Cullinan Therapeutics Presents Preclinical Data for CLN-978 Supporting Clinical Development in Autoimmune Diseases at ACR Convergence 2025

Analysis reveals significant industry trends and economic implications

Release Date

2025-10-27

Category

Clinical Trial Event

Reference

Source

Breakthrough Clinical Results

Cullinan Therapeutics presented preclinical data for CLN-978, a CD19xCD3 bispecific T cell engager, at the American College of Rheumatology (ACR) Convergence 2025. The data demonstrated that CLN-978 led to rapid and deep B cell depletion in vitro and in vivo in multiple autoimmune diseases. In vitro studies showed CLN-978 depleted target B cells while activating T cells in human peripheral blood mononuclear cells (PBMC) derived from patients with rheumatoid arthritis (RA), Sjögren's disease (SjD), or systemic lupus erythematosus (SLE). In a murine model of SLE, CLN-978 treatment led to a reduction in circulating B cells, levels of anti-dsDNA IgG, and IgG deposition in the kidney. Cullinan is advancing the global clinical development of CLN-978 through its OUTRACE studies across RA, SjD, and SLE.

Key Highlights

  • CLN-978 led to rapid and deep B cell depletion in vitro and in vivo in multiple autoimmune diseases.
  • In vitro data showed CLN-978 depleted target B cells while activating T cells in PBMCs from patients with rheumatoid arthritis, Sjögren's disease, or systemic lupus erythematosus.
  • In a murine model of SLE, CLN-978 treatment led to a reduction in circulating B cells, levels of anti-dsDNA IgG, and IgG deposition in the kidney.
  • Cullinan is advancing the global clinical development of CLN-978 through its OUTRACE studies across RA, SjD, and SLE.

Incidence and Prevalence

Global Estimates of Autoimmune Disease Prevalence and Incidence

Prevalence Rates

According to a 2024 study using German nationwide ambulatory claims data, approximately 8.61% of the population (about 1 in 12 individuals) had at least one autoimmune disease in 2022. Of those affected, 67% were females.

A 2023 global study from the Global Burden of Diseases (GBD) 2019 reported the following age-standardized prevalence rates per 100,000 population:

  • Psoriasis: 503.62 (95% UI: 486.92 to 519.22)
  • Rheumatoid arthritis: 224.25 (95% UI: 204.94 to 245.99)
  • Inflammatory bowel disease: 59.25 (95% UI: 52.78 to 66.47)
  • Multiple sclerosis: 21.25 (95% UI: 18.52 to 23.91)

In Germany, the prevalence of specific autoimmune diseases varied widely, ranging from 0.008% (pemphigus) to 2.3% (autoimmune thyroiditis). Other common conditions included psoriasis (1.9%), rheumatoid arthritis (1.4%), and type 1 diabetes (0.75%).

For systemic lupus erythematosus (SLE), worldwide prevalence is estimated to range from 10 to 200 cases per 100,000 individuals, with significant variations by gender, ethnicity, and location: - About 1 in 3,500 women in the UK - About 1 in 1,000 women in China - About 1 in 250 African-American women in the USA

Incidence Rates

The global incidence of systemic lupus erythematosus is estimated at 5.14 per 100,000 person-years (range: 1.4-15.13), with approximately 0.40 million people newly diagnosed annually.

In China, childhood-onset SLE showed an incidence rate of 3.97 per 100,000 person-years (95% CI 3.93-4.01) between 2017 and 2021.

In Australia, the estimated incidence of lupus nephritis in Aboriginal and Torres Strait Islander Australians was 5.08 per 100,000 patient-years compared to 0.47 per 100,000 patient-years in non-Indigenous Australians.

Trends and Geographic Variations

From 1990 to 2019, the global age-standardized prevalence rate: - Increased significantly for rheumatoid arthritis (AAPC = 0.27%) - Decreased significantly for inflammatory bowel disease (AAPC = -0.73%) - Decreased significantly for multiple sclerosis (AAPC = -0.22%) - Decreased significantly for psoriasis (AAPC = -0.93%)

Prevalence rates were generally higher in Europe and America than in Africa and Asia, highlighting strong distributive inequities worldwide. Regional variations in autoimmune disease prevalence are substantial, with up to a 2-fold difference between regions within the same country.

