Roivant Sciences, a biotech company founded by GOP presidential candidate Vivek Ramaswamy, inked a deal with Pfizer to form a new company focused on developing a TL1A drug candidate for inflammatory and fibrotic diseases.
Pfizer announced the collaboration with Roivant Sciences in December 2022.
From Pfizer:
Roivant Sciences (Nasdaq: ROIV) and Pfizer Inc. (NYSE: PFE) today announced formation of a new Vant to develop and commercialize PF-06480605 (now RVT-3101). RVT-3101 is a fully human monoclonal antibody targeting TL1A, which is currently in Phase 2b development in ulcerative colitis (UC). The Vant has the exclusive option to collaborate with Pfizer on a next-generation TL1A directed antibody which recently entered Phase 1.
RVT-3101 is a potential first-in-class agent that targets both inflammatory and fibrotic pathways by inhibiting TL1A, which has been shown to modulate the location and severity of inflammation and fibrosis by stimulating TH1 and TH17 pathways, in addition to activating fibroblasts. As such, RVT-3101 has the potential to provide greater efficacy by hitting multiple inflammatory pathways as well as fibrotic pathways.
RVT-3101 has been evaluated in an earlier Phase 2 study (TUSCANY) in 50 patients, and is being evaluated in a large global Phase 2b study (TUSCANY-2) in 245 adult participants with moderate to severe ulcerative colitis. The induction portion of TUSCANY-2 is complete, and the maintenance portion remains ongoing.
“Our internally discovered antibody against TL1A, could potentially be the first agent to bring biomarker-selected precision medicine to people living with inflammatory bowel disease,” said Mikael Dolsten, Pfizer’s Chief Scientific Officer, President, Worldwide Research, Development and Medical. “We are very excited about the preliminary data from the TUSCANY-2 study and for this new Vant to drive the advancement of this asset. At the same time, it enables Pfizer to bring additional innovative breakthrough medicines and vaccines to patients in need more quickly, allowing us to serve more people.”
Roivant Sciences has remained active in the ulcerative colitis (UC) market.
Fierce Biotech explained:
Roivant Sciences has shown its hand in the red-hot race for a new ulcerative colitis market. Weeks after Prometheus Biosciences wowed investors, and with the ink on its deal with Pfizer to enter the race still drying, Roivant has shared phase 2b data it claims position it as a best-in-class contender.
The data come from a study of the anti-TL1A antibody RVT-3101. Because TL1A modulates the location and severity of inflammation and fibrosis, researchers have flagged the protein as a way to treat a range of conditions including ulcerative colitis. Pfizer established itself as a front-runner in the race, only to pass the baton on to Roivant shortly before the delivery of phase 2b data.
Now, Roivant has shared the data. The trial, TUSCANY-2, randomized 245 biologic-experienced and naïve ulcerative colitis patients to receive one of three monthly, subcutaneous doses of RVT-3101 or placebo.
At the end of the 12-week induction period, 32% of patients on RVT-3101 were in clinical remission compared to 12% of their counterparts in the placebo arm. Narrowing the analysis to biomarker-positive patients increased the placebo-adjusted remission rate from 21% to 27%. The placebo-adjusted rate of endoscopic improvement was 21% in all comers and 41% in the biomarker subpopulation. The expected phase 3 dose generally performed slightly better than the pooled analysis of all patients on RVT-3101.
Roivant compared the results favorably to other investigational and approved ulcerative colitis drugs, showing off how the rates of clinical remission and endoscopic improvement bettered those reported in the study of Prometheus’ rival TL1A prospect and the results achieved by AbbVie’s Rinvoq, Johnson & Johnson’s Stelara and Bristol Myers Squibb’s Zeposia in biologic-experienced patients.
Vivek Ramaswamy founded Roivant Sciences in 2014, served as CEO until 2021, and served on the company’s board of directors until February 2023 to focus on his presidential campaign.
From Roivant Sciences:
Roivant Sciences (Nasdaq: ROIV) today announced that its founder Vivek Ramaswamy has stepped down from the company’s board of directors to focus on his U.S. presidential campaign.
