St. Vincent's Hospital Sydney Pty Ltd.

SAN FRANCISCO and SUZHOU, China, July 1, 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, announced oral presentation of the latest Phase 1 clinical data of an innovative anti-CLDN18.2 ADC (IBI343) for the treatment of advanced gastric/gastroesophageal junction adenocarcinoma (G/GEJ AC) at the ESMO Gastrointestinal Cancers (ESMO GI) Congress 2024 (NCT05458219). The data demonstrates promising efficacy and a favorable safety profile for IBI343 in patients with advanced gastric cancer whose tumors express CLDN18.2. Gastric cancer is one of the most common malignant tumors in the world. According to the GLOBOCAN 2022 statistics[1], gastric cancer ranks as the 5th most common malignant tumor and the 5th leading cause of cancer death around the world. It accounts for an estimated 970,000 cases and 660,000 deaths worldwide. Each year, China reports 359,000 new cases and 260,000 deaths from gastric cancer, representing 37.0% and 39.4% of the global totals, respectively, highlighting a significant unmet medical need. The data presented at this conference is from a Phase 1 study conducted in China and Australia with IBI343 and are as follows: In participants with high expression of CLDN18.2 (≥75% tumor cells with membranous staining intensity ≥2+ by IHC) at the 6 mg/Kg dose (N=30), the ORR and DCR were 36.7% and 93.3%, respectively. At the 8 mg/kg dose (N=17), the ORR was 47.1% and the DCR was 88.2%. With a median follow-up time of 7.2 months in the 6 mg/kg dose group, the median progression-free survival (mPFS) of participants with high CLDN18.2 expression was up to 6.8 months. The majority of treatment emergent adverse events (TEAEs) were grade 1-2. In the 6 mg/kg dose group, 31.6% patients had ≥ Grade 3 treatment-related adverse events (TRAEs). ≥ Grade 3 gastrointestinal toxicities were extremely low (<5%). No interstitial lung disease (ILD) occurred. Dr Jia (Jenny) Liu, translational lead of early phase clinical trials at The Kinghorn Cancer Centre, St Vincent's Hospital Sydney, said : "As a next generation anti-CLDN18.2 antibody-drug conjugate that is Fc silenced, IBI343 has shown encouraging tolerability and clinical benefit in patients with advanced gastric and gastroesophageal junction adenocarcinomas that had moderate to high expression of CLDN18.2. Furthermore, the gastrointestinal toxicity of the drug we observed in the Phase 1 trial appears lower than that of other drugs targeting CLDN18.2, and there were no cases of interstitial lung disease. We look forward to seeing the results of ongoing Phase 3 trials comparing the efficacy and tolerability of IBI343 with standard-of-care treatments." Dr. Hui Zhou, Senior Vice President of Innovent Biologics, said, "With a unique ADC platform designed to deliver effective and more tolerable therapeutics, the data in gastric cancer is a testimony to the molecular design of IBI343. We will further explore IBI343 in combination with other treatments, including immunotherapies, across different tumor types in order to benefit cancer patients worldwide. As a pioneer company in the field of oncology, Innovent is committed to advancing and promoting global innovation to develop and commercialize high quality biopharmaceuticals that are affordable to ordinary people." Apart from gastric cancer, Innovent is also exploring IBI343's therapeutic potential in solid tumors such as pancreatic cancer. Earlier this month, the data from the Phase 1 clinical study of IBI343 in the treatment of patients with pancreatic cancer were presented at the American Society of Clinical Oncology (ASCO) 2024 Annual Meeting, demonstrating encouraging efficacy and a favorable safety profile. [details link] About Gastric/ Gastroesophageal Junction Adenocarcinoma Gastric cancer is one of the most prevalent malignant tumors worldwide and a leading cause of cancer-related deaths globally. The 5-year survival rate of patients with metastatic gastric cancer is less than 5%[2]. China and Japan have the highest incidence rates of gastric cancer[3]. Currently, the standard-of-care treatments for patients with advanced metastatic gastric cancer include a chemotherapy combination of fluoropyrimidine and platinum, as well as immune checkpoint inhibitor therapy. However, systemic therapy has limited efficacy in advanced gastric cancer. In