IL-2Rγ

– First presentation of ANV700, a targeted IL-21 employing proximity activated potentiation of cytokine signaling – – New mechanistic data provide insights into the mode of action of ANV600, currently in clinical development – BASEL, Switzerland I October 30, 2024 I Anaveon, a clinical stage, immuno-oncology company, today announced that it will present posters on ANV700 and ANV600 at the Society for Immunotherapy of Cancer (SITC) 39th Annual Meeting being held from Friday, November 8, 2024, to Sunday, November 10, 2024, in Houston, Texas. “ANV700 is a novel powerful PD-1 targeted therapeutic which focuses IL-21 signaling on T cells in the tumor microenvironment with the potential to reverse exhaustion,” said Christoph Huber, Chief Scientific Officer of Anaveon . “We will further develop this molecule towards clinical studies to determine the therapeutic benefit in patients.” Posters will be available on the virtual meeting platform and at anaveon.com beginning Nov. 7 at 9 a.m. CST. Details of the poster presentations: Saturday, Nov. 9, 12:15 – 1:45 pm CST Poster #960 Title: ANV700 is a novel proximity-activated IL-21 receptor agonist designed to selectively reinvigorate tumor-reactive PD-1 expressing T cells Authors: A. Rau, N. Egli, P. Murer, L. Petersen, C. Stocker, K. Richter, C. Huber Poster #954 Title: ANV600, a cis-signaling αPD-1/IL-2Rβ/γ agonist, expands both CD4+ and CD8+ tumor-specific T cells by acting in the tumor microenvironment and draining lymph nodes Authors: P. Murer, A. Zurbach, L. Petersen, N. Egli, A. Katopodis, C. Huber Anaveon is developing selective cytokine receptor agonists with the potential to therapeutically enhance a patient’s immune system to respond to tumors. ANV419, currently in Ph II studies in multiple cancer indications, is designed to preferentially signal through the IL-2 beta/gamma receptor resulting in strong proliferation of effector cells in patients. The follow-on compound, ANV600, targets the selective IL-2 receptor moiety to intratumoral effector cells and may have therapeutic benefit in less immunogenic tumors. These novel types of therapeutics, if approved, could potentially have a wide utility in oncology, including in combination with checkpoint inhibitors, cell therapies, vaccines, and radiotherapy. About Anaveon: Anaveon is a biotechnology company located in Basel, Switzerland. Using our immunological knowledge and expertise in protein engineering, we develop medicines to deliver meaningful benefits to cancer patients. Our lead compounds, ANV419 and ANV600, are currently in clinical trials in solid tumors. Find out more at > anaveon.com SOURCE: Anaveon

SAN FRANCISCO and SUZHOU, China, Sept. 17, 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, autoimmune, cardiovascular and metabolic, ophthalmology and other major diseases, announces that clinical data of IBI363 (first-in-class PD-1/IL-2α-bias bispecific antibody fusion protein) combined with bevacizumab in advanced colorectal cancer is presented at the 2024 ESMO Congress. Currently, Innovent is conducting Phase 1/2 clinical trials in China, the United States, and Australia to evaluate the safety, tolerability and efficacy of IBI363 in subjects with advanced solid tumors. First-in-class PD-1/IL-2 α-bias bispecific antibody fusion protein IBI363 combined with bevacizumab in patients with advanced colorectal cancer: Results from Phase 1 study This Phase 1 study was conducted to evaluate the safety, tolerability and preliminary efficacy of IBI363 combined with bevacizumab in subjects with advanced colorectal cancer. A total of 35 subjects received treatment of IBI363 combined with bevacizumab, demonstrating promising anti-tumor efficacy with good tolerability and safety As of the data cutoff date (Aug 30, 2024), a total of 35 subjects with advanced colorectal cancer received combination treatment at 3 different dose levels (0.6 mg/kg IBI363 combined with 5 mg/kg bevacizumab Q2W, 1 mg/kg IBI363 combined with 5 mg/kg bevacizumab Q2W, and 1.5 mg/kg IBI363 combined with 7.5 mg/kg bevacizumab Q3W). Among them, 91.4% of the subjects had advanced colorectal cancer with microsatellite stable (MSS) or proficient mismatch repair (pMMR), and the MSI/MMR status was unknown in 8.6% subjects. 91.4% of the subjects had previously received 2 or more lines of systemic anti-tumor treatment. 51.4% of the subjects had liver metastases. 25.7% of the subjects had received prior immunotherapy. 