This issue focuses on: Neena Bitritto-Garg, founder, president and executive chair of Ensho Therapeutics.

Company vision: Ensho is dedicated to developing an oral α4β7 integrin inhibitor that modulates T-cell inflammatory responses in the gut, offering a breakthrough treatment for inflammatory bowel disease (IBD). The company officially launched at the end of June and, after acquiring a portfolio of oral α4β7 integrin inhibitor assets from EA Pharma, a subsidiary of Eisai, already has an IBD program ready to enter Phase 2 clinical trials.

Significance: Currently, the only marketed anti-α4β7 integrin drug requires injection or infusion; an oral formulation would offer a differentiated alternative in the market.

"There is truly a transformative opportunity here to own an asset that could be transformative for the IBD space," said Bitritto-Garg. "People are especially enthusiastic about α4β7."

Ensho is not the only company developing oral α4β7 inhibitors. Morphic, which Eli Lilly is acquiring for $3.2 billion this month, is conducting two Phase 2 studies for ulcerative colitis and one Phase 2 study for Crohn's disease, all involving oral α4β7 integrin inhibitors. Gilead also has an oral α4β7 inhibitor in mid-stage clinical trials.

"The interest we've received has far exceeded my initial expectations... We will be able to raise significantly more capital than originally planned."

—Neena Bitritto-Garg, founder, president and executive chair of Ensho Therapeutics

In the past few months, other deals have emerged in the IBD space, including AbbVie's acquisition of Celsius Therapeutics for $250 million and its acquisition of Landos Biopharma for $138 million, both of which are developing IBD therapies. In October, Roche acquired Roivant subsidiary Telavant and its promising IBD candidate RVT-3101 for $7 billion.

Strong start

Ensho plans to use its lead candidate NSHO-101 for the treatment of ulcerative colitis, following a positive Phase 1 program completed by EA Pharma. The licensing agreement also includes three additional assets, and Bitritto-Garg said Ensho's "scientific team will explore the characteristics of three follow-on compounds beyond the lead drug NSHO-101 to identify potential opportunities for these assets."

Ensho has assembled a strong executive team to advance the candidates to the next stage.

Bitritto-Garg is a veteran in biotechnology and biopharmaceutical equity research, having worked at JPMorgan, Deutsche Bank, and Citigroup, where she served as head of U.S. biotechnology equity research. She also worked in business development at Eisai.

The company's C-suite includes several heavyweights, which Bitritto-Garg calls "a world-class management team in the IBD space."

In fact, three of the executives previously worked at Telavant, including CEO Bittoo Kanwar, who was previously chief medical officer at a Pfizer partner company.

"The entire team we've built behind him is essentially the team he has built over the past 15 years or so," said Bitritto-Garg.

The road ahead

Eli Lilly's announcement of the Morphic acquisition just days after Ensho's launch brought enthusiasm and attention to the startup's initial funding round. In fact, Bitritto-Garg said they have already raised their initial fundraising target multiple times.

"The interest we've received has far exceeded my initial expectations," she said. "We look back at our original goals and laugh a little, because we will be able to raise significantly more capital than originally planned."

Bitritto-Garg said that once the Series A round is complete, the company's focus will be "100% on... getting the Phase 2a study of lead compound NSHO-101 up and running."

Bitritto-Garg said their goal is to initiate the Phase 2a study in the first half of 2025 and the Phase 2b study in the second half of 2025, both targeting ulcerative colitis.

"We will move as quickly as possible to enroll patients," she said. "So we expect to have Phase 2a data in 2026."