Lamassu Pharma Bridges Scientific Knowledge and Patient Care

In the realm of drug development, the industry puts a great deal of emphasis on centering the patient experience. As a result, it is imperative that drug developers consider how they translate scientific and medical knowledge into actionable insights that support the patient journey. To delve deeper into this topic, Pharmaceutical Technology^® sat down with Gabi Hanna, co-founder and CEO of Lamassu Pharma, to talk about the company’s beginnings, as well as its novel small molecule MDM2 inhibitor that activates P53 to control cancer growth.

PharmTech: Starting with the inception of Lamassu Pharma and the corporate focus, can you tell us about initial clinical indications?

Hanna: The company was founded in 2018 by three founders who are physicians and scientists. We focused on addressing unmet needs and translating scientific knowledge to patient care. When we started, there was a lot of knowledge but few options for conveying it to patients. That was the big gap we tried to bridge. I'm the director of the drug development center at Duke University. The second co-founder, Rabi Hanna, MD, is the director of pediatric oncology at the Cleveland Clinic. The third co-founder, Greg Palmer, PhD, is the associate director for the Duke Cancer Institute. With our experience, we had the basic knowledge to achieve our goal and maintain a focus on science while also remaining patient centric.

Our first project involved partnering with Mayo Clinic in 2019 to develop a treatment for acute pancreatitis. In just a few years, we advanced it to Phase I, partnered with another group, Arrivo BioVentures, completed Phase I successfully, and are now in Phase II. Two years ago, we partnered with the European company Adamed. We developed a very novel oncology platform focused on wild-type P53, which potentially can target 50% of all cancers. P53 is perhaps the most important gene regulating cancer; in fact, it's called the "guardian of the genome." Our therapy, a small molecule MDM2 inhibitor, activates P53 to control cancer growth.

PharmTech: What's the trajectory in sarcoma? Where are you in terms of development, and when will you initiate the clinical trial?

Hanna: The MDM2 inhibitor can potentially target up to 50% of cancers. We are focusing on sarcoma, a field in which treatment has not changed in ~30 years. We received investigational new drug (IND) approval from the United States Food and Drug Administration (FDA), and we have a novel therapeutic protocol agreed upon by the FDA. Our leading site is the Cleveland Clinic, so it will be a multi-site study that first starts with the Cleveland Clinic and lead to expansion. There is a consortium we will expand to, but we will begin with the acceleration phase, treating the first few patients at the Cleveland Clinic with our strategic partners leading the trial. We expect to have the first patient treated within the next two months.

PharmTech: Will this be a traditional dose-escalation study to find the optimal dose in Phase I?

Hanna: Yes. The approach will be traditional but also innovative. The FDA has allowed us, given the significant unmet need, to use a smaller group of patients to escalate the dose more quickly. Typically, dose escalation starts at a low, safe dose and gradually increases to find the best dose. However, this can be ethically challenging for cancer patients who might receive sub-optimal doses initially. The FDA is helping us by allowing a smaller patient group to escalate quickly. We will start with one patient to find the optimal dose faster, benefiting sarcoma patients who have limited treatment options.

PharmTech: Are you envisioning running the study entirely within the company, or will you potentially partner with pharmaceutical companies?

Hanna: We do not use contract research organizations (CROs). We run the trials directly due to our expertise, experience, and network. As mentioned, we come from academia, with scientific and practical backgrounds. We already have partnerships with the National Cancer Institute (NCI) and the National Institutes of Health (NIH). We have direct knowledge and collaboration with principal investigators and scientists. We've run CROs before, so we have the team to manage the trial directly. This approach serves patients best, accelerates development, and allows us to react in real time to any issues, which is crucial given that we are treating very sick patients.

We manage direct patient care with the principal investigator (PI) and the hospital. Our goal is to advance the drug to NDA approval. If we find a good partner along the way, we will partner, but we are not planning to conduct a study and then wait for a partner. However, like with our acute pancreatitis program, if we find a good partner, such as Arrivo BioVentures, we will collaborate. We are open to partnering in oncology at any stage if we find a suitable partner.

PharmTech: Other companies have studied the MDM2 pathway. What makes your approach different? Is it the P53 wild-type aspect?

Hanna: That's correct. We consider our approach as more of a third-generation solution, addressing some of the safety issues seen before. There's no approved MDM2 inhibitor drug currently. One advantage of coming into this area later is learning from previous lessons, identifying potential pitfalls early, and testing whether we can overcome them. The disadvantage is that we are a bit behind, but we believe our asset could potentially be best in class. Our in-house testing shows it to be more potent and to have a better safety profile.

Additionally, P53 MDM2 represents a significant market. Targeting 50% of all cancer patients is a huge opportunity, with room for multiple routes if proven efficacious and safe. Sarcoma is one of the biggest unmet needs, with over 90% of sarcoma patients having P53 wild-type. Because it's a smaller market, with around 13,000 patients in the US, development can be faster. It falls under the rare oncology category. As a smaller company, we focus on early proof of concept before tackling larger cancer types. Scientifically and ethically, it is good to address the biggest unmet needs first. Starting strategically with the biggest unmet needs and smaller, more controllable studies allows us to expand to larger cancer treatments later.

PharmTech: In terms of clinical development priority, given that you're already in Phase II, would pancreatitis be your lead indication with cancer following that?

Hanna: These are two different categories. We partnered with Arrivo BioVentures for pancreatitis, but they are not involved in the cancer aspect. Pancreatitis is inflammation, while cancer is a separate focus.

PharmTech: Tell us about the leadership team at Lamassu Bio and the growth trajectory in terms of expanding the team. How many full-time employees do you have right now?

Hanna: We intentionally keep the team small to maintain direct oversight and efficiency. We aim to have three to four assets maximum, keeping the group small and focused. We work closely with universities and rely on outsourcing. We do have more than 10 but aim to keep it under 20. This smaller size allows for direct interaction and fewer hierarchical levels, enabling faster decision-making and problem-solving, especially when treating very sick cancer patients. We prioritize patient care over company interests, adhering to our ethical code.

PharmTech: Do you have any additional thoughts on the future directions of the company?

Hanna: We are in discussions to bring in more partners and assets, particularly in oncology. We are expanding our team to manage trials directly and are also expanding to Canada, specifically Montreal, where we have established a partnership with McGill University. Our focus will be on oncology and direct management.