Company: LNAI
Filing Date: 2025-02-19
Form Type: 10-K/A
Source: 0001731122-25-000252
Chunk: 8

Company: Lunai Bioworks Inc.
Filing Date: 2025-02-19
Form: 10-K/A
Chunk 8
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 Allogeneic Dendritic Cell Therapeutic Vaccine as Potential Product for Long-term Remission of Solid Tumors; specifically Pancreatic tumors

Allogeneic Cell Therapy Platform – Completed pre-IND, IND-enabling phase.

Based
on learnings from our internal research, literature reviews of ongoing clinical development for solid tumors, and recent advances in immune
modulation, we have designed an innovative therapeutic vaccination platform that could potentially be used to induce life-long remission
from some of the deadliest solid tumors such as pancreatic, liver, triple negative breast and head & neck cancers.

The platform may one day enable broad immune enhancements that are combined
with cancer specific antigens that could be applicable to a wide range of solid tumors. This approach allows us to quickly adapt our approach
to any patient solid tumor using the same banked allogenic drug substance.

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RENB-DC20: Genetically modified Allogeneic Dendritic Cell Therapeutic Vaccine as Potential Treatment Product for Long-term Remission of Triple Negative Breast Cancer

Triple Negative Breast Cancer (TNBC) is a subtype of breast cancer that is negative
for estrogens receptor (ER) negative, progesterone receptor (PR) negative and human epidermal growth factor receptor 2 (HER2). TNBC is
characterized by its unique molecular profile, aggressive nature, and distinct metastatic patterns that lack targeted therapies. TNBC
is well known for its aggressive behavior and is characterized by onset at a younger age, high mean tumor size, and higher-grade tumors.

Based upon
our internal research, literature reviews of ongoing clinical development for solid tumors, and recent advances in immune modulation,
we believe we may have the ability to design an innovative therapeutic vaccination platform that could potentially be used to treat some
of the deadliest and hard-to-treat solid tumors that include triple negative breast cancer.

Infectious Diseases:

RENB-HV12: Genetically Modified Allogeneic Dendritic Cell Therapeutic Vaccine as Potential Treatment Product for Long-term Remission of HIV; A Chronic Infectious Disease

The oncology therapeutic vaccine
technology could potentially be adapted to target infectious disease antigens and be a viable therapeutic approach in difficult to treat
chronic infectious diseases. As described above, the engineered allogenic dendritic cell drug substance is thought to be able to be loaded
with various cancer antigens for specific solid tumors but could or may be loaded with infectious disease antigens to elicit a