Lunai Bioworks Inc. · NASDAQ:LNAI
Lunai Bioworks — Renovaro Biosciences — Investor Presentation (January 2024)
28 slides from Lunai Bioworks's investor presentation, Jan 16, 2024
Slide 1: Oncology Platform Overview
Renovaro Biosciences ONCOLOGY PLATFORM OVERVIEW
Slide 2: Cautionary Statement Forward-Looking Statements
Cautionary Statement Forward-Looking Statements • This communication contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. All statements, other than statements of histori
Slide 3: Vision
VISION • Freedom from toxic chemotherapy for solid tumors in our lifetime • Initial focus on tumors with poor longevity to provide hope for those without hope and to facilitate rapid progression through the regulatory process (intent to pursue accelerated approvals by end 2025/early 2026) 3
Slide 4: Solid Tumors Equivalent to 80% of Market Landscape
MARKET LANDSCAPE Solid Tumors With Poor Longevity SOLID TUMORS EQUIVALENT TO Pancreatic Liver Triple Negative 80% OF Cancer Cancer Breast CANCERS 2030 PROJECTION 2030 PROJECTION 2030 PROJECTION $7.91B $7.38B $1.46B REFERENCES CAGR CAGR CAGR 13.6% 20.2% 5.5% Pancreatic cancer Market size: US$2.22 bil
Slide 5: Cell- and Gene Immunotherapy Platforms
CELL- AND GENE IMMUNOTHERAPY PLATFORMS The basis for immune modulation at Renovaro is to retrain the immune system to better recognize and destroy diseased cells • Cancer: neo-antigens, Tumor Associated Antigens (TAA) • Infectious Disease: Pathogen-specific antigens RENB-DC11 • Engineered Dendriti
Slide 6: Leading Efficacy for Therapeutic Vaccines in Preclinical Models for Human Solid Tumors
LEADING EFFICACY FOR THERAPEUTIC VACCINES IN PRECLINICAL MODELS FOR HUMAN SOLID TUMORS RENB-DC11 treated animals compared to controls Untreated tumor Tumor treated with untransduced Dendritic Cells (mainstream cancer vaccine approach) Tumor treated with vector control transduced Dendritic Cells •
Slide 7: Expanding Preclinical Testing in Various Solid Tumors and Disease Progression Stages
EXPANDING PRECLINICAL TESTING IN VARIOUS SOLID TUMORS AND DISEASE PROGRESSION STAGES Studies conducted by UCLA and a leading independent Contract Research Organization demonstrating: • Promising preliminary data in liver cancer with apparent enhanced survival and decreased tumor progression/metastas
Slide 8: RENB-DC11 Is a True Platform for Personalized, Precision Medicine
RENB-DC11 IS A True Platform For Personalized, Precision Medicine Drug substance off-the-shelf, ready to pulse with any tumor type, infectious disease agent Multiple flexibilities in manufacturing final drug products, including future universal cancer antigens for true off-the-shelf products. Can
Slide 9: Dendritic Cells Are the Professional Antigen-Presenting Cells Key to Adaptive Immunity
DENDRITIC CELLS ARE THE PROFESSIONAL ANTIGEN- PRESENTING CELLS KEY TO ADAPTIVE IMMUNITY: AN ESSENTIAL PART OF CANCER AND INFECTIOUS DISEASE-FIGHTING IMMUNITY Dendritic cells orchestrate the immune response by “presenting” pieces of a tumor (antigens) to stimulate a reaction “Training” immune cells
Slide 10: Tumor Cells Can Evade Normal Immune Response
