JSKN003 / Alphamab, CSPC Pharma - LARVOL DELTA

A pooled analysis of JSKN003, a biparatopic anti-HER2 antibody conjugate (ADC), in patients with advanced HER2-overexpressing (IHC 3+) gastrointestinal tumors. (ASCO 2025) - P1, P1/2 | "Clinical Trial Registration Number: NCT05494918, NCT05744427 The abstract will be released to the public on May 22, 2025 at 5:00 PM EDT"

Metastases • Retrospective data • Gastrointestinal Cancer • Gastrointestinal Disorder • Oncology • Solid Tumor

JSKN003, a biparatopic HER2-targeting ADC, in heavily pretreated HER2-positive breast cancer: A pooled analysis of early-phase studies. (ASCO 2025) - P1, P1/2 | "Clinical Trial Registration Number: NCT05494918; NCT05744427 The abstract will be released to the public on May 22, 2025 at 5:00 PM EDT"

Retrospective data • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2

JSKN003 Versus Trastuzumab Emtansine (T-DM1) for HER2-Positive, Advanced Breast Cancer (clinicaltrials.gov) - P3 | N=228 | Recruiting | Sponsor: Shanghai JMT-Bio Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor

Anti-HER2 Biparatopic ADC JSKN003 Has Been Granted Breakthrough-Therapy Designation for the Treatment of PROC (PRNewswire-Asia) - "Alphamab Oncology...and CSPC Pharmaceutical Group...jointly announced that anti-HER2 biparatopic antibody-drug conjugate (ADC) JSKN003 has been granted Breakthrough Therapy Designation by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA). The designation is for the treatment of platinum-resistant recurrent epithelial ovarian cancer (PROC), primary peritoneal cancer, or fallopian tube cancer, not restricted to HER2 expression levels....The grant of Breakthrough Therapy Designation is based on the pooled analysis of two clinical studies, JSKN003-101 and JSKN003-102. JSKN003-101 (NCT05494918) is an open-label, multicenter, dose-escalation Phase I clinical study conducted in Australia, enrolling patients with advanced solid tumors expressing HER2 (IHC≥1+) or with HER2 mutations. JSKN003-102 (NCT05744427) is a Phase I/ II study conducted in China."

Breakthrough therapy • Epithelial Ovarian Cancer • Fallopian Tube Cancer • Ovarian Cancer • Peritoneal Cancer

First Patient Dosed in a Phase III Clinical Study of Anti-HER2 Biparatopic ADC JSKN003 for the Treatment of HER2-positive Breast Cancer (PRNewswire-Asia) - "Alphamab Oncology...and CSPC Pharmaceutical Group...jointly announced that the first patient has been successfully dosed in the Phase III clinical study (Study ID: JSKN003-301) of anti-HER2 biparatopic antibody-drug conjugate (ADC) JSKN003. The study aims to compare the efficacy and safety of JSKN003 versus trastuzumab emtansine (T-DM1) for the treatment of HER2-positive advanced breast cancer....JSKN003-301 is a randomized, controlled, open-label, multicenter, Phase III clinical study aimed at evaluating the efficacy and safety of JSKN003 compared to emtansine (T-DM1) in the treatment of patients with HER2-positive, unresectable locally advanced or metastatic breast cancer who have previously received trastuzumab or taxane-based therapies."

Trial status • HER2 Positive Breast Cancer

JSKN003 Versus Trastuzumab Emtansine (T-DM1) for HER2-Positive, Advanced Breast Cancer (clinicaltrials.gov) - P3 | N=228 | Not yet recruiting | Sponsor: Shanghai JMT-Bio Inc.

New P3 trial • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor

Alphamab Oncology Announces the First Patient Dosed in a Phase III Clinical Study for Ovarian Cancer of Anti-HER2 Bispecific ADC JSKN003 (PRNewswire-Asia) - "Alphamab Oncology...announced that the first patient has been successfully dosed in the Phase III clinical study (Study ID: JSKN003-306) of anti-HER2 biparatopic antibody-drug conjugate (ADC) JSKN003....JSKN003-306 is a randomized, open-label, parallel-controlled, multi-center Phase III clinical study for patients with platinum-resistant recurrent epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer, regardless of HER2 expression levels."

