In this discussion, Moe Alsumidaie interviews Peter Schiemann, CEO and Chairman of Ymmunobio, about the company’s innovative approaches to targeted therapy. Dr. Schiemann shares insights on targeting cancer at a molecular level, regulatory strategies, and plans to enhance patient outcomes and attract investment.
Moe Alsumidaie: How is Ymmunobio advancing targeted therapies to treat solid tumors more effectively at a molecular level?
Peter Schiemann: At Ymmunobio, we are pioneering the development of targeted immunotherapies by identifying a novel tumor target with exceptional properties. This target is present in at least 13 solid tumors, with a high prevalence in patients—up to 95% in colorectal cancer and 90% in breast cancer, for example. This biomarker is hardly present in healthy tissue, offering a significant advantage over current oncology biomarkers that often appear widely in normal tissues. We are developing three therapeutic approaches, including an immuno-oncology compound with bispecific antibodies besides ADCs and radiopharmaceuticals. These bi-specific antibodies are designed to bind to T cells, inducing cytokine release to target tumor cells specifically. Our target’s uniqueness of being
absent in normal tissue gives us a significant edge over existing therapies. This specificity reduces the risk of off-target effects, making our approach safer and more effective.
Moe Alsumidaie: What challenges do you face in balancing innovation with regulatory compliance in immuno-oncology?
Peter Schiemann: Surprisingly, we do not face many challenges in this area. Our team comprises experts with 25 to 30 years of experience in oncology drug development and are well-versed in regulatory environments. We are aware of the developments and do not foresee significant hurdles. Regulations often support our efforts rather than hinder them. For instance, we might not need in vivo tests with transgenic mice, which are costly, to progress into human trials with our bispecific antibodies. This regulatory flexibility could expedite our development process and reduce costs, allowing us to focus on innovation. Our experienced team ensures we remain compliant while pushing the boundaries of what’s possible in immuno-oncology.
Moe Alsumidaie: How are you adapting study design to enhance patient recruitment and retention in rare diseases?
Peter Schiemann: In oncology, we start with dose escalation studies in various solid tumors to ensure safety and efficacy. Once we have that data, we will move to expansion cohorts, focusing on high-incidence cancers like colorectal or breast cancer. Our strategy depends on the therapeutic we advance, whether a radiopharmaceutical, bispecific antibody or ADC. Real-world data might not be feasible for all, especially with radiopharmaceuticals, due to the need for special facilities. For example, our radiopharmaceutical development with the Paul Scherrer Institute involves testing isotopes like lutetium and terbium, which require specific handling and infrastructure. By tailoring our approach to each therapeutic, we aim to maximize patient recruitment and retention while ensuring the highest safety and efficacy standards.
Moe Alsumidaie: How do you plan to leverage recent funding to attract further investment and advance your pipeline?
Peter Schiemann: To date, we raised 1.322 million Swiss francs from founders and friends, plus additional support from the Swiss Government for developing radiopharmaceuticals. Our goal is to achieve proof of concept in the preclinic, crucial for attracting larger investors. We have a convertible loan currently open for investors, aiming to reach proof of concept in one of our therapeutic areas. This funding will help us conducting necessary preclinical tests to demonstrate the efficacy and safety of our therapies, which is essential for securing further investment and advancing to clinical trials. We aim to build investor confidence and secure the resources needed to bring our innovative therapies to market by achieving these milestones. In addition, we are also currently speaking with pharmaceutical companies regarding possible co-development partnerships.
Moe Alsumidaie: How do you differentiate your antibody therapies from those of other biotech companies?
Peter Schiemann: Our competitive advantage lies in our unique target, which is present in at least 13 solid tumors and hardly in normal tissue; in addition, it has a high prevalence in patients, e.g. colorectal cancer 95%, breast cancer 90%, cervical cancer 90%, pancreatic cancer 80%, etc. We have filed two patents, making it difficult for competitors to work on the same target. Our target’s properties, such as its role in embryonic development and downregulation post-birth, provide a clear advantage in developing therapies with minimal off-target effects. This specificity allows us to focus on solid tumors without affecting healthy tissues, a common challenge in cancer therapies.
Moe Alsumidaie: Would you like to add anything else?
Peter Schiemann: We are also working on a diagnostic partnership to analyze extracellular vesicles, which could aid in early cancer detection and screening. This method involves a simple blood test that could detect our target, potentially identifying cancer at a very early stage. Additionally, we are developing a SPECT scan option for imaging tumor locations, enhancing treatment precision. Our focus remains on demonstrating proof of concept in animal models to validate our approach. These diagnostic tools could revolutionize cancer screening and monitoring, providing a comprehensive approach to cancer care. By integrating diagnostics with our therapeutic strategies, we aim to improve patient outcomes and advance the field of oncology.
Moe Alsumidaie is Chief Editor of The Clinical Trial Vanguard. Moe holds decades of experience in the clinical trials industry. Moe also serves as Head of Research at CliniBiz and Chief Data Scientist at Annex Clinical Corporation.
