Press release | 20th Jun 2023

Gutsy moves in the pharma industry

Pharma companies are collaborating with small biotechs to develop regulatory T cell (Treg) therapies for autoimmune diseases like IBD, pushing new boundaries for broader, safer, and potentially curative options for millions of patients.

Biologics rule the market

IBD is a chronic condition with no cure or durable treatments. Current treatment options are predominantly monoclonal antibodies that are injected every other week (Humira) or infused every eight weeks (Entyvio, Stelara, Remicade). Newer options include daily oral treatments such as S1P modulators (Zeposia) or JAK inhibitors (Rinvoq, Xeljanz), however the latter MoA comes with an FDA ‘black box’ warning due to the risk of dangerous cardiovascular side effects.

*Sources: Cowen, Evaluate Pharma

IBD – a growing opportunity for pharma

It is estimated that the IBD population in the US, UK, and EU4 will increase by 39% between 2020 and 2030*. Sales of the top five most lucrative products approved for Crohn’s Disease (CD) equalled over $15 billion for the indication in 2022, while those for ulcerative colitis (UC) reached over $6 billion**.

*Source: Kaplan and Windsor, 2021
**Source: Evaluate Pharma

Potential for Tregs in IBD

As the name suggests, Tregs regulate the immune system, preventing autoimmune diseases by stopping our body’s defenses (effector T cells, or Teffs) attacking our own tissues. In IBD, Treg functionality is impaired, leading to an imbalance whereby excess Teff activity in the GI tract leads to inflammation, diarrhoea, cramping, and rectal bleeding. Sonoma Biotherapeutics believes Tregs can rebalance the immune system for a lasting response, or even cure IBD, however, there is no strong clinical data to support this claim. It is also thought that engineering Tregs to target specific disease-causing antigens reduces the potential for unwanted systemic effects. In 2021, Pandion and its lead candidate, PT101, was acquired by Merck for a total equity value of $1.85 billion. A single dose of PT-101, an engineered variant of IL-2 mutein designed to selectively activate Tregs, was well-tolerated and caused a 3.6-fold increase in Treg numbers in a Phase 1 trial. While not a cell therapy, Merck has banked on promoting Tregs to treat autoimmune diseases. Meanwhile, BMS announced a partnership with GentiBio worth $1.9 billion in 2022 to develop the biotech’s Tregs platform for IBD, however, no clinical data has been published so far.

Is cell therapy the future for IBD?

The industry is clearly seeing the prospects for cell therapies such as Tregs in autoimmune diseases, but the potential remains largely unknown. With no clinical efficacy data, it is too early to tell if Tregs could be a real life-changing treatment for patients with IBD. Nevertheless, the toolkit of therapeutics for immunological conditions continues to evolve from small molecules and biologics to cell therapies. As a potentially-curative treatment, Tregs could negate the need for chronic and burdensome treatments such as mABs. However, it will likely be at least 10-15 years before these treatments could be available, and the technology is also likely to come with a hefty price tag, limiting the access to a small proportion of the market, with the rest met by current modalities. While potentially groundbreaking for patients, new modalities such as these could pose competitive risk at a quicker pace, showing the need for companies to prepare with fine-tuned intelligence gathering and continuous re-assessment of the risks and opportunities.

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