RegulationPriority Review (US), Breakthrough Therapy (US), Fast Track (US), Orphan Drug (US), Orphan Drug (EU), Priority Review (CN), Orphan Drug (AU), Priority Review (SG), Conditional marketing approval (CN)

Structure/Sequence

Sequence Code 453640391L

Source: *****

Sequence Code 524455911H

Source: *****

505

Clinical Trials associated with Toripalimab

NCT06657144

/ Not yet recruitingPhase 1

A Phase 1B, Multicenter, Open-Label Study of the Safety and Efficacy of CHS-114 in Combination With Toripalimab With or Without Other Treatments in Participants With Advanced or Metastatic Solid Tumors

The main purpose of this study is to evaluate the safety and preliminary efficacy of CHS-114 in combination with toripalimab and/or other standard of care (SOC) compound(s) in participants with advanced or metastatic solid tumors.

Start Date01 Mar 2025

Sponsor / Collaborator

Coherus BioSciences, Inc.

NCT06389526

/ Not yet recruitingPhase 1

A Phase 1, Multicenter, Open-Label Study of CHS-1000 as a Single Agent and in Combination With Toripalimab-tpzi in Participants With Advanced or Metastatic Solid Tumors

The primary purpose of this trial is to assess the tolerability and safety of CHS-1000 alone and in combination with toripalimab-tpzi in participants with advanced solid tumors.

Start Date15 Feb 2025

Sponsor / Collaborator

Coherus BioSciences, Inc.

NCT06771622

/ Not yet recruitingPhase 1/2

Phase Ib/IIa, Open-label, Multicenter, Dose Escalation, and Dose Expansion Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of HCB101 in Combination with Multiple Agents in Subjects with Advanced Solid Tumors

This is a non-randomized, open-label, dose-escalation, and dose-expansion Phase Ib/IIa study to evaluate the safety, tolerability, PK profile, and preliminary efficacy of HCB101 in combination therapies in subjects with advanced solid tumors. The trial consists of four cohorts, each including a part I of the dose-escalation phase (Phase Ib) and a part II of the dose-expansion phase (Phase IIa).

Start Date31 Jan 2025

Sponsor / Collaborator

HanchorBio inc

100 Clinical Results associated with Toripalimab

100 Translational Medicine associated with Toripalimab

100 Patents (Medical) associated with Toripalimab

508

Literatures (Medical) associated with Toripalimab

15 Feb 2025·INTERNATIONAL JOURNAL OF CANCER

A new treatment approach of toripalimab in combination with concurrent platinum‐based chemoradiotherapy for locally advanced cervical cancer: A phase II clinical trial

Article

Author: Cao, Yuanjie ; Yuan, Zhiyong ; Li, Junyi ; Chen, Jie ; Shi, Jinming ; Li, Chen

Abstract:

This study investigated the efficacy and safety of toripalimab in combination with concurrent platinum‐based chemoradiation in patients with untreated locally advanced cervical cancer. Eligible patients received toripalimab 240 mg once every 3 weeks in combination with concurrent platinum‐based chemoradiotherapy, followed by the maintenance of toripalimab once every 6 weeks up to 1 year. The primary endpoint was objective response rate (ORR). Secondary endpoints included 2‐year and 3‐year progression‐free survival (PFS) rates, 3‐year overall survival (OS) rate, and safety. Biomarker analysis of PD‐L1 expression and genomic mutational analysis by next‐generation sequencing were conducted, as well as PD‐L1 expression on tumor biopsies. A total of 82 patients were enrolled. The median follow‐up was 21 months (range, 5.2–44.5 months). The ORR and disease control rate were both 87.8% among the 82 patients. Median PFS and OS were not reached. A trend toward longer PFS was observed in the populations with a PD‐L1 combined positive score ≥10, low tumor mutation burden and loss of heterozygosity in human leukocyte antigen (HLA LOH) detected populations. A total of 37 patients experienced treatment‐related adverse events, of which 17 (20.7%) patients experienced grade 3 or higher adverse events. Collectively, toripalimab plus concurrent platinum‐based chemoradiotherapy showed promising antitumor efficacy with acceptable safety profiles in patients with untreated locally advanced cervical cancer.

