A Phase 3, Multicenter, Randomized, Open Label Study to Compare the Efficacy and Safety of Golcadomide in Combination With Rituximab (Golca + R) Vs Investigator's Choice in Participants With Relapsed/Refractory Follicular Lymphoma

The study is designed as a multicenter, randomized, open label Phase 3 study to compare the efficacy and safety of golcadomide in combination with rituximab vs investigator's choice in participants with relapsed/refractory follicular lymphoma who have received at least one line of prior systemic therapy.

Start Date08 Jul 2025

Sponsor / Collaborator

Celgene Corp.

NCT06834373

/ RecruitingPhase 2IIT

Phase 2 Study of Golcadomide With Rituximab as a Bridging Therapy Prior to CAR-T for Patients With Relapsed or Primary Refractory Aggressive B-Cell Non-Hodgkin Lymphoma (NHL)

This phase II trial tests the effectiveness of golcadomide and rituximab as bridging treatment before chimeric antigen receptor (CAR) T-cell therapy in patients with aggressive B-cell non-Hodgkin lymphoma that has come back after a period of improvement (relapsed) or that has not responded to previous treatment (refractory). Patients that are able to receive CAR T-cell therapy have a potential for cure, however, many will not be qualified to receive therapy due to relapse. Bridging therapy is therapy intended to transition a patient from one therapy or medication to another or maintain their health or status until they are a candidate for a therapy or have decided on a therapy. Golcadomide may help block the formation, growth or spread of cancer cells. Rituximab is a monoclonal antibody. It binds to a protein called CD20, which is found on B cells (a type of white blood cell) and some types of cancer cells. This may help the immune system kill cancer cells. Giving golcadomide and rituximab as bridging therapy before CAR T-cell therapy may kill more tumor cells and may improve the chance of proceeding to CAR T-cell therapy in patients with relapsed or refractory aggressive B-cell non-Hodgkin lymphoma.

Start Date02 Apr 2025

Sponsor / Collaborator

Mayo Clinic

NCT06835530

/ Not yet recruitingPhase 2IIT

A Combination of Rituximab and CC-99282 As Front-line Therapy for Older Frail Patients with Diffuse Large B-cells Non-Hodgkin Lymphoma Evaluated with a Simplified Geriatric Assessment (sGA): a Phase II Study of the Fondazione Italiana Linfomi (FIL)

Prospective, multicenter, single arm, phase II study, to evaluate the efficacy of the combination rituximab-golcadomide as a chemo free approach in a population of older patients with new diagnosis of DLBCL, defined as frail according to a sGA evaluation and not candidate for the standard R-CHOP (or R-CHOP like) treatments.

Start Date01 Apr 2025

Sponsor / Collaborator-

100 Clinical Results associated with Golcadomide Hydrochloride

100 Translational Medicine associated with Golcadomide Hydrochloride

100 Patents (Medical) associated with Golcadomide Hydrochloride

Literatures (Medical) associated with Golcadomide Hydrochloride

25 Jan 2024·Journal of medicinal chemistryQ1 · MEDICINE

Trends in Neosubstrate Degradation by Cereblon-Based Molecular Glues and the Development of Novel Multiparameter Optimization Scores

Q1 · MEDICINE

Article

Author: Edwards, Jacob T. ; Weiss, Dahlia R. ; Chekler, Eugene L. P. ; Szewczyk, Suzanne M. ; Verma, Isha

Molecular glues enable the degradation of previously "undruggable" proteins via the recruitment of cereblon (CRBN) to the target. One major challenge in designing CRBN E3 ligase modulating compounds (CELMoDs) is the selectivity profile toward neosubstrates, proteins recruited by CRBN E3 ligase agents for degradation. Common neosubstrates include Aiolos, Ikaros, GSPT1, CK1α, and SALL4. Unlike achieving potency and selectivity for traditional small molecule inhibitors, reducing the degradation of these neosubstrates is complicated by the ternary nature of the complex formed between the protein, CRBN, and CELMoD. The standard guiding principles of medicinal chemistry, such as enforcing hydrogen bond formation, are less predictive of degradation efficiency and selectivity. Disclosed is an analysis of our glutarimide CELMoD library to identify interpretable chemical features correlated to selectivity profiles and general cytotoxicity. Included is a simple multiparameter optimization function using only three parameters to predict whether molecules will have undesired neosubstrate activity.

01 Jan 2023·Blood reviews

Targeting cereblon in hematologic malignancies

Review

Author: Fuchs, Ota

The protein cereblon (CRBN) is a substrate receptor of the cullin 4-really interesting new gene (RING) E3 ubiquitin ligase complex CRL4^CRBN. Targeting CRBN mediates selective protein ubiquitination and subsequent degradation via the proteasome. This review describes novel thalidomide analogs, immunomodulatory drugs, also known as CRBN E3 ubiquitin ligase modulators or molecular glues (avadomide, iberdomide, CC-885, CC-90009, BTX-1188, CC-92480, CC-99282, CFT7455, and CC-91633), and CRBN-based proteolysis targeting chimeras (PROTACs) with increased efficacy and potent activity for application in hematologic malignancies. Both types of CRBN-binding drugs, molecular glues, and PROTACs stimulate the interaction between CRBN and its neosubstrates, recruiting target disease-promoting proteins and the E3 ubiquitin ligase CRL4^CRBN. Proteins that are traditionally difficult to target (transcription factors and oncoproteins) can be polyubiquitinated and degraded in this way. The competition of CRBN neosubstrates with endogenous CRBN-interacting proteins and the pharmacology and rational combination therapies of and mechanisms of resistance to CRL4^CRBN modulators or CRBN-based PROTACs are described.