Trial status • Fallopian Tube Cancer • Ovarian Cancer • Peritoneal Cancer

Anti-HER2 Bispecific ADC JSKN003 Received Approval to Initiate a Phase III Clinical Study for the Treatment of HER2-positive Breast Cancer (PRNewswire-Asia) - "Alphamab Oncology...and CSPC Pharmaceutical Group...jointly announced that anti-HER2 biparatopic antibody-drug conjugate (ADC) JSKN003 has received approval from the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) to initiate a Phase III clinical study (Study ID: JSKN003-301). The study aims to compare the efficacy and safety of JSKN003 versus trastuzumab emtansine (T-DM1) for the treatment of HER2-positive advanced breast cancer....JSKN003-301 is a randomized, controlled, open-label, multicenter, Phase III clinical study aimed at evaluating the efficacy and safety of JSKN003 compared to emtansine (T-DM1) in the treatment of patients with HER2-positive, unresectable locally advanced or metastatic breast cancer who have previously received trastuzumab or taxane-based therapies."

New P3 trial • HER2 Positive Breast Cancer

JSKN003 in Platinum-Resistant, Relapsed Epithelial Ovarian Cancer (clinicaltrials.gov) - P3 | N=430 | Not yet recruiting | Sponsor: Jiangsu Alphamab Biopharmaceuticals Co., Ltd

New P3 trial • Epithelial Ovarian Cancer • Fallopian Tube Cancer • Oncology • Ovarian Cancer • Solid Tumor

JSKN003-102: Safety and Tolerability of JSKN003 in Chinese Subjects With Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=725 | Recruiting | Sponsor: Jiangsu Alphamab Biopharmaceuticals Co., Ltd | N=300 ➔ 725 | Trial completion date: Dec 2025 ➔ Dec 2026

Enrollment change • Trial completion date • Breast Cancer • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • HER2 Breast Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • HER-2

Alphamab Oncology’s JSKN003 is approved for Phase III clinical trial in ovarian cancer [Google translation] (new.qq.com) - "...on December 27 that JSKN003 has been approved by the CDE of the National Medical Products Administration to conduct a Phase III clinical study (JSKN003-306), which targets the entire population of patients with platinum-resistant recurrent epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer who have received 1 to 4 lines of treatment."

New P3 trial • Fallopian Tube Cancer • Ovarian Cancer • Peritoneal Cancer

BOCOM International: Maintain "Neutral" rating on Alphamab-B (09966) and lower target price to HK$5 [Google translation] (iis.aastocks.com) - "Zhitong Finance APP learned that BoCom International released a research report saying that it has lowered the target price of Alphamab-B...to HK$5 and maintained a 'neutral' rating. The company's product sales are under short-term pressure, and the research and development of multiple assets in the HER2 channel are rapidly advancing. The bank predicts that KN026 and JSKN003 are expected to generate a combined peak sales of nearly 5 billion yuan in the country....However, considering the impact of industry compliance regulations on Envida sales and individual drugs under development, The launch pace has been delayed, the 2025 revenue forecast has been lowered to 450 million yuan, and the POS-adjusted peak sales of Envida and KN046 have been lowered to 1.1 billion and 500 million yuan."

