Company: LNAI
Filing Date: 2025-02-19
Form Type: 10-Q/A
Source: 0001731122-25-000250
Chunk: 70

Company: Lunai Bioworks Inc.
Filing Date: 2025-02-19
Form: 10-Q/A
Chunk 70
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 specific antigens that could be applicable to a wide range of solid tumors. We initially
plan to target pancreatic cancer. Other potential targets for later development could include triple-negative breast cancer, liver or
mesothelioma amongst many. Similar to our approach with HIV, RENB-DC11 would potentially allow for outpatient therapy without wiping out
or significantly impairing the patient’s immune system often associated with standard of care chemotherapies.

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Renovaro Biosciences has initiated
a collaboration with Dr. Anahid Jewett from UCLA to study further the in vitro and in vivo effectiveness of the approach
in pancreatic cancer. Dr. Jewett created an innovative pancreatic cancer mouse model that comprises the human immune system repertoire
in combination with human cancer cells implanted in the corresponding anatomical location found in human cancer. Multiple experiments
in different humanized mouse models are consistently showing with only one regimen cycle of therapy (2 injections in mice, likely 5-6
in human) - what Dr. Jewett calls “the Holy Grail of cancer research” with now seven independent animal studies:

| 1. | Consistent superior therapeutic effect compared to mainstream cancer vaccine approach and other control dendritic cell therapies |

| 2. | Significant infiltration of effector immune cells into the tumor |

| 3. | Significant peripheral T and NK cell immune activation |

| 4. | Primary tumor reduction and no metastases |

| 5. | Effective in early stage and late-stage cancer |

The confirming reproducibility
and robustness of the therapeutic response in an aggressive form of human pancreatic cancer in several models is promising. We received
FDA input from pre-IND interactions which helped solidify our IND-enabling plan as well as our investigational plan. We are now fully
committed to process development/improvements and IND-enabling activities. We believe that we can complete IND-enabling activities in
the second half of 2024 which if successful, would enable the start of clinical trials in humans during the first half of 2025. The investigational
plan discussed with the FDA includes phase 1 safety testing broadly in all solid tumor types, followed by a phase 2a focusing on a few
solid tumor types that are difficult to treat and have poor life expectancy, for example triple negative breast, second-line liver, and
head and neck cancers. Phase 2b would expand cohorts in cancers with the strongest response in phase 2a.

RENB