TRACON Pharmaceuticals (NASDAQ:TCON) Inc said it has submitted an application to initiate a trial combining a new drug to be taken in combination with two other medications by patients with various types of tumours.
Tracon said it has filed an investigational new drug (IND) application to the US Food and Drug Administration (FDA) for the initiation of a phase one and two clinical study of CTLA-4 antibody YH001 in combination with envafolimab and doxorubicin for front-line patients with sarcomas, including those who have not previously received therapy.
The phase one and two trial will assess the safety and efficacy of YH001 and envafolimab with or without doxorubicin in patients with the rare sarcoma subtypes of alveolar soft part sarcoma and chondrosarcoma and in the common sarcoma subtypes of leiomyosarcoma and dedifferentiated liposarcoma.
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In a statement, Tracon’s CEO Charles Theuer said: "With the submission of the IND, we are one step closer to bringing our triple combination of YH001, envafolimab and doxorubicin to front-line sarcoma patients, and pending clearance of the IND, we look forward to initiating the trial before end of this year."
YH001, an IgG1 antibody against CTLA-4 invented by Biocytogen, the parent company of Eucure Biopharma, and licensed by TRACON, has shown enhanced antibody-dependent cellular cytotoxicity (ADCC) and complement-dependent cytotoxicity (CDC) in vitro.
CTLA-4 is a protein receptor that can lower immune responses, particular in the case of some cancers.
In preclinical studies, YH001 demonstrated superior T cell activation and superior tumor growth inhibition activity compared to ipilimumab. YH001 also demonstrated superior activity compared to ipilimumab in human transgenic mouse tumour models when combined with a PD-(L)1 antibody.
In these models, single agent YH001 depleted regulatory T cells and increased CD8+ T cells in tumor tissue. YH001 has been dosed as a single agent in a phase one trial in China and in combination with the PD-1 antibody toripalimab in a phase one trial in Australia.
The phase one and clinical trial is a multicentre, open-label study of YH001 initially given in combination with envafolimab, and then given in combination with envafolimab plus doxorubicin in patients with advanced or metastatic sarcoma, followed by phase two cohorts of patients with select histologies of advanced or metastatic sarcoma, including patients new to treatment.
The primary objective of the phase one portion of the trial is to determine the recommended phase two dose of YH001 in combination with envafolimab and in combination with envafolimab with doxorubicin.
The primary objective of the phase two portion is to determine the objective response rate (ORR) of the combination of YH001 and envafolimab in patients with alveolar soft part sarcoma and chondrosarcoma and the ORR of the combination of YH001, envafolimab and doxorubicin in patients with leiomyosarcoma and dedifferentiated liposarcoma.
TRACON is a clinical-stage biopharmaceutical company using a cost-efficient, CRO-independent, product development platform to advance its pipeline of novel targeted cancer therapeutics and to form partnerships with other life science companies.
Contact the author at susie@proactiveinvestors.com