VIVEbiotech: A Lentiviral Vector Specialist Bridging the Gap Between R&D and Commercialisation
Natalia Elizalde PhD, Chief Business Development Officer, VIVEbiotech . VIVEbiotech is a GMP Contract Development and Manufacturing Organisation (CDMO) fully specialised in lentiviral vectors working according to both EMA´s and FDA´s regulations operating since 2015 for more than 40 international clients in Europe, US, Asia and Australia. Specifically, the company is specialised in the manufacture of lentiviral vectors that are being used for the development of both gene-modified cell therapy products -ex-vivo administration- as well as for gene therapy products -in-vivo administration-. VIVEbiotech has a well-established manufacturing platform that is employed from developmental phases to GMP production. More than 100 batches in reactors have been manufactured in a scalable, timely, and cost-effective manner, adhering to EMA and FDA GMP regulatory standards and adapting to the specific scale required for each phase. There are two main reasons why the company fully specialised on lentiviral vectors: the growing market demands, from one side, and the high technical expertise that is required to manufacture this kind of viral vectors, from the other. Referring to the market growing demands, it is important to highlight that the cell & gene therapy (CGT) area is forecasted to be the fastest growing segment within the pharmaceutical market. Indeed, the current market value stands tall at $758 Bn in 2020, with the potential for a significant growth beyond $1.200 Bn in 2026. The CAGR for the CGT market is expected to be around 50% by 2026 while that of the overall pharmaceutical sector is predicted to be around 8%. There is indeed a scarcity of players with the capacity to offer end-to-end manufacturing services. This is why CDMOs like VIVEbiotech, which bridge the gap between R&D and commercialisation, are experiencing an increasing demand. Moreover, a significant number of pharmaceutical and biotechnology companies currently do not possess the capability to internally manufacture CGT. This is the driving factor behind the projected growth of outsourced lentiviral vector supply, expected to achieve a Compound Annual Growth Rate (CAGR) of 15% from 2020 to 2026. This expected growth can be easily justified linked to the fact that more and more CGT approvals are happening in the last years – there have been more approvals in the last 3 years than in the prior 15 years- among which lentiviral vectors have been the gene transfer technology used in 8 of these marketed therapies. The CGT pipeline is getting stronger with 2,061 ongoing clinical trials globally at 1H´22, with immuno-oncology the most common therapeutic area under study. Specifically, lentiviruses are the main vector used for immuno-oncology applications as they are very efficient in gene delivery, they guarantee long-lasting transfer gene expression, they have improved safety features and present low immunogenicity. ×
As reflected in the latest H1 2023 ARM report, immuno-oncology remains at the forefront among all ongoing clinical trials (+50%) of which the majority consist of T-cell and NK cell therapies (+90%). This is somewhat expected considering that there is an increase in the number of people being diagnosed with cancer and is expected to grow by a further 50% compared to 2020, exceeding 28 million people. Moreover, CGTs are progressively expanding beyond rare diseases. Increasingly more frequent or prevalent diseases are being treated with lentiviral vectors which are being used for manufacturing vaccines or viral like particles, among others. Indeed, currently lentiviral vectors are being used in 48% of total clinical trials, which is more than double the usage for AAVs. All of this information taken together makes it clear that lentiviral vector manufacturing capacity is a pivotal factor in the development of these therapies. Therefore, the scarcity of experienced CDMOs with established virology expertise is the primary reason why it can be asserted that viral vector manufacturing constitutes a critical bottleneck for the industry, affecting both cost and the high-quality provision of vectors at a suitable scale for every phase. Speaking of the significant technical expertise involved, the manufacture of lentiviral vectors is a highly intricate process that demands skilled personnel possessing knowledge in both virology and GMP regulations for the production of sterile products. Viral vectors are highly sensitive; therefore, limiting their exposure to harsh environments is necessary to minimise product loss. Lentiviral vectors are sensitive to factors such as pH, temperature, shear, and chemical composition (salt), necessitating controlled conditions during both processing and storage. Ensuring that the process is regulatory compliant, scalable, and cost-effective from the very early stages, and executing it in a timely manner, is indeed crucial for the successful manufacture of a given therapy at a commercial scale. Thus, VIVEbiotech has specialised Technological Innovation, Upstream and Downstream Optimisation departments whose objective is adapting to the very specific requirements of our partners to make sure that the vector that is being produced is scalable and cost-effective, and high titers and pure vectors are obtained from the very beginning. Moreover, some of the ongoing innovative projects that VIVEbiotech is working on include various pseudotypes, modified cells, and/or stable cell lines, among others. Moreover, in the global landscape of the lentiviral vector space, there exists a very limited number of fully specialised players. VIVEbiotech is the sole GMP CDMO fully specialised in lentiviral vectors in Europe. Taken together, these factors clearly demonstrate an interest in CDMOs leveraging their unique expertise to bridge the gap between R&D up to commercialisation. In this regard, VIVEbiotech stands out by adapting to the real needs of the market in a rational and sustainable growth mode, aligned with current demands offering specialised services in lentiviral vectors, covering the entire spectrum from the initial phases to GMP-compliant commercial scale.

