The main objective is to compare the effect of a single injection of two doses of rituximab versus placebo on 6 months left ventricular systolic function, using CMR, in patients who have had an acute anterior STEMI.
The primary endpoint is the left ventricular ejection fraction (LVEF) by CMR at 6 months.

Start Date01 Jun 2022

Sponsor / Collaborator

Assistance Publique des Hôpitaux de Paris SA

[+1]

NCT04447716

/ RecruitingPhase 1IIT

A Phase I Study of Venetoclax + Lenalidomide + Rituximab Hyaluronidase in Relapsed or Refractory (R/R) Indolent Non-Hodgkin's Lymphoma (iNHL).

This phase I trial studies the side effects and best dose of venetoclax when given together with lenalidomide and rituximab hyaluronidase in treating patients with follicular lymphoma and marginal zone lymphoma that has come back after treatment (relapsed) or has not responded to treatment (refractory). Venetoclax may stop the growth of cancer cells by blocking the action of a protein called Bcl-2, that helps cancer cells survive. Immunotherapy with lenalidomide, may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. Immunotherapy with monoclonal antibodies, such as rituximab and rituximab hyaluronidase, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. The purpose of this research is to determine if the combination of three drugs, venetoclax, lenalidomide, and rituximab hyaluronidase are safe to administer in patients whose low-grade lymphoma (follicular or marginal zone) has come back after initial therapy or was not responsive to initial therapy.

Start Date16 Oct 2020

Sponsor / Collaborator

Thomas Jefferson University

[+1]

NCT02382575

/ Unknown statusPhase 4IIT

Efficacy and Safety of Rituximab to That of Calcineurin Inhibitors in Children With Steroid Resistant Nephrotic Syndrome

The vast majority of children with idiopathic nephrotic syndrome respond well to corticosteroid treatment. However, as many as 20% experience a more complicated course with steroid resistance (SRNS). Repeated and prolonged courses of steroids in these children often result in long-term complications. The goal of treatment is to reduce the rate of relapses, the cumulative dose of corticosteroids, and the incidence of serious complications. In order to minimize the side effects of steroid therapy, different steroid sparing agents such as cyclophosphamide, calcineurin inhibitors(CNI), levamisole, and mycophenolate mofetil (MMF) have been used in SRNS. Whereas CNI are usually considered the steroid sparing drug class of first choice, rituximab is increasingly used as alternative to minimize CNI toxicity. Various prospective studies suggest that Rituximab, a B cell depleting monoclonal antibody, could be a safe and effective alternative to steroid or immunosuppressants to achieve and maintain remission in this population. Rituximab infusion have been shown to be efficacious for 6 to 12 months and the side effect profile observed to date is very benign. Studies comparing the usefulness of these agents are lacking. In this proposed randomized controlled trial, the investigators want to compare the efficacy and safety of CNI to that of Rituximab in treating children with SRNS.

Start Date15 Mar 2015

Sponsor / Collaborator-

100 Clinical Results associated with Rituximab/Hyaluronidase

100 Translational Medicine associated with Rituximab/Hyaluronidase

100 Patents (Medical) associated with Rituximab/Hyaluronidase

Literatures (Medical) associated with Rituximab/Hyaluronidase

01 Apr 2025·JCO Global Oncology

Phase I Study of Subcutaneous Rituximab Hyaluronidase Combined With CHOP Chemotherapy for the Treatment of Diffuse Large B-Cell Lymphoma in Uganda

Article

Author: Ddungu, Henry ; Kambugu, Joyce ; Puronen, Camille ; Warren, Edus H. ; Adams, Scott V. ; Orem, Jackson ; Towlerton, Andrea M.H. ; Mubiru, Kelvin R. ; Uldrick, Thomas S. ; Asea, Jacqueline ; Menon, Manoj P. ; Namuli, Prossy ; Namagembe, Rosemary

