Radiopharm Ventures institutional & VC presentation
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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 therapeutic uses, is pleased to announce a presentation on the progress of
Radiopharm Ventures, the joint venture between RAD and MD Anderson, to multiple US biotech
specialised funds and venture capital firms.
The presentation was given at the ‘Oncology/Cell Tx Innovation: The Texas Trifecta’ event, featuring
MD Anderson Cancer Center (MDA), Baylor College of Medicine (BCM) & Rice University (RU) and
organized by Truist Securities Life Sciences.
RAD CEO & Managing Director Riccardo Canevari and Professor David Piwnica-Worms presented on
the lead agent for Radiopharm Ventures, RV 01, a B7H3 targeted radiopharmaceutical
therapy designed with strong affinity for the 4IG isomer of B7H3 that is highly expressed in the
tumor and not in the healthy tissues. The presentation also covered detail on the new surfaceomes
platform.
“It was an excellent opportunity for RAD and Radiopharm Ventures to be invited to present at this
event, and our presentation generated significant interest from the attendees,” said Mr Canevari.
The presentation slides used at the event are attached below.
About Radiopharm Theranostics
Radiopharm Theranostics is a clinical stage company developing a world-class platform of innovative
radiopharmaceutical products for diagnostic and therapeutic applications in areas of high unmet
medical need. Radiopharm has been listed on the ASX (RAD) since November 2021. The company
has a pipeline of distinct and highly differentiated platform technologies spanning peptides, small
molecules and monoclonal antibodies for use in cancer, in pre-clinical and clinical stages of
development from some of the world’s leading universities and institutes. The pipeline has been
built based on the potential to be first-to-market or best-in-class. The clinical program includes one
Phase II and two Phase I trials in a variety of solid tumour cancers including lung, pancreas and brain.
Learn more at Radiopharmtheranostics.com.
Authorized on behalf of the Radiopharm Theranostics Board of Directors by Executive Chairman
Paul Hopper.
For more information:
Riccardo Canevari
CEO & Managing Director
P: +1 862 309 0293
E: rc@radiopharmtheranostics.com
Radiopharm Theranostics Limited
Suite 1, Level 3, 62 Lygon Street, Carlton South VIC 3053 Australia
ABN: 57 647 877 889
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/radiopharmtheranostics/
InvestorHub – https://investorhub.radiopharmtheranostics.com/
Radiopharm Theranostics Limited
Suite 1, Level 3, 62 Lygon Street, Carlton South VIC 3053 Australia
ABN: 57 647 877 889
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 Radiopharm Theranostics Ltd ACN 647 877 889 (Company). In preparing this
presentation, the Company did not take into account the investment objectives, financial situation and
particular needs of any particular investor. Further advice should be obtained from a professional investment
adviser before taking any action on any information dealt with in the presentation. Those acting upon any
information without advice do so entirely at their own risk.
Whilst this presentation is based on information from sources which are considered reliable, no representation
or warranty, express or implied, is made or given by or on behalf of the Company, any of its directors, or any
other person about the accuracy, completeness or fairness of the information or opinions contained in this
presentation. No responsibility or liability is accepted by any of them for that information or those opinions or
for any errors, omissions, misstatements (negligent or otherwise) or for any communication written or
otherwise, contained or referred to in this presentation. Neither the Company nor any of its directors, officers,
employees, advisers, associated persons or subsidiaries are liable for any direct, indirect or consequential loss
or damage suffered by any person as a result of relying upon any statement in this presentation or any
document supplied with this presentation, or by any future communications in connection with those
documents and all of those losses and damages are expressly disclaimed.
Certain statements contained in this presentation, including, without limitation, statements containing the
words “believes,” “plans,” “expects,” “anticipates,” and words of similar import, constitute “forward-looking
statements.” Such forward-looking statements involve known and unknown risks, uncertainties and other
factors that may cause the actual results, performance or achievements of the Company to be materially
different from any future results, performance or achievements expressed or implied by such forward-looking
statements. Such factors include, among others, the following: the risk that our clinical trials will be delayed
and not completed on a timely basis; the risk that the results from the clinical trials are not as favourable as we
anticipate; the risk that our clinical trials will be more costly than anticipated; and the risk that applicable
regulatory authorities may ask for additional data, information or studies to be completed or provided prior to
their approval of our products. Given these uncertainties, undue reliance should not be placed on such
forward-looking statements. The Company disclaims any obligation to update any such factors or to publicly
announce the results of any revisions to any of the forward-looking statements contained herein to reflect
future events or developments except as required by law.
