2021-08-012 + 2019-06-008 - ONCOBOTS - The use of self-propelled urease nanoparticles for the treatment of non-invasive bladder cancer

ONCOBOTS

2021-08-012 + 2019-06-008

Novel solution to obtain a proportional (fair) allocation of resources among DASH clients in dense wireless networks

The institution has a clear commitment towards the inclusion and diversity,employee engagement, human rights and wellbeing. The project has a clear focus on health and safety, striving to improve therapeutic approaches for diseases with high social impact such as BC. Governance aspects are strongly taken into account as well, de to the integrity of the licensee's managing team.

The therapeutic platform developed in this project could be applied to other clinical indications beyond BC, in the oncology field as well as in others (e.g., osteoarticular diseases). The impact of such a disruptive technology would be huge, allowing to improve the efficacy of current and future treatments in many clinical indications, improving quality of life in patients and reducing the overall burden on healthcare systems.

Several cancer diseases are lacking effective therapies due to poor biological barriers drug penetration, posing significant challenge in drug efficacy and often leading to high relapsing rates. Bladder cancer (BC) is the 9th most common cancer in the world, and despite having good survival rates, is the most expensive cancer to treat, due to recurrent tumor relapse. Non-muscle invasive bladder cancer (NMIBC) accounts for ~75% of BC at diagnosis and its current standard of care has significant limitations, including high recurrence rates and potential disease progression to muscle-invasive stages. Mucinous tumors are a group of rare diseases caracterized by a high amount of mucus around tumor cells. Mucus acts as an important barrier to drug delivery, leading to chemoresistance and high relapsing rates. Standard of care thus lacks efficacy and leaves patients with poor prognostics and reduced quality of life. We present a novel technological platform based on functionalized enzyme-powered nanomotors that improves the therapeutic index of existing or developing therapies. It is a new approach to actively penetrate biological barriers, enabling homogenous drug delivery to tumours like NMIBC and mucinous cancers.

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Our business model is based on commercializing our platform technology by establishing co-developments or licensing our portfolio. We first expect to expand the license agreements with Nanobots Therapeutics to new assets and then to sublicense to large pharmaceutical company for later clinical development and commercialization of the assets. Licensing events are expected to occur with the first positive clinical data of the lead asset NBT-101, whereas co-developments may happen at any time during the drug development process.

There is a high market need to develop new drug delivery approaches enabling to cross biological barriers and enhancing the therapeutic efficacy of hard to reach pathologies . The first targeted indication is NMIBC, a type of bladder cancer with a high recurrence rate (60%). With over 500,000 new cases and 200,000 deaths annually, NMIBC remains one of the costliest cancers to treat, with an estimated cost of €187K per case . Despite recent FDA approvals of Adstiladrin and Anktiva, recurrence rates remain high, with 65% of patients relapsing within 12 months. Around 50% of NMIBC patients are not eligible for first_x0002_line platin-containing chemotherapies and around 30% of patients receiving BCG immunotherapy do not respond favourably to it. Efficient drug delivery to basal membrane and cancer stem cells has been the holy grail of bladder cancer during decades to minimize recurrence. We are also exploring other biomedical applications such as mucinous tumours, biofilm penetration, joint disease treatment, and retinal therapies. The overall market for these applications is expected to reach $182.3 billion by 2027, with a growth rate of 19.9%

The bladder cancer market in the 7MM was valued at $670.00M in 2018 and is expected to reach $5.59B by the end of 2028 (TAM), growing at a CAGR of 23,6% during that period (source: GlobalData). Nanobots Tx targets the NMIBC market (SAM), which accounts for ~75% of BC, aiming at a SOM of over 400m$ (market share: 10% of SAM)

The spin-off rised almost 1M€ to fund the regulatory pre-clinical development of its first asset to treat NMIBC (NBT-101). By the end of 2025/early 2026, a Series A is expected to complete the pre-clinical development and establish the initial clinical validation.