PURPOSEPatients with diffuse large B-cell lymphoma (DLBCL) who are treated in low-resource settings have inferior outcomes compared with those in high-resource settings. Rituximab, an anti-CD20 monoclonal antibody, when combined with chemotherapy, improves overall survival (OS) for DLBCL. However, in part due to the limited availability of infusion centers in low-resource countries, rituximab is rarely used. Subcutaneous rituximab (sqR) is a potential solution; however, its safety and efficacy have not been tested in low-income countries.METHODSThis open-label phase I study enrolled patients 18 years or older with newly diagnosed DLBCL. The first cohort (n = 6) received intravenous rituximab plus CHOP. This cohort received sqR for subsequent cycles. The second cohort (n = 12) received sqR plus CHOP for all cycles. Safety and tolerability were evaluated; secondary outcomes included response rates and treatment completion.RESULTSBetween October 25, 2019, and October 7, 2022, 18 patients, with a median age of 36.5 years, were enrolled; 10 were male, and 10 presented with advanced-stage disease. The most common hematologic toxicity was neutropenia (n = 9, 50%). Fifteen of the 18 participants completed treatment; 14 (93.3%) patients achieved a complete response, and one patient (6.7%) had a partial response. The OS and progression-free survival (PFS) at 12 months were 83% (95% CI, 68 to 100) and 67% (95% CI, 48 to 92), respectively. The OS and PFS at 24 months were 66% (95% CI, 47 to 92) and 67% (95% CI, 48 to 92), respectively.CONCLUSIONAs demonstrated in other parts of the world, sqR together with CHOP was safe, well-tolerated, and efficacious among Ugandan patients with DLBCL. The very high OS rates are nearly double those of historical controls and comparable with outcomes expected in resource-rich settings. This study demonstrated the feasibility, safety, and efficacy of sqR-CHOP, increased the research infrastructure in Uganda, and will improve care in other resource-limited settings.

01 Jan 2020·Current Therapeutic Research

A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Recombinant Human Hyaluronidase PH20 Administered Intravenously in Healthy Volunteers

Article

Author: Zepeda, Monica ; Sugarman, Barry J ; Printz, Marie A ; DeNoia, Emanuel P ; Maneval, Daniel C ; Kang, David W ; Harrigan, Rena ; Souratha, Jennifer ; Dychter, Samuel S

BACKGROUNDRecombinant human hyaluronidase PH20 (rHuPH20) is used in subcutaneous formulations (eg, RITUXAN HYCELA [rituximab and hyaluronidase human], HERCEPTIN HYLECTA [trastuzumab and hyaluronidase-oysk], PHESGO [pertuzumab/trastuzumab/hyaluronidase-zzxf], and Darzalex FASPRO [daratumumab and hyaluronidase-fihj]) to increase the dispersion and absorption of coadministered therapeutics. Although unlikely, subcutaneous products that include rHuPH20 could be mistaken for the intravenous formulation of the corresponding drugs (eg, RITUXAN [rituximab], HERCEPTIN [trastuzumab], and DARZALEX [daratumumab]). To understand the potential effects of inadvertent intravenous injection of rHuPH20, we investigated the safety profile, pharmacokinetics (PK), and pharmacodynamics (PD) of rHuPH20 administered intravenously.OBJECTIVESThis Phase I, open-label, single-center study in healthy volunteers was designed to assess the safety profile, tolerability, PK, and PD of rHuPH20 administered intravenously.METHODSHealthy volunteers received 5 mL intravenous infusion of either 10,000 U (n = 12) or 30,000 U (n = 12) rHuPH20 over 5 minutes. Blood samples for PK and PD analysis were obtained at baseline and at various times after initiation of infusion. Adverse events and laboratory parameters were measured to assess the safety profile and tolerability of the intravenous infusion. The PK of rHuPH20 was assessed using both an enzymatic assay and a mass-based immunoassay, and plasma hyaluronan concentrations were measured as a PD marker using an HPLC-MS/MS disaccharide assay.RESULTSAll 24 volunteers (mean age = 36.5 years) completed the study, and no serious adverse events were reported in either treatment group. Overall, 2 adverse events (both Grade 1) were reported; catheter site pain in the 10,000 U group and hypotension in the 30,000 U group. Plasma concentrations of rHuPH20 increased during the 5-minute intravenous infusion (median t_max = 6 minutes from intravenous initiation) followed by a rapid plasma clearance (t_1/2 ∼10 minutes from intravenous initiation). Plasma hyaluronan concentrations increased with dose and time (t_max range = 45‒120 minutes from intravenous initiation) and returned to baseline within 1 week of administration. Changes in both PK and PD measurements appeared proportional to dose.CONCLUSIONSThe study demonstrated that intravenous administration of up to 30,000 U rHuPH20 was well tolerated, rapidly cleared from the plasma, and did not appear to be associated with any serious adverse effects at doses used in subcutaneous therapeutic products. (Curr Ther Res Clin Exp. 2020; 81).

