Onxeo appoints Dr. Shefali Agarwal as Chief Executive Officer

PARIS–(BUSINESS WIRE)–Regulatory news:

Onxeo SA(Euronext Growth Paris: ALONX, Nasdaq First North Copenhagen: ONXEO), hereinafter “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, director at Invus SAS, who was appointed interim CEO in January 2022.

I have worked side-by-side with Dr. Agarwal in her capacity as President to grow our business, strengthen our Board of Directors, and most 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 for the position of CEO.“, said Julien Miara, interim CEO. “She has the expertise to partner with our strong team to rapidly advance AsiDNA® into the clinic, grow our robust preclinical pipeline and provide Onxeo with international visibility given its exposure within the US investment community..”

Dr. Agarwal is a physician by training and until recently was Medical and Development Director 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 consulting role while carrying out 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 extensive experience in oncology, I am encouraged by the work we have done at Onxeo and by the opportunities generated by our platON® platform.“, said Dr Shefali Agarwal. “As we continue to advance our first DDR inhibitor AsiDNA® into the clinic and conduct preclinical proof-of-concept studies on our next-generation PARP agonist, OX401 and its follow-up optimized versions, we will continue to seek ways to achieve better clinical outcomes for patients. With an eye on the US market, I am pleased that we will be refocusing our clinical research efforts from France to the US, developing our infrastructure and expanding our team in Massachusetts’ growing biotech hub. The new capital inflow from our two main shareholders, who support our vision, will help us achieve our objectives, allowing Onxeo to move towards the second quarter of 2023.”

Prior to joining Epizyme in 2018, Dr. Agarwal held various leadership positions in 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. Prior to 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 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 having obtained his medical degree, Dr. Agarwal holds a master’s degree in public health and a master’s degree in business sciences. Dr. Agarwal is a board member of three US biotechnology companies, ITB Med (private), Gritstone Bio (NASDAQ: GRTS) and Fate Therapeutics (Nasdaq: FATE). She also serves on the Scientific Advisory Board of Imvax, Inc. and is the founder of the Cancer Shakti Foundation, a voluntary nonprofit organization dedicated to raising cancer awareness.

Robert L. Coleman, MD, Onxeo Board Member and Chief Scientific Officer of US Oncology Research, saidWe are delighted to welcome Dr. Agarwal to Onxeo as CEO. She brings unique expertise and clinical insight to Onxeo, based on a successful history as a director in several biopharmaceutical companies. This transition foundation provides a unique perspective on unmet clinical needs, the treatment landscape, regulatory processes and capital management to carefully review and execute strategic initiatives for drug development and growth at company level. I am so honored to work alongside him to bring uniquely designed therapeutic assets to the clinic. On behalf of Onxeo’s Board of Directors, we welcome Dr. Agarwal to his 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 area of ​​tumor damage response. DNA (DDR). The Company is focused on bringing novel or innovative compounds from early-stage translational research to clinical proof of concept, an attractive value-creating inflection point for potential partners.

Plato is Onxeo’s proprietary chemistry platform of oligonucleotides acting as decoy agonists, which generates new innovative compounds and expands the Company’s product portfolio.

AsiDNA, platON’s first compound, 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 several 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-damaging agents. tumor DNA such as radio-chemotherapy. AsiDNA is currently undergoing combined clinical trials in hard-to-treat solid tumors.

OX401 is a new drug candidate from platON, designed to be a next-generation PARP inhibitor acting both on the DNA damage response and on the activation of the immune response, without inducing resistance. OX401 is currently being optimized and undergoing preclinical proof-of-concept studies, alone and in combination with immunotherapies.

For more information, visit www.onxeo.com.

Forward-looking statements
This communication expressly or implicitly contains certain forward-looking statements concerning Onxeo and its business. These statements involve certain known and unknown risks, uncertainties and other factors, which could cause Onxeo’s actual results, financial condition, performance or achievements to be materially different from any future results, performance or achievements expressed or implied. implied by these 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 the risks and uncertainties that could cause Onxeo’s actual results, financial condition, performance or achievements to differ from those contained in the forward-looking statements, please refer to the risk factors described in the most recent reference of the Company 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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