Paradigm Change in Immunotherapy for Solid Tumors
Transforming a deadly disease into a chronic, manageable condition
The Key Problem Today: 70-90% of patients with solid tumors do not have long-lasting clinical benefits from current immunotherapies
- Exploding costs do not translate into survival benefits for patients
- Current immunotherapy focuses on adaptive immunity only, inevitably leading to T cell exhaustion, tumors adapt, resulting in progression
- Emerging combination therapies drive a massive cost explosion (up to several USD 100k per patient)
- The system is inefficient, more drugs and higher costs do not translate into any meaningful, durable patient benefit!
NUACRES®: Game-Changing Solution Centered around Innate Immunity
Durable overall survival can only be achieved by activation of innate immunity for education of adaptive immunity
- Sustainable survival can only be achieved if innate and adaptive immunity are activated in a well-timed, orchestrated, alternating manner, tailored to the patient’s individual TME (tumor microenvironment “hot” vs. “cold”).
We call it ALTINADISUR®
ALTernating activations of INnate and ADaptive immunity for Immune SURveillance
- Proprietary, tumor-agnostic immunotherapy clinical trial architecture
- Counteracts downregulation of adaptive immune response in hot tumors
- Biomarker-driven adaptive treatment approach
- Activation of immune surveillance in cold tumors (innate immunity)
- Maintenance of immune surveillance in hot tumors (adaptive immunity)
- It’s about the treatment architecture paving the way to long term disease control
ALTINADISUR®: A patented clinical trial architecture to achieve long-term disease control
- Adaptive: Adaptive immunity maintained by immune checkpoint blockers, such as PD-1/PD-L1 blockers or T-Cell engagers
- Innate: Innate immunity activated by TLR9 agonists for presentation of neo-antigens
ES-SCLC: The Ideal Starting Point
ES-SCLC
Extremely poor long-term survival:
5-year survival rates range from 4% (population level) to 12% in long-term follow-up of modern chemo-immunotherapy trials.
- Clear and established benchmark therapies as reference point
- Rapid progression enables fast OS signals
- Regulatory openness for innovation
Limited treatment options
Current Standard of Care (SoC), chemotherapy combined with immunotherapy:
- Low response rates
- Resistance
- Severe immune-related adverse events
De-risked path to market
Our drug for immune surveillance activation is clinically validated, sufficient clinical material available, ready to be used in clinical trials
- 600 patients treated so far, excellent safety profile demonstrated
- Orphan Drug Designation (ODD) in Europe: 10 years exclusivity upon market authorization
- Multiple prior clinical trials demonstrated effective immunological responses and beneficial modulation of the TME
- Market potential*
- SCLC market is expected to grow to almost 13 billion USD by 2031
- 10.8% compound annual growth rate expected for 2025-2031E
* ResearchAndMarkets report “Small Cell Lung Cancer Therapeutics Market – Global Industry Size, Share, Trends, Opportunity and Forecast 2021-2031”
ALTINADISUR®: Path to Market Authorization
Stepwise validation, early inflection points, de-risked clinical strategy
- NIS (non-interventional study, 20 patients) – Goal: Biomarker quantification (“hot” vs. “cold” TME) – Launched in April 2026
- Phase II (run-in study for registrational trial, 55 patients) – Goal: Safety, first PoC (proof of concept) – Start: Early 2027
- Phase III (registrational trial, 200 patients) – Goal: Market authorization – Start: 2028
NUACRES®: Not a one-asset company
ALTINADISUR®
ALTernating activations of INnate and ADaptive immunity for Immune SURveillance
- Proprietary, tumor-agnostic immunotherapy clinical trial architecture
- Counteracts downregulation of adaptive immune response in hot tumors
- Biomarker-driven adaptive treatment approach
- Activation of immune surveillance in cold tumors (innate immunity)
- Maintenance of immune surveillance in hot tumors (adaptive immunity)
SLISUR®-EvoX
Upside from multi-modal platform technology
Bi-functional Nucleic Acid-based immunomodulation
- Next-gen Immune Surveillance Activator molecules (SLISUR®-EvoX) in pre-clinical development
- 5–10x more powerful innate immune activation vs. first-gen TLR9 agonists
- Cost-effective production, multipronged anti-tumor activity
- Strong international patent protection until 2046+
- Multi-modal therapy approach by additionally inhibiting transcription factors such as STAT3 and NFκB selectively in tumor cells
NUACRES®: Now is the Right Time to Invest
Key considerations for investors
ALTINADISUR® addresses a systematic failure in immunotherapy
Strong scientific rationale
Capital-efficient, de-risked path to market authorization
Clear exit options post phase II data end of 2027
- ALTINADISUR® clinical trial architecture
- SLISUR-EvoX® next-generation molecules addressing solid tumors in immunotherapy
Why Large Pharma will Love this…
> $40b annual revenues are at risk from 2028 onwards as the US patent expires for the three most successful ICB (Keytruda, Opdivo and Tecentriq)*.
Large pharma companies are looking to defend and expand their multi-billion-dollar franchises.
Investing in NUACRES® offers the solution!
* https://www.delveinsight.com/blog/key-developments-in-pd-l1-inhibitors
NUACRES®: Leadership
Prof. Dr.
Burghardt Wittig
Co-Founder and Managing Partner
DNA- and RNA-medicines driven by Molecular Biology & Bioinformatics
45+ years in research, 30+ years as biotech entrepreneur
Gerhard Th. Greif
Co-Founder and Managing Partner
Attorney & biotech entrepreneur
40+ years in finance &
capital markets
Rainer Wetzler
Chief Operating Officer
International manager
30+ years in medtech and biotech
Dr. Marcus Wieprecht
Chief Financial Officer
Life Sciences Investment Banking
30+ years in life science, finance, marketing & BD
Dr. Alfredo Zurlo
Chief Medical Officer
MD, oncology & radiation
25+ years in oncology trials (early & late stage) across pharma & biotech