Innovent Biologics IBI343 (CLDN 18.2 antibody drug conjugate) completed the dosing of the first subject in Australia

ROCKVILLE, USA and Suzhou, China, Oct.
31, 2022 /PRNewswire/ -- Innovent Biopharmaceutical Group (HKEx: 01801), a biopharmaceutical company dedicated to the development, production and sale of innovative drugs for major diseases such as oncology, autoimmunity, metabolism and ophthalmology, today announced its recombinant human anti-tight connexin 18.
2 (Claudin 18.
2, CLDN18.
2) antibody drug conjugate (development code: IBI343) completed the first subject dosing
in a Phase I clinical trial conducted in Australia.
This is the first antibody drug conjugate (ADC) candidate in Innovent to enter the clinical stage
.

The clinical study (NCT05458219) is an open-label, multicenter Phase I study with the primary objective of evaluating the safety, tolerability and preliminary efficacy of IBI343 in subjects with advanced solid tumors and determining the maximum tolerated dose (MTD) and/or the recommended dose of phase II (RP2D).

IBI343 is a recombinant human anti-CLDN18.
2 ADC, which, when combined with CLDN18.
2-expressing tumor cells, can internalize CLDN18.
2-dependent ADC and release toxin drugs to cause DNA damage, leading to apoptosis
of tumor cells.
Free toxin drugs can also spread through the plasma membrane to reach and kill adjacent tumor cells, so IBI343 also has a bystander effect
.
IBI343 showed good antitumor activity in the tumor-bearing pharmacological model with low expression and high expression of CLDN18.
2, and had good safety characteristics and controllable
overall safety in the preclinical model.

Dr.
of Pindara Private Hospital, Queensland, Australia Andrea Tazbirkova said: "The anti-tumor efficacy of monoclonal antibodies and CAR-T drugs targeting CLDN18.
2 has been clinically verified, and the overall safety is controllable, but the monotherapy efficacy is limited and only effective in people with high expression of CLDN18.
2, and there is still a large unmet need
in patients with low expression.
Given the robust evidence and good controllable safety profile of IBI343 in a variety of preclinical tumor types, we expect positive clinical safety
, tolerability and efficacy outcomes for IBI343.
" "

Dr.
Zhou Hui, Senior Vice President of Innovent Biopharmaceutical Group, said: "Targeted therapies for tumors such as gastric cancer and pancreatic cancer are scarce, and there is a huge unmet clinical need
.
CLDN18.
2 is highly expressed in gastric cancer and pancreatic cancer, and drugs targeting CLDN18.
2 are potential new anti-tumor treatment options, and Innovent Biologics has completely laid out a number of candidate therapies with different mechanisms of action in this field, aiming to strive for druggability while seeking differentiated therapeutic value
.
We are pleased that IBI343 has completed the dosing of the first subject in the Phase 1 clinical study in Australia and look forward to positive results
for IBI343 in advanced solid tumor subjects.
" This is Innovent Biologics' first ADC product candidate to enter the clinical stage, further improving our R&D pipeline, the company will accelerate the development of more innovative molecules with global potential, give full play to the advantages of cross-regional R&D and clinical resource synergy, and adhere to the long-term development strategy of "taking innovation as the cornerstone and taking the road of globalization" to benefit
more and more cancer patients.
"

About tight junction protein 18.
2 (Claudin 18.
2).

Claudin18.
2 is a member of the Claudin protein family and is normally expressed
only in differentiated epithelial cells on the gastric mucosa.
However, it shows a phenomenon of high expression in tumors such as gastric cancer, pancreatic cancer, tube esophageal adenocarcinoma, and colorectal adenocarcinoma
.
This feature makes Claudin 18.
2 an ideal target for immunotherapy for
solid tumors.

Globally, monoclonal antibodies, bispecific antibodies, antibody conjugates and CAR-T cell products targeting Claudin 18.
2 are still in the clinical development stage, and no products have been approved
.

About IBI343

IBI343 is a recombinant human anti-CLDN18.
2 ADC, which, when combined with CLDN18.
2-expressing tumor cells, can internalize CLDN18.
2-dependent ADC and release toxin drugs to cause DNA damage, leading to apoptosis
of tumor cells.
Free toxin drugs can also spread through the plasma membrane to reach and kill adjacent tumor cells, so IBI343 also has a bystander effect
.
IBI343 is currently in a Phase 1 clinical study in Australia (NCT05458219) to evaluate the safety, tolerability and preliminary efficacy of IBI343 in subjects with advanced solid tumors and to determine the maximum tolerated dose (MTD) and/or the recommended dose of phase II (RP2D).

About Innovent Biologics

"Starting from faith, reaching in action", developing high-quality biological drugs that are affordable to the people is the ideal and goal
of Innovent Biologics.
Founded in 2011, Innovent is committed to developing, manufacturing and marketing innovative drugs
in major diseases such as oncology, autoimmunity, metabolism, and ophthalmology.
On October 31, 2018, Innovent Biologics was listed on the main board of The Stock Exchange of Hong Kong Limited with stock code: 01801
.

Since its founding, the company has distinguished
itself from many biopharmaceutical companies with its innovative achievements and international operating model.
It has established a product chain including 35 new drug varieties, covering tumor, autoimmunity, metabolism, ophthalmology and other disease fields, of which 7 varieties have been selected as the national "major new drug creation" special project
.
The company has 8 products (sindilimab injection, trade name: Daboshu ^®, English trademark: TYVYT^®; Bevacizumab biosimilar, trade name: Da Youtong ^®, English trademark: BYVASDA^®; adalimumab biosimilar, trade name: Su Lixin ^®, English trademark: SULINNO^®; Rituximab biosimilar, trade name: Daberhua ^®, English trademark: HALPRYZA^®; Pemetinib tablets, trade name: Dabertan ^®, English trademark: PEMAZYRE^®; orebatinib tablets, trade name: Nerix ^®; Ramoxilumab, trade name: Xiranxu, ^® English trademark: CYRAMZA^®; Sepulinib capsules) were approved for marketing, 2 varieties are under NMPA review, 4 new drug molecules have entered phase III or key clinical studies, and 21 new drug species have entered clinical research
.

Innovent has established a team of high-end biopharmaceutical development and industrialization talents with international advanced level, including many returnee experts, and reached strategic cooperation
with international partners such as Lilly Pharmaceutical, Sanofi, Adimab, Incyte and MD Anderson Cancer Center.
Innovent hopes to work together with everyone to improve the development level of China's biopharmaceutical industry, so as to meet the people's pursuit of drug accessibility and people's wishes
for life and health.
For details, please visit the company's website: www.
innoventbio.
com or company LinkedIn account www.
linkedin.
com/company/innovent-biologics/
.

Statement:

Innovent does not recommend the use of any unapproved drugs/indications;

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.
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