Artificial Intelligence, Pharma, BioPharma

Celsius Therapeutics heats up with $83M and an IBD drug on path to the clinic

Single-cell analysis biotech Celsius Therapeutics has raised $83 million to advance its pipeline of drugs for autoimmune disorders and cancer. The startup’s lead autoimmune program, a TREM1-blocking antibody for inflammatory bowel disease, is expected to begin human testing in early 2023.

 

Single-cell analysis reveals biological insights that are not accessible when looking at cells collectively. Celsius Therapeutics has been working with its single-cell analysis technology for four years and the biotech startup now has an autoimmune disease drug candidate and $83 million to support development of that antibody drug along with two programs in cancer.

Cambridge, Massachusetts-based Celsius launched in 2018 backed by a $65 million Series A round of funding. The new cash announced Thursday is an extension of the biotech’s Series A financing along with a Series B round.

Celsius’s lead autoimmune disease target is inflammatory bowel disease (IBD), a disorder that is currently treated with anti-inflammatory medications, including therapies that block the pro-inflammatory signaling protein tumor necrosis factor (TNF). However, not all patients respond to anti-TNF therapies, so Celsius aims to offer an alternative by developing a drug for a different target.

The drug candidate that Celsius unveiled Thursday is an antibody that blocks TREM1. Expressed by myeloid cells, this protein also plays a key role in amplifying the inflammation characteristic of IBD. Celsius said it identified the antibody, named CEL383, through the single-cell analysis of hundreds of clinical samples. The company’s proprietary technology employs machine-learning algorithms to identify and characterize subsets of a pathogenic cell type that drives resistance to anti-TNF therapies. The biotech added that it has defined a series of targets modulating behavior of these cell subtypes, and TREM1 is the first of these targets.

Celsius is also using its technology to discover drugs for cancer. The company has two internal drug discovery programs in oncology, each addressing targets identified by the single-cell analysis of hundreds of solid tumor samples. Those targets and other details about the programs remain undisclosed. The first Celsius cancer program is in colorectal cancer, and it is progressing under a partnership with France-based Servier. In a prepared statement, Celsius President and CEO Tariq Kassum said that his company’s technology has now performed single cell RNA sequencing of more than 1,000 clinical tissue samples, building the startup’s dataset.

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A Deep-dive Into Specialty Pharma

A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.

Casdin Capital led the Series B financing. Other participants in the latest round include earlier investors Alexandria Venture Investments, GV, Heritage Provider Network, and Third Rock Ventures. They are joined by new investors that include Amgen Ventures, Amplitude Ventures, Catalio Capital, Co-Win Ventures, Fast Track Initiative, Section 32. With an IBD drug candidate now identified, Celsius expects to file an investigational new drug application with the FDA within the next year; a Phase 1 study could follow in early 2023.

“2022 is a really exciting year for Celsius,” Kassum said on brief video posted to the biotech’s Twitter feed. “It’s the year in which all the science and work that we’ve done over the last few years really translates into actionable therapies for patients with inflammatory bowel disease and cancer.”

Photo by Flickr user kami rao via a Creative Commons license