Poolbeg Pharma plc (LON:POLB), a leading infectious disease focused biopharmaceutical company, has announced the strategic expansion of POLB 001 into oncology. While investigating the role of cytokine release syndrome in severe influenza, Poolbeg discovered data specific to the overt immune response in CAR T cell patients that suggest POLB 001 as a potential treatment option for this severe complication. The Company has submitted a patent application for the use of POLB 001 in addressing the impact of CRS in CAR T cell patients.
Key Highlights
- Newly filed patent application to protect use of POLB 001 for new oncology indication
- Scientific findings indicate POLB 001 has the potential to dampen the pro-inflammatory cytokine release syndrome affecting patients receiving CAR T cell therapies
- Patent application covers a method of use of all p38 inhibitors during CAR T cell therapy
- Progressing towards trial initiation in CAR T cell patients in 2024
CAR T cell therapies are a form of immunotherapy for cancer that have produced remarkable results across a range of haematological malignancies, including cases of complete and durable responses in patients with advanced leukaemia and lymphoma who failed on previous therapies. A significant number of patients suffer treatment related side effects, including CRS which in severe form can be life threatening. Cell therapies may induce these effects in up to 95% of patients1. Poolbeg has identified POLB 001 as a potentially valuable companion therapy to be used in conjunction with existing CAR T cell therapies to address this significant unmet need. POLB 001’s mode of action, reducing hyperinflammation which is associated with CRS, has the potential to significantly reduce the serious adverse effects experienced by many CAR T cell patients.
The filed patent application is expected to provide class protection for use of p38 inhibitors in CAR T cell treatment and opens up a significant new market opportunity for POLB 001 in addition to severe influenza.
A long-term strategic objective for Poolbeg has been and continues to be to evaluate POLB 001’s potential in additional indications to fully unlock the potential value of the molecule and strengthen Poolbeg’s position with a view to potential partnering and out-licensing. The Company is performing oncology clinical trial enabling activities to progress towards trial initiation in CAR T cell patients in 2024. Further oncology-related data, regulatory feedback and non-clinical development updates are expected in 2023.
Prof Brendan Buckley, Scientific Advisory Board member at Poolbeg Pharma, said: “Hyperinflammation as a driver of disease severity in influenza is also fundamental to CRS, which can severely complicate CAR T cell therapy of patients with blood cancers. By reducing runaway inflammation associated with CRS, POLB 001 has the potential to significantly reduce the serious adverse effects that many CAR T cell patients suffer. With 18-19 million cases of cancer diagnosed globally each year, the use of cell therapies is predicted to expand significantly over the coming years with the CAR T cell market expected to grow to an estimated $6 billion by 2031. With oncology clinical trial enabling activities for POLB 001 underway, we look forward to updating the market as to the progress of this exciting programme.”
Cathal Friel Poolbeg Pharma Chairman told DirectorsTalk,
“Delighted to share with you that we have strategically expanded POLB 001 into oncology, which complements the strong initial data from the LPS challenge trial announced last week and is in line with the stated objective at IPO to expand POLB 001 to additional indications.
Scientific findings indicate that POLB 001 has the potential to dampen cytokine release syndrome (that can be life threatening) which effects patients receiving CAR T cell therapies. As such, POLB 001 could prove to be a valuable companion therapy. We have filed a patent application which covers a method of use of all p38 inhibitors during CAR T cell therapy, this opens up a significant new market opportunity for POLB 001 in addition to severe influenza. We are performing oncology clinical trial enabling activities to progress towards clinical trial initiation in CAR T cell patients in 2024. Further oncology-related data, regulatory feedback and non-clinical development updates are expected in 2023.
As you know our plan is to out-license / partner with pharma and biotech, and we are delighted that this additional indication significantly strengthens our position in out-licensing discussions. It is important to note that this expansion to CAR T will not have any impact on timelines for partnering.”