40% of the subjects had KRAS/NRAS exon 2/3/4 mutations. The most common treatment related adverse events (TRAEs) were arthralgia, thyroid disorders, and rash. The total incidence of TRAEs ≥ grade 3 was 22.9%. Immune related adverse events (irAEs) ≥ grade 3 occurred in 5.7% of subjects. The safety profile of the combination regimen was similar to that of IBI363 monotherapy, and no new safety signals were identified. Promising anti-tumor activity in subjects with MSS/pMMR colorectal cancer ; durable responses with a trend towards long-term benefit As of the cutoff date, 32 subjects were efficacy evaluable having underwent at least one post-baseline tumor assessment. The ORR was 21.9% (confirmed ORR was 15.6%), and DCR was 65.6%. The median DoR was 8.1 months (95% CI: 1.5~8.2). The median PFS follow-up time was 7.6 months (95% CI: 4.0~9.4), and the median PFS was 4.1 months (95% CI: 1.7~8.1). The median OS was not reached. Promising efficacy signals in colorectal cancer with and without baseline liver metastases Among the 17 subjects with baseline liver metastases who underwent at least one post-baseline tumor assessment, ORR was 11.8% and DCR was 58.8%. Among the 15 subjects without baseline liver metastases who underwent at least one post-baseline tumor assessment , ORR was 33.3% and DCR was 73.3%. Promising efficacy signals in both IO-treated and IO-naïve colorectal cancer Among the 8 subjects who had received prior immunotherapy and underwent at least one post-baseline tumor assessment, ORR was 25.0% and DCR was 62.5%. Among the 24 IO -naïve subjects who underwent at least one post-baseline tumor assessment, ORR was 20.8% and DCR was 66.7%. Promising efficacy signals in colorectal cancer with and without KRAS/NRAS exon 2/3/4 mutations Among the 14 subjects with RAS exon 2/3/4 mutations and who had undergone at least one post-baseline tumor assessment, ORR was 21.4% and DCR was 57.1%. Among the 10 subjects without RAS exon 2/3/4 mutations who had undergone at least one post-baseline tumor assessment, ORR was 30.0% and DCR was 90.0%. In addition, data from a Phase 1 clinical study of IBI363 monotherapy in a colorectal cancer cohort, presented at ASCO 2024, showed promising efficacy and good tolerability. Ongoing studies are now exploring IBI363 in other malignancies, including NSCLC, melanoma and other solid tumors, as well as in combination regimens for MSS/pMMR advanced colorectal cancer. Updates on relevant data and analysis will be shared at upcoming academic conferences and in journals. Professor Tao Zhang, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, stated: "Colorectal cancer is the third most common cancer type globally and ranks fourth in cancer-related mortality[1]. Despite recent advancements in colorectal cancer treatment, challenges such as chemotherapy toxicity and resistance continue to affect patients and clinicians. While immunotherapy offers new hope for advanced colorectal cancer patients, it is currently only approved for those with MSI-H/dMMR tumors. Research indicates that immunotherapy has limited efficacy in non-MSI-H/dMMR advanced colorectal cancer[2]. As an important cytokine activating tumor-specific CD8+T cells, IL-2 is complementary to immune checkpoint inhibitors in MOA. The combination of PD-1 and IL-2 may reverse the exhaustion of tumor-specific CD8+ T cells thereby overcoming immune resistance. The PD-1/IL-2α-bias bispecific molecule IBI363, when combined with bevacizumab, has shown promising anti-tumor activity in patients with non-MSI-H/dMMR advanced colorectal cancer. This combination has shown clinical benefits in both ORR and PFS, and maintains a manageable safety profile. Additionally, the combination regimen has proven effective in colorectal cancer patients with or without liver metastasis, prior immunotherapy, and RAS exon 2/3/4 mutations. IBI363 combined with bevacizumab elicited encouraging objective response rates and disease control rates, with durable responses and a trend towards long-term benefits, without introducing new safety risks in a colorectal cancer population that has previously shown very little response to immunotherapy. Overall, current clinical data suggest that IBI363 combined with bevacizumab holds significant promise for colorectal cancer and deserves further exploration." Dr. Hui Zhou, Senior Vice President of Innovent, stated: "On top of the preliminary data reported at ASCO, we are presenting more updated data at the ESMO Congress. In non-MSI-H/dMMR advanced colorectal cancer, the combination of IBI363 with bevacizumab has demonstrated strong anti-tumor effects, with durable responses and a trend towards long-term benefits. These promising results in a relatively 'cold' tumor suggest significant potential for IBI363 