ATACs: Unique new mode of action to fight cancer
May 2024
Safe harbor
Forward looking statements
This communication contains certain forward-looking statements, relating to the Company's business, which can be identified by the use of forward-looking terminology such as "estimates", "believes", "expects", "may", "will" "should" "future", "potential" or similar expressions or by general discussion of strategy, plans or intentions of the Company. Such forward-looking statements involve known and unknown risks, uncertainties and other factors, which may cause our actual results of operations, financial condition, performance, or achievements, or industry results, 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: uncertainties related to results of our clinical trials, the uncertainty of regulatory approval and commercial uncertainty, reimbursement and drug price uncertainty, the absence of sales and marketing experience and limited manufacturing capabilities, attraction and retention of technologically skilled employees, dependence on licenses, patents and proprietary technology, dependence upon collaborators, future capital needs and the uncertainty of additional funding, risks of product liability and limitations of insurance, limitations of supplies, competition from other biopharmaceutical, chemical and pharmaceutical companies, environmental, health and safety matters, availability of licensing arrangements, currency fluctuations, adverse changes in governmental rules and fiscal policies, civil unrest, acts of God, acts of war, and other factors referenced in this communication.
Given these uncertainties, prospective investors and partners are cautioned not to place undue reliance on such forward-looking statements. We disclaim any obligation to update any such forward-looking statements to reflect future events or developments.
This material is not intended as an offer or solicitation for the purchase or sale of shares of Heidelberg Pharma AG. This material may not be distributed within countries where it may violate applicable law.
ATAC® is a registered trademark of Heidelberg Pharma Research GmbH.
© Heidelberg Pharma AG | 2 |
Management team with strong pharma and R&D experience
Prof. Dr. Andreas Pahl
CEO
Heidelberg Pharma since 2012, CEO since 2024
Professor of Pharmacology and Toxicology at the University of Erlangen- Nuremberg (FAU) with 25 years experience in research and higher education
Walter Miller
CFO
Heidelberg Pharma since 2023
More than 20 years of experience in corporate finance, M&A, strategic controlling, accounting and corporate development
Dr. András Strassz
CMO
Heidelberg Pharma since 2020
More than 15 years experience in clinical drug development including roles at Sandoz, Amgen and biotech companies
Dr. George Badescu
CBO
Heidelberg Pharma since 2018
More than 15 years experience in industry roles including leadership positions at Abzena
Dr. Jörg Kemkowski
COO
Heidelberg Pharma since 2023
More than 30 years experience in human and animal healthcare industry in different R&D leadership positions
© Heidelberg Pharma AG | 3 |
Building a world class ADC pipeline
Differentiated ADC Technologies
- In Plug & Play mode
- 3 years from target to IND
GMP Manufacturing
- Fully synthetic process for Amanitin
- 5 GMP batches completed
Clinical Stage
- Data from HDP-101 dose escalation shows first objective responses and partial remissions
- HDP-102CTA & FPI this year
- 2 additional CTAs in preparation
© Heidelberg Pharma AG
Strong IP
- Several IP families
- Monopoly in the Amanitin/MoA space
Partnerships
- Huadong: China-focused
- Takeda: ATAC technology
- Healthcare Royalty: Telix Pharma
Corporate & Finance
- Experienced leadership team; 105 employees
- Cash (runway): €32.6 million* (mid-2025)
- 75m USD milestone payment expected end of 2024
- as per end of February 2024
4
Strong in-house R&D capabilities and expertise
Synthetic chemistry | Antibody generation | Preclinical testing | ||||||||
& bioconjugation | ||||||||||
CMC | Bioanalytical sciences | Clinical Development |
Best ADC candidate in the shortest time
© Heidelberg Pharma AG | 5 |
Value creation through development of best-in-class ADC assets
Discovery & development engine
Scouting
Partnering
In-licensing
We are NOT a Target ID Company
Toolbox
of proprietary
payloads
Multiple targets
Development
AntibodiesExpertise
Partnering at IND-ready, First clinical data, EOP1, Clinical POC
Co-Development
Upside: Retain territorial rights for potential commercialization
© Heidelberg Pharma AG | 6 |
Payload Toolbox - Multiple MOAs
Developing an ADC toolbox and clinical product pipeline to overcome tumor resistance across cancer types
Toolbox
of proprietary
payloads
ATAC Technology
RNA-Polymerase II Inhibitor
Amanitin based
TOPO I Technology
Topoisomerase I Inhibitor
Exatecan based
Immune-modulation
Technology
TLR7 agonist
Different payloads and antibodies will lead to multiple development candidates with different modes of actions
© Heidelberg Pharma AG | 7 |
Growing pipeline of proprietary and partnered programs
Product | Target | Indication | Research Preclinic Phase I Phase II | Phase III Partner | |||||
HDP-101 | BCMA | Multiple Myeloma | Huadong (China+*) | ||||||
pipeline | |||||||||
HDP-102 | CD37 | NHL (DLBCL/CLL) | Huadong (option China+) | ||||||
ATAC | |||||||||
HDP-103 | PSMA | Prostate cancer | Huadong (China+) | ||||||
HDP-104 | GCC | Gastrointestinal (e.g., CRC) | Huadong (option China+) | ||||||
TOPO | HDP-201 | GCC | Gastrointestinal | Proprietary | |||||
ATAC partners | TAK-ATAC | n/a | Oncology | Takeda | |||||
assets | TLX250-CDx | CA-IX | Renal Carcinoma | Telix | |||||
Urothelial Carcinoma, TNBC | |||||||||
Legacy | |||||||||
TLX250 | CA-IX | Renal carcinoma | Telix | ||||||
RHB-107 | Oncology/GI, Covid-19 | RedHill | |||||||
- People's Republic of China, Hong Kong, Macao, Taiwan, South Korea, Indonesia, Singapore, The Philippines, Thailand, Bangladesh, Bhutan, Brunei, Myanmar, Cambodia, Laos, Malaysia, Maldives, Mongolia, Nepal and Vietnam; excludes Japan, India, Pakistan, Sri Lanka
© Heidelberg Pharma AG | 8 |
Resistance is one of the biggest challenges in oncology
1 in 2 | > 90% |
people will be diagnosed | of cancer deaths |
with cancer in their | are caused by drug |
lifetime | resistance |
© Heidelberg Pharma AG | 9 |
The journey of many cancer patients
Before Treatment | Treatment | Resistance & Relapse |
Wagke, N.et al, J Clin Oncol. 2011; 29(22): 3085-3096
We need new drugs with new mode-of-action to overcome resistance
© Heidelberg Pharma AG | 10 |
Attachments
- Original Link
- Original Document
- Permalink
Disclaimer
Heidelberg Pharma AG published this content on 14 May 2024 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 14 May 2024 13:31:05 UTC.