Rhizen Pharmaceuticals S.A. Announces Publication of Clinical Data from the Phase I/Ib study of Tenalisib (RP6530) in Patients with Relapsed/Refractory T-Cell Lymphoma (TCL)

La Chaux-de-Fonds, Switzerland, Sept. 24, 2020 (GLOBE NEWSWIRE) -- Rhizen Pharmaceuticals S.A.. today announced the publication of the results from the Phase I/Ib study of Tenalisib (RP6530), the company’s novel next generation dual PI3K δ/γ inhibitor, in the journal Cancers.  

--- Single-agent Tenalisib was well tolerated with a good overall response rate (ORR) in both peripheral and cutaneous T-cell Lymphoma patients (PTCL and CTCL)

The results include safety and efficacy information from 58 heavily pre-treated patients with relapsed/refractory peripheral and cutaneous T-Cell Lymphoma treated with single-agent Tenalisib.   Tenalisib was well tolerated with favorable safety profile compared to prior generation dual PI3K δ/γ inhibitors.  

Tenalisib showed promising activity with an overall response rate (ORR) of 45.7% (9%Complete Response and 37%Partial Response) and median duration of response (DoR) comparable to currently approved therapies for T-Cell Lymphoma’s. Unlike other PI3K inhibitors, late onset toxicities like colitis, pneumonitis were not seen with Tenalisib even in patients treated for more than six months. Five patients were on therapy for more than 18 months and did not report any late onset immune toxicities. This indicates an emerging differentiated safety profile for Tenalisib.

Dr. Swaminathan P. Iyer, Professor, T-Cell Lymphoma’s Director, Department of Lymphoma/Myeloma, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center in Houston, TX, and Principal Investigator of this study stated, “We are pleased to have been involved in the early clinical development phase of single-agent Tenalisib (RP6530) in patients with relapsed/refractory T-Cell Lymphoma and believe this oral targeted drug has an important place in the treatment landscape of these patients.  The outstanding safety profile of Tenalisib lends itself to be combined with other approved/standard of care drugs, and we are currently involved in the ongoing Phase I/II combination study of Tenalisib plus romidepsin in relapsed/refractory T-Cell Lymphoma."  (ClinicalTrials.gov Identifier: NCT03770000).

Article: Phase I/Ib Study of Tenalisib (RP6530), a Dual PI3K delta/gamma inhibitor in Patients with Relapsed/Refractory T-Cell Lymphoma.   The online version of the published article can be accessed at

Cancers 202012(8), 2293; https://doi.org/10.3390/cancers12082293

About Tenalisib (RP6530):

Tenalisib (RP6530) is a highly selective next generation orally active dual PI3K δ/γ inhibitor, which is in Phase 2 clinical development for hematological malignancies and solid tumors.  Tenalisib has been granted US FDA Fast Track Designations for treatment of relapsed/refractory peripheral T-cell lymphoma and cutaneous T-cell lymphoma (R/R PTCL and R/R CTCL), in addition to Orphan-Drug Designations for treatment of peripheral and cutaneous T-cell lymphoma (PTCL and CTCL).

About T-Cell Lymphomas: 

T-Cell Lymphomas (TCL), are a group of cancers that originate in T-cells and develop in lymphoid tissues such as the lymph nodes and spleen, or outside of lymphoid tissues (i.e., gastrointestinal tract, liver, nasal cavity, skin, and others). TCL constitute ~7-15% of all NHL cases and can be generally classified on the basis of their presentation, as indolent or aggressive.

Peripheral T-Cell Lymphoma (PTCL), describes a heterogeneous group of lymphoproliferative disorders arising from mature T-Cells and accounts for ~10% of all NHL cases. PTCL is an aggressive disease that most commonly presents in patients over the age of 60 and usually has a worse prognosis than diffuse large B cell lymphoma.

Cutaneous T-Cell Lymphoma (CTCL) describes a group of typically indolent lymphomas that appear on, and are most often confined to, the skin and accounts for ~3% of all NHL cases and usually affects adults. CTCL subtypes include the more common and indolent Mycosis Fungoides (MF), which is largely confined to the skin, and the less common but more severe Sézary Syndrome (SS) that affects both the skin and blood and has poor prognosis. 

About Rhizen Pharmaceuticals S.A.:

Rhizen Pharmaceuticals is an innovative, clinical-stage biopharmaceutical company focused on the discovery and development of novel therapeutics for the treatment of cancer and inflammatory diseases.  Since its establishment in 2008, Rhizen has created a diverse pipeline of proprietary drug candidates targeting several cancers and immune associated cellular pathways.  Rhizen is headquartered in La-Chaux-de-Fonds, Switzerland.  For additional information, please visit Rhizen’s website, www.rhizen.com.

Contact:         
Kumar V. Penmetsa, Ph.D.
Executive Vice President, Corporate Development
Rhizen Pharmaceuticals S.A.
Telephone:  +1-267-207-5707
Email:  kvp@rhizen.com

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