particular, the prognosis for patients with third-line or higher gastric cancer is usually poor, with fewer treatment options and shorter survival expectations. The median survival times for these patients is only about 0.5 year[4]. Claudin, a member of the tight junction molecule family, is a key structural and functional component of epithelial tight junctions. Among them, CLDN18.2 is normally buried in the gastric mucosa, but the development of malignancy leads to disruption of tight junctions and exposure of CLDN18.2 epitopes on the membrane of tumor cells[5]. CLDN18.2 is expressed in up to 80% of patients with gastric cancer. About IBI343 （ Anti CLDN18.2 ADC ） IBI343 is a recombinant human anti-CLDN18.2 monoclonal antibody-drug conjugate (ADC) developed by Innovent Biologics. IBI343 binds to the CLDN18.2-expressing tumor cells, the CLDN18.2 dependent ADC internalization will occur and the drug is released resulting in DNA damage and eventually apoptosis of the tumor cells. The freed drug can also diffuse across the plasma membrane to reach and kill the neighboring cells, resulting in "bystander killing effect". As an innovative TOPO1i ADC, IBI343 has demonstrated tolerable safety and encouraging efficacy signals in this Phase 1 clinical studies. The therapeutic potential of IBI343 is currently being explored in tumor types such as gastric cancer and pancreatic cancer. In May 2024, China's National Medical Products Administration (NMPA) granted breakthrough therapy designation (BTD) to IBI343 for use as a single agent in patients with CLDN18.2–positive gastric or gastroesophageal junction (GEJ) adenocarcinoma who experienced disease progression following two prior lines of systemic treatment. The multi-center Phase 3 trial of IBI343 for this indication is in preparation. In June 2024, IBI343 received Fast Track Designation by the U.S. Food and Drug Administration (FDA) for the treatment of advanced unresectable or metastatic pancreatic ductal adenocarcinoma (PDAC) that has relapsed and/or is refractory to one prior line of therapy. About Innovent Biologics 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 10 products in the market. It has 4 new drug applications under regulatory review, 4 assets in Phase III or pivotal clinical trials and 18 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 , or follow Innovent on Facebook and LinkedIn. Disclaimer: Innovent does not recommend any unapproved drugs/indications. Forward-Looking Statements 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, Inc. ("Innovent" or "Company"), 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 materialize or turn out to be incorrect. References SOURCE Innovent Biologics

SAN FRANCISCO and SUZHOU, China, May 19, 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 the company will deliver oral presentations on clinical data of its first-in-class PD-1/IL-2 bispecific antibody fusion protein (R&D code: IBI363) and novel Topoi anti-Claudin18.2 ADC (R&D code: IBI343) at the upcoming medical conferences in June, including ESMO Virtual Plenary and ESMO Gastrointestinal Cancers Congress (ESMO GI) 2024. Details are as follows: ESMO Virtual Plenary, June 13-June 14, 2024 Title: First-in-class PD-1/IL-2 bispecific antibody fusion protein IBI363 in patients (pts) with advanced solid tumors: First-in-human phase I study Presentation Form: Oral Presentation Time: 13 Jun 2024 18:30-19:30 CEST & 14 June 2024 13:00-14:10 CEST Presenting Author: Prof. Xueli Bai, The first affiliated hospital, Zhejiang University School of Medicine ESMO Gastrointestinal Cancers Congress, June 26-June 29, 2024, Munich, Germany Title: Anti-claudin 18.2 (CLDN18.2) antibody-drug conjugate (ADC) IBI343 in patients (pts) with solid tumors and gastric/gastro-esophageal junction adenocarcinoma (G/GEJ AC): A phase 1 study Publication Number: 396MO Presentation Form: Oral Presentation Time: 29 June 2024 08:45-10:00 CEST Presenting Author: Jia (Jenny) Liu, St Vincent's Hospital Sydney Dr. Hui Zhou, Senior Vice President of Innovent, stated: "We will present a robust set of clinical data for our next-generation innovative bispecific antibodies and ADC molecules at multiple conferences in the near term. We observed the preliminary efficacy and safety signals for those innovative candidates, underscoring their potential for further development and clinical value. Innovent leverages our world-class antibody-based platform, differentiated ADC technology and deep scientific understanding to build the new generation innovative pipeline of "IO+ADC". We strive to solve the unmet needs of existing therapies and fill the treatment gap for cancer patients worldwide." 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

