Matuzumab

ROCKVILLE, Md. and SUZHOU, China, April 7, 2024 /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 as well as antibody-drug-conjugates (ADCs) from its oncology pipeline are presented at the American Association for Cancer Research (AACR) Annual Meeting 2024. Late-Breaking Research: Experimental and Molecular Therapeutics 1 Topic: IBI3001: a potentially first-in-class site-specific glycan-conjugated B7-H3/EGFR bispecific ADC for multiple solid tumors Abstract Number: LB055 Presentation Form: Poster Presentation Time : Sunday Apr 7, 2024 1:30 PM - 5:00 PM Location: Poster Section 53 Presenting Author: Dr. Kaijie He IBI3001 is a potentially first-in-class bispecific ADC against B7-H3 and EGFR that is site-specifically glycan-conjugated using the clinically validated SYNtecanE® platform. IBI3001 has multiple anti-tumor mechanisms of action: (1) enhanced EGFR signaling blockade; (2) EGFR- and B7-H3-aided payload internalization and cytotoxicity; and (3) potent bystander killing effects of ADC. The optimized B7-H3 arm not only enhances the EGFR signaling blockade but also reduces EGFR on-target toxicities. IBI3001 showed strong anti-tumor efficacy in vitro and in vivo across multiple solid tumors and is well tolerated with the therapeutic index at 40. Topic: IBI334, a novel ADCC-enhanced B7-H3/EGFR bispecific antibody, demonstrated potent pre-clinical efficacy in solid tumors Abstract Number: LB056 Presentation Form: Poster Presentation Time : Sunday Apr 7, 2024 1:30 PM - 5:00 PM Location: Poster Section 53 Presenting Author: Dr. Kaijie He IBI334 is an afucosylated bispecific antibody against B7-H3 and EGFR that is constructed using Innovent's proprietary Innobody platform. With the aid of B7-H3, IBI334 showed better tumor growth inhibition in vitro and in vivo than EGFR monoclonal antibody and c-met/EGFR bispecific antibody benchmarks. IBI334 has a favorable safety profile with the highest non-severely toxic dose (HNSTD) in cynomolgus monkeys at 120 mg/kg and a large therapeutic window of > 200 folds. As a promising bispecific antibody against multiple solid tumors, IBI334 is currently under clinical evaluation. Topic: Discovery and preclinical characterization of IBI343, a site-specific glycan-conjugated anti-Claudin18.2 ADC for treating solid tumors Abstract Number: LB057 Presentation Form: Poster Presentation Time : Sunday Apr 7, 2024 1:30 PM - 5:00 PM Location: Poster Section 53 Presenting Author: Dr. Kaijie He IBI343 is a potentially first-in-class anti-Claudin 18.2 ADC that is site-specifically glycan-conjugated to cytotoxin exatecan via Synaffix's GlycoConnect® technology. It demonstrated Claudin 18.2-specific in vitro cytotoxicity on a series of cancer cell lines at varying levels of target expression, and potent in vivo efficacy in multiple xenograft models. The glycan-based conjugation technology leads to enhanced stability of the ADC molecule. IBI343 displayed good safety profile in GLP toxicology study in rhesus monkey and was well tolerated up to 30 mg/kg. IBI343 has favorable pre-clinical efficacy and safety, and it is currently in preparation for Phase 3 clinical trial for Claudin-18.2-positive HER2-negative gastric cancer. Dr. Kaijie He, Vice President of Innovent, stated: "We are pleased that the pre-clinical studies of our novel anti-cancer drugs are accepted for Late-Breaking Research poster presentation at the 2024 AACR conference. This is the result of dedicated work from scientists at Innovent Academy with the aim to tackle cancers with innovative drugs that are more effective and safer. With careful design and optimization, our molecules can achieve favorable therapeutic windows of 40 to more than 200 times. We look forward to their performance in clinical settings and hope that these innovations can eventually benefit cancer patients." Poster Session: Immunology - Single Target and Bispecific Antibodies Topic: A novel TROP2-targeted immune stimulating antibody conjugate (ISAC) with potent anti-tumoral activity and acceptable safety Abstract Number: 2718 Presentation Form: Poster Presentation Time: Monday Apr 8, 2024 1:30 PM - 5:00 PM Location: Poster Section 6 Poster Board Number: 9 Presenting Author: Dr. Huizhong Xiong Immune stimulating antibody conjugates (ISACs) are a unique class of ADC in which antibodies recognizing tumor antigens are conjugated with immune agonists. ISACs target tumor tissue and specifically activate intra-tumoral myeloid cells, unleashing downstream immune response. Like the other immune agonists, balance between efficacy and safety remains a challenge for ISACs. Here we describe a potential first-in-class TROP2 ISAC with rationally selected antibody and TLR7/8 agonist linker-payload. The anti-TROP2 antibody elicited robust ADCP of TROP2+ tumor cells by macrophages. In-vitro, TROP2 ISAC mildly activated myeloid cells only in the presence of TROP2+ tumor cells. In-vivo, the molecule potently suppressed tumor growth in different TROP2+ xenograft tumors, and effectively enhanced killing of an ADC. In terms of safety, the ISAC was tolerated in both WT and hTROP2KI mice, and, importantly, in monkeys. Taken together, our data demonstrate a novel TROP2 ISAC with outstanding efficacy and manageable safety profile, which may benefit patients with TROP2+ tumors. Poster Session: Immunology - Immune Modulation Employing Agonist or Co-Stimulatory Approaches Topic: Tumor targeted-CD28 bispecific antibody with optimized potency, robust anti-tumoral activity and stringent CD3-dependence Abstract Number: 5295 Presentation Form: Poster Presentation Time: Tuesday Apr 9, 2024 1:30 PM - 5:00 PM Location: Poster Section 3 Poster Board Number: 4 Presenting Author: Dr. Huizhong Xiong We reported a rationally screened CD28 agonist antibody and its PSMAxCD28 bispecific format, IAR038. IAR038 has minimal activity in the absence of