DEVELOPMENT PIPELINE

Pioneering a more inclusive era of cancer drug development

At Day One, our unique approach to drug development represents the start of a new, more inclusive age in targeted therapies for people of all ages with life-threatening diseases.

Day One’s pipeline is deeply rooted in cancer biology to treat the right patient with the right medicine for the right target. It is also designed for efficiency and speed and will expand beyond cancer into other life-threatening diseases. Together with our collaborators and advisors, we are leveraging novel clinical and scientific insights to inform our development efforts.

Our lead product candidate, DAY101 (tovorafenib), is in a pivotal Phase 2 study (FIREFLY-1). It has the potential to become the first approved therapy for the most common form of childhood brain cancer.

Product Candidate
Indication
  • Pre-CN
  • Ph 1
  • Ph 2
  • Ph 3
DAY101 Type II Pan-RAF Inhibitor

Indication: Relapsed pLGG

Progress: Phase 2

Clinical Trial: Enrolling (FIREFLY-1) 1

  • PH2
Enrolling (FIREFLY-1) 1

Indication: Frontline pLGG

Progress: Phase 2

Clinical Trial: Planned

  • PH2
Planned

Indication: RAF-altered solid tumors 2*

Progress: Phase 2

Clinical Trial: Enrolling (FIRELIGHT-1)

  • PH2
Enrolling (FIRELIGHT-1)
Pimasertib MEK1/2 Inhibitor

Indication: MAPK-altered solid tumors 3*

Progress: Phase 1

Clinical Trial: Enrolling (FIRELIGHT-1)4

  • PH1
Enrolling (FIRELIGHT-1)4
1 FIREFLY-1 is a pivotal Phase 2 trial expected to support registration.

2 DAY101 adult monotherapy Phase 1 dose escalation and expansion trial previously completed.

3 Pimasertib Phase 1 dose escalation and expansion trial previously completed.

4 Trial in combination with DAY101.

* Includes patients ≥12 years of age.

Learn more about Day One’s ongoing
clinical trial programs.