01 Jan 2025·Science China-Life Sciences

Antithetical impacts of deleterious LRP1B mutations in non-squamous and squamous NSCLCs on predicting benefits from immune checkpoint inhibitor alone or with chemotherapy over chemotherapy alone: retrospective analyses of the POPLAR/OAK and CHOICE-01 trials

Article

Author: Zhou, Wenyong ; Wang, Guoqiang ; Li, Leo ; Xu, Yu ; Wang, Zhijie ; Wang, Jinliang ; Cai, Shangli ; Zhou, Qiaoxia ; Wang, Wenxian ; Xu, Chunwei ; Duan, Jianchun ; Wang, Jie

In non-small cell lung cancers, the non-squamous and squamous subtypes (nsqNSCLC and sqNSCLC) exhibit disparities in pathophysiology, tumor immunology, and potential genomic correlates affecting responses to immune checkpoint inhibitor (ICI)-based treatments. In our in-house training cohort (n=85), the presence of the LRP1B deleterious mutation (LRP1B-del) was associated with longer and shorter progression-free survival (PFS) on ICIs alone in nsqNSCLCs and sqNSCLCs, respectively (P_interaction=0.008). These results were validated using a larger public ICI cohort (n=208, P_interaction<0.001). Multiplex immunofluorescence staining revealed an association between LRP1B-del and increased and decreased numbers of tumor-infiltrating CD8⁺ T cells in nsqNSCLCs (P=0.040) and sqNSCLCs (P=0.014), respectively. In the POPLAR/OAK cohort, nsqNSCLCs with LRP1B-del demonstrated improved PFS benefits from atezolizumab over docetaxel (hazard ratio (HR) =0.70, P=0.046), whereas this benefit was negligible in those without LRP1B-del (HR=1.05, P=0.64). Conversely, sqNSCLCs without LRP1B-del benefited more from atezolizumab (HR=0.60, P=0.002) than those with LRP1B-del (HR=1.30, P=0.31). Consistent results were observed in the in-house CHOICE-01 cohort, in which nsqNSCLCs with LRP1B-del and sqNSCLCs without LRP1B-del benefited more from toripalimab plus chemotherapy than from chemotherapy alone (P_interaction=0.008). This multi-cohort study delineates the antithetical impacts of LRP1B-del in nsqNSCLCs and sqNSCLCs on predicting the benefits from ICI alone or with chemotherapy over chemotherapy alone. Our findings highlight the distinct clinical utility of LRP1B-del in guiding treatment choices for nsqNSCLCs and sqNSCLCs, emphasizing the necessity for a detailed analysis based on pathological subtypes when investigating biomarkers for cancer therapeutics.

24 Dec 2024·Zhonghua yi xue za zhi

[A prospective phase Ⅱ clinical trial of toripalimab combined with platinum-based concurrent chemoradiotherapy and consolidation chemotherapy in patients with locally advanced cervical cancer].

Article

Author: Yuan, Z Y ; Shi, J M ; Li, J Y ; Cao, Y J ; Chen, J ; Li, C

Objective: To explore the efficacy and safety of toripalimab combined with platinum-based chemoradiotherapy in the treatment of locally advanced cervical cancer. Methods: A total of 82 patients diagnosed as locally advanced cervical cancer who received toripalimab combined with platinum-based concurrent chemoradiotherapy at Tianjin Medical University Cancer Institute and Hospital from May 24^th 2019 to August 31^st 2022 were enrolled prospectively. After undergoing concurrent chemoradiotherapy, the patient received six cycles of treatment with toripalimab in combination with paclitaxel and platinum-based agents. The primary endpoint of the study was the objective response rate (ORR), and the secondary endpoints included disease control rate (DCR), safety, progression-free survival, and overall survival. Kaplan-Meier curves were used to depict the cumulative incidence of progression-free survival (PFS) and overall survival (OS) for patients with different expression levels of programmed death-ligand 1 (PD-L1) and genetic mutation burdens, and log-rank tests were used to compare the difference between groups. Results: The median age of the patients was 53.6 (45.5,58.7) years, and 76 patients (92.7%) had squamous cell carcinoma. The overall ORR and DCR for the 82 patients were both 87.8% (72 patients, 95%CI: 78.7%-94.0%). Among the 82 patients, 64 (78.0%) achieved complete remission, 8 (9.8%) had partial remission, 8 (9.8%) had disease progression, and 2 (2.4%) were not evaluable. During the treatment, 37 patients (45.1%) experienced treatment-related adverse events, of which 17 patients (20.7%) had grade 3 or higher adverse reactions. The most common grade 3 or higher treatment-related adverse reaction was radiation enteritis (n=5, 6.1%). The median follow-up time was 20.6 (14.0, 27.9) months. The median progression-free survival (mPFS) and median overall survival (mOS) were not reached. The 2-year PFS rate was higher in patients with PD-L1 combined positive score (CPS)≥10 compared to those with CPS<10 (92.4% vs 81.2%, χ²=0.68, P=0.409), and higher in patients with low tumor mutation burden (TMB-L) compared to those with high tumor mutation burden (TMB-H) (95.2% vs 83.3%, χ²=1.91, P=0.167). Conclusion: Patients with locally advanced cervical cancer can achieve favorable objective response rates when treated with toripalimab in combination with platinum-based concurrent chemoradiotherapy and consolidative chemotherapy.

