Intepirdine

One of biotech’s most noteworthy entrepreneurs is reportedly considering a run for President of the United States. Vivek Ramaswamy has recently spent time in Iowa meeting with locals and testing potential messages in the run-up to a campaign for president, Politico reported Monday. The founder and ex-CEO of Roivant Sciences, Ramaswamy would seek the Republican nomination and challenge former President Donald Trump, as well as other potential GOP candidates such as Florida Gov. Ron DeSantis and former Vice President Mike Pence. Ramaswamy made a name for himself in biopharma through Roivant, promising to upend the traditional industry model by launching a series of umbrella companies colloquially known as “Vants” to focus on specific experimental drugs or disease areas. The results were mixed, with some successes and a handful of high-profile failures. Most notably was Axovant, a biotech focused on turning an old GSK Alzheimer’s drug into a winner despite years of failures in the field. The drug, known as intepirdine, flunked a Phase III study in 2017 — a failure that wiped out nearly $2 billion in market cap. Axovant later rebranded as Sio Gene Therapies in 2020 and its board voted in December to dissolve after other setbacks. But Ramaswamy also helped engineer a $3 billion sale of some of his companies to Sumitomo Dainippon in 2018. After he left Roivant’s CEO post in early 2021, another of his companies, Myovant, was also acquired by Sumitomo Dainippon (now Sumitomo Pharma) for $2.9 billion late last year after winning two FDA approvals and partnering with Pfizer. Lately, Ramaswamy has been a frequent guest on right-wing cable news programs such as “Tucker Carlson Tonight” and become a staunch critic of “ESG investing,” or investing strategies that consider environmental, social and governance factors. Per Politico, he plans to make ESG investing a centerpiece of his campaign. Ramaswamy quote-tweeted the Politico report, saying “Stay tuned…” on Monday morning. Only former President Trump has officially launched his bid for the 2024 Republican nomination. But DeSantis, Pence and several other former Trump administration officials have tested the waters in recent weeks for presidential bids, in addition to a handful of anti-Trump Republicans like New Hampshire Gov. Chris Sununu and former Maryland Gov. Larry Hogan.

Roivant's newfound momentum follows two difficult years marred by a rocky jump to Wall Street and layoffs. Matt Gline has had enough of the quips. Over the course of his seven-year tenure at Roivant Sciences—the last two as CEO—he's fended off what he thinks are condescending characterizations that the “vant” parent company is a discard-reliant pharma and prognostications about the potential of the drugs it works on.  Roivant, according to Gline, is more than just the “cute narrative” that follows it.  “I think that there are lots of other companies built on drugs that have been in-licensed from a variety of places and they just don't quite wear the same branding that we do,” the CEO said in an interview with Fierce Biotech.  So Gline is fighting back against what he considers a persistent yet unfounded reputation, one he believes doesn’t accurately reflect the potential of the company’s pipeline. The one-man PR campaign may at one point have been less consequential, but this year Roivant and its units are expecting a number of crucial readouts. At or near the core of the company’s broader ambitions is RVT-3101, an inflammation med nabbed from Pfizer that’s in a battle over anti-TL1A bragging rights with Prometheus Biosciences. Both companies recently posted positive phase 2 data in patients with ulcerative colitis, which could provide an alternative to blockbusters like Johnson & Johnson’s Stelara or AbbVie’s Rinvoq. Roivant expects the final analysis of the data to be available within the first half of the year and is also working on developing the med for Crohn’s disease. Up for grabs is a combined market for Crohn’s and ulcerative colitis worth north of $16 billion, according to the company.  “It's exciting to be in a position where we are generating a whole bunch of important clinical data this year because, at some level, everything other than generating clinical data is just noise,” Gline said. “It doesn't matter.” The significance of RVT-3101 is its ability to build off the momentum of Vtama, the company's FDA-approved topical treatment for plaque psoriasis. At the J.P. Morgan Healthcare Conference earlier this month, Gline reported that Vtama became the No. 1 prescribed topical for psoriasis within two months of its launch. Anybody who is not afraid of a lupus study is an idiot, you shouldn’t trust them." — Matt Gline, Roivant CEO But just because Gline and the team have notched a couple of recent wins doesn't mean he’s getting cocky. Among the readouts expected this year is a phase 2 trial of brepocitinb, another Pfizer collab, to treat lupus, which Gline admits is a toss-up. “Anybody who is not afraid of a lupus study is an idiot, you shouldn’t trust them,” he said.  The larger meaning of Roivant's budding and potential commercial prospects is that the company is rebounding. It went public at arguably the worst possible time, in May 2021, three months after biotech capital markets started to depreciate from their overheated value spurred by the pandemic. The market debut was also conducted via a SPAC no less, a blank check vehicle to Wall Street that was briefly a trend among biotechs. Last year, the company cut 12% of staff, joining more than a hundred other biopharmas that had to lay off employees in 2022.  “Look, the last two years didn't go as planned for Roivant,” Gline conceded. “We were very fortunate that our capital position was such that it didn't have a lasting impact on our business.” Gline noted that in addition to losing staff, the company has had to end work on some exciting clinical programs, including a treatment for sickle cell disease, acknowledging that some of the gene editing companies tackling the condition appear to have an advantage.  “When the world closes down around you, you have to focus on a sooner horizon, and so that's what we did,” he said.  As a new dawn beckons, one measure of success is external interest. The chief executive did not deny interest, but said it's "hard to comment on" when asked if the company had fielded calls for the immunology-focused subsidiary Immunovant. “We would be silly not to be open to the full spectrum of possibilities there," he said. Immunovant’s prize possession is batoclimab, which is currently in five mid -to late-stage studies, three of which are potentially registrational. The advanced studies include myasthenia gravis, thyroid eye disease and chronic inflammatory demyelinating polyneuropathy (CIDP). Main competitor argenx has an FDA-approved treatment for myasthenia gravis and a registrational trial ongoing for patients with CIDP. Gline predicted that argenx will ultimately be acquired. While Gline's confidence suggested that few corporate or clinical moves were earnestly off the table, don’t expect another reentrance into the Alzheimer’s market any time soon. He lamented that much is still unknown about the disease mechanism, a well-known but sober acknowledgment that punctuates his decision-making. Roivant previously tried to develop intepirdine, an Alzheimer's med acquired from GSK in 2014, but the 5-HT6 inhibitor consistently failed, forcing Roivant to dump it three years later.  “We, candidly, have not come particularly close to working in Alzheimer's disease since then,” said Gline.