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Preliminary Data from Two Clinical Trials with ADC Candidates were Presented Orally at the 2025 ASCO Annual Meeting
SHANGHAI and CHICAGO, June 4, 2025 /PRNewswire/ -- The 2025 ASCO Annual Meeting is taking place in Chicago, US, from May 30 to June 3. Duality Bio (HKEX: presented the preliminary data of two clinical trials, HER3 ADC candidate DB-1310 and B7H3 ADC candidate DB-1311/BNT324, which is being jointly developed with BioNTech, in Oral/Rapid Oral presentations. B7H3 ADC candidate DB-1311/BNT324: Data from the ongoing Phase 1/2 clinical trial (NCT05914116) in patients with heavily pre-treated castration-resistant prostate cancer (CRPC) were presented during an oral session on BNT324/DB-1311, an B7H3-targeted ADC candidate. The data indicated early clinical activity and a manageable safety profile with low discontinuation rates. Most common adverse events were gastrointestinal and hematologic toxicities. In the 52 efficacy evaluable patients with heavily pretreated CRPC based on RCIST v1.1, the confirmed objective response rate (cORR) was 30.8%, DCR was 90.4%. Among 68 evaluable patients, the 6-month rPFS rate was 69.8%. Similar outcomes were observed across both dose levels (6 mg/kg or 9 mg/kg). Outcomes appeared better in earlier treatment lines and in patients who received one prior NHT, while antitumor activity was also observed in later lines and regardless of type of prior treatment or metastatic site. The clinical trial is currently enrolling post Lu-177 CRPC (Cohort 11) and taxane-naïve CRPC (Cohort 12). As the incidence rate of prostate cancer is increasing[1],1 there is a high unmet need for new effective therapies for patients with heavily pretreated CRPC[1]. The DB-1311/BNT324 program received Fast Track Designation by the U.S. Food & Drug Administration ("FDA") for the treatment of patients with advanced/unresectable or metastatic CRPC that has progressed on or after standard systemic regimens in 2024. HER3 ADC DB-1310： Data from the first-in-human Phase I/IIa study (NCT05785741) presented by Professor Aaron E. Lisberg of the University of California, Los Angeles (UCLA), demonstrated that DB-1310 showed encouraging efficacy and a manageable safety profile in patients with advanced solid tumors who had failed standard treatments. Among 123 efficacy evaluable patients, the unconfirmed objective response rate (uORR) was 31%, and the disease control rate (DCR) reached 84%. Notably, efficacy was particularly striking in the key subgroup of patients with EGFR-mutated non-small cell lung cancer (NSCLC) (n=46) where uORR reached 44%, DCR was 91%, median progression-free survival (mPFS) was 7.0 months, and median overall survival (mOS) was 18.9 months. The uORR reached an impressive 66.7% at the 5.5 mg/kg Q3W dose level (n=12). In addition, DB-1310 was well-tolerated with a manageable safety profile. The most common treatment-related adverse events (TRAEs) were Grade 1-2 hematological and gastrointestinal events with a low treatment-related discontinuation rate of 3.5%. These positive results support the continued development of DB-1310 in advanced solid tumors, particularly in patients with EGFR-mutated NSCLC. The company is advancing its global development program, including exploring DB-1310 as a monotherapy in additional tumor types, as well as exploring DB-1310 in combination with EGFR TKIs and HER2-targeted therapies. About DualityBio Duality Biotherapeutics is a clinical-stage biotech company dedicated to the discovery and development of next-generation ADC to treat cancer and autoimmune diseases. DualityBio has successfully built several cutting-edge ADC technology platforms with global intellectual property rights. Leveraging a robust pipeline, DualityBio is conducting multiple global clinical trials across 17 countries, has enrolled over 2,000 patients for multiple clinical-stage ADC candidates. Additionally, DualityBio have established strategic collaborations with global MNCs and leading biotech innovators. As a global ADC powerhouse, DualityBio is developing candidates including bispecific ADCs, novel-payload ADCs, and autoimmune ADCs. For more information, please visit [1]. Sherman RL et al. Cancer 2025;131(9):e35833; 2. Narayan V et al. Clin Genitourin Cancer 2024;22(6):102188; View original content to download multimedia: SOURCE Duality Biologics Sign in to access your portfolio
