(TSE : 4587)
Corporate Overview
July 2024
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Forward-Looking Statements
This presentation contains forward-looking statements. These forward-looking statements are current plans, forecasts, assumptions and
strategies based on currently available information. There are various inherent risks as well as uncertainties involved. The actual results of
business performance may differ from those forecasts due to various factors.
These factors include, but are not limited to: (1) risks of delays, interruptions or failures associated with drug discovery and development; (2) risks of unexpected program disruptions or terminations due to changes in client policies; (3) risks associated with manufacturing products and the procurement of raw materials; (4) the impact of reduced competitiveness due to the competitors and competing technologies; (5) declining product sales capabilities; (6) adverse rulings in infringements or significant litigation against our Group's intellectual property rights;
(7) adverse changes in economic conditions and related laws and regulations; and (8) fluctuations in interest rates and currency exchange rates.
The information in this material with respect to drugs (including those under development) is not intended to provide advertising or medical
advice.
This material is intended to provide information on our Group's business and is not intended to solicit investment in securities.
PeptiDream assumes no responsibility for any damages resulting from the use of this material or its content, including without limitation damages related to the use of erroneous information.
The PeptiDream Group
PeptiDream and PDRadiopharma
The Largest Biotech Company in Japan
-
The PeptiDream Group is a drug discovery company (PeptiDream)
with a vertically integrated radiopharmaceutical company (PDRadiopharma) focused on the discovery, development, and commercialization of peptide-based therapeutics, peptide-drug conjugates, and radiopharmaceuticals (radiotherapeutics/radiodiagnostics) - Combined company has 750+ employees, spanning discovery, development, manufacturing, regulatory, and sales in Japan
- Growing revenue and profitability since 2011
The Global Leader in the Discovery of Peptide Therapeutics
- PeptiDream (established in 2006) is largely credited with establishing the macrocyclic peptide field - high global reputation across the pharma industry.
- Collaborations with the majority of the worlds pharmaceutical companies
Leading Targeted-radiopharmaceutical Position in Japan
- PDRadiopharma (established in 1968) is one of two radiopharmaceutical companies licensed to operate in Japan (currently sells 8 radiotherapeutic and 21 radiodiagnostic products in Japan)
- Ideally positioned to capture a large share of the radiopharmaceutical field in Japan, while contributing through partnerships globally
TSE Prime: 4587
PeptiDream Inc.
PDRadiopharma Inc.
PDRadiopharma facility (Chiba)
PeptiDream headquarters (Kawasaki)
3
Peptide Therapeutics - Next Generation Modality
Evolution of Peptide Drug Discovery
1980~ | 2000~ | 2006 | 2010~ | 2020~ | ||||
(Product Origin) | (Key R&D Progress) | PeptiDream Established | ||||||
• | • | Oral IL-23 for I&I | ||||||
Human Peptide Analogs | Rational Drug Design | ✓ Unparalleled Peptide Library & Hit Finding Platform | Oral PCSK9 for CV | |||||
• | Naturally Derived from | • | Expansion of Target | ✓ Diverse Discovery and Development Portfolio | Expansion to | |||