01 Jan 2019·Drug DeliveryQ2 · MEDICINE

ENHANZE^® drug delivery technology: a novel approach to subcutaneous administration using recombinant human hyaluronidase PH20

Q2 · MEDICINE

ReviewOA

Author: LaBarre, Michael J. ; Maneval, Daniel C. ; Locke, Kenneth W.

ENHANZE^® drug delivery technology is based on the proprietary recombinant human hyaluronidase PH20 enzyme (rHuPH20; Halozyme Therapeutics, Inc.) that facilitates the subcutaneous (SC) delivery of co-administered therapeutics. rHuPH20 works by degrading the glycosaminoglycan hyaluronan (HA), which plays a role in resistance to bulk fluid flow in the SC space, limiting large volume SC drug delivery, dispersion, and absorption. Co-administration of rHuPH20 with partner therapies can overcome administration time and volume barriers associated with existing SC therapeutic formulations, and has been shown to reduce the burden on patients and healthcare providers compared with intravenous formulations. rHuPH20 (as HYLENEX^® recombinant) is currently FDA-approved for subcutaneous fluid administration for achieving hydration, to increase the dispersion and absorption of other injected drugs, and in subcutaneous urography for improving resorption of radiopaque agents. rHuPH20 is also co-formulated with two anticancer therapies, trastuzumab (i.e. Herceptin^® SC) and rituximab (i.e. RITUXAN HYCELA^®/RITUXAN^® SC/MabThera^® SC) and dosed sequentially with human immunoglobin to treat primary immunodeficiency (i.e. HyQvia^®/HYQVIA^®). This article reviews pharmaceutical properties of rHuPH20, its current applications with approved therapeutics, and the potential for future developments.

News (Medical) associated with Rituximab/Hyaluronidase

14 Apr 2025

·pipelinereview.com

European Commission approves Roche’s Columvi as the first bispecific antibody for diffuse large B-cell lymphoma after initial therapy