VIVEbiotech: A Lentiviral Vector Specialist Bridging the Gap Between R&D and Commercialisation

Plant
Increases production capacity by 400% to deliver commercial-size batches for Cell and Gene Therapy Sector. , a gene transfer technologies CDMO developing and manufacturing lentiviral vectors, is opening new facilities for the manufacture of lentiviral vectors for the cell and gene therapy sector. The facility will be capable of manufacturing batches ranging from those for early stage research to GMP for clinical and future commercial uses. The expanded facilities will allow the company to significantly increase its production capacity and deliver commercial-size batches of lentiviral vectors to both new and existing customers across the cell and gene therapy industry. VIVEbiotech’s production capacity will increase by 400%, with an increase in average batch size per year from 20 in 2020 to 80 in 2022. VIVEbiotech will also be able to broaden its product portfolio, and scale its delivery of products for all phases of clinical trial and commercialization. VIVEbiotech will install the largest bioreactor currently available on the global market, with seven cleanrooms set up specifically for lentiviral-vector manufacturing. Versatility in the design will result in a more flexible configuration enabling the possibility of further clean rooms in the future as well as making it feasible accommodating a much larger number of batches. VIVEbiotech has also expanded other key departments including R&D, upstream and downstream process development departments, and is expanding its workforce to 85 employees by the end of 2021. Kristin Brooks 06.02.21
Kristin Brooks 06.02.21
Kristin Brooks 06.02.21
Tim Wright, Editor, Contract Pharma 06.01.21
Tim Wright, Editor, Contract Pharma 06.01.21
Tim Wright, Editor, Contract Pharma 06.01.21
Kristin Brooks 05.28.21
Charles Sternberg, Assistant Editor 05.26.21
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Tim Wright, Editor, Contract Pharma 05.21.21
Kristin Brooks 05.20.21
Kristin Brooks 05.20.21

VIVEbiotech Launches Lentiviral Vectors Mfg. Plant

El  CDTI , a través de su  programa Innvierte , conjuntamente con  Inveready Biotech III  y  EASO Ventures , han alcanzado un acuerdo con los socios de  VIVEbiotech, S.L. para entrar en el capital de la startup. La aportación comprometida por CDTI es de algo más de 1 millón de euros. VIVEbiotech SL es una empresa ubicada en San Sebastián que inició sus actividades en 2015, dedicada al desarrollo y la producción de vectores lentivirales que tienen aplicación en diferentes áreas de tratamiento mediante la terapia génica, entre las que se incluyen enfermedades raras y cáncer (inmuno-oncología, CAR-Ts). Se tratará de un gran avance, pues actualmente el incremento en el desarrollo de tratamientos mediante terapias génicas (que necesitan de vectores virales para ser administrados), ha llevado a que la demanda de vectores virales sea superior a la oferta existente. Esta situación compromete el desarrollo y comercialización futuros de tratamientos mediante terapia génica. Actualmente la empresa participa en cerca de treinta proyectos internacionales con empresas de relevancia en el sector de la terapia génica. Gurutz Linazasoro, CEO de VIVEbiotech SL asegura que “la entrada de CDTI en el capital de la compañía da solidez institucional a su composición accionarial y permite seguir desarrollando su estrategia y ampliar su negocio por medio de un incremento de su capacidad productiva”. Inveready, con sede en San Sebastián, es una de las gestoras de Capital Riesgo líderes en España en Ciencias de la Vida. Actualmente, invierte en empresas tecnológicas de reciente creación a través de 4 verticales especializados (Tecnologías de la información, Ciencias de la Vida, Venture Debt y Financiación híbrida -deuda y capital – para empresas cotizadas)
Inveready cuenta con más de €400 millones de activos bajo gestión y más de 110 empresas en su porfolio. Durante los últimos 11 años la gestora ha completado desinversiones exitosas en más de 20 empresas, algunas de ellas adquiridas por multinacionales de la talla de Intel, Symantec y Red Hat (IBM), y otras saliendo a cotizar en mercados públicos como el IBEX 35, el NASDAQ o el MAB. Hacer posibles las ambiciones de emprendedores audaces se ha convertido en parte de nuestro ADN. Como consecuencia de este crecimiento y trayectoria, Inveready se enorgullece de haber recibido varios reconocimientos, resaltando los premios de ASCRI a la mejor gestora de capital riesgo en España, a la mejor operación de capital riesgo y la mejor operación de deuda. EASO Ventures es una Sociedad de Venture Capital de San Sebastián, constituida en el 2018 y formada por cerca de 100 inversores. Invierte en startups y empresas principalmente del País Vasco para poder ayudarles a impulsar sus proyectos. En sus 2 años de existencia ha invertido ya en 28 empresas innovadoras. El CDTI es el órgano de la Administración General del Estado que apoya la innovación basada en conocimiento, asesorando y ofreciendo ayudas públicas a la innovación mediante subvenciones o ayudas parcialmente reembolsables. El CDTI también internacionaliza los proyectos empresariales de I+D e innovación de empresas y entidades españolas y gestiona la participación española en los organismos internacionales de I+D+I, como  Horizonte2020  y  Eureka , y en las industrias de la Ciencia y el Espacio. Adicionalmente, a través de la iniciativa Innvierte Economía Sostenible, apoya y facilita la capitalización de empresas tecnológicas.

