CTLA-4 Inhibitors Clinical Trial Pipeline: DelveInsight Highlights Major Advances, Transformative Therapies, and 40+ Leading Players Wheeling the Therapeutics Segment

The CTLA-4 inhibitors pipeline and clinical trial analysis report deliver important insights on ongoing research, clinical strategies, upcoming therapeutics, and commercial analysis. 

LAS VEGAS, May 31, 2023 /PRNewswire/ -- DelveInsight's 'CTLA-4 Inhibitors Competitive Landscape – 2023' report provides comprehensive global coverage of available, marketed, and pipeline CTLA-4 inhibitors in various stages of clinical development, major pharmaceutical companies working to advance the pipeline space, company assessment, comparative assessment, and future growth potential of the CTLA-4 inhibitors competitive domain.

Key Takeaways from the CTLA-4 Inhibitors Competitive Landscape Report

• Over 40+ CTLA-4 inhibitors companies are evaluating 50+ CTLA-4 inhibitors drugs in various stages of development, and their anticipated acceptance in the CTLA-4 inhibitors market would significantly increase market revenue. 
• Key CTLA-4 inhibitors companies such as Innovent Biologics, Alphamab Oncology, Agenus, Harbour BioMed, AstraZeneca, Alpine Immune Sciences, Henlix Biotech, DotBio, TrueBinding, Ocean Biomedical, Xencor, Molecular Templates, Akeso, Inc., TRACON Pharmaceuticals, Inc., Biocytogen Pharmaceuticals, and others are evaluating new CTLA-4 inhibitors drugs to improve the treatment landscape.
• Promising CTLA-4 inhibitors pipeline drugs such as KN046, IBI-310, Botensilimab, Porustobart, Tremelimumab, Davoceticept, HLX-13, DB-002, IMT-400, OCX 909, Vudalimab, MT-8421, AK104, YH001, and others are under different phases of CTLA-4 inhibitors clinical trials.
• In March 2023, Molecular Templates, Inc. received clearance from the United States Food and Drug Administration ("FDA") following a review of its Investigational New Drug Application ("IND") to proceed with clinical testing of its novel MT-8421 ETB program targeting CTLA-4 in patients with relapsed/refractory solid tumors previously exposed to checkpoint inhibitors. Preclinical data from MT-8421 showed that in a transgenic mouse model expressing human CTLA-4 and bearing syngeneic subcutaneous tumors, MT-8421 treatment depleted immune suppressive Tregs in the TME but not in the periphery.
• In October 2022, the FDA approved the CTLA-4 immune checkpoint inhibitor tremelimumab (Imjudo) as part of a first-line immunotherapy combination for unresectable hepatocellular cancer (HCC). Under the specifics of the new indication, tremelimumab is given as a single 300 mg priming dose along with the PD-L1 inhibitor durvalumab (Imfinzi) at a dose of 1,500 mg every 4 weeks -- dubbed the STRIDE regimen (single tremelimumab, regular interval durvalumab).
• In August 2022, Biocytogen Pharmaceuticals and TRACON Pharmaceuticals, Inc., jointly announced that the U.S. Food and Drug Administration (FDA) has approved the Investigational New Drug (IND) application for the initiation of Phase I/II clinical study of YH001 in combination with envafolimab and doxorubicin for the treatment of sarcoma patients, including patients who have not received prior therapy.
• In June 2022, Akeso, Inc. announced that its PD-1/CTLA-4 bi-specific antibody (Cadonilimab injection, AK104) has received marketing approval from the National Medical Products Administration (NMPA) of China, for the treatment of relapsed or metastatic cervical cancer (R/M CC) patients who progressed on or after platinum-based chemotherapy.
• In November 2022, Xencor, Inc. announced the presentation of data from the first patients in the Phase 2 combination study of vudalimab, a selective PD-1 x CTLA-4 XmAb® bispecific antibody, in patients with metastatic castration-resistant prostate cancer (mCRPC) and data from multiple preclinical-stage XmAb programs at the 37th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) in Boston. A patient in Cohort E with an 89% reduction in PSA from baseline experienced a partial response (PR) at week 18 and continued treatment at 35 weeks. Treatment continued for one additional patient in Cohort C, at 4 weeks. In addition to the patient experiencing a PR in Cohort E, six other patients were efficacy evaluable and experienced the best response of stable disease (n=5) or non-complete response/non-progressive disease (non-CR/non-PD; n=1).