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Innovent's IBI363 (PD-1/IL-2α-bias Bispecific Antibody Fusion Protein) Receives Second NMPA Breakthrough Therapy Designation for Immuno-resistant Squamous Non-Small Cell Lung Cancer
SAN FRANCISCO and SUZHOU, China, June 4, 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, autoimmune, cardiovascular and metabolic, ophthalmology, and other major diseases, announced that the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA) has granted a second Breakthrough Therapy Designation (BTD) to its first-in-class PD-1/IL-2α-bias bispecific antibody fusion protein, IBI363, for the treatment of unresectable, locally advanced, or metastatic squamous non-small cell lung cancer (sqNSCLC) that has progressed following anti-PD-(L)1 immunotherapy and platinum-based chemotherapy. To date, IBI363 has received BTDs from China's NMPA CDE and Fast Track Designations (FTDs) from the U.S. FDA for two indications—sqNSCLC and melanoma. The latest BTD further advances IBI363's potential in addressing immunotherapy resistance and cold tumor challenges. The latest data from the Phase 1 clinical study of IBI363 in subjects with squamous non-small cell lung cancer (sqNSCLC) who previously received immunotherapy were reported in an oral presentation at the 2025 ASCO Annual Meeting. Manageable safety, encouraging efficacy, and long-term survival benefits were observed in both immunotherapy-resistant squamous non-small cell lung cancer and wild-type lung adenocarcinoma, offering new therapeutic hope for immunotherapy-resistant patients. At this year's ASCO conference, IBI363 presented breakthrough clinical findings in three immunotherapy-resistant and cold tumor types: non-small cell lung cancer, colorectal cancer, and melanoma, garnering significant attention. Dr. Hui Zhou, Senior Vice President of Innovent, stated, "IBI363 could potentially be a promising next-generation IO agent by combining dual mechanisms—PD-1 blockade and IL-2-driven tumor-specific T-cell populations expansion—thus reshape the tumor microenvironment. Recent regulatory milestones, including multiple FTDs and BTDs, underscore its clinical value in addressing unmet needs. We are accelerating IBI363's global development across multiple tumor types: the first registrational study in acral and mucosal melanoma, a head-to-head trial against pembrolizumab, has already been initiated. We will communicate with regulatory authorities about additional registrational clinical trials for lung cancer and colorectal cancer, bringing innovation therapies at the forefront of immunotherapy to benefit global patients." NMPA Breakthrough Therapy Designation is intended to facilitate and expedite the development and review of investigational drugs for serious diseases or conditions when preliminary clinical evidence indicates substantial improvement over current therapies. BTD qualifies a drug candidate for accelerated review by the CDE and provides the sponsor with timely advice and communication to expedite the approval process, helping to address the unmet clinical needs of patients more swiftly. About Squamous Non-Small Cell Lung Cancer (sqNSCLC) Lung cancer is the most common and deadliest malignancy worldwide, including in China[1], posing a significant public health challenge. Non-small cell lung cancer (NSCLC) accounts for more than 80% of all lung cancer cases[2], with squamous cell carcinoma being one of its two major subtypes[2]. In recent years, immune checkpoint inhibitors have transformed the treatment landscape for NSCLC. However, for patients with NSCLC who have failed immunotherapy and lack driver gene mutations, there remains a significant and urgent unmet need for effective treatment options. The standard second- or third-line treatment, docetaxel, offers limited efficacy, with a median progression-free survival (PFS) of less than four months[3],[4]. While antibody-drug conjugates (ADCs) have shown promise, two large Phase 3 studies in squamous NSCLC have yet to demonstrate satisfactory efficacy[3],[4]. 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. At this year's ASCO conference, IBI363 presented breakthrough clinical findings in three immunotherapy-resistant and cold tumor types: non-small cell lung cancer, colorectal cancer, and melanoma, garnering significant attention. 