Rhizen Pharmaceuticals SA Announces Presentation of the Interim Results of the Phase I/II study of Tenalisib (RP6530) in Combination with Romidepsin in Relapsed/Refractory T-cell Lymphoma at American Society of Hematology (ASH) annual meeting, 2020
Rhizen Pharmaceuticals, a clinical-stage oncology-focussed biopharmaceutical company, today announced presentation of the interim results of a Phase I/II combination study of Tenalisib with Romidepsin for relapsed/refractory T-Cell Lymphoma patients at the upcoming 62nd American Society of Hematology (ASH) annual meeting and exposition, to be held virtually from December 5 – 8, 2020.
The poster presentation at ASH, 2020 includes interim data from a multi-center, open label, Phase I/II study in patients with T cell lymphoma (NCT03770000) with the objective of determining the MTD/optimal dose of Tenalisib given in combination with Romidepsin and assessing the preliminary efficacy of the combination. No dose limiting toxicities were reported and Tenalisib 800 mg BID plus Romidepsin 14 mg/m2 was determined to be the maximum tolerated dose for the expansion cohorts. Overall, the Tenalisib and Romidepsin combination was well tolerated across all patients (N=33) with no unexpected adverse events or increased frequency of adverse events previously reported for the individual agents.
As of the cut-off date (5th Nov 2020) for data analysis, seven PTCL patients had completed their first efficacy assessment (C3D1), of which four patients showed a complete response, one demonstrated a partial response and two had stable disease. The duration of response ranged from 1.4+ to 8.16+ months. Of the eleven CTCL patients who had completed their first efficacy assessment (C3D1), one patient showed a complete response, three demonstrated a partial response and five had stable disease. The duration of response ranged from 1.20+ to 10.6+ months.
Swaroop Vakkalanka, the company’s President and CEO stated, “We are extremely encouraged by the interim data being presented today which reinforces Tenalisib’s stellar safety and impressive efficacy when studied in combination with Romidepsin. Both PTCL and CTCL are difficult to treat indications and patients quickly run out of options, so we are excited with the preliminary results. We expect this study to eventually support a pivotal trial of the combination and we plan to approach the FDA when the full study results are available.
The Tenalisib poster session details at ASH 2020 are noted below:
- Poster Title: A Multi-Center, Open Label, Phase I/II Study to Assess the Safety and Efficacy of Tenalisib Given in Combination with Romidepsin in Patients with Relapsed/Refractory T-Cell Lymphoma (Publication Number: 1155)
- Session: 624. Hodgkin Lymphoma and T/NK Cell Lymphoma—Clinical Studies: Poster I
- Date: Saturday, December 5, 2020; 7:00 AM - 3:30 PM (Pacific Time)
- Presenter: Swaminathan P Iyer, MD, Professor, Department of Lymphoma/Myeloma, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX
About Tenalisib (RP 6530):
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 based on 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 Sezary 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 onco-therapeutics. 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 https://www.rhizen.com/.
Manager, Corporate Affairs & Communications
Rhizen Pharmaceuticals S.A.
Telephone: +41 32 580 0113
About Business Wire
(c) 2018 Business Wire, Inc., All rights reserved.
Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
GPD Companies, Inc. to Acquire Distrupol22.1.2021 14:33:00 CET | Press release
GPD Companies, Inc., an affiliate of One Rock Capital Partners, LLC (“One Rock”), today announced that it has entered into a definitive agreement to acquire Distrupol, a subsidiary of Univar Solutions Inc. (NYSE: UNVR) and a leading European distributor of thermoplastics to the polymer processing industry. Terms of the transaction, which is expected to close in the first half of 2021, were not disclosed. Headquartered in Surrey, England, with broad geographic reach across Europe, Distrupol has provided value-added sales and application development of thermoplastic resins for over 50 years. Through its decades-long relationships with world class supply partners, the company offers a robust array of superior performance products and solutions that meet the needs of diverse end users from leading and emerging industries, such as the consumer, medical, automotive, and electrical sectors, among others. Distrupol caters to over 1,300 customers across 13 countries with a portfolio of over 4,0
Schlumberger Announces Fourth-Quarter and Full-Year 2020 Results22.1.2021 12:50:00 CET | Press release
Schlumberger Limited (NYSE: SLB) today reported results for the fourth-quarter and full-year 2020. Fourth-Quarter Results(Stated in millions, except per share amounts)Three Months EndedChangeDec. 31, 2020Sept. 30, 2020Dec. 31, 2019SequentialYear-on-yearRevenue $5,532 $5,258 $8,228 5% -33%Income (loss) before taxes - GAAP basis $471 $(54) $452 n/m 4%Net income (loss) - GAAP basis $374 $(82) $333 n/m 12%Diluted EPS (loss per share) - GAAP basis $0.27 $(0.06) $0.24 n/m 12% Adjusted EBITDA* $1,112 $1,018 $1,648 9% -33%Adjusted EBITDA margin* 20.1% 19.4% 20.0% 73 bps 6 bpsPretax segment operating income* $654 $575 $1,006 14% -35%Pretax segment operating margin* 11.8% 10.9% 12.2% 90 bps -40 bpsNet income, excluding charges & credits* $309 $228 $545 35% -43%Diluted EPS, excluding charges & credits* $0.22 $0.16 $0.39 37% -44% Revenue by Geography International $4,343 $4,210 $5,834 3% -26%North America 1,167 1,034 2,339 13% -50%Other 22 14 55 n/m n/m $5,532 $5,258 $8,228 5% -33% *These are non-
