That project is one of four investments, totaling US$120m, made by Pfizer in the second half of 2020 under its breakthrough growth program focused on clinical stage biotech companies of potential future strategic interest to the pharma giant.
Located in Cambridge, Massachusetts, Vedanta Biosciences is looking to develop a new category of therapies for immune-mediated diseases based on human microbiome-derived bacteria.
The company intends to use the funding to support a Phase 2 study of its orally administered investigational live biotherapeutic product (LBP), VE202, in inflammatory bowel disease (IBD), which it plans to initiate in 2021.
A Phase 1 study data showed VE202 was generally safe and well-tolerated at all doses and demonstrated durable and dose-dependent colonization, said Vedanta.
VE202 was designed to induce immune tolerance via the gut and thereby potentially treat IBD. Results describing the biology and candidate selection of VE202 were previously published in Science and Nature.
The LBP is produced under GMP conditions from pure, clonal bacterial cell banks, which yield a standardized drug product in powdered form and bypasses the need to rely on direct sourcing of fecal donor material of inconsistent composition.
“Inflammatory bowel disease has a daily, chronic impact on as many as 1.6 million Americans, and with cases on the rise in the US, patients urgently need new therapeutic options,” said Michael Vincent, Senior VP and CSO, inflammation and immunology research unit, Pfizer. “We believe Vedanta’s approach to modulating the microbiome may hold promise for people living with IBD.”
As part of the investment, Dr Vincent will join Vedanta’s Scientific Advisory Board. Vedanta will retain control of all its programs and has granted Pfizer a right of first negotiation on VE202.
Oher pharma companies are exploring this category.
In April last year, Gilead announced partnership to identify microbiome biomarkers associated with a clinical response in compounds within its portfolio.
Second Genome analyses the human microbiome to discover biomarkers, biological pathways and targets for the development, or augmentation, of treatments. The company’s focus on IBD dovetails with Gilead’s own work in the gastrointestinal area.
The partnership consists of a four-year collaboration, including the possibility of a further two-year extension, which sees Second Genome receive $38m (€34m) upfront and a potential $300m (€274m) for each target discovery programs as they progress.
Gilead will select up to five compounds from its pipeline in inflammation and fibrosis, among other diseases, which will then be matched against biomarkers discovered by Second Genome’s microbiome analytics platform. The focus will be on the potential development of targets or drug candidates relevant to IBD.
Established in June 2020, the Pfizer Breakthrough Growth Initiative (PBGI) focuses on non-controlling equity investments primarily in public companies with small- to medium-sized market capitalizations and mature private companies that are developing clinical-stage assets aligned with Pfizer’s core areas of focus: internal medicine, inflammation and immunology, oncology, rare disease, vaccines, and hospital.
Through PBGI, the pharma giant is ready to invest up to US$500m in biotechnology companies.
This time out, besides Vedanta, Pfizer also invested in ESSA Pharma, Trillium Therapeutics, and Homology Medicines:
- ESSA Pharma, based in Vancouver, British Columbia, received US$10m from Pfizer – it is focused on developing novel and proprietary therapies for the treatment of patients with prostate cancer.
- Pfizer ploughed US$25m into Cambridge, Massachusetts-headquartered, Trillium Therapeutics, a clinical-stage immuno-oncology company working on the development of innovative therapies for the treatment of cancer. In addition, Jeff Settleman, senior VP and CSO of Pfizer’s oncology research and development group, was named to Trillium’s Scientific Advisory Board.
- The pharma giant is backing Bedford, Massachusetts-based, Homology Medicines, to the tune of US$60m – it is a clinical-stage genetic medicines company exploring the use of treatments for rare genetic diseases with significant unmet medical needs. In addition, Seng Cheng, senior VP and CSO of Pfizer’s rare disease research unit, has joined Homology’s Scientific Advisory Board for matters related to Homology’s gene therapy and gene editing programs for phenylketonuria (PKU).
“Pfizer has a long history of collaborating across the healthcare ecosystem with the shared goal of turning great science into innovative new medicines,” said Debbie Baron, senior VP of business development, Pfizer. “Our investments in Homology, Vedanta, Trillium, and ESSA reflect our commitment to find new and creative ways to leverage Pfizer’s resources to deliver breakthroughs to patients.”