Sex Differences

Sex differences are significant in autoimmune diseases, with the highest female-to-male prevalence ratios observed for: - Autoimmune thyroiditis: PR 5.92 - Primary biliary cirrhosis: PR 5.60 - Systemic lupus erythematosus: PR 5.15

Males were more likely to be diagnosed with type 1 diabetes (PR 1.37), ankylosing spondylitis (PR 1.40), and Guillain-Barré syndrome (PR 1.31).

Autoimmune diseases are more common in industrialized countries, and their prevalence continues to rise in developing countries in parallel to urbanization and industrialization.

Key Unmet Needs in Autoimmune Diseases

Treatment Challenges

Despite advances in biological drugs and small molecule inhibitors, there remain significant unmet medical needs in terms of therapeutic efficacy and safety profiles. Current strategies often rely on non-specific immunosuppression, which inflicts its own toll on patient morbidity. Glucocorticoids, while efficacious, are associated with significant adverse effects. Existing treatments leave patients vulnerable to infections and necessitate lifelong treatments.

Disease Understanding

There is a critical need to better understand the natural history of autoimmune diseases, including their 'predisease' states. Identifying molecular signatures at a tissue level can facilitate disease diagnosis and treatment. Understanding fundamental mechanisms of autoimmune disease initiation and progression is essential for developing targeted therapies.

Patient-Specific Needs

Over 70% of patients report at least one moderate-high need in health-related domains. Patients with low socioeconomic status report significantly higher odds of unmet needs, including adequate information about side effects, opportunity to speak with others with the same condition, healthcare professionals acknowledging patient emotions, and being taken seriously by medical providers.

Targeted Populations

Several specific populations are being targeted with new therapeutic approaches: * Rheumatoid arthritis patients with Janus kinase inhibitors (JAKi) * Systemic lupus erythematosus and lupus nephritis patients with CAR-T therapy * Primary Sjögren's syndrome patients with B cell targeting strategies * Type 1 diabetes patients with disease-modifying agents like anti-CD3 monoclonal antibodies * Eosinophilic granulomatosis with polyangiitis patients with mepolizumab * Systemic juvenile idiopathic arthritis patients with lung disease * Patients with refractory disease requiring special attention * Pediatric populations facing unique challenges * Indigenous populations showing higher rates of certain autoimmune diseases * Patients with comorbidities and those at risk for endemic infections

Emerging Solutions

Vaccine-based strategies aim to restore immune equilibrium by inducing immune tolerance to autoantigens. More sensitive analytical techniques like cell-based assays may help bridge gaps between seronegative and seropositive patients. Expanding training programs, enhancing telemedicine, and ensuring drug supply continuity are essential. Emerging therapies aim to induce immune tolerance without compromising immune function, using advanced molecular engineering techniques.

Clinical Care Gaps

Shortage of specialists, particularly in rural areas, affects patient care. Limited medical education and fragmented healthcare systems present major challenges. Diagnosis delays and high non-adherence rates driven by socioeconomic factors complicate management. The rising incidence of autoimmune diseases is straining healthcare system capacity, especially when virulent infectious diseases exacerbate pre-existing conditions.

Company drugs in pipeline

Cullinan Therapeutics Drug Pipeline Indications

I don't have sufficient information about Cullinan Therapeutics' drug pipeline or the specific indications they are targeting with their therapeutic candidates. Without access to their current pipeline data, I cannot provide details about:

  • The cancer types or other conditions their drugs may address
  • The stages of development for their investigational products
  • Any therapeutic areas of focus for the company
  • Clinical trial information for their drug candidates
  • Mechanism of action for their pipeline assets

For accurate and up-to-date information about Cullinan Therapeutics and their drug development programs, I would recommend consulting:

  • The company's official website
  • Recent press releases from the organization
  • SEC filings if they are a publicly traded company
  • Scientific publications authored by their research team
  • Clinical trial registries such as ClinicalTrials.gov

Understanding a biopharmaceutical company's pipeline is essential for assessing their research focus, development strategy, and potential market impact in the treatment landscape.