New Year biotech IPO hopefuls gun for $369M

money

Four biotechs spanning a diverse set of therapy targets are seeking out nearly $400 million in a series of IPOs announced just before the New Year.

In what looks like a healthy start to the public offering sphere for biotechs for 2018, Solid Biosciences, ARMO BioSciences, resTORbio and Menlo Therapeutics are hoping for strong early starts.

We covered dermatology biotech Menlo’s $98 million offering last week, but now we have three more to add to that list: First up, Cambridge, MA-based Solid, which is seeking a $100 million IPO for its work on gene therapies to treat Duchenne muscular dystrophy (DMD).

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Its leading light, SGT-001, is a gene transfer under early clinical work (started in Q4) to restore functional dystrophin protein expression in patients’ muscles, something a number of biopharmas have/are tackling.

“Based on our preclinical program that included multiple animal species of different phenotypes and genetic variations, we believe the mechanism of action of SGT-001, if our clinical trials prove to be successful, has the potential to slow or even halt the progression of DMD, regardless of the type of genetic mutation or stage of the disease,” the biotech says in its SEC filing.

It’s also working on a portfolio of “complementary disease-modifying therapies” to address some of the issues surrounding DMD, and includes a preclinical biologic candidate, SB-001, a mAb designed to reduce fibrosis (scarring) and inflammation. It got off a $50 million series C last March.

Then there is PureTech Health affiliate resTORbio, a Boston, MA-based company founded less than two years’ ago to help fight against ageing, and wants $85 million to help that fight.

Its work focuses on the decline of the immune system in the elderly, and it is using the mechanistic target of rapamycin, or mTOR, pathway, to help combat this.

It sees this pathway as regulating aging, and is seeking selective inhibition of the target of rapamycin complex 1, or TORC1.

“Our initial focus is on the development of RTB101, an orally administered, small molecule, potent TORC1 inhibitor, alone and in combination with other mTOR inhibitors such as everolimus—as a first-in-class immunotherapy program designed to improve immune function and thereby reduce the incidence of RTIs in the elderly regardless of the causative pathogen,” the biotech says in its SEC.

Last year, it licensed worldwide rights to the TORC1 program, including RTB101 alone or in combo with Afinitor (everolimus), or other mTOR inhibitors, from Novartis.

Novartis pioneered this mechanism with its Afinitor (everolimus) mTOR inhibitor product for cancer, which made $775 million in sales last year, mainly from use in breast cancer. mTOR signalling occurs through two complexes—TORC1 and TORC2—and blocking the former seems to be linked to beneficial effects on aging-related diseases. TORC2 inhibition on the other hand seems to cause adverse events, including hyperglycemia and raised cholesterol.

A study with RTB101 alone and in combination with Novartis Afinitor is currently in a phase 2b test for the reduction in the incidence of RTIs in the elderly; the biotech expects to report top-line data from this trial in the second half.

Just two months ago, it pocketed another $40 million from a second-round financing.

And finally, there is ARMO BioSciences, which wants $86 million for its work on immunotherapies targeting various cancers. The biotech, founded back in 2012 and based in Redwood City, CA, is at work on its lead product candidate, AM0010 (pegilodecakin), a long-acting form of human Interleukin-10 (IL-10).

IL-10 is a naturally occurring immune cell growth factor in humans that stimulates the survival, expansion and tumor-killing capacity of a particular white blood cell of the immune system, called the CD8+ T cell. “We have focused on CD8+ T cells because these cells have been shown to recognize and kill cancer cells,” the biotech says in its SEC-1 form. “An abundance of tumor-infiltrating CD8+ T cells improves the prognosis and lengthens the survival of cancer patients.”

It is currently undergoing a phase 3 pivotal test, known as SEQUOIA, which compares a combo of AM0010 and chemo agent Folfox to Folfox alone, as a second-line therapy after tumor progression during or following treatment with Lilly’s Gemzar (gemcitabine).

“We initiated this trial in the fourth quarter of 2016, enrolled the first patients in early 2017 and we expect the first interim analysis to be conducted in early 2018,” the company notes.

It adds: “The second interim analysis, which could provide the basis for a Biologics License Application submission to the FDA, is expected to be conducted in 2020. Depending on the outcome of this trial, we may expand the SEQUOIA program and further develop this combination or potentially combinations of AM0010 and other chemotherapies, including gemcitabine-based chemotherapies, as a first-line therapy for pancreatic cancer.”

The FDA has already granted fast track status to AM0010 in combination with Folfox as a second-line therapy in patients with pancreatic cancer, a notoriously difficult cancer to treat with low survival rates, and low success rates in recent trials. In August, it got $67 million from the likes of Celgene and GV, Google's venture arm.

RELATED: Biotech IPOs roared back in 2017, but what will the next year bring?

2016 was a dire year for biotech IPOs, and it didn’t start so great in early 2017, but roared back into life from the second quarter; a number of private companies told FierceBiotech they were awaiting the right environment to test the public waters – this start to 2018 may see more jumping in.

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