Company: HCWB
Filing Date: 2025-03-28
Form Type: 10-K
Source: 0000950170-25-046724
Chunk: 20

Company: HCW Biologics Inc.
Filing Date: 2025-03-28
Form: 10-K
Item: Item 1
Chunk 20
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 among women and the deadliest of gynecologic cancers. Although risk of developing and dying from ovarian cancer is almost twice as high in developed countries, the actual burden (number of cases) is much higher in less developed countries due to population sizes. For example, China has the largest number of diagnoses per year (34,575), followed by India (26,934), then the United States. In the United States, ovarian cancer accounts for 2.5% of cancers in women. In the United States, while ovarian cancer is the 11th most common cancer among women, it is the fifth leading cause of cancer-related death among women. Worldwide, ovarian cancer is the seventh most common cancer in women. It is estimated that by 2035, the incidence of ovarian cancer will increase by 55% to 371,000 worldwide, and deaths will increase by 67% to 254,000 worldwide. 

Treatment for ovarian cancer usually involves a combination of surgery and chemotherapy. This cancer mainly develops in older women. About half of the women who are diagnosed with ovarian cancer are aged 63 years or older.  The most important risk factor for ovarian cancer other than age is a family history of breast or ovarian cancer. This includes those with inherited gene changes like BRCA1, BRCA2, and Lynch syndrome. 

Ovarian cancer survival rates vary widely. The latest five-year survival rates largely fall between 30% and 50% and in general have begun to improve over the last 20 years. In the United States, the relative five-year survival rate for ovarian cancer is 50.8%. Overall, survival rates fall well below that of other cancers.  

(See: World Ovarian Cancer Coalition, American Cancer Society and Center for Disease Control and Prevention.)

Class I TRBC Molecules:  Multi-Functional Immune Cell Stimulators

Class I TRBC Molecules combine several different immune functional domains on the TRBC scaffold. The Company has conducted preclinical studies that demonstrate that this multi-functional group of molecules is highly effective at inducing CD8+ T cell and NK cell responses without triggering unwanted side effects in human immune cells animal models. HCW11-006 also exhibits anti-tumor efficacy in relevant solid tumor animal models.

In addition to HCW11-006, the Company is investigating various structures with different combinations of cytokines in our quest to identify lead product candidate(s) in this group of molecules.  We anticipate the completion of our efficacy assessment in mice and safety profiling in a small study