- Clinical-stage pipeline includes envafolimab to treat sarcoma, a rare group of cancers
- Looking for partnerships in which it can lead the regulatory and clinical development of drugs in the US by sharing in the risk and cost of development
- Proof-of-concept data from the Phase 1/2 trial of TRC253 in patients with metastatic prostate cancer expected in first half 2020
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 Food and Drug Administration (FDA). Dr Theuer received a bachelor's degree in science from the Massachusetts Institute of Technology, a MD from the University of California, San Francisco, and PhD from the University of California, Irvine.
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 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’s Phase 2 proof-of-concept data from a Phase 1/2 trial of TRC253 in patients with metastatic prostate cancer is expected in the first half of 2020. The data will trigger Janssen’s 90-day option to reacquire the rights to TRC253 for an opt-in payment of $45 million to TRACON and obligations to pay milestones worth up to $137.5 million in success-based milestones as well as a royalty on net sales. If Janssen does not opt in, TRACON would own global rights to TRC253.
In more recent deals, TRACON has secured US commercial rights. On its list of recent collaborations is a December pact with 3D Medicines Co Ltd of Beijing and Jiangsu Alphamab Biopharmaceuticals, a second Chinese biopharma with a focus on oncology, to develop envafolimab, also known as KN035, a PD-L1 single domain antibody that TRACON plans to develop to treat a rare cancer called soft tissue sarcoma.
According to the deal’s terms, TRACON will oversee clinical trials and US commercialization in sarcoma while 3D Medicines and Jiangsu Alphamab will supply envafolimab at pre-negotiated prices. TRACON expects orphan drug designation for envafolimab and expects to initiate enrollment of patients in a potential pivotal clinical study in sarcoma this year.
In other advances, top-line data from a Phase 1 study of TJ004309, a CD73 antibody being developed in combination with Tecentriq, a PD-L1 antibody being supplied by Roche, are also expected in the second half of the year. TJ004309 is being developed in collaboration with TRACON’s partner I-Mab Biopharma.
On the financial front, the biotech has extended its cash runway into 2021 following a raise with gross proceeds of $5.3 million via ATM sales in December and January.
The company ended 2019 with cash, cash equivalents and short-term investments of $16.4 million.
- TRACON expects it will soon meet with the FDA to discuss the potential pivotal trial design for envafolimab, apply for orphan drug status, and initiate enrollment in a potential pivotal trial of envafolimab in 2020
- Strong momentum expected from the company’s Phase 2 proof-of-concept data from its a Phase 1/2 trial of TRC253 in patients with prostate cancer expected in the first half of the year
- Topline data expected from a Phase 1 study of TJ004309, a CD73 antibody being developed in combination with Tecentriq, a PD-L1 antibody being supplied by Roche, also expected in the second half of the year
What the boss says:
In a recent interview with Proactive, TRACON CEO Charles Theuer said: “Our product development platform allows us to do trials at lower cost, higher quality and on faster timelines and includes US commercialization expertise.”
He added: “By leveraging our platform, we were able to license a potential best-in-class checkpoint inhibitor envafolimab that we expect to approve and commercialize in the US, to dramatically improve the standard of care of sarcoma patients.”
Contact the author Uttara Choudhury at [email protected]
Follow her on Twitter: @UttaraProactive