877

News (Medical) associated with Toripalimab

14 Jan 2025

·www.prnewswire.com

Non-Small Cell Lung Cancer Clinical Trial Pipeline Boom as Over 100 Companies Leading the Charge in Research and Development | DelveInsight

Advancements in targeted therapies have transformed the treatment landscape for NSCLC, enabling precision medicine approaches that improve outcomes. These therapies focus on specific genetic mutations or molecular drivers, such as EGFR, ALK, ROS1, BRAF, and MET, which are commonly implicated in NSCLC. Drugs targeting these mutations, such as tyrosine kinase inhibitors (TKIs), offer significant benefits, including higher response rates, improved progression-free survival, and fewer off-target effects compared to traditional chemotherapy. Additionally, continuous innovation has led to the development of next-generation inhibitors that overcome resistance to earlier therapies, further enhancing their efficacy. LAS VEGAS, Jan. 14, 2025 /PRNewswire/ -- DelveInsight's ' Non-Small Cell Lung Cancer Pipeline Insight 2025 ' report provides comprehensive global coverage of pipeline NSCLC therapies in various stages of clinical development, major pharmaceutical companies are working to advance the pipeline space and future growth potential of the NSCLC pipeline domain. Key Takeaways from the Non-Small Cell Lung Cancer Pipeline Report DelveInsight's NSCLC pipeline report depicts a robust space with 100+ active players working to develop 120+ pipeline therapies for NSCLC treatment. Key NSCLC companies such as Merck Sharp & Dohme LLC, AbbVie, Qilu Pharmaceutical Co., Ltd., Suzhou Puhe Pharmaceutical Technology Co., LTD, Exelixis, Genmab, OncoResponse, Inc., Next Point Therapeutics, Inc., Light Chain Bioscience - Novimmune SA, Immunitas Therapeutics, Hansoh BioMedical R&D Company, Mythic Therapeutics, Shanghai Henlius Biotech, and others are evaluating new NSCLC drugs to improve the treatment landscape. Promising NSCLC pipeline therapies such as V940, Telisotuzumab Vedotin, QL1706, YK-029A, XL092, PRO1184, OR2805, NPX267, NI-1801, IMT-009, HS-20117, MYTX-011, HLX301, and others are under different phases of NSCLC clinical trials. In December 2024, the FDA granted breakthrough therapy designation to sacituzumab tirumotecan (MK-2870/SKB264/) for the treatment of patients with advanced or metastatic nonsquamous non–small cell lung cancer (NSCLC). In September 2024, AbbVie announced that it had submitted a Biologics License Application (BLA) to the US Food and Drug Administration (FDA) for accelerated approval of elotuzumab vedotin (Teliso-V) in adult patients with previously treated, locally advanced or metastatic epidermal growth factor receptor (EGFR) wild type, nonsquamous non-small cell lung cancer (NSCLC) with c-Met protein overexpression. In August 2024, the FDA granted Fast track designation to Deltacel (KB-GDT-01) with low-dose radiation therapy to potentially treat patients with metastatic non–small cell lung cancer (NSCLC) whose disease progressed on 2 or more prior lines of standard-of-care therapy, including immune checkpoint inhibitors, platinum-based chemotherapy, and targeted therapy. In July 2024, Nuvalent announced the first patient dosed in HEROEX-1 Phase Ia/Ib clinical trial of NVL-330, its novel HER2-selective Inhibitor. In April 2024, ABVC BioPharma announced that the Company and its affiliate Rgene Corporation entered into a comprehensive licensing agreement with OncoX for the drug ABV-1501. Under the terms of the agreement, ABVC grants OncoX exclusive rights for one of ABVC's four products in its Oncology pipeline to develop, manufacture, and commercialize BLEX 404. In April 2024, Hansoh Pharma announced that the Class 1 new drug " HS-10504 tablet" independently developed by its subsidiary Jiangsu Hansoh Pharmaceutical Group Co., Ltd. and Shanghai Hansoh Biomedical Technology Co., Ltd. had obtained the clinical trial notification letter issued by the National Medical Products Administration of the People's Republic of China. It is intended for the treatment of advanced non-small cell lung cancer, with specific indications to be determined after clinical trials. In February 2024, the FDA granted breakthrough therapy designation to NVL-520 as a treatment for patients with ROS1-positive metastatic non–small cell lung cancer (NSCLC) who received prior treatment with at least 2 ROS1 tyrosine kinase inhibitors (TKIs). Request a sample and discover the recent advances in NSCLC treatment drugs @ Non-Small Cell Lung Cancer Pipeline Report The NSCLC pipeline report provides detailed profiles of pipeline assets, a comparative analysis of clinical and non-clinical stage NSCLC drugs, inactive and dormant assets, a comprehensive assessment of driving and restraining factors, and an assessment of opportunities and risks in the NSCLC clinical trial landscape. Non-Small Cell Lung Cancer Overview Non-small cell lung cancer (NSCLC) is the most prevalent form of lung cancer, originating in the tissues of the lungs. Unlike small cell lung cancer, which grows rapidly, NSCLC typically develops more slowly but often spreads to other parts of the body by the time it is diagnosed, emphasizing the need for early detection and treatment. Small-cell lung cancer derives its name from the small, round appearance of its cells under a microscope, while the cells in NSCLC are larger. Despite its slower growth, NSCLC is frequently diagnosed at an advanced stage, further underscoring the importance of early intervention. In the United States, approximately 230,000 people are diagnosed with lung cancer annually, and it accounts for an estimated 135,000 deaths each year. Lung cancer causes more deaths than prostate, breast, brain, and colorectal cancers combined. It is the leading cause of cancer deaths in men and the second most common in women. However, these figures are declining, largely due to anti-smoking initiatives and reduced tobacco use. The classification of lung tumors is based on the 2015 World Health Organization (WHO) guidelines, which utilize immunohistochemistry and light microscopy to guide treatment decisions and predict outcomes. NSCLC encompasses several subtypes, including adenocarcinoma, squamous cell carcinoma, and large cell carcinoma. Adenocarcinoma, the most common subtype, accounts for nearly half of all lung cancer cases. Squamous cell carcinoma, once the most prevalent, typically originates in the tracheobronchial tree but is now more frequently found in peripheral lung areas. Large cell carcinoma is a diagnosis of exclusion, characterized by poor differentiation and lack of specific classification through immunohistochemistry or electron microscopy. The causes of NSCLC can be divided into avoidable and unavoidable risk factors. Tobacco use remains the most significant preventable risk factor, while other causes include alcohol consumption, exposure to secondhand smoke, asbestos, radon, arsenic, chromium, nickel, ionizing radiation, and polycyclic aromatic hydrocarbons. Diagnosis involves a comprehensive blood count (CBC), a complete metabolic panel (CMP), and imaging studies. Hypercalcemia or elevated alkaline phosphatase may indicate metastasis to bones. Initial imaging with a chest X-ray can help identify nonspecific signs, followed by computed tomography (CT) for detailed characterization. A tissue biopsy is essential for confirming the diagnosis through histopathologic and immunohistochemistry evaluation. Treatment options for NSCLC include standard therapies like surgery, radiation, chemotherapy, targeted therapy, and immunotherapy, as well as newer approaches like laser therapy, photodynamic therapy (PDT), and cryosurgery. The choice of treatment depends on the cancer's stage, the patient's functional status, comorbidities, and the molecular characteristics of the tumor. Surgery is often required for localized cases, while advanced stages may call for a combination of therapies. Participation in clinical trials can also offer access to emerging treatments. Managing NSCLC requires a collaborative, interprofessional approach, beginning with prevention. Primary care providers play a critical role in smoking cessation counseling and early detection through lung cancer screening, which can improve prognosis by identifying the disease before it progresses to advanced stages. Find out more about NSCLC treatment drugs @ Drugs for Non-Small Cell Lung Cancer Treatment A snapshot of the Non-Small Cell Lung Cancer Pipeline Drugs mentioned in the report: Learn more about the emerging NSCLC pipeline therapies @ Non-Small Cell Lung Cancer Clinical Trials Non-Small Cell Lung Cancer