> Dr. Agarwal is Currently Chairwoman of
Onxeo’s Board, a Position Held Since June 2021
> Company Outlines Development Strategy Plans
Including Preparation for U.S. Pre-IND Meeting for First-in-Class
DDR Inhibitor AsiDNA® and Plans for Building Infrastructure in the
United States
> New Private Financing Expands Onxeo’s Runway
Into Second Quarter 2023
Regulatory News:
Onxeo S.A. (Euronext Growth Paris: ALONX, Nasdaq First
North Copenhagen: ONXEO), hereafter “Onxeo” or the
“Company”, a clinical-stage biotechnology company
specializing in the development of innovative drugs targeting tumor
DNA Damage Response (DDR), today announced the appointment of Dr.
Shefali Agarwal as President and Chief Executive Officer. Dr.
Agarwal succeeds Julien Miara, a Principal at Invus SAS, who was
named interim CEO in January 2022.
“I have worked side by side with Dr. Agarwal in her capacity as
Chairwoman to grow our Company, strengthen our Board and,
importantly, advance our pipeline. It became very clear to me and
the Board that Dr. Agarwal, who has extensive experience in drug
development, was the right choice to fill the CEO role,” said
Julien Miara, interim CEO. “She has the expertise to partner
with our strong team on expeditiously progressing AsiDNA® through
the clinic, developing our robust, pre-clinical pipeline and
providing Onxeo with international visibility given her exposure
among the U.S. investment community.”
Dr. Agarwal is a physician by training, and, until recently, was
the Chief Medical and Development Officer at Epizyme, Inc., a
biopharmaceutical company developing novel epigenetic therapies for
cancer, where she led global clinical development and regulatory
strategy. She will remain an advisor to Epizyme in a consultant
role while fulfilling her duties at Onxeo.
“I am honored to become the next CEO of Onxeo and look forward
to working more closely with this talented team as we continue to
grow the business. Given my deep experience in oncology, I’m
encouraged by the work we’ve done at Onxeo and by the opportunities
our platON® platform has generated,” said Dr. Shefali
Agarwal. “As we continue to progress our first-in-class DDR
inhibitor AsiDNA® through the clinic and are conducting
pre-clinical proof-of-concept studies on our next generation PARP
agonist, OX401 and its follow-on optimized versions, we will be
continually looking for ways to drive better clinical outcomes for
patients. With an eye on the U.S. market, I’m pleased that we will
be refocusing our clinical research efforts from France to the
U.S., building out our infrastructure and expanding our team in the
growing biotech hub in Massachusetts. The new influx of capital
from our top two shareholders, who support our vision, will help us
achieve our goals, providing Onxeo runway into Q2 2023.”
Prior to joining Epizyme in 2018, Dr. Agarwal held various
leadership positions across medical research, clinical development,
clinical operations, and medical affairs. She served as chief
medical officer at SQZ Biotech, where she built and led the
clinical development organization, which included clinical research
operations and the regulatory function. Before SQZ Biotech, she
held leadership positions at Curis and Tesaro. At Curis, she
oversaw the Phase 2 study for its dual HDAC/PI3K inhibitor in
diffuse large B-cell lymphoma, and the Phase 1 study in solid
tumors for its oral checkpoint inhibitor. At Tesaro, she led the
NDA and EMA submissions for ZEJULA® (niraparib) in ovarian cancer.
Shefali has also held positions of increasing responsibility at
Covidien, AVEO Oncology and Pfizer.
In addition to receiving her medical degree, Dr. Agarwal holds a
Master of Public Health and a Master of Science in business. Dr.
Agarwal is a member of the Board of Directors of three U.S.
biotechnology companies, ITB Med (private), Gritstone Bio (NASDAQ:
GRTS) and Fate Therapeutics (Nasdaq: FATE). She is also on the
Scientific Advisory Board of Imvax, Inc. and is the Founder of
Cancer Shakti Foundation, a voluntary non-profit organization
dedicated to raising cancer awareness.