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 various tumor indications, including immune-resistant, cold tumors, and front-line treatments. The first pivotal trial of IBI363 was initiated in 2025 for unresectable locally advanced or metastatic mucosal or acral melanoma who have not received prior systemic therapy. IBI363 has received two fast track designations (FTD) from the U.S. FDA and two breakthrough designations (BTD) from the China NMPA, for the treatment of squamous non-small cell lung cancer and melanoma, respectively. 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 (NDA) 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, 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. 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 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. References: 1 Globocan 2022 (version 1.1) - 08.02.2024 2 NCCN guidelines (NSCLC, version 3.2025) 3 J Clin Oncol . 2025 Jan 20;43(3):260-272. doi: 10.1200/JCO-24-01544. 4 J Clin Oncol . 2024 Aug 20;42(24):2860-2872. doi: 10.1200/JCO.24.00733. View original content: SOURCE Innovent Biologics Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
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BioNTech (NasdaqGS:BNTX) Enters Global Co-Development Agreement With Bristol Myers Squibb
BioNTech has seen a significant price movement in the past week, with its stock rising by 15%, compared to a 2% increase in the broader market. The recent co-development and co-commercialization agreement between BioNTech and Bristol Myers Squibb for the bispecific antibody BNT327 may have supported this upswing. Additionally, the anticipation surrounding BioNTech's presentations at the ASCO Annual Meeting, showcasing promising clinical trial data, possibly added weight to the positive sentiment. While the market has performed well, these focused developments in BioNTech's oncology pipeline likely provided an additional boost. Buy, Hold or Sell BioNTech? View our complete analysis and fair value estimate and you decide. Rare earth metals are an input to most high-tech devices, military and defence systems and electric vehicles. The global race is on to secure supply of these critical minerals. Beat the pack to uncover the 24 best rare earth metal stocks of the very few that mine this essential strategic resource. The co-development agreement between BioNTech and Bristol Myers Squibb for the bispecific antibody BNT327, alongside BioNTech's presentations at the ASCO Annual Meeting, could significantly impact its revenue and earnings forecasts. The collaboration and new clinical data may enhance BioNTech's oncology portfolio, potentially driving revenue growth from innovative treatments and first-in-class approvals. Despite this, high R&D expenses and dependency on COVID-19 vaccine sales remain critical risks that could affect financial stability if not offset by new product launches. Over a five-year period, BioNTech has achieved a total return of 134.10%, indicating strong longer-term appreciation. This contrasts with the past year's performance, where the company outperformed the US Biotech industry, which experienced a decline of 13.1%. Despite this favorable long-term total return, the current share price, having climbed 15% recently, still falls short of analyst price targets, suggesting a potential growth opportunity if analyst expectations for the stock materialize. The valuation report we've compiled suggests that BioNTech's current price could be inflated. This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned. Companies discussed in this article include NasdaqGS:BNTX. This article was originally published by Simply Wall St. Have feedback on this article? Concerned about the content? with us directly. Alternatively, email editorial-team@ Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
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Alphamab Oncology Presented Multiple Clinical Data of Anti-HER2 Biparatopic ADC JSKN003 at the 2025 ASCO Annual Meeting