Therapeutics Assessment The NSCLC pipeline report proffers an integral view of the NSCLC emerging novel therapies segmented by stage, product type, molecule type, mechanism of action, and route of administration. Scope of the Non-Small Cell Lung Cancer Pipeline Report Coverage: Global Therapeutic Assessment By Product Type: Mono, Combination, Mono/Combination Therapeutic Assessment By Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III Therapeutics Assessment By Route of Administration: Oral, Intravenous, Subcutaneous, Parenteral, Topical Therapeutics Assessment By Molecule Type: Recombinant fusion proteins, Small molecule, Monoclonal antibody, Peptide, Polymer, Gene therapy Therapeutics Assessment By Mechanism of Action: Immunostimulants, Antibody-dependent cell cytotoxicity, Cytotoxic T-lymphocyte antigen 4 inhibitors, Programmed cell death 1 receptor antagonists, T lymphocyte stimulants, Apoptosis stimulants, Mitosis inhibitors, Tubulin inhibitors, Tubulin polymerization inhibitors, Epidermal growth factor receptor antagonists, Proto-oncogene protein c-met inhibitors Key Non-Small Cell Lung Cancer Companies: Merck Sharp & Dohme LLC, AbbVie, Qilu Pharmaceutical Co., Ltd., Suzhou Puhe Pharmaceutical Technology Co., LTD, Exelixis, Genmab, OncoResponse, Inc., Next Point Therapeutics, Inc., Light Chain Bioscience - Novimmune SA, Immunitas Therapeutics, Hansoh BioMedical R&D Company, Mythic Therapeutics, Shanghai Henlius Biotech, and others Key Non-Small Cell Lung Cancer Pipeline Therapies: V940, Telisotuzumab Vedotin, QL1706, YK-029A, XL092, PRO1184, OR2805, NPX267, NI-1801, IMT-009, HS-20117, MYTX-011, HLX301, and others Dive deep into rich insights for new drugs for NSCLC treatment, visit @ Non-Small Cell Lung Cancer Drugs Table of Contents For further information on the NSCLC pipeline therapeutics, reach out @ Non-Small Cell Lung Cancer Treatment Drugs Related Reports Non-Small Cell Lung Cancer Market Non-Small Cell Lung Cancer Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, market share of the individual therapies, and key NSCLC companies including EMD Serono, Merck, Cellular Biomedicine Group, Inc., Celgene, CellSight Technologies, Inc., BeyondSpring Pharmaceuticals Inc., J Ints Bio, Forward Pharmaceuticals Co., Ltd., AstraZeneca, Bristol-Myers Squibb, Teligene US, Rain Oncology Inc, ReHeva Biosciences, Inc., Amgen, Novartis, RedCloud Bio, Parexel, Vitrac Therapeutics, LLC, Mythic Therapeutics, Instil Bio, Mirati Therapeutics Inc., Daiichi Sankyo, Inc., AstraZeneca, Precision Biologics, Inc, Promontory Therapeutics Inc., Palobiofarma SL, Regeneron Pharmaceuticals, Revolution Medicines, Inc., Cullinan Oncology, LLC, Iovance Biotherapeutics, Inc., Innate Pharma, among others. HER2-mutant Non-Small Cell Lung Cancer Pipeline HER2-mutant Non-Small Cell Lung Cancer Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key HER2-mutant non-small cell lung cancer companies, including Dizal Pharmaceuticals, Puma Biotechnology, AstraZeneca, Jiangsu Hengrui Medicine, among others. Small Cell Lung Cancer Market Small Cell Lung Cancer Market Insights, Epidemiology, and Market Forecast – 2032 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key advanced small cell lung cancer companies, including Ascentage Pharma, Merck & Co, AstraZeneca, Advenchen Laboratories, Advanced Accelerator Applications, Trillium Therapeutics, Wigen Biomedicine, Linton Pharm, Carrick Therapeutics, among others. Small-cell Lung Cancer Pipeline Small-cell Lung Cancer Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key small-cell lung cancer companies, including Ascentage Pharma, Merck & Co, AstraZeneca, Advenchen Laboratories, GlaxoSmithKline, Advanced Accelerator Applications, Trillium Therapeutics, Vernalis, Oncoceutics, NewBio Therapeutics, Wigen Biomedicine, Linton Pharm, Carrick Therapeutics, Xencor, Jiangsu HengRui Medicine, Aileron Therapeutics, Roche, Ipsen, Celgene, Lee's Pharmaceutical Limited, AbbVie, G1 Therapeutics, Chipscreen Biosciences, Luye Pharma Group, Shanghai Henlius Biotech, CSPC ZhongQi Pharmaceutical Technology, Impact Therapeutics, among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Contact Us Shruti Thakur [email protected] +14699457679 Logo: SOURCE DelveInsight Business Research, LLP WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