This presentation is not a prospectus or other disclosure document under the Corporations Act 2001 (Cth) and
will not be lodged with the Australian Securities and Investments Commission. This presentation is for
information purposes only and is not an invitation or offer of securities for subscription, purchase or sale in
any jurisdiction. The distribution of this presentation (including electronically) outside Australia may be
restricted by law. If you come into possession of this presentation, you should observe such restrictions as any
non-compliance with these restrictions could contravene applicable securities laws (see the section captioned
‘International offer restrictions’). In particular, this document does not constitute an offer to sell, or a
solicitation of an offer to buy, securities in the United States. The New Shares have not been, and will not be,
registered under the US Securities Act of 1933 and may not be offered or sold in the United States except in
transactions exempt from, or not subject to, the registration requirements of the US Securities Act and
applicable US state securities laws.
Any opinions expressed reflect the Company’s position at the date of this presentation and are subject to
change.
Radiopharm Theranostics Limited
Suite 1, Level 3, 62 Lygon Street, Carlton South VIC 3053 Australia
ABN: 57 647 877 889
A Joint Venture between
Company Presentation – April 2024
COMPANY VISION & STRATEGY
B7H3 FRANCHISE & NOVEL TARGETS FOR RADIOPHARMACEUTICAL THERAPIES
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: ASX)
Intellectual Property
•
B7H3 targeting mAb with patent protection 2044+ (Global rights, exclusivity, any therapeutic Isotope)
•
Three additional technologies not yet disclosed, with potential indications in multiple solid tumors, targeting novel
pathways
Deep Expertise in Radiopharmaceuticals
•
Executive team includes top MD Anderson scientists and Radiopharm Theranostics Leadership Team
•
Radiopharm Ventures has access to MD Anderson preclinical labs (in vitro and animal models), nuclear medicine
facilities (radiolabeling) & clinical development experts (Phase I-II trial and protocol design)
R AD I O P H AR M V E N T U R E S L L C 2 0 2 4
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LEADERSHIP TEAM and JV SCIENTIFIC COMMITTEE
Prof. David
Piwnica-Worms
Prof. Sam Hanash
Riccardo Canevari
• Inventor B7H3 targeting molecule
• Inventor three technologies (undisclosed)
• Radiopharm Theranostics CEO since 2021
• Department Chair, Department of
Cancer Systems Imaging, Division of
Diagnostic Imaging, MDACC
• Director, Department of Red and Charline
McCombs Institute for the Early Detection
and Treatment of Cancer, MDACC
• Previously, Chief Commercial Officer of
Novartis Company Advanced Accelerator
Applications S.A.
• Professor, Department of Cancer
Systems Imaging, Division of Diagnostic
Imaging, MDACC
• Co-Director, Department of Center for
Global Cancer Early Detection, MDACC
• Lead for Lutathera in-market growth
strategy and Pluvicto launch strategy
• Distinguished Chair, Department of Evelyn
& Sol Rubenstein Distinguished Chair for
Cancer Prevention, MDACC
• Senior Vice President & Global Head,
Breast Cancer Franchise, for Novartis
Oncology
• Professor, Department of Clinical Cancer
Prevention - Research, Division of OVP,
Cancer Prevention and Population
Sciences, MDACC
• Lead for CDK4/6 (Kisqali) global launch in
HR+ Breast Cancer
• Executive Director, Quantitative
Imaging Analysis Core (QIAC), Division of
Diagnostic Imaging, MDACC
• Gerald Dewey Dodd, Jr., Endowed
Distinguished Chair in Diagnostic
Imaging, Division of Diagnostic Imaging,
MDACC
• Lead for PI3K inhibitor (Piqray) global
