We are open to partnering, contact our team at
POLB 001 is a Phase 2 ready, orally-administered p38 MAP Kinase inhibitor being developed for the prevention of Cytokine Release Syndrome (CRS) associated with Bispecific Antibodies and CAR T immunotherapy treatments.
At a Glance
- Phase 2 ready oral small molecule
- Strong pre-clinical data package
- Proven safety profile & well tolerated in Phase 1 clinical trial
- Efficacy demonstrated in Phase 1b LPS human challenge trial
- Efficacy demonstrated in reducing cancer immunotherapy-induced CRS in an in vivo animal model
- Rapid advancements in cancer immunotherapy are driving demand for effective CRS treatments
- POLB 001 has the potential to positively impact patients and healthcare systems worldwide by enabling broader, safer delivery of these therapies to the cancer patients who need them
1. Average rate from Summary of Product Characteristics (SmPCs) for Yescarta, Tecartus, Abecma, Kymriah, Carvykti, Breyanzi, Elrexfio, Columvi, Epkinly, Tecvayli and Talvey.
2. Independent research commissioned by Poolbeg. 3. Datamonitor Healthcare. Forecast: Diffuse Large B-Cell Lymphoma and Multiple Myeloma, 2023. 4. Abramson JS et al. Blood Adv. 2021 Mar 23;5(6):1695-1705
1. Average rate from Summary of Product Characteristics (SmPCs) for Yescarta, Tecartus, Abecma, Kymriah, Carvykti, Breyanzi, Elrexfio, Columvi, Epkinly, Tecvayli and Talvey.
2. Independent research commissioned by Poolbeg. 3. Datamonitor Healthcare. Forecast: Diffuse Large B-Cell Lymphoma and Multiple Myeloma, 2023. 4. Abramson JS et al. Blood Adv. 2021 Mar 23;5(6):1695-1705
Navigate POLB 001:
Market Opportunity
At Poolbeg Pharma, we have identified a potential preventative therapy to help address cancer immunotherapy-induced CRS.
Independent research conducted on behalf of Poolbeg confirms a >US$10 billion market opportunity for POLB 001 in cancer immunotherapy-induced CRS as an orally delivered preventative therapy.
An effective oral preventative therapy for cancer immunotherapy-induced CRS has the potential to significantly reduce direct costs in healthcare systems and improve patient access to these therapeutics, potentially including access to these therapies outside of specialist centres, augmenting wider market uptake.
Poolbeg recently announced promising in vivo results for POLB 001 in addressing cancer immunotherapy-induced CRS, where CRS clinical symptoms were significantly improved by administration of POLB 001. Dose dependent reductions were seen in all serum proinflammatory cytokines measured.
Major Market Opportunity in a Rapidly Growing Field
Bispecific Antibody and CAR T Therapy market expected to grow exponentially, similar to antibodies in the early 2000s
1. Grand View Research. CAR T-Cell Therapy Market Analysis 2023-2030. 2. Grand View Research. Bispecific Antibodies Market Size, Share & Trends Analysis Report. 3. Datamonitor Healthcare. Forecast: Diffuse Large B-Cell Lymphoma and Multiple Myeloma, 2023.
CRS Preventative Therapy: a >$10bn Market Opportunity
Cancer immunotherapies are used to treat a growing number of cancers, rapid advancements are being made in multiple myeloma (MM), diffuse large B-cell lymphoma (DLBCL) and other cancers
1st, 2nd and 3rd line+ MM and DLBCL patients in the US and EU5, receive CAR T cell and Bispecific Antibody therapy1
An effective CRS preventative therapy could enable wider uptake of cancer immunotherapies beyond current forecasts due to potential for outpatient administration2
Significant upside potential across additional haematological malignancies, solid tumours, and indications in separate therapeutic areas such as severe influenza
Addressable MM and DLBCL population by 2030 in the US and EU5
Estimate encompasses solely MM and DLBCL due to the rapid advancements in BsAb and CAR T treatment for these indications
ALL, Acute Lymphoblastic Leukemia; BsAb, Bispecific Antibody; CAR T, Chimeric Antigen Receptor T-cell therapy; CRS, Cytokine Release Syndrome; DLBCL, Diffuse Large B-Cell Lymphoma; MM, Multiple Myeloma
1. Datamonitor Healthcare. Forecast: Diffuse Large B-Cell Lymphoma and Multiple Myeloma, 2023. 2. Hansen DK et al, Cancers (Basel). 2023. 7;15(24):5746.
Strong Patent Portfolio
- Oncology patent applications first filed in 2023, with potential for protection out to at least 2043; in vivo animal data enhances & facilitates expansion of patent applications.
- Granted patents for severe influenza which provide protection until at least 2038.
CRS is anticipated to create a treatment “Bottleneck”
Effective prevention of CRS by POLB 001 may enable a broader and safer delivery of cancer immunotherapies
- Current treatments with Bispecific Antibodies are administered on an in-patient basis, largely due to the risk of CRS in the hours and days following treatment
- CRS is a potentially life-threatening condition which requires monitoring by trained and adequately resourced healthcare professionals so that the symptoms can be recognised early
- Severe CRS requires intensive medical care, mild CRS prolongs hospital stays until it resolves
The risk of CRS limits the potential to administer cancer immunotherapies more broadly, outside of cancer centres, and the direct costs of managing CRS is estimated to create a significant additional financial burden on health systems
Key Opinion Leaders Supportive of POLB 001’s Significant Potential
POLB 001 Scientific & Supporting Data
Potent and Selective Inhibition of p38 MAPK Signaling
Potent and Selective Inhibition of p38 MAPK Signaling
Effective target engagement demonstrated in LPS human challenge trial
Levels of phosphorylated p38 MAPK in circulating monocytes
- POLB 001 was widely distributed
- POLB 001 inhibited p38 MAPK activation, direct measurement of activation
- POLB 001 inhibited in vivo and ex vivo responses to LPS-induced TNF-α, indirect measurement p38 activity
Blood samples were taken before and after administration of intravenous LPS. Peripheral blood samples were analyzed by flow cytometry. Monocytes were gated by FSC, SSC and CD14+. Data is presented as mean MFI values of phospho-p38 +/- SEM
Reduced Key Inflammatory Cytokines Following LPS Challenge
Reduced Key Inflammatory Cytokines Following LPS Challenge
Dose dependent reductions, without ablation of immune function
TNF-α
TNF-α reduction of 73.5% and 56.2% seen for 70 mg and 150 mg doses respectively (p = 0.0003†)
IL-6
IL-6 reduction of 57.4% and 63.5% seen for 70 mg and 150 mg doses respectively (p = 0.0002†)
IL-8
IL-8 reduction of 80.7% and 76.7% seen for 70 mg and 150 mg doses respectively (p < 0.0001†)
TNF-α, IL-6 and IL-8 levels decreased between 56-81% in subjects treated with 70 mg or 150 mg POLB 001 twice daily
†The exploratory analysis suggested statistically significant improvement in treatment (p<0.05) for the endpoints examined.
Reduced Key Indicators of LPS-Induced Systemic Inflammation
Reduced Key Indicators of LPS-Induced Systemic Inflammation
The reduction of systemic cytokines align with improvement in clinically meaningful endpoints
Mean Body Temperature
No significant effect on body temperature with a trend towards reduction compared to placebo
Heart Rate Rise (bpm)
Suppressed increase in heart rate following IV LPS administration
C-Reactive Protein (CRP)
CRP level reductionof 33.1% and 33.3% seen for 70mg and 150mg doses respectively