Robert L. Coleman, MD, Onxeo Board member and Chief
Scientific Officer of US Oncology Research, said, “We are
excited to welcome Dr. Agarwal to Onxeo as CEO. She brings unique
expertise and clinical acumen to Onxeo, based on a successful
history as a director in several biopharma companies. This bridging
foundation provides a unique perspective into unmet clinical needs,
treatment landscape, regulatory processes, and capital stewardship
to carefully vet and execute on strategic initiatives for drug
development and enterprise-level growth. I’m so honored to work
alongside her to bring uniquely designed therapeutic assets to the
clinic. On behalf of the Onxeo Board, we welcome Dr. Agarwal to her
new leadership role.”
***
About Onxeo
Onxeo (Euronext Paris, NASDAQ Copenhagen: ONXEO) is a
clinical-stage biotechnology company developing innovative oncology
drugs targeting tumor DNA-binding functions through unique
mechanisms of action in the sought-after field of DNA Damage
Response (DDR). The Company is focused on bringing early-stage
first-in-class or disruptive compounds from translational research
to clinical proof-of-concept, a value-creating inflection point
appealing to potential partners.
platON is Onxeo’s proprietary chemistry platform of
oligonucleotides acting as decoy agonists, which generates new
innovative compounds and broaden the Company’s product
pipeline.
AsiDNA, the first compound from platON, is a highly
differentiated, clinical-stage first-in-call candidate in the field
of DNA damage response (DDR) applied to oncology. Its decoy and
agonist mechanism acting upstream of multiple DDR pathways results
in distinctive antitumor properties, including the ability to
prevent or abrogate tumor resistance to targeted therapies such as
PARP inhibitors and strong synergy with tumor DNA-damaging agents
such as radio-chemotherapy. AsiDNA is currently in combination
clinical trials in difficult-to-treat solid tumors.
OX401 is a new drug candidate from platON, designed to be
a next-generation PARP inhibitor acting on both the DNA Damage
Response and the activation of immune response, without inducing
resistance. OX401 is currently being optimized and is undergoing
preclinical proof-of-concept studies, alone and in combination with
immunotherapies.
For further information, please visit www.onxeo.com.
Forward looking statements This communication expressly
or implicitly contains certain forward-looking statements
concerning Onxeo and its business. Such statements involve certain
known and unknown risks, uncertainties and other factors, which
could cause the actual results, financial condition, performance or
achievements of Onxeo to be materially different from any future
results, performance or achievements expressed or implied by such
forward-looking statements. Onxeo is providing this communication
as of this date and does not undertake to update any
forward-looking statements contained herein as a result of new
information, future events or otherwise. For a discussion of risks
and uncertainties which could cause actual results, financial
condition, performance or achievements of Onxeo to differ from
those contained in the forward-looking statements, please refer to
the risk factors described in the most recent Company’s
registration document or in any other periodic financial report and
in any other press release, which are available free of charge on
the websites of the Company Group (www.onxeo.com) and/or the AMF
(www.amf-france.org).
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version on businesswire.com: https://www.businesswire.com/news/home/20220406006012/en/
Onxeo Valerie Leroy, Investor Relations
investors@onxeo.com +33 1 45 58 76 00
Media Relations - France Nicolas Merigeau NewCap
onxeo@newcap.eu +33 1 44 71 94 98
Investor Relations / Strategic Communication Dušan
Orešanský / Emmanuel Huynh NewCap onxeo@newcap.eu +33 1 44 71 94
92
Certified Adviser for Nasdaq First North Kapital Partner
www.kapitalpartner.dk info@kapitalpartner.dk +45 89 88 78 46
Media Relations – United States Aulani Capuchin Real
Chemistry acapuchin@realchemistry.com +1 559 355 2673
Onxeo (EU:ALONX)
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