- Clinical-stage pipeline includes envafolimab to treat soft-tissue sarcoma
- Awarded Orphan Drug designation for TRC102 to treat brain and spinal cord cancers
- Looking for partnerships to help with regulatory and clinical development of drugs in the US
What TRACON does:
TRACON Pharmaceuticals Inc (NASDAQ:TCON) has positioned itself as a collaboration partner that leads the regulatory filings, clinical trials, as well as US commercialization of best-in-class drug candidates, as an alternative to expensive contract research organization (CRO) based development.
By sharing in the cost and risk of clinical development and leading US commercialization, San Diego, California-based TRACON serves as a solution for companies without clinical and commercial capabilities in the US.
In its early years, TRACON adopted the standard way most biotech companies develop drugs, which is to outsource the work to a CRO. In 2011, after disappointment with the cost, quality and speed of CRO-based drug development, the company internalized all of the clinical development operations that most companies outsource to a CRO.
TRACON boss Charles Theuer has incredible experience and knowledge in the oncology space. He was director of clinical oncology at Pfizer Inc (NYSE:PFE), and led the clinical development of kidney cancer therapy Sutent, which was approved by the US Food and Drug Administration (FDA).
In 2016, Dr Theuer steered TRACON to its first partnership, a collaboration with Johnson & Johnson’s (NYSE:JNJ) Janssen Pharmaceutica NV. As part of the deal, TRACON secured the rights to develop a pair of Janssen's oncology drugs. The first is TRC253, a small molecule drug being developed for treating prostate cancer, and the second is TRC694 which addresses blood cancers such as myeloma. Johnson & Johnson Innovation made a $5 million equity investment in TRACON via the purchase of stock at $59.50 per share.
The company’s clinical-stage pipeline also includes envafolimab, which is being developed for the treatment of sarcoma and TRC102, a small molecule drug being developed for the treatment of lung cancer.
How is it doing:
TRACON Pharmaceuticals (NASDAQ:TCON) ended its second-quarter 2021 with cash and equivalents of $25.6 million as of June 30, 2021, which doesn’t include proceeds from its $15 million underwritten public offering at $3.82 per share that closed July.
The company noted it has sufficient funds to sustain its operations into 2023.
In August, TRACON said the Independent Data Monitoring Committee for the ENVASARC pivotal trial of potential cancer drug envafolimab recommended that the trial proceed as planned after reviewing the 12-week safety data from more than 20 patients enrolled in the study as of May 2021.
The company said the safety data reviewed included information and data from more than 10 patients enrolled into cohort A of treatment with single-agent envafolimab and more than 10 patients enrolled into cohort B of treatment with envafolimab and Yervoy (ipilimumab) for sarcoma, a rare group of cancers that arise in the bones and connective tissue.
The ENVASARC trial is a multi-center, open-label, randomized, non-comparative, parallel cohort study at around 25 top cancer centers in the US that began dosing in December 2020.
TRACON expects the trial to enroll 160 patients with undifferentiated pleomorphic sarcoma (UPS) or myxofibrosarcoma (MFS) who have progressed following one or two lines of prior treatment and have not received an immune checkpoint inhibitor, with 80 patients enrolled into cohort A of treatment with single-agent envafolimab and 80 patients enrolled in cohort B of treatment with envafolimab and Yervoy.
The primary endpoint is overall response rate (ORR) by blinded independent central review with the duration of response a key secondary endpoint.
Meanwhile in June, the company announced that the US Food and Drug Administration (FDA) had granted orphan drug designation to envafolimab, a novel, single-domain antibody against PD-L1.
Envafolimab is the first subcutaneously injected PD-L1 inhibitor to be studied in pivotal trials. The antibody gained orphan drug status from the FDA following TRACON's submission of an amended application that included Phase 1 clinical trial data from sarcoma patients treated with single-agent envafolimab.
Clinical trial data was submitted in response to an FDA request to provide data using envafolimab to treat patients with soft tissue sarcoma that demonstrated a therapeutic effect, the company added.
On the corporate front, TRACON appointed Dr Brenda Marczi as its senior vice president, Regulatory Affairs. Marczi brings more than three decades of regulatory affairs experience to her new role, including senior roles at Eagle Pharmaceuticals (NASDAQ:EGRX) and Berlex - now Bayer AG (ETR:BAYN, OTC:BAYZF) - where she oversaw the filing of multiple successful new drug applications.
As well, the company appointed Ya Huang as its executive director of Statistical Programming. Huang brings more than two decades of broad statistical programming experience to TRACON, including most recently as a senior director at Arena Pharmaceuticals, and past roles at Halozyme Therapeutics, Gilead, and Amylin Pharmaceuticals.
- Interim efficacy data from the ENVASARC trial
- FDA breakthrough therapy designation or fast track designation for envafolimab
- Decision on the envafolimab New Drug Application in MSI-H/dMMR cancer
What the boss says:
Commenting on the company’s 2Q 2021 financial and operating results, TRACON Pharmaceuticals (NASDAQ:TCON) CEO Charles Theuer said in a statement: “We remain on track to announce interim efficacy data from the pivotal ENVASARC trial by the end of this year and final data in 2022.”
Theuer added: “Last week the IDMC recommended the study proceed as planned following review of interim safety data and we will continue to focus our efforts on enrolling this pivotal trial.”
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