Alentis Therapeutics is a Swiss-based biotechnology company pioneering the development of antibody-drug conjugates and antibodies targeting Claudin-1 for the treatment of cancer and fibrosis.
Roberto, you have a rich professional experience, including at Roche. What brought you to Alentis Therapeutics five years ago?
I am an MD/ PhD by training, having studied in Italy and completed my PhD at the Max Planck Institute in Germany. Since childhood, my dream has been to discover a medicine, which is why, following my PhD, I decided to learn how to develop drugs. I was fortunate to be hired by Roche, where I gained extensive experience in leading programs and understanding the complexities of drug development, including innovation and regulatory requirements. My last role at Roche was heading rare disease research, which exposed me to many biotech companies and venture capitalists.
During this period, I realized that while big pharma plays a crucial role, the majority of innovative drugs actually originate from biotech. This prompted me to explore another side of the industry. I joined Versant Ventures, a global VC firm, where I had the opportunity to be involved in launching biotech companies such as Black Diamond Therapeutics and Bright Peak Therapeutics. It was during this period that I met Professor Thomas Baumert and became intrigued by his research on Claudin-1. This led to the founding of Alentis, which began with just three people and minimal funding, but a clear vision that Claudin-1 could become a key driver of innovation.
Could you introduce us to the significance of Claudin-1?
The significance of Claudin-1 became even more evident when we closed our Series D funding round last year, attracting leading investors such as Orbimed, Novo Holdings, Jeito, Longitude, RA Capital, and others. This reinforced the idea that our approach is both unique and valuable. Our board includes industry leaders such as William Pao, the former global head of pRED at Roche and later the Chief Development Officer of Pfizer, where he was involved in Pfizer’s $40 billion acquisition of Seagen. This acquisition was based on a breakthrough in antibody-drug conjugates (ADCs), a new oncology therapeutic modality that we are now leveraging in our own approach.
ADCs work by using antibodies to target proteins specifically expressed on cancer cells. This allows for highly precise delivery of a chemotherapeutic, significantly reducing toxicity compared to traditional treatments. Many patients suffer from severe side effects of chemotherapy, including neuropathy, hair loss, and neutropenia. With ADCs, we can deliver treatment directly to cancer cells while sparing healthy ones. We identified that Claudin-1 is overexpressed in several common cancers, such as colorectal, lung squamous, and head and neck cancers. By targeting it with anti-Claudin-1 ADCs, we saw remarkable preclinical results—one dose was enough to eliminate tumors in humanized mouse models. This led us to move rapidly toward clinical trials, supported by strong investor backing.
What is the relationship between Claudin-1 and fibrosis, which is another major focus of Alentis?
Claudin-1 plays a crucial role in fibrosis, just as it does in cancer. Chronic inflammation can lead to fibrosis, which in turn can increase the risk of cancer. This intrinsic connection between fibrosis and cancer is what initially drew our founder, Professor Baumert, to study Claudin-1. Unlike in cancer cells, where Claudin-1 is overexpressed in a pathological manner, in fibrosis, its expression alters the stiffness of the surrounding tissue, leading to organ dysfunction.
For instance, in kidney fibrosis, excessive tissue stiffness prevents normal organ function, which can eventually lead to end-stage renal disease and the need for dialysis. Our first clinical trial focused on a severe kidney inflammation and fibrosis disorder known as ANCA-associated vasculitis with rapidly progressive glomerulonephritis. Without adequate treatments, these patients can lose renal function within weeks. This study provided early clinical validation of Claudin-1’s role in fibrotic diseases, paving the way for our broader research into targeting organ fibrosis such as in liver fibrosis and idiopathic pulmonary fibrosis.
Your company recently received an FDA Fast Track designation…
Yes, we recently received Fast Track designation for our ADC program, ALE.P02, which is a significant achievement. This designation not only accelerates our development timeline but also underscores the potential impact of our therapy.
Where do you conduct your clinical trials?
Our clinical trials are conducted globally, with a strong focus on the U.S. and Asia, including Singapore, Hong Kong, South Korea, and Taiwan. We also conduct our trials in Europe but unfortunately, Europe often lags behind due to regulatory delays. It is not a matter of preference but rather a reality of the slower processes in Europe compared to the U.S. and Asia. This is a challenge for European competitiveness in biotech innovation. We hope that Europe will streamline its processes to remain at the forefront of drug development. Speed is critical in bringing potential medicines to patients, and these delays create real challenges for both companies and patients in need of innovative treatments.
As a result, we have expanded our presence in Asia, where countries like Singapore and South Korea have highly competitive timelines. There is an urgent need for Europe to accelerate its clinical research infrastructure. While university grants and preclinical innovation are important, Europe must also streamline clinical trial guidelines and decision-making processes. Often, we face delays simply due to uncertainties around which regulatory body to refer to for submissions. We hope that policymakers recognize this issue and take steps to improve the efficiency of clinical trial approvals.
What can we expect from your pipeline in the coming years?
We focus on months, not years, because our priority is to move as quickly as possible. Our pipeline is built around a high-value target, and we have a strong team in Switzerland and the U.S., backed by top investors primarily from the U.S., along with key European investors. This gives us all the necessary ingredients to advance our programs efficiently.
Our lead candidate in oncology, ALE.P02, is a groundbreaking ADC under FDA Fast Track designation for squamous histology cancers. Traditionally, cancers are classified by organ, but histological differences such as squamous versus adenocarcinoma are crucial. Our Fast Track designation covers all Claudin-1-positive squamous tumors, regardless of the organ—whether lung, head and neck, cervical or esophageal cancer. We are currently dosing the first patients in a Phase 1/2 clinical trial, and within the next 10-12 months, we expect to see initial response rates. By 2026, we aim to consolidate these results. Additionally, we plan to initiate clinical development of our second ADC program, ALE.P03, targeting CLDN1+ tumors including colorectal cancer in the second half of 2025, likely starting in the U.S. before expanding to Asia.
Why should investors and industry leaders follow Alentis’s progress?
Alentis is leading the way in targeting Claudin-1 for antibody-drug conjugates, addressing a significant unmet medical need in cancers such as lung squamous and colorectal cancer. There is a clear scarcity of new targets in this space, and we are uniquely positioned as pioneers in Claudin-1 research.
With nine potential indications, a highly differentiated approach, and strong scientific backing, we are well-positioned to make a substantial impact in oncology. Investors should follow Alentis because we are at the forefront of this innovation, driving the development of highly targeted, effective therapies that can redefine cancer treatment.