Vivek founded Roivant in 2014 with the vision of revolutionizing drug development. Over the past decade, the FDA has granted six FDA approvals for medicines developed at Vants launched by Roivant, including VTAMA, approved for plaque psoriasis in 2022.
In January 2021, Vivek transitioned out of his day-to-day role as CEO of the company. He served as Roivant’s Chairman until February 20, 2023.
“On behalf of the entire company, I would like to extend our deepest gratitude to Vivek for his vision and leadership over the years. Vivek started Roivant in 2014 to transform the way that meaningful therapies were developed and commercialized, and that mission is still very much a part of Roivant’s DNA today. We are grateful for Vivek’s contributions to the board and to the organization, and we wish him well in his future endeavors,” said Matt Gline, CEO of Roivant.
WLTReport questioned if the GOP presidential candidate was exposed earlier this week.
Ramaswamy made controversial statements about masks and COVID-19 injections during the height of the COVID-19 plandemic.
"Wearing a mask = personal responsibility. It’s puzzling when conservatives oppose it. But before deriding them, remember this: CDC and WHO discouraged wearing masks in March - a 'noble lie' to save masks for healthcare workers. Institutional lying erodes public trust in science," he said in July 2020.
Wearing a mask = personal responsibility. It’s puzzling when conservatives oppose it. But before deriding them, remember this: CDC and WHO discouraged wearing masks in March - a “noble lie” to save masks for healthcare workers. Institutional lying erodes public trust in science.
— Vivek Ramaswamy (@VivekGRamaswamy) July 9, 2020
Ramaswamy responded to criticism from his prior remarks.
— Samantha Aschieris (Renck) (@samantharenck) July 15, 2023
In a 2022 Wall Street Journal op-ed co-written by Ramaswamy, he said the "most important step in fighting the Covid-19 pandemic was the distribution of vaccines."
He also proposed developing "new vaccines against novel strains more quickly."
In his vax pushing op-Ed, he states masks and social distancing work. This was in 2022.https://t.co/VZUvuAyme6
— Melissa Blasek (@MelissablasekNH) July 16, 2023
From The Wall Street Journal:
Why not prepare for this outcome simply by developing new vaccines against novel strains more quickly? Because even mRNA vaccines can’t be developed fast enough to outrun a vaccine-resistant supervariant. On Dec. 8, Pfizer committed to delivering its first batch of new vaccines that cover the Omicron variant within 100 days. Yet by mid-March, a significant percentage of the U.S. population will have already been infected with Omicron.
Meanwhile, mask mandates and social-distancing measures will have created fertile ground for new variants that evade vaccination even more effectively. Significant antigenic shifts may create new strains that are increasingly difficult to target with vaccines at all. There are no vaccines for many viruses, despite decades of effort to develop them.
Will relaxing restrictions come at the cost of more hospitalizations and deaths as the next variant starts to spread? Perhaps, but it would reduce the risk of a worst-case scenario and greater loss of life in the long run.
The most important step in fighting the Covid-19 pandemic was the distribution of vaccines. With this milestone now achieved, the global response should shift from preventing the spread to minimizing the probability of an antigenic shift. Whether SARS-CoV-2 was made in a lab is the subject of debate, but let’s make sure we don’t manufacture an even more dangerous strain of the virus with misguided policies.
"But new variants aren’t emerging in the U.S. They’re emerging in places with a higher percentage of unvaccinated individuals. Those variants are the ones that have the greatest potential to drift, and possibly shift, away from the strain that initial vaccines were designed to protect against. Those strains won’t disappear with masking and social distancing policies, but the efficacy of vaccines will," Ramaswamy said in January 2022.
protect against. Those strains won’t disappear with masking and social distancing policies, but the efficacy of vaccines will.
I normally don't like long Twitter threads on technical subjects, which is why @apoorva__tewari and I chose to publish in WSJ. Thanks for engaging w/ us
— Vivek Ramaswamy (@VivekGRamaswamy) January 12, 2022
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