in this disease area. We are confident in the broad development prospects of IBI363 and look forward to seeing more mature data from higher doses and extended follow-up, which will help us advance to the next stage of clinical development." About IBI363 (First-in-class PD-1/IL-2α-bias bispecific antibody fusion protein) IBI363 is a first-in-class PD-1/IL-2α-bias bispecific antibody fusion protein independently developed by Innovent Biologics. It functions by both blocking the PD-1/PD-L1 pathway and activating the IL-2 pathway. The IL-2 arm of IBI363 is designed to maintain its affinity for IL-2Rα while reducing binding to IL-2Rβ and IL-2Rγ, thereby minimizing toxicity. The PD-1 binding arm not only blocks PD-1 but also selectively delivers IL-2. This approach targets and activates tumor-specific T cells that express both PD-1 and IL-2α, leading to more precise and effective activation of this T cell subpopulation. IBI363 has demonstrated robust antitumor activity in various tumor-bearing pharmacological models, but also showed outstanding efficacy in PD-1 resistance and metastasis models. In response to urgent clinical needs, Innovent is conducting clinical studies in China, the United States and Australia to further explore the efficacy and safety of IBI363 in advanced tumors. 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 11 products in the market. It has 3 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. 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, are intended to identify certain of such forward-looking statements. Innovent 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 Innovent 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 Innovent'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, Innovent's competitive environment and political, economic, legal and social conditions. Innovent, the Directors and the employees of Innovent 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. SOURCE Innovent Biologics WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

SAN FRANCISCO and SUZHOU, China, Sept. 10, 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, autoimmune, cardiovascular and metabolic, ophthalmology and other major diseases, announced the presentation of Phase 1 clinical data (ClinicalTrials.gov, NCT04085185) for IBI363 (first-in-class PD-1/IL-2α-bias bispecific antibody fusion protein) in advanced non-small cell lung cancer at the 2024 World Conference on Lung Cancer (WCLC). Currently, Innovent is conducting Phase 1/2 clinical trials in China, U.S. and Australia to evaluate the safety, tolerability and efficacy of IBI363 in subjects with advanced solid tumors. First-in-class PD-1/IL-2 α-bias bispecific antibody IBI363 in patients with advanced non-small cell lung cancer in a Phase 1 study This update on previously reported Phase 1 results focuses on the safety and efficacy of IBI363 in advanced non-small cell lung cancer (NSCLC). As of the follow-up data cutoff date of August 2, 2024, 134 patients were enrolled and received IBI363 monotherapy (up to 3 mg/kg Q3W), with 95.5% having received prior PD-(L)1 immunotherapy. The median duration of IBI363 exposure was 10 weeks, and 77.6% remained on treatment. In the group of 125 patients having at least one post-baseline tumor assessment, the overall ORR was 20.8% and DCR was 74.4%. IBI363 demonstrated encouraging efficacy signals in IO-treated squamous NSCLC, with a trend toward relatively higher ORR and DCR in the 3 mg/kg Q3W group (n=29）compared to the 1/1.5 mg/kg Q2W/Q3W group (n=27) (see table below). Despite relatively short follow-up time for the 3mg/kg Q3W subgroup, among the 18 patients who had at least 12 weeks of follow-up or end of study, the ORR and DCR were 50% and 88.9%, respectively. *6 patients had confirmed PR; **9 out 10 patients had confirmed PR; ***8 of 9 patients had confirmed PR. As of the data cutoff date, for patients with squamous NSCLC who were treated with IBI363 at 1/1.5 mg/kg, the median follow up time was 7.5 months, and the median PFS was 5.5 months (95% CI, 1.5-8.3); currently, the 12-month PFS rate is 30.7%, showing a long-term benefit advantage of immunotherapy. The median PFS was not reached for subjects who received 3mg/kg Q3W. Similar responses were observed among squamous NSCLC patients with PD-L1 TPS<1% (n=22) and TPS≥1% (n=22) treated across the 1/1.5 mg/kg and 3 mg/kg doses, with ORRs of 36.4% and 31.8% respectively, suggesting IBI363 has efficacy regardless of PD-L1 expression. IBI363 has a manageable safety profile. The most common treatment related adverse events (TRAEs) included