BASEL, Switzerland I April 14, 2025 I Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the European Commission has approved Columvi® (glofitamab) in combination with gemcitabine and oxaliplatin (GemOx) for the treatment of adult patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) not otherwise specified who are ineligible for autologous stem cell transplant (ASCT). With this approval, this Columvi combination is the first bispecific antibody regimen available for people with DLBCL in Europe whose cancer has returned or for those who did not respond to initial treatment. In July 2023, Columvi received a conditional marketing authorisation to treat people with R/R DLBCL after two or more lines of systemic therapy. In addition to today’s approval, a condition to convert the existing marketing authorisation to a regular approval has been fulfilled. “Columvi is the first treatment of its kind to improve survival outcomes for people with DLBCL whose cancer has returned after first-line therapy,” said Levi Garraway, MD, PhD, Roche’s Chief Medical Officer and Head of Global Product Development. “With this approval, Columvi can now benefit patients even earlier in their treatment, adding to its existing value as an important treatment for DLBCL.” “People with R/R DLBCL not eligible for ASCT represent a challenging population, especially those with primary refractory disease or early relapse whose need for a readily accessible and effective therapy is insufficiently addressed globally,” said Franck Morschhauser, MD, PhD, Professor of Haematology, University Hospital Lille and STARGLO study investigator. “This new Columvi combination is immediately available if a patient’s cancer returns or doesn’t respond to first-line therapy, which is a welcome addition to manage DLBCL.” Approval is based on results from the pivotal phase III STARGLO study, where Columvi in combination with GemOx demonstrated a statistically significant and clinically meaningful overall survival (OS) improvement versus MabThera®/Rituxan® (rituximab) and GemOx (R-GemOx) in people with R/R DLBCL. 1,2 In the primary analysis (conducted after a median follow-up of 11.3 months), there was a 41% reduction in the risk of death in patients treated with Columvi plus GemOx versus R-GemOx (hazard ratio [HR]=0.59, 95% CI: 0.40-0.89, p=0.011). The Columvi combination also met its key secondary endpoints, with a 63% reduction in risk of disease worsening or death (progression-free survival, PFS) compared to R-GemOx (HR=0.37; 95% CI: 0.25–0.55, p<0.0001). 1,2 Follow-up analyses were conducted after all patients had completed therapy (median follow-up of 20.7 months), showing a 25.5 month median OS for people treated with the Columvi combination, nearly double what was seen for people treated with R-GemOx at 12.9 months (HR=0.62, 95% CI: 0.43-0.88). 1,2 Additionally, more than twice as many patients experienced a complete response (58.5% versus 25.3% respectively, with a difference of 33.2% [95% CI: 20.9-45.5]). 1,2 Safety of the combination was consistent with the known safety profiles of the individual medicines. 1,2 DLBCL is an aggressive (fast-growing) type of lymphoma and is one of the most prevalent types of blood cancer among adults. In Europe, an estimated 38,000 people are diagnosed with DLBCL each year. 3,4 Approximately four out of ten DLBCL patients will relapse after first-line treatment and the majority of patients who require subsequent lines of therapy have poor outcomes. 5,6 Whilst second-line treatment advances have been made, challenges with the accessibility of existing medicines and the aggressive nature of DLBCL underscores the urgent need for immediately available treatment options that can control the disease and improve survival. 7 Columvi in combination with GemOx offers an ‘’off-the-shelf’’ treatment regimen, readily available for infusion in any setting, meaning patients can avoid delays in starting their next treatment. Columvi is also designed to be given for a fixed period offering a target end date for people’s course of therapy and the possibility of a treatment-free period after completion. Columvi, along with Lunsumio® (mosunetuzumab), is part of Roche’s industry-leading CD20xCD3 bispecific antibody programme. Together with the clinical development of off-the-shelf allogeneic CAR T-therapies, Roche aims to provide tailored treatment options that suit the diverse needs, preferences, and experiences of people with blood cancers and healthcare systems. About the STARGLO study The STARGLO study [GO41944; NCT04408638 ] is a phase III, multicentre, open-label, randomised study evaluating the efficacy and safety of Columvi® (glofitamab) in combination with gemcitabine plus oxaliplatin (GemOx) versus MabThera®/Rituxan® (rituximab) in combination with GemOx in patients with relapsed or refractory diffuse large B-cell lymphoma who have received at least one prior line of therapy and who are not candidates for autologous stem cell transplant, or who have received two or more prior lines of therapy. Preclinical research indicated an increased antitumour effect when combining Columvi with GemOx over GemOx alone, so the STARGLO study was initiated to further explore the potential complementary effects of the treatment combination. Outcome measures include overall survival (primary endpoint), progression-free survival, complete response rate, objective response rate, duration of objective response (secondary endpoints), and safety and tolerability. About Columvi® (glofitamab) Columvi is a CD20xCD3 T-cell engaging bispecific antibody designed to target CD3 on the surface of T cells and CD20 on the surface of B cells. Columvi was designed with a novel 2:1 structural format. This T-cell engaging bispecific antibody is engineered to have one region