Shaperon | Inflammasome inhibitors, NanoMab antibodies and AI-driven immunotherapy

Competitiveness

• First-in-class GPCR19-targeting anti-inflammatory therapy, offering a novel mechanism of action beyond existing PDE4 inhibitors, JAK inhibitors, and steroid-based treatments
• Simultaneous inhibition of sensitization (Priming) and activation, demonstrating differentiated anti-inflammatory efficacy compared to existing therapies
• Improvement in key atopic dermatitis clinical endpoints, including EASI and vIGA, with no rebound observed after treatment discontinuation
• GPCR19-mediated immune modulation minimizes systemic toxicity and adverse effects, supporting long-term use
• Biomarker-based approach toward personalized treatment tailored to individual patient characteristics

Market Outlook

• Approximately 170 million patients worldwide with atopic dermatitis (Prevalence: ~10% in children, ~3% in adults)
• Global market size projected at USD 13 billion by 2025, with a CAGR of 16.4%, and expected to reach USD 33 billion by 2030
• Limitations and adverse effects of existing PDE4 and JAK inhibitors are driving demand for new therapeutic options

Unmet Need

• Lack of safe and effective long-term topical therapies for patients with mild to moderate atopic dermatitis
• NuGel is positioned as a new standard-of-care candidate addressing this unmet need

Development Status

• Phase 2a clinical trial completed in Korea, demonstrating improvement in EASI and vIGA scores as well as safety
• Phase 2b clinical trial approved by the U.S. FDA (177 patients, 12-week treatment period) - ongoing
• Global Phase 2b trial expected to conclude in 2026, with active out-licensing discussions underway
• Preparation underway for commercialization as a prescription topical therapy

Competitiveness

• First-in-class GPCR19-targeting anti-inflammatory therapy that fundamentally modulates chronic inflammation and immune imbalance in non-healing wounds
• Superior tissue penetration, safety, and cost competitiveness compared to growth factor-based therapies such as EGF and PDGF
• Promotion of wound healing in chronic inflammatory conditions through inhibition of NLRP3 inflammasome activation and NETosis
• Preclinical data demonstrating improved wound contraction and tissue regeneration compared to EGF

Market Outlook

• The global diabetic population is projected to reach 850 million by 2025 and 1.2 billion by 2050
• Approximately 19-34% of diabetic patients are expected to experience diabetic foot ulcers (DFUs) during their lifetime, with 9-26 million new cases annually
• High rates of amputation and mortality associated with treatment failure are driving demand for safe and effective next-generation therapies
• Limitations of growth factor therapies (low clinical success rates and high costs) are creating opportunities for inflammation-modulating wound therapeutics

Unmet Need

• Existing growth factor-based treatments show variable efficacy, limited tissue penetration, high costs, and potential cancer risk
• Therapeutic options remain limited for infected or recurrent DFUs
• There is a lack of treatments capable of preventing recurrence through fundamental control of chronic inflammation
• NuDifin is being developed as a first-in-class inflammation-modulating wound therapy to address these unmet needs

Development Status

• In preclinical studies, NuDifin demonstrated superior wound healing and tissue regeneration efficacy compared to EGF
• Phase 2 clinical trial entry targeted for 2026-2027
• Confirmed topical stability, supporting development as a locally applied wound therapy

Competitiveness

• First-in-class GPCR19-targeting oral therapy offering superior convenience and safety compared to antibody-based treatments
• Dual mechanism of action: Reduction of neuroinflammation + Promotion of amyloid-β (Aβ) clearance
• No observed risk of ARIA (amyloid-related imaging abnormalities), including cerebral edema, unlike anti-Aβ antibody therapies → Suitable for long-term administration due to favorable safety profile

Market Outlook

• Approximately 55 million patients worldwide with Alzheimer’s disease, projected to exceed 78 million by 2030
• Antibody-centric markets face challenges due to high costs, injection burden, and safety concerns, creating unmet demand for alternative therapies
• Rapid growth of next-generation oral and disease-modifying therapies focused on safety and convenience (estimated CAGR ~20%)
• Increasing demand for long-term, orally administered treatments for early-stage and prodromal patients

Unmet Need

• Existing antibody therapies suffer from high costs, safety risks, and administration inconvenience, limiting accessibility
• Lack of orally available therapies suitable for long-term use in early-stage and mild cognitive impairment patients
• Amyloid clearance-focused approaches alone are insufficient, highlighting the need for integrated modulation of neuroinflammation
• NuCerin is being developed as a first-in-class, neuroinflammation-modulating oral therapy to address these gaps

Development Status

• Phase 1 clinical trial ongoing in Korea (Part A completed, Part B ongoing)
• Preclinical studies demonstrated: Improved cognitive function, Neuronal regeneration, Reduction of amyloid-β levels
• Oral formulation with confirmed safety and stability, suitable for long-term administration

