Startups, BioPharma

Two new Series A rounds inject $72M into regenerative medicine and NASH

Two of the hottest fields in biopharma got another boost this week, with a $32 million Series A raised by a regenerative medicine startup and a separate $40 million in financing for the treatment of liver fibrosis and NASH.

Dollars funding money investment

Two of the hottest fields in biopharma got another injection of cash this week, with a combined $72 million in Series A financing.

That includes $32 million raised by Frequency Therapeutics to further its novel regenerative medicine approach, and a separate $40 million round for Cirius Therapeutics’ take on liver fibrosis and NASH.

Headquartered in Woburn, Massachusetts, Frequency Therapeutics was founded in 2015 with a mission to kickstart one of the body’s natural healing mechanisms. Its $32 million Series A financing round was led by CoBro Ventures, with support from Morningside Ventures, Emigrant Capital, Korean Investment Partnership, Alexandria Real Estate Equities, and others.

Frequency is built around its so-called Progenitor Cell Activation (PCA) platform developed by Robert Langer and Jeffrey Karp from MIT and Harvard Medical School. Progenitor cells are slightly more specialized than stem cells. And while they typically lie dormant after fetal development, they can be activated to regenerate damaged tissues — similar to the way stems cells do.

They’re “already in the right place and trained to do the right job,” explained Frequency cofounder and CSO Chris Loose, in an email forwarded by a company representative.

While the PCA platform could theoretically be applied to many fields, such as skin disorders, muscle regeneration, and gastrointestinal diseases, the initial R&D focus will be chronic hearing loss. This often occurs with the gradual loss of key cells in the inner ear, called sensory hair cells.

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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.

Frequency’s small molecule therapy would activate the progenitor cells waiting in the wings, helping to replace the lost cells and loss of function for the remainder of the patient’s life.

“Once a new hair cell is regenerated, we expect it to be long-lasting,” Loose explained. “The hair cells you are born with are the ones you die with, so a hair cell can survive and function for over 100 years in some people.”

Also on Tuesday, Cirius Therapeutics (previously known as Octeta Therapeutics) publicized a $40 million Series A round. The financing was led by Frazier Healthcare Partners and Novo A/S.

The money is destined to fund the company’s ongoing EMMINENCE trial, a Phase 2b study of its second-generation insulin sensitizer, MSDC-0602K, for the treatment of non-alcoholic steatohepatitis (NASH) and liver fibrosis.

It speaks to the novel approach Cirius is taking to control the silent epidemic of NASH, which often strikes alongside obesity, metabolic syndrome, and type 2 diabetes.

In a company statement, newly-announced CEO Bob Baltera explained the connection.

“A great deal of experimental data, including results from a Phase 2 trial in patients with Type 2 diabetes, has been generated demonstrating that these next-generation insulin sensitizers act in a novel way to positively impact the underlying metabolic parameters that drive NASH,” Baltera said.

The challenge for the company is ensuring the safety of its candidate, MSDC-0602K. While promising, existing insulin sensitizers come with an array of problematic side effects — and NASH is a high-risk patient population.

On the other hand, there are no disease-modifying therapies on the market, so a little benefit will go a long way.

Echoing others in the field, one of the lead investors noted that a combination approach to NASH will likely work best.

“At Frazier, we believe the future of NASH therapies will be a multi-drug approach, with a need for therapies that address the underlying metabolic drivers of disease, as well as resultant fibrosis and inflammation,” said Dan Estes of Frzaier Healthcare. “We see a distinct opportunity for MSDC-0602K to become a cornerstone therapy in NASH, both as monotherapy but ultimately as part of combination approaches.”

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