Candid Therapeutics launches to treat autoimmune disorders

Candid Therapeutics launched Monday with $370 million in funding. Its goal is to manufacture bispecific T-cell engagers (TCEs) to combat autoimmune disorders. The company has not only raised a huge series A fundraising round but also acquired two clinical-stage TCE antibody assets—CND106 and CND261—by merging with biotechs Vignette Bio and TRC 2004.

The new firm is led by President and CEO Kevin Song, who previously headed up the radiopharmaceutical firm RayzeBio. He says he sees an opportunity for TCEs to act as simpler and more scalable alternatives to cell-based therapies for autoimmune disorders.

In autoimmune disorders like rheumatoid arthritis and myasthenia gravis, a person’s B cells create antibodies to self cells, or they can present antigens to T-cells, which induces autoimmunity. So, depleting these offending B cells is an attractive treatment option. While some companies want to use CAR-T cells to do this, Candid plans to use TCE antibodies that bind to two targets: one on the surface of a target B cell and the other on a T cell, resulting in the death of the B cell. “Rheumatologists and neurologists are not familiar with cell therapy,” Song says. “Whereas [they] prescribe antibodies all the time, so we’re able to provide a drug format that’s very familiar.”

Song also points out other benefits of TCEs. For example, CAR-T therapies are expensive and difficult to manufacture, while manufacturing antibodies is much easier, he says.

After treatment, it is important to reset the immune system so that once defective B cells are cleared, new ones are generated that work properly. A study from Germany published early this year showed that this was possible with CAR-T cell therapy (N. Engl. J. Med., DOI: 10.1056/NEJMoa2308917). But the patients in the German study were preconditioned with chemotherapy to make room for transplanted T-cells, which would be difficult for autoimmune patients and make redosing pretty much impossible. In contrast, Song says this would not be necessary for T-cell engagers, which should make TCEs more scalable as a therapy for autoimmunity compared with CAR-T cells.

Candid is not the only company operating in the TCE space. Clasp Therapeutics launched earlier this year to treat cancer with TCEs.

Song says the company’s goal is to file investigational new drug applications with the US Food and Drug Administration by early 2025 and get these candidates into clinical trials. The company has not disclosed a target indication, but Song noted that the molecules target two different antigens on the B cell lineages, which may prompt future trials to see which antibody is better at treating a single indication or if they should be used together.