Bio‑Sourcing, a Belgium-based biotech company, and Danish Zerion Pharma have agreed to develop an oral (biobetter) formulation of trastuzumab (reference drug Herceptin®; Genentech/Roche), the pioneer monoclonal antibody used to treat breast cancer. The project has been awarded funding under the EUREKA Eurostars program, the only European funding programme dedicated to supporting early-stage R&D-performing companies, including start-ups.*
This is Bio‑Sourcing’s second Eurostars success, and together with Zerion’s breakthrough Dispersome® technology, it will support the development of an oral formulation of an anti‑HER2 antibody for the treatment of HER2‑positive breast cancer.
Researchers believe that an oral formulation of trastuzumab offers patient convenience, improves adherence, and reduces healthcare burden by delivering the biologic orally. However, to achieve efficient delivery of trastuzumab via non-parenteral routes, particularly the oral route, novel concepts are needed not only to overcome significant enzymatic and diffusion barriers but also to ensure stability and biological activity. [1][2]
Platform technologies
The program brings together Bio‑Sourcing’s disruptive BioMilk™ platform, which leverages natural milk components to protect and transport biologics through the gastrointestinal tract, and Zerion’s solid-oral-dosage capabilities using its protein‑based Dispersome technology.
Over 36 months, the consortium will optimize an orally deliverable trastuzumab biobetter produced in goat milk and advance it through preclinical validation, with the aim of preparing for entry into Phase I clinical studies around 2030.
The total project budget is €1.3 million, with Bio‑Sourcing as the lead and Zerion as the partner.
An effective oral therapy for HER2 breast cancer has the potential to move care beyond infusion centers, improving patient convenience and adherence while reducing pressure on healthcare resources. The differentiated oral route offers a compelling value proposition in a mature trastuzumab market and creates a platform opportunity to expand oral delivery to other biologics.
With the global trastuzumab market estimated at USD 4.1 billion by 2030, an orally delivered formulation offers clear differentiation and the potential to both capture a significant share of this demand and increase overall market size.
Unique strategy
“We are delighted by Eurostars’ confirmation of the relevance of our unique strategy for oral administration of monoclonal antibodies. I am confident that our partnership with Zerion will further accelerate the development and commercialization of this disruptive breast cancer formulation,” said Bertrand Mérot, Chief Executive Officer of Bio‑Sourcing.
“We are continuing our strategy of developing oral administration of monoclonal antibodies, which has already led to the production of OralimuMab™ and TrastuzOral™ in a synergistic partnership with Zerion to further enhance this paradigm shift. The development of this breakthrough in the systemic oral administration of monoclonal antibodies will not only greatly improve patient comfort but also increase access to these innovative treatments, thereby significantly expanding the biopharmaceutical markets,” Mérot added.
Significant promise
“I believe that our joint project holds a significant promise for improving the treatment of breast cancer patients and will further open up a plethora of additional opportunities for switching injectables to orally administered drugs,” noted Ole Wiborg, Chief Executive Officer of Zerion Pharma.
“This blue stamping from EUREKA is also another recognition of our Dispersome technology and our excellent team of scientists, who have relentlessly transformed great academic science into a commercially successful technology. I am grateful for that,” Wiborg concluded.
__
Note: * Eurostars is a joint programme between EUREKA and the European Commission, co-funded from the national budgets of 37 Eurostars Participating States and Partner Countries, and by the European Union through the Horizon Europe framework, supporting innovative SMEs and project partners, including universities and research organizations, through funding for international collaborative R&D and innovation projects.
Highlights of Prescribing Information
Trastuzumab (Herceptin®; Genentech/Roche)[Prescribing Information]
Reference
[1] Namiki N. [Formulation Development for the Purpose of Improving Medication Adherence]. Yakugaku Zasshi. 2021;141(10):1173-1184. Japanese. doi: 10.1248/yakushi.21-00117. PMID: 34602514.
[2] Madani F, Hsein H, Busignies V, Tchoreloff P. An overview on dosage forms and formulation strategies for vaccines and antibodies oral delivery. Pharm Dev Technol. 2020 Feb;25(2):133-148. doi: 10.1080/10837450.2019.1689402. Epub 2019 Nov 24. PMID: 31690146.
Featured image licensed under the Unsplash+ License.
DOI
 formulation of trastuzumab (reference drug Herceptin®; Genentech/Roche), the pioneer monoclonal antibody used to treat breast cancer. The project has been awarded funding under the EUREKA Eurostars program, the only European funding programme dedicated to supporting early-stage R&D-performing companies, including start-ups.){kind=link}