arthralgia, anemia, hyperthyroidism, hypothyroidism and rash. Overall, 20.1% of patients experienced TRAEs ≥ grade 3 and 6.0% experienced TRAE leading to treatment discontinuation. In the 3 mg/kg Q3W subgroup (n=57), 17.5% experienced TRAEs ≥ grade 3 and 5.3% experienced TRAEs leading to treatment discontinuation. The safety profile was consistent with the overall population. No new safety signals were identified. Given that IBI363 has shown encouraging efficacy signals and good tolerability, this study continues to investigate the long-term efficacy and safety and to determine the RP2D in NSCLC. Additional studies are also underway to evaluate IBI363 in combination with other therapies and in other solid tumors. Relevant data and analyses will be shared in future academic conferences or publications. Professor Jianya Zhou, The First Affiliated Hospital, School of Medicine, Zhejiang University, stated: "Lung cancer is the leading cause of cancer-related deaths globally, with non-small cell lung cancer accounting for approximately 80% of cases[1]. While PD-1/PD-L1 inhibitors have shown promising efficacy in non-small cell lung cancer, most patients eventually develop primary or secondary resistance to these immune checkpoint inhibitors. For NSCLC patients who fail IO therapy, effective treatment options are limited, with chemotherapy, such as docetaxel, achieving only about an ORR of 10% and a median PFS of under 4 months[2]. As a key cytokine that activates tumor-specific CD8+T cells, IL-2 complements immune checkpoint inhibitors in its MOA. Combining PD-1 with IL-2 may reverse the exhaustion of tumor-specific CD8+ T cells and help overcome immune resistance. As a PD-1/IL-2α-bias bispecific molecule, IBI363 has demonstrated promising antitumor activity in IO-resistant, driver gene wild-type NSCLC, with clinical benefits shown in both ORR and PFS. Additionally, its manageable safety profile, even at higher doses, provides confidence in its therapeutic potential." Dr. Hui Zhou, Senior Vice President of Innovent, stated: "We are pleased to present the latest data on IBI363 in lung cancer at WCLC. The data highlights the promising trend of IBI363 showing better ORR and DCR at higher doses, alongside a manageable safety profile. Although the follow-up period for the 3 mg/kg dose group is still relatively short, we anticipate more mature data from longer-term follow-up and expect to see its potential as an immunotherapy for long-term survival benefits to patients. Meanwhile, in non-small cell lung cancer, particularly in IO-treated squamous NSCLC, IBI363 has demonstrated potent anti-tumor effects regardless of PD-L1 expression levels. This indicates that IBI363 could potentially offer breakthroughs in treating cold tumors with low or absent PD-L1 expression. We will continue to advance the clinical exploration of IBI363 in squamous NSCLC and other tumor types." About IBI363 (First-in-class PD-1/IL-2α-bias bispecific antibody fusion protein) IBI363 is a first-in-class PD-1/IL-2α-bias bispecific antibody fusion protein developed independently by Innovent Biologics. It functions by both blocking the PD-1/PD-L1 pathway and activating the IL-2 pathway. The IL-2 arm of IBI363 is designed to maintain its affinity for IL-2Rα while reducing binding to IL-2Rβ and IL-2Rγ, thereby minimizing toxicity. The PD-1 binding arm not only blocks PD-1 but also selectively delivers IL-2. This approach targets and activates tumor-specific T cells that express both PD-1 and IL-2Rα, leading to more precise and effective activation of this T cell subpopulation. IBI363 has demonstrated robust antitumor activity in various tumor-bearing pharmacological models, including those resistant to PD-1 resistance and models of metastasis. In response to urgent clinical needs, Innovent is conducting clinical studies in China, the United States and Australia to further explore the efficacy and safety of IBI363 in advanced tumors. 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 11 products in the market. It has 3 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. 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, are intended to identify certain of such forward-looking statements. Innovent 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 Innovent 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 Innovent'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, Innovent's competitive environment and political, economic, legal and social conditions. Innovent, the Directors and the employees of Innovent 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. SOURCE Innovent Biologics