01 Oct 2022·Clinical Lymphoma Myeloma & Leukemia

ABCL-412 Clinical Activity of CC-99282, a Novel, Oral, Small Molecule Cereblon E3 Ligase Modulator (CELMoD) Agent, in Patients With Relapsed/Refractory Non-Hodgkin Lymphoma (R/R NHL) –Results From CC-99282-NHL-001 (NCT03930953) a First-in-Human, Phase 1, Open-Label, Multicenter Study

Article

Author: Nastoupil, Loretta ; Guarinos, Carla ; Patah, Poliana ; Bachy, Emmanuel ; Carpio, Cecilia ; Feldman, Tatyana A ; Wu, Fan ; Buchholz, Tonia J ; Kuruvilla, John ; Chou, Wen-Chi ; Pourdehnad, Michael ; Michot, Jean-Marie ; Morillo, Daniel ; Carrancio, Soraya ; Ribrag, Vincent ; Ferrari, Silvia ; Li, Shaoyi ; Pinto, Antonio ; Chavez, Julio C

CC-99282, a CELMoD® agent, co-opts cereblon to induce targeted degradation of Ikaros/Aiolos. In preclinical studies, CC-99282 exhibited stronger antiproliferative, apoptotic, and immunostimulatory activities compared with lenalidomide and other CELMoD agents. Here we present results of CC-99282 monotherapy in patients with R/R NHL. This 2-part study comprises CC-99282 monotherapy dose escalation (part A) and expansion ± combination partners (part B). Part A includes patients with R/R diffuse large B-cell lymphoma (DLBCL) or follicular lymphoma (FL) that progressed after ≥2 lines of therapy (LOTs) and patients with R/R DLBCL unfit for transplant who have received ≥1 standard LOT. CC-99282 at 0.2, 0.4, 0.6, or 0.8 mg is administered once daily in 3 intermittent, 28-day cycle dosing schedules, with ≥3 patients per cohort. By October 6, 2021, 50 patients received CC-99282 in part A (38 DLBCL, 12 FL; median age 66y; 58% male; 3 median prior LOTs [range 1-8]); 17 remain on treatment, 26 discontinued due to progressive disease. Treatment-related grade 3/4 adverse events were observed in 32 (64%) patients, primarily neutropenia (29 [58%] patients) which was managed with dose modifications and granulocyte colony-stimulating factors. Grade 4 neutropenia during the first month of CC-99282 treatment correlated with prior therapy with ≥4 lines of alkylating agents. All dose-limiting toxicities were hematologic. Maximal recommended doses on the 7/14- and 14/28-days schedules of interest were 0.6 mg and 0.4 mg, respectively. For doses ≥0.4 mg on schedules of interest, responses were durable, and overall response rate was 42% (15/36 evaluable patients; 6 complete and 9 partial responses; 6 FL, 9 DLBCL); responders included patients who progressed on/after cellular therapy and/or immunomodulatory/CELMoD agents. Responses also correlated with early reduction in circulating tumor DNA. CC-99282 was absorbed rapidly with a prolonged median terminal half-life (~50 hours [doses ≥0.4 mg]). Increase in CC-99282 plasma exposure and Ikaros/Aiolos degradation in peripheral T cells were dose-dependent (maximum degradation [>90%] by treatment day 4 [doses ≥0.4 mg]). CC-99282 monotherapy demonstrated a manageable safety profile, with promising efficacy in heavily pretreated patients with R/R NHL. Pharmacokinetic/pharmacodynamic data were consistent with robust/rapid CC-99282-mediated antitumor activity. This BMS-funded study is enrolling patients.

News (Medical) associated with Golcadomide Hydrochloride

28 Nov 2024

·www.prnewswire.com

Follicular Lymphoma Clinical Trial Pipeline Appears Robust With 50+ Key Pharma Companies Actively Working in the Therapeutics Segment | DelveInsight

