SAN FRANCISCO and SUZHOU, China, April 27, 2025 /PRNewswire/ -- Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of oncology, cardiovascular and metabolic, autoimmune, ophthalmology and other major diseases, announces that preclinical data on multiple novel bispecific antibodies, tri-specific antibodies as well as bispecific antibody-drug-conjugates (ADCs) from its oncology pipeline will be presented at the American Association for Cancer Research (AACR) Annual Meeting 2025. The AACR meeting will take place April 25-30, 2025, in Chicago, Illinois.
Dr. Kaijie He, Cancer Biology and ADC Vice President of Innovent, stated: "With continuous advancement of Innovent Academy's integrated technology platforms, our global R&D capabilities have reached new heights, further strengthening our competitive position in the international biopharmaceutical landscape. This progress has accelerated our ability to design and develop innovative therapeutic candidates with significant global impact. We are proud to showcase a batch of preclinical research findings at this year's AACR Annual Meeting, including multiple globally first-in-class bispecific antibodies, multi-specific antibodies, and antibody-drug conjugates (ADCs). These scientific advancements highlight our expanding research expertise and underscore our unwavering dedication to creating life-changing treatments for patients across the globe. Moving forward, we remain deeply committed to scientific innovation—advancing target selection precision and pioneering unexplored biological mechanisms—to deliver breakthrough solutions for difficult-to-treat diseases and ensure more patients worldwide can access the benefits of cutting-edge therapeutic technologies. "
Research highlights as below:
Late-Breaking Research: Immunology 2 Topic: Preclinical data of IAR037, a novel CD40/PD-L1 bispecific antibody for the treatment of advanced solid tumors resistant to immune checkpoint inhibitors Abstract Number: LB139 Presentation Form: Poster Presentation Time: Monday April 28, 2025, 9:00 AM - 12:00 PM Location: Poster Section 52
IAR037 is a novel CD40/PD-L1 bispecific antibody, which simultaneously activates CD40 and blocks PD-1/L1, demonstrating potent anti-tumor efficacy in PD-1-resistant syngeneic mouse models and synergy with PD-1/IL-2α-bias fusion protein IBI363. Preclinical studies show tumor-specific immune activation with minimal systemic effects and a favorable safety profile in cynomolgus monkeys.
IAR037 presents a novel therapeutic approach for ICI-resistant advanced solid tumors and the IND-enabling study of IAR037 is ongoing.
Late-Breaking Research: Clinical Research 1 Topic: Preclinical characterization of IBI3010, a FRα targeting biparatopic antibody-drug conjugate (ADC), for the treatment of FRα expressing tumors Abstract Number: LB222 Presentation Form: Poster Presentation Time: Monday April 28, 2025, 2:00 PM - 5:00 PM Location: Poster Section 53
IBI3010 is a FRα targeting biparatopic ADC with novel topoisomerase I inhibitor NT1 (DAR8). The biparatopic design enhances tumor binding/internalization.
IBI3010 shows superior cytotoxicity and bystander effect versus mirvetuximab soravtansine (IMGN853) in vitro. IBI3010 demonstrated superior antitumor activity to IMGN853 in FRα-expressing CDX models, particularly in low-FRα expression models. GLP tox studies in cynomolgus monkeys established 60 mg/kg as HNSTD with full tolerability.
These data support the clinical development of IBI3010 to evaluate its potential as an ADC therapeutic for FRα-expressing solid tumors.
Poster Session:Experimental and Molecular Therapeutics - Biochemical Modulators of Cancer / Differentiation Therapeutic Strategies Topic: IBI3014, a TROP2xPD-L1 bi-specific ADC integrating ADC killing with checkpoint blockade within one molecule, exhibits promising efficacy and safety in preclinical models Abstract Number: 344 Presentation Form: Poster Presentation Time: Sunday April 27, 2025, 2:00 PM - 5:00 PM Location: Poster Section 16 Poster Board Number: 11
IBI3014 is a bispecific ADC targeting TROP2 and PD-L1. Its dual mechanism integrates TROP2-directed tumor killing with PD-L1 immune checkpoint blockade, enhancing immunogenic cell death and T cell infiltration.
In CDX models with varying TROP2/PD-L1 expression, IBI3014 demonstrated superior cytotoxicity compared to benchmark ADCs, covering broader tumor types. It maintained stability in mice and monkeys, with a well-tolerated HNSTD of 50 mg/kg in monkeys.
IBI3014's dual mechanism of action not only enhances therapeutic efficacy but also maintains a favorable safety profile, which provides a promising approach for cancer therapy.
Poster Session:Experimental and Molecular Therapeutics - Biochemical Modulators of Cancer / Differentiation Therapeutic Strategies Topic: Trop2 and B7H4 bi-specific ADC with improved efficacy and safety for gynecologic cancers Abstract Number: 345 Presentation Form: Poster Presentation Time: Sunday April 27, 2025, 2:00 PM - 5:00 PM Location: Poster Section 16 Poster Board Number: 12
IBI3022, a bi-specific ADC targeting Trop2 and B7H4, aims to enhance tumor antigen expression and reduce off-tumor toxicity associated with Trop2 by incorporating a single-arm Trop2 antibody and a less toxic Topoi NT3 linker payload.
In vitro studies demonstrate that IBI3022 exhibits superior cytotoxicity in HT29 cells overexpressing Trop2 and B7H4 compared to mono-specific ADC benchmarks targeting Trop2 or B7H4. In vivo, IBI3022 demonstrates enhanced tumor suppression compared to mono-specific ADC benchmarks in various tumor models with differing levels of Trop2 and B7H4 expression.