El CDTI invierte junto a Inveready Biotech III y EASO Ventures en VIVEbiotech

El CDTI invierte junto a Inveready Biotech III y EASO Ventures en VIVEbiotech
El CDTI , a través de su programa Innvierte , conjuntamente con Inveready Biotech III y EASO Ventures , han alcanzado un acuerdo con los socios de VIVEbiotech, S.L. para entrar en el capital de la startup. La aportación comprometida por CDTI es de algo más de 1 millón de euros. VIVEbiotech SL es una empresa ubicada en San Sebastián que inició sus actividades en 2015, dedicada al desarrollo  y la producción de vectores lentivirales que tienen aplicación en  diferentes áreas de tratamiento mediante la terapia génica, entre las que se incluyen enfermedades raras y cáncer (inmuno-oncología, CAR-Ts). Se tratará de un gran avance, pues actualmente el incremento en el  desarrollo de tratamientos mediante terapias génicas (que necesitan de  vectores virales para ser administrados), ha llevado a que la demanda de  vectores virales sea superior a la oferta existente. Esta situación  compromete el desarrollo y comercialización futuros de tratamientos  mediante terapia génica. Actualmente la empresa participa en cerca de  treinta proyectos internacionales con empresas de relevancia en el  sector de la terapia génica. Gurutz Linazasoro, CEO de VIVEbiotech SL asegura que “la entrada de  CDTI en el capital de la compañía da solidez institucional a su  composición accionarial y permite seguir desarrollando su estrategia y  ampliar su negocio por medio de un incremento de su capacidad  productiva”. Inveready
Inveready ,  con sede en San Sebastián, es una de las gestoras de Capital Riesgo  líderes en España en Ciencias de la Vida. Actualmente, invierte en  empresas tecnológicas de reciente creación a través de 4 verticales  especializados (Tecnologías de la información, Ciencias de la Vida,  Venture Debt y Financiación híbrida -deuda y capital – para empresas  cotizadas)
Inveready cuenta con más de €400 millones de activos bajo gestión y  más de 110 empresas en su porfolio. Durante los últimos 11 años la  gestora ha completado desinversiones exitosas en más de 20 empresas,  algunas de ellas adquiridas por multinacionales de la talla de Intel,  Symantec y Red Hat (IBM), y otras saliendo a cotizar en mercados  públicos como el IBEX 35, el NASDAQ o el MAB. Hacer posibles las  ambiciones de emprendedores audaces se ha convertido en parte de nuestro  ADN. Como consecuencia de este crecimiento y trayectoria, Inveready se  enorgullece de haber recibido varios reconocimientos, resaltando los  premios de ASCRI a la mejor gestora de capital riesgo en España, a la  mejor operación de capital riesgo y la mejor operación de deuda. EASO Ventures
EASO Ventures es una Sociedad de Venture Capital de San Sebastián, constituida en el  2018 y formada por cerca de 100 inversores. Invierte en startups y  empresas principalmente del País Vasco para poder ayudarles a impulsar  sus proyectos. En sus 2 años de existencia ha invertido ya en 28  empresas innovadoras. El CDTI
El CDTI es el órgano de la  Administración General del Estado que apoya la innovación basada en  conocimiento, asesorando y ofreciendo ayudas públicas a la innovación  mediante subvenciones o ayudas parcialmente reembolsables. El CDTI  también internacionaliza los proyectos empresariales de I+D e innovación  de empresas y entidades españolas y gestiona la participación española  en los organismos internacionales de I+D+I, como Horizonte2020 y Eureka ,  y en las industrias de la Ciencia y el Espacio. Adicionalmente, a  través de la iniciativa Innvierte Economía Sostenible, apoya y facilita  la capitalización de empresas tecnológicas.

El CDTI invierte junto a Inveready Biotech III y EASO Ventur...