launch in HR+ Breast Cancer
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COMPANY PIPELINE
CODE
TARGET &
MOLECULE
INDICATION
Dx/Tx
ISOTOPE
NOTES
CMC GMP production ongoing
Preclinical studies completed
RV 01
B7H3
mAb
Prostate, Lung,
Hepatocellular
Carcinoma, Pancreatic,
Colorectal, Head &
Neck, Breast
Therapy
Next steps: complete CMC, and conduct
IND enabling GLP Tox and Biodistribution
studies
Lu177 (β)
Entering Phase 1 in the first half of 2025
RV02
Targets
UNDISCLOSED
RV03
RV04
BINDING MOIETY:
Nanobody
platform
Multiple solid tumors
Therapy
Lu177(β)
Tb161 (β+Au)
Ac225 (α)
Candidate selection ongoing
Supply Chain Enhancement
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RV01: Lead Candidate
B7H3-Targeting Monoclonal Antibody (mAb) for Beta-Radioligand
Therapy
FIVE B7H3 ANTIBODY DRUG CONJUGATES IN DEVELOPMENT
PHASE 2 READOUT WITH ADC IN PROSTATE CANCER EXPECTED SOON
Ph2 TAMARAK B7H3 study in mCRPC*
Interim efficacy data May 31st, 2024
Ph3 Ideate-2 B7H3 study in SCLC**
Initiation in 2024
Source: BioMed Tracker, Leerink Partners Research
*mCRPC: Metastatic Castration Resistant Prostate Cancer. NCT05551117
** SCLC: Small Cell Lung Cancer. NCT06203210
DIFFERENT MODALITIES
TO TARGET B7H3
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FIRST AND ONLY SELECTIVE B7H3 RADIOPHARMACEUTICAL IN
DEVELOPMENT
BETABART®
®
Isoform-Selective Targeting of 4Ig-B7-H3
CANCER CELL
TARGET
4Ig-B7H3
for PET Imaging and Beta-Radioligand Therapy
LINKER
TARGETING
MOLECULE
Betabart
RADIOACTIVE
ISOTOPE
177Lu
THERAPY
•
Multi-indication potential in B7H3+ solid tumors
(Prostate, Pancreatic, Hepatocellular Carcinoma,
Colorectal, Breast, H&N, Lung, Ovarian, …)
•
Phase I planned in early 2025
Figure made with Biorender.com
•
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.
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CLINICAL DEVELOPMENT & REGULATORY STRATEGY
•
Preclinical models validated selective targeting of tumor cells
•
Significant tumor reduction and increased survival in the animal model
•
GMP CMC production ongoing. GMP batch in Q3 2024
•
GLP TOX and Biodistribution studies in Q3 –Q4 2024
•
Phase I trial in the first half of 2025
Preclinical
PHASE I
Basket trial in multiple indications
CMC GMP, GLP Tox, BioD
25 pts
completed by end 2024
Opening in first half 2025
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Targeting B7H3 in Advanced Prostate Cancer may Optimize Clinical
Outcomes, Reduce Off-Tissue Toxicities & Improve Quality of Life
Current SoC Treatments: ARis, PARPs, PSMA RLT*
Lu 177
Abiraterone
Darolutamide
Enzalutamide
Olaparib
B7H3
PSMA RLT
NOVEL ARIs
& PARPs
Apalutamide
Pb 212
PLUVICTO
ADVC001l
PNT 2002
AB001
PSMA I&T
Rucaparib
Cu 67
Ac 225
FPI 225
PSMA R2
First and only selective B7H3
radiopharmaceutical
in development
CD46
ADC mAb
STEAP1
T-cell engager
At 211
Pelgi
Trillium
Most advanced B7H3 ADC in
development
bisPSMA
PSMA 617
*SoC: Standard of Care
ARis: Androgen Receptor inhibitors
PARPs: Poly (ADP-ribose) Polymerase
RLT: Radioligand Therapies
NEW Mechanisms of Action
PSMA
Conv01
Alpha01
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PRECLINICAL DATA
DEEP DIVE
Isoform-Selective Targeting of 4Ig-B7H3
for Imaging and Beta-Radioligand Therapy
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B7H3 PATHWAY HIGHLY ATTRACTIVE PAN-TUMOR TARGET
Loo, D. et. al. Clinical Cancer Research (2012).
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B7H3 IS EXPRESSED AS MULTIPLE ISOFORMS
•
The 4Ig-B7H3 isoform is the dominant
isoform in human cancers.
•
A soluble 2Ig-B7H3 isoform circulating
in the blood is a potential pseudotarget decoy (sink) not widely
appreciated as a confounding factor
in therapy.
