Project Optimus Services

Project Optimus has been a true game changer in the space of getting the most appropriate dose in Oncology. The days when we developed oncology drugs based on the maximum tolerated dose (MTD) approach are behind us or close to it. The new era of drug development is a patient centric approach and ensuring drugs are developed with the right dose with a focus beyond just efficacy.

Lack of adequate efficacy from all comer trials in the dose escalation space can pose challenges when choosing doses for Phase Ib/run-in Phase 2 trials. In these cases, additional biomarker and/or target engagement data over a dose range as well as preclinical safety and efficacy data, is imperative to support the chosen dose levels. Translational (PK/PD/ tumor kinetic) modeling of preclinical data is used to help predict exposures needed in clinical studies to achieve the needed effect in humans. The integrated preclinical and clinical data is then used to support and justify the doses planned for Phase Ib or safety and efficacy run-in of Phase II studies.

At Vanadro, we firmly believe in following a Project Optimus approach and have assisted countless clients in planning for this throughout all stages of development including:

• Strategize and design preclinical studies used to translate and justify doses in future development
• Work with study team in IND submission phase to plan for Project Optimus support
• Provide strategy on timing on clinical Project Optimus assessment as a part of Dose Expansion or Run-In Phase 2
• Strategize with the team prior to EOPh1 to prepare for Project Optimus discussion with FDA
• Prepare FDA briefing books with dose rationale and justification including exposure-safety and exposure-efficacy analyses to support doses and dosing regimen/s

Project Optimus Services

• Working with clients with Project Optimus needs in all stages of development
• Aiding clients in protocol designs that are in line with project Optimus requirements
• Plan preclinical studies to support future doses in development
• Strategize timing of Project Optimus assessment
• Prepare analyses and FDA documents to support Project Optimus discussion and dose decisions