BARCELONA, Spain I August 08, 2023 I La Merie Publishing announced the release of the report entitled “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.

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.

CLDN18.2 biomarker overlaps very little with HER2 and high levels of PD-L1 overexpression, which helps CLDN18.2-directed therapies to address a patient population very much in need of a targeted agent to address cancer progression.

The naked monoclonal antibody zolbetuximab has become the current gold standard and benchmark for all follow-on anti-CLDN18.2 immunotherapy candidates as zolbetuximab is the only candidate that has been evaluated in controlled pivotal clinical studies. Regulatory agencies in the US, the European Union, Japan and China have accepted license applications for zolbetuximab in June/July 2023 and potential approvals and market launches are expected during the course of 2024.

The clinical profile of the naked monoclonal antibody zolbetuximab showed statistically significant and clinically relevant improvements in progression free survival by 1.94 or 1.41 months and in overall survival of 2.69 or 2.23 in the SPOTLIGHT or GLOW phase III trials, respectively. Major adverse events were gastrointestinal symptoms nausea, vomiting and decreased appetite. Furthermore, only 39.1% of gastric cancer patients were eligible to treatment with zolbetuximab. One of the inclusion criteria was expression of CLDN18.2 in tumor tissue defined by moderate to strong staining in ≥75% of cancer cells.

This product profile leaves sufficient space for improvements in efficacy, safety and patient eligibility by next generation anti-CLDN18.2 immunotherapy candidates. To generate more effective and safe CLDN18.2-targeted antibody and cell therapy candidates, several drug modalities with potential for enhanced effector function, increased safety and broader patient population have applied:

  • Naked monoclonal antibodies (mAbs) with enhanced target affinity and increased ADCC, CDC & ADCP;
  • Antibody-drug conjugates (ADCs) with improved linker & conjugation technology and payloads;
  • Chimeric antigen receptor (CAR) T-Cells (CAR-T) with improved constructs (signalling domains, armored, modular design);
  • Anti-CLDN18.2 Bispecific T-Cell Engaging (BiTE or TCE) Antibodies for recruitment of cytotoxic T-cells;
  • 2-Targeted Bispecific Immuno-Oncology (I-O) Antibodies for checkpoint blockade or immune stimulation.

The report evaluates the industry landscape of claudin18.2-targeted novel antibody and cell therapy candidates. The report is based on the identification and description of 48 companies with research and development activities in the field and 68 distinct product candidates.

For each company, a profile has been elaborated providing information about the company background/history, the financial situation, relevant technology, partnering deals and CLDN18.2-specific pipeline overview.

Specific profiles of 56 anti-CLDN18.2 immunotherapy candidates have been prepared to describe design and construct of the candidate, applied technologies, the preclinical in vitro and in vivo profile and clinical experience, if available. All information is fully referenced, either with 107 scientific references (conference abstracts, Posters, presentations, full paper) or hyperlinks leading to the source of corporate information, such as press releases, corporate presentations, annual reports, SEC disclosures and homepage content.

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

The report Claudin 18.2-Targeted Immunotherapy: a landscape analysis of stakeholders, drug modalities, pipeline and business opportunities from an industry perspective can be acquired at La Merie Publishing’s online store:

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SOURCE: La Merie Publishing