GOAL: DEVELOP A HIGH-AFFINITY 4IG-ISOFORM-SPECIFIC
ANTI-B7H3 TUMOR-TARGETING ANTIBODY
Figure made with Biorender.com
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MILL33B, THE MURINE PREDECESSOR MAB CONTAINING THE CDR*, AND OUR
HUMANIZED MAB (BETABART®) DEMONSTRATE HIGH AFFINITY & SELECTIVITY
FOR HUMAN 4IG-B7H3
MIL33B ELISA
BIO-LAYER INTERFEROMETRY ANALYSIS
Human B7-H3 4Ig EC50 = 90.0 pM (n = 6)
Mouse B7-H3 2Ig EC50 = 1.5 nM (n = 6)
OD450 nm
3
2
1
0
-14
-12
-10
-8
-6
log(M)
MILL33B Affinity Ratio
4Ig to 2Ig : ~17
*CDR: Complementarity-Determining Region
https://2bind.com/bli/
BETABART® Affinity Ratio
4Ig to 2Ig : >300
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THERAPEUTIC EFFICACY: TUMOR REDUCTION
I.V. TREATMENT OF ESTABLISHED IR-RESISTANT
CT26 TUMORS WITH I.V. 90Y-DOTA-MIL33B
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THERAPEUTIC EFFICACY: 56% SURVIVAL WITH SINGLE INJECTION
CT26 hB7H3 100uCi 90Y-DOTA-MIL33B I.V. (n = 15)
CT26 Vector 100uCi 90Y-DOTA-MIL33B I.V. (n = 9)
100
90
CT26 hB7H3 Saline I.V. (n = 23)
CT26 hB7H3 nothing (n = 20)
70
CT26 4Ig-B7H3 Tumors
60
50
100 µCi 90Y-DOTA-MIL33B
40
***
*
30
**
Percent Survival
80
No Treatment
20
10
0
0
20
40
60
Days Post Tumor Injection
80
100
(* p = 0.0376, log-rank test)
(** p = 0.0034, log-rank test)
(*** p = 0.003, log-rank test)
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BETABART PREDECESSOR INDUCES IMMUNOLOGICAL MEMORY
(TUMOR REJECTION FROM RADIOTHERAPY PRE-TREATMENT)
RECHALLENGE SURVIVAL CURVES:
PRE-TREATED SURVIVORS VERSUS
TREATMENT-NAIVE MICE
LONG-TERM SURVIVORS OF
90Y-DOTA-MIL33B TREATMENT
RECHALLENGED WITH CT26 TUMOR CELLS
100
CT26 hB7-H3 90Y-DOTA-MIL33B(n
= 4)
CT26 hB7-H3 90Y-DOTA-MIL33B
CT26 hB7-H3 naive (n=6)
CT26 hB7-H3 naive (n=6)
80
Percent survival
Percent survival
100
60
40
20
80
60
** p = 0.0035
log-rank test ** p = 0.0035
log-rank test
40
20
0
0
20 0
40
60
80
0
20
40
Days Post Rechallenge
100-120
days
post initial
treatment
100
60
80
100
Days Post Rechallenge
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CONCLUSIONS: FIRST AND ONLY SELECTIVE B7H3
RADIOPHARMACEUTICAL THERAPY IN DEVELOPMENT
• 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 preclinical model
• Initial promising evidence of immune system stimulation and ability to
confer immune memory.
• Pre-IND studies to be completed in 2H 2024
• Phase I therapeutic trial to be started in 1H 2025
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PIPELINE
FOLLOW-ON ASSETS
Surfaceomes (or Cell surface) Platform
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THREE NOVEL “SURFACEOMES” TARGETS IDENTIFIED BY IN-DEPTH
PROFILING OF TUMOR CELLS
HIGHLY RELEVANT FOR RADIOPHARMACEUTICAL THERAPIES
• Cell surface expression - critical for radiopharmaceutical effective mechanism of actions
• Target characteristics:
a. Testis antigens
b. Expressed almost exclusively in the cancer cells;
c. Minimal / no expression in healthy tissues
d. Not currently in development with any modality (targeted therapy, ADC, RLT)
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DIFFERENTIATION VS CURRENTLY KNOWN TARGETS
CONSIDERABLY MORE RESTRICTED GENE EXPRESSION IN NORMAL TISSUES
“Target D”
TROP2
EGFR
HER2
TROP2
EGFR
HER2
Target G
Target I
Target D
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EXAMPLE “TARGET D” IN PRECLINICAL DEVELOPMENT
▪ Description: Testis antigen
▪ Expression in normal tissues: largely limited to testis
▪ Cancer types with surface expression : Highly expressed in TNBC, ovarian, SCLC, gastric
Normal tissues
Ovarian serous carcinoma tumor
Ovarian serous carcinoma ascites tumor cells
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MULTI-INDICATION POTENTIAL FOR EACH SELECTED TARGET
Target D
Target I
Target G
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A Joint Venture between
CONTACT:
RICCARDO CANEVARI
rc@radiopharmtheranostics.com
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