Guest article

IP considerations for early stage biotech – Quell Therapeutics

In 2025 the award of the Physiology or Medicine Nobel Prize went to Mary Brunkow, Fred Ramsdell and Shimon Sakaguchi for the discovery of T regulatory cells and their mechanisms of action. Quell Therapeutics is at the heart of this revolution in medicine.

Background

Quell is a London-based biotech company advancing engineered T regulatory cell therapies for the treatment of severe immune disorders. The company was founded in 2019, at a time when the engineered T regulatory cell field was largely academic and preclinical, with only a handful of companies working in the area. This early stage environment offered a unique opportunity for innovation and filing intellectual property (IP) that had the potential to provide the company with a commercial advantage as the industry matured.

Quell had a strong focus on patent protection from the outset. Its early investment in expertise demonstrated the commitment of our investors and the senior management team to IP, and the ability to obtain patent protection was a key driver in the selection of our initial product. Although early-stage companies are often founded on research from universities, and therefore may have some initial in-licensed IP, early resource spend on building out the patent portfolio, such as that committed by Quell, can result in multiple benefits, including providing fall back positions for any existing IP; building trust early on with investors to provide confidence that innovation is being protected; developing a portfolio for later fund raising to meet expectations of current and new investors; and particularly in younger fields, establishing broad claims to provide product spanning IP.

 

Quell’s products

Quell’s products are based upon multi-modular engineered T regulatory cells, which utilise both product specific and platform technologies. Our cell products contain a chimeric antigen receptor (CAR) allowing their specific targeting to a site of disease within the body and activation of the cells upon target engagement. The CAR is a product-specific piece of technology (i.e. different CARs are used for different products/different disease conditions), usually having an extracellular domain derived from an antibody and an intracellular signalling domain. Protection of the CAR with IP typically provides protection for individual pipeline products which may be important e.g. for partnering (typically control over product-specific filings can be more easily handed over to a partner than platform filings), and which may build on any patent term which exists for earlier platform filings. However, depending on the stage of the field and prior art around the target for the CAR, it may still be possible in some territories to obtain broader protection, which can be invaluable for blocking the field more broadly and early stage companies should consider this possibility.

Quell also has a toolbox of other different modules which may be expressed within our cell products to provide different functionalities, to stabilise phenotype, or to increase persistence as necessary. Given the early stage of the field in 2019, we initially looked to develop and protect a platform technology that could beneficially be used across a range of products and which had the potential to effectively block competitors. The technology that we selected allowed the manufacture of cells with a highly stable T regulatory phenotype (as compared to cells without the technology which can have an unstable phenotype under proinflammatory conditions), enabling the production of high-quality product across our pipeline. The technology clearly differentiates Quell from others working in the field and filing IP in relation to platform technology developments, has resulted in protection from competitors and a proprietary position which we can leverage to attract interest in our business.

 

The journey

In early 2021, Quell had several products in its pipeline and was able to close an extended Series A financing, to circa $84 million, with our initial investors. By this time, additional competitor companies had also been founded in the T regulatory cell field demonstrating the criticality of early IP filings for any business around its platform. In October 2021, Quell presented data showing at a conference for the first time that our proprietary platform technology was able to enhance the safety, stability and efficacy of Treg cells.

Quell was simultaneously developing a manufacturing process to enable reliable production of a high quality and high yield product, to supply our clinical trials. Being an early player in the field, meant that manufacturing processes were not well known or disclosed in the art to fit these needs. Quell’s process development throughout our journey resulted in a highly optimised manufacturing process which provided the company with further opportunities to build our IP portfolio (with consideration to both patent protection and trade secrets/know how) and an advantage over our competitors.

Having an IP portfolio has proved extremely important during diligence and subsequent fund raising ($156 million in an oversubscribed Series B) and large pharma partnering. IP has enabled Quell to develop platform technology and a manufacturing process that we can call proprietary and that differentiates our company from our competitors. Further, our product-specific IP that has been filed during development of our pipeline, builds confidence that we will have long term protection, which is important due to the extended development timelines for cell therapies.

Biotech companies need to collaborate with different third parties at different stages of their journey (CROs, CDMOs, academic institutions, investors, potential partners etc). For Quell, collaboration has been essential and we have interacted with multiple partners across different business functions during the past 6 years. Having IP protection really makes collaboration easier and enables interaction with confidence at every level, providing another reason as to how IP can work for a business before commercialisation of any products.

 

Today

The T regulatory field is still as or maybe more exciting than it was in 2019, particularly with the recent 2025 award of the Physiology or Medicine Nobel Prize. The growing interest in the field means that IP will be as important as ever going forwards, to protect new innovation and future products to ensure investment and eventual commercialisation for the ultimate benefit of patients.

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