SUZHOU, China, June 3, 2025 /PRNewswire/ -- Alphamab Oncology (stock code: announced that multiple clinical data updates for anti-HER2 biparatopic antibody-drug conjugate (ADC) JSKN003 were presented as posters at the 2025 Annual Meeting of American Society of Clinical Oncology (2025 ASCO Annual Meeting) from May 30 to June 3, 2025, in Chicago, IL, U.S.. The results covered platinum-resistant ovarian cancer, HER2-positive breast cancer, and HER2-overexpressing gastrointestinal tumors. Title: JSKN003, a biparatopic anti-HER2 antibody drug conjugate (ADC), in the treatment of platinum-resistant ovarian cancer (PROC): Updated findings from two clinical trialsAbstract Number for Publication: 5557Session Type and Title: Poster Session - Gynecologic CancerSession Date and Time: 6/1/2025 9:00 AM-12:00 PM CDTPresenter: Xiaohua Wu, Fudan University Shanghai Cancer Center Methods JSKN003-101 (NCT05494918) is a Phase I study in Australia and JSKN003-102 (NCT05744427) is a Phase I/II study in China. Both trials enrolled patients with advanced solid tumors who were to receive JSKN003 monotherapy at various dose levels. Pooled results have demonstrated that JSKN003 monotherapy has promising efficacy signals in patients with PROC, and the efficacy was observed across patients with (IHC 1+/2+/3+) or without (IHC 0) HER2 expression, with or without prior bevacizumab and prior PARP inhibitor. Preliminary data from the pooled analysis of these two studies were presented at the 2024 European Society for Medical Oncology (ESMO) Congress for the first time. The latest findings for non-primary platinum-refractory PROC patients at a longer follow-up time were reported at this ASCO Annual Meeting. Results As of February 28, 2025, 46 PROC patients were enrolled and received JSKN003 every three weeks across five doses levels, among which 2 patients at the dose of 4.2 mg/kg, 2 patients at the dose of 5.2 mg/kg, 40 patients at the dose of 6.3 mg/kg (RP2D), 1 patient at the dose of 7.3mg/kg, and 1 patient at the dose of 8.4mg/kg. Efficacy: With a median follow-up time of 9.3 months, 46 patients were efficacy evaluable. 42 patients (91.3%) exhibited tumor shrinkage. The objective response rate (ORR) was 63.0%, the median progression-free survival (PFS) was 7.7 months, and the 9-month overall survival (OS) rate was 89.9%. Efficacy was observed across different HER2-expression subgroups. The ORR was 52.4% and the median PFS was 6.6 months in patients with HER2 IHC 0. The ORR reached 72.2% and the median PFS was 9.4 months in patients with HER2 expression (IHC 1+/2+/3+). Safety: Grade 3-4 treatment-related adverse events (TRAEs) occurred in 9 patients (19.6%). Serious TRAEs were reported in 6 patients (13.0%). No TRAEs leading to death. Interstitial lung disease (ILD) was observed in 5 patients (10.9%), all were Grade 1/2. Conclusions With extended follow-up, JSKN003 demonstrated robust PFS improvement in PROC, along with early signals of OS benefit. A confirmatory trial (JSKN003-306, NCT06751485) is currently enrolling all comers regardless of HER2 expression to validate JSKN003 as a treatment option for this patient population. Title: JSKN003, a biparatopic HER2-targeting ADC, in heavily pretreated HER2-positive breast cancer: A pooled analysis of early-phase studiesAbstract Number for Publication: 1028Session Type and Title: Poster Session - Breast Cancer - MetastaticSession Date and Time: 6/2/2025 9:00 AM-12:00 PM CDTPresenter: Yiqun Du, Fudan University Shanghai Cancer Center Methods The pooled analysis was performed to evaluate the efficacy and safety of JSKN003 in HER2-positive (IHC 3+ or 2+/ISH+) advanced breast cancer from the Phase I clinical trial (JSKN003-101, NCT05494918) in Australia and the Phase I/II clinical trial (JSKN003-102, NCT05744427) in China. Results As of February 28, 2025, the median follow-up duration was 6.1 months. A total of 88 patients with HER2-positive breast cancer were enrolled, with the majority receiving 6.3 mg/kg or 8.4 mg/kg doses. The median age was 55 years (range: 32-79), with 77.3% ECOG PS 1. All patients had stage IV disease, with 76.1% having visceral metastases. All patients had prior anti-HER2 therapy, including 85.2% with prior ADCs or TKIs, and 55.7% having at least three prior lines treatment. Efficacy: A total of 80 T-DXd-naïve patients were enrolled, of whom 75 were evaluable for efficacy. In this population (N=75), JSKN003 demonstrated a confirmed ORR of 54.7% (95% CI: 42.7-66.2). The disease control rate (DCR) and clinical benefit rate (CBR) were 94.7% and 66.7%, respectively. Among 30 patients treated at the RP2D of 6.3 mg/kg, the confirmed ORR was 73.3%, and CBR reached 83.3%. Subgroup analyses by line of therapy showed ORRs of 66.7% in the prior first line group of 15 patients and 63.2% in the prior second line group of 19 patients, respectively. In addition, 8 patients who had previously received T-DXd were enrolled, among whom 7 had evaluable efficacy data. One patient achieved a partial response (PR), four had stable disease (SD), and tumor shrinkage was observed in four patients. These patients were analyzed separately for exploratory purposes. The median duration of response (DoR) in the overall population was 18.4 months (95% CI: 9.9-NE). Median PFS was not mature at the time of data cutoff. The 3-month and 6-month PFS rates were 88.4% (95% CI: 78.8–93.8) and 75.4% (95% CI: 62.3–84.4), respectively. Safety: 15.9% of patients experienced Grade 3 or higher TRAEs. Serious TRAEs were reported in 5.7% of patients. Dose reductions due to TRAEs occurred in 12.5% of patients, and one patient discontinued due to a TRAE. No TRAEs led to death. The most common TRAEs (≥20%) were nausea, increased alanine aminotransferase, decreased white blood cell count, vomiting, anemia, decreased appetite, thrombocytopenia, fatigue, neutropenia, and diarrhea. ILD was reported in 4 patients (4.5%), mostly Grade 1-2; one case was Grade 3. Conclusions JSKN003 demonstrated promising antitumor activity and manageable safety in heavily pretreated HER2-positive breast cancer, including patients previously treated with T-DXd. Its biparatopic HER2 antibody design may enhance target binding and contribute to the observed clinical benefit. A pivotal Phase III trial (JSKN003-301, NCT06846437) is ongoing to compare JSKN003 with T-DM1 in patients with HER2-positive advanced breast cancer who were previously treated with trastuzumab. Title: A pooled analysis of JSKN003, a biparatopic anti-HER2 antibody conjugate (ADC), in patients with advanced HER2-overexpressing (IHC 3+) gastrointestinal tumorsAbstract Number for Publication: 3022Session Type and Title: Poster Session - Developmental Therapeutics - Molecularly Targeted Agents and Tumor BiologySession Date and Time: 6/2/2025 1:30 PM-4:30 PM CDTPresenter: Dan Liu, Beijing Cancer Hospital Methods The pooled analysis was performed to evaluate the efficacy and safety of JSKN003 in HER2-overexpressing (IHC 3+) metastatic gastric cancer or gastroesophageal junction cancer (GC/GEJC) and colorectal cancer (CRC) patients from the Phase I clinical trial (JSKN003-101, NCT05494918) in Australia and the Phase I/II clinical trial (JSKN003-102, NCT05744427) in China. Results As of February 28, 2025, a total of 50 patients with HER2-overexpressing gastrointestinal tumors (27 patients in GC/GEJC and 23 patients in CRC) were enrolled and treated with JSKN003 monotherapy across 7 dose levels: 1 patient at the dose of 2.1 mg/kg, 1 patient at the dose of 4.2 mg/kg, 1 patient at the dose of 5.2 mg/kg, 43 patients at the dose of 6.3 mg/kg, 1 patient at the dose of 7.3 mg/kg, 2 patients at the dose of 8.4 mg/kg and 1 patient at the dose of 10.5 mg/kg. The median age was 60 years (range: 52-66), with 86.0% ECOG PS 1. Most patients were heavily pretreated: 38.0% had at least three lines of prior therapies, 68.0% received anti-HER2 therapy, 48.0% received Irinotecan. Efficacy: Among 48 patients who had at least one tumor assessment after baseline, JSKN003 demonstrated the ORR of 62.5% and the DCR was 93.8%. Among 27 patients with GC/GEJC, the ORR was 63.0% and DCR reached 92.6%. Among 21 patients with CRC, the ORR was 61.9% and DCR reached 95.2%. Among twenty patients with BRAF V600E-wild type, the ORR was 65.0%. Additionally, among 24 patients (4 patients in GC/GEJC and 20 patients in CRC) who were pretreated with irinotecan, the ORR achieved 58.3%. The median DoR in GC/GEJC patients was 9.6 months (95% CI: 3.0-NE), while the median DoR in CRC patients was 12.1 months (95% CI: 5.8-NE). Median PFS was 9.6 months (95%CI: 4.3, 11.6) with 70.4% PFS rate at 6 months in GC/GEJC patients. Median PFS was 13.8 months (95% CI: 6.8, NE) with 88.9% PFS rate at 6 months in CRC patients. Safety: 18.0% of patients experienced Grade 3 or higher TRAEs. Serious TRAEs were reported in 6.0% of patients. Dose reduction due