Other Indications
Hematopoietic Stem Cell Transplantation
BK polyomavirus (BKV) is a major cause of hemorrhagic cystitis (HC) following allogeneic hematopoietic stem cell transplantation (allo-HSCT). BKV-associated hemorrhagic cystitis occurs in approximately 15% of transplant recipients and can be severe, prolonged, and debilitating, significantly impacting patient outcomes and healthcare resource utilization.
Each year, approximately 35,000 allo-HSCT procedures are performed worldwide, underscoring the substantial clinical burden of this complication. No approved or specific curative therapies are currently available to prevent or treat BKPyV-associated HC, leaving clinicians with limited and largely supportive management options.
In this context, SPK004 has the potential to offer a unique and much-needed therapeutic solution, addressing both the prevention and treatment of BKV-associated hemorrhagic cystitis in highly immunocompromised patients.
Progressive Multifocal Leukoencephalopathy (PML)
Thanks to its high potency against JC polyomavirus (JCPyV), SPK004 may offer a novel preventive approach for patients suffering from Progressive Multifocal Leukoencephalopathy (PML).
JCPyV is the causative agent of PML, a rare but often fatal demyelinating disease occurring primarily in immunocompromised patients.
Individuals receiving immunosuppressive therapies such as natalizumab (Tysabri®) for multiple sclerosis or anti-CD20 antibodies such as rituximab (Rituxan®) face a progressively increasing risk of JCPyV reactivation and subsequent PML over time.
Despite advances in supportive care, PML remains associated with very high morbidity and mortality, and no approved antiviral treatment is currently available beyond discontinuation of the causative immunosuppressive therapy.
Based on discussions with key opinion leaders, SPK004 could represent a differentiated therapeutic option for patients at risk, with the potential to prevent or control JCPyV infection and thereby address a major unmet medical need in PML.
SPK005
UNDISCLOSED
SpikImm has recently entered into a broad strategic partnership, formalized through a first-right agreement with the Institut Pasteur, and is currently actively reviewing additional in-licensing opportunities to further expand its pipeline