Simon Burns: [00:00:00] Dr. Sachse, thank you for joining us on First In Human.
Dr. Richard Sachse: You’re welcome. a pleasure to meet you. Thanks for the invite.
Simon Burns: Of course. Maybe to kick it off, we’d love to do quick introductions. Tell us about yourself. You’re currently Chief Medical Officer at SOTIO, but you’ve had a very illustrious career. Tell us about your background.
Dr. Richard Sachse: My name is Richard Sachse, I am a physician. I’m trained in internalism. I have a board certification in clinical pharmacology. And I have a long-standing experience with pharmaceutical industries for more than 25 years covering the entire value chain from late-stage preclinicals through to registration. In the first parts of my career, mostly with big pharma at some stage, joining smaller companies, typically in the function of a chief medical officer.
I am now since three years with SOTIO. SOTIO being an ambitious biotech with a very interesting stable pipeline. We have three platform technologies. We have immunocytokines, we have ADZ’s and we have cell therapies, CAR T therapies in treatment of solid tumor.
All of those three are already in the clinical stage. This is extraordinary for a biotech company to have three different project platforms in the clinic. We are very proud of this achievement over the last three years. We are looking forward to continue the progress of our pipeline.
Simon Burns: Let’s take here a retrospective on your career in drug development. What are the key lessons learned throughout your time? Were there failures that led to later successes that you thought were instrumental?
Dr. Richard Sachse: This is a question I frequently get. In my experience, one of the key lessons learned is the early discussion between clinical and research. Which can never start too early. An early in depth discussion between both functions on a medical need, on clinical outcome measures, on the patient perspective is vital for research to design the right experiments at an early stage.
There needs to be an early mutual understanding of the potential and of the limitations of pharmacodynamics markers, certification markers, and predictive markers in order to design early on the right strategy. As well as to come up with definition of early go, no-go criteria.
I have seen smooth project progress if criteria and decision points have been defined upfront. And this is really critical and important to come up with decisions early and even to terminate unsuccessful projects early. In some companies, there might be a tendency to not define strict go, no criteria simply because people are afraid of terminating a project.
By this they may base their resources on unsuccessful projects which they could more wisely spend on a more promising project. It’s highly important and I would always encourage to establish translational markers which inform the development program as early as possible. And ideally such markers would enable you to make the right decision on the project. In particular go, no-go decisions. But all the decision on dose, dosing frequency. And any other decisions that might influence the progress of your development program.
Simon Burns: Let’s go back to some of the programs you have in clinic with SOTIO. Several programs, and not necessarily easy programs either. CAR T, ADC’s, you’ve got some complexity in there. Walk us through some of the complexities and some of the lessons learned running complex oncology clinical trials.
Dr. Richard Sachse: One of the challenges is certainly the recruitment into immuno-oncology trials. This has been challenging in the past. With shortages inside staffing as a side-effect of the COVID pandemic, this is becoming even more challenging.
But this holds through also for any clinical trials in any other therapeutic area. Some of the major issues that influence recruitment in your trial are the complexity of the trials. The ongoing competitive trials, recruiting is similar. Or, even the same patient population.
The complexity of a trial really impacts the resource needs at the site. This is an important topic to consider. There is always a balance between measurements of parameters that are mandatory. Parameters that have an impact on the project progress, and on future decisions. Some parameters that are just nice to have.
We try to reduce, as much as possible, of the complexity. But we also have to consider all of the topics that we just discussed two minutes ago when we were discussing the need for these translational by-markers. It’s inevitable that [00:05:00] you will need to make a compromise, at least to some extent. But, you should not simplify the trial too much so that it will not be informative anymore and not help you with your next project decisions.
It’s also important to work closely with the sites and to support the sites from the very beginning. This starts with all of the processes from contracting to site activation. Which requires a very strong alignment between the CRO and the sponsor. But also a strong support of the site by both the CRO and the sponsor.
A close interaction and communication between sponsor and CRO, including clear definitions of responsibilities are then key to also ensure appropriate communication with the sites, which is one of the key factors in progressing our clinical studies.