that binds to CD3, a protein on T cells, a type of immune cell, and two regions that bind to CD20, a protein on B cells, which can be healthy or malignant. This dual-targeting brings the T cell in close proximity to the B cell, activating the release of cancer cell-killing proteins from the T cell. Columvi is part of Roche’s broad and industry-leading CD20xCD3 T-cell-engaging bispecific antibody clinical development programme that also includes Lunsumio® (mosunetuzumab), which aims to provide tailored treatment options that suit the diverse needs, preferences, and experiences of people with blood cancers and healthcare systems. Roche is investigating Columvi as a monotherapy and in combination with other medicines for the treatment of diffuse large B-cell lymphoma (DLBCL) and mantle cell lymphoma. As part of Roche’s efforts to elevate treatment standards in the earlier stages of DLBCL, where there is the best opportunity to improve long-term outcomes and prevent relapse, Columvi is also being investigated in combination with Polivy® (polatuzumab vedotin) and MabThera®/Rituxan® (rituximab), cyclophosphamide, doxorubicin and prednisone (R-CHP) in previously untreated DLBCL in the phase III SKYGLO study [GO44145; NCT06047080 ]. About diffuse large B-cell lymphoma (DLBCL) DLBCL is an aggressive (fast-growing) type of non-Hodgkin lymphoma (NHL) and the most common form, accounting for about one in three cases of NHL. 3 Approximately 160,000 people worldwide are diagnosed with DLBCL each year. 3,8 While it is generally responsive to treatment in the frontline, as many as 40% of people will relapse or have refractory disease, at which time salvage therapy options are limited and survival is short. 5,6 Improving treatments earlier in the course of the disease and providing much needed alternative options could help to improve long-term outcomes. About Roche in haematology Roche has been developing medicines for people with malignant and non-malignant blood diseases for more than 25 years; our experience and knowledge in this therapeutic area runs deep. Today, we are investing more than ever in our effort to bring innovative treatment options to patients across a wide range of haematologic diseases. Our approved medicines include MabThera®/Rituxan® (rituximab), Gazyva®/Gazyvaro® (obinutuzumab), Polivy® (polatuzumab vedotin), Venclexta®/Venclyxto® (venetoclax) in collaboration with AbbVie, Hemlibra® (emicizumab), PiaSky® (crovalimab), Lunsumio® (mosunetuzumab) and Columvi® (glofitamab). Our pipeline of investigational haematology medicines includes T-cell engaging bispecific antibody cevostamab, targeting both FcRH5 and CD3 and Tecentriq® (atezolizumab). Our scientific expertise, combined with the breadth of our portfolio and pipeline, also provides a unique opportunity to develop combination regimens that aim to improve the lives of patients even further. About Roche Founded in 1896 in Basel, Switzerland, as one of the first industrial manufacturers of branded medicines, Roche has grown into the world’s largest biotechnology company and the global leader in in-vitro diagnostics. The company pursues scientific excellence to discover and develop medicines and diagnostics for improving and saving the lives of people around the world. We are a pioneer in personalised healthcare and want to further transform how healthcare is delivered to have an even greater impact. To provide the best care for each person we partner with many stakeholders and combine our strengths in Diagnostics and Pharma with data insights from the clinical practice. For over 125 years, sustainability has been an integral part of Roche’s business. As a science-driven company, our greatest contribution to society is developing innovative medicines and diagnostics that help people live healthier lives. Roche is committed to the Science Based Targets initiative and the Sustainable Markets Initiative to achieve net zero by 2045. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit www.roche.com . All trademarks used or mentioned in this release are protected by law. References [1] Abramson J, et al. Glofitamab plus Gemcitabine and Oxaliplatin (Glofit-GemOx) for Relapsed/Refractory (R/R) Diffuse Large B-Cell Lymphoma (DLBCL): Results of a Global Randomized Phase III trial (STARGLO). Presented at: EHA Hybrid Congress; 2024 Jun 3-16. Abstract #LB3438. [2] Abramson J, et al. Glofitamab plus gemcitabine and oxaliplatin (GemOx) versus rituximab-GemOx for relapsed or refractory diffuse large B-cell lymphoma (STARGLO): a global phase 3, randomised, open-label trial. Lancet 2024; 404 (10466): 1940-1954. [3] UpToDate. Patient education: Diffuse large B cell lymphoma in adults (Beyond the Basics). [Internet; cited 2025 April]. Available from: https://www.uptodate.com/contents/diffuse-large-b-cell-lymphoma-in-adults-beyond-the-basics . [4] World Health Organization. Numbers derived from GLOBOCAN 2022. Europe Factsheet [Internet; cited 2025 April]. Available from: https://gco.iarc.who.int/media/globocan/factsheets/populations/908-europe-fact-sheet.pdf . [5] Maurer MJ, Ghesquières H, Jais JP, et al. Event-free survival at 24 months is a robust end point for disease-related outcome in diffuse large B-cell lymphoma treated with immunochemotherapy. J Clin Oncol. 2014;32(10):1066-1073. [6] Sehn LH, et al. Diffuse Large B-Cell Lymphoma. N Engl J Med. 2021;384(9):842-858. [7] Fabbri N, Mussetti A and Sureda A. Second-line treatment of diffuse large B-cell lymphoma: Evolution of options. Semin Hematol 2023; 60(5): 305–312. [8] World Health Organization. Numbers derived from GLOBOCAN 2022. Non-Hodgkin Lymphoma Factsheet [Internet; cited 2025 April]. Available from: https://gco.iarc.who.int/media/globocan/factsheets/cancers/34-non-hodgkin-lymphoma-fact-sheet.pdf . SOURCE: Roche

