SpikImm and SATT Conectus Sign a Definitive Licensing Agreement for Prophylactic Treatment Against the BK Virus, to Prevent Severe Complications in Transplant Patients

SpikImm, a clinical-stage biotechnology company founded in 2021 by Truffle Capital in collaboration with Institut Pasteur and dedicated to the development of monoclonal antibodies to prevent viral infections in immunocompromised patients, today announced the signature with SATT Conectus of an exclusive collaboration and worldwide license agreement for potent monoclonal antibodies targeting the BK virus. These monoclonal antibodies were developed through the project HuMABK led by Pr. Samira FAFI-KREMER, Director of the Institut de Virologie de Strasbourg and Pr. Pascal POIGNARD, Head of the "Antibodies and Infectious Diseases" research team at the Institut de Biologie Structurale of Grenoble. This agreement reinforces SpikImm's portfolio and expertise for the prophylactic treatment of viral infections in immunocompromised patients. Since the option agreement signed in 2024, SpikImm has already made progress in its preclinical work, and has successfully completed the development of the cell line for GMP manufacturing. The aim is to carry out the first in human studies by 2026.

BK virus (BKV) infects most individuals early in life and typically remains latent without causing disease. However, under immunosuppressive treatment, in particular in transplant patients, BKV can reactivate and replicate in the urinary tract, leading to potentially serious complications. In kidney transplant recipients; BKV reactivation may result in graft loss and increase the risk of bladder cancer. In addition, BKV is responsible for severe hemorrhagic cystitis in bone marrow graft recipients. No BKV-specific antiviral therapies or vaccines are currently available. Therefore, there is an urgent medical need for the development of novel anti-BKV prophylactic treatments.

Thanks to the work of Pr. FAFI-KREMER, Head of renowned Institut de Virologie of Strasbourg (U1109 University of Strasbourg / Inserm, Strasbourg University Hospitals) and her team, the key role of anti-BKV neutralizing antibodies for protection against BKV infection and associated diseases was uncovered. Building upon these insights, Pr. FAFI-KREMER and Pr. POIGNARD joined forces to develop anti-BKV neutralizing monoclonal antibodies under the HuMABK project, funded by ANR and SATT Conectus. The expertise in antibody discovery of Pr. POIGNARD and collaborators of the Institut de Biologie Structurale (CEA/CNRS / University of Grenoble Alpes / UMR 5075) enabled the successful isolation of broad and potent anti-BKV neutralizing human monoclonal antibodies. These monoclonal antibodies represent promising candidates for future clinical development as potential best-in-class options.

SpikImm and SATT Conectus today announced the signature of a worldwide exclusive licensing agreement for the anti-BKV monoclonal antibodies. These antibodies are engineered to potentially provide effective, long-lasting protection against the serious complications associated with BKV, offering a prophylactic solution for transplant recipients.

With its partners Institut Pasteur and LFB, SpikImm has already demonstrated its expertise in rapidly bringing from discovery to clinical trials two anti-SARS COV2 monoclonal antibodies within twelve months, creating a unique platform for the accelerated discovery and development of monoclonal antibodies to the benefit of patients.

SpikImm is focused on the accelerated development of long-acting monoclonal antibodies to protect immunocompromised patients from several viral infections, including SARS-CoV-2 and BKV.

Pr. FAFI-KREMER, PharmD, PhD, University Professor-Hospital Practitioner, Head of Institut de Virologie de Strasbourg (U1109 University of Strasbourg / Inserm, Strasbourg University Hospitals) and Pr. POIGNARD, M.D., Ph.D, University Professor-Hospital Practitioner (University of Grenoble Alpes - CHU Grenoble-Alpes), Head of "Antibodies and Infectious Diseases" research team at the Institut de Biologie Structurale of Grenoble (CEA-CNRS-UGA Mixed Research Unit 5075) comment: "Reactivation of the BK virus in patients receiving kidney transplant, bone marrow or stem cell grafts has potential serious consequences and represents a growing medical challenge. The HuMABK monoclonal antibodies discovered by Grenoble's Institut de Biologie Structurale in collaboration with Strasbourg's Institut de Virologie are remarkably effective in neutralizing this virus and represent a promising antiviral strategy. We are convinced that the collaboration with SpikImm will ensure a rapid clinical development. Specifically, we anticipate that the monoclonal antibodies will significantly enhance patient care, notably by preserving kidney transplants, and promoting favorable outcomes in bone marrow recipients.”

