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Linkinvax completes first batch production of PanCov with GTP Bioways Biologics CDMO

PanCov is born from a collaboration with French GTP BIOWAYS and European FAREVA to provide effective, rapid and innovative solutions to unmet healthcare needs.

Paris – Toulouse – July, 20 2023 – LinKinVax, a clinical-stage biotechnology company, announced the manufacture and bottling of a GMP batch of its next generation pan-sarbecovirus vaccines, known as PanCov, designed to prevent COVID-19 and other known coronavirus diseases.

This new protein-based vaccine is unique because it targets sequences of SARS-CoV-2 and its variants, as well as sequences common to other coronaviruses. Its aim is to induce broad and long- lasting immune responses.

PanCov falls within the WHO’s booster vaccination strategy for the world’s health systems. The objective of this health policy is to avoid a resurgence of the pandemic and its medico-economic consequences on world population. This strategy led to the creation by the US of the NextGen programme defining the requirements of next generation COVID-19 vaccines. These vaccines must be multi-variant, long-lasting, and both easy and cheaper to manufacture and store, and PanCov meets all these criteria.

AndJacques AubertonHervé, President and Co-Founder of LinKinVax, declared: Our ambition is to develop a robust and longlasting vaccine with a booster effect, effective on the multiple variants of SARS-CoV-2, as well as on other coronaviruses to prevent the emergence of new pandemics. The data collected during the production process with GTP Bioways will help us accelerate the production of new vaccines generated by our innovative platform. The use and training of the latest artificial intelligence (AI) tools on these databases, which we will continue to enrich, form an integral part of LinKinVax’s differentiation strategy to accelerate the production of effective vaccine solutions in the event of a pandemic.”

Alain Sainsot,  President  of  GTP  Bioways,  added:  “Our  teams  in  Toulouse  and  Saint-Julien-en- Genevois are delighted to have concluded in a timely and efficient manner the collaboration with LinKinVax announced in March 2022, that led to the production of the first GMP batch of this next generation COVID-19 vaccine. This partnership highlights the ability of the French industry to provide solutions to unmet global health needs. AndréJacques AubertonHer, CEO of LinKinVax, has also personally helped our digital strategy  by putting us in touch with global AI leaders, to boost our biomanufacturing offer and position GTP Bioways at the cutting edge of innovation.

Fareva  is  proud  of  its  contribution  to  the  production  of  a  next  generation  COVID-19  vaccine,  in partnership with key players. The achievement of this first milestone illustrates the industry’s excellence in the development and production of highly innovative healthcare products, and confirms its international standing,” added Alexandre Bastit, CEO of Business Unit Pharma and API at FAREVA.

The release of the PanCov GMP batch with compliance validation and toxicology results is expected in Q3 2023, and the clinical trials are due to start early 2024.

The PanCov vaccine was designed in France by the centre of excellence Vaccine Research Institute (VRI/INSERM/UPEC), founded and directed by Prof. Yves Lévy, and developed by LinKinVax with the support of Bpifrance as part of the PSPC Evidence Project and the French Investing for the Future Programme (PIA).

LinKinVax Contact:

Corinne Margot – corinne.margot@linkinvax.com

LinKinVax Press Contact:

Annie-Florence Loyer – afloyer@newcap.fr – +33(0) 6 88 20 35 59

GTP Bioways Contact:

Laurence Padiolleau – laurence.padiolleau@gtp-bioways.com – +33 7 71 18 64 73 Séverine Hountondji – severine.hountondji@gtp-bioways.com

FAREVA Contact :

Olivier Naudan – ONaudan.corporate@fareva.com

About the LinKinVax technology

LinKinVax’s vaccine platform is based on a humanised monoclonal antibody that binds to the pathogen’s regions of interest and targets CD40 molecules expressed by dendritic cells (DC), which play a key role in immune stimulation. Studies have demonstrated the advantages of this strategy, including the small quantity of antigens required to activate the immune system, with or without an adjuvant, and an ability to generate a lasting cellular and humoral immune response. This platform also uses the extensive safety data of protein-based vaccines, accumulated for over 30 years. Three products are or will be entering clinical trials: a prophylactic HIV vaccine currently in phase I/IIa, a SARS-CoV-2 vaccine targeting the variants of interest, and a therapeutic vaccine against papillomavirus-related head and neck cancer. Our SARS-CoV-2 vaccine targets areas other than the Spike protein, and thus induces an immunity against the whole Sarbecovirus subgenus.

About LinKinVax

LinKinVax was founded in 2020 and is led by two internationally renowned personalities in the worlds of medicine, industry and business, namely André-Jacques Auberton-Hervé, Honorary Chairman and founder of SOITEC, and Prof. Yves Levy, MD, PhD, immunologist, and Director of the Vaccine Research Institute (VRI/INSERM/UPEC). LinKinVax is developing an innovative protein- based vaccine platform that can accelerate availability of vaccines by leveraging the research conducted at the Vaccine Research Institute (VRI). This DC Targeting-based protein vaccine platform can adapt to changes and mutations in the target pathogens. For further information, please visit www.linkinvax.com

About GTP Bioways

GTP Bioways is a CDMO (Contract Development and Manufacturing Organization), offering a unique service in developing production processes and manufacturing biotherapies, antibody-drug conjugates and nanomedicines. With its development and production sites based in France, GTP Bioways supports biopharma companies aiming to develop innovative molecules, from R&D through to clinical trials, thanks to its GMP production development and aseptic filling capabilities. GTP Bioways has a strategic partnership with the Fareva group for the operation of the GMP clinical antibody production facility in Saint-Julien-en-Genevois (France). The majority of the Toulouse-based company’s shareholders are French. The various members of the GTP Bioways group will generate a turnover of €20 million in 2022. It employs 60 staff. www.gtp-bioways.com

About FAREVA

FAREVA, a leading French contract development and manufacturing company, offers a wide range of services for the pharmaceutical and cosmetic industry, including R&D support, preparation and manufacturing – including APIs -, and final packaging of clinical or commercial batches. A wide range of pharmaceutical forms and technologies are available through its extensive network of sites. FAREVA is a family-owned group providing tailor-made technical solutions for its customers. Thanks to its financial independence, capacity for innovation and customer focus, FAREVA is present in 13 countries worldwide and has a turnover of €2.1 billion. With 41 production sites and 13,000 employees worldwide, FAREVA helps its customers and partners to grow their business. Its head office is in Tournon-sur Rhône. www.fareva.com