CD3, even under stringent conditions, different from benchmark antibody in clinical development. It demonstrated moderate activity in vitro in a CD3-dependent and PSMA-dependent manner. Notably, IAR038 elicited superior tumor killing in vivo and combined effectively with anti-PD1 antibody. In addition, it had an improved half-life compared with the Benchmark antibody. These features may translate to a wider therapeutic window and improved safety for CRPC patients. Dr. Huizhong Xiong, Senior Director of Immunology of Innovent, stated: "We keep pushing for deeper understanding and more rational design of agonistic and costimulatory molecules. Our work on tumor targeted TLR7/8 agonist and tumor targeted CD28 antibody demonstrates the capability of our biology-driven drug development to achieve better balance between efficacy and safety, made possible by our advanced technology platforms." About Innovent Innovent is a leading biopharmaceutical company founded in 2011 with the mission to provide high-quality biologics that are affordable to all. The company discovers, develops, manufactures and commercializes innovative medicines that treat some of the most intractable diseases. Its pioneering therapies treat cancer, cardiovascular and metabolic, autoimmune and eye diseases. Innovent has 10 products in the market, 3 new drug applications under the NMPA review, 5 assets in Phase III or pivotal clinical trials and 18 more molecules in early clinical stage. Innovent partners with over 30 global healthcare leaders, including Eli Lilly, Roche, Sanofi, Adimab, Incyte 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 , or follow Innovent on Facebook and LinkedIn. Statement: Innovent does not recommend the use of any unapproved drug (s)/indication (s). 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. SOURCE Innovent Biologics

CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Bicara Therapeutics, a clinical-stage biotechnology company developing dual-action biologics to elicit a potent and durable immune response, today announced the publication of a manuscript in Cancer Research, a journal of the American Association for Cancer Research (AACR), describing the design and characterization of its lead program, BCA101, a first in class dual-action bifunctional antibody designed to inhibit EGFR and disable TGF-β directly at the tumor site. “Over the last two decades, targeting EGFR alone has demonstrated variable clinical success while targeting TGF-β independently has shown limited clinical benefit. The bifunctional antibody fusion design of BCA101 provides a unique approach to addressing the complexities of the tumor microenvironment in EGFR expressing tumors. The data to date show that BCA101 inhibits EGFR and neutralizes TGF-β simultaneously to induce immune activation and suppress tumor growth,” said senior author Pradip Nair, Associate Research Director at Syngene International. “Our findings suggest that the dual action of BCA101 may potentially offer improved clinical efficacy and a superior safety pro to current approaches that separately inhibit EGFR and sequester TGF-β.” The manuscript describes the important roles of the EGFR and TGF-β signaling pathways as mediators of tumorigenesis, and how the crosstalk between them contributes to cancer progression and drug resistance. The authors detail how BCA101, an anti-EGFR IgG1 monoclonal antibody linked to the extracellular domain of human TGF-β receptor II, is able to bind EGFR, inhibit tumor proliferation, while functionally neutralizing TGF-β and restoring the cytolytic activity of the local immune cells. Data suggest that BCA101 has a potential advantage over EGFR inhibitors, such as cetuximab, in activating the immune cells within the tumor microenvironment known to be suppressed by the presence of TGF-β. In addition, BCA101 in combination with anti-PD1, further improved tumor inhibition in both EGFR-expressing mouse models and humanized mice bearing PC-3 xenografts. Taken together, these data suggest that BCA101 may exert superior anti-tumor effects as a monotherapy, and in combination, by targeting both EGFR and TGF-β simultaneously. “Based on these findings, we are working to rapidly advance BCA101 through the clinic because we believe this therapy can be very impactful across multiple tumor types in patients who both express EGFR and have elevated levels of TGF-β,” said Rachel Salazar, SVP of R&D Strategy and Operations at Bicara Therapeutics. Bicara has previously reported promising clinical data from its ongoing Phase 1/1b study of BCA101 in head and neck cancer, including efficacy as both a monotherapy and in combination with pembrolizumab. Preclinical data, also being presented today at the 2023 AACR Annual Meeting further support BCA101’s mechanism of action and provide evidence of its potential to induce durable anti-tumor responses in various tumor types. The paper, entitled “BCA101 is a tumor-targeted bifunctional fusion antibody that simultaneously inhibits EGFR and TGF-β signaling to durably suppress tumor growth,” is published online today and can be accessed here. About Bicara Therapeutics Bicara Therapeutics is a clinical-stage biotechnology company developing first-in-class biologics engineered to bring together the precision of targeted therapy and the power of tumor modulators. The company’s bifunctional antibodies are designed to deliver an immunomodulatory payload directly to the tumor microenvironment to ramp up immune cell activity, potentially offering long-lasting efficacy. Bicara’s lead asset, BCA101, a first-in-class EGFR / TGF-β-trap bifunctional antibody, is currently enrolling patients in a Phase 1/1b study. Bicara’s experienced team brings deep expertise across immunology, oncology, clinical development, business development and operational strategy. More information is available at .