CytoDyn hires Syneos for second leronlimab trial
CytoDyn has hired Syneos Health for a second study of its monoclonal antibody candidate, leronlimab, this time in patients suffering from colorectal cancer.
Under the deal Syneos will assess the drug in a Phase II in patients with relapsed microsatellite stable CRC.
In a press statement CytoDyn said the program – the final protocol for which was filed with the FDA in September - is expected to start screening potential participants early next year.
CytoDyn CEO Jacob Lalezari said, “Investigating leronlimab in the field of oncology remains our top priority, and we are excited to further invest in our promising relationship with Syneos Health.
“With this expanded mandate, we expect to generate clinical data affirming the utility of leronlimab in combination with trifluridine plus tipiracil (TAS-102) and bevacizumab,” Lalezari added.
Earlier this year CytoDyn shared details of the Phase II program, explaining it would be an open label, randomized, multicenter trial to evaluate the anti-tumor activity of leronlimab at doses of 350 mg and 700 mg in approximately 60 patients.
Clinical development
Leronlimab, a humanized IgG4 monoclonal antibody (mAb) that binds a protein called C-C chemokine receptor type 5 (CCR5) present on certain immune system cells, which is thought to play a role in numerous disease processes.
News of the Syneos agreement marks the end of a busy six months for CytoDyn, which began with the FDA lifting the clinical hold on clinical trials of leronlimab.
The hold – specifically, a partial clinical hold on CytoDyn’s HIV program and a full clinical hold on its COVID-19 program – had been in place since 2022.
Just prior to the FDA’s lifting of the hold, CytoDyn submitted a revised HIV trial protocol, stating, “We believe this protocol will help clarify the mechanisms by which leronlimab can be used as an immune modulator in HIV and a variety of other therapeutic areas.”
CRO
Syneos already has experience working with leronlimab.
In August, CytoDyn hired the CRO to run a Phase II study of the drug as a treatment for chronic inflammation.
At the time Lalezari said, “We are looking forward to working with Syneos Health to advance our Phase II study of leronlimab’s effects on chronic inflammation.
“With the company’s support, our goal is to generate clinical data that we believe will affirm the utility of leronlimab in addressing a number of medical concerns impacting patients globally.”
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