Creating
tomorrows...
brighter
Life-changing
Therapies in Leukemia and Cancer
We are a privately-owned biotech pioneering late-stage therapy for hematology/oncology and chronic inflammation. Both our clinical-stage biologic agents have been and are being clinically tested and our lead candidate, Lenzilumab (LENZ), is completing a Phase 2/3 trial which is almost fully enrolled as a therapy for patients who have treatment-naive Chronic MyeloMonocytic Leukemia (CMML).
LENZ is demonstrating encouraging data in a range of myeloid disorders. Recent epidemiology and independent patient registries from leading centers and governments in 5 different countries lead to an estimated 60,000 patients in the US and European major 5 countries for CMML.
The clinical response rate to LENZ in CMML, on top of Standard of Care of >80% (using well-accepted clinical measures) is more than 4 times the published standard of care response when used alone and LENZ is demonstrating excellent safety and tolerability in this condition, as it has in all the other conditions in which it has previously studies. More than 700 patients have received LENZ in multiple studies and conditions and in many different countries.
Additional encouraging data with LENZ has been presented in other serious, life-threatening myeloid conditions, such as AML and in MDS, effectively doubling the patient population to well over 100,000 people. This positions LENZ as a potential valuable medicine in the fight against a range of serious and life threatening leukemias and associated conditions. Further, research is pointing to myeloid conditions being associated with prior chemotherapy, opening up the possibility of yet further potential uses. While LENZ has not yet been approved for marketing, it is in the final stages of development and further studies in other conditions may follow.
In addition, LENZ has demonstrated promising data in clinical studies as a companion therapy to CAR-T to minimize or eliminate serious and potentially life-threatening side-effects associated with the CAR-T therapy.
A Phase 3 protocol for potential registration for LENZ in this use has been signed off by FDA.
Our Products
Our products are changing the approach to disease therapies, impacting lives, and trials are proving effective for positive outcomes.
Backed by Data
Sharing the data that is making the difference.
LENZ data in CMML and AML.
Opportunities
Significant Investment To Date, Extensive Market OpportunitIES to create myeloid disorder franchise
Our Partners in Life-changing Care...
More Than Facts and Figures.
Real People. Real Impact.
Multiple patients in the PREACH-M Phase 2/3 study being completed in Australia have elected to receive LENZ under compassionate use, once their 2 years cycle on the study has been completed and they are still well. All are high-risk patients and the vast majority remain well, in some cases 3 or 4 years into treatment, which is longer than would be expected on current standard of care only.
More Than Facts and Figures.
Real People. Real Impact.
Taran arranged for a patient in France to receive LENZ under compassionate use. He and his family were incredibly grateful they were able to spend a few more months together.
More Than Facts and Figures.
Real People. Real Impact.
This cherished girl, diagnosed with Juvenile Myelomonocytic Leukemia, received LENZ under compassionate use in the US. Although she did not recover, along with her parents, we believe the treatment helped to extend her life and give her and her family more precious time together.
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