Sales projection • Breast Cancer • Gastric Cancer • Gastroesophageal Cancer • Gastrointestinal Cancer • HER2 Breast Cancer • Oncology • Solid Tumor

JSKN033, an innovative subcutaneous-injected fixed-dose combination (FDC) of biparatopic anti-HER2 antibody drug conjugate (ADC) and PD-L1 inhibitor in advanced solid tumor (SITC 2024) - P1/2 | "Subcutaneous (SC) delivery offers a safer alternative, with comparable efficacy to intravenous delivery, as demonstrated by treatments like amivantamab. JSKN033 is a FDC for SC injection, utilizing innovative technology, comprising JSKN003, a biparatopic HER2-directed ADC, and KN035, a NMPA-approved PD-L1 inhibitor...These results encourage further clinical development of JSKN033. Additionally, the formulation technology may be applicable to other ADC therapies.View this table:View inline View popup Download powerpoint Abstract 1496 Table 1"

IO biomarker • Late-breaking abstract • Metastases • Biliary Cancer • Biliary Tract Cancer • Breast Cancer • Colorectal Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Positive Breast Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Salivary Gland Cancer • Solid Tumor

Technical, preclinical, and clinical developments of Fc-glycan-specific antibody-drug conjugates. (PubMed, RSC Med Chem) - "Notably, JSKN003 and IBI343 have demonstrated promising results in phase 1 trials and are advancing into phase 3 studies. This review discusses the advantages of Fc-glycan-conjugation, various glycan-specific conjugation techniques, and the preclinical and clinical development of gsADCs. While challenges such as increased manufacturing cost for large-scale production need continuous innovation to overcome and there are different opinions regarding the pros and cons of reduced/diminished affinities to Fc gamma receptors, ongoing research and clinical progress underscore the potential of gsADCs to renovate ADC cancer therapy."

Journal • Preclinical • Review • Oncology

Alphamab Oncology and CSPC Achieved a Licensing Agreement on Anti-HER2 Bispecific ADC JSKN003 in Mainland China (PRNewswire-Asia) - "Alphamab Oncology...announced that Jiangsu Alphamab Biopharmaceuticals...entered into a licensing agreement (the 'Licensing Agreement') on anti-HER2 bispecific antibody-drug conjugate (ADC) JSKN003 with JMT-Bio Technology....According to the terms of the Licensing Agreement, JMT-Bio will obtain 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. JMT-Bio shall bear at its own costs and expenses for the clinical development activities under the Licensing Agreement.... According to the Licensing Agreement, the Company is entitled to receive upfront payment and milestone payments of up to RMB 3.08 billion in total..."

Licensing / partnership • Solid Tumor

Evaluation of the safety and efficacy of JSKN003 in patients with advanced HER2-positive (IHC 3+) solid tumors (excluding breast cancer) (ESMO 2024) - P1, P1/2 | "JSKN003 was well tolerated with encouraging preliminary antitumor activity in heavily pretreated pts with advanced HER2-positive (IHC ≥ 3+) solid tumors, which support further clinical development."

Clinical • Metastases • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2

JSKN003, a HER2-targeting antibody-drug conjugate, in patients with platinum-resistant ovarian cancer: A pooled analysis of two studies (ESMO 2024) - P1, P1/2 | "Most pts (16/27, 59.3%) received ≥ 3 prior lines of therapy, 13 (48.1% ) pts had received prior bevacizumab, and 8 (29.6%) pts had received prior PARP inhibitors. In heavily pretreated PROC patients, irrespective of HER2 expression, JSKN003 demonstrated acceptable safety and encouraging preliminary efficacy, which supports further clinical development in PROC."

Retrospective data • Oncology • Ovarian Cancer • Solid Tumor

A pooled analysis of the two studies evaluated the safety and efficacy of JSKN003 in patients with platinum-resistant ovarian cancer (PROC). (Alphamab Press Release) - P1 | N=45 | NCT05494918 | Sponsor: Alphamab (Australia) Co Pty Ltd. | P1/2 | N=300 | NCT05744427 | Sponsor: Jiangsu Alphamab Biopharmaceuticals Co., Ltd | "As of July 15, 2024, 50 patients with PROC had received JSKN003 across five dose levels, among which 2 patients at the dose of 4.2mg/kg, 2 patients at the dose of 5.2mg/kg, 44 patients at the dose of 6.3mg/kg, 1 patient at the dose of 7.3mg/kg, and 1 patient at the dose of 8.4mg/kg...The median duration of treatment was 12.4 weeks (range: 0.7 - 51.0 weeks)...3 patients experienced interstitial lung disease (ILD)/pneumonitis. 5 patients (10.0%) experienced grade 3 treatment-related adverse events (TRAEs)...No TRAEs led to death; Among the 44 efficacy evaluable patients who had at least one post-baseline tumor assessment, the objective response rate (ORR) was 56.8% (95% CI: 41.0, 71.7), with 39 patients (88.6%) showing tumor shrinkage. JSKN003 exhibited a favorable tolerability and safety profile..."