TUMOR CELLS CAN EVADE NORMAL IMMUNE RESPONSE Cancer cells can evolve to evade immune responses by releasing inhibitory signals against, or hiding from, key parts of the system designed to seek and kill tumors Secrete inhibitory signals Extensive solid tumor matrix Preventing recognition Is difficult
Slide 11: Quality by Design Aims to Introduce Enhanced Product Attributes
QUALITY BY DESIGN AIMS TO INTRODUCE ENHANCED PRODUCT ATTRIBUTES BYPASS TUMOR IMMUNE RESPONSE EVASION AND ENHANCE TUMOR ERADICATION Induces T-Cell killing and suppresses Regulatory T-Cells Activates cytotoxic T-Cells known to be the most effective immune cell population to kill the cancer cells Promo
Slide 12: RENB-DC11: Allogenic HSC-Derived Gene-Enhanced Dendritic Cell Vaccine for Solid Tumors
RENB-DC11: ALLOGENIC ADULT HEMATOPOIETIC STEM CELL (HSC)- DERIVED GENE-ENHANCED DENDRITIC CELL VACCINE FOR SOLID TUMORS Day -30 to -2 Day -2 to 0 Day 0 Day 1-4 Day 5-16 Day 16-19 Day 20-21 Day 21? Proliferation- Transduction differentiation Drug substance Drug product Source Material 1 2 3 4 5 6 7
Slide 13: RENB-DC11 Manufacturing Process Facilitates Scale Up and Patient Access
RENB-DC11 MANUFACTURING PROCESS FACILITATES SCALE UP AND PATIENT ACCESS Source material Process Yield Safety Risk Cost Autologous Patient- One patient one No disease transmission Production failure Very high. Every Monocyte-derived derived, patient treatment risks, well documented risks: Donor hea
Slide 14: Procedural Flow: Patient, Manufacturing Site, Patient
PROCEDURAL FLOW: PATIENT MANUFACTURING SITE PATIENT Operating Room Renovaro manufacturing site Outpatient setting Tumor resection Biopsy Shipped and stored Tumor lysate Pulse frozen at site Biopsy histopath Formalin Biopsy Product: Fresh frozen Biopsy Personalized Processed Drug Product Thaw and
Slide 15: Humanized Mouse Model Closely Replicates Human Immune System
HUMANIZED MOUSE MODEL CLOSELY REPLICATES HUMAN IMMUNE SYSTEM Result is greater than 90% human immune cell reconstitution in the blood Human Immune Reconstitution in 8 weeks. CD3+ CD4+% CD3% CD3+ CD8+% CD16% Human thymus and liver is implanted under the kidney capsule, coupled with the injection of C
Slide 16: RENB-DC11 Treatment Significantly Reduced Size of Pancreatic Tumors in Humanized Mice
RENB-DC11 TREATMENT SIGNIFICANTLY REDUCED SIZE OF PANCREATIC TUMORS IN HUMANIZED MICE IN FIVE INDEPENDENT STUDIES (TWO REPRESENTATIVE STUDIES BELOW) Tumor weight Tumor volume 0.8 2500 Tumor weight (grams) ***p= 0.0001 Tumor volume (mm3) ***p= 0.0006 2000 *p= 0.01 0.6 n=4 **p= 0.001 n=4 1500 0.4 n=4
Slide 17: RENB-DC11 Outperformed Genetically Unmodified Dendritic Cells
RENB-DC11 OUTPERFORMED GENETICALLY Tumor Weight UNMODIFIED DENDRITIC CELLS/APPROACH MOSTLY USED BY OTHERS. 1.6 * (p=0.01) * (p=0.02) 1.2 n=2 Weight (Grams) 0.8 Tumor+ Untreated 0.4 0.0 Untreated Tumor Tumor+ Mock DC unmodified Tumor+TD RENB-DC11 Tumor+ TD_Optimized RENB-DC11 Tumor + Tumor (optimized
Slide 18: RENB-DC11 Treated Mice Showed No Signs of Metastatic Disease
RENB-DC11 TREATED MICE SHOWED NO SIGNS OF METASTATIC DISEASE Group Metastasis Metastasis Ascites* Liver Intestine/stomach Tumor+ Untreated 1/3 3/3 3/3 Tumor + Unmodified DC 2/2 2/2 2/2 Tumor + RENB-DC11 0/3 0/3 0/3 * Fluid collecting in the abdominal cavity 18
