Company: HURA
Filing Date: 2025-05-23
Form Type: 424B3
Source: 0001193125-25-125499
Chunk: 545

Company: TuHURA Biosciences, Inc./NV
Filing Date: 2025-05-23
Form: 424B3
Chunk 545
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 immune cell populations in NSCLC and found high levels in several NSCLC
histologies (Figure 10).

354

Figure 10.VISTA expression in NSCLC. (A) Normal lung tissue and (B) NSCLC
lung cancer tissue stained for VISTA expression (brown)

Source: Kineta data

More than
150,000 patients in the U.S. each year are diagnosed with CRC, and more than 50,000 deaths are attributed to the disease. In advanced and metastatic CRC, five-year survival rates are only 14%. The mainstay of treatment for CRC that is detected early
is surgical resection. However, patients diagnosed with locally or regionally advanced disease can benefit from adjuvant chemotherapy, in addition to surgical resection. About 22% of patients are initially diagnosed with advanced or metastatic
disease. For these patients, and for patients with recurrent disease, chemotherapy and targeted therapy result in only very slight increases in PFS and OS. Radiation therapy has no proven benefit in CRC. Keytruda, Yervoy and Opdivo are approved for the treatment of mismatch repair deficient
or microsatellite unstable/microsatellite instability-high tumors, but this accounts for only 4% of CRC patients.

Like NSCLC, CRC is
characterized by many VISTA positive innate immune cells and presents an excellent clinical indication for KVA12123 (Figure 11).

355

Figure 11.VISTA expression in CRC. (A) Normal colon tissue and
(B) colorectal cancer tissue stained for

VISTA expression (brown)

Source: Kineta data

A small number of
mostly gynecological cancers express VISTA on tumor cells and on infiltrating immune cells. One example is OC, where tumor cells express high levels of VISTA (Figure 12). More than 60% of OC cases are diagnosed at an advanced stage of disease, and
five-year survival rates for these patients are less than 50%. Platinum/taxane combination chemotherapy is widely used in this indication, with modest improvements in PFS and OS. OC represents a third potential clinical indication for KVA12123.

356

Figure 12.VISTA expression in ovarian cancer. (A) Normal ovarian tissue and
(B) ovarian cancer tissue

stained for VISTA expression (brown)

Source: Kineta data

VISTA-101Clinical Trial (VISTA-101)

Kineta announced dosing of the first patient with KVA12123 as a