Investors to complete the seed round and to launch the Series A. Grants such as EIC Transition & Accelerator, EuroStars and Neotec to pursue the developments and increase the assets portfolio in the other targeted indications

- Developing and scaling nanobots production and preclinical regulatory studies - CMC - EMA document submission - Seres A round closed

Our solution is the only approach that shows improved efficacy, is flexible to conjugate drugs, is tumor-selective, shows low immunogenicity, and can be administered by intravesical injection. Additional advantages include: (1) improved drug or antibody diffusion into solid-tumour masses, (2) reduced therapeutic doses, (3) improved antibody stability, (4) improved efficacy and (4) cancer tumour detection and imaging.

- Early-stage project that requires high-risk investment. - Competitive market – other platform technologies. - Collaboration with a (big) pharmaceutical company shall be sought to test nanobots loaded with drug candidate. The Pharma should finally acquire Nanobots Tx. - Complex regulatory process and manufacturing.

2016-2020: in vitro evidence (cell lines + 3D bladder spheroids) of anticancer drug delivery using enzyme-powered nanobots + imaging by PET-CT; 2018: IP protection; 2020-2021: in vivo monitoring within bladder; 2021-2024: in vivo validation of radionuclide therapy based on nanobots for bladder cancer; 2023: spin-off created (Nanobots Therapeutics) + licensing agreement signed + pre-seed round closed; 2024: Master Collaboration Agreement signed + seed round closed + patent granted (EP, Ch, Jp) + awarded in 2nd edition of IMPACTO program from Spanish Association Against Cancer (450 000€); 2025-2027: CMC + IND-enabling completed for NMIBC + patent granted in remaining territories and application for new patents + series A ; 2028-2029: clinical trials phase 1&2; 2030: exit (licensing to a big pharma company).

The technology has been patented (publication n. WO2020115124). It has received favourable evaluation with all claims considered novel, inventive and with industrial applicability. It has now entered the national phase in 9 countries and has already been granted in EU, China and Japan. It is not limited to oncology but applicable to every medical indication or condition. Additional IP has been generated (co-owned by IBEC and ICREA), based on the use of nanobots to cross biological barriers in tumours (publication n. WO2025098967).

The asset was licensed worldwide to Nanobots Therapeutics for exploitation in all medical fields. Strategic partnerships for the preclinical development of the asset for NMIBC indication include CIC-Biomagune and UAB in Spain.

Know-how on synthesis, modification, characterization and in vitro/in vivo validation of nanomotors.

Regulatory development and CMC plans have been prepared by specialized consulting firms and validated by an international expert, a former member of the EMA, and highly knowledgeable about these technologies from a regulatory point of view. Showing the feasibility of scale-up when producing our technology is one of the requirements of future Series A investors.

Patents: PCT/EP2019/083662

Bladder cancer (BC) is diagnosed in 550K patients and causes 200K deaths annually, making it the 9th most common cancer worldwide. Among the bladder cancer, the non-muscle invasive bladder cancer (NMIBC) is found in almost 80% of the cases. Despite the relative good survival rates, NIMBC has frequent relapses, and due to the cost of current therapies and patient monitoring techniques, this cancer is the most expensive malignancy to treat. Current treatments for NMIBC include transurethral tumor resection, followed by adjuvant intravesical chemotherapy, typically maintained at least 1 year and up to 3 years. However, these treatments do not present long-term responses and produce side-effects, and immunotherapeutic approaches such as the use of Bacillus Calmette Guérin (BCG) vaccine are prescribe in recurrence but with a rise in severe side-effects. All these limitations lead to unnecessary risks for patients, and costs for health care (direct costs, as hospitalization, repeated cystoscopies and treatments) and patients (indirect costs, as labour and quality of life). In fact, approximately 60% of the lifetime cost related to BC is due to tumour surveillance and relapses. Hence, the development of novel therapies with improved efficacies, capable of long-term responses is a critical need.