Tianyan Pharmaceutical announced its ADG126Ib/II anti-CTLA-4 antibody Phase 126Ib/II clinical dose escalation interim data

On January 9, the company announced clinical trial data
on the combination of its masked anti-CTLA-4 safe antibody SAFEbody ADG126 and anti-PD-1 therapy in patients with advanced/metastatic solid tumors.

As of January 6, 2023, clinical trial results in 14 patients who underwent multiple rounds of pre-treatment showed that ADG126 showed good safety and preliminary efficacy
in combination with anti-PD-1 therapy.
The company plans to present detailed dose-escalation data
at medical meetings in the first half of 2023.

Key data includes:

● Demonstrated a compelling safety profile in combination regimens with anti-PD-1 therapy: ADG126 at a maximum dose of 10 mg/kg in combination with a fixed dose of anti-PD-1 drug (teripalimab, administered at a dose of 240 mg), including repeated dosing at a frequency of every three weeks, demonstrated good tolerability, no dose-limiting toxicity was observed, and the maximum tolerable dose
was not achieved.
As of January 6, 2023, an additional 10 patients were evaluated
in a separate clinical trial for ADG126 in combination with pembrolizumab.

● Dose optimization under FDA's Optimus* program initiative: After completing the dose escalation phase, enter an expansion phase based on two ADG126 dose levels (6 mg/kg and 10 mg/kg, administered every three or six weeks) to advance the innovation of
the dose optimization and dose selection paradigm in oncology drug development based on two ADG126 dose levels (6 mg/kg and 10 mg/kg, administered every three or six weeks).

● Confirmed clinical response and antitumor activity: The company also confirmed that objective remission
of different tumor types has been observed in the dose escalation phase of combination therapy.
In addition, persistent tumor atrophy was observed in patients with cold tumors (e.
g.
, MSS bowel cancer) and tumor immunoresistant refractory tumors, indicating that ADG126 and its parent antibody ADG116 have a new generation of anti-CTLA-4 therapy mechanism, that is, to improve efficacy
by efficiently clearing regulatory T cells.

"The latest data show that the new generation of anti-CTLA-4 antibody has demonstrated a unique safety and efficacy
.
" John Park, a medical oncologist at the Department of Clinical Medicine at Macquarie University and a fellow of the Royal Australian College of Physicians, said: "We have observed the clinical efficacy of the new generation of anti-CTLA-4 antibodies in patients including cold tumors, while existing anti-CTLA-4 therapies have little
effect on this type of tumor due to their dose-dependent toxicity.
For severe patients who have already tried multi-line therapy and have no alternative, we are pleasantly surprised to observe tumor response and clinical benefit
in the early dose escalation phase.
The clinical potential of ADG126 is exciting
.
"

Safe antibody SAFEbody^® technology addresses the safety and tolerability challenges
of many antibody therapies by minimizing the toxic side effects induced by targeting targets expressed in healthy tissues 。 The safe antibody ADG126 acts on the parental anti-CTLA-4 antibody ADG116 with precision masking technology to achieve the specific activation of the safe antibody ADG126 in the tumor microenvironment, and improve the therapeutic index by solving the existing anti-CTLA-4 effective dose and optimizing the dose-dependent toxicity problem in the dosing cycle
.

The unique epitope of the CTLA-4 target bound by the masked ADG126 is the same as that of ADG116, which steadily accumulates and prolongs the exposure of drugs in tumor tissues to enhance safety and efficacy
by strongly removing regulatory T cells in the tumor microenvironment and exerting partial distributor blocking effect.

"The data observed in the combination therapy trial against ADG126 safe antibody is consistent with our clinical target product performance and highlights the great potential
of Tianyan's next-generation anti-CTLA-4 therapy to become best-in-class.
" Dr.
Peizhi Lo, co-founder, CEO and chairman of Tianyan, said, "In 2023, we look forward to continuing our and Roche-sponsored clinical programs, and plan to announce detailed results of these dose expansion cohorts this year and present Phase II proof-of-concept data
from dose expansion cohorts for target indications.
"