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NEW YORK, Nov.
11, 2022 /PRNewswire/ -- TD Biologics, a clinical-stage biotechnology company developing new cancer drugs, today announced the presentation of CFI-402411 at the 37th Annual Meeting of the Society for Cancer Immunotherapy (SITC), which is being held Nov.
8-12, 2022, at the Boston Convention Center and Network in Boston, Massachusetts.
A world's first oral inhibitor against hematopoietic progenitor cell kinase 1 (HPK1), which negatively regulates immune cell activation
.
This presentation will provide an interim update
from the ongoing TWT-101 clinical trial, the first human trial of CFI-402411 sponsored by TD Biologics in advanced solid tumors.
"Inhibition of HPK1 with CFI-402411 may be a safe and effective means to
stimulate anti-tumor immunity.
" We continue to observe new signs of good tolerability and clinical activity in patients, including failure of anti-PD1 therapy," said
Omid Hamid, Ph.
D.
, Head of Research and Immunotherapy, Los Angeles Clinic and Research Institute, an affiliate of Cedars-Sinai, Los Angeles, California.
"We are encouraged
by the emerging clinical features of CFI-402411.
" Dr.
Michael Tusche, co-CEO of TD Biologics, said, "We hope to determine the recommended Phase 2 dose of the molecule in the near term and are excited
about CFI-402411 as the next phase of development as monotherapy and checkpoint blocking combination therapy.
"
SITC Poster 2022 and details:
TWT-101: Hematopoietic progenitor cell kinase-1 (HPK1) inhibitor CFI-402411 as a single agent and in combination with pembrolizumab in subjects with advanced solid malignancies
Publication Number: 750 Poster Hall
Date and Time: November 11, 2022, 7:00 - 20:30
In a first-in-phase 1/2 study titled TWT-101: Hematopoietic Progenitor Kinase-1 (HPK1) Inhibitor CFI-402411 as a Single Agent and in Combination with Pembrolizumab for the Treatment of Subjects with Advanced Solid Malignancies CFI-402411 demonstrated clinical safety controllability
at once-daily doses up to 560 mg with exposure increasing proportionally with dose.
Of the 31 people whose efficacy was assessable, two patients achieved a partial response with the best response
.
Both cases occurred in patients
with head and neck squamous cell carcinoma (HNSCC) who had previously been treated with pembrolizumab.
One of the patients received monotherapy (400 mg) and the other received combination therapy (60 mg + pembrolizumab), with a reduction of target lesions of 36% and 81%,
respectively.
The best response for nine patients was to stabilize their condition and continue to undergo the study for at least 4 cycles
.
The most common treatment-induced toxicity of any grade (experienced in more than 10% of patients) included diarrhea (61%), fatigue (39%), nausea (33%), decreased appetite (30%), vomiting (26%), dehydration (17%), elevated alanine aminotransferase (15%), indigestion (15%), and back pain (11%)
.
About CFI-402411 CFI-402411 is a highly potent HPK1
inhibitor that has been shown to have immunoactivating effects including mitigating inhibitory effects on T cell receptors (TCRs), disrupting abnormal expression of cytokines, and altering the tumor immunosuppressive environment through effector cells (i.
e.
, regulatory T cells or Tregs).
and potent antileukemia effects
in several mouse models.
About TWT-101 TWT-101 is a Phase 1/2 clinical trial
of CFI-402411
for the treatment of advanced solid malignancies.
The purpose of this study was to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of CFI-402411, as well as to determine its optimal dose
as monotherapy and in combination with the anti-PD1 antibody pembrolizumab.
The trial can enroll up to 170 patients
at 15 sites in North America and Asia.
This will involve 5 areas, including dose escalation and expansion of monotherapy and combination therapies for various types of tumors, and backfilling
of biomarkers.
About TD Biologics TD Biologics
is a science-driven, clinical-stage multimolecular oncology company
.
The company is developing first-in-class and best-in-class drugs to address the unmet needs
of cancer patients.
The Company's robust in-house development pipeline includes best-in-class CFI-400945 (PLK4 kinase inhibitor), best-in-class CFI-402257 (TTK inhibitor), and CFI-402411
.
TD Biologics also has a fast-moving preclinical pipeline with multiple biologics and next-generation TCR-based autologous cell therapy programs
.
For more information, please visit www.
treadwelltx.
com
.
Contact Investor
Inquiries:
Jantzen Kwan
Investor Relations
ir@treadwelltx.
com
General Enquiries:
info@treadwelltx.
com