SpikImm, a French clinical-stage biotechnology company, announced the signing of an exclusive worldwide licensing agreement with SATT Conectus for potent monoclonal antibodies targeting BK virus (BKV). The agreement, announced on June 12, 2025, addresses a critical unmet medical need for transplant patients who face serious complications from BK virus reactivation under immunosuppressive treatment.
The monoclonal antibodies were developed through the HuMABK project led by Professor Samira Fafi-Kremer, Director of the Institut de Virologie de Strasbourg, and Professor Pascal Poignard, Head of the "Antibodies and Infectious Diseases" research team at the Institut de Biologie Structurale of Grenoble. This collaboration between two leading French research institutes has produced what researchers describe as "remarkably effective" neutralizing antibodies against BK virus.
Critical Medical Need in Transplant Medicine
BK virus infects most individuals early in life and typically remains latent without causing disease. However, under immunosuppressive treatment, particularly 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. Additionally, BKV is responsible for severe hemorrhagic cystitis in bone marrow graft recipients.
Currently, no BKV-specific antiviral therapies or vaccines are available, creating an urgent medical need for novel anti-BKV prophylactic treatments. The research team's work has uncovered the key role of anti-BKV neutralizing antibodies for protection against BKV infection and associated diseases.
Scientific Development and Collaboration
The HuMABK project, funded by ANR and SATT Conectus, leveraged the antibody discovery expertise of Professor Poignard and collaborators at the Institut de Biologie Structurale. This expertise enabled the successful isolation of broad and potent anti-BKV neutralizing human monoclonal antibodies, which represent promising candidates for future clinical development as potential best-in-class options.
Professor Fafi-Kremer and Professor Poignard commented on the significance of their work: "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."
Clinical Development Timeline
Since signing an option agreement in 2024, SpikImm has made significant progress in preclinical work and has successfully completed the development of the cell line for GMP manufacturing. The company aims to carry out first-in-human studies by 2026, demonstrating its commitment to rapid clinical development.
SpikImm has previously demonstrated its expertise in accelerated development, having brought two anti-SARS-CoV-2 monoclonal antibodies from discovery to clinical trials within twelve months in partnership with Institut Pasteur and LFB. This track record positions the company well for the rapid advancement of the anti-BKV program.
Strategic Significance
James Phillips, MD, CEO of SpikImm, expressed enthusiasm about the agreement: "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, emphasized the strategic fit: "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."
The antibodies are engineered to potentially provide effective, long-lasting protection against the serious complications associated with BKV, offering a prophylactic solution for transplant recipients. The researchers anticipate that the monoclonal antibodies will significantly enhance patient care, notably by preserving kidney transplants and promoting favorable outcomes in bone marrow recipients.
Technology Transfer Success
Emmanuel Poteaux, Chairman and CEO of SATT Conectus, highlighted the collaborative achievement: "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."
This licensing agreement represents a significant milestone in addressing the unmet medical need for BK virus prevention in immunocompromised patients, potentially transforming care for transplant recipients who currently have no specific therapeutic options against this serious viral complication.
