TD Biologics announces the latest advances in the clinical trial of the first-of-its-kind HPK1 inhibitor, CFI-402411, at the 2022 STIC Annual Meeting

TD Biologics, a clinical-stage biotechnology company developing new cancer drugs, announced on November 11 that CFI-402411, the world's first oral inhibitor of hematopoietic progenitor cell kinase 1 (HPK1), negatively regulates
immune cell activation at the 37th Annual Meeting of the Society for Cancer Immunotherapy (SITC) (November 8-12, 2022), which is being held at the Boston Convention Center and Network in Boston, Massachusetts 。 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 2022 Poster Presentation and Details:

TWT-101: The first Phase 1/2 study of the 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 presentation titled "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", 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 could be assessed, 2 patients achieved partial remission
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 optimal response for 9 patients was to be stable and continue to undergo the study for at least 4 cycles
.
The most common treatment-induced toxicity of any grade (present 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 in preclinical studies to have immunoactivating effects, including mitigating inhibitory effects on T cell receptors (TCRs), disrupting abnormal expression of cytokines, altering the tumor immunosuppressive environment through effector cells (i.
e.
, regulatory T cells or Tregs), and potent anti-leukemia 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 is 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.