Novartis Inks $840 Million Collaboration and Option Deal with IFM Due

IFM Therapeutics announced that one of its subsidiaries, IFM Due (pronounced doo-way), had inked a collaboration and option deal with Novartis. The companies will develop a group of immunotherapies that inhibit the cGAS/STING pathway to treat a broad range of inflammatory and autoimmune diseases.

Under the terms of the deal, Novartis will make payments to fully cover IFM Due’s research and development costs. In return, it will have the option to acquire IFM Due. If Novartis exercises the option, IFM Due’s shareholders will be entitled to up to $840 million in aggregate value including an upfront payment.

“IFM was founded to address novel targets of the innate immune system that are believed to underlie numerous serious conditions,” stated Gary D. Glick, co-founder and chief executive officer of IFM. “In the four years since, we have developed an array of distinct small molecules for inflammatory disorders and cancer that are now in clinical development, demonstrating our team’s ability to progress novel, high-value programs rapidly. Today’s announcement represents a significant milestone in the continued advancement of our pipeline.”

The cGAS/STING pathway is involved in inflammatory responses. Mutations that activate the pathway are implicated in several serious autoinflammatory and autoimmune diseases, including rare diseases like Aicardi-Goutieres syndrome (AGS), STING-associated vasculopathy with onset in infancy (SAVI) and a subgroup of systemic lupus erythematosus (SLE). It is also connected to more common diseases like nonalcoholic steatohepatitis (NASH), chronic obstructive pulmonary disease (COPD), age-related macular degeneration (AMD) and Parkinson’s disease.

In April, Novartis acquired another IFM Therapeutics subsidiary, IFM Tre. Novartis paid $310 million up front with another $1.265 billion in various milestones. IFM Tre launched in July 2018 and focuses on NLRP3 antagonists for inflammatory diseases.

As part of that deal, Novartis picked up all rights to IFM Tre’s portfolio of NLPR3 antagonists, which included one clinical and two preclinical programs. IFM-2427 is the clinical stage project, which is being developed for atherosclerosis and NASH. One preclinical program is for inflammatory bowel disease and the other is a central nervous system (CNS)-penetrant molecule.

“IFM Tre’s compounds have demonstrated that they can fine-tune the immune system, offering a potentially potent approach for treating a large variety of diseases associated with inflammation,” stated Jay Bradner, president of the Novartis Institutes for BioMedical Research.

In light of the data-manipulation scandal around Novartis and its gene therapy Zolgensma for spinal muscular atrophy (SMA), the question has been raised if Novartis is leery of the data related to products in these acquisitions and deals. Although it did not apparently affect the outcomes of the Zolgensma approval or undermine its efficacy or safety, the U.S. Food and Drug Administration (FDA) indicated that some of the preclinical data submitted by AveXis, a Novartis subsidiary, had been manipulated.

The short answer is that Novartis trusts the data.

“The challenge is always, do we trust the team?” Prakash Raman, global head of business development and licensing for the Novartis Institutes for Biomedical Research, told the Boston Business Journal. “There are a few people from Novartis at IFM, so we felt comfortable with the team, and the rigor of testing we expect is in line with what they expect. We’re always partnering. It’s much easier to address some issues earlier than later.”