Advances in immunotherapy have ushered in a new era of treatment for follicular lymphoma (FL), particularly for patients who have experienced relapse after conventional chemotherapy regimens. This paradigm shift is characterized by the emergence of innovative therapies like CAR T-cell therapy and bispecific antibodies, which have demonstrated remarkable efficacy in targeting and eradicating lymphoma cells. CAR T-cell therapy represents a groundbreaking approach where a patient's own T-cells are genetically engineered to recognize and attack cancer cells. This personalized treatment has shown significant promise, especially for individuals who have undergone extensive previous therapies. One notable example is Axicabtagene ciloleucel (Yescarta), a CAR T-cell therapy approved for use in patients with relapsed or refractory follicular lymphoma. Clinical trials have highlighted its ability to induce durable remissions, with some patients experiencing long-term remission even after multiple prior therapies. LAS VEGAS, Nov. 28, 2024 /PRNewswire/ -- DelveInsight's ' Follicular Lymphoma Pipeline Insight 2024 ' report provides comprehensive global coverage of pipeline follicular lymphoma therapies in various stages of clinical development, major pharmaceutical companies are working to advance the pipeline space and future growth potential of the follicular lymphoma pipeline domain. Key Takeaways from the Follicular Lymphoma Pipeline Report DelveInsight's follicular lymphoma pipeline report depicts a robust space with 50+ active players working to develop 55+ pipeline therapies for follicular lymphoma treatment. Key follicular lymphoma companies such as Chia Tai Tianqing Pharmaceutical Group, Incyte Corporation, Mabworks, Johnson & Johnson Innovative Medicine, Nektar Therapeutics, Xynomic Pharmaceuticals, Merck Sharp & Dohme, Jiangsu HengRui Medicine Co., Ltd., ADC Therapeutics, Bristol-Myers Squibb, Swedish Orphan Biovitrum, Zhejiang DTRM Biopharma, Immpact Bio, Galapagos, Immunitas Therapeutics, Enterome, CRISPR Therapeutics, CHO Pharma, Shanghai Blueray Biopharma, BeiGene, AstraZeneca, AVM Biotechnology, Mustang Bio, Merck, Pell Bio-Med Technology, Schrodinger Inc., Sana Biotechnology, Poseida Therapeutics, OncoNano Medicine, Inc., Nurix Therapeutics, Inc., NovalGen, Pfizer, Xencor, Wellington Zhaotai Therapies, MEI Pharma, Sutro Biopharma, Synthekine, Verismo Therapeutics, Vincerx Pharma, Novartis, Century Therapeutics, Newave Pharmaceuticals, Bio-Path Holdings, Affimed GmbH, Iksuda Therapeutics, Allogene Therapeutics, Adicet Bio, Carna Biosciences, Inc., BeiGene, Boryung Pharmaceutical, Accutar Biotechnology, Atara Biotherapeutics, AbbVie, InnoCare Pharma, NeoImmuneTech, and others are evaluating new follicular lymphoma drugs to improve the treatment landscape. Promising follicular lymphoma pipeline therapies such as Parsaclisib, TQ-B3525, Tafasitamab, MIL62, Ibrutinib, AZD0486, NKTR-255, Abexinostat, Acalabrutinib, Zilovertamab vedotin, SHR2554, Nivolumab, Loncastuximab tesirine, Golcadomide, Emapalumab, DTRM-555, Capivasertib, IMPT 314, GLPG5101, IMT-009, EO2463, CTX112, CHO-H01, BR1733, BGB-16673, BGB-10188, AZD5492, AVM0703, MB106, MK-1026, PL001, SGR-1505, SC291, SC262, P-CD19CD20-ALLO1, ONM 501, NX-5948, NX 2127, NVG-111, Mevrometostat, Plamotamab, WZTL-002, Voruciclib, STRO001, SYNCAR-001 + STK-009, SynKIR-310, VIP-152, VAY736, CNTY-101, LP-168, BP1002, IOA-244, IKS 03, ALLO-501, ADI-001, AS-1763, BGB-21447, BR101801, AC676, ATA3219, ABBV-319, ABBV-101, ICP-B02, ICP-B05, C-CAR039, Efineptakin Alfa, and others are under different phases of follicular lymphoma clinical trials. In August 2024, the company expects to file a supplemental Biologics License Application for tafasitamab for the treatment of patients with FL who have failed at least one prior systemic anti-CD20 immunotherapy or chemo-immunotherapy by the end of 2024 based on the positive Phase III results. In June 2024, a consortium of Eugene Private Equity and Korea Development Bank Private Equity announced that they would acquire 80% of South Korean vaccine maker Boryung Biopharma Co. for 320 billion won (USD 231 million). In February 2024, Incyte announced that it had entered into an asset purchase agreement with MorphoSys AG, which gives Incyte exclusive global rights for tafasitamab. Incyte will now recognize revenue and cost for all US commercialization and clinical development and MorphoSys will no longer be eligible to receive future milestone, profit split and royalty payments. In September 2023, OncoNano Medicine, Inc. announced a clinical trial supply agreement with Regeneron for the use of Libtayo (cemiplimab), a PD-1 inhibitor, in the combination stage of the first human trial of ONM-501, a dual-activating STING (STimulator of INterferon Genes) agonist and lead therapeutic development candidate. The ONM-501 first-in-human