License out/in

13 Jan 2025

·www.prnewswire.com

Rise Therapeutics Receives FDA IND Clearance to Initiate Clinical Testing of R-5780 in Cancer

ROCKVILLE, Md., Jan. 13, 2025 /PRNewswire/ -- Rise Therapeutics, a biotechnology company engaged in developing novel oral Immunotherapeutics, today announced that the U.S. Food and Drug Administration (FDA) has accepted its investigational new drug (IND) application to proceed with a cancer Phase 1 clinical trial for its program candidate, R-5780. This is Rise Therapeutics' fourth clinical program to enter patient clinical testing. For separate products, other clinical studies are ongoing for the treatment of ulcerative colitis, rheumatoid arthritis, and type 1 diabetes. Continue Reading R-5780 is an orally delivered immune oncology drug candidate being developed for the treatment of cancer. R-5780 has demonstrated a pronounced ability to engage immune pathways that enhance the effectiveness immune checkpoint inhibitor therapy. This drug candidate builds upon the growing understanding of how certain gut-regulated immune pathways can help promote efficacy of immune oncology drugs. R-5780 is a precision-directed synthetic biology medicine that engages selective immune pathways that can support a robust anti-tumor T cell response. This revolutionary immune oncology drug candidate is one of the first of its kind in the context of mechanism of action and potential for success in the context of cancer treatment. Rise Therapeutics Receives FDA IND Clearance to Initiate Clinical Testing of R-5780 in Cancer Post this "The FDA's clearance for R-5780 is a testament to the innovation and dedication of our team at Rise Therapeutics driving novel immunotherapies forward into human proof-of-concept" states Christian Furlan Freguia, Senior Vice President of Research at Rise Therapeutics. "R-5780 represents a pioneering approach that leverages the power of gut-regulated immune pathways to enhance the effectiveness of immune checkpoint inhibitors... We believe R-5780 has the potential to expand responses in patients that become refractory to immune checkpoint inhibitors and increase responsiveness in tumors initially unresponsive to these medications". The Phase I clinical trial (NCT06398418) will be a multi-dose clinical trial assessing the safety, drug exposure, and clinical activity of R-5780 in patients with cancer. The study will enroll up to 33 participants. About Rise Therapeutics Rise Therapeutics is an emerging, privately held biotechnology company located in Rockville, Maryland, which leverages its expertise in synthetic biology and immunological drug development to create novel cellular-based immune therapies. With a strong emphasis on product development and its internal clinical GMP manufacturing infrastructure, Rise is focused on developing immunological-based biological medicines using a unique and proprietary oral biologics delivery platform. For more information, go to . Contact: [email protected] SOURCE Rise Therapeutics WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

ImmunotherapyINDPhase 1

13 Jan 2025

·www.prnewswire.com

A28 Therapeutics and GATC Health Announce Comprehensive AI-Powered Analysis, Predicting Efficacy, Safety, and Potential Off-Target Effects of A28's AT-101 Cancer Drug Candidate

The analysis provides detailed insights to optimize clinical trial strategy, accelerate development, and de-risk decision-making. SAN FRANCISCO, Jan. 13, 2025 /PRNewswire/ -- A28 Therapeutics, Inc., a clinical stage biopharmaceutical company developing a novel platform technology for the treatment of multiple cancer types, today announced during the J.P. Morgan Healthcare Conference the completion of a comprehensive activity analysis for its AT-101 cancer drug candidate. This AI analysis by GATC Health Corp, a leader in AI-driven drug discovery, not only validates the potential of AT-101 but also provides A28 Therapeutics with a powerful tool to optimize its clinical trial strategy. By accurately assessing efficacy, safety, and potential off-target effects, the analysis provides actionable insights for reducing development risks, accelerating timelines, and lowering costs, paving the way for a more efficient path to clinical success. Continue Reading "GATC has set the standard in leveraging advanced AI to objectively analyze drug compounds to provide valuable insight into key endpoints, like mechanisms of action and toxicity, while exposing non-obvious areas of risk," explained Dr. Stanley Lewis, CEO of A28. "As an advisory board member since 2022, I have had direct access to the GATC team and understanding of the powerful toolset GATC uses to greatly de-risk research, development and financial decisions. This analysis provides an objective assessment of how our AT-101 drug candidate will perform in our next clinical trial." The analysis provides insights to optimize clinical trial strategy, accelerate development, and de-risk decision-making. Post this GATC's Multiomics Advanced Technology™ (MAT) AI platform performed in-silico experiments to determine the safety, efficacy and side-effect profile for A28's asset. Specifically, the MAT platform generated predictions for primary pharmacokinetics, bioaccumulation, toxicology, ADME considerations, adverse event analysis, side effects, endpoint matching, efficacy ratios, mechanisms of action, and immune response. "GATC Health's work with A28 demonstrates our ability to quickly provide deep insights and value into clinical-stage drug candidates utilizing the same technologies we employ for therapeutic discovery and early-stage development that can save years and tens of millions of dollars compared to traditional methods," noted Jayson Uffens, co-founder and CTO. "This collaboration showcases our value to empower leaders and researchers in biotech to accelerate their pre-clinical development and de-risk their clinical and fundraising efforts." A28 Therapeutics, Inc. A28 Therapeutics is a clinical stage biotechnology company developing first in class targeted oncolytic peptides (TOPs), for treatment of cancer. A28's lead candidate, AT-101, is currently being developed to treat hepatocellular carcinoma (HCC) leveraging its unique biodistribution that results in prolonged exposure in the liver. The immunologically favorable mechanism of tumor elimination provides for synergy with existing oncology medications including immune checkpoint inhibitors. To date, AT-101 has been tested in more than 75 patients where it demonstrated tolerability and remarkable anti-cancer activity. The A28 TOPs platform has produced a pipeline of products targeting multiple cancer types and cell receptors. For more information, please visit About GATC Health GATC Health Corp is a technology company revolutionizing drug discovery and development through its transformative AI platform and approach. The company's validated and proprietary Multiomics Advanced Technology™ (MAT) simulates human biochemistry's billions of interactions to rapidly create novel therapeutics, identify and confirm targets, accelerate development, and de-risk drug pipelines by predicting efficacy, safety, and off-target effects. For more information, please visit gatchealth.com SOURCE GATC Health; A28 Therapeutics WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

