Company: HCWB
Filing Date: 2025-03-28
Form Type: 10-K
Source: 0000950170-25-046724
Chunk: 7

Company: HCW Biologics Inc.
Filing Date: 2025-03-28
Form: 10-K
Item: Item 1
Chunk 7
---
 first compound in this class is HCW11-018, and we are collaborating with others to develop versions with different targeting capabilities.  •The size and scale of the GLP preclinical and clinical studies required for the development of Class III Molecules is more appropriate for well-capitalized Big Pharma.   •Prioritized for development through licensing with Big Pharma.   

Clinical Development Strategy

Our goal is to develop transformative immunotherapies to lengthen health span by disrupting the link between cellular senescence, chronic inflammation, and age-related diseases and conditions.  Based on human-data read-out from clinical studies and extensive preclinical research, we believe that our data point toward the possibility we have created a new class of immunotherapeutics for cancer and other age-related diseases, and beyond therapies that to slow down or reverse the effects of aging itself.  

6 

We have constructed second-generation immunotherapeutics that we believe could represent a new class of drugs with the potential to fundamentally transform the treatment of diseases and conditions promoted by chronic inflammation, especially those related to aging – enhancing health span through the treatment for indications that enhance quality-of-life and extending longevity by developing treatments for indications for which there are no known cures.  

The future of the Company’s clinical development will be primarily based on the molecules we have constructed with the TRBC drug development platform.  These compounds offer the potential to treat oncology, autoimmune diseases, infectious diseases, and chronic inflammatory conditions, offering broader therapeutic targets and more adaptable solutions compared to the Company’s TOBI platform.  The TRBC platform’s flexibility and capacity to bind multiple targets allow for more precise and potentially more effective treatments. By targeting specific cell-surface antigens, these novel therapeutics can improve patient clinical outcomes, offering potential benefits across a wider range of indications.  The Company will select molecules for in-house development and those which are strong candidates to be developed with a partner through a licensing agreement.  

In settling the Arbitration with ImmunityBio, the Company removed uncertainty regarding our rights to TOBI-based molecules.  With this clarity, we forged a new path for our clinical development for molecules created with the TOBI platform.  We will continue to develop HCW9302, our lead product candidate, for which the FDA recently cleared us to initiate a Phase 1 clinical study in alopecia areata.  Our strategy is to expand to other indications upon successful completion of the Phase 1 study.  We are less certain about the path forward for HCW9218, now a