Mustang inks a deal for in vivo CAR-T tech from the Mayo Clinic; How a spilled cup of tea landed one biotech $11.7 million
As part of its push to develop an off-the-shelf CAR-T therapy, Mustang Bio has inked a deal for new technology out of the Mayo Clinic designed to form CAR-T cells inside the patient.
The two-step approach comes from the lab of Larry Pease, principal investigator and former director of the Mayo Clinic’s Center for Immunology and Immune Therapies. First, the patient receives a peptide that drives the rapid reproduction of the body’s own resident T cells. Then, a viral CAR construct is administered directly into the patient’s lymph nodes. That construct infects the activated T cells, and essentially forms CAR-T cells in vivo.
“The immune cells are activated in vivo using the natural methods employed by the body to deal with infection rather than the artificial activation used to manufacture traditional CAR T cells ex vivo,” Pease said in a statement. “This could potentially reduce the substantial toxicities that are characteristic of traditional CAR T therapy.”
Mustang is keeping mum about the financial terms of the deal for now. Preclinical development will continue at the Mayo Clinic until Mustang identifies a lead construct and files an IND.
How a spilled cup of tea landed one biotech $11.7M
Some of the biggest ideas come to us by accident. According to HAGAR, a Tel Aviv-based biotech working on non-invasive glucose monitoring tech, Gerry Waintraub’s lightbulb moment came when he spilled a cup of tea on a radio frequency device during a routine experiment.
The sugar in the tea caused a dramatic reaction on the system’s monitors, leading Waintraub to wonder if the technology could be used to help diabetes patients. That discovery led to GWave — a device about a third of the size of a smartphone that’s designed to detect glucose blood levels. And on Thursday, HAGAR reeled in $11.7 million to conduct pivotal trials.
GWave measures glucose levels in the blood rather than from interstitial fluid, according to HAGAR. The company’s latest model in development, GWave 2.0, is designed as a sensor that can be integrated into a smartwatch.
“RF can positively change diabetes monitoring and care for good,” Taire Rubin, co-founder and VP of business development, said in a statement. “We’ve dedicated ourselves to ensure our technology gets smarter, more efficient, and increasingly cost-effective to help improve the lives of nearly 500 million people living with diabetes today.”
Dermata soaks up $18M for freshwater sponge therapy
Dermata Therapeutics launched in late 2014 to see if a freshwater sponge could be used to treat skin conditions like acne, psoriasis and rosacea. Now the company’s soaking up $18 million, after pricing an IPO at $7 per share — the low end of an expected $7 to $9 range.
Dermata’s platform is based on Spongilla lacustris, a naturally growing freshwater sponge that’s traditionally used as a folk medicine for various inflammatory conditions. However, Dermata believes Spongilla’s natural defense mechanisms could prove useful in treating skin conditions, like acne vulgaris.
A majority of the IPO proceeds will go toward DMT310, the company’s lead program that’s headed toward Phase III for the treatment of moderate to severe acne. Dermata says it plans on initiating two pivotal trials in the second half of next year, with topline results expected in the first half of 2024. Some of the funds will also be used to conduct Phase II and Phase I trials in rosacea and psoriasis, respectively.
Dermata says its exclusive supplier has been harvesting Spongilla for more than 18 years, and has the resources to collect and process large enough quantities for the research.
FDA sets 2022 decision date for Dermavant’s psoriasis cream
Dermavant’s $330 million bet on GSK’s topical plaque psoriasis drug could soon pay off.
The FDA has accepted Dermavant’s NDA for tapinarof — the “cosmetically elegant” vanishing cream Vivek Ramaswamy’s team plucked from back in 2018 — and set a PDUFA date for Q2 2022, the company announced on Tuesday.
While drugs like Stelara, Skyrizi and Cosentyx currently dominate the plaque psoriasis market, Dermavant CEO Todd Zavodnick has a distinct commercial plan in mind for tapinarof. He sees the candidate as a replacement for steroids in the topical space, while leaving the most severe cases to the ultra-effective biologics, where the cream could act as an add-on therapy.
Regulators will base their decision on Phase III data from the PSOARING 1 and 2 trials, as well as interim results from PSOARING 3, a 40-week, open-label safety study.
Back in April, Zavodnick announced that around 20% of moderate to severe patients given tapinarof in PSOARING 1 and 2 achieved 90% disease clearance, measured by the Psoriasis Area and Severity Index (PASI 90) at Week 12. Less than 3% of patients on placebo in each trial achieved PASI90, he said at the time.
Zavodnick said in a statement that Dermavant is already prepping for a commercial launch, should they win FDA approval next year.