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CTLA-4 Inhibitors Overview

CTLA-4 (cytotoxic T lymphocyte antigen-4) is a key negative regulator of T cell activation. The well-defined B7:CD28/CTLA-4 pathway controls the production and maintenance of immune responses through a complex integration of positive and negative co-stimulatory signals. Inhibiting negative regulation via CTLA-4 binding has been demonstrated to increase adaptive immunity stimulation and T cell activation potentiation. CTLA-4-blocking antibodies have shown efficacy as monotherapy in several murine malignancy models; additionally, they have shown synergistic anti-tumor action when combined with other treatments such as vaccinations, chemotherapy, and radiation.

T cell activation necessitates not only stimulation of the T cell receptor (TCR) on antigen-presenting cells (APCs) by peptide-major histocompatibility complexes (MHCs) but also an orchestrated balance of co-stimulatory and inhibitory signals that modulate the magnitude and effectiveness of the immune response. Multiple mechanisms control the activation of effector CD4+ and CD8+ T lymphocytes (Teffs), including cell surface proteins that augment or suppress T cell responses. Negative regulatory proteins on T cells, including CTLA-4, PD-1, B7 family member B7-H4, T cell immunoglobulin and mucin domain-containing protein 3 (Tim-3), and lymphocyte activation gene-3 (LAG-3), interact with their cognate ligands on a variety of cell types, including APCs, regulatory T cells (Tregs), and nonhematopoietic cells, resulting in decreased T cell proliferation and functional activity.

Find out more about CTLA-4 inhibitors drugs @ CTLA-4 Inhibitors Analysis

CTLA-4 Inhibitors Pipeline Analysis: Drug Profile

KN046: Alphamab Oncology

Jiangsu Alphamab developed KN046 as an independent PD-L1/CTLA-4 bispecific antibody. Its new designs include: a CTLA-4 domain combined with a PD-L1 single-domain antibody; tailored to target the tumor microenvironment with high PD-L1 expression; and Treg inhibits tumor immunity-clearing activity. In Australia and China, there are over 20 clinical trials using KN046 in various phases covering more than ten types of tumors including NSCLC, thymic cancer, pancreatic cancer, HCC, ESCC, and TNBC. The outcomes of these clinical trials have revealed good data in terms of patient survival. Based on the clinical outcomes in China and Australia, Alphamab Oncology has acquired FDA approval to begin later-stage trials of KN046. Furthermore, KN046 has been granted orphan drug status by the US Food and medication administration for thymic epithelial tumor in September 2020. Four key clinical trials are presently underway. The drug is currently in Phase III development for the treatment of Squamous Non-small-cell Lung Cancer.

IBI-310: Innovent Biologics

IBI-310 is under development for the treatment of advanced, recurrent, or metastatic non-small-cell lung cancer(NSCLC), unresectable or relapsed or metastatic advanced Biliary tract cancer, metastatic solid tumors including advanced hepatocellular carcinoma, recurrent and metastatic nasopharyngeal carcinoma, acral melanoma, liver cancer, cervical cancer, renal cell carcinoma, EBV-positive advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma. The medication candidate is delivered intravenously. It works by interacting with the cytotoxic T-lymphocyte protein 4 receptor (CTLA4). It was also being studied as a therapy for metastatic melanoma and metastatic colorectal adenocarcinoma. The medication is currently under Phase III clinical trial evaluation for the treatment of Hepatocellular Carcinoma.

A snapshot of the CTLA-4 Inhibitors Pipeline Drugs mentioned in the report:

Learn more about the emerging CTLA-4 inhibitors pipeline drugs @ CTLA-4 Inhibitors Clinical Trials

Scope of the CTLA-4 Inhibitors Competitive Landscape Report 

• Coverage: Global 
• Key CTLA-4 Inhibitors Companies: Innovent Biologics, Alphamab Oncology, Agenus, Harbour BioMed, AstraZeneca, Alpine Immune Sciences, Henlix Biotech, DotBio, TrueBinding, Ocean Biomedical, Xencor, Molecular Templates, Akeso, Inc., TRACON Pharmaceuticals, Inc., Biocytogen Pharmaceuticals, and others
• Key CTLA-4 Inhibitors Pipeline Drugs: KN046, IBI-310, Botensilimab, Porustobart, Tremelimumab, Davoceticept, HLX-13, DB-002, IMT-400, OCX 909, Vudalimab, MT-8421, AK104, YH001, and others
• Company Analysis, Therapeutic Assessment, Pipeline Assessment, Inactive drugs assessment, Unmet Needs

Dive deep into rich insights for new CTLA-4 inhibitors drugs, visit @ CTLA-4 Inhibitors Drugs

Table of Contents

For further information on the CTLA-4 inhibitors pipeline therapeutics, reach out @ CTLA-4 Inhibitors Therapeutic Assessment

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SOURCE DelveInsight Business Research, LLP