drugset / Press release

PsiVac and Lonza Enter a Strategic Agreement for the Process Development and cGMP Manufacturing of Ixovex-1

2021-02-08 · Psivac Ltd · original psivac.com ↗

Lonza Group Ltd│ Muenchensteinerstrasse 38 │CH-4002 Basel │Switzerland +41 61 316 81 11 │ www.lonza.com │ [email protected] MEDIA RELEASE PsiVac and Lonza Enter a Strategic Agreement for the Process Development and cGMP Manufacturing of Ixovex-1 ▪ The strategic agreement covers process development and cGMP manufacturing of Ixovex-1, a unique patented oncolytic virus designed to address key limitations of first- and second-generation oncolytic viruses and to provide personalized therapy for cancer patients ▪ PsiVac grants Lonza the exclusive right to cGMP manufacture Ixovex-1 ▪ Process development activities started at Lonza’s Houston facility , and a phase 1 clinical trial is planned for Q2 2022 Imad Mardini, Chief Operating Officer, PsiVac: “We are delighted to collaborate with Lonza recognizing their team of experts who will lead the process development and GMP manufacture of Ixovex -1, a highly potent next-generation, tumor-selective oncolytic virus that can be used in a wide variety of solid tumors”. Ghassan Alusi, Founder and Chairman, PsiVac: “This marks another key milestone in the development of Ixovex-1 and brings greater hope to patients through the life-saving potential of this unique oncolytic virus.” Alberto Santagostino, SVP, Head of Cell & Gene Technologies, Lonza: “PsiVac‘s radical new approach to introducing a critical single base pair mutation to create viruses, rather than engineer the viral genome , holds the promise to deliver a step -change in efficacy and enhanced safety for patients . Our process development expertise a nd manufacturing capabilities will support PsiVac to scale and produce Ixovex -1 to demonstrate this science through a clinical trial.” London, UK and Basel, Switzerland, 8 February 2021 – PsiVac, a subsidiary of Ixogen; a UK biotechnology research and development company focused on the development of new therapeutic cancer treatments for solid tumor s, and Lonza, a world leader in contract manufacturing, today announced their agreement for the process development and cGMP manufacturing of Ixovex-1. Under the terms of the parties’ strategic agreement, PsiVac will grant Lonza the exclusive right to cGMP manufacture the Ixovex-1 product. Lonza Group Ltd│ Muenchensteinerstrasse 38 │CH-4002 Basel │Switzerland +41 61 316 81 11 │ www.lonza.com │ [email protected] Ixovex-1 is the first patented adenovirus with a single base pair mutation, enabling the creation of highly selective viruses that replicate rapidly. To gain patent protection, other oncolytic viruses have been engineered to add or delete part of the viral genome to achieve selectivity for tumor cells, which has been found to weaken replication efficiency. Ixovex -1 has no insertion or deletion, making this therapy a unique and highly effective oncolytic virus. In preclinical trials, PsiVac demonstrated that the replication of Ixovex-1 was significantly attenuated in healthy cells , suggesting this virus will be safer than more traditional oncolytic viruses. PsiVac has also generated compelling efficacy data in killing a broad range of tumor cells, including head and neck, bladder, liver, pancreatic and ovarian, suggesting that it could have potential utility in a wide range of solid tumor indications. Having shown that Ixovex-1 is safe, powerful, and replication efficient, PsiVac is now read y to move to human clinical trials. Lonza has carried out successful small-scale feasibility production studies, paving the way for upscaling and GMP production. The process development activities were initiated at Lonza’s Houston (USA) facility. A phase 1 clinical trial for Ixovex-1 is planned for Q2 2022. About Lonza Lonza is the preferred global partner to the pharmaceutical, biotech and nutrition markets. We work to prevent illness and enable a healthier world by supporting our customers to deliver new and innovative medicines that help treat a wide range of diseases. We achieve this by combining technological insight with world -class manufacturing, scientific expertise and process excellence. These enable our customers to commercialize their discoveries and innovations in the healthcare sector. Founded in 1897 in the Swiss Alps, today Lonza operates across three continents. With approximately 14,000 full-time employees, we are built from high-performing teams and of individual talent who make a meaningful difference to our own business, as well as to the communities in which we operate. The company generated sales of CHF 4.5 billion in 2020 with a CORE EBITDA of CHF 1.4 billion. Find out more at www.lonza.com. Follow @Lonza on LinkedIn Follow @LonzaGroup on Twitter About PsiVac PsiVac is a UK based Research & Development Biotech nology Company founded in 2019 by Professor Ghassan Alusi who recognized the need for dramatically more effective therapies to treat patients that suffered from Head and Neck Cancers and other solid tumours generally. Today PsiVac is a preclinical stage company pioneering the next generation of oncolytic virus therapy to improve the treatment of patients with cancer with exclusive rights to a patented modified adenovirus derived from the common cold virus. In preclinical studies, Ixovex-1has demonstrated high efficacy and an impressive safety and tolerability profile. The PsiVac team is supported by a preeminent Scientific Advisory Board and are excited to commence their Ph ase I studies. Find out more at www.psivac.com. Lonza Group Ltd│ Muenchensteinerstrasse 38 │CH-4002 Basel │Switzerland +41 61 316 81 11 │ www.lonza.com │ [email protected] Lonza Contact Details Victoria Morgan Head of External Communications Lonza Group Ltd Tel +41 61 316 2283 [email protected] Dr. Martina Ribar Hestericová Trade Media Lead Lonza Group Ltd Tel +41 61 316 8982 [email protected] Dirk Oehlers Investor Relations Lonza Group Ltd Tel +41 61 316 8540 [email protected] PsiVac Contact Details Imad Mardini Chief Operating Officer Ixogen Tel +44 20 7971 1100 [email protected] Cheryl Buxton Strategic Advisor PsiVac Tel +1 609 865 9275 [email protected] Additional Information and Disclaimer Lonza Group Ltd has its headquarters in Basel, Switzerland, and is listed on the SIX Swiss Exchange. It has a secondary listing on the Singapore Exchange Securities Trading Limited (“SGX -ST”). Lonza Group Ltd is not subject to the SGX-ST’s continuing listing requirements but remains subject to Rules 217 and 751 of the SGX-ST Listing Manual. Certain matters discussed in this news release may constitute forward -looking statements. These statements are based on current expectations and estimates of Lonza Group Ltd, although Lonza Group Ltd can give no assurance that these expectations and estimates will be achieved. Investors are cautioned that all forward -looking statements involve risks and uncertainty and are qualified in their entirety. The actual results may differ mater ially in the future from the forward -looking statements included in this news release due to various factors. Furthermore, except as otherwise required by law, Lonza Group Ltd disclaims any intention or obligation to update the statements contained in this news release.

The release as fetched from its publisher. psivac.com ↗