Pipeline

We are advancing multiple assets through the clinic, including our small molecule, TCR cell therapy and biologic programs.

Therapeutic Modality

Program

Indication

Discovery

Phase 1

Phase 2

Small Molecule

CFI-400945

(PLK4 Inhibitor)

AML, MDS, CMML

(Monotherapy and HMA combos)
Trial Name: TWT-202

A Study of CFI-400945 With or Without Azacitidine or Decitabine in Patients With AML, MDS or CMML (TWT-202)

Condition:

Acute myeloid leukemia (AML), myelodysplastic syndromes (MDs), chronic myelomonocytic leukemia (CMML)

Phase:

Phase 1/2

Status:

Actively recruiting

ClincalTrials.gov

Phase 2

Small Molecule

CFI-400945

(PLK4 Inhibitor)

Breast Cancer

(Monotherapy – TNBC, ER+)
Trial Name: IND.237

CFI-400945 in Patients With Advanced/Metastatic Breast Cancer (IND.237)

Condition:

Advanced/metastatic breast cancer

Phase:

Phase 1/2

Status:

Actively recruiting

ClincalTrials.gov

Phase 2

Small Molecule

CFI-400945

(PLK4 Inhibitor)

Breast Cancer

(Durvalumab combo –TNBC)
Trial Name: IND.239

CFI-400945 and Durvalumab in Patients With Advanced Triple Negative Breast Cancer (IND.239)

Condition:

Triple negative breast cancer

Phase:

Phase 1/2

Status:

Active, not recruiting

ClincalTrials.gov

Phase 2

Small Molecule

CFI-400945

(PLK4 Inhibitor)

Prostate Cancer

(Monotherapy)
Trial Name: IND.234D

Prostate Cancer Biomarker Enrichment and Treatment Selection (IND.234D)

Condition:

Prostate cancer

Phase:

Phase 1/2

Status:

Actively recruiting

ClincalTrials.gov

Phase 2

Small Molecule

CFI-400945

(PLK4 Inhibitor)

Solid Tumors

(Monotherapy dose escalation)
Trial Name: 945-001

A Study of CFI-400945 Fumarate in Patients With Advanced Cancer (945-001)

Condition:

Advanced solid tumor cancers

Phase:

Phase 1

Status:

Active, not recruiting

ClincalTrials.gov

Phase 1

Small Molecule

CFI-400945

(PLK4 Inhibitor)

AML, MDS

(Monotherapy dose escalation)
Trial Name: 945-002

Study of CFI-400945 Fumarate in Patients With Relapsed or Refractory AML or MDS (945-002)

Condition:

Relapsed or refractory acute myeloid leukemia (AML) or myelodysplastic syndromes (MDs)

Phase:

Phase 1

Status:

Active, not recruiting

ClincalTrials.gov

Phase 1

Small Molecule

CFI-402257

(TTK Inhibitor)

2L ER+ Breast Cancer

(fulvestrant combo, post CDK4/6 inhibitors)
Trial Name: TWT-203

CFI-402257, a Potent and Selective TTK Inhibitor, in Solid Tumors and With Fulvestrant in Breast Cancer (TWT-203)

Condition:

Breast cancer

Phase:

Phase 1/2

Status:

Enrolling soon

ClincalTrials.gov

Phase 2

Small Molecule

CFI-402257

(TTK Inhibitor)

Solid Tumors

(dose escalation with multiple expansions)
Trial Name: 2275-001

A Study of Investigational Drug CFI-402257 in Patients With Advanced Solid Tumors (2275-001)

Condition:

Advanced solid tumor cancers

Phase:

Phase 1/2

Status:

Actively recruiting

ClincalTrials.gov

Phase 2

Small Molecule

CFI-402257

(TTK Inhibitor)

Breast Cancer

(Taxol combo)
Trial Name: IND.236

CFI-402257 in Combination With Paclitaxel in Patients With Advanced/Metastatic HER2-Negative Breast Cancer (IND.236)

Condition:

Advanced/metastatic HER2-negative breast cancer

Phase:

Phase 1/2

Status:

Actively recruiting

ClincalTrials.gov

Phase 2

Small Molecule

CFI-402411

(HPK1 Inhibitor)

Solid Tumors

(Monotherapy and pembrolizumab combo)
Trial Name: TWT-101

Safety and Efficacy Study Of CFI-402411 in Subjects With Advanced Solid Malignancies (TWT-101)

Condition:

Advanced solid tumor cancers

Phase:

Phase 1

Status:

Actively recruiting

ClincalTrials.gov

Phase 1

TCR-based cell therapy

Multiple TCRs

TBD

(Solid and Liquid Tumors)

Discovery

Biologic

Multiple candidates

TBD

(Solid and Liquid Tumors)

Discovery

Company Sponsored
Investigator-Initiated Studies
Preclinical

Expanded Access Policy

Treadwell may provide patients with access to investigational drugs outside of a clinical trial when there is sufficient evidence of the safety and effectiveness of the investigational drug to support its use for the circumstance and suitability of the patient for treatment based on the assessment of their medical history by a medical doctor. Any use of a Treadwell investigational drug outside a clinical study in any country must be in accordance with local laws and regulations governing such programs and Treadwell’s procedures.

For questions or requests regarding our expanded access policy, please contact clinicaltrials@treadwelltx.com. For additional information on Expanded Access Policies, please visit the U.S. Food and Drug Administration website.