Organ transplants require drugs that reduce the chances of the body rejecting a donor organ, but these immuno-suppressive therapies also raise the risk of infection. That risk is ongoing as anti-rejection therapies must be taken for life. Quell Therapeutics aims to offer an alternative: an immune cell engineered into a cell therapy that prevents organ rejection. The biotech is approaching its first clinical test and on Monday it unveiled $156 million to support that research.

London-based Quells therapies are made by engineering regulatory T cells, more commonly referred to as Tregs. In the immune system, T cells stand ready take on invading pathogens, a response that promotes inflammation. Tregs serve a counterbalancing role, tamping down excessive inflammatory responses.

To make its Treg therapies, Quell borrows from the process that produced the first wave of autologous therapies engineered from a patients own T cell. Like those personalized CAR-T cancer treatments, Quells therapies are made by taking cells from a sample of a patients blood, engineering those cells in a lab, multiplying them, and then infusing them back into a patient.

The difference between CAR-T therapies and Quells Treg approach is in the type of cells selected and the engineering step in the lab. Quell engineers Tregs with an antigen that directs those cells to the desired target in the body. In addition to tissue targeting, Quell said its technology can also give its Treg therapies disease-specific efficacy and safety, producing a better Treg compared to earlier approaches to engineering these cells.

Quells lead Treg therapeutic candidate, called QEL-001, is being developed to prevent organ rejection in liver transplant patients. The company says this cell therapy is intended to induce durable immune tolerance, which could potentially eliminate the need for patients to take immune-suppressive therapies for life.

Other companies have tried to improve upon the anti-rejection therapies available to transplant patients. Novartis was developing a drug designed to block a receptor that is part of a pathway activated in organ rejection. But in September, the pharmaceutical giant said it would stop a mid-stage test of that antibody drug, iscalimab, after interim results showed the therapy did not work as well as standard of care anti-rejection drugs.

Talaris Therapeutics is taking a cell therapy approach, but not by working with a patients own immune cells. Instead, the Louisville, Kentucky-based biotech takes immune and stem cells from the organ donor and uses those cells to reprogram the immune system of the organ recipient. These cells train the immune system to tolerate the transplanted organ by achieving chimerism, in which two sets of DNA coexist in the same body. A Phase 3 study is underway in living donor kidney transplant patients. In Talariss announcement of third quarter financial results earlier this month, the company reported that all patients who have reached the three month post-transplant mark have achieved chimerism.

Last month, Quell received regulatory clearance from U.K. authorities to begin clinical testing of its Treg therapy. Now that it has closed its new financing, the company said it expects patient recruitment in a Phase 1/2 study will begin in liver transplant patients by the end of this year.

Organ transplants are just the first potential application of Quells technology. The biotech is also researching use of its Tregs to treat autoimmune and inflammatory conditions. That research puts the company in the midst of an increasingly competitive Treg space. In February, Merck struck a $1.85 billion deal to acquire Pandion Therapeutic, a clinical-stage biotech that engineers fusion proteins to selectively expand Tregs in the body as a way of treating inflammatory disorders. The research of preclinical Abata Therapeutics is closer to Quells approach. The Boston-based biotech engineers a patients own Tregs with a T cell receptor that directs the cell therapy to the target tissue.

Paris-based Egle Therapeutics is developing Treg cancer immunotherapies for its own pipeline and in partnership with Takeda Pharmaceutical. Other companies developing Treg cell therapies include GentiBio, Sonoma Biotherapeutics, and TRexBio.

Quell was founded in 2019 by Syncona, a healthcare investment firm. In February, Quell announced that its Series A financing had expanded to $84 million. The Series B round of financing announced Monday was co-led by Jeito Capital, Ridgeback Capital Investments, SV Health Investors, and Fidelity Management & Research Company. Founding investor Syncona also participated. Additional new investors include British Patient Capital through its Future Fund: Breakthrough program, Janus Henderson Investors, Monashee Investment Management, Point72, and funds managed by Tekla Capital Management.

Public domain Treg image by Flickr user NIH Image Gallery

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Cell therapy biotech Quell adds $156M for alternative to organ transplant meds - MedCity News

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