James PHILLIPS, MD, CEO of SpikImm, comments: "We are delighted to sign this agreement for these highly promising monoclonal antibodies against the BK virus. SpikImm will be able to draw on the exceptional quality of the research team, as well as the strong support of SATT Conectus, to advance this project and bring new hope to the vulnerable immunocompromised patients.”

Philippe POULETTY, MD, chairman of SpikImm comments "SpikImm’s mission is to protect immunocompromised patients from severe viral diseases. These potent anti-BKV monoclonal antibodies will reinforce SpikImm’s pipeline to offer broad protection against several severe infections. SpikImm embodies Truffle Capital approach: to actively create and grow companies with outstanding science to address major unmet needs.”

Emmanuel POTEAUX, Chairman and CEO of SATT Conectus, highlights: "The signing of this technology licence marks an outstanding scientific collaboration between two leading researchers working at the heart of two regions of academic excellence, Alsace and Grenoble. The combined financial investment from the ANR and SATT Conectus made it possible to obtain and validate robust preclinical results, paving the way for clinical development. We are delighted that SpikImm is taking over to continue the development of this major health innovation for patients.”

The HuMABK project is supported by:

About SpikImm

SpikImm is a French clinical-stage biotech founded by Truffle Capital in collaboration with Institut Pasteur in 2021 to develop human monoclonal antibodies for the prevention of severe infectious diseases affecting immunocompromised patients. SpikImm’s lead candidates SPK001 and SPK002, have been originally developed in the laboratory of Humoral Immunology (Institut Pasteur & Inserm U1222) headed by Dr Hugo MOUQUET, as long-acting monoclonal antibodies for the prevention of COVID-19 in immunocompromised patients. SpikImm is currently expanding its portfolio of monoclonal antibodies against severe viral infections, through collaborations with prestigious academic research teams, starting with BKV infection.
More information: https://spikImm.com/

About Truffle Capital

Founded in 2001, Truffle Capital is an independent European Venture Capital firm specializing in Life Sciences (MedTech and BioTech) and disruptive technologies in the I.T. sector (FinTech and InsurTech). Truffle Capital's mission is to support the creation and development of young innovative companies capable of becoming tomorrow's leaders. Managed by Dr. Philippe Pouletty and Bernard-Louis Roques, co-founders and CEOs, Truffle Capital has €500 million in assets under management. It has raised more than €1.2 billion since its creation and has supported more than 70 companies in the digital technology and life sciences sectors.
More information: http://www.truffle.com— Twitter: @trufflecapital

About SATT Conectus

SATT* Conectus is the main entry point for business partners and companies to access all the innovations and capabilities from public research in Alsace, one of the top ranked territories for the excellence of research in France. Thanks to its investment fund, SATT CONECTUS offers advanced, applicative technologies whose proofs of concept have been established, and ready to industrialize. Therefore investors will have access to groundbreaking startups built around those breakthrough yet matured technologies. Another type of collaboration allows companies to co-develop high potential innovative projects with public research, in order to tailor them to their specific needs.
* technology transfer acceleration organization
More information: http://www.conectus.fr/en

About the Institut de Virologie de Strasbourg

The Institut de Virologie de Strasbourg, headed by Pr. FAFI KREMER is affiliated with the Faculty of Medicine of the University of Strasbourg, the Strasbourg University Hospitals and the Inserm Unit U1109, LabEx TRANSPLANTEX. For more than 10 years, his research has focused on the study of virus-host interaction in the pathogenesis of polyomaviruses (BK virus)-associated diseases in immunocompromised individuals, particularly transplant patients. The central aim is to ultimately identify accurate and personalized biomarkers and to develop urgently needed, preventive and therapeutic antiviral strategies.

About the Institut de Biologie Structurale (IBS)

The IBS, a mixed research unit CEA-CNRS-Université Grenoble Alpes (UMR 5075), hosts the "Antibodies and Infectious Diseases" research team headed by Pr. POIGNARD, specialized in the study of humoral responses to viral, bacterial and parasitic infections. After playing a key role in the discovery of broadly neutralizing antibodies against HIV, P Poignard has extended his interest to other viruses, such as the BK virus, but also to bacteria and parasites. In particular, his team focuses on the development of innovative strategies for the discovery of human monoclonal antibodies to develop new therapeutic approaches and help vaccine design.

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