Pipeline
CellProtect
CellProtect, autologous ex vivo expanded and activated Natural killer (NK) cells with restored cytotoxicity, is our leading investigational drug candidate. Cellprotect is intended to be administered to the patient by infusions in open care.
CellProtect has a unique mechanism of action different from the treatment regiments currently used. Considering the nature of CellProtect as an autologous cell therapy product it may also be used as adjunct therapy to current clinical praxis and in combination with other therapies to expand the treatment options for an improved effect, and curative potential. Given the safety profile of CellProtect and its unique mechanism of action, it is likely to be investigated in cancer prevention studies.
CellProtect has been granted Orphan Drug Designation (ODD) for the treatment of MM from the EC and are planning to advance the clinical development and reach the market via accelerated/conditional approval. An ODD application has been submitted to the FDA.
ACP-001
A First in Human phase I/II clinical study, EudraCT No: 2010-0223330-83, was conducted at the Hematology Center at Karolinska University Hospital Huddinge for our leading indication, consolidation treatment after high dose autologous stem cell transplantation in patients newly diagnosed with multiple myeloma.
The clinical study was an open, single arm, triple escalating dose/patient study to primarily investigate the safety and tolerability of CellProtect. The secondary objectives were to investigate the effect of CellProtect to deepening the response, i.e. further decrease in serum Ig level (M-protein) in patients who did not achieve complete remission or reaching a less MRD in patients achieving complete remission. Follow-up of progression free survival (PFS) and overall survival (OS) as also been done.
CellProtect was administered to the patient in three escalating weekly infusions post auto HSCT with the doses 5×10⁶, 5×10⁷, and 1×10⁸ cells/kg. Evaluation of results was done 4 weeks after infusion at 6 months follow up and onwards.
Six patients completed the study including evaluation and a six-month follow-up after last infusion.
ISA-HC-NK
A phase II clinical trial combining CellProtect with an anti-CD38 antibody (EudraCT: 2020-000994-26) is in planning phase. In total, 60 patients are planned to be treated of which 30 patients will be given CellProtect.