Radiopharm Theranostics Limited · ASX:RAD
Radiopharm Theranostics — Oncology/Cell Tx Innovation: The Texas Trifecta (April 2024)
26 slides from Radiopharm Theranostics's conference presentation, Apr 22, 2024
Slide 1: Radiopharm Ventures Institutional & Venture Capital Presentation
ASX ANNOUNCEMENT 22 APRIL 2024 RADIOPHARM VENTURES INSTITUTIONAL & VENTURE CAPITAL PRESENTATION Sydney, Australia – 22 April 2024 – Radiopharm Theranostics (ASX:RAD, “Radiopharm” or the “Company”), a developer of a world‐class platform of radiopharmaceutical products for both diagnostic and therapeu
Slide 2: For personal use only
ASX ANNOUNCEMENT 22 APRIL 2024 Matt Wright NWR Communications P: +61 451 896 420 E: matt@nwrcommunications.com.au Follow Radiopharm Theranostics: Website – https://radiopharmtheranostics.com/ Twitter – https://twitter.com/TeamRadiopharm Linked In – https://www.linkedin.com/company/radiopharm- theran
Slide 3: Important Notice and Disclaimer
ASX ANNOUNCEMENT 22 APRIL 2024 IMPORTANT NOTICE AND DISCLAIMER The information in this presentation does not constitute personal investment advice. The presentation is not intended to be comprehensive or provide all information required by investors to make an informed decision on any investment in
Slide 4: A Joint Venture between
For personal use only A Joint Venture between Company Presentation – April 2024
Slide 5: Company Vision & Strategy
COMPANY VISION & STRATEGY B7H3 FRANCHISE & NOVEL TARGETS FOR RADIOPHARMACEUTICAL THERAPIES For personal use only Private Company created in Q4 2022 between MD Anderson Cancer Center (MDACC) and RAD • Four technologies licensed from MDACC • R&D costs currently covered by Radiopharm Theranostics (RAD:
Slide 6: Leadership Team and JV Scientific Committee
For personal use only LEADERSHIP TEAM and JV SCIENTIFIC COMMITTEE Prof. David Prof. Sam Hanash Riccardo Canevari Piwnica-Worms • Inventor B7H3 targeting molecule • Inventor three technologies (undisclosed) • Radiopharm Theranostics CEO since 2021 • Department Chair, Department of • Director, Departm
Slide 7: Company Pipeline
COMPANY PIPELINE TARGET & CODE INDICATION Dx/Tx ISOTOPE NOTES MOLECULE CMC GMP production ongoing For personal use only Preclinical studies completed Prostate, Lung, Hepatocellular RV 01 B7H3 Carcinoma, Pancreatic, Therapy Lu177 (β) Next steps: complete CMC, and conduct mAb Colorectal, Head & IND en
Slide 8: RV01: Lead Candidate
For personal use only RV01: Lead Candidate B7H3-Targeting Monoclonal Antibody (mAb) for Beta-Radioligand Therapy
Slide 9: Five B7H3 Antibody Drug Conjugates in Development
FIVE B7H3 ANTIBODY DRUG CONJUGATES IN DEVELOPMENT PHASE 2 READOUT WITH ADC IN PROSTATE CANCER EXPECTED SOON For personal use only Ph2 TAMARAK B7H3 study in mCRPC* Interim efficacy data May 31st, 2024 Ph3 Ideate-2 B7H3 study in SCLC** Initiation in 2024 DIFFERENT MODALITIES Source: BioMed Tracker, Le
Slide 10: First and Only Selective B7H3 Radiopharmaceutical in Development
FIRST AND ONLY SELECTIVE B7H3 RADIOPHARMACEUTICAL IN DEVELOPMENT For personal use only BETABART® ® Isoform-Selective Targeting of 4Ig-B7-H3 for PET Imaging and Beta-Radioligand Therapy LINKER CANCER CELL TARGET TARGETING RADIOACTIVE 4Ig-B7H3 MOLECULE ISOTOPE 177Lu Betabart THERAPY • Multi-indication
Slide 11: Clinical Development & Regulatory Strategy
CLINICAL DEVELOPMENT & REGULATORY STRATEGY • Preclinical models validated selective targeting of tumor cells • Significant tumor reduction and increased survival in the animal model For personal use only • GMP CMC production ongoing. GMP batch in Q3 2024 • GLP TOX and Biodistribution studies in Q3 –
Slide 12: Targeting B7H3 in Advanced Prostate Cancer
Targeting B7H3 in Advanced Prostate Cancer may Optimize Clinical Outcomes, Reduce Off-Tissue Toxicities & Improve Quality of Life For personal use only Current SoC Treatments: ARis, PARPs, PSMA RLT* NEW Mechanisms of Action NOVEL ARIs PSMA RLT B7H3 & PARPs Lu 177 Pb 212 Abiraterone Most advanced B7H
Slide 13: Preclinical Data Deep Dive