100 Deals associated with Toripalimab

External Link

KEGG	Wiki	ATC	Drug Bank
-	-	L01XC	DB15043

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Metastatic Esophageal Squamous Cell Carcinoma	EU	Tmc Pharma (Eu Ltd.	19 Sep 2024
Metastatic Esophageal Squamous Cell Carcinoma	IS	Tmc Pharma (Eu Ltd.	19 Sep 2024
Metastatic Esophageal Squamous Cell Carcinoma	LI	Tmc Pharma (Eu Ltd.	19 Sep 2024
Metastatic Esophageal Squamous Cell Carcinoma	NO	Tmc Pharma (Eu Ltd.	19 Sep 2024
Nasopharyngeal Neoplasms	EU	Tmc Pharma (Eu Ltd.	19 Sep 2024
Nasopharyngeal Neoplasms	IS	Tmc Pharma (Eu Ltd.	19 Sep 2024
Nasopharyngeal Neoplasms	LI	Tmc Pharma (Eu Ltd.	19 Sep 2024
Nasopharyngeal Neoplasms	NO	Tmc Pharma (Eu Ltd.	19 Sep 2024
Oesophageal squamous cell carcinoma recurrent	EU	Tmc Pharma (Eu Ltd.	19 Sep 2024
Oesophageal squamous cell carcinoma recurrent	IS	Tmc Pharma (Eu Ltd.	19 Sep 2024
Oesophageal squamous cell carcinoma recurrent	LI	Tmc Pharma (Eu Ltd.	19 Sep 2024
Oesophageal squamous cell carcinoma recurrent	NO	Tmc Pharma (Eu Ltd.	19 Sep 2024
Unresectable Esophageal Squamous Cell Carcinoma	EU	Tmc Pharma (Eu Ltd.	19 Sep 2024
Unresectable Esophageal Squamous Cell Carcinoma	IS	Tmc Pharma (Eu Ltd.	19 Sep 2024
Unresectable Esophageal Squamous Cell Carcinoma	LI	Tmc Pharma (Eu Ltd.	19 Sep 2024
Unresectable Esophageal Squamous Cell Carcinoma	NO	Tmc Pharma (Eu Ltd.	19 Sep 2024
Triple Negative Breast Cancer	CN	Shanghai Junshi Biosciences Co., Ltd.	18 Jun 2024
Extensive stage Small Cell Lung Cancer	CN	Shanghai Junshi Biosciences Co., Ltd.	04 Jun 2024
Metastatic Renal Cell Carcinoma	CN	Shanghai Junshi Biosciences Co., Ltd.	02 Apr 2024
Unresectable Renal Cell Carcinoma	CN	Shanghai Junshi Biosciences Co., Ltd.	02 Apr 2024

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Metastatic melanoma	NDA/BLA	CN	Shanghai Junshi Biosciences Co., Ltd.	12 Aug 2024
Unresectable Melanoma	NDA/BLA	CN	Shanghai Junshi Biosciences Co., Ltd.	12 Aug 2024
Advanced Hepatocellular Carcinoma	NDA/BLA	CN	Shanghai Junshi Biosciences Co., Ltd.	18 Jul 2024
Nasopharyngeal Cancer, Recurrent	NDA/BLA	EU	Tmc Pharma (Eu Ltd.	14 Nov 2022
Recurrent Lung Non-Squamous Non-Small Cell Carcinoma	Phase 3	CN	Shanghai Junshi Biosciences Co., Ltd.	11 Jul 2024
Small cell lung cancer limited stage	Phase 3	US	Shanghai Junshi Biosciences Co., Ltd.	15 Nov 2023
Small cell lung cancer limited stage	Phase 3	CN	Shanghai Junshi Biosciences Co., Ltd.	15 Nov 2023
Small cell lung cancer limited stage	Phase 3	BE	Shanghai Junshi Biosciences Co., Ltd.	15 Nov 2023
Small cell lung cancer limited stage	Phase 3	FR	Shanghai Junshi Biosciences Co., Ltd.	15 Nov 2023
Small cell lung cancer limited stage	Phase 3	GE	Shanghai Junshi Biosciences Co., Ltd.	15 Nov 2023