Simon Burns: So say there was a young biotech company. They’re running into their first clinical trial, they might have filed their first IND zero selection, site selection, how to think about, protocol design endpoints, et cetera. What are some key mistakes you see small biotech companies make? And what advice would you have for this generic, hypothetical small biotech?
Dr. Richard Sachse: Financing is always a critical topic for all companies, not only for small biotechs, but in particular for small biotechs. A close alignment between management and board is required where management clearly outlines the risks and opportunities related to certain investments.
Also, it’s already emphasized earlier in this discussion, a clear definition of go no-go criteria. Clear definition of value inflection points is key in building a trustful relationship between board, investors, and management.
SOTIO is driven by medical need and science. We aim to bring in novelty therapies to patients offering significant benefits over existing treatments. The execution of our development plans in moving forward projects along the value chain is driven by an experienced, very engaged team of drug developers.
The internal focus here is on strategic planning and on decision-making while we work with the external parties on the execution of those relevant activities. For every project, we are predefining project specific value inflection point which will then trigger the next activities. This means we can ensure that we de-risk our projects and respective investments while realizing that R&D in the pharmaceutical and biotech industry is always and will always remain a risky exercise.
However, I have to say the potential reward is high when you see individual patients benefiting from your treatment, even at a very early development stage. We are observing such early stage case studies with patients who were relapsing under all previous treatment regimen suddenly respond to our investigational drug. This is a very high reward any drug developer shouldn’t miss. When you realize that you were able to help a patient who did not have any other treatment alternatives, this is very rewarding.
Simon Burns: We’d love your thoughts, Dr. Sachse on the future of ADC’s, the future of CAR T. Take us three or five years out. What are you tracking closely, and what do you think the impact is gonna be?
Dr. Richard Sachse: It’s always hard to predict the future. In any case, immunotherapy in oncology will continue to revolutionize the medical treatment of cancer patients. This may be triggered by new immunocytokines. This may be triggered by new cellular therapies, by ADC’s, or any other treatment modalities working via activation or redirection of the immune system.
We will most likely see more projects moving forward into the clinical development stage. Providing to patients and physicians a broad spectrum of innovative treatment modalities for individual patients with the potential to address more individually specific patient needs. Such patient needs may be defined by the nature of the tumor, by the nature of the tumor microenvironment.
Some other patient specifics are living circumstances. The patient will have individual needs for maximum duration of hospitalization. For instance, specific needs for treatment schedule, convenient administration schedule, et cetera.
In other words, the space will be even more crowded. Thus, it will be even more important that the sponsor, together with the CRO, will be able to fully address the clinical site’s needs as well as the patient’s needs in order to motivate both to [00:10:00] participate in this particular trial and not in a trial run by somebody else.
Simon Burns: Lastly, at Vial we think a lot about clinical trial technology, infrastructure to run trials more efficiently, and applications of technology to make trials more efficient. We’d love your thoughts on where you think there’s room for technology to be applied to run trials more efficiently.
Dr. Richard Sachse: Technology is one of the major drivers for future clinical development. As highlighted with the entire environment becoming more complex, more resource intensive. In an environment which is lacking resources. You need to implement certain technologies enabling you to cover for the lack of those resources. There are things which always will need to be done manually by the clinical staff, be it the administration of study drug, taking blood, or any other work directly with the patient.
However, the logistic around the clinical conduct, the collection of the data, the transfer of data into a database, the automated interpretation of data and a lot of other things. This is still offering a wide range of opportunities to further improve clinical processes. Such improvements will be essential in order to run a competitive trial, which is interactive not only to the patient but also to the clinical trial site. And therefore, the implementation of advanced technology is important, it’s vital for clinical development.
Simon Burns: Dr. Sachse, thank you so much for your time. I appreciate it very much. Have a great rest of your day.
Dr. Richard Sachse: You’re very welcome. It was a pleasure talking to you. Thanks very much for inviting me.