JEOL: Release of a New Cold Field Emission Cryo-Electron Microscope CRYO ARM™ 300 II (JEM-3300)22.1.2021 07:00:00 CET | Press release
JEOL Ltd. (TOKYO:6951) (President & COO Izumi Oi) announces the release of a new cold field emission cryo-electron microscope (cryo-EM), the CRYO ARM™ 300 II (JEM-3300), to be released in January 2021. This new cryo-EM has been developed based on the concept of "Quick and easy to operate and get high-contrast and high-resolution images". This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210121005316/en/ Cold Field Emission Cryo-Electron Microscope CRYO ARM(TM) 300 II (JEM-3300) (Photo: Business Wire) Development Background Recent dramatic improvement of resolution in single particle analysis (SPA) using cryo-EM has led to SPA as an essential method for structural analysis of proteins. To address this market, JEOL released the CRYO ARM™ 300 in 2017. Equipped with a cold field emission gun (Cold FEG) for enhanced resolution and a cryo-stage for loading multiple samples, the CRYO ARM™ 300 has continued to achieve best-in-class res
ViiV Healthcare announces FDA approval of Cabenuva (cabotegravir, rilpivirine), the first and only complete long-acting regimen for HIV treatment21.1.2021 23:12:00 CET | Press release
ViiV Healthcare, the global specialist HIV company majority owned by GlaxoSmithKline plc (“GSK”), with Pfizer Inc. and Shionogi Limited as shareholders, today announced that the US Food and Drug Administration (FDA) approved Cabenuva, the first and only complete long-acting regimen for the treatment of HIV-1 infection in adults. Cabenuva is provided as a co-pack with two injectable medicines — ViiV Healthcare’s cabotegravir and Janssen’s rilpivirine— dosed once monthly, as an option to replace the current antiretroviral (ARV) regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies per milliliter [mL]) on a stable regimen, with no history of treatment failure, and with no known or suspected resistance to either cabotegravir or rilpivirine. Prior to initiating treatment of Cabenuva, oral dosing of cabotegravir and rilpivirine should be administered for approximately one month to assess the tolerability of each therapy.1 Lynn Baxter, Head of North America, ViiV He
Incyte Announces Acceptance and Priority Review of BLA for Retifanlimab as a Potential Treatment for Patients with Squamous Cell Carcinoma of the Anal Canal (SCAC)21.1.2021 22:30:00 CET | Press release
Incyte (Nasdaq:INCY) today announced that the U.S. Food and Drug Administration (FDA) has accepted for Priority Review its Biologics License Application (BLA) for retifanlimab, an intravenous PD-1 inhibitor, as a potential treatment for adult patients with locally advanced or metastatic squamous cell carcinoma of the anal canal (SCAC) who have progressed on, or who are intolerant of, platinum-based chemotherapy. The BLA submission is based on data from the Phase 2 POD1UM-202 trial evaluating retifanlimab in previously treated patients with locally advanced or metastatic SCAC who have progressed on, or are intolerant of, standard platinum-based chemotherapy. The trial enrolled 94 patients, including several with well-controlled human immunodeficiency virus (HIV) infection. The study, which was recently presented at the European Society for Medical Oncology (ESMO) Virtual Congress 2020, resulted in an objective response rate (ORR) of 14% for retifanlimab monotherapy as determined by inde
Wistron and Kalray Announce FURIO1200™ Storage Appliance21.1.2021 17:45:00 CET | Press release
Wistron, a leader in ICT (Information and communications technology) products, and Kalray (Paris:ALKAL) (Euronext Growth Paris: ALKAL), a leading provider in new generation of processors specialized in Intelligent Data Processing from Cloud to Edge, announce the availability of FURIO1200™, a 24-Flash-Drive NVMe-oF based storage node appliance, integrating Kalray’s NVMe-oF K200™ smart storage adapter, powered by its MPPA® Coolidge™ intelligent processor, and Wistron LYMMA chassis. FURIO1200™ is a new type of hyper-fast disaggregated storage solution delivering ultra-high throughput and reliability. It is the ideal solution for Cloud Service Providers and Enterprises running applications with intensive AI and Data Analytics workloads as well as to optimize their next generation storage. Data Centers are undergoing a very important revolution due to the explosion of usages, the surge of data to be processed and the exponential growth of the number of machines to be managed to support this
NumAlim Selects Dawex and Orange Business Services for its Data and Services Exchange Platform21.1.2021 17:40:00 CET | Press release
NumAlim announced an agreement with Dawex, the leader in Data Exchange technology, and Orange Business Services, a network-native digital services company, to deploy its agri-food digital exchange platform. By relying on these two leading players, NumAlim chose secure technological solutions guaranteeing the sovereignty of French food data. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210121005722/en/ (Photo: Dawex) As early as Q1 2021, the NumAlim data and services exchange "Hub" will offer 18,000 companies in the food industry the opportunity to valorize, acquire and enrich all types of data: production, consumption, traceability, consumer opinions and research, as well as a wide range of services based on data (trend analysis, reformulation, regulatory watch…). "NumAlim is the answer to the needs for transparency, value creation and trust expressed by the food industry, consumers, and public authorities.” says Jérôme Fr