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.”

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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.