P1 data • Ovarian Cancer

Alphamab Oncology Presented the Latest Clinical Data from Two Studies on Anti-HER2 Bispecific ADC JSKN003 at the ESMO Congress 2024 (Alphamab Press Release) - P1 | N=45 | NCT05494918 | Sponsor: Alphamab (Australia) Co Pty Ltd. | P1/2 | N=300 | NCT05744427 | Sponsor: Jiangsu Alphamab Biopharmaceuticals Co., Ltd | "As of July 15, 2024, 29 patients (9 colorectal cancer, 6 gastric cancer, 4 biliary tract carcinoma, 3 esophageal carcinoma, 2 ovarian cancer, 1 head and neck cancer and 4 others) were enrolled and received JSKN003 monotherapy intravenously (Q3W)...Among the 28 efficacy evaluable patients, the ORR and disease control rate (DCR) were 75.0% and 89.3%, respectively. For 7 patients who received prior anti-HER2 ADC, the ORR was 71.4%. The ORR of gastric cancer and colorectal cancer were 83.3% (5/6) and 66.7% (6/9) respectively...6 patients (20.7%) experienced grade 3 or higher TRAEs...JSKN003 exhibited a favorable tolerability and safety profile, with a lower incidence of hematological toxicity. Encouraging antitumor activity was observed in heavily pretreated patients with advanced patients with advanced HER2-positive solid tumors."

P1 data • Biliary Tract Cancer • Colorectal Cancer • Esophageal Cancer • Gastric Cancer • Head and Neck Cancer • Ovarian Cancer

Alphamab Oncology to Present the Latest Clinical Data of Anti-HER2 Bispecific ADC JSKN003 at the ESMO Congress 2024 (PRNewswire-Asia) - "Alphamab Oncology...announced that the latest clinical data from two studies on anti-HER2 bispecific antibody-drug conjugate (ADC) JSKN003 in patients with platinum-resistant ovarian cancer and patients with advanced HER2-positive (IHC 3+) solid tumors, will be presented as posters at the 2024 European Society for Medical Oncology Congress (ESMO Congress 2024) from September 13 to 17, 2024, in Barcelona, Spain....The data of the phase I clinical trials conducted in Australia and China respectively demonstrated favorable tolerability, safety profile and encouraging preliminary anti-tumor activity. The latest clinical data of JSKN003 to be presented at the ESMO Congress 2024 are from the pooled analysis of both studies."

Clinical data • Ovarian Cancer • HER-2

Safety and efficacy of JSKN003 in patients with advanced/metastatic solid tumors: A first-in-human, dose-escalation, multicenter, open-label, phase I study. (ASCO 2024) - P1 | "JSKN003 was well tolerated with encouraging preliminary antitumor activity in heavily pretreated pts with advanced/metastatic solid tumors, especially in pts with HER2 expressed tumors. As of the cut-off date, no DLT was observed, MTD has not been reached yet."

Clinical • Metastases • P1 data • Anemia • Breast Cancer • Fatigue • Hematological Disorders • HER2 Breast Cancer • HER2 Positive Breast Cancer • Infectious Disease • Oncology • Pneumonia • Respiratory Diseases • Solid Tumor • HER-2

Evaluation of the safety, pharmacokinetics, and efficacy of JSKN003 in patients with advanced solid tumors: A phase I/II clinical study. (ASCO 2024) - P1/2 | "MTD of JSKN003 was not reached yet. And safety of JSKN003 was extremely excellent with encouraging preliminary antitumor activity in heavily pretreated pts with advanced solid tumors."

