TRX518 is a humanized monoclonal antibody with agonist activity that has been designed to target the glucocorticord-inducible TNF-superfamily receptor (GITR). The GITR agonist has been engineered to improve immune responses to cancer.
Avelumab, on the other hand, is a human anti-programmed death ligand-1 (PD-L1) antibody. The drug, which has been co-developed by Merck and Pfizer, has been shown in preclinical models to engage the adaptive and innate immune functions.
Leap Therapeutics clinical development vice president Cynthia Sirard said: “The combination of TRX518 with anti-PD-L1 immunotherapy and cyclophosphamide has a solid scientific rationale and we look to build upon our early clinical and preclinical data highlighting the potential benefits of such a combination.”
Under the collaboration agreement signed by the parties, Leap will carry out a phase I/II clinical trial in advanced solid tumors, which will include expansion populations in patients with relapsed/refractory ovarian, breast, and prostate cancers.
Merck Biopharma business global clinical development head Alise Reicin said: “Combination therapy remains a major focus in our clinical development program for avelumab in an effort to advance the treatment landscape for patients with challenging cancers.
“Through our collaboration with Leap Therapeutics, we are eager to further understand the potential of this novel immunotherapy combination in this patient population.”
The clinical trial of the TRX518/avelumab combo with chemotherapy is anticipated to start enrolling patients in the first quarter of 2019.
Leap Therapeutics is evaluating TRX518 in another combination study for the treatment of advanced solid tumors.
In January, the company said that it had launched a phase 1 clinical trial to assess the GITR agonist in combination with gemcitabine chemotherapy or in combination with Merck’s Keytruda (pembrolizumab) or Bristol-Myers Squibb’s Opdivo (nivolumab).
The trial called as TRX518-003 is evaluating TRX518 as a single agent and in combination with gemcitabine, Keytruda, or Opdivo in patients with advanced solid tumor malignancies.