trial is a multicenter Phase Ia/b dose escalation and dose expansion study of intratumoral ONM-501 as monotherapy and in combination with Libtayo in patients with advanced solid tumors and lymphomas. OncoNano is the sponsor of the clinical trial, and Regeneron will supply cemiplimab. In May 2023, Janssen Pharmaceutical Companies of Johnson & Johnson announced that it had entered into a worldwide collaboration and license agreement with Cellular Biomedicine Group Inc. (CBMG) to develop, manufacture, and commercialize next-generation chimeric antigen receptor (CAR) T-cell therapies for the treatment of B-cell malignancies. Under the terms of the agreement, CBMG will grant Janssen a worldwide license to develop and commercialize the CAR-T assets, except in Greater China. Janssen and CBMG will negotiate an option for Janssen to commercialize the products in the Chinese territory. Janssen will make an upfront payment of USD 245 million that will be accounted for in the second quarter as a research and development expense. Additional future payments will be based upon achieving certain development, regulatory, and sales milestones, as well as tiered royalty payments on worldwide net trade sales, excluding Greater China. Request a sample and discover the recent advances in follicular lymphoma treatment drugs @ Follicular Lymphoma Pipeline Report The follicular lymphoma pipeline report provides detailed profiles of pipeline assets, a comparative analysis of clinical and non-clinical stage follicular lymphoma drugs, inactive and dormant assets, a comprehensive assessment of driving and restraining factors, and an assessment of opportunities and risks in the follicular lymphoma clinical trial landscape. Follicular Lymphoma Overview Follicular lymphoma is a common type of non-Hodgkin lymphoma (NHL) that originates from B-cells, a kind of white blood cell responsible for producing antibodies. This cancer is characterized by the growth of abnormal lymphoid follicles, which can disrupt normal lymphatic function. While the exact causes of follicular lymphoma are not fully understood, certain factors may increase the risk, including age (most commonly affecting adults over 60), a family history of lymphoma, and potential environmental factors such as exposure to pesticides or chemicals. Symptoms of follicular lymphoma can vary widely but may include painless swelling of lymph nodes in the neck, armpit, or groin, unexplained weight loss, night sweats, fatigue, and fever. Some patients may remain asymptomatic for extended periods, as this type of lymphoma can progress slowly. Diagnosis typically involves a combination of physical examinations, blood tests, imaging studies (like CT scans), and a biopsy of affected lymph nodes. The biopsy helps determine the subtype and stage of the lymphoma, which is crucial for planning treatment. Treatment for follicular lymphoma depends on the stage of the disease and the patient's overall health. Options may include watchful waiting for asymptomatic cases, chemotherapy, immunotherapy (such as monoclonal antibodies), and targeted therapies. In some cases, stem cell transplants may be considered for patients with more aggressive forms or those who do not respond to initial treatments. Given the indolent nature of follicular lymphoma, ongoing management, and regular monitoring are vital for achieving the best possible outcomes. Find out more about follicular lymphoma treatment drugs @ Drugs for Follicular Lymphoma Treatment A snapshot of the Follicular Lymphoma Pipeline Drugs mentioned in the report: Learn more about the emerging follicular lymphoma pipeline therapies @ Follicular Lymphoma Clinical Trials Follicular Lymphoma Therapeutics Assessment The follicular lymphoma pipeline report proffers an integral view of the follicular lymphoma emerging novel therapies segmented by stage, product type, molecule type, mechanism of action, and route of administration. Scope of the Follicular Lymphoma Pipeline Report Coverage: Global Therapeutic Assessment By Product Type: Mono, Combination, Mono/Combination Therapeutic Assessment By Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III Therapeutics Assessment By Route of Administration: Intra-articular, Intraocular, Intrathecal, Intravenous, Oral, Parenteral, Subcutaneous, Topical, Transdermal Therapeutics Assessment By Molecule Type: Oligonucleotide, Peptide, Small molecule Therapeutics Assessment By Mechanism of Action: Phosphatidylinositol 3 kinase delta inhibitors, Phosphatidylinositol 3 kinase gamma inhibitors, Emt protein-tyrosine kinase inhibitors, Interleukin 15 receptor agonists, Histone deacetylase inhibitors, Rad51 recombinase inhibitors, Agammaglobulinaemia tyrosine kinase inhibitors, Apoptosis stimulants, Cell cycle inhibitors, Tubulin inhibitors, Tubulin polymerisation inhibitors, Enhancer of zeste homolog 2 protein inhibitors, Antibody-dependent cell cytotoxicity, Programmed cell death 1 receptor antagonists, T lymphocyte stimulants, Alkylating agents, DNA cross-linking agents Key Follicular Lymphoma Companies: Chia Tai Tianqing Pharmaceutical Group, Incyte Corporation, Mabworks, Johnson & Johnson Innovative Medicine, Nektar Therapeutics, Xynomic Pharmaceuticals, Merck Sharp & Dohme, Jiangsu HengRui Medicine Co., Ltd., ADC Therapeutics, Bristol-Myers Squibb, Swedish Orphan Biovitrum, Zhejiang DTRM Biopharma, Immpact Bio, Galapagos, Immunitas Therapeutics, Enterome, CRISPR Therapeutics, CHO Pharma, Shanghai Blueray Biopharma, BeiGene, AstraZeneca, AVM Biotechnology, Mustang Bio, Merck, Pell Bio-Med Technology, Schrodinger Inc., Sana Biotechnology, Poseida Therapeutics, OncoNano Medicine, Inc., Nurix Therapeutics, Inc., NovalGen, Pfizer, Xencor, Wellington Zhaotai Therapies, MEI Pharma, Sutro Biopharma, Synthekine, Verismo Therapeutics, Vincerx Pharma, Novartis, Century Therapeutics, Newave Pharmaceuticals, Bio-Path Holdings, Affimed GmbH, Iksuda Therapeutics, Allogene Therapeutics, Adicet Bio, Carna Biosciences, Inc., BeiGene, Boryung Pharmaceutical, Accutar Biotechnology, Atara Biotherapeutics, AbbVie, InnoCare Pharma, NeoImmuneTech, and others. Key Follicular Lymphoma Pipeline Therapies: Parsaclisib, TQ-B3525, Tafasitamab, MIL62, Ibrutinib, AZD0486, NKTR-255, Abexinostat, Acalabrutinib, Zilovertamab vedotin, SHR2554, Nivolumab, Loncastuximab tesirine, Golcadomide, Emapalumab, DTRM-555, Capivasertib, IMPT 314, GLPG5101, IMT-009, EO2463, CTX112, CHO-H01, BR1733, BGB-16673, BGB-10188, AZD5492, AVM0703, MB106, MK-1026, PL001, SGR-1505, SC291, SC262, P-CD19CD20-ALLO1, ONM 501, NX-5948, NX 2127, NVG-111, Mevrometostat, Plamotamab, WZTL-002, Voruciclib, STRO001, SYNCAR-001 + STK-009, SynKIR-310, VIP-152, VAY736, CNTY-101, LP-168, BP1002, IOA-244, IKS 03, ALLO-501, ADI-001, AS-1763, BGB-21447, BR101801, AC676, ATA3219, ABBV-319, ABBV-101, ICP-B02, ICP-B05, C-CAR039, Efineptakin Alfa, and others. Dive deep into rich insights for new drugs for follicular lymphoma treatment, visit @ Follicular Lymphoma Drugs Table of Contents For further information on the follicular lymphoma pipeline therapeutics, reach out @ Follicular Lymphoma Treatment Drugs Related Reports Follicular Lymphoma Market Follicular Lymphoma Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, market share of the individual therapies, and key follicular lymphoma companies including Epizyme, Eisai, Bayer Healthcare Pharmaceuticals, Verastem Oncology, Gilead Sciences, TG Therapeutics, Bristol-Myers-Squibb, Roche, Incyte Corporation, Bristol Myers Squibb, ADC Therapeutics, MorphoSys, Nordic Nanovector, AbbVie, Regeneron Pharmaceuticals, Janssen Research & Development, Novartis, MEI Pharma, and BeiGene, among others. Non-Hodgkin Lymphoma Market Non-Hodgkin Lymphoma Market Insights, Epidemiology, and Market Forecast – 2032 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, market share of the individual therapies, and key Non-Hodgkin lymphoma companies, including Roche, Pfizer, Amgen, Novartis, Teva Pharmaceuticals, Genentech, ACD Therapeutics, among others. Non-Hodgkin Lymphoma Pipeline Non-Hodgkin Lymphoma Pipeline Insight – 2024 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key Non-Hodgkin lymphoma companies, including Novartis, AstraZeneca, Genentech, BioInvent, Genmab, SystImmune, Nordic Nanovector, Pacylex Pharmaceuticals, Artiva Biotherapeutics, Inc., Chipscreen Biosciences, Ltd., Timmune Biotech Inc., Chia Tai Tianqing Pharmaceutical Group Co., Ltd., Gilead Sciences, Acerta Pharma BV, Adagene Inc, Conjupro Biotherapeutics, Inc., Rhizen Pharmaceuticals, Juventas Cell Therapy Ltd., Incyte Corporation, HUYA Bioscience International, SecuraBio, Genor Biopharma Co., Ltd., Kyowa Kirin Co., Ltd., Antengene Therapeutics Limited, Regeneron Pharmaceuticals, Jiangsu HengRui Medicine Co., Ltd., Xynomic Pharmaceuticals, Inc., BioTheryX, Inc., UWELL Biopharma, Kronos Bio, Bio-Thera Solutions, Spectrum Pharmaceuticals, Inc., Aptose Biosciences Inc., Miltenyi Biomedicine GmbH, Precision BioSciences, Inc., Teneobio, Inc., TCR2 Therapeutics, IGM Biosciences, Inc, among others. Diffuse Large B-cell Lymphoma Market Diffuse Large B-cell Lymphoma Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, market share of the individual therapies, and key DLBCL companies, including AbbVie, Genmab, Merck, Roche, Xencor, Janssen, Denovo Biopharma, Calithera Biosciences IMV, Biogen, Autolus Therapeutics, Allogene Therapeutics, Novartis, Miltenyi Biomedicine, Regeneron Pharmaceuticals, Debiopharm, Seagen, Takeda, AstraZeneca, Gilead Sciences, among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Contact Us Shruti Thakur [email protected] +14699457679 Logo: SOURCE DelveInsight Business Research, LLP WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

ImmunotherapyLicense out/inPhase 3VaccineCell Therapy

18 Nov 2024

·www.businesswire.com

Foresight Diagnostics to Present New Data on Foresight CLARITY™ Ultra-Sensitive MRD Detection Across Multiple Studies at the 66th American Society of Hematology Annual Meeting

BOULDER, Colo.--( BUSINESS WIRE )-- Foresight Diagnostics , a leader in ultrasensitive minimal residual disease (MRD) testing, today announced the presentation of multiple studies showcasing Foresight CLARITY™ MRD at the upcoming 66 th American Society of Hematology Annual Meeting and Exposition taking place December 7-10 in San Diego, California. The presentations span various lymphoma types and treatment settings, demonstrating the broad applicability of the Foresight CLARITY MRD detection technology for monitoring treatment response and predicting patient outcomes. The studies include collaborations with multiple pharmaceutical companies and research institutions, including AstraZeneca, Bristol Myers Squibb (BMS), Daiichi Sankyo (DSI), Stanford University, Washington University, and others. "These studies add to the growing body of evidence supporting ultra-sensitive MRD testing as a critical tool in lymphoma care and drug development," said David Kurtz, MD, PhD, Chief Medical Officer and Head of Research at Foresight Diagnostics. "We see in these studies that MRD measurement with Foresight CLARITY consistently enables earlier and more accurate treatment response assessment than conventional imaging-based methods. The ability to monitor disease status in real-time with ultra-sensitive MRD assays like Foresight CLARITY may help accelerate clinical trials and lead to more personalized decision-making for patient care." Results utilizing Foresight CLARITY MRD technology are featured in six abstracts, including three that are co-authored by Foresight. Presentation highlights include: LBCL/DLBCL: ctDNA-MRD as a surrogate endpoint for 2L CAR T – Analysis of the Phase 3 TRANSFORM trial in second-line treatment for large B-cell lymphoma (LBCL) reinforced the potential of circulating tumor DNA (ctDNA) as an earlier endpoint for response assessment and assessment of clinical trial results. In the TRANSFORM study, patients receiving lisocabtagene maraleucel (liso-cel) had significantly improved event-free survival compared to standard of care. Consistent with this result, patients receiving liso-cel also demonstrated higher rates of MRD clearance, demonstrating CLARITY's ability to measure differential treatment responses. MRD Response with novel first-line therapy in high-risk DLBCL – Analysis of a Phase 1b trial CC-220-DLBCL-001 combining golcadomide with R-CHOP in previously untreated aggressive B-cell lymphoma showed promising MRD clearance rates. The data demonstrated that 90% of patients achieved MRD negativity at end of treatment with golcadomide 0.4mg + R-CHOP, with strong responses observed even in high-risk patients. These data further support the ongoing Phase 3 GOLSEEK-1 study investigating this novel combination therapy in high-risk 1L LBCL. Enhanced risk stratification by MRD vs. traditional methods – New research investigates the predictive value of the International Prognostic Index (IPI), currently the primary pre-treatment risk assessment tool for DLBCL. The study revealed that pre-treatment IPI scores did not significantly correlate with end-of-treatment MRD status, with MRD testing being a superior predictor of progression-free survival. Follicular Lymphoma: MRD-based response assessment of novel FL therapies – Two studies demonstrated the value of MRD assessment in follicular lymphoma trials, with new treatment approaches showing early clearance. The CD19xCD3 bispecific antibody AZD0486 achieved 89% MRD negativity in relapsed or refractory FL patients by 12 weeks in complete responders. In the 1L setting, the chemotherapy-free combination of mosunetuzumab and polatuzumab vedotin showed similar early MRD clearance, with 7 of 8 complete responders achieving MRD negativity before cycle 3. These results highlight the potential for MRD as an early indicator of therapeutic response in FL clinical trials. PTCL: ctDNA as a prognostic biomarker for T-cell lymphoma – Analysis from the VALENTINE-PTCL01 Phase 2 trial in relapsed/refractory peripheral T-cell lymphoma (PTCL) revealed that patients achieving early, deep ctDNA reduction (>5-fold decrease by Cycle 2 Day 1) experienced significantly longer progression-free survival, establishing ctDNA monitoring as a powerful tool for early response assessment. Information on abstract presentation time and dates can be found below. To meet with Foresight Diagnostics, visit booth #3423 or contact us at BD@foresight-dx.com. Oral Presentations: Circulating Tumor DNA (ctDNA) as an Early Outcome Predictor in Patients with Second-Line Large B-Cell Lymphoma After Lisocabtagene Maraleucel Versus Standard of Care Treatment from the Phase 3, Randomized TRANSFORM Study Presenter: Ash Alizadeh, MD, PhD (Stanford University) Session 628 Date/Time: Saturday, December 7, 2024, 10:45 a.m. Sponsor: Bristol Myers Squibb Co-authored by Foresight Diagnostics Escalating Doses of AZD0486, a Novel CD19xCD3 T-Cell Engager, Result in High Complete Remissions with Rapid Clearance of Minimal Residual Disease in Patients with Relapsed/Refractory Follicular Lymphoma Presenter: Jing-Zhou Hou, MD, PhD (UPMC Hillman Cancer Center) Session 623 Date/Time: Saturday, December 7, 2024, 5 p.m. Sponsor: AstraZeneca Golcadomide (GOLCA) Plus R-CHOP Has High Minimal Residual Disease (MRD) Negativity across High-Risk, Untreated Aggressive B-Cell Lymphoma (a-BCL) Presenter: Jason R. Westin, MD (MD Anderson) Session 627 Date/Time: Sunday, December 8, 2024, 12:30 p.m. Sponsor: Bristol Myers Squibb International prognostic index poorly predicts EOT ctDNA MRD status in DLBCL and has limited impact on its predictive value for outcomes Presenter: Jordan S. Goldstein, MD, MS (Stanford University) Session 626 Date/Time: Sunday, December 8, 2024, 5 p.m. Co-authored by Foresight Diagnostics Poster Presentations: Prediction of Clinical Response by Phased Variants in Circulating Tumor DNA (ctDNA) in the VALENTINE-PTCL01 trial of Patients with Relapsed or Refractory Peripheral T-Cell Lymphoma Presenter: Neha Mehta-Shah, MD, MSCI (Washington University) Abstract #4342, Session 621 Date/Time: Monday, December 9, 2024, 6-8 p.m. Sponsor: Daiichi Sankyo Co-authored by Foresight Diagnostics Mosunetuzumab Plus Polatuzumab Vedotin Induces Early Complete Responses in Previously Untreated High Tumor Burden Follicular Lymphoma Presenter: David A Russler-Germain, MD, PhD (Washington University) Abstract #4414, Session 623 Date/Time: Monday, December 9, 2024, 6-8 p.m. About Foresight Diagnostics Foresight Diagnostics is a privately-held cancer diagnostics company and CLIA-registered laboratory. Its liquid biopsy platform, Foresight CLARITY™, is a novel assay that measures minimal residual disease (MRD) with reported detection limits in parts per million 1. The improved sensitivity of Foresight CLARITY has the potential to provide actionable information to physicians and biopharmaceutical companies to enable more personalized treatment approaches for patients with solid tumor and hematologic malignancies. For more information, please visit foresight-dx.com and follow us on Twitter and LinkedIn. Foresight CLARITY™ IUO is an investigational device. Limited by United States Law to investigational use. 1 Foresight CLARITY™ IUO is an investigational device. Limited by United States Law to investigational use.

Clinical ResultPhase 3ASH

12 Dec 2023

·www.biospace.com

Two Early Studies Evaluating Potential First-in-Class CELMoD™ Agent Golcadomide for the Treatment of Non-Hodgkin Lymphomas Presented at ASH 2023

Phase 1b DLBCL-001 study reinforces promising activity and combinability of golcadomide with R-CHOP in patients with previously untreated aggressive B-cell lymphoma Phase 1/2 CC-99282-NHL-001 study demonstrates activity and combinability with rituximab in heavily pretreated patients with diffuse large B-cell lymphoma PRINCETON, N.J.--(BUSINESS WIRE)-- Bristol Myers Squibb (NYSE: BMY) announced the results of two early studies evaluating combinations of potential first-in-class CELMoD™ agent golcadomide in non-Hodgkin lymphomas. These data are being presented in separate posters (#4459, #4496, #1631) at the 2023 American Society of Hematology (ASH) Annual Meeting from December 9-12. “Golcadomide is a novel, oral CELMoD agent representing one of several compelling assets generated from our differentiated targeted protein degradation research platform,” said Michael Pourdehnad, M.D., senior vice president, Head of Early Clinical Development, Hematology, Oncology and Cell Therapy Development, Bristol Myers Squibb. “In the studies being presented at ASH 2023, golcadomide has shown potential warranting further evaluation in patients with first-line and previously treated large B-cell lymphomas. We are encouraged by the growing body of evidence for this purposefully designed lymphoma agent as we continue toward a registrational program.” CC-220-DLBCL-001 In the dose expansion phase of this Phase 1b study, patients were randomized 1:1 to golcadomide at one of two recommended Phase 2 dose levels (DL) (DL-1: 0.2 mg day 1-7, n=35; DL1: 0.4 mg day 1-7, n=37) plus R-CHOP-21 for a fixed duration of 6 cycles. A total of 65 (83.3%) patients completed 6 cycles of the combination with 13 discontinuing treatment. There were 71 patients evaluable for efficacy, and results showed: Overall response rate (ORR) at end of treatment rate was 84.5% in patients overall, with 87.9% of patients in the DL1 arm achieving a complete metabolic response (CMR) compared to 63.6% in the DL-1 arm. Minimal residual disease negativity at the end of treatment was achieved in 93% (14/15) of patients treated with 0.4 mg of golcadomide plus R-CHOP compared to 70% (7/10) treated with 0.2 mg of golcadomide plus R-CHOP. At both DL1 and DL-1, steady-state levels of golcadomide reduced Ikaros over 80%, to levels predicted to optimize tumor cell killing and to stimulate T and NK cells. In the safety population (n=78), the majority of patients (98.7%) experienced at least one treatment-emergent adverse event (TEAE). Grade 3/4 TEAEs were primarily hematologic with neutropenia (89.7%), thrombocytopenia (42.3%) and anemia (32.1%) being the most common. Any grade febrile neutropenia was reported in 21.8% of patients. Median relative dose intensity of key R-CHOP components was maintained at >90%. CC-99282-NHL-001 A separate poster detailed the efficacy and safety results from the dose expansion segment of a Phase 1/2 open-label study of two doses of golcadomide (0.2 mg, 0.4 mg) plus rituximab in relapsed/refractory patients with non-Hodgkin lymphoma. Patients were heavily pre-treated with a median number of 4 prior therapies (range 1-11), including 61% who had prior CAR T. In patients evaluable for efficacy (n=26), the ORR was 42% (11/26) with 19% (5/26) achieving a complete response (CR). The median duration of response was 7.5 months (1.8-14.5). The ORR and CR rate was greater for patients in the 0.4 mg arm compared to the 0.2 arm (55% vs. 33% and 27% vs. 13%, respectively). In the study, neutropenia was the most common TEAE of any grade, occurring in 50% of patients (22/44). Febrile neutropenia was observed in 2 patients, with 1 patient at each dose level. A total of 6 patients had serious adverse events with only pneumonia and pyrexia occurring in more than 1 patient (2 each). There were 4 deaths on treatment during the study with one considered related to the study treatment. About Non-Hodgkin Lymphoma and Large B-Cell Lymphoma Non-Hodgkin lymphoma (NHL) is a cancer that starts in white blood cells called lymphocytes, which are part of the body’s immune system.1 Diffuse large B-cell lymphoma (DLBCL) is a rapidly growing, aggressive disease and the most common form of non-Hodgkin lymphoma (NHL), accounting for one out of every three cases diagnosed.2 More than two-thirds of patients with DLBCL will not respond to or will relapse following second-line treatment. For patients who relapse or do not respond to initial therapies, conventional treatment options that provide durable remission are limited and median life expectancy is about six months, leaving a critical need for new therapies.3,4 Bristol Myers Squibb: Creating a Better Future for People with Cancer Bristol Myers Squibb is inspired by a single vision — transforming patients’ lives through science. The goal of the company’s cancer research is to deliver medicines that offer each patient a better, healthier life and to make cure a possibility. Building on a legacy across a broad range of cancers that have changed survival expectations for many, Bristol Myers Squibb researchers are exploring new frontiers in personalized medicine and, through innovative digital platforms, are turning data into insights that sharpen their focus. Deep understanding of causal human biology, cutting-edge capabilities and differentiated research platforms uniquely position the company to approach cancer from every angle. Cancer can have a relentless grasp on many parts of a patient’s life, and Bristol Myers Squibb is committed to taking actions to address all aspects of care, from diagnosis to survivorship. As a leader in cancer care, Bristol Myers Squibb is working to empower all people with cancer to have a better future. About Bristol Myers Squibb Bristol Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information about Bristol Myers Squibb, visit us at BMS.com or follow us on LinkedIn, Twitter, YouTube, Facebook and Instagram. Cautionary Statement Regarding Forward-Looking Statements This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 regarding, among other things, the research, development and commercialization of pharmaceutical products. All statements that are not statements of historical facts are, or may be deemed to be, forward-looking statements. Such forward-looking statements are based on current expectations and projections about our future financial results, goals, plans and objectives and involve inherent risks, assumptions and uncertainties, including internal or external factors that could delay, divert or change any of them in the next several years, that are difficult to predict, may be beyond our control and could cause our future financial results, goals, plans and objectives to differ materially from those expressed in, or implied by, the statements. These risks, assumptions, uncertainties and other factors include, among others, that future study results may not be consistent with the results to date, that the product candidates described in this release may not receive regulatory approval for the indications described in this release, that any marketing approvals, if granted, may have significant limitations on their use, and, if approved, whether such product candidates for such indications will be commercially successful. No forward-looking statement can be guaranteed. Forward-looking statements in this press release should be evaluated together with the many risks and uncertainties that affect Bristol Myers Squibb’s business and market, particularly those identified in the cautionary statement and risk factors discussion in Bristol Myers Squibb’s Annual Report on Form 10-K for the year ended December 31, 2022, as updated by our subsequent Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other filings with the Securities and Exchange Commission. The forward-looking statements included in this document are made only as of the date of this document and except as otherwise required by applicable law, Bristol Myers Squibb undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, changed circumstances or otherwise. References American Cancer Society. What is non-Hodgkin lymphoma? Available at: . Accessed November 2023. American Cancer Society. Types of B cell lymphoma. Available at: . Accessed March 2022. Crump M, Neelapu SS, Farooq U et al. Outcomes in refractory diffuse large B-cell lymphoma: results from the international SCHOLAR-1 study. Blood. 2017; 130(16): 1800-1808. Raut LS, Chakrabarti PP. Management of relapsed-refractory diffuse large B cell lymphoma. South Asian J Can. 2014; 3(1): 66-70. corporatefinancial-news View source version on businesswire.com: Contacts Bristol Myers Squibb Media Inquiries: media@bms.com Investors: investor.relations@bms.com Source: Bristol Myers Squibb View this news release online at:

