Debiopharm, an independent Swiss biopharmaceutical company based in Lausanne, seeks to carve a niche in the competitive oncology and infectious disease markets. Its business model focuses on in-licensing promising drug candidates from universities and smaller biotechs, aiming to add value through development. (The company is also partnering with AI-focused firms like VeriSIM Life.) Sandra von Meier, its head of business development, highlights the company’s exploration of DNA damage response pathways, with Debio 0123, a Wee1 kinase inhibitor, as a notable Phase I asset. Debiopharm also emphasizes its proprietary Multilink linker technology for antibody-drug conjugates, a field with potential to improve therapeutic outcomes.
We’ve lightly edited the responses for brevity.
Can you provide a broad overview of Debiopharm and its drug discovery and development strategy?
Sandra von Meier
Sandra von Meier: Debiopharm is a privately owned, mid-size biopharmaceutical company focusing on developing innovative therapies in oncology and infectious diseases. We do not work on drug discovery but seek to partner with universities and small biotechs to in-license early stage drugs. Then we add value through translational medicine and clinical development with the aim of out-licensing to larger pharmaceutical companies for commercialization.
So, our business model includes both in and out licensing. In at pre-IND stage, focusing mainly on oncology, but no commercialization on our own. We do collaborate for discovery (Genome, Ubix) as well as clinical collaboration for late stage assets (see Repare), in addition access to novel AI via our investments done by our investment arm DPIF
Debio 0123, your Wee1 kinase inhibitor, recently entered phase I testing. Can you discuss the preclinical data supporting this program and what you hope to demonstrate in the phase I trial?
Sandra von Meier: Hard-to-treat cancers such as small cell lung cancer and glioblastoma carry a high burden of genomic instability and have limited treatment options and poor prognoses. We have started several clinical trials with Debio 0123, our specific Wee1 inhibitor to enhance the effect of DNA damaging agents, as such we are running a study in small cell lung cancer and glioblastoma brain cancer with standard chemotherapy in combination. Debio 0123 has excellent potential to be used with other DNA damaging agents to exacerbate the genomic instability of cancer cells. Consistent with this, Debio 0123 shows strong synergy and anti-tumour efficacy in vivo in combination with chemotherapy and radiotherapy. Through our phase I research we are aiming to demonstrate anti-tumor activity and safety profile both as monotherapy and in combination with other cancer therapies.
Primary brain tumors are notoriously hard to treat due to the lack of treatments that can pass the blood brain barrier; more brain penetrant compounds are needed.
Debio 0123 has shown the ability to penetrate the brain so we have high hopes for this difficult to treat patient population.
Recently we entered into a clinical collaboration with Repare to combine Debio 0123 with Repares’ lunresertib, a PKMYT1 inhibitor in patients with advanced solid tumors, following preclinical results showing synthetic lethality .
You have several antibody-drug conjugate programs using your proprietary Multilink linker technology. How is this linker designed to improve over existing ADC linkers on the market?
Sandra von Meier: Multilink is a new cleavable linker platform with the potential to improve both the safety and efficacy of ADCs. It is compatible with any conjugation technology, enabling the production of ADCs with high DAR (drug-to-antibody ratio). Multilink’s unique design allows the loading of multiple payloads on an antibody and offers a rapid, specific intracellular cleavage mechanism for efficient payload release. It allows rapid and specific intracellular cleavage of a hydrophilic linker, resulting in efficient payload release. Despite higher DAR, there is lower toxicity in comparison to other non-cleavable linkers.
We recently partnered with SunRock, a Spanish biotech, to develop novel ADCs targeting HER2/HER3 expressing tumors, which have shown promise in breast and lung cancers. Additionally, we’re developing a CD37-targeting ADC for hematological cancers. Our proprietary Multilink technology allows us to couple multiple payloads to an antibody, potentially increasing the efficacy and stability of this ADC. We’re actively exploring further collaborations using Multilink and are excited to move our first Multilink-based ADC into the clinic next year.
You announced a partnership with Merck KGaA in 2021 to develop Debio 1143, an IAP antagonist. What made you decide to partner with this program and what can Merck bring to the table?
Sandra von Meier: This partnership shows our success story in developing meaningful novel treatment options for patients, Xevinapant is enhancing the effect of radio and chemotherapy and is developed in Head and Neck cancer by Merck KGaA.
The main reason we decided to partner with Merck KGaA, is their strong footprint in head and neck cancer through its Erbitux franchise. Discussions and research led us to understand that they are the right partner to move this program through the two phase 3 trials currently ongoing. We will receive the first phase 3 readout still this year and hope we can bring with Merck KGAA as our commercialization partner this novel treatment to patients in high need of novel therapies.
How do you decide which programs to advance internally versus seeking partnerships?
Sandra von Meier: We focus on creating value through clinical development, de-risking projects to attract pharma partners for commercialization. When we’ve established preliminary clinical efficacy and safety for a drug, we seek partners with the expertise and resources for pivotal late-stage research and global market access.
Can you provide a high-level overview of your overall R&D strategy and which specific focus areas or approaches you choose to prioritize?
Sandra von Meier: In terms of in-licensing we are open to all modalities with first-in-class or best-in-class potential. At this time, however, much of our development is focused on ADCs, and DNA damage repair (DDR) molecules as demonstrated by our most recent deal making in 2023. We mainly closed deals in the ADC space as well as strengthened our DDR expertise through addition of Debio0432, the USP1 inhibitor from Forma, which was acquired by Novo Nordisk before entering our development pipeline. In addition to our expertise in ADCs and DDR, we are developing long-acting formulations for hormone dysregulation related illnesses.
What are a couple early-stage assets that you are particularly excited about right now and why?
Sandra von Meier: We are looking forward to seeing the efficacy and safety data for our Debio0123 which is in multiple phase 1/2 trials currently under investigation. We are also thrilled about the pre-clinical advancement of Debio 1562M, an ADC leveraging our linker technology Multilink . We are currently very excited about our clinical readouts to come as these will show if our novel therapies can benefit patients. Concerning later stage assets, as mentioned Xevinanpant Ph3 data (Trilynx) will readout this year.
Filed Under: clinical trials, Drug Discovery, machine learning and AI, Oncology
