Houston-based AlloVir Raises $120 Million Series B For Virus-Targeting Immunotherapies

By James Rowley 

Houston-based biopharmaceutical company AlloVir (formerly known as ViraCyte) recently announced $120 million in Series B funding. Fidelity Management and Research Company led the deal. Participating investors include Gilead Sciences, F2 Ventures, Invus, Leerink Partners, Redmile Group, EcoR1 Capital, and Samsara BioCapital.

AlloVir is also the first venture to publicly join the portfolio of ElevateBio, a recently-launched Cambridge, MA-based company which aims to advise and assist cell and gene therapy upstarts throughout the discovery, development, and commercialization lifecycle. Earlier this month, ElevateBio announced it raised $150 million in venture funding led by UBS Oncology Impact Fund. AlloVir financiers Samsara BioCapital, Redmile Group, and EcoR1 Capital also back ElevateBio.

According to a press release published by ElevateBio on Wednesday, AlloVir “is a leading innovator in allogenic, off-the-shelf, multi-virus specific T-cell immunotherapies.” What does that mean?

Let’s break it down:

“Allogenic,” meaning, basically, that biological material used to create the company’s treatments are sourced from (compatible) donors, rather than from the patient themselves.

 

“Off-the-shelf,” in this specific case, means that AlloVir’s products could be integrated into a treatment regime immediately, sitting in storage in the meantime. In the context of T-cell therapeutics (which we’ll get to in a moment), a treatment wouldn’t be “off the shelf” if it required sampling, modifying, and culturing cells from the patient.

 

Jumping out of order a bit: T cells are a foundational part of the human immune system. There are many types of T cells, all of which play specific roles in responding to infection. Cancer patients, HIV positive people, transplant recipients, people with chronic infections, people with autoimmune diseases, or other immuno-suppressed populations have lower counts of these key cells. This makes them more susceptible to infection and illness.

 

According to AlloVir, its primary T cell therapy offering, Viralym-M (ALVR105), can target six different viral pathogens, including: BK virus (which can affect kidney transplant patients), cytomegalovirus, adenovirus, Epstein-Barr virus (which causes mononucleosis, aka “mono”), JC virus, and human herpesvirus 6.

Preliminary research findings on the company’s next therapy, ALVR106, which “targets four common and devastating community-acquired respiratory viruses” were published in the journal Haematologica last month.

So, basically, AlloVir is in the business of sourcing and training immune cells from healthy donors to fight viral infections in folks with compromised immune systems.

AlloVir’s therapies are still in clinical trials. The company published results from its Phase 2 study in the Journal of Clinical Oncology, finding that 93 percent of treated patience "demonstrated a clinical response (or met clinical response criteria) following treatment with Viralym-M.” ElevateBio CEO David Hallal told Xconomy that AlloVir will start Phase 3 trials of Viralym-M in 2020.

AlloVir’s as-yet-unnamed ALVR106—targeting respiratory syncytial virus, influenza, parainfluenza virus, and human metapneumovirus—is expected to enter the first phase of clinical trials within the next 12 months, according to coverage in Biospace.

This latest funding round brings AlloVir’s total backing to at least $159 million. The company (which at the time was still called ViraCyte) filed a Form D with the SEC in September 2018. The regulatory filing disclosed the company closed at least $30 million out of a targeted $50 million funding round. It’s unclear whether ViraCyte has closed the remaining $20 million from that round.

Prior to that deal, the company raised $8.99 million in grant funding from the Cancer Prevention and Research Institute of Texas.

Note. The Crunnchbase News team are not doctors or medical researchers, and we don’t play them on the internet. If we got any part of this wrong, please email the author: jason@crunchbase.com

Source. Crunchbase, James Rowley, May 23, 2019

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ElevateBio Gets $150M to Grow a Crop of Gene & Cell Therapy Startups

By Frank Vinulan

When a biotech startup is ready to test an experimental therapy it faces a pricey choice: Should it make its drug in-house, or hire a contract manufacturer? The decision is particularly expensive for companies developing complex gene and cell therapies, which need to make large batches of engineered viruses to test their work.

A new Cambridge, MA, company called ElevateBio aims to offer an alternative path.

ElevateBio is building a facility that is intended to manufacture experimental gene and cell therapies for multiple startups, and aims to invest in those companies and help them grow. The company has raised $150 million led by UBS Oncology Impact Fund and F2 Ventures to execute its plan. Co-founder and CEO David Hallal says that the ElevateBio site will be more efficient as a shared resource than it would be if it were owned by a single company.

“We get to build it once and then run multiple companies through it,” he says.

Startups developing chemical drugs often lean on contract manufacturers to make their products. But ElevateBio chief scientific officer Mitch Finer says contractors are too expensive for most cell and gene therapy startups. Gene and cell therapy products involve engineering viruses and filling them with genetic instructions. And for some gene and cell therapies, companies have to extract cells from a patient, modify them in a lab, and infuse them back into the body—a complex and costly process that can take weeks. Finer saw this firsthand as the chief scientific officer of cell and gene therapy developer Bluebird Bio (NASDAQ: BLUE), which built its own manufacturing capabilities. Last year, it reported $448 million in research and development expenses alone.

The need for gene and cell therapy manufacturing expertise has grown considerably as these cutting edge treatments have progressed forward. Multiple gene and cell therapies are now approved in the US and Europe, and many more are in development. The FDA, for instance, could approve the spinal muscular atrophy gene therapy Zolgensma, from Novartis (NYSE: NVS), this month. Others for hemophilia, beta-thalassemia, Duchenne muscular dystrophy, and more could follow.

Biopharma is investing heavily in gene therapy’s future: Roche, Biogen (NASDAQ: BIIB), Johnson & Johnson (NYSE: JNJ), and Pfizer (NYSE: PFE) have all bought gene therapy assets this year. What’s more, two contract manufacturers who specialize in gene and cell therapy work, Paragon Bioservices and Brammer Bio, have both been acquired since March. Upon buying Paragon for $1.2 billion, Catalent (NYSE: CTLT) estimated that the addressable market for gene therapy tools is worth $40 billion, and “is expected to have sustained growth of 25 percent in the medium term.”

ElevateBio is trying to capitalize on this momentum by meeting the manufacturing needs of startups. It is currently building a 100,000 square-foot complex in Waltham, MA, that it calls BaseCamp (pictured above). The site, which is still under construction, will be capable of manufacturing both gene and cell therapies, Finer says. BaseCamp will be able to support several companies, though Hallal wouldn’t say how many it can house at one time. Finer adds that the facilities will meet quality control standards and the requirements of US and European regulations.

But ElevateBio isn’t doing this just to be a contract manufacturer. It will operate as a holding company that invests in nascent cell and gene therapy startups spun out of academia. Hallal says his team is already talking with scientists at universities in the US and abroad about bringing their early gene and cell therapy work into ElevateBio.

ElevateBio’s plan is to nurture these startups until they progress, get more private financing, or go public, Hallal says. Each startup that leaves the nest will clear the way for a new company. The goal is to spark a cycle of gene and cell therapy companies being created, grown, and spun out of the Waltham space, Hallal says.

ElevateBio’s Waltham facility is expected to become fully operational in the second half of next year. But Hallal says startups can start working with the company sooner. Right now, it has lab space in Cambridge.

EcoR1 Capital, Redmile Group, and Samsara BioCapital invested in ElevateBio along with UBS Oncology and F2. Before emerging from stealth, ElevateBio was incubated within MPM Capital, where both Hallal and Finer are executive partners.

Source. Xeconony, Frank Vinulan, May 13, 2019

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