Vaccitech makes short move to new headquarters; EnteroBiotix raises more than $21M in Series A
Oxford biotech Vaccitech is moving headquarters — but only about 20 minutes away.
Vaccitech signed a lease for 31,000 square feet within the Zeus development at Harwell Science and Innovation Campus. The firm plans to relocate its headquarters there next spring from its current headquarters in Oxford. The length of the lease was not disclosed.
The company’s operations will be taking about half the space in that building, according to a Vaccitech statement.
Vaccitech COO Chris Ellis said in a statement: “The need for new space designed primarily for state-of-the-art wet laboratory and offices to house our growing team was our first priority, and staying within the Oxfordshire infrastructure, drove our decision to relocate to the Zeus building at Harwell Campus.”
Vaccitech is the newest company to join Harwell’s campus, which is already home to other companies in Harwell’s designated “Health Cluster” such as the Rosalind Franklin Institute, Oxford Nanopore and the Vaccines Manufacturing and Innovation Centre.
Vaccitech, the company that owns the technology behind the AstraZeneca vaccine, also filed for an IPO earlier this year. — Paul Schloesser
EnteroBiotix raises $21.5 million in Series A
Scottish biopharma Enterobiotix today announced the closing of its $21.5 million Series A financing. The proceeds will be used to further advance the company’s microbiome drug pipeline and support its product development and manufacturing capabilities.
One of the products that the company is working on is a pill to replace a procedure called fecal microbiota transplant, or FMT. EnteroBiotix has prided itself on complete in-house manufacturing — a crucial step in controlling the supply chain in order to make a consistent pill possible. Additionally, part of the funding raised by the Series A will fund developing analytical tools to characterize what’s really in their product.
“I think, fundamentally, the approach EnteroBiotix is taking is that we’re not taking a reductionist approach to the ecosystem,” CEO James McEllroy said about the potential FMT pill. “We’re actually combining ecosystems together to create a highly diverse product that retains both the spore-forming fraction of the microbiome and the non-spore-forming fraction of the microbiome. The setbacks that have happened to date have taken reductionist approaches and have destroyed parts of the ecosystem whereas what we want to do is retain the diversity, which we hope will be functional diversity, and create something which is compositionally consistent at the same time.”
The financing was led by Scottish investment firm Thairm Bio and includes new US-based investor Kineticos Ventures, joining other investors including Scottish Enterprise and SIS Ventures. — Paul Schloesser
Citius acquires Phase III oncology therapy E7777
New Jersey biopharma Citius has entered into an agreement with Dr. Reddy’s Laboratories to acquire its exclusive license of E7777 (denileukin diftitox), a late-stage oncology immunotherapy for the treatment of a rare form of non-Hodgkin lymphoma know as CTCL. E7777 is an improved formulation of Ontak, which was previously approved by the FDA for treatment of patients with persistent or recurrent CTCL.
The last patient in a pivotal trial of E7777 has been enrolled, and a BLA for the drug’s first indication in CTCL is expected to be filed with the FDA by the end of next year, according to a Citius statement.
Under the agreement, Citius will acquire Dr. Reddy’s exclusive license of E7777 from Eisai and other related assets owned by Dr. Reddy’s. Citius’ exclusive license rights include rights to develop and commercialize E7777 in all markets except for Japan and certain parts of Asia, which will remain with Eisai. Dr. Reddy’s will receive $40 million upfront, and is entitled to up to $110 million more in milestone payments related to CTCL approvals in the U.S. and other markets, along with additional indications of the drug.
Eisai will receive a $6 million development milestone payment upon initial approval and additional commercial milestone payments related to the achievement of net product sales thresholds. Eisai will be responsible for completing the current CTCL clinical trial, and CMC activities through the filing of a BLA with the FDA. Citius will be responsible for development costs associated with potential additional indications.
Myron Czuczman, executive VP and CMO of Citius, said in a statement that “We look forward to the planned completion of the pivotal Phase 3 trial and submission of the BLA next year.” — Paul Schloesser
Travere says it’s cleared to go after accelerated approval after FDA snub
It appears Travere Therapeutics will be able to go after accelerated approval after all.
The biotech formerly known as Retrophin and previously run by Martin Shkreli, Travere announced Tuesday that the FDA has given the go-ahead for an accelerated approval plan after agreeing to include more data from an ongoing study. Travere is aiming to get a drug called sparsentan on the market for focal segmental glomerulosclerosis, a rare type of kidney scarring disease.
“If the additional data further strengthen the prediction of long-term benefit in the study as we expect, we anticipate submitting a New Drug Application for accelerated approval of sparsentan for FSGS in the middle of next year and furthering our preparations to deliver it as a potential new treatment standard for FSGS, if approved,” CEO Eric Dube said in a statement.
Regulators spurned Travere’s accelerated pitch back in May, saying the data at the time did not support use of the pathway. The biotech wanted to go straight to market following an interim analysis from February, saying 42% of patients in the treatment arm achieved the FSGS partial remission of proteinuria endpoint after 36 weeks, versus 26% in the control group (p=0.0094).
But last month, Travere revealed new data for the drug in IgA nephropathy, with 49.8% of patients seeing a mean reduction from baseline in excessive protein in the urine, compared to 15.1% in a group of patients on standard of care (p<0.0001). That update has ostensibly strengthened Travere’s application. — Max Gelman