Clinical • Metastases • P1/2 data • PK/PD data • Breast Cancer • Colorectal Cancer • Gastric Cancer • Gastrointestinal Cancer • Hematological Disorders • HER2 Breast Cancer • HER2 Positive Breast Cancer • Interstitial Lung Disease • Lung Cancer • Neutropenia • Oncology • Ovarian Cancer • Pulmonary Disease • Respiratory Diseases • Solid Tumor

Alphamab Oncology Presented Chinese Clinical Data of Anti-HER2 Bispecific ADC JSKN003 for the First Time at the 2024 ASCO Annual Meeting (PRNewswire) - P1/2 | N=300 | NCT05744427 | Sponsor: Jiangsu Alphamab Biopharmaceuticals Co., Ltd | "Alphamab Oncology...announced that data from the clinical study conducted in China (JSKN003-102) of anti-HER2 bispecific antibody-drug conjugate (ADC) JSKN003 for the treatment of HER2-expressing advanced solid tumors, were presented for the first time at the 2024 Annual Meeting of American Society of Clinical Oncology (2024 ASCO Annual Meeting)...Following a single dose, exposures (C_max and AUC) of JSKN003 increased with dose escalation and the mean half-life of JSKN003 is approximately 5 days for 6.3 mg/kg....Among the 45 efficacy evaluable patients, the ORR and DCR were 51.1% (95%CI: 35.8, 66.3) and 93.3% (95%CI: 81.7, 98.6), respectively. The ORR in patients with IHC 1+, 2+ and 3+ was 14.3% (95% CI: 0.4, 57.9), 35.0% (95% CI: 15.4, 59.2), and 83.3% (95% CI: 58.6, 96.4), respectively."

P1/2 data • PK/PD data • Breast Cancer • Gastric Cancer • HER2 Breast Cancer • Oncology • Solid Tumor • HER-2

Safety and efficacy of JSKN003 in patients with advanced/metastatic solid tumors: A first-in-human, dose-escalation, multicenter, open-label, phase I study (AACR 2024) - P1 | "JSKN003 was well tolerated with encouraging preliminary antitumor activity in heavily pretreated pts with advanced/metastatic solid tumors, especially in pts with HER2 amplified tumors. As of the cut-off date, no DLT was observed, MTD has not been reached yet.Clinical trial information: NCT05494918"

Clinical • Metastases • P1 data • Bladder Cancer • Breast Cancer • Esophageal Cancer • Gastric Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Head and Neck Cancer • HER2 Breast Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Solid Tumor

Alphamab Oncology Presented the Dose-escalation Results from JSKN003 in Patients with Advanced/Metastatic Solid Tumors at AACR (PRNewswire-Asia) - P1 | N=45 | NCT05494918 | Sponsor: Alphamab (Australia) Co Pty Ltd. | "Alphamab Oncology...announced the data from phase I clinical study conducted in Australia (JSKN003-101) of anti-HER2 bispecific antibody-drug conjugate (ADC) JSKN003 for the treatment of HER2-expressing advanced solid tumors, were presented as a poster at the American Association for Cancer Research Annual Meeting 2024....32 patients were enrolled and received JSKN003 during the dose-escalation part across 7 dose levels (1.0 - 8.4 mg/kg, Q3W)....As of the cut-off date March 15, 2024, the objective response rate (ORR) and disease control rate (DCR) was 56.3% (95%CI: 37.7%, 73.6%) and 90.6% (95%CI: 75.0%, 98.0%), respectively. The ORR in patients with IHC 1+, 2+ and 3+ was 66.7% (6/9), 37.5% (6/16), and 85.7% (6/7), respectively. As for the efficacy of the HER2+ BC and HER2-low BC, the ORR was 100% (5/5) and 50.0% (5/10), respectively."

P1 data • Bladder Cancer • Breast Cancer • Esophageal Cancer • Gastric Cancer • Head and Neck Cancer • Lung Cancer • Ovarian Cancer