Phase 3Clinical ResultDrug ApprovalImmunotherapyCell Therapy

13 Sep 2024

·www.fiercepharma.com

Roche doubles down with another subcutaneous FDA nod, this one for MS star Ocrevus

The FDA has signed off on Genentech's subcutaneous version of multiple sclerosis blockbuster Ocrevus, which will give patients a convenient alternative to the treatment's original infused formulation. When Roche's Genentech gained approval for Ocrevus in 2017, the first-in-class infused drug quickly became the best-selling treatment in a crowded multiple sclerosis (MS) market. Three years later, Novartis’ next-in-class Kesimpta stole some of Ocrevus’ thunder, offering a convenience edge with its once-monthly, at-home prefilled injection. Now, Genentech has responded with a new formulation as the FDA has endorsed a subcutaneous version of Ocrevus. While it can’t match the at-home convenience of Kesimpta, subcutaneous Ocrevus Zunovo, with its twice-a-year, under-the-skin dosing regimen, provides an attractive option.“This is something than can be provided in clinics and doesn’t require people to go to an infusion center,” David Jones, Genentech’s medical director for MS, said in an interview. “This will expand access to individuals who may not be able to access Ocrevus now, especially for reasons like geography or rural setting, individuals that might have challenges with their healthcare provider.”Ocrevus Zunovo can be injected in 10 minutes, compared to the two-plus hours needed for an infusion of the drug. For patients who experience side effects, the intravenous infusion can take up to four hours. Oddly enough, on Thursday, Genentech also earned an FDA nod for a subcutaneous formulation of another of its key products as cancer drug Tecentriq Hybreza got a thumbs-up.Setting up Ocrevus Zunovo’s approval was a phase 3 study that showed its noninferiority to its original version as measured by the level of drug in the blood 12 weeks after administration. The injected formulation also matched the performance of the infused treatment in controlling magnetic resonance imaging lesion activity in the brain over 12 weeks.A later look at the OCARINA II study showed that 97% of patients on subcutaneous Ocrevus experienced no relapses for up to 48 weeks after injection. The subcutaneous treatment also suppressed brain lesions by 97%. Most patients had no T1 gadolinium-enhancing lesions or worsening T2 lesions, which are markers of active inflammation and burden of disease. Ocrevus Zunovo requires more medicine, at 920 mg per dosing, versus 600 mg for an infusion, which is “not really surprising because not all of the drug is going to be absorbed,” Jones said. Ocrevus is designed to target CD20-positive B cells, which are responsible for inflammatory damage to nerve cells in MS.Ocrevus Zunovo was developed using Halozyme Therapeutics’ Enhanze drug delivery technology, which employs an enzyme to allow large molecules like Ocrevus to be given under the skin.The hookup between the companies is well established as it paved the way for the Tecentriq Hybreza FDA nod as well as approvals for subcutaneous versions of Genentech’s blood cancer drug Rituxan Hycela and injectable cancer treatments Herceptin Hylecta and Phesgo. Ocrevus is currently Roche’s top-selling product, with 2023 sales reaching 6.38 billion Swiss francs ($7 billion), which was good for 13% growth over 2022 at constant exchange rates. Ocrevus holds about a 24% MS patient share across the U.S. and five largest European markets.Meanwhile, Kesimpta doubled sales in 2023 to $2.17 billion. The drug has secured new-to-brand share leadership in seven of the 10 major markets outside of the U.S., according to a Novartis report in January.The two CD20 antibodies are among the most expensive MS treatments. While Ocrevus carries a list price of $79,000 annually, Kesimpta goes for $83,000 per year before rebates and discounts.Another force in the MS market is Merck KGaA’s DMD treatment Mavenclad, which generated sales of $1.1 billion last year. Former MS blockbusters that have lost their market exclusivity in the last few years include Teva’s Copaxone, Sanofi’s Aubagio and Novartis’ Gilenya.

