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

What is expanded access?
Expanded access, also referred to as compassionate use, is a pathway for patients to access investigational new drugs outside of the usual clinical trial process. Unlike the use of an investigational drug in a clinical trial setting, the primary purpose of expanded access is to use the investigational drug for patient treatment purposes, rather than to obtaining safety and effectiveness information for the development of the drug.

What is Treadwell Pharmaceuticals’ policy on Expanded Access?
The best way to access Treadwell Pharmaceuticals’ investigational products is through participation in one of our ongoing clinical trials. Access outside of a Treadwell Therapeutics clinical trial may interfere with the progress of our development programs, which would, in turn, may delay access to many other patients, also in need of new therapies.

Therefore, Treadwell Therapeutics has reached the difficult decision to not accept expanded access requests at this time. This policy is subject to change at the discretion of Treadwell Therapeutics and this webpage will be updated should there be a change.

How can I get more information?
For more information on clinical trials, see https://clinicaltrials.gov. Search “Treadwell” under the Sponsor name to find clinical trials that may currently be recruiting. Physicians can obtain more information about FDA’s Expanded Access policies and requirements for enrolling in Expanded Access programs here: Expanded Access | Information for Physicians | FDA