Innovent Announces First Patient Dosed in Phase 1 Study of IBI3020, Global First-in-class Dual Payload CEACAM5 ADC, in Patients with Advanced Malignancies
Rhea-AI Summary
Innovent Biologics has achieved a significant milestone with the first patient dosing of IBI3020, a groundbreaking dual-payload CEACAM5 ADC, in a Phase 1 clinical trial for advanced solid tumors. This marks a global first-in-class development in cancer treatment technology.
The multi-regional Phase 1 study, approved in both China and the U.S., will evaluate the safety, tolerability, and preliminary efficacy of IBI3020. The drug, developed from Innovent's proprietary DuetTx® dual-payload ADC platform, works by selectively binding to CEACAM5-expressing tumor cells and releasing two types of cytotoxic payloads to kill cancer cells.
Preclinical studies have shown promising results, with IBI3020 demonstrating strong antitumor activity and manageable safety profiles. The drug targets CEACAM5, a protein overexpressed in various solid tumors including colorectal cancer, non-squamous lung cancer, gastric cancer, and pancreatic cancer, while showing limited expression in healthy tissues.
Positive
- First-in-class dual-payload CEACAM5 ADC entering clinical trials, demonstrating innovation leadership
- Successful IND approval in both US and China markets, expanding global reach
- Robust preclinical results showing strong antitumor activity across various models
- Proprietary DuetTx® platform technology with independent intellectual property rights
- Strategic advancement in 'IO+ADC' portfolio with potential market differentiation
Negative
- Early Phase 1 stage with no proven clinical efficacy yet
- Significant R&D expenses expected during clinical trials
- Competitive market with existing cancer treatments
- Long pathway to potential commercialization with no guaranteed success
News Market Reaction
On the day this news was published, IVBIY gained 2.71%, reflecting a moderate positive market reaction.
Data tracked by StockTitan Argus on the day of publication.
The study is an open-label, multi-regional Phase 1 study evaluating the safety, tolerability, and preliminary efficacy of IBI3020 in participants with advanced solid tumors, as well as determining the recommended Phase 2 dose (RP2D). The study has received IND approval in the
As a global first-in-class ADC candidate, IBI3020 is generated from Innovent's proprietary DuetTx® dual-payload ADC platform. The internationalization of the CEACAM5-dependent ADC occurs after IBI3020 selectively binds to CEACAM5-expressing tumor cells, followed by lysosomal degradation. This process releases two types of cytotoxic payloads, leading to cell killing of tumor cells.
In preclinical studies, IBI3020 has demonstrated robust antitumor activity across various tumor-bearing pharmacology models, with a notable bystander killing effect. Additionally, IBI3020 has shown favorable safety characteristics in preclinical models, with an overall manageable safety profile.
Professor Yu Jinming, Shandong Cancer Hospital, stated:" Carcinoembryonic antigen (CEA), also known as CEACAM5, is a glycosylphosphatidylinositol-anchored cell-surface glycoprotein involved in cell adhesion, invasion, and metastasis of cancer cells. There is a significant clinical need for effective therapies in advanced colorectal cancer, non-squamous lung cancer, gastric cancer, pancreatic cancer, and others. CEACAM5 is overexpressed in these solid tumors but shows limited expression in healthy tissues, making it a potentially safe and promising therapeutic target. The dual payload of IBI3020 consists of two types of payloads that have been clinically validated. This dual-payload design has demonstrated enhanced tumor-killing effects in preclinical studies. We look forward to observing the clinical profiles and potential breakthrough of IBI3020 in terms of safety, tolerability, and efficacy in clinical trials."
Dr. Hui Zhou, Senior Vice President of Innovent, stated: "We are pleased to announce the successful dosing of the first patient dose with IBI3020. We will continue to advance the global development of IBI3020, aiming to offer better treatment options for patients with advanced solid tumors. Innovent possesses innovative ADC technology platforms with independent intellectual property rights. Multiple ADC molecules have clinically validated their differentiated competitiveness. IBI3020, Innovent's first dual-payload ADC, has successfully entered clinical trials and is the first dual-payload ADC globally known in the same class to complete the first-in-human dosing, marking a breakthrough in Innovent's ADC technology. We will continue our "IO+ADC" strategy, focusing on next-generation innovations with global potential to benefit cancer patients worldwide."
About IBI3020
IBI3020 is a global first-in-class ADC candidate developed from Innovent's proprietary DuetTx® dual-payload ADC platform. The CEACAM5 dependent ADC internalization occurs after IBI3020 selectively binds to the CEACAM5-expressing tumor cells, followed by the lysosomal degradation. This process releases two types of cytotoxic payloads, leading to tumor cell killing.
The multi-regional Phase 1 study of IBI3020, initiated in China, assesses the safety, tolerability, and preliminary efficacy of IBI3020 in patients with advanced solid tumors and aims to determine the recommended Phase 2 dose (RP2D). The study has also received IND approval in the
About Innovent
Innovent is a leading biopharmaceutical company founded in 2011 with the mission to empower patients worldwide with affordable, high-quality biopharmaceuticals. The company discovers, develops, manufactures and commercializes innovative medicines that target some of the most intractable diseases. Its pioneering therapies treat cancer, cardiovascular and metabolic, autoimmune and eye diseases. Innovent has launched 15 products in the market. It has 3 new drug applications under regulatory review, 3 assets in Phase III or pivotal clinical trials and 16 more molecules in early clinical stage. Innovent partners with over 30 global healthcare companies, including Eli Lilly, Sanofi, Incyte, Adimab, LG Chem and MD Anderson Cancer Center.
Guided by the motto, "Start with Integrity, Succeed through Action," Innovent maintains the highest standard of industry practices and works collaboratively to advance the biopharmaceutical industry so that first-rate pharmaceutical drugs can become widely accessible. For more information, visit www.innoventbio.com, or follow Innovent on Facebook and LinkedIn.
Statement: (1) Innovent does not recommend the use of any unapproved drug (s)/indication (s). |
(2) Ramucirumab (Cyramza) and Selpercatinib (Retsevmo) and Pirtobrutinib (Jaypirca) were developed by Eli Lilly and Company. |
Forward-Looking Statements
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