Clinical ResultPhase 3Drug Approval

25 Jan 2021

·www.biospace.com

KSQ® Therapeutics Appoints Qasim Rizvi, MB ChB., M.B.A., as Chief Executive Officer

CAMBRIDGE, Mass.--(BUSINESS WIRE)-- KSQ, a biotechnology company using its proprietary CRISPRomics® discovery platform to systematically screen the whole genome to identify optimal gene targets for oncology and autoimmune disease, today announced it has appointed Qasim Rizvi as chief executive officer. Dr. Rizvi joins KSQ today as CEO and will also become a member of the company’s board of directors. Dr. Rizvi is a highly accomplished healthcare executive with broad experience in the biopharmaceuticals industry and was most recently senior vice president of operations and chief commercial officer at Kiniksa Pharmaceuticals. This press release features multimedia. View the full release here: Qasim Rizvi, MB.ChB. (Photo: Business Wire) “Qasim is an accomplished leader with a distinguished track record of innovation and operational excellence, coupled with a strong commitment to collaboration and teambuilding. He joins KSQ at an important inflection point in the company’s strategic evolution, as we advance our expanding pipeline and prepare to transition to development stage,” said Theo Melas-Kyriazi, chair of the KSQ board of directors. “The board is confident that Qasim, along with the entire KSQ leadership team, will provide the expertise, vision and leadership required to advance KSQ’s ambitions to deliver breakthrough products for patients.” Dr. Rizvi commented, “This is an exciting time for the company. KSQ has created the most comprehensive capability to identify and validate novel targets in cancer cells and T cells. Its approach has broad implications across a range of oncology, immuno-oncology, and immune indications. The recently completed Takeda collaboration provides a world-class strategic partner for our immuno-oncology programs and validation for our truly groundbreaking CRISPR-based discovery platform. In addition, the company recently presented data on KSQ-4279 at the 32nd EORTC-NCI-AACR Symposium in October 2020, demonstrating the power of its approach. There is much work to be done. I am humbled and excited to serve as KSQ’s CEO, and I’m very much looking forward to diving in with the full team to deliver on the platform’s potential and positively impact the lives of patients.” Prior to joining KSQ, Dr. Rizvi was senior vice president of operations & chief commercial officer at Kiniksa Pharmaceuticals. He held previous positions at Genentech, where he most recently served as vice president and franchise head of Tecentriq®, with commercial responsibilities for Genentech’s cancer immunotherapy portfolio. Earlier, he led Roche’s hematology franchise, as VP of global product strategy and lifecycle leader for Hemlibra® for hemophilia A. Dr. Rizvi has a record of success in building exceptional teams that deliver results. He has extensive launch experience in the oncology space; having launched Herceptin®, Perjeta® and Kadcyla® for HER2-positive breast cancer as well as Venclexta® for chronic lymphocytic leukemia and Gazyva® for follicular lymphoma. Under his leadership, Rituxan Hycela® received FDA approval as the first sub-cutaneous treatment for non-Hodgkin’s lymphoma. Prior to joining Genentech, Dr. Rizvi was at Novo Nordisk and Eli Lilly, where he served in numerous roles in sales, marketing, business development and new product planning. Dr. Rizvi earned an MB.ChB. from the University of Dundee Medical School in Scotland. He completed his residency in general surgery, including rotations in neurosurgery, orthopedics, ENT and accident and emergency care. He also holds an M.B.A. from the Ross School of Business at the University of Michigan. About KSQ Therapeutics KSQ Therapeutics is advancing a pipeline of tumor- and immune-focused drug candidates for the treatment of cancer across multiple drug modalities including targeted therapies, adoptive cell therapies and immuno-therapies. KSQ’s proprietary CRISPRomics® discovery engine enables genome-scale, in vivo validated, unbiased drug discovery across broad therapeutic areas. KSQ was founded by thought leaders in the field of functional genomics and pioneers of CRISPR screening technologies. For more information, please visit the company’s website at and follow @ksq_tx on Twitter. View source version on businesswire.com:

Cell TherapyImmunotherapyAACR

100 Deals associated with Rituximab/Hyaluronidase

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Non-Hodgkin Lymphoma	China	Roche Holding AG	07 Apr 2024
Follicular Lymphoma	United States	Genentech, Inc.	22 Jun 2017
Chronic Lymphocytic Leukemia	Canada	Roche Holding AG	22 Nov 2016
Diffuse Large B-Cell Lymphoma	Canada	Roche Holding AG	22 Nov 2016

