TL1A inhibitor (Nimble Therapeutics)

A biotech with plans to make an oral drug that has the same target as Humira, formerly the world’s top-selling medicine, has raised $47.5 million in a Series A. The money arrived last year, but PsiThera is just now unveiling the round three months after bringing on former Seres Therapeutics CEO Eric Shaff as its new chief executive. The investors, disclosed Wednesday morning, are Samsara BioCapital, Lightstone Ventures, Roivant and others. It’s been a long journey for PsiThera. The biotech’s computational intelligence platform is derived from Silicon Therapeutics, a startup formed about a decade ago that was later scooped up by Roivant for $450 million in equity in 2021. Roivant then renamed Silicon to Psivant and further developed the platform. Roivant decided to offload the biotech while retaining an equity stake in the independent company, which was renamed PsiThera. Now, the 30-employee PsiThera is working on multiple R&D projects going after the tumor necrosis factor (TNF) superfamily, which comprises 19 cytokine proteins. The first program is aimed at TNF alpha, the target of Humira. AbbVie’s autoimmune drug was a megablockbuster for years, thanks in part to patent extensions. PsiThera plans to have a development candidate by the end of next year, Shaff said. But rather than making an injectable biologic, PsiThera wants to make oral medicines that are easier for patients to take and likely come with fewer manufacturing complexities and lower cost of goods. “Momentum is building for ‘biologics-in-a-pill,’ especially in the I&I space, and great science applied to this approach can potentially help patients,” Shaff said, pointing to the eczema data from Kymera on Monday. PsiThera’s approach could include traditional small molecules, macrocycles, peptides, degraders and glues, founder and chief innovation officer Woody Sherman said in a joint interview. “Areas where atoms matter and the jigglings and wigglings of molecules matter,” Sherman said. “One of the benefits of a physics-based predictive platform is that the physics is essentially the same for these different types of molecules.” Beyond TNF alpha, PsiThera is also looking at TL1A, CD40L and other targets of the TNF superfamily. TL1A has a rich history at Roivant. The biotech bought a TL1A inhibitor from Pfizer and quickly flipped the asset into a $7.1 billion exit to Roche in the fall of 2023. PsiThera will still be preclinical for a couple of years. In contrast, Silicon made it into the clinic with a small molecule STING agonist that spun out into the biotech Stingthera, which Roivant did not acquire. Some of the original Silicon team has gone elsewhere to build new biotechs around similar concepts to its computational approach, Sherman said. “If we’re able to progress the science the way that we plan and hope, then we think the opportunity will follow, whether that’s private or public,” Shaff said. Shaff joined PsiThera this fall after a decade at Seres, a public microbiome biotech that got an FDA approval in 2023 . Shaff replaced interim CEO James Edwards, a venture partner at PsiThera investor Samsara. He’s now board director at Cold Start Therapeutics, a biotech with a pipeline including molecular glue degraders aimed at beta-catenin and MYC, as well as a triple-G small molecule agonist (GLP-1R, GIPR and GCGR), according to its LinkedIn page.

Dive Brief:Enveda Biosciences said Thursday it raised $150 million in Series D financing, doubling the cash its pulled in from venture capitalists this year to further its drug discovery.Its latest round was led by Premji Invest, the family office of Indian billionaire Azim Premji, and included backing from a mix of tech and biotechnology investors such as Kinnevik, Dimension and Lux Capital.Enveda also announced it has started Phase 1b testing of its lead drug candidate in atopic dermatitis. Several other experimental drugs are expected to enter human trials in the coming year.Dive Insight:Founded in 2019, Enveda launched with the goal of building an artificial intelligence platform to discover new drugs. It says its technology can mine large datasets to find promising molecules that already exist in nature.Nature has been running the most sophisticated R&D program on Earth for billions of years, yet nearly all of its chemistry remains unexplored, said Viswa Colluru, Envedas CEO, in a statement.Its lead program, dubbed ENV-294, is a small molecule Enveda claims is a completely new chemical class that showed kinase inhibitor-like and steroid-like behavior in preclinical testing, and a safety profile similar to biologics in toxicology studies. Early study data released in May showed ENV-294 was well tolerated in trial participants, with no serious adverse events reported.Enveda is aiming at “very large markets, large indications that affect broader society, and plans to tackle diseases that are driven by more than one mechanism, said Daniel Wee, Enveda's chief execution officer.Last year, the company raised $130 million in Series C funding led by Kinnevik and FPV. Sanofi joined Enveda's investor group in February, helping to boost its total haul to $150 million.By banking capital, the company aims to get several of its programs into the clinic. “In startups, at the growth stage, you never let up off the gas, Wee said.Enveda plans to file investigational new drug applications for other programs over the next year. In its pipeline are an NLRP3/TL1A+ pathway inhibitor for inflammatory bowel disease, another TL1A+ inhibitor for various inflammatory and fibrotic conditions and a hormone mimetic for obesity. Twelve other programs are disclosed.The theory of leveraging what life has already created and building on top of that will give us a better success rate, Wee said.Supporters of AI-designed drugs have touted the technology as a way to reduce the amount of time and money spent on finding new molecules. But few have entered clinical testing, and even fewer have yielded data. Those that have showed mixed results.Former Pfizer Chief Scientific Officer Mikael Dolsten will also join Envedas board of directors. '