Other Organisms | Therapeutic Areas | through Both In-house and Partnerships Efforts | Multiple | |||||
✓ | Large Indications | |||||||
• | Innovations in | Broad Range of Pipeline Programs Spanning | ||||||
Established | MK-0616 for | JNJ-2113 for Psoriasis | ||||||
Macrocyclic Peptides | Variety of Peptide Modalities | |||||||
Hypercholesterolemia | ||||||||
(Ph3 Initiated in 2023) | ||||||||
(Ph3 Initiated in Aug 2023)
Innovations in Oral Peptides
Next-GenGLP-1 Launches and
Expansion to Weight Management Field
Innovations in | Ozempic® | Mounjaro® | |||||||||||
Wegovy® | |||||||||||||
(Selected Peptide Drugs) | Peptide-Drug Conjugates | Zepbound® | |||||||||||
Rybelsus® | |||||||||||||
‒ | Insulin & analogues (~1950s) | ‒ | Octreotide (1988) | (PDC) | |||||||||
‒ | for Diabetes | for Acromegaly, | Expansion in | ||||||||||
Cyclosporine (1983) | ‒ | Neuroendocrine Tumors, etc. | Oncology Field | ||||||||||
‒ | for Transplantation | Daptomycin (2003) | |||||||||||
Leuprolide (1985) | for Infectious Diseases | Pulvicto® | |||||||||||
for Cancer | Lutathera® | ||||||||||||
‒ | Vancomycin (1986) | (GEP-NETs) | 1) | (PSMA-positive | |||||||||
mCRPC)2) | Multiple Product Launches of | ||||||||||||
for Infectious Diseases | |||||||||||||
Targeted Radiotherapy | |||||||||||||
for Multiple Oncology Indications | |||||||||||||
Limited Discovery | Continuous Innovations and | Further Acceleration of | |||||||||||
Unfolding of Peptide Drug Discovery | |||||||||||||
Peptide Drug Applications | |||||||||||||
4 | |||||||||||||
Note: 1) GEP-NETs:Gastroenteropancreatic-neuroendocrine tumors, 2) mCRPC: metastatic Castration-resistant Prostate Cancer | |||||||||||||
Merck & Co., Inc., Rahway, NJ, USA |
PeptiDream - The Epicenter of Peptide Drug Discovery
PeptiDream's Evolving Proprietary PDPS Drug Discovery Platform
Amino Acid (AA) Building Blocks | Randomized DNA Library |
Trillions of Peptides in Each Library
Macrocyclic peptides
PeptiDream's 3,000+ AAs
Continuously Evolving Platform
Continuous expansion of AA building blocks that libraries be made with and optimized form (grew from 200 to >3,000)
Automation of the platform (high throughput)
Growing in-silico methods and computer simulation & modeling to predict optimal features
Protected by a broad patent portfolio
(e.g.)
10 positions with
20 building blocks
2010 = 10,240,000,000,000
different peptides in a library
Robust, cell-free synthesis derived by nature's way of making peptides
Each peptide "barcoded" via its
mRNA/cDNA tag
High Rate of Hit Finding Success
Discover high affinity and highly selective macrocyclic peptide binders to almost any target quickly and efficiently
Yields unique hit candidates unlike any other technology
Technology can be used to optimize and fine-tune the drug-like properties
(2006)
Few big pharma
engaged in peptide drug
discovery
(Today)
Every big pharma
engaged in peptide drug
discovery
PeptiDream has played a significant role in advancing Peptide Drug Discovery
5
Our Key Areas of Focus
Radiopharmaceuticals (RI)
Targeted Radio Therapy
Cancer Targeting Peptide Ligand
+ Radioisotope (RI)
Diagnostic Radionuclides
Tumor | RI |
Targeting | |
Therapeutic Radionuclides | |
Peptide | |
Combining the powerful tumor targeting ability of macrocyclic peptides with the cell killing ability of RI
Focused on Rapidly Growing a Deep Pipeline of Targeted
Therapeutics and Diagnostics
Non-Radiopharmaceuticals
Peptide Therapeutics
Broad range of disease and
therapeutic applications
Peptide Drug Conjugates (PDCs)