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Prostatic Cancer	Phase 2	United States	Genentech, Inc.	01 Jul 2013
CD20 positive B-Cell Lymphoma	Discovery	Germany	Roche Pharma AG	04 Jul 2012

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


REDO trial (ACR2021)	Not Applicable	Rheumatoid Arthritis	142	Rituximab 1000mg	aqcslodkdq(jqixxcxhsg) = ejjjohwdjz leuvzlidwc (dmrfktfenm, 704 - 1425)	Positive	08 Nov 2021
				Rituximab 500mg	aqcslodkdq(jqixxcxhsg) = gneyslnhfm leuvzlidwc (dmrfktfenm, 704 - 1425)
EULAR2021	Not Applicable	Rheumatoid Arthritis	755	Rituximab 2x500mg	unrcmtyzop(xywdhfixah) = wjumgpyowe npnhxunfiq (ljkhgadwzo )	-	02 Jun 2021
				Rituximab 2x1000mg	unrcmtyzop(xywdhfixah) = wxkjvlzdso npnhxunfiq (ljkhgadwzo )
ESMO2020	Not Applicable	Chronic Lymphocytic Leukemia \| Non-Hodgkin Lymphoma	-	Subcutaneous rituximab	zbqpxpslby(aixnowgpqv) = elfuovevyb azgmmqdiyk (mfzuxccuou ) View more	-	17 Sep 2020
				Intravenous rituximab	qdwalguvnx(xhvfrzwpyv) = zlvqhtzhvt mfavcjjhxt (afooulfuoh ) View more
NCT02390362 (RAMP, CTgov)	Phase 3	Nephrotic Syndrome	3	Rituximab (Rituximab)	miixgotgcd(wxeeqtutqi) = xrhxhhfxup rkdmxwgnfm (etlofbkkep, ckdnelurpx - qryfdnxggr) View more	-	26 Mar 2019
				MMF (Mycophenolate Mofetil (MMF))	miixgotgcd(wxeeqtutqi) = xfeqzyibgw rkdmxwgnfm (etlofbkkep, fiadwqmpbs - uiejoygdeo) View more
NCT02169219 (SCOUT, CTgov)	Phase 4	Granulomatosis With Polyangiitis \| Microscopic Polyangiitis	20	Glucocorticoids+Rituximab	(styohmakkq) = rjkryqsruj rclgwtaxmi (ooonmlhipa, zsbpdfbzbz - madhujnpna) View more	-	17 Aug 2018
ACTRIMS2018	Phase 1	CXCL13 \| CCL19 \| CCL21 ... View more	36	Intrathecal Rituximab 25 mg	xcviwuinbl(plticxnddz) = Two participants had worsening of their EDSS over 48 weeks of follow up wrueobhpzk (qwsgixqioo ) View more	Negative	14 Mar 2018
EHA2017	Not Applicable	Lymphoproliferative Disorders	40	Subcutaneous Rituximab	zzwnuyrcpn(wsznmjtwst) = qgswhowguq wdxsqoucrr (nihztphtdj )	-	18 May 2017
EHA2017	Phase 3	Non-Hodgkin Lymphoma	220	Rituximab subcutaneous formulation	xzigfrpeqk(unkrntomcn) = ebrzvlkruh qtzerscesc (tpsukdawjo )	-	18 May 2017
				Rituximab intravenous administration	xzigfrpeqk(unkrntomcn) = zgpfffzpqo qtzerscesc (tpsukdawjo )
EULAR2016	Not Applicable	Rheumatoid Arthritis ANA positive \| hypergammaglobulinaemia	396	Rituximab 2x500mg	-	Positive	08 Jun 2016
				Rituximab 2x1000mg
EULAR2015	Not Applicable	Neuropsychiatric Systemic Lupus Erythematosus	22	Rituximab 1000mg	tjlpfiolfa(fjjdsjcfky) = jnghndckrv emhgbyhiln (lfsjwzzhqb )	Positive	10 Jun 2015
				Rituximab 2000mg	tjlpfiolfa(fjjdsjcfky) = uqzzcxbpfu emhgbyhiln (lfsjwzzhqb )

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