to TRAEs occurred in 20.0% of patients and 16.3% at RP2D. No TEAEs led to discontinuation or death. The most common TRAEs (≥20%) were nausea, diarrhea, decreased appetite, decreased white blood cell count, anemia, fatigue, decreased neutrophil count, decreased platelet count and vomiting. ILD was reported in 3 patients (6.0%), with Grade 1 in 2 patients and Grade 2 in 1 patient. Conclusions JSKN003 demonstrated promising efficacy in heavily pretreated HER2-overexpressing (IHC3+) gastrointestinal tumors including patients previously treated with irinotecan, with a manageable and predictable safety profile. The HER2 biparatopic ADC design may contribute to the observed clinical benefit. About JSKN003 JSKN003 is a bispecific ADC developed based on KN026 using Alphamab's proprietary glycan-specific conjugation platform. JSKN003 can bind HER2 on the surface of tumor cells and release topoisomerase I inhibitors (TOPIi) through cellular endocytosis, thereby exerting anti-tumor effects. Compared with its ADC counterparts, JSKN003 demonstrated better serum stability and stronger bystander effect, which effectively expands the therapeutic window. Results of multiple clinical studies at various stages of JSKN003 in China and Australia have demonstrated favorable safety profile, with promising efficacy of JSKN003 in heavily pretreated patients with advanced solid tumors, especially in patients with platinum-resistant ovarian cancer (PROC), HER2-expressing breast cancer (BC), or high HER2-expressing solid tumors. JSKN003 was granted breakthrough therapy designation by CDE. The designation is for the treatment of platinum-resistant recurrent epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer. Three Phase III clinical studies of JSKN003 for the treatment of HER2-low expressing BC, PROC, and HER2-positive BC as well as multiple exploratory Phase II clinical studies are currently undergoing smoothly. In September 2024, the Company entered a licensing agreement with JMT-Bio Technology Co., Ltd. ("JMT-Bio"), a wholly-owned subsidiary of CSPC Pharmaceutical Group Co., Ltd. ("CSPC") (stock code: pursuant to which, JMT-Bio was granted the exclusive license and sublicense rights to develop, sell, offer for sale and commercialize JSKN003, for the treatment of tumor-related indications (the "Field") in mainland China (excluding Hong Kong, Macau or Taiwan) (the "Territory") and become the sole marketing authorization holder for JSKN003 for the Field in the Territory. Alphamab retains the sole right to supply JSKN003. About Alphamab Oncology Alphamab Oncology is an innovative biopharmaceutical company focusing on oncology therapeutics. By leveraging its proprietary core technology platforms including single-domain antibodies, bispecific antibodies, glycan-specific conjugation, linker-payload, dual-payload antibody conjugation, and subcutaneous high concentration formulation for biologics, the Company has established a product portfolio with differentiated innovation and global competitiveness, covering cutting-edge areas such as antibody-drug conjugates (ADCs), bispecific antibodies, and single-domain antibodies. The Company has one product approved for marketing (Envafolimab, the world's first subcutaneously injectable PD-(L)1 inhibitor), which has made a significant breakthrough in the convenience and accessibility of cancer treatment. Additionally, the Company has multiple bispecific antibodies and bispecific ADCs in clinical stage, while rapidly advancing the preclinical pipeline prioritizing bispecific ADCs and dual-payload ADCs. Multiple strategic collaborations based on innovative products or technology platforms have been established with partners such as CSPC, ArriVent, and Glenmark. Our overarching mission is to make cancer manageable and curable by addressing unmet clinical needs in oncology. Alphamab Oncology is continuously dedicated to the development of effective, safe, and globally competitive anti-tumor drugs, delivering China-innovated cancer therapies to benefit patients worldwide. View original content: SOURCE Alphamab Oncology Sign in to access your portfolio
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2025 ASCO ｜Oral Presentation: Disitamab Vedotin Achieves Stellar Efficacy as First-Line Therapy for HER2-Expressing Locally Advanced or Metastatic Gastric Cancer