Tissue Targeting Peptide | Tumor Targeting Peptide | Target Binding Peptide | |||
Oligonucleotides | Small Molecules | Others |
Peptide Targeted delivery of various non-RI payloads
Growing the Next-Generation of Oral Peptide Therapeutics
and Non-RI Peptide Drug Conjugates
6
Radiopharmaceuticals
Targeted Radiotherapies - Revolutionizing How We Treat Cancer
Concept of Targeted Radiotherapy
Radioactive Rays | ||
Target-specific | ||
ligand | ≡ | |
Chelator | RI | |
Linker Radioisotope | Cancer targeting peptide | |
(RI) | ligand + Radioisotope (RI) | |
Cancer cell |
Delivery of RI
selectively to tumors
Radioisotope: Alpha (α) and Beta (β) Isotopes Advantages of Targeted Radiotherapy | Why Peptide As Ligand |
Radioisotopes kill cancer cells via DNA strand breaks
α emitters | β emitters | |
Difficult to Address | Brain, Skin, Liver, |
Kidney, Colon, | |
by ADC1) | |
Pancreas, Uterine, etc. | |
Prior Diagnosis | |
Is Essential2) |
High Affinity and Specificity for Target Receptor
Favorable Pharmacokinetics (PK) Profile
- Higher LET* (80-100 kEv/μm) (double strand breaks)
- Shorter range (20-80μm)
- Lower LET (0.2-0.5 kEv/μm) (single strand breaks)
- Longer range (2-11.5mm)
Stromal cell, etc. | |
Concern of Treatment | Breast, Bladder, |
Resistance3) | Ovarian, etc. |
Difficult to | |
Address by | |
Immuno-Oncology4) | Lung, Prostate, etc. |
Fast Renal Clearance
Lower Immunogenicity and Toxicity
Versatility and Ease of
Synthesis/ Modification
Source: 1) PeptiDream's in-house analysis. 2) F. Zhuravlev. Curr Radiopharm., 2021, 14, 374-393.B.M. Privé, et al., Eur J Nucl Med Mol Imag., 2023, 50, 1906-1918.3) J. Karlsson, et al., Front. Med., 2022, 1071086. M. Barok, et al., Breast Cancer Res., 2014, 16: 209. M.E. Autenrieth, et al., Eur J Nucl Med Mol Imaging., | 7 |
2018, 45, 1364-1371. C.A. Kunos, et al., Front. Oncol., 2019, 9: 00180. 4) N.A. Ridge, et al., Adv Radiat Oncol., 2022, 7, 100936; R.B. Patel, et al., Sci Transl Med., 2021, 13(602), eabb3631. 5) Clarivate, Evaluate, GlobalData, company websites. |
Power of Combining Diagnostic and Therapeutic
Theranostics |
(Thx) |
Radioisotope for Diagnosis (Dx) |
Dx |
Targeting |
Peptide |
Chelator |
Tx |
Radioisotope for Treatment (Tx) |
The same peptide-conjugate |
can be utilized for both |
diagnosis and treatment by |
just changing the RI |
RI-Specific Quickest Path to Product Development | |||||||||||
Pre-Clinical Development | Human ePoC | Clinical Development | |||||||||
"Rapid Validation" | "De-risk" | "Accelerate" | |||||||||
Candidate Compounds | Inject to | Phase 0 | Phase 1/2 | ||||||||
Candidate A | Candidate B | Xenografted | Evaluate | ||||||||
Dx | Distribution | ||||||||||
Dx | Tx | Dx | Tx | Mouse | |||||||
in the Body and | Dx | Tx | |||||||||
Candidate C | |||||||||||
Accumulation | |||||||||||
Candidate D, E… | Administer Small | ||||||||||
Dx | Tx | in Cancer Cells | Cancer Patients | ||||||||
Dose of Dx-RI and | 2) | ||||||||||
Evaluate Clear Detection of Tumor, | Generate Human | Before | After | Before | After | ||||||
Imaging Data | Therapy | 3 Cycles | Therapy | 3 Cycles | |||||||
Rapid Renal/Blood Clearance, Specific Distribution | |||||||||||
3) | 3) | ||||||||||
in Tumor, and Anti-tumor Effects | |||||||||||
1 hr Post-dosing | 4 hr Post-dosing | 24 hr Post-dosing | 48 hr Post-dosing | 1) | |||||||
Cancer Patients | |||||||||||
PET-CT Imaging | Simpler mechanism of Tx-RI, | ||||||||||
Rapidly establish tumor targeting and | |||||||||||