Slide 19: RENB-DC11 Activates Natural Killer Cell-Mediated Killing of Pancreatic Tumor Cells
RENB-DC11 ACTIVATES NATURAL KILLER CELL-MEDIATED KILLING OF PANCREATIC TUMOR CELLS * *anti-CD16 specifically blocks induced NK-mediated Killing to show response specificity 19
Slide 20: RENB-DC11 Treatment Increases Percentages of T Cells in Peripheral Blood
RENB-DC11 TREATMENT OF PANCREATIC TUMOR-BEARING HUMANIZED MICE SIGNIFICANTLY INCREASES THE PERCENTAGES OF T CELLS IN PERIPHERAL BLOOD N=2-3 20
Slide 21: RENB-DC11 Activates Interferon Gamma, a Marker of Cancer Killing Activity
RENB-DC11 ACTIVATES RECOGNIZED MAKER OF CANCER KILLING ACTIVITY (INTERFERON GAMMA (IFNG) WHICH ACCUMULATES IN THE SPLEEN) * * * IL2 + antiCD3/28 or IL2 + sAJ4 further Activate response 21
Slide 22: Strong Infiltration by Helper T-Cells (CD4+) of Tumor Tissue
STRONG INFILTRATION BY KEY IMMUNE CELLS (HELPER T-CELLS (CD4+)) OF TUMOR TISSUE UPON RENB-DC11 TREATMENT COMPARED TO CONTROL DENDRITIC CELLS AND UNTREATED TUMORS Control Tumor Tumor + CTRL vector DC Tumor + RENB-DC11 CD4 Tumor 800 p=0.07 CD4 expression/µm2 600 400 200 0 or D k ol oc +T m tr +M Tu on
Slide 23: Strong Infiltration by Killer T-Cells (CD8+) of Tumor Tissue
STRONG INFILTRATION BY KEY IMMUNE CELLS (KILLER T-CELLS (CD8+)) OF TUMOR TISSUE UPON RENB- DC11 TREATMENT COMPARED TO NON-MODIFIED DC AND UNTREATED TUMORS Control Tumor Tumor + CTRL vector DC Tumor + RENB-DC11 CD8 Tumor 1000 *p=0.05 800 CD8 expression/µm2 600 400 200 0 or D k ol oc +T m tr +M Tu on
Slide 24: Clinical Target Product Profile
CLINICAL TARGET PRODUCT PROFILE Attributes Target Patient population Locally (inoperable) advanced to metastatic solid tumors (failed to respond to standard of care) P1 safety all solid tumor Basket P2a pick 3-4 indications: Pancreas, Liver, Triple Neg breast, Head/Neck, Mesothelioma. Registrational
Slide 25: Initial Clinical Study RENB-DC11-01
INITIAL CLINICAL STUDY RENB-DC11-01 Phase I/IIa – Open to all solid tumors, focus on Patients with Pancreatic Cancer Phase I (2025) – Safety assessment: Ascending dose ranging cohort of up to 6 patients/dose level Phase IIa (enrollment starting in late 3Q 2025)– Fixed dose multi-cohort design (one
Slide 26: RENB-DC11-01 Study Strategy
RENB-DC11-01 STUDY STRATEGY Biotech companies often outsource the full study to a CRO There are large costs associated with layers of project management in this model and risks to meeting regulatory requirements by ceding full control Initial estimates based upon prior experience with the full
Slide 27: No Offer or Solicitation; Important Additional Information Regarding the Transaction
No Offer or Solicitation This report is not intended to and shall not constitute an offer to sell or the solicitation of an offer to sell or the solicitation of an offer to buy any securities or a solicitation of any vote or approval, nor shall there be any sale of securities in any jurisdiction in
Slide 28: Thank You
THANK YOU www.Renovarobio.com
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