YANTAI, China, June 2, 2025 /PRNewswire/ -- On June 2 (Chicago time), in an oral presentation at the 2025 ASCO Annual Meeting, Dr. Lin Shen from Beijing Cancer Hospital presented the results of a Phase 2 clinical study conducted in China evaluating the efficacy and safety of disitamab vedotin (DV), developed by Remegen Co., Ltd., and toripalimab (PD-1) combined with CAPOX or trastuzumab as the first-line therapy for HER2-expressing patients with locally advanced or metastatic (la/m) gastric cancer. Comparing to the control group who received standard-of-care therapy, the DV combination therapy demonstrated clinically meaningful efficacy improvement, potentially to benefit patients who are non-responders to traditional targeted therapies. The data presented are from the Phase 2 part of a randomized, multi-cohort, seamlessly connecting Phase 2/3 study, which enrolled systematic chemotherapy-native patients with different HER2 expression levels. As of April 7, 2025, the results showed: Among HER2-overexpressing gastric cancer patients, compared to the PD-1-trastuzumab-CAPOX combination therapy, DV and PD-1 + chemotherapy as well as DV and PD-1 + trastuzumab both demonstrated statistically significant efficacy and favorable safety profiles. Objective response rate (ORR): 66.7% vs 82.4% vs 68.8%; Median progression-free survival (mPFS): NR vs NR vs 14.1 months, with risk of disease progression decreasing by 54%（HR=0.46）and 41% (HR: 0.59); 12-month PFS rate: 66.3%, 67% and 53.6%； Common TRAEs of grade 3-5: diarrhea, neutrophil count decreased, platelet count decreased, etc. In patients with HER2-low-expressing gastric cancer, promising efficacy was observed with DV + PD-1 + CAPOX comparing to PD-1 + CAPOX, with a manageable safety profile. ORR: 72.0% vs 47.8%; mPFS: 9.9 vs 7.2 months, with risk of disease progression decreasing by 31% (HR: 0.69); Common TRAEs of grade 3-5: diarrhea, neutrophil count decreased, platelet count decreased, etc. Dose optimization conducted in patients with HER2-median/low-expressing gastric cancer. Compared to PD-1 + CAPOX, DV at 2.5 mg/kg or 2.0 mg/kg combined with PD-1 + reduced-dose CAPOX showed significant efficacy, and better safety over the full-dose chemotherapy. ORR: 71.4% vs 66.7% vs 56.3%; 6-month PFS rate: 71.4%，72.7% and 53.3%. Globally, this is the first study to explore the triple combination therapy of "HER2 ADC + PD-1 + targeted medication" as first-line treatment of patients with la/m gastric cancer, pioneering a new mode of synergistic therapy. The multi-cohort design of this study provides precision treatment regimen for gastric cancer patients with different level of HER2 expression. For the HER2-overexpressing gastric cancer patients, DV + PD-1 + trastuzumab has the potential to become the new standard first-line treatment; for the HER2-low-expressing gastric cancer patients, DV + PD-1 + chemotherapy has the potential to fill the treatment gap of these patients. Based on the data obtained from the phase 2 study, the phase 3 clinical study of the triple combination therapy in patients with HER2-median/low-expressing gastric cancer has been initiated in April, 2025, in which 616 participants were planned to be enrolled, to further validate the efficacy of the DV combination therapy. Gastric cancer is the fifth most common malignant tumor in the world, and China accounts for about 42.6% of new cases and 45.0% of deaths worldwide. HER2 is an important target in the treatment of gastric cancer, while the traditional targeted drug trastuzumab is only effective in the population with high expression (IHC 3+ or IHC 2+/FISH+), and can easily become resistant. There is a lack of effective targeted therapy options for patients with low/median HER2 expression (IHC 1+ or IHC 2+/FISH-), and the efficacy of chemotherapy combined with immunotherapy is not satisfactory. As the first domestic HER2-targeted ADC drug in China, DV not only precisely kills tumor cells with HER2 over expression but also attacks adjacent cells with HER2 low expression through the bystander effect. Preclinical studies have also shown that the combination of DV with PD-1 inhibitor and trastuzumab can enhance anti-tumor activity. View original content to download multimedia: SOURCE RemeGen Co., Ltd Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