VIVEbiotech collaborates with Xyphos Biosciences for clinical development support of convertibleCAR-T(TM) cell therapy
San Sebastián, Spain, June 4, 2020 -  VIVEbiotech, S.L ., a gene transfer technologies Contract Development and Manufacturing Organization (CDMO) developing and GMP manufacturing lentiviral vectors, today announces a collaboration with Xyphos Biosciences. The collaboration will concentrate on the development and manufacturing of GMP-grade lentiviral vectors. Xyphos Biosciences, an Astellas company, has chosen VIVEbiotech to be the company’s GMP clinical lentiviral vector manufacturing provider. Xyphos specifically selected VIVEbiotech as a result of its flexibility, as well as its lentiviral expertise in early as well as later stage GMP manufacturing. The agreement covers VIVEbiotech long-term supplying lentiviral vectors for Xyphos’ upcoming clinical trial of its lead convertibleCAR-T(TM) program. This involves VIVEbiotech manufacturing lentiviral vectors for both preclinical and clinical phases. “We are extremely pleased to be working with VIVEbiotech for the production of the Xyphos lentiviral vector,” said David Martin, M.D., CSO of Xyphos Biosciences. “The scientists at VIVEbiotech truly understand the needs and priorities of emerging biotech companies and the importance of providing high quality product in a timely manner.”
 
“This collaboration with an important Astellas company like Xyphos Biosciences is an ideal opportunity to utilize VIVEbiotech’s international capabilities as a CDMO with our considerable expertise in virology and lentiviral vectors,” said Gurutz Linazasoro, CEO of VIVEbiotech S.L. “Working together with Xyphos Biosciences´ team in this project will be very enriching. We are planning for this collaboration to pave the way for further partnerships using VIVEbiotech’s new GMP facility covering commercial productions. Both companies are fully committed to bring their respective expertise to the fight against cancer.”    
 
About Xyphos Biosciences
Xyphos, acquired by Astellas Pharma Inc. (“Astellas”) in December 2019, is a development-stage biotechnology company, is focused on the creation and development of immuno-oncology therapeutics designed to harness the power of the patient’s immune system to cure cancer. Xyphos’ novel and proprietary ACCEL(TM) (Advanced Cellular Control through Engineered Ligands) technology platform allows new and potentially better ways to mobilize and control immune cells to find and destroy specifically targeted cells throughout the body. The platform enables the patient’s own natural immune cells to be redirected by bispecific antibodies or to be reprogrammed to express a highly flexible and versatile Chimeric Antigen Receptor (CAR). The proprietary technology enables the exclusive or preferred delivery of various classes of single or multiple targeting and modulating agents, including bispecific antibodies, cytokines and kill functions. Resulting convertibleCAR-cells can be specifically directed to tumor cells, and their activity towards tumor destruction can be tightly controlled from outside the CAR-cell, potentially leading to safer and more efficacious treatments. Xyphos’ first convertibleCAR cell product candidate is in preclinical development and is scheduled to be tested in a first-in-human clinical study in 2021. The company is headquartered in South San Francisco, CA. For more information, visit  https://www.xyphosinc.com/
 
About Astellas
Astellas Pharma Inc., based in Tokyo, Japan, is a company dedicated to improving the health of people around the world through the provision of innovative and reliable pharmaceutical products. For more information, please visit our website at  https://www.astellas.com/en
 
About VIVEbiotech S.L. VIVEbiotech is a company fully specialized in lentiviral vectors with expertise as a GMP CDMO focused on the manufacture of lentiviral vectors from early stages to GMP. Working with European and US-based companies, its main aim is to adapt to customer own requirements from a technical and timeline perspective. In addition, VIVEbiotech´s technology development strategy is focused on providing a response to the main hurdles that currently exist within the gene therapy field, mainly the need of cost-effective processes and the enhancement of the safety profile of viral vectors. In this setting, VIVEbiotech has its own worldwide licensed technology: a non-integrative episomal stable lentiviral vector (LENTISOMA). For more information, visit  https://www.vivebiotech.com/
Editor Details

VIVEbiotech collaborates with Xyphos Biosciences for clinical development support of convertibleCAR-T(TM) cell therapy

Xyphos Biosciences is a privately held development-stage biotechnology company that focuses on the creation and development of immuno-oncology therapeutics designed to harness the power of the patient's immune system to cure cancer.

On December 27, 20109 Xuphos Biosciences was acquired by Astellas Pharma at a valuation of $665M.

Xyphos Biosciences

We are planning for this collaboration to pave the way for further partnerships using VIVEbiotech 's new GMP facility covering commercial productions .

Series A

Series A - II

VIVEbiotech is a GMP Contract Development and Manufacturing Organization (CDMO) specialized in Lentiviral vectors. The company is focused on the manufacture of Research, Preclinical toxicology and GMP-grade lentiviral vectors.

Name	Juan Carlos Ramirez
Work History
Title	Chief Technology Officer
Status	Current

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