successful Type B meeting with FDA for Pivotal Study of Envafolimab in sarcoma

As a result of the FDA meeting, TRACON expects to initiate enrollment in its ENVASARC trial in the second half of 2020

TRACON Pharmaceuticals - TRACON Pharmaceuticals announces successful Type B meeting with FDA for Pivotal Study of Envafolimab in Sarcoma
Envafolimab is an antibody being developed to treat sarcoma, uncommon cancers that affect any part of the body

TRACON Pharmaceuticals (NASDAQ:TCON) said it has successfully completed a Type B pre-IND meeting with the US Food and Drug Administration (FDA).

The clinical stage biopharmaceutical company said the FDA has agreed with its proposals regarding key elements of the pivotal ENVASARC trial for envafolimab in the soft tissue sarcoma subtypes of undifferentiated pleomorphic sarcoma and myxofibrosarcoma.

READ: TRACON Pharmaceuticals retains rights to prostate cancer drug candidate, targets China for commercialization

As a result, TRACON expects to initiate enrollment in the ENVASARC trial in the second half of 2020.

Envafolimab is an antibody being developed to treat sarcoma, uncommon cancers that can affect any part of the body including muscle, bone, tendons, blood vessels and fatty tissues.

In a statement, Charles Theuer, president and chief executive of TRACON said: “We appreciate the valuable discussions and guidance from our Type B meeting discussion with the FDA and concurrence on the design for the pivotal trials of envafolimab in sarcoma.

"Following the successful completion of the regulatory meeting, we are focused on advancing envafolimab as a single agent and in combination with Yervoy (ipilimumab) for the treatment of the sarcoma subtypes of UPS and MFS, both of which have been shown to be responsive to immune checkpoint inhibition treatment. We look forward to initiating ENVASARC later this year.”

TRACON is developing target therapies for cancer including envafolimab as well as other treatments in its pipeline such as TRC253, a small molecule drug candidate for the treatment of prostate cancer; TRC102, a small molecule drug candidate being developed for the treatment of lung cancer; and TJ004309, a CD73 antibody for the treatment of advanced solid tumors.

Contact the author of this article at [email protected]

Follow him on Twitter @Cal_Proac

Quick facts: TRACON Pharmaceuticals

Price: 9.08 USD

NASDAQ:TCON
Market: NASDAQ
Market Cap: $124.8 m
Follow

Add related topics to MyProactive

Create your account: sign up and get ahead on news and events

NO INVESTMENT ADVICE

The Company is a publisher. You understand and agree that no content published on the Site constitutes a recommendation that any particular security, portfolio of securities, transaction, or investment strategy is...

In exchange for publishing services rendered by the Company on behalf of TRACON Pharmaceuticals named herein, including the promotion by the Company of TRACON Pharmaceuticals in any Content on the Site, the Company...

FOR OUR FULL DISCLAIMER CLICK HERE

TRACON's partners submit new drug application for approval of envafolimab to...

TRACON Pharmaceuticals Inc (NASDAQ:TCON) CEO Charles Theuer tells Proactive its corporate partners, Alphamab Oncology and 3D Medicines, have submitted a new drug application for the approval of envafolimab in the indication of MSI-H/dMMR cancer to the National Medical Products Administration in...

1 week, 5 days ago

2 min read