I-Mab Biopharma and TRACON Pharmaceuticals Announce Dosing of the First Patient in the U.S. Phase 1 Clinical Trial of the CD73 Antibody TJD5 in Patients with Advanced Solid Tumors
The multicenter, open-label, dose escalation Phase 1 study will evaluate safety and tolerability of TJD5, and determine a recommended dose for further clinical studies of its efficacy and safety as a single agent and in combination with standard dose TECENTRIQ® in patients with advanced or metastatic cancer who are refractory to or intolerant of all available therapy.
TJD5, a novel, differentiated humanized antibody against CD73, is from I-Mab’s proprietary discovery pipeline being co-developed through a corporate collaboration between TRACON and I-Mab signed in
“TJD5 builds on earlier successes of I-Mab’s proprietary innovative pipeline and is the third internally discovered drug candidate to enter clinical studies in the U.S. This clinical milestone is the result of our well-executed ‘Fast-to-PoC (proof of concept) Global Approach’ to advancing our proprietary innovative drug candidates towards clinical validation in
“Submitting the IND and dosing the initial cancer patient with TJD5 following the signing of our first partnership agreement with I-Mab is an important milestone, as we have both expanded our pipeline in immuno-oncology and further demonstrated TRACON’s product development capabilities designed to reduce the cost and time of clinical development for our partners,” commented
About TJD5 (TJ004309)
TJD5 is a novel, humanized antibody against CD73, an ecto-enzyme expressed on stromal cells and tumors that converts extracellular adenosine monophosphate (AMP) to adenosine, which is highly immunosuppressive. TJD5 is in a Phase 1 clinical trial in the US to assess the tolerability and preliminary efficacy as a single agent and in combination with TECENTRIQ®, a PD-L1 antibody marketed by
About I-Mab
I-Mab is a dynamic and fast-growing global biotech company focusing on developing innovative biologics drugs of first-in-class and best-in-class potential in the therapeutic areas of immuno-oncology and autoimmune diseases. I-Mab's pipeline of clinical and pre-clinical stage drug candidates is driven by the company's Fast-to-PoC (Proof-of-Concept) and Fast-to-Market development strategies through internal R&D capabilities and global partnerships. I-Mab's vision is to bring transformational medicines to patients through innovation. The company is on track to become an end-to-end fully integrated biopharma and is well-recognized by capital markets to have successfully raised approximately
About TRACON
TRACON develops targeted therapies for cancer and ophthalmic diseases. The Company’s clinical-stage pipeline includes: DE-122, the ophthalmic formulation of carotuximab, an endoglin antibody that is being developed for patients with wet AMD through a license to
Forward-Looking Statements
Statements made in this press release regarding matters that are not historical facts are “forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward‐looking statements. Such statements include, but are not limited to, statements regarding TRACON's and I-Mab’s plans to further develop product candidates, expectations regarding the timing of regulatory submissions and clinical trials, expected development milestones, and potential utility of product candidates. Risks that could cause actual results to differ from those expressed in these forward‐looking statements include: risks associated with clinical development; whether TRACON or others will be able to complete or initiate clinical trials on TRACON’s expected timelines, if at all; the fact that future preclinical studies and clinical trials may not be successful or otherwise consistent with results from prior studies; the fact that TRACON’s collaboration agreements are subject to early termination; whether additional product candidates are selected to be developed under TRACON’s and I-Mab’s collaboration; potential changes in regulatory requirements in the US and foreign countries; TRACON’s reliance on third parties for the development of its product candidates, including the conduct of its clinical trials and manufacture of its product candidates; whether TRACON will be able to obtain additional financing; and other risks described in TRACON’s filings with the
I-Mab Company Contact:
Raven Lin
VP of Corporate Development
raven.lin@i-mabbiopharma.com
I-Mab Investor Contact:
Jielun Zhu
CFO
jielun.zhu@i-mabbiopharma.com
I-Mab Media Contact:
Amanda Dai
Associate Director of Public Relations
Zhenhua.dai@i-mabbiopharma.com
TRACON Company Contact:
Chief Business Officer
(858) 550‐0780 ext. 236
mwiggins@traconpharma.com
TRACON Investor Contact:
LifeSci Advisors LLC
646-597-6987
Andrew@lifesciadvisors.com
Source: TRACON Pharmaceuticals, Inc.