Imaging technology shows that bone-resorbing osteoclasts gather in distinct pockets, leading to new insights for osteoporosis and cancer treatment. Cutting-edge imaging sheds new light on cells that break down bone Imaging technology developed at Garvan shows that bone-resorbing osteoclasts gather in distinct pockets, leading to new insights for osteoporosis and cancer treatment. Bone may seem as if it's a hard, lifeless structure, but now the cells living within have been imaged in unprecedented detail, thanks to an innovative imaging method developed at the Garvan Institute of Medical Research. The new method lets researchers study cells inside the bones of mice, to visualise not just isolated sections, but the entire length of a bone. With a new level of visual detail, the researchers discovered that osteoclasts, cells that break down bone tissue, are more active in some parts of the bone compared to others. This knowledge could be used to develop new treatments for osteoporosis, and for dormant cancer cells, which can stay hidden in bone for years until they are reactivated by osteoclasts. "Our method has given us an unprecedented window into how cells go about breaking down bone, giving us a new way to investigate osteoporosis and cancer relapse in bone," says Professor Tri Phan, Head of the Intravital Microscopy Lab and Gene Expression (IMAGE) Lab, immunologist at St Vincent's Hospital Sydney, Co-Director of the Precision Immunology Program at Garvan and senior author of the paper, published in Nature Protocols. "We can finally image processes inside bone that we thought were happening, but which were until now beyond the limits of conventional microscopy techniques. We are only beginning to understand the implications of this exciting technology." Giving disease-causing cells no place to hide Osteoclasts are crucial to the normal maintenance and repair processes of bone, but when they are overly active, they can cause excessive breakdown, known as osteoporosis. "The inside of living bone is a 'dark space' that is difficult to study, because of its hard, mineralised structure," says co-first author Dr Nayan Deger Bhattacharyya, post-doctoral researcher in the IMAGE Lab. "In order to understand diseases such as osteoporosis and cancer recurrence, we've needed to develop the technology to look inside bone tissue." The new technique developed at Garvan's ACRF INCITe Centre can be used to image other dynamic cellular processes until now hidden in bone. "Our new imaging method is minimally invasive and lets us map out localised populations of cells along the length of an entire bone in our mouse models, instead of just in small sections," says co-first author Wunna Kyaw, PhD student in the IMAGE Lab. The researchers tracked down distinct pockets of bone resorption activity as the cells 'morph' between actively resorbing osteoclasts and an intermediate cell state called osteomorphs, in real time. "We suspect these osteomorphs are dangerous as they can accumulate while osteoporosis treatment is administered but can rapidly reform activated osteoclasts to supercharge bone breakdown as soon as treatment is stopped. This would explain an observation in the clinic, that many osteoporosis patients taking the medication denosumab, which blocks osteoclasts from resorbing bone, experience rebound vertebral fractures after they stop using the drug. We will use our imaging method to study how this withdrawal effect could be prevented," says co-author Professor Peter Croucher, Head of the Bone Biology Lab at Garvan. The researchers say their method could also be used to investigate cancer cells that can migrate to bone during cancer treatment and lie dormant there for years, only to be reactivated by osteoclasts breaking down the bone tissue that surrounds them. "Being able to see cells and molecules interact in the bone -- and one day target them -- could be a critical new tool for diseases relating to bone," says Professor Phan.