ONXEO Offers Replace on the Improvement Program For Its First-in-class Drug Candidate AsiDNATM

• Section 1b/2 trial of AsiDNA^TM together with olaparib initiated in america in recurrent ovarian, breast and metastatic castration-resistant prostate most cancers

• Section 1b/2 trial (REVOCAN), AsiDNA^TM together with PARP inhibitors for the remedy of ovarian most cancers in sufferers with rising CA125 ranges: interim evaluation demonstrates encouraging preliminary knowledge

• Section 1b/2 trial, of AsiDNA^TM together with radiotherapy, in youngsters and adolescents and younger adults with relapsed high-grade glioma (HGG) is actively enrolling

PARIS, January 25, 2023–(BUSINESS WIRE)–Regulatory Information:

Onxeo S.A. (Euronext Progress Paris: ALONX) (Paris:ALONX), hereafter “Onxeo” or the “Firm“, a clinical-stage biotechnology firm specializing within the growth of modern tumor particular medicine focusing on tumor DNA Harm Response (DDR) and driver oncogenes, in the present day gives an replace on the scientific growth program of its first-in-class drug candidate AsiDNA^TM.

Onxeo activated its first US scientific examine web site, Subsequent Oncology San Antonio. This section 1b/2 multicenter, basket trial intends to evaluate the protection and preliminary exercise of AsiDNA^TM together with olaparib in sufferers with recurrent ovarian, breast and metastatic castration-resistant prostate most cancers (mCRPC) who’ve progressed on earlier PARP inhibitor remedy. The first endpoint of the examine will assess the protection and tolerability of the mix in addition to to find out the beneficial Section 2 dose. Key secondary endpoints will assess the preliminary exercise and length of response for the mix.

Shefali Agarwal, Chairwoman of the Board of Administrators and CEO, mentioned: “We’re delighted with the initiation of this essential scientific trial within the US to additional discover the potential of our first-in-class drug candidate, AsiDNA^TM. This investigational product has been in scientific growth in Europe for the previous couple of years, in recurrent strong tumors. In scientific research AsiDNA^TM seems to be nicely tolerated with encouraging scientific exercise within the studied sufferers until date. The activation of this primary examine within the US is a crucial subsequent step in direction of its world scientific growth.

The latest encouraging exercise noticed from the preliminary knowledge within the REVOCAN examine signifies the potential of AsiDNA^TM to re sensitize sufferers to PARP remedy which doubtlessly addresses an unmet want and will meaningfully influence sufferers residing with recurrent ovarian most cancers who’ve progressed on an preliminary remedy with a PARP inhibitor. Moreover, this lays a powerful basis for our subsequent first at school drug candidate OX425 which is sourced from the identical proprietary PlatON™ platform and is a PARP/DDR particular decoy agonist thereby presumably not inducing tumor resistance to remedy. This profile represents a possible differentiation in security and exercise from different focused therapies comparable to PARP inhibitors and we’re on monitor to file an IND in mid- 2023″.

The REVOCAN examine is an open label, multicenter, section 1b/2 examine evaluating the protection and efficacy of AsiDNA^TM, together with PARP inhibitors in sufferers with relapsed platinum delicate ovarian most cancers already beneath remedy with a PARP inhibitor. The examine is sponsored by Gustave Roussy Most cancers Campus, Grand Paris, led by Dr Patricia PAUTIER and supported by ONXEO. The examine crew just lately accomplished its first interim evaluation (IA) of 10 sufferers. The mix of AsiDNA^TM and PARPi was usually nicely tolerated with no new security alerts or dose limiting toxicities. The IA additionally demonstrated encouraging scientific exercise with six sufferers reaching a secure illness (SD) and one affected person demonstrating an entire response (CR) with illness management fee of round 70%. The examine continues to enroll sufferers. The detailed outcomes of the IA will probably be revealed by the investigator.

Moreover, AsiDNA^TM is being evaluated in Kids and younger adults with recurrent high-grade glioma (HGG). This section 1b/2 trial, sponsored by Institut Curie, is being carried out throughout the framework of the European ITCC consortium. The trial is evaluating the protection and scientific exercise of AsiDNA^TM together with radiotherapy in youngsters or younger adults with recurrent HGG. The trial has already been opened at 8 scientific trial websites in France and 5 sufferers have been enrolled. Up to now, the mix has been nicely tolerated. Additional trial web site activation is deliberate for 2023 in Italy, the Netherlands, and Germany.

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About Onxeo

Onxeo (Euronext Paris) is a clinical-stage biotechnology firm growing modern oncology medicine focusing on tumor DNA-binding capabilities by way of distinctive mechanisms of motion within the sought-after area of DNA Harm Response (DDR). The Firm is concentrated on bringing early-stage first-in-class or disruptive compounds from translational analysis to scientific proof-of-concept, a value-creating inflection level interesting to potential companions.

platON is Onxeo’s proprietary chemistry platform of oligonucleotides performing as decoy agonists, which generates new modern compounds and broaden the Firm’s product pipeline.

AsiDNA, the primary compound from platON, is a extremely differentiated, clinical-stage first-in-class candidate within the area of DNA injury response (DDR) utilized to oncology. Its decoy and agonist mechanism performing upstream of a number of DDR pathways ends in distinctive antitumor properties, together with the power to stop or abrogate tumor resistance to focused therapies comparable to PARP inhibitors and robust synergy with tumor DNA-damaging brokers comparable to radiotherapy or chemotherapy. AsiDNA is at present being studied in Europe and US together with different remedy modalities in difficult-to-treat strong tumors.

OX425, the second compound from platON, is a novel DDR Decoy Agonist with excessive antitumor exercise. It additionally mediates a number of immunostimulatory results by activating the STING pathway. OX425 is at present in IND-enabling preclinical growth.

For additional info, please go to www.onxeo.com.

Ahead wanting statements

This communication expressly or implicitly accommodates sure forward-looking statements regarding Onxeo and its enterprise. Such statements contain sure identified and unknown dangers, uncertainties and different elements, which may trigger the precise outcomes, monetary situation, efficiency or achievements of Onxeo to be materially completely different from any future outcomes, efficiency or achievements expressed or implied by such forward-looking statements. Onxeo is offering this communication as of this date and doesn’t undertake to replace any forward-looking statements contained herein on account of new info, future occasions or in any other case. For a dialogue of dangers and uncertainties which may trigger precise outcomes, monetary situation, efficiency or achievements of Onxeo to vary from these contained within the forward-looking statements, please confer with the chance elements described in the latest Firm’s registration doc or in another periodic monetary report and in another press launch, which can be found freed from cost on the web sites of the Firm Group (www.onxeo.com) and/or the AMF (www.amf-france.org).

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