IBI3022 represents a promising bi-specific ADC for the treatment of gynecologic cancers, offering improved efficacy and safety profiles.
Poster Session:Experimental and Molecular Therapeutics - Therapeutic Approaches to Attack the Tumor Microenvironment Topic: IBI3026, a first-in-class anti-PD-1/IL-12 fusion protein, demonstrates the potential to be a new immuno-oncology therapy by releasing the breaks in immune response and strongly activating T and NK cells in the tumor microenvironment Abstract Number: 3118 Presentation Form: Poster Presentation Time: Monday April 28, 2025, 2:00 PM - 5:00 PM Location: Poster Section 24 Poster Board Number: 2
IBI3026 is a bispecific immune agonist targeting PD-1 and IL-12 receptor, designed to improve safety profile by reducing IL-12 activity while enabling tumor-targeted activation through PD-1+ T cell enrichment.
IBI3026 demonstrated potent immune activation (STAT4/IFN-γ signaling) in pre-treated human PBMCs and achieved complete tumor suppression in multiple models (EMT6, CT26, A375, BxPC-3). In cynomolgus monkeys, the highest non-severely toxic dose (HNSTD) of IBI3026 is 150 mg/kg and the calculated therapeutic index is 63.
As a first-in-class candidate, IBI3026 combines PD-1 blockade with localized IL-12 activation, offering a promising strategy for tumors resistant to current immunotherapies.
Poster Session:Immunology - T Cell Engagers Topic: A 2+1 format MUC16 targeting T cell engager induces MUC16-dependent T cell activity and superior anti-tumor efficacy Abstract Number: 3510 Presentation Form: Poster Presentation Time: Monday April 28, 2025, 2:00 PM - 5:00 PM Location: Poster Section 38 Poster Board Number: 18
We developed a 2+1 format MUC16 TCE, with improved tumor cell binding affinity, enhanced tumor cell killing potency, and MUC16-dependent T cell binding and activation.
Compared to the benchmark molecule, this MUC16 TCE showed limited T cell binding and activation without MUC16, minimizing off-target activity. This 2+1 format MUC16 TCE also showed a favorable pharmacokinetics profile in mice. Functionally, systemic administration of this MUC16 TCE showed superior anti-tumor efficacy, with undetectable toxicity, in xenograft models.
This innovative TCE shows significant potential for treating MUC16-positive cancers, particularly chemotherapy-resistant ovarian cancer.
Poster Session:Experimental and Molecular Therapeutics - New and Emerging Cancer Drug Targets Topic: IBI3019, a first-in-class EGFR/CDH17/CD16A tri-specific antibody, demonstrated potent efficacy against CRC and an excellent safety profile in preclinical studies Abstract Number: 4249 Presentation Form: Poster Presentation Time: Tuesday April 29, 2025, 9:00 AM - 12:00 PM Location: Poster Section 17 Poster Board Number: 6
IBI3019 is a novel tri-specific antibody targeting EGFR, CDH17, and CD16A for colorectal cancer treatment. It demonstrated strong tumor-specific EGFR inhibition by targeting the overexpressed CDH17 on tumors, while significantly reducing skin toxicities commonly associated with EGFR therapies.
Additionally, IBI3019 incorporates a high-affinity CD16A nanobody that showed better antibody-dependent cell cytotoxicity than those mediated by low-fucose Fc. Importantly, IBI3019 not only demonstrated superior in vitro and in vivo anti-tumor efficacy to Cetuximab and Amivantamab but was also highly tolerable in cynomolgus monkeys with HNSTD at 150 mg/kg in a pilot tox study. These promising preclinical findings warrant further clinical exploration.
Poster Session:Immunology - Modulation of Tumor Microenvironment: Modulation of Lymphocyte Influx Topic: A PD1-IFNα fusion protein, with an attenuated IFNα fused to a clinically validated PD1 mAb, elicited PD1-dependent IFNα signaling and superior anti-tumor efficacy Abstract Number: 4881 Presentation Form: Poster Presentation Time: Tuesday April 29, 2025, 9:00 AM - 12:00 PM Location: Poster Section 40 Poster Board Number: 9
We engineered a novel PD1-IFNα fusion protein that combines attenuated IFNα with Sintilimab, inducing potent PD1/PDL1 blockade while eliciting highly PD1-dependent IFNα signaling, selectively activating in PD1-high cells.
Preclinical studies demonstrate superior anti-tumor efficacy compared to PD1 mAb alone in multiple mouse syngeneic tumor models, with undetectable toxicity and a favorable pharmacokinetics profile.
This bi-functional molecule potentially benefits patients with ICB-refractory cancers including pancreatic, ovarian, and MSS colorectal cancers.
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, 4 assets in Phase III or pivotal clinical trials and 15 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 statement
This news release may contain certain forward-looking statements that are, by their nature, subject to significant risks and uncertainties. The words "anticipate", "believe", "estimate", "expect", "intend" and similar expressions, as they relate to Innovent Biologics ("Innovent"), are intended to identify certain of such forward-looking statements. The Company does not intend to update these forward-looking statements regularly.
These forward-looking statements are based on the existing beliefs, assumptions, expectations, estimates, projections and understandings of the management of the Company with respect to future events at the time these statements are made. These statements are not a guarantee of future developments and are subject to risks, uncertainties and other factors, some of which are beyond the Company's control and are difficult to predict. Consequently, actual results may differ materially from information contained in the forward-looking statements as a result of future changes or developments in our business, the Company's competitive environment and political, economic, legal and social conditions.
The Company, the Directors and the employees of the Company assume (a) no obligation to correct or update the forward-looking statements contained in this site; and (b) no liability in the event that any of the forward-looking statements does not materialise or turn out to be incorrect.
