ElevateBio Announces that AlloVir Joins its Portfolio of Highly Innovative Cell and Gene Therapy Companies

ElevateBio, a cell and gene therapy holding company, announced today
that AlloVir, formerly known as ViraCyte, has joined its growing
portfolio of highly innovative companies. AlloVir, a late-clinical stage
allogeneic cell therapy company, is built on an innovative technology
platform developed by researchers at Baylor College of Medicine’s Center
for Cell and Gene Therapy. The company’s platform and manufacturing
process enables the potential for the treatment and/or prevention of
multiple devastating viruses with each single allogeneic cell therapy
targeting multiple viruses at once. AlloVir’s scientific founders are
working with ElevateBio to continue to build the company and accelerate
development of its highly innovative pipeline to transform the lives of
patients suffering from virus-associated diseases. Today, AlloVir also
announced a $120 million Series B financing led by Fidelity Management
and Research Company, and joined by Gilead Sciences, F2 Ventures,
Redmile Group, Invus, EcoR1 Capital, Samsara BioCapital, and Leerink
Partners Co-investment Fund, LLC.

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AlloVir's Viralym-M (ALVR105) is in late-stage clinical development as an allogeneic, off-the-shelf multi-virus specific T-cell therapy targeting six common viral pathogens. (Photo: Business Wire)

AlloVir is leading the way in the clinical development of novel
therapies designed to restore natural T-cell immunity against
virus-associated diseases in patients who are immunocompromised,
including recipients of stem cell and solid organ transplants. AlloVir’s
lead product, Viralym-M (ALVR105), is in late-stage clinical development
as an allogeneic, off-the-shelf, multi-virus specific T-cell therapy
targeting six common viral pathogens in immunocompromised individuals:
BK virus, cytomegalovirus, adenovirus, Epstein-Barr virus, human
herpesvirus 6, and JC virus. In a positive Phase 2 proof-of-concept
study, published in the Journal of Clinical Oncology (Tzannou,
JCO, 2017), greater than 90% of patients who failed conventional
treatment and received the company’s lead allogeneic T-cell therapy,
Viralym-M, demonstrated a predefined criteria for a complete or partial
clinical response, most with complete elimination of detectable virus in
the blood and resolution of major clinical symptoms. AlloVir’s second
allogeneic, off-the-shelf multi-virus specific T-cell therapy, ALVR106,
targets four common and devastating community-acquired respiratory
viruses: respiratory syncytial virus, influenza, parainfluenza virus,
and human metapneumovirus (Vasileiou, Haematologica, 2019).

“We are excited to now be building AlloVir as an ElevateBio portfolio
company,” said Ann Leen, Ph.D., AlloVir Co-Founder, CSO, and Professor
of Pediatrics at Baylor College of Medicine. “This partnership provides
AlloVir with fully integrated bench-to-bedside capabilities to
accelerate the development and commercialization of our allogeneic,
off-the-shelf, multi-virus specific T-cell immunotherapies.”

“Over many years, AlloVir’s world-leading scientists have developed a
highly innovative pipeline of allogeneic, off-the-shelf, T-cell
therapies being studied to treat and prevent many devastating and
life-threatening virus-associated diseases,” said David Hallal, AlloVir
CEO and co-founder of ElevateBio. “Following successful meetings with
the FDA, we are delighted to be working with the medical community to
plan and initiate pivotal Phase 3 studies for Viralym-M and advance
ALVR106 into the clinic over the next 12 months.”

AlloVir will continue to benefit from its visionary founders and
world-class scientists from Baylor College of Medicine’s Center for Cell
and Gene Therapy who will play an active role in the company as
leadership and advisors, including:

• Ann Leen, Ph.D., Chief Scientific Officer (Professor of Pediatrics,
  Baylor College of Medicine)
• Juan Vera, M.D. Chief Product Development Officer and Director
  (Associate Professor of Medicine, Baylor College of Medicine)
• Malcolm Brenner, M.D., Ph.D., SAB Member and Director (Founding
  Director of Baylor College of Medicine’s Center for Cell and Gene
  Therapy)
• Helen Heslop, M.D., DSC, SAB Member (Director of Baylor College of
  Medicine’s Center for Cell and Gene Therapy)
• Cliona Rooney, Ph.D., SAB Member (Professor of Pediatrics, Baylor
  College of Medicine)

In conjunction with the $120MM Series B, AlloVir is pleased to welcome
Morana Jovan-Embiricos, Ph.D., Managing Partner, F2 Ventures, as a
Director, and Diana Brainard, Senior Vice President, HIV and Emerging
Viral Infections, Gilead Sciences, as a Board Observer, as the company
advances toward initiating multiple registration and proof-of concept
studies in immunocompromised patients suffering from life-threatening
virus-associated diseases.

About AlloVir’s Approach:

Virus-specific T-cells (VSTs) from the body’s natural defense system
provide protection against thousands of disease-causing viruses.
However, these viruses can go unchecked in immunocompromised patients,
such as after hematopoietic stem cell transplantation (HSCT), organ
transplant, or patients suffering with primary immunodeficiencies,
cancer or HIV. Typically, when viruses attack immunocompromised
patients, standard of care does not address the underlying problem of a
weakened immune system and therefore, many patients suffer with
life-threatening outcomes such as multi-organ damage and failure, and
even death.

Through decades of innovative scientific research, AlloVir has developed
a series of investigational cell therapies designed to restore natural
immunity for patients by administering multi-virus specific T-cells that
recognize and attack specific pathogenic viruses.

AlloVir has developed Viralym-M, an investigational cell therapy to
treat active virus-associated diseases, including from BK hemorrhagic
cystitis, cytomegalovirus, adenovirus, Epstein-Barr virus, JC virus and
human herpesvirus 6. The company uses natural immune stimulant proteins
called cytokines combined with non-harmful fragments of the virus to
activate and expand out naturally occurring cells against these six
viruses. These cells are then provided to immunocompromised patients
with the focus to restore natural T-cell immunity and eradicate the
reactivated virus and associated morbidities. AlloVir has developed a
proprietary manufacturing process that allows hundreds of patients to be
treated with virus specific T-cells manufactured from a single donor.

About AlloVir

AlloVir, formerly ViraCyte, was founded in 2013 and is the leader in the
development of novel cell therapies with a focus on restoring natural
immunity against life-threatening virus-associated diseases in patients
with severely weakened immune systems. The company’s technology
platforms deliver commercially scalable solutions by leveraging
off-the-shelf, allogeneic, multi-virus specific T-cells targeting
devastating viral pathogens for immunocompromised patients under viral
attack. AlloVir’s technology and manufacturing process enables the
potential for the treatment and/or prevention of up to six devastating
viruses with each single allogeneic cell therapy. The company is
advancing multiple mid- and late-stage clinical trials across its
product portfolio. More information can be found at www.allovir.com

About ElevateBio

ElevateBio, LLC, is a Cambridge-based biotechnology company, established
to create and operate a broad portfolio of cell and gene therapy
companies with leading academic researchers, medical centers and
entrepreneurs. ElevateBio builds single- and multi-product companies by
providing scientific founders with fully-integrated bench-to-bedside
capabilities including world-class scientists, manufacturing facilities,
drug developers and commercial expertise. ElevateBio BaseCamp, a
company-owned Cell and Gene Therapy Center of Innovation, will serve as
the R&D, process development and manufacturing hub across the entire
ElevateBio portfolio while also supporting selected strategic partners.

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