Rain Therapeutics and Roche to Jointly Conduct Immunotherapy Trial Solid Tumor Treatment

Milademetan and Atezolizumab, in combination, will assess the potential for MDM2-checkpoint inhibition in genetically selected patient populations.

FREMONT, CA: Patients benefit from clinical trials because they help researchers find cures and preventative measures in the fight against diseases. It is impossible to discover what works in the laboratory or on animals and what does not in humans until clinical trials are conducted. Rain Therapeutics Inc., a late-stage company developing precision oncology therapeutics, has entered into a clinical supply agreement with Roche to supply atezolizumab, an anti-Programmed Death Ligand-1 (PD-L1) monoclonal antibody.

“We are excited to evaluate the combination of MDM2 inhibition and cancer immunotherapy with milademetan and atezolizumab, and believe it presents a strong mechanistic rationale,” states Avanish Vellanki, co-founder and chief executive officer of Rain. 

“We believe the therapeutic index afforded by milademetan will enable synergistic combination with PD-L1 checkpoint inhibition and are excited about the potential for favorable results from the Phase 1 study to support moving into subsequent studies across various MDM2-dependent cancers.”

Milademetan, an oral mouse double minute 2 (MDM2) inhibitor, is being evaluated in clinical trials with atezolizumab to treat patients from genetically distinct populations. Rain will sponsor the anticipated clinical trials under this agreement, while Roche will supply atezolizumab.

A Phase 1 clinical trial will be conducted to assess the safety, tolerability, and efficacy of milademetan in combination with atezolizumab in patients with advanced solid tumors who lack cyclin-dependent kinase inhibitor 2A (CDKN2A) but have wildtype p53. CDKN2A encodes the tumor suppressor p14ARF, which acts as an MDM2 inhibitor, and CDKN2A deficiency may result in MDM2-dependent cancers. The Phase 1 clinical trial will begin in the second half of 2022. Additional tumor types may be included in subsequent Phase 2 clinical trials evaluating the combination of milademetan and atezolizumab.