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ChiCTR2000039155 (ESMO_IO2024) Manual	Phase 2	thymic carcinoma First line	24	Toripalimab + Paclitaxel + Carboplatin	dtuvbpdnjj(swdkuuujqd) = qyxmhscazq bpuskbiqss (xfvmgryzww, 14.1 - 36.5) View more	Positive	12 Dec 2024
NCT03430297 (MELATORCH, PRNewswire) Manual	Phase 3	Melanoma First line	255	特瑞普利单抗	rsryuzryut(xcdeneilcm) = dlxudqvshm gwlunryoln (huvdluurwh ) View more	Positive	29 Sep 2024
				达卡巴嗪	rsryuzryut(xcdeneilcm) = adgxyhxrel gwlunryoln (huvdluurwh ) View more
HEPATORCH (PRNewswire) Manual	Phase 3	Hepatocellular Carcinoma	326	特瑞普利单抗+贝伐珠单抗	asyaysewip(hsvsxnrwnw) = pgnovjfzkk vdfkuthawv (tzjvwegaom ) View more	Positive	29 Sep 2024
				索拉非尼	asyaysewip(hsvsxnrwnw) = bjfjjeddnt vdfkuthawv (tzjvwegaom ) View more
NCT04005170 (EC-CRT-001, ESMO2024) Manual	Phase 2	Esophageal Squamous Cell Carcinoma	42	Toripalimab plus definitive chemoraditoripalimab	bacqopxgjg(dborogijtu) = whbaofttfr sjbajhlssu (npbxjhmcye, 31.9 - 62.8) View more	Positive	16 Sep 2024
				Chemotherapy (paclitaxel and cisplatitoripalimab	-
NCT03926338 (PICC, ESMO2024) Manual	Phase 2	Microsatellite instability-high colorectal cancer Neoadjuvant MSI-High \| Deficient DNA Mismatch Repair (dMMR)	43	Toripalimab 3 mg/kg + Celecoxib 200 mg	mvxgvnumsb(nelagwvtpa) = xlhqxxfgxf qffmiawrlg (gdwxhpqxlb, 70 - 96) Met View more	Positive	16 Sep 2024
				Toripalimab 3 mg/kg	mvxgvnumsb(nelagwvtpa) = hdnogwoilg qffmiawrlg (gdwxhpqxlb, 57 - 88) Met View more
ChiCTR2000030405 (NEOTAX, ESMO2024) Manual	Phase 2	Renal Cell Carcinoma Neoadjuvant	25	Toripalimabaxitinib	mvpesqmfsu(fammaulkmb) = roqcdrfgtk nynhafsntq (oktqwkywiv, 62.7 - 97.2) View more	Positive	15 Sep 2024
ChiCTR2000039175 (ESMO2024) Manual	Phase 2	Recurrent Glioblastoma	54	Toripalimab in combination with Anlotinib	nhapaxtwmf(xbornfreqj) = ixpbkselgm pxvhgvepaz (bmrdfpgclf ) View more	Positive	15 Sep 2024
ChiCTR2000035573 (ESMO2024) Manual	Phase 2	Non-Small Cell Lung Cancer First line	40	Toripalimab + CIK + Chemotherapy	usqnsqunre(ehejzuycmv) = ssleujdctc ldywyjyaol (zideogegzb ) View more	Positive	14 Sep 2024
				Toripalimab + CIK	usqnsqunre(ehejzuycmv) = hrusuaxfpu ldywyjyaol (zideogegzb ) View more
NCT06117566 (ESMO2024) Manual	Phase 1/2	Squamous Cell Carcinoma of Head and Neck	65	WX390aToripalimab	vsvfuprpbs(hhuxslkjcy) = esdcymcttw imbqdcvzdg (nkkvbmughq ) View more	Positive	14 Sep 2024
				WX390Toripalimab	qivtgunuvs(ibhffoevby) = ikuxaordzu luxhvcudmv (hnpxbggdfu ) View more
NCT04856631 (ESMO2024) Manual	Phase 1/2	Squamous Cell Carcinoma of Head and Neck First line PD-L1 Positive	43	Toripalimab cetuximab	phuiqlakyp(qhkvlokieb) = legyfmfhvf eojvmwufsz (qldxkvvjlq, 27.0 - 57.9) View more	Positive	14 Sep 2024

Translational Medicine

Boost your research with our translational medicine data.

view full example data

Deal

Boost your decision using our deal data.

view full example data

Core Patent

Boost your research with our Core Patent data.

view full example data

Clinical Trial

Identify the latest clinical trials across global registries.

view full example data

Approval

Accelerate your research with the latest regulatory approval information.

view full example data

Regulation

Understand key drug designations in just a few clicks with Synapse.

view full example data

Chat with Hiro

Get started for free today!

Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

Start your data trial now!

Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis