Latest news with #BCMA
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Business Standard
02-06-2025
- Health
- Business Standard
Glenmark's cancer drug shows strong results in early trial for Myeloma
Glenmark Pharmaceuticals' arm, Ichnos Glenmark Innovation (IGI), shared encouraging early results from a new cancer drug being tested on patients with a difficult form of blood cancer—relapsed or refractory multiple myeloma (RRMM). The results were presented at the American Society of Clinical Oncology (ASCO) 2025 Annual Meeting. The drug, called ISB 2001, is the first of its kind to target three markers (BCMA, CD38, and CD3) in a single treatment and has shown strong response rates in patients who have already undergone multiple prior therapies. In the dose-escalation stage of the trial, 35 patients were treated, most of whom had received a median of six prior therapies. Among 33 patients who received active doses (50 micrograms and above), the overall response rate (ORR) was 79 per cent, and 30 per cent achieved a complete or near-complete response. Safety data showed that cytokine release syndrome (CRS) occurred in 69 per cent of patients, mostly at Grade 1 severity. Four patients experienced Grade 2 CRS, and no cases of severe CRS or dose-limiting toxicities were reported. One patient experienced a mild neurological side effect, and infection rates remained low. The trial is continuing with a dose-expansion phase to determine the recommended Phase 2 dose and the optimal dosing schedule. According to Professor Hang Quach of the University of Melbourne and St Vincent's Hospital, ISB 2001 showed activity in patients who had previously received multiple treatment types, including T-cell redirecting and BCMA-targeted therapies. Lida Pacaud, Chief Medical Officer at IGI, said the current focus is on identifying the appropriate dose and expanding the trial to a broader patient population.
Mint
02-06-2025
- Business
- Mint
Glenmark-Ichnos cancer drug shows 74% response in phase-1 trial
Mumbai: Ichnos Glenmark Innovation (IGI), a joint venture between Glenmark Pharmaceuticals and Ichnos Sciences, on Monday shared promising results from an ongoing phase-1 trial of ISB 2001, a novel drug targeting relapsed or refractory multiple myeloma. The data, presented at the 2025 Annual Meeting of the American Society of Clinical Oncology (ASCO), showed an overall response rate (ORR) of 74% in heavily pre-treated patients. Refractory multiple myeloma refers to cases where the cancer does not respond or stops responding to treatment. Multiple myeloma is a rare, incurable blood cancer affecting plasma cells. While several therapies have been approved in recent years, most patients eventually relapse or become resistant, leaving limited treatment options. ISB 2001 is being developed by IGI to address this unmet need, particularly in patients who have previously received T-cell–based therapies such as CAR T-cells or bispecific antibodies. It is a first-in-class tri-specific antibody designed to simultaneously target BCMA, CD38, and CD3—three proteins associated with multiple myeloma. The drug aims to overcome resistance mechanisms seen with earlier-generation immunotherapies, while minimizing off-tumour toxicity. The phase-1 trial, known as TRIgnite-1, is evaluating the drug's safety and efficacy in patients who have exhausted standard treatment options. The latest data, from the full dose-escalation phase, covered 35 patients with a median of six prior lines of therapy. The overall response rate was 74%. 'The high response rates and low safety concerns demonstrated in the dose-escalation portion of the TRIgnite-1 study, conducted in a heavily pre-treated population across multiple types of therapies, reinforce the promise of ISB 2001 as a potential new treatment for patients,' said Lida Pacaud, M.D., chief medical officer at IGI. 'As we advance to the second part of the TRIgnite-1 study, our focus is now on defining the recommended dosing schedule and evaluating ISB 2001 in a larger population of heavily pre-treated RRMM patients, where we hope to observe similarly impressive treatment responses and tolerability,' Pacaud said. Among patients receiving higher, active dose levels (≥50 µg/kg), the ORR rose to 79%, with 30% achieving complete or stringent complete responses. Patients who had not previously received T-cell–based treatments saw an ORR of 84%. Even among those with prior exposure to CAR T or CD38-targeted therapies, response rates remained strong, ranging from 71% to 73%. The safety profile of ISB 2001 was favourable, with no dose-limiting toxicities reported. The most common side effect was cytokine release syndrome (CRS), seen in 69% of patients—mostly mild (Grade 1), with only four cases classified as moderate (Grade 2). There were no severe neurological adverse events. The market for multiple myeloma is projected to grow to about $33 billion by 2030, according to estimates by Bloomberg Intelligence. The trial has now entered its dose-expansion phase, which will determine the recommended Phase 2 dose and optimal dosing schedule. ISB 2001 was granted Orphan Drug Designation by the U.S. Food and Drug Administration (FDA) in 2023 and recently received Fast Track status, underscoring the agency's recognition of its potential.
Medscape
23-05-2025
- Health
- Medscape
Blenrep Gets European Nod to Treat Multiple Myeloma
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has given a positive opinion for Blenrep (belantamab mafodotin) for the treatment of relapsed or refractory multiple myeloma. The drug is an antibody drug conjugate comprising a humanized IgG1κ monoclonal antibody targeting the B-cell maturation antigen (BCMA), conjugated with a cytotoxic agent, maleimidocaproyl monomethylauristatin F (mcMMAF). Belantamab mafodotin binds to BCMA on the surface of myeloma cells, causing cell cycle arrest and inducing antibody-dependent cellular cytotoxicity. According to the manufacturer, GSK, it is the first such conjugate to be approved and represents a new mechanism of action compared with existing agents. Generally Poor Prognosis Multiple myeloma is a rare and incurable disease of the plasma cells, typically affecting adults older than 60 years of age. First-line therapy is usually with targeted cancer drugs such as lenalidomide or bortezomib in combination with a steroid, sometimes with chemotherapy and a stem cell transplant. Relapses are treated similarly. The disease has a generally poor prognosis and there is a need for novel effective therapies. Blenrep had been designated as an orphan medicine, and the EMA will now review the information to determine whether this can be maintained. CHMP said that two phase 3, randomized, open-label studies had shown that adding Blenrep to standard therapy of either bortezomib and dexamethasone in patients who have received at least one prior therapy, or pomalidomide and dexamethasone in patients who have received at least one prior therapy including lenalidomide, prolonged progression-free survival in patients with relapsed or refractory multiple myeloma. Ocular Side Effects Common The safety and tolerability profiles of the Blenrep combinations were broadly consistent with those of the individual agents. The most common side effects with Blenrep include reduced visual acuity, corneal examination abnormalities (including keratopathy), thrombocytopenia, blurred vision, dry eye, foreign-body sensation in eyes, eye pain, photophobia, eye irritation, neutropenia, anemia, and diarrhea. Patients should have an ophthalmic examination, including visual acuity and slit-lamp examination, by an eye care professional before each of the first four doses of Blenrep, and as clinically indicated thereafter. Patients should be encouraged to inform their physicians of any ocular symptoms. The drug will be available as 70 mg or 100 mg powder for concentrate for solution for infusion. It is administered as a 30-minute infusion every 3 or 4 weeks. Treatment should be prescribed by physicians experienced in the treatment of multiple myeloma. Detailed recommendations will be described in the summary of product characteristics (SmPC), which will be published on the EMA website in all official European Union languages after the marketing authorization has been granted by the European Commission.
Yahoo
16-05-2025
- Business
- Yahoo
AbelZeta Announces Upcoming Oral Presentations at LUPUS 2025
ROCKVILLE, Md., May 16, 2025 /PRNewswire/ -- AbelZeta Pharma, Inc. ("AbelZeta" or the "Company"), a global clinical-stage biopharmaceutical company focused on discovery and development of innovative and proprietary cell-based therapeutic products, today announced the acceptance of an abstract related to C-CAR168 for presentation at the 16th International Congress on Systemic Lupus Erythematosus ("LUPUS 2025"), taking place in Toronto, Canada on May 21-24, 2025. C-CAR168 is a novel autologous bi-specific CAR-T therapy targeting both CD20 and B-cell maturation antigens (BCMA) in the treatment of patients with autoimmune diseases and neurological diseases, such as resistant and refractory Lupus Nephritis (LN), Systemic Lupus Erythematosus (SLE), and progressive Multiple Sclerosis (MS). The Food and Drug Administration (FDA) previously granted clearance of the Investigational New Drug (IND) application to proceed with the Phase 1 clinical development of C-CAR168 and preclinical data from the study was presented at the American College of Rheumatology (ACR) Convergence 2024 held in Washington, DC, in November 2024. Details of the oral presentation are as follows: Abstract: Abstract Title: Clinical Impact of C-CAR168, A Novel Anti-CD20/BCMA Composite Autologous CAR-T Therapy, in Refractory Lupus Nephritis Session Title: Abstract Concurrent Session 04: Advancing Lupus Therapies and Insights Presentation Time and Date: May 22, 2025 / 14:10 – 14:20 Presenter: Nan Shen, M.D., PhD, Principal Investigator (PI) Location: Westin Harbour Castle, Toronto, Ontario, Canada Room: Queens Quay In addition, the Company's Vice President of Clinical Development, Barbara Mittleman, M.D, is an invited speaker at the congress in the following Scientific Session: Session Name: Cell Therapy in Lupus Session Time and Date: May 23, 2025 / 11:35 – 12:20 Room: Pier 2&3 The session will cover the following topics:1. Cell Therapy in SLE: Where We Are and how We Got Here2. Considerations, Challenges and Opportunities About AbelZeta Pharma, Inc. AbelZeta is a global clinical-stage biopharmaceutical company with centers of excellence in Rockville, Maryland and Shanghai, China. AbelZeta is focusing on developing innovative and proprietary cell-based therapeutic products and is committed to ushering in bespoke treatments that harness the body's own immune system to fight against hematological malignancies and solid tumors, as well as inflammatory and immunological diseases. AbelZeta advances research and development in its own GMP facilities at its centers of excellence for early-stage clinical studies, with a pipeline comprised of CAR-T and TIL therapies. Forward-Looking Statements Statements in this communication relating to plans, strategies, specific activities, and other statements that are not descriptions of historical facts are forward-looking statements. Forward-looking information is inherently subject to risks and uncertainties, and actual results could differ materially from those currently anticipated due to a number of factors, which include any risks detailed from time to time in the Company's reports. Such statements are based on the management's current beliefs and expectations and are subject to significant risks and uncertainties outside of management and the Company's control. Given these uncertainties, you should not place undue reliance on these forward-looking statements, which speak only as of the date hereof. Except as otherwise required by law, the Company does not undertake any obligation, and expressly disclaims any obligation, to update, alter or otherwise revise any forward-looking statements, whether written or oral, that may be made from time to time, whether as a result of new information, future events or otherwise. Company Contact:Sarah KellyDirector of CommunicationsAbelZeta Pharma, Inc.+1 (240) 552 View original content to download multimedia: SOURCE AbelZeta Pharma, Inc. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
12-05-2025
- Business
- Yahoo
CARsgen Announces Preliminary Clinical Data for Allogeneic BCMA CAR-T CT0596, Demonstrating Favorable Safety and Efficacy
SHANGHAI, May 11, 2025 /PRNewswire/ -- CARsgen Therapeutics Holdings Limited (Stock Code: a company focused on developing innovative CAR T-cell therapies, announces preliminary clinical data for CT0596, an allogeneic BCMA-targeted CAR-T developed using the THANK-u Plus™ platform. CT0596 is currently being evaluated in an early exploratory clinical study for relapsed/refractory multiple myeloma (R/R MM) or relapsed/refractory plasma cell leukemia (R/R PCL) to assess its safety, and preliminary efficacy. As of May 6, 2025, 8 patients with R/R MM who had received at least three prior lines of therapy were enrolled and infused with CT0596 following lymphodepletion with the FC regimen (fludarabine 22.5-30 mg/m² and cyclophosphamide 350-500 mg/m²). Key findings from up to four months of follow-up include: No dose-limiting toxicities (DLTs), ≥Grade 3 cytokine release syndrome (CRS), immune effector cell-associated neurotoxicity syndrome (ICANS), or graft-versus-host disease (GVHD) were reported. The product demonstrated a favorable safety profile, with no patients discontinuing treatment due to adverse events. 1) Among 5 patients who completed the first efficacy assessment at Week 4, 3 patients (60%) achieved stringent complete response/complete response (sCR/CR), and 4 patients (80%) achieved minimal residual disease (MRD)-negativity in the bone marrow. 2) Early efficacy data from 2 patients at Day 14 showed reductions in measurable lesions by ≥92% and ≥65%, respectively. 3) 1 patient had not yet reached the protocol-specified efficacy assessment timepoint. All sCR/CR patients remained in ongoing responses, including the first patient who completed the four-month follow-up. Based on the preliminary safety and efficacy data, CT0596 demonstrated favorable tolerability and encouraging efficacy signals in R/R MM patients across all predefined dose levels, with CAR-T expansion observed. These findings warrant further exploration not only in R/R MM, but also in other plasma cell malignancies and autoimmune diseases mediated by autoreactive plasma cells. CARsgen plans to present detailed clinical data at upcoming scientific conferences. The company anticipates submitting an Investigational New Drug (IND) application for this product candidate in the second half of 2025. About THANK-u Plus™ CARsgen has developed the THANK-u Plus™ platform as an enhanced version of its proprietary THANK-uCAR® allogeneic CAR-T technology to address the potential impact of NKG2A expression levels on therapeutic efficacy. THANK-u Plus™ demonstrates sustained expansion regardless of varying NKG2A expression levels on NK cells and exhibits significantly improved expansion compared to THANK-uCAR®. Preclinical studies show that THANK-u Plus™ delivers superior antitumor efficacy in the presence of NK cells compared to THANK-uCAR®. Allogeneic BCMA or dual-targeting CD19/CD20 CAR-T cells developed using this platform exhibit robust antitumor activity in the presence of NK cells, indicating that THANK-u Plus™ has broad potential for developing diverse allogeneic CAR-T therapies. CARsgen is developing allogeneic CAR-T products using THANK-u Plus™ platform to increase CAR T cell expansion, persistence and efficacy. About CARsgen Therapeutics Holdings Limited CARsgen is a biopharmaceutical company focusing on developing innovative CAR T-cell therapies to address the unmet clinical needs including but not limited to hematologic malignancies, solid tumors and autoimmune diseases. CARsgen has established end-to-end capabilities for CAR T-cell research and development covering target discovery, preclinical research, product clinical development, and commercial-scale production. CARsgen has developed novel in-house technologies and a product pipeline with global rights to address challenges faced by existing CAR T-cell therapies. Efforts include improving safety profile, enhancing the efficacy in treating solid tumors, and reducing treatment costs, etc. CARsgen's mission is to be a global biopharmaceutical leader that provides innovative and differentiated cell therapies for patients worldwide and makes cancer and other diseases curable. Forward-looking Statements All statements in this press release that are not historical fact or that do not relate to present facts or current conditions are forward-looking statements. Such forward-looking statements express the Group's current views, projections, beliefs and expectations with respect to future events as of the date of this press release. Such forward-looking statements are based on a number of assumptions and factors beyond the Group's control. As a result, they are subject to significant risks and uncertainties, and actual events or results may differ materially from these forward-looking statements and the forward-looking events discussed in this press release might not occur. Such risks and uncertainties include, but are not limited to, those detailed under the heading "Principal Risks and Uncertainties" in our most recent annual report and interim report and other announcements and reports made available on our corporate website, No representation or warranty is given as to the achievement or reasonableness of, and no reliance should be placed on, any projections, targets, estimates or forecasts contained in this press release. Contact CARsgen For more information, please visit View original content to download multimedia: SOURCE CARsgen Therapeutics Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