Competitiveness

• First-in-class GPCR19-targeting intravenous anti-inflammatory therapy designed to fundamentally suppress hyperinflammatory responses, including cytokine storm
• Simultaneous blockade of inflammatory initiation and amplification pathways, demonstrating greater efficacy than existing therapies
• Rapid clinical response confirmed in Phase 2a, with fast onset of action and no severe adverse events observed
• Broad potential for indication expansion, including: Severe viral pneumonia, Sepsis, COVID-19, CRS (Cytokine Release Syndrome) following immunotherapy

Market Outlook

• Sustained demand for high-risk, hospitalized patient anti-inflammatory therapies, even in the post-COVID-19 era
• WHO and CDC reports indicate persistently high mortality rates among critically ill patients, highlighting continued treatment gaps
• Applicability across systemic inflammatory response syndrome (SIRS), pneumonia, and virus-induced hyperinflammation, supporting a market potential exceeding USD 10 billion
• Repositioning as a rapid-response therapeutic platform for future pandemics and public health emergencies

Unmet Need

• Antiviral therapies alone show limited ability to reduce immune-mediated mortality
• Continued safety concerns with JAK/IL-6 inhibitors, including increased infection risk
• Lack of effective treatments for severe COVID-19 and other hyperinflammatory conditions
• NuSepin is being developed as a next-generation systemic anti-inflammatory therapy applicable across infectious and immune-mediated hyperinflammatory diseases

Development Status

• Selected as a Korea Drug Development Fund (KDDF)-supported project
• Global Phase 2b clinical trial completed

Competitiveness

• First-in-class GPCR19-targeting oral therapy designed to reduce adverse events and improve long-term treatment convenience compared to existing therapies
• Anti-fibrotic mechanism via inhibition of inflammasome activation, addressing not only disease progression but also promoting tissue recovery
• Demonstrated efficacy comparable to existing treatments, with improvement in Ashcroft scores and reduced expression of fibrotic marker α-SMA in preclinical models
• Selective modulation of immune cells, minimizing systemic adverse effects and supporting long-term administration

Market Outlook

• Idiopathic Pulmonary Fibrosis (IPF) shows a 5-year survival rate of approximately 20%, with a global market size estimated at USD 2.5 billion
• Among currently approved therapies, treatment discontinuation rates due to adverse events remain high (≈18%)
• Aging populations are driving increasing prevalence and demand for safe, long-term oral therapies
• Emergence of a new therapeutic market focused on inflammation–fibrosis dual-modulation mechanisms

Unmet Need

• Existing therapies are largely limited to slowing disease progression, with minimal improvement in survival outcomes
• Long-term treatment adherence is challenging due to gastrointestinal and other adverse effects
• No approved therapies capable of achieving meaningful functional recovery and quality-of-life improvement
• NuPulin is being developed as a next-generation oral therapy that simultaneously suppresses inflammation and fibrosis to address these unmet needs

Development Status

• Phase 1 clinical trial ongoing in Korea (Part A completed, Part B ongoing)
• In preclinical studies, NuPulin demonstrated suppression of pulmonary fibrosis and improvement in lung function (based on the bleomycin-induced fibrosis model)
• Confirmed oral stability; under development as a once-daily oral formulation

Competitiveness

• World’s first bispecific NanoMab simultaneously targeting PD-L1 and CD47
• Maximizes tumor cell elimination by effectively neutralizing immune evasion mechanisms in cancer cells
• Addresses anemia, the most critical adverse effect associated with conventional CD47 antibody therapies
• Demonstrated favorable safety profile in non-human primate studies and superior tumor growth inhibition in vivo compared to existing antibodies
• Small, high-stability nanobody format enables scalable manufacturing and reduced production costs

Market Outlook

• The global bispecific antibody market is projected to grow from USD 18 billion in 2025 to USD 48.5 billion by 2034
• The global acute myeloid leukemia (AML) market is expected to grow at a CAGR exceeding 10%, reaching approximately USD 10 billion by 2028
• Despite strong interest, CD47-based immunotherapies have faced commercialization delays due to hematologic toxicities
• Rapid expansion of the next-generation immuno-oncology market focused on safe immune activation

Unmet Need

• Existing anti-PD-L1 monotherapies show limited response rates and resistance issues
• Many CD47 antibodies have been discontinued due to severe anemia and hemagglutination-related toxicities
• Strong demand for safe bispecific or novel-format immunotherapies
• Papiliximab is positioned as a next-generation bispecific immuno-oncology candidate designed to overcome these limitations

Development Status

• Preclinical development completed
• In humanized mouse models of AML and lymphoma, Papiliximab demonstrated:
• Superior tumor growth inhibition compared to comparator groups
• More than five-fold improvement in overall survival
• Non-human primate studies confirmed:
• No red blood cell binding
• No hemagglutination
• Favorable pharmacokinetic (PK) stability
• Strategically positioned as the first clinical entry candidate leveraging Shaperon’s bispecific NanoMab platform