Interview with Ola Nilsson, Neogap Therapeutics

A few weeks ago, we had the opportunity to meet with Ola Nilsson, Head of Neoantigen Production & Development at Neogap Therapeutics, to discuss their ongoing study. This First-In-Human Phase I/II trial aims to evaluate the safety and effectiveness of a novel T-cell immunotherapy in patients with advanced colorectal cancer. 

As close collaborators with Neogap, a Swedish immuno-oncology company, we were eager to hear their thoughts on the study as they move forward with their drug candidate in clinical trials. Founded in 2016, Neogap is now on the brink of demonstrating the results of eight years of preparation. 

The Future of Cancer Treatment: Immunotherapy 

Neogap’s vision is clear: to cure cancer through personalized, advanced immunotherapy. They are confident that this vision can be realized.  

But before jumping into the how, let’s take a few steps back and provide some context.  

Immuno-oncology is a field of medicine that focuses on using the immune system to combat cancer. The immune system is designed to recognize and eliminate foreign invaders, such as viruses and bacteria, as well as abnormal cells, including cancer cells. However, cancer cells can sometimes evade detection and develop ways to avoid destruction by the immune system.  

Immunotherapy represents a promising frontier in cancer treatment. It aims to harness the body’s natural defenses to combat the disease more effectively and with fewer side effects than traditional treatments like chemotherapy and radiation. However, challenges persist in predicting patient responses and managing potential immune-related side effects such as inflammation and autoimmune reactions. 

CAR-T cell therapy is a type of immunotherapy that has been a hot topic during the past years. In this therapy, the patient’s own T-cells are taken out, genetically modified, and then reinfused back into the patient. This approach shows groundbreaking advancements in cancer treatment but continues to face challenges related to managing side effects. Recently, another T cell product, the tumour-infiltrating cell product Lifleucel, was approved in the US by the FDA. 

Neogap takes a different approach by using the patient’s own T-cells to target cancer in a personalized and precise manner, without genetic modification. 

Neogap’s Unique Approach 

Neogap’s innovative approach targets neoantigens, which are specific to each patient’s tumor, allowing for a highly personalized treatment.  

But what exactly are neoantigens? These are formed when mutations in the genetic code, which occur randomly during cell division, result in an amino acid change that can alter the function of the resulting protein. A healthy immune system typically recognizes and eliminates these neoantigens, but if they go unnoticed, cancer can develop. As a tumor forms, cancer cells find new ways to “hide” from the immune system’s T cells. 

Neogap’s technology trains the patient’s own T cells to recognize and attack these neoantigens. The immunotherapy process involves identifying the most relevant neoantigens, expressing them as recombinant protein targets, and delivering them using the EpiTCer® bead technology to train and multiply the patient’s neoantigen-specific T cells. Unlike CAR-T cell, Neogap does not genetically modify the T cells. Instead, their approach enhances the patient’s natural immune response through a highly personalized and targeted approach.  

“The T cells are not manipulated to become more aggressive, only more targeted,” explains Ola.  

How Does Simsen Diagnostics Come into the Picture? 

The challenge within this technology lies in the fact that each patient and tumor are unique, with tumors containing multiple mutations and, hence, multiple neoantigens. Effective therapy requires targeting the most relevant mutations. With 22,000 genes in each individual, identifying the most relevant mutations presents a big challenge. To address this, Neogap has developed proprietary software, PIOR®, which identifies the most relevant neoantigens. It’s also here that Simsen Diagnostics enters the picture with their solution, Simsen® Personal—a crucial piece of the puzzle.  

“PIOR® enables us to select the most relevant mutations and neoantigens to target with our therapy. The personalized panel in Simsen® Personal is then used to monitor each mutation over time. Each of the 36 neoantigens detected by PIOR® for each patient can be monitored with the help of Simsen’s panel,” says Ola.  

“This is a major step up from traditional cancer panels, which are impractical for this purpose, as they contain few, if any, of the mutations targeted by PIOR®,” adds Ola.  

The personalized approach is what sets Neogap’s immunotherapy apart, significantly improving the ability to assess the therapy’s effectiveness for each patient.  

The Beginning of a New Era? 

Ola Nilsson has been a key member of Neogap Therapeutics since the start. Alongside CEO Samuel Svensson, founder Hans Grönlund, and a team of expert scientists, Ola has played a crucial part in developing both the PIOR® software and the EpiTCer® beads technology. He is eagerly looking forward to the upcoming study: 

 “The pilot study with Simsen Diagnostics last year showed promising results, and this study marks an important milestone for Neogap’s treatment development. Using Simsen technology to closely monitor the treatment’s progress will provide valuable insights. This eight-year journey has led us to this important moment,” says Ola. 

Although this specific study focuses on patients with colorectal cancer (CRC), the treatment is expected to have a significant impact on other cancer types as well. CRC represents 10% of all cancer cases and is the second most common cause of cancer-related deaths. While early detection often allows for successful treatment, the five-year survival rate for patients with stage IV metastasized disease is only 13%. Ola and the team acknowledge a significant unmet medical need and high market demand for this patient group, evidenced by strong interest in patient recruitment. 

Expectations for this study are high, but the Neogap team sees it as the beginning of a transformative journey towards achieving their ultimate goal: to cure cancer through next-generation cell therapies. 

“We are proud to contribute to this groundbreaking study and look forward to the potential it holds for advancing cancer treatment,” says Pontus Rehn, CEO of Simsen Diagnostics. 

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Pontus Rehn

Chief Executive Officer (CEO)

Pontus Rehn has over 20 years of experience in commercial leadership roles in the medical device and IVD industries, including global and regional positions like VP Market Development, Chief Commercial Officer, and Director of Commercial Strategy. 

Lina Said

Laboratory and Quality Manager

Lina Said, a licensed Biomedical Scientist, brings 18 years of experience from Sahlgrenska University Hospital to her role as the Lab and Quality Manager at Simsen Diagnostics. Her primary focus is ensuring quality assurance and fostering an optimal work environment for the lab. 

My Vu

Lead Laboratory Technician

My Vu is currently doing a master’s degree in biotechnology and demonstrates expertise in laboratory procedures. Her previous experience includes analyzing COVID samples and conducting her bachelor’s thesis at Fraunhofer. My is analyzing all the samples that comes to the lab.  

Stefan Filges

Chief Technology Officer (CTO)

Stefan Filges, an accomplished bioinformatician with a Ph.D. in ultrasensitive sequencing, became part of Simsen Diagnostics in 2022. He played a crucial role as a co-author in the original publication of SiMSen-Seq, which was published in Nature Protocols. 

Camilla Hietanen

Head of Sales and Marketing

Camilla Hietanen holds an M.Sc. in Business Development from the Chalmers School of Entrepreneurship. Her academic background encompasses studies in Sports & Nutrition, and she brings prior experience from various Start-ups. Within Simsen Diagnostics, her primary focus lies in Sales and Marketing. 

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