IO Biotech has dosed the first patient in a clinical trial testing the safety and efficacy of IO102 in combination with Merck’s Keytruda (pembrolizumab) as a first-line treatment for patients with metastatic non-small cell lung cancer (mNSCLC).
The Phase 1/2 open-label, randomized study (NCT03562871) is sponsored and conducted by IO biotech. Merck (known as MSD outside North America) provides Keytruda.
It aims to test the safety and effectiveness of the combo, with or without chemotherapy, as a first-line treatment for patients with mNSCLC.
“The enrolment of the first patient in our Phase I/II trial for NSCLC represents a major milestone for IO Biotech, and we are excited that our global trial is now active and recruiting patients,” Eva Ehrnrooth, chief medical officer of IO Biotech, said in a press release.
The study expects to enroll about 110 patients at more than 20 sites across Europe and the United States. For more information about ongoing enrollment, visit the trial’s page.
IO102 is the lead anti-cancer therapy candidate of IO Biotech, a company that focusses on the development of disruptive immune therapies for cancer treatment.
The treatment is a derivate of an enzyme called 2,3 dioxygenase (IDO) that modulates the immune system, increasing the response by effector cells and inhibiting immune cells with suppressive functions.
IO102 has a dual mode of action. It directly targets and kills cancer and immune suppressive cells. This way, it attacks the tumor directly and indirectly, since the reduction of suppressive cells increases natural immune responses against a tumor.
This kind of treatment appears to have best potential when combined with therapies that act as checkpoint inhibitors, such as Keytruda.
Keytruda specifically binds to a protein called PD-1 that is expressed by immune cells; this protein prevents tumor cells from interacting with immune cells, a mechanism used by cancers to evade an immune response.
By interacting with PD-1, Keytruda promotes the natural anti-tumor immune response.
The ongoing trial will be conducted in two parts. First is a safety run-in part to determine the treatment’s safety and incidence of adverse events. Then, in a second part, researchers will determine if adding IO102 to Keytruda, with or without chemotherapy, increases the proportion of patients with lesser tumor volume. Patients in this Phase 2 part of the trial will be treated for up two 35 cycles, with each cycle spaced three weeks apart.
Additional measures include the response rate in patients with different PD-L1 levels at baseline (study’s start).
Primary data collection is expected to finish in November 2020.
“Through this trial, we expect to get a diverse set of clinical data. This will enable us to explore the potential of IO102 when added to the current standard of care,” Ehrnrooth concluded.