Clinical ResultPhase 1ASHCell TherapyAACR

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R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Follicular Lymphoma	Phase 3	United States	Celgene Corp.	08 Jul 2025
Follicular Lymphoma	Phase 3	China	Celgene Corp.	08 Jul 2025
Follicular Lymphoma	Phase 3	Australia	Celgene Corp.	08 Jul 2025
Follicular Lymphoma	Phase 3	Brazil	Celgene Corp.	08 Jul 2025
Follicular Lymphoma	Phase 3	Canada	Celgene Corp.	08 Jul 2025
Follicular Lymphoma	Phase 3	Chile	Celgene Corp.	08 Jul 2025
Follicular Lymphoma	Phase 3	Finland	Celgene Corp.	08 Jul 2025
Follicular Lymphoma	Phase 3	France	Celgene Corp.	08 Jul 2025
Follicular Lymphoma	Phase 3	Germany	Celgene Corp.	08 Jul 2025
Follicular Lymphoma	Phase 3	Greece	Celgene Corp.	08 Jul 2025

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04884035 (CC-220-DLBCL-001, ASH2024)	Phase 1	B-Cell Lymphoma Ikaros/Aiolos \| ctDNA \| p53 mutant ... View more	-	GOLCA 0.2 mg	flttspxsmi(ymxuewhxgd) = cosetudmrr exbnvsstwx (voobfngiol ) View more	Positive	08 Dec 2024
NCT04884035 (CC-220-DLBCL-001, ASH2024)	Phase 1		-	GOLCA 0.4 mg	flttspxsmi(ymxuewhxgd) = qlsibzjsyv exbnvsstwx (voobfngiol ) View more	Positive	08 Dec 2024
ASH2024	Not Applicable	Follicular Lymphoma	-	GOLCA mono	ejdhltwzqg(uzroqflfep) = The most frequent grade (G) 3+ TEAEs were neutropenia (44%) and anemia (12%). The incidence of febrile neutropenia was 7%. Serious adverse events occurred in 30% of pts, with febrile neutropenia and pneumonia being the most common, in 2 pts (5%) each, as well as pulmonary embolism in 1 pt. Neutropenia led to GOLCA dose interruption in 4 pts (9%) and dose reduction in 1 pt. No pts discontinued treatment because of GOLCA-related TEAEs. Non-hematological TEAEs (e.g., GI toxicity, rash, fatigue) were all low-grade (except 1 pt with G3 fatigue). There were no new safety signals identified for GOLCA mono (part A) at the 30-mo follow up period. tixghnkikc (zududfyvju ) View more	-	08 Dec 2024
ASH2024	Not Applicable	Follicular Lymphoma	-	GOLCA + RTX 0.2 mg		-	08 Dec 2024
NCT04884035 (CC-220-DLBCL-001, SOHO2024)	Phase 1	B-Cell Lymphoma First line lactate dehydrogenase	78	GOLCA+R-CHOP	uirklifgjq(rgsimsxmlz) = 87% cqbqmwizly (gcypwapzwe ) View more	Positive	04 Sep 2024
NCT03930953 (CC-99282-NHL-001, EHA2024) Manual	Phase 1/2	Follicular Lymphoma lenalidomide (LEN)	31	Golcadomide monotherapy	epofhrugtw(swzcpqxqkc) = In the combo-treated safety population, neutropenia was the most common any-grade treatment-related adverse event (TRAE) related to GOLCA, occurring in 10 (59%) pts, including 8 (47%) grade 3/4. Febrile neutropenia occurred in 1 (6%) pt; G-CSF were used in 11 (65%) pts. Two (12%) serious TRAEs were reported (pleural effusion and pulmonary embolism, n=1 each in the 0.2 mg group). No grade 5 treatment-emergent AEs (TEAE) occurred. TEAEs led to GOLCA discontinuation in 1 (6%) pt (pulmonary embolism). mbtkezabve (cmdxqatcaz )	Positive	13 Jun 2024
NCT03930953 (CC-99282-NHL-001, EHA2024) Manual	Phase 1/2	Follicular Lymphoma lenalidomide (LEN)	31	Golcadomide+Rituximab		Positive	13 Jun 2024
NCT04884035 (CC-220-DLBCL-001, EHA 12024 \| EHA 22024) Manual	Phase 1	B-Cell Lymphoma First line	78	GOLCA+R-CHOP	taskiwhirb(nlrhpffsqe) = nxyqastksj hmtlyzzteg (akgsuywmpd ) View more	Positive	14 May 2024
NCT03930953 (CC-99282-NHL-001, ASH2023)	Phase 1/2	Non-Hodgkin's lymphoma refractory	35	Golcadomide	foludubrwa(qmpcabtzre) = fehbyayaoz monkesxxpp (ilfliakcoc ) View more	-	11 Dec 2023
ASH2023	Phase 1	B-Cell Lymphoma	78	GOLCA plus R-CHOP	karyjhufzy(fjsspkcaeu) = eravetcgxk xugxxrvotu (wtbzlmmypo, 80.4 - 97.0) View more	-	11 Dec 2023
ASH2023	Phase 1	B-Cell Lymphoma	-	Golcadomide (CC-99282) + R-CHOP	hizfgcxozo(wnajytifnb) = fusjtjiwma gblkftesua (noaphidhgu )	-	09 Dec 2023
NCT03930953 (CC-99282-NHL-001, ICML2023)	Phase 1/2	Recurrent Follicular Lymphoma \| Recurrent Non-Hodgkin Lymphoma \| Non-Hodgkin Lymphoma ... View more	50	CC-99282 monotherapy	gayotnilxa(slwzmkheff) = Severe AEs included fever (n = 2), and dyspnoea and fatigue (n = 1 each) sdejgnwzcm (wdrwwkghre ) View more	Positive	09 Jun 2023
NCT03930953 (CC-99282-NHL-001, ICML2023)	Phase 1/2		50	CC-99282 + Rituximab		Positive	09 Jun 2023
NCT03930953 (CC-99282-NHL-001, EHA2022) Manual	Phase 1	Non-Hodgkin Lymphoma	50	CC-99282	jnwpwaoqdi(eulmkvpyuk) = All dose-limiting toxicities were hematologic. puofuhveqx (cgmedvjgvi ) View more	Positive	12 May 2022

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