STUTTGART, Germany I April 01, 2024 I Astellas Pharma recently announced (source) that on March 26, 2024, Japan’s Ministry of Health, Labour and Welfare (MHLW) approved VYLOY (zolbetuximab), an anti-claudin 18.2 (CLDN18.2) monoclonal antibody for patients with CLDN18.2 positive, unresectable, advanced or recurrent gastric cancer. VYLOY is the first and only CLDN18.2-targeted therapy approved by any regulatory agency in the world. VYLOY is the first and only CLDN18.2-targeted therapy approved by any regulatory agency in the world.

The Vyloy (zolbetuximab) approval is setting the stage for a benchmark analysis of competitor compounds in the pipeline. More than 44 CLDN18.2-targeted immunotherapy candidates are being evaluated in clinical studies around the globe. And further ten candidates are awaiting clinical assessment. Among the drug modalities applied to create CLDN18.2-targeted development candidates are naked monoclonal antibodies, antibody-drug conjgates (ADC), chimeric antigen receptor (CAR) T-cells and natural killer (NK) cells, bispecific T-cell engaging monoclonal antibodies and anti-CLDN18.2 bispecific antibodies directed against immune-oncology targets PD-L1, 4-1BB (CD13), CD47/SIRPα or CD8.

La Merie Publishing supports such competitor analysis by its portfolio of reports about claudin 18.2:

Claudin 18.2-Targeted Immunotherapeutics – a Competitor Analysis

This Competitive Intelligence report about Claudin 18.2 (CLDN18.2) Targeted Immunotherapeutics provides a competitor evaluation in the field of recombinant antibodies and cellular therapeutics targeting claudin 18.2 as of April 2024.

Claudin 18.2-Targeted Immunotherapy: a landscape analysis of stakeholders, drug modalities, pipeline and business opportunities from an industry perspective.

This report provides a landscape description and analysis of discovery and development of claudin 18.2 (CLDN18.2)-targeted antibody and cell therapy candidates from an industry perspective as of August 2023.

Report Package: Claudin 18.2-Targeted Immunotherapeutics

This report package includes the full report of August 2023 analyzing in depth the landscape of  claudin 18.2-targeted immunotherapy regarding stakeholders, drug modalities, pipeline and business opportunities from an industry perspective. The competitor analysis of April 2024 updates the competitive field of CLDN18.2-targeted immunotherapy candidates.

CLDN18.2 is transmembrane protein selectively expressed on the cancer cell surface of gastric epithelial cells. Its expression in normal tissues is strictly confined to differentiated epithelial cells of the gastric mucosa, but it is absent from the gastric stem cell zone. CLDN18.2 is retained on malignant transformation and is expressed in a significant proportion of primary gastric cancers and the metastases thereof. Gastric cancer is the fifth most commonly diagnosed cancer worldwide. It is responsible for over one million (1,089,103) new cases in 2020 and an estimated 769,000 deaths.

The reportClaudin 18.2-Targeted Immunotherapeutics – a Competitor Analysisconsists of a competitor description in a tabular format provided as a pdf document and an one-month online access to La Merie Publishing’s database for this product (report code: LMTP0147) (prerequisite: access to internet). The pdf report includes a compilation of currently active and discontinued projects in research and development of immunotherapy candidates targeting claudin 18.2:

  • Claudin 18.2 (CLDN18.2) Targeted Naked Monoclonal Antibodies
  • CLDN18.2 Targeted Antibody-Drug Conjugates
  • CLDN18.2 Targeted CAR T Cells & NK Cells
  • CLDN18.2 Targeted T-Cell Recruiting Bispecific Antibodies
  • CLDN18.2 & PD-L1 Targeted Bispecific Antibodies
  • CLDN18.2 & 4-1BB (CD137) Targeted Bispecific Antibodies
  • CLDN18.2 & CD47/SIRPα or CD8 Targeted Bispecific Antibodies

The report “Claudin 18.2-Targeted Immunotherapy: a landscape analysis of stakeholders, drug modalities, pipeline and business opportunities from an industry perspectivebrings you up-to-date with information about and analysis of

  • Claudin 18.2 target identification and validation;
  • Differential expression profile of claudin 18.2 in health and tumor tissues;
  • Incidence of cancers with significant expression of claudin 18.2 in major countries;
  • Scope and economic terms of licensing agreements for anti-CLDN18.2 immunotherapy candidates and discovery technologies;
  • Stakeholders in the field: major pharma and biotech, ex-China biotech companies; Chinese major pharma and Chinese emerging biopharma companies;
  • Specific company profiles, especially of Chinese, including financial situation;
  • Pipeline description and analysis regarding drug modalities, indications, territories (global vs regional), R&D stage;
  • Preclinical and clinical experience with CLDN18.2 immunotherapy candidates;
  • Specific profiles of anti-CLDN18.2 immunotherapy candidates.

Both reportscan be acquired at La Merie Publishing’s online store as a discounted package: https://lamerie.com/report/report-package-claudin-18-2-targeted-immunotherapeutics/ or purchased individually.

About La Merie Publishing

La Merie Publishing is an independent business information provider for the biotechnology and pharmaceutical industry. La Merie Publishing prepares brief and full reports. La Merie Publishing products can be purchased in the online store www.lamerie.com and from selected Resellers.

La Merie Publishing offers the service of custom report preparation for corporate clients, including, but not limited to, pipeline analysis reports, drug profiles and any other competitive intelligence elaboration of interest.

SOURCE: La Merie Publishing