Company: LNAI
Filing Date: 2025-02-19
Form Type: 10-Q/A
Source: 0001731122-25-000250
Chunk: 71

Company: Lunai Bioworks Inc.
Filing Date: 2025-02-19
Form: 10-Q/A
Chunk 71
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-DC-12--XX: Genetically modified Allogeneic Dendritic Cell Therapeutic Vaccine as Potential Product for Long-term Remission of Additional Indications

The technology is a platform that
could potentially be adapted to other solid tumors first line and/or salvage therapy, by itself or, potentially, in combination with other
cancer treatments. Additional cancer vaccine designs are being evaluated strategically to balance risk and opportunity to advance therapeutic
development quickly in cancer indications with few treatment options.

Infectious Diseases:

HIV:

RENB-HV12: HIV Therapeutic Vaccines for Potential Long-term Remission/Cure

Allogeneic Cell Therapy Platform - Advanced Pre-Clinical Stage; Non-Human Primate Studies Ongoing.

In persons living with HIV who
are controlling the spread of virus with anti-retroviral (ARV) treatment, boosting the immune system in a different way than the virus
already has through infection, could allow for control of HIV after stopping ARVs.

Renovaro
Biosciences is developing RENB-HV12 that utilizes a novel cellular and immunotherapy approach that could potentially provide therapeutic
vaccines for HIV. A non-human study of the therapeutic vaccine in primates at the Fred Hutchinson Cancer Research Center is ongoing. Animals
began receiving the first injections of the potential therapeutic vaccine in August, 2023. Preliminary results assessment may potentially
be available in the second half of 2024. A Pre-IND request could be submitted in the first half of 2025, with IND submission and the beginning
of Phase I clinical trials by mid- to end-2025.

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RENB-HV21: Immunotherapy with Allogeneic NK/GDT Cells

Allogeneic Cell Therapy Platform - Pre-IND conducted - Advanced Pre-Clinical with Human Data through a Collaboration

We are also exploring RENB-HV21,
an innovative treatment for HIV with allogeneic Natural Killer (NK) and Gamma Delta T-Cells (GDT). It is believed that the GDT cells,
a small subset of immune cells that can be infected with HIV, could both be infected by, and be a key factor in controlling the virus.
The initial scientific findings were presented during the American Society of Gene & Cell Therapy (ASCGT) Annual Meeting in 2021.
We have an exclusive license to use the underlying patent to develop RENB-HV21 for potential treatment or