For personal use only PRECLINICAL DATA DEEP DIVE Isoform-Selective Targeting of 4Ig-B7H3 for Imaging and Beta-Radioligand Therapy R AD I O P H AR M V E N T U R E S L L C 2 0 2 4 10
Slide 14: B7H3 Pathway Highly Attractive Pan-Tumor Target
B7H3 PATHWAY HIGHLY ATTRACTIVE PAN-TUMOR TARGET For personal use only Loo, D. et. al. Clinical Cancer Research (2012). R AD I O P H AR M V E N T U R E S L L C 2 0 2 4 11
Slide 15: B7H3 Is Expressed as Multiple Isoforms
B7H3 IS EXPRESSED AS MULTIPLE ISOFORMS For personal use only • The 4Ig-B7H3 isoform is the dominant isoform in human cancers. • A soluble 2Ig-B7H3 isoform circulating in the blood is a potential pseudo- target decoy (sink) not widely appreciated as a confounding factor in therapy. GOAL: DEVELOP A HI
Slide 16: Betabart Demonstrates High Affinity & Selectivity for Human 4Ig-B7H3
MILL33B, THE MURINE PREDECESSOR MAB CONTAINING THE CDR*, AND OUR HUMANIZED MAB (BETABART®) DEMONSTRATE HIGH AFFINITY & SELECTIVITY FOR HUMAN 4IG-B7H3 For personal use only MIL33B ELISA BIO-LAYER INTERFEROMETRY ANALYSIS Human B7-H3 4Ig EC50 = 90.0 pM (n = 6) 3 Mouse B7-H3 2Ig EC50 = 1.5 nM (n = 6) 2
Slide 17: Therapeutic Efficacy: Tumor Reduction
THERAPEUTIC EFFICACY: TUMOR REDUCTION For personal use only I.V. TREATMENT OF ESTABLISHED IR-RESISTANT CT26 TUMORS WITH I.V. 90Y-DOTA-MIL33B R AD I O P H AR M V E N T U R E S L L C 2 0 2 4 14
Slide 18: Therapeutic Efficacy: 56% Survival with Single Injection
THERAPEUTIC EFFICACY: 56% SURVIVAL WITH SINGLE INJECTION For personal use only 100 CT26 hB7H3 100uCi 90Y-DOTA-MIL33B I.V. (n = 15) CT26 Vector 100uCi 90Y-DOTA-MIL33B I.V. (n = 9) 90 CT26 hB7H3 Saline I.V. (n = 23) 80 CT26 hB7H3 nothing (n = 20) 70 Percent Survival CT26 4Ig-B7H3 Tumors 60 50 100 µCi
Slide 19: Betabart Predecessor Induces Immunological Memory
BETABART PREDECESSOR INDUCES IMMUNOLOGICAL MEMORY (TUMOR REJECTION FROM RADIOTHERAPY PRE-TREATMENT) For personal use only RECHALLENGE SURVIVAL CURVES: PRE-TREATED SURVIVORS VERSUS LONG-TERM SURVIVORS OF TREATMENT-NAIVE MICE 90Y-DOTA-MIL33B TREATMENT RECHALLENGED WITH CT26 TUMOR CELLS 100 CT26 hB7-H3
Slide 20: Conclusions: First and Only Selective B7H3 Radiopharmaceutical Therapy
CONCLUSIONS: FIRST AND ONLY SELECTIVE B7H3 RADIOPHARMACEUTICAL THERAPY IN DEVELOPMENT For personal use only • High affinity (72 pM) antibody specific for 4Ig-B7H3. • Treatment with a single I.V. dose leads to complete regression of established solid tumors and long-term survival of 56% in our precli
Slide 21: Pipeline Follow-On Assets: Surfaceomes Platform
For personal use only PIPELINE FOLLOW-ON ASSETS Surfaceomes (or Cell surface) Platform R AD I O P H AR M V E N T U R E S L L C 2 0 2 4 18
Slide 22: Three Novel Surfaceomes Targets Identified by Profiling of Tumor Cells
THREE NOVEL “SURFACEOMES” TARGETS IDENTIFIED BY IN-DEPTH PROFILING OF TUMOR CELLS HIGHLY RELEVANT FOR RADIOPHARMACEUTICAL THERAPIES For personal use only • Cell surface expression - critical for radiopharmaceutical effective mechanism of actions • Target characteristics: a. Testis antigens b. Expres
Slide 23: Differentiation vs Currently Known Targets
DIFFERENTIATION VS CURRENTLY KNOWN TARGETS CONSIDERABLY MORE RESTRICTED GENE EXPRESSION IN NORMAL TISSUES For personal use only “Target D” TROP2 EGFR HER2 TROP2 EGFR HER2 Target G Target I Target D R AD I O P H AR M V E N T U R E S L L C 2 0 2 4 20
Slide 24: Example Target D in Preclinical Development
EXAMPLE “TARGET D” IN PRECLINICAL DEVELOPMENT ▪ Description: Testis antigen ▪ Expression in normal tissues: largely limited to testis For personal use only ▪ Cancer types with surface expression : Highly expressed in TNBC, ovarian, SCLC, gastric Normal tissues Ovarian serous carcinoma tumor Ovarian
Slide 25: Multi-Indication Potential for Each Selected Target
MULTI-INDICATION POTENTIAL FOR EACH SELECTED TARGET For personal use only Target D Target I Target G R AD I O P H AR M V E N T U R E S L L C 2 0 2 4 22
Slide 26: Contact
For personal use only A Joint Venture between CONTACT: RICCARDO CANEVARI rc@radiopharmtheranostics.com
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