David Hallal brings his first cell therapy company into the fold, and it's tied to a major league financing deal
David Hallal wasn’t kidding around when he said that his startup ElevateBio was ready to do business.
The ex-Alexion CEO is unveiling his first portfolio deal for his $150 million cell and gene therapy startup ElevateBio this morning. And it’s tied into a major league financing round that puts Hallal’s team right on the threshold of a Phase III campaign, with an immediate need to ramp up manufacturing and start laying the foundation for potential commercial work.
Baylor spinout AlloVir, which has been operating in Houston up to now as ViraCyte, is taking up official residence in Cambridge under the guidance of the ElevateBio team, which will lend its expertise to build up manufacturing and more needed for a looming Phase III pivotal study and commercialization prep. The biotech will keep its small research team in Houston, which will now coordinate with Hallal’s group.
AlloVir, which had largely been run on grant money to date, is also getting a $120 million megaround to pay the bills for late-stage development. And the raise includes some big names, indicating that a large amount of venture money is available for more deals. The round was led by Fidelity Management and Research Company, with Gilead Sciences, F2 Ventures, Redmile Group, Invus, EcoR1 Capital, Samsara BioCapital, and Leerink Partners Co-investment Fund chipping in.
AlloVir had come to a crossroads, says Hallal, in talks with potential pharma partners but also with “a hope the AlloVir founders could stay with their innovation as long as possible and even see it get to patients.”
“It’s an immune system in a dish,” is how company CSO and Baylor professor Ann Leen describes it. The cells are extracted from healthy patients with the right characteristics, then expanded and prepped for use on patients whose immune systems have been compromised.
“It’s not genetically modified,” stresses Leen. “We can manufacture really huge numbers of these cells.”
A university spinout can do a great job with the science right through the Phase II readout, she adds. But Phase III, scaling up manufacturing and thinking of a global plan is another ballgame entirely.
Why AlloVir as the first ElevateBio portfolio company?
It’s not a big operation, just a handful of staffers, says Hallal. He likes the technology and the people involved. It also underscores his interest in building up a full range of portfolio companies, from early-stage right through to a late-stage player like AlloVir. And more deals like this are coming.
A little less than 2 years ago, AlloVir ran their lead product Viralym-M through a Phase II program, testing their off-the-shelf T-cell immunotherapy on 38 stem cell transplant patients suffering from 45 different drug-resistant viral infections triggered by 5 targeted viruses.
Here’s the nut graph from their release at the time:
Viralym-M achieved a 92% overall clinical response after a single infusion and demonstrated efficacy against all five targeted viruses with the following cumulative response rates in infections refractory to standard therapy: 100% for BK virus (n=16), 94% for cytomegalovirus (n=17), 71% for adenovirus (n=7), 100% for Epstein-Barr virus (n=2) and 67% for human herpesvirus-6 (n=3). Thirty-one patients were treated for a single viral infection and seven patients were treated for multiple simultaneous infections. Notably, rapid disease alleviation was reported in patients with BK-associated hemorrhagic cystitis (BK-HC), which can cause incapacitating pain, significant blood loss, and potentially renal failure.
Hallal and Leen describe AlloVir as a platform company, with plans to extend their research work into new programs as well as taking on immune-compromised patients following solid organ transplants.
Now they have money for all of that, plus Phase III.