Breakthrough Clinical Results
Chugai Pharmaceutical and Gero PTE. LTD. have entered a joint research and license agreement to develop novel antibody therapies for age-related diseases. Chugai will leverage its antibody engineering technologies to create drug candidates targeting diseases identified by Gero's AI-driven platform analyzing human datasets. Gero grants Chugai exclusive worldwide rights for development and commercialization. The agreement includes an upfront payment and potential milestone payments totaling up to $250 million USD, plus royalties on sales.
Key Highlights
- Joint research and license agreement between Chugai and Gero to develop therapies for age-related diseases.
- Chugai will utilize its antibody engineering technologies to develop novel antibody drug candidates.
- Gero's AI-driven platform identifies drug targets through analysis of human datasets.
- Potential milestone payments up to $250 million USD plus royalties on sales for Chugai.
Incidence and Prevalence
Global Estimates of Age-Related Diseases
The population is aging much faster in China than other low- and middle-income countries, which has led to an increased incidence and disease burden of age-related diseases. According to the Global Burden of Diseases, Injuries, and Risk Factors Study (GBD), 69 diseases in 2017, 78 in 1997, and 72 in 2007 were identified as age-related diseases out of the 293 diseases listed in the study.
More than half of these age-related diseases were categorized as non-communicable diseases (NCDs) throughout the study period. Encouragingly, the rate of age-standardized age-related disease burden decreased between 1997 and 2017. The DALYs (disability-adjusted life years) showed a significant reduction, decreasing by 50.15% for age-related diseases compared to a 24.89% decrease for non-age-related diseases during this 20-year period.
Gender differences are notable in the burden of age-related diseases. The age-related disease burden of men was consistently higher than that of women, though both genders showed substantial improvement with decreasing trends of -46.23% in men and -54.90% in women.
China specifically faces a dual threat from both NCDs and communicable diseases, with NCDs accounting for the vast majority of the age-related disease burden in the country.
For specific age-related conditions, in 2000, the prevalence of Alzheimer's disease in the United States was estimated to be 4.5 million individuals, with projections indicating an increase to 14 million by 2050.
Aging itself is recognized as one of the most important risk factors for a wide range of health conditions, including infections, cancer, cardiovascular and neurodegenerative diseases.
Among the oldest old, particularly centenarians, the prevalence of ADL loss (Activities of Daily Living) is relatively high at 72.5%. The most common functional limitations in this population include stair-climbing (79.0%), moving (59.1%), walking (44.3%), and using the toilet (41.3%).
Stroke represents the largest cause of disability and the third largest cause of mortality in the United States, with age and metabolic syndrome being the most significant risk factors.
Type 2 diabetes mellitus (T2DM) is another significant age-related disease associated with metabolic syndrome, obesity, insulin resistance, hyperlipidemia, hypertension, hyperglycemia, and endothelial activation and dysfunction.
More recently, COVID-19 morbidity and mortality has been strongly associated with older age, male gender, cardiovascular disease, diabetes, and smoking.
Research has identified a periodic pattern among the relative number of deaths per year for major age-related diseases in humans, observed across 178 causes-of-death in different populations.
It's worth noting that Asian populations have traditionally been underrepresented in studies focused on understanding age-related diseases, despite the rapid aging occurring in many Asian countries.
Economic Burden
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Economic Burden of Age-Related Diseases in the USA and Europe
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Drug used in other indications
Novel Antibody Drug Candidates and Clinical Trial Approaches
Therapeutic Indications
Monoclonal antibodies and immunotherapies are currently being clinically tested for various indications beyond age-related diseases, including:
Cancer Indications
- Non-small cell lung cancer (NSCLC) with approved agents like nivolumab, pembrolizumab, atezolizumab, and durvalumab
- Chronic lymphocytic leukemia (CLL) with agents like alemtuzumab and rituximab
- Clear cell renal cell carcinoma (ccRCC), particularly metastatic disease
- Melanoma, especially unresectable or metastatic forms using anti-PD-1 antibodies
- Multiple myeloma, including relapsed/refractory multiple myeloma (RRMM)
- Metastatic colorectal cancer using cetuximab
Autoimmune Conditions
- Rheumatoid arthritis (RA) using TNF inhibitors, tocilizumab, rituximab, and abatacept
- Polyneuropathy with immunoglobulin M (IgM) monoclonal gammopathy using rituximab
- Latent autoimmune diabetes of adult (LADA) - studies examining effects of treatment choices
Infectious Diseases
- COVID-19 treatment with monoclonal antibodies (Bamlanivimab, Casirivimab/Imdevimab, Etesevimab/Bamlanivimab)
Intervention Models and Clinical Trial Designs
Dosing Regimens
- Subcutaneous administration every 2 weeks (q2w) as seen with sarilumab at doses of 150 mg or 200 mg
- In a rheumatoid arthritis study, 132 adults were randomized to receive either 150 mg (n=65) or 200 mg (n=67) of sarilumab subcutaneously every 2 weeks for 24 weeks
- For metastatic colorectal cancer, cetuximab was administered intravenously weekly for four weeks
- Some patients also received oral sorafenib twice daily on days 1-28, with recycling every four weeks
Combination Approaches
- Combination therapies are common, such as cetuximab with sorafenib for metastatic colorectal cancer
- Immune checkpoint inhibitors (ICIs) are often paired with antiangiogenic agents or other immunomodulators
Novel Therapeutic Platforms
- Bispecific antibodies
- Chimeric antigen receptor (CAR) T-cell therapy
- Therapeutic vaccines, cytokines, and oncolytic viruses
- Immune checkpoint inhibitors (ICIs) targeting PD-1/PD-L1 and CTLA-4
Trial Settings and Endpoints
- COVID-19 monoclonal antibody treatments studied in both outpatient (402) and hospitalized (350) settings in a retrospective observational study
- Immune checkpoint inhibitors (ICIs) being investigated as maintenance therapy for advanced or metastatic cancers
- Five randomized controlled trials (n=2828) identified in one meta-analysis
- Common endpoints include progression-free survival (PFS), overall survival (OS), objective response rate (ORR), and incidence of antidrug antibodies (ADAs)
- For metastatic colorectal cancer trials, primary endpoint was response rate and secondary endpoints included adverse effects, time to progression, and overall survival
Safety Monitoring
- Tracking of adverse events, with infections and neutropenia being common in some studies
- Monitoring of laboratory parameters like absolute neutrophil count, alanine aminotransferase level, and platelet count
- Development of predictive biomarkers for immunotherapy response
- Understanding mechanisms of response and resistance