confirmation of Dx-RI's delivery to the | More efficiently design Ph1/Ph2 studies | ||||||||||
in vivo efficacy of best peptide candidate | |||||||||||
cancer lesion increases the certainty | by leveraging Ph0 results | ||||||||||
in animal tumor models | |||||||||||
of drug efficacy and safety | |||||||||||
Unique Theranostic approach of targeted-radiopharmaceuticals, | |||||||||||
allows for the quickest path to human ePoC, accelerating overall product development |
Source: 1) in-house data. 2) K. Herrmann, et al., Lancet Oncol., 2020, 21, e146-e156. 3) C. Kratochwil, et al., Journal of Nuclear Medicine, Aug 2016, 57 (8), 1170-1176 | 8 |
Note: ePOC: early Proof-of-Concept |
Rapidly Growing Targeted Radiotherapy Field
Market Size 1) | (2030E) |
(2022) | $29.4bn |
$8.4bn | |
(CAGR: 19.5%) |
Compelling Therapeutic Approach
Simple, Powerful MoA
PeptiDream - The Center of Innovation in RI Targeted Therapy
Accelerating entry of biopharma into RI therapies field, through a sequence of acquisitions
PeptiDream has been chosen as key collaboration partner by a multitude of leading players in this field and continues to build extensive partnered and internal pipeline programs
- Limited treatment resistance
- Overcoming tumor heterogeneity
True Precision Medicine
- "See it & Treat it" by Theranostics
- Efficient & accurate screening of patients
Clinical & Commercial Success Driving Further Excitement, Investment and Market Entry
Lutathera® Approval (2018): Neuroendocrine Tumors
(First key Targeted RI therapy that established the market)
Pluvicto® Approval (2022): Prostate Cancer
(Annualized $1bn+ Sales in 20242); aims multibillion blockbuster in mid-to-long term)
Acquired in Dec. 2023
(ca. $4.1bn)
Collaboration with
PeptiDream
in Sep. 2023
Acquired in Mar. 2024
(ca. $2.4bn)
Lutathera® & Pluvicto®
Acquired AAA and
Endocyte in 2018
Mariana Oncology
in May 2024
(Total of ca. $7.75bn)3)
Acquired Noria and
PSMA Therapeutics
in 2021
Acquired
in Oct. 2023
(ca. $1.4bn)
Note: 1) Market size estimates based Fortune Business Insights (Nuclear Medicine Market Size, Share & COVID-19 Impact Analysis 2023-2030), 2) 2024 Q1 Sales of $310mm (+47% in Q1), annualized sales estimate of $1bn plus sales range, 3) Including potential milestone | 9 |
payments |
Radiopharmaceuticals - PeptiDream Group
Uniquely Positioned with Multiple Paths to Drive Value Creation
RI Market Landscape
Japan
Only 2 Licensed RI Companies
High Barrier to Market Entry
- Strict Regulations/ Compliance
- Supply Chain Requirement, etc.
Partnering with a Local Company is
Essential for Global Pharma to
Commercialize Their RI Products
Global
Growing Demand of RI
Expanding Dx & Tx Applications
Challenges by Each Region
- Regulations/ Compliance
- Supply Chain Requirement
PeptiDreamPeptiDream+ +PDRPDRBusinessB i Modelodel
1 Discovery Commercialization
2 | 4 | 3 |
Overseas RI Players
Rapidly growing number of RI companies to potentially partner with PD+PDR
Execution Strategy
1 Develop In-house Programs
2
Develop Collaboration Programs
- Leverage partners clinical data to bridge into Japan Market (Data Bridging)
3
In-licensing/Service Agreements
- PD/PDR provides overseas companies with access to Japan RI markets
4
Out-licensingex-Japan Rights
- Out-licensingPD in-house programs
- PD provides collaboration partners with ex- Japan Global rights
- PDR develops for Japan market
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PeptiDream Inc. published this content on 01 July 2024 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 01 July 2024 14:39:09 UTC.