CD19 inhibitors(B-lymphocyte antigen CD19 inhibitors), CD3D agonists(CD3 delta subunit of T-cell receptor complex agonists), CD3ε agonists(CD3e molecule agonists)

Therapeutic Areas

NeoplasmsImmune System DiseasesInfectious Diseases+ [2]

Active Indication

Follicular LymphomaDiffuse large B-cell lymphoma refractoryRefractory Mature B-Cell Non-Hodgkin Lymphoma+ [11]

Inactive Indication-

Originator Organization

TeneoBio, Inc.

Active Organization

AstraZeneca PLCAstraZeneca AB

Inactive Organization-

Drug Highest PhasePhase 3

First Approval Date-

Regulation-

Gene Sequence

Sequence Code 524306457L

Source: *****

Sequence Code 631408146H

Source: *****

Sequence Code 931729386H

Source: *****

Clinical Trials associated with Surovatamig

NCT06526793 / RecruitingPhase 2

A Modular Phase 2, Single-arm, Multicenter, Open-label Study to Evaluate the Efficacy and Safety of AZD0486 in Participants With Relapsed or Refractory (R/R) B-cell Non-Hodgkin Lymphoma (SOUNDTRACK-B)

This is a Phase 2 global, multi-center, open-label study to assess the efficacy, safety and tolerability of AZD0486 monotherapy in adult participants with relapsed/refractory B-cell non-Hodgkin lymphoma (NHL) who have received at least two prior lines of therapies. The study has 2 Modules: Module 1 for FL and Module 2 for DLBCL.

Start Date27 Nov 2024

Sponsor / Collaborator

AstraZeneca PLC

CTR20243136 / RecruitingPhase 1/2

一项评价AZD0486在复发性或难治性B细胞急性淋巴细胞白血病青少年和成人受试者中的安全性和有效性的I/II期研究

[Translation] A Phase I/II study evaluating the safety and efficacy of AZD0486 in adolescent and adult subjects with relapsed or refractory B-cell acute lymphoblastic leukemia

A部分剂量递增：评估AZD0486在16~80岁（含）Ph（+）或Ph（-）R/R B-ALL受试者中的安全性和耐受性。 B部分剂量优化：根据NCCN疗效标准评价AZD0486的初步有效性；评估AZD0486在12~80岁（含）R/R Ph（-）B-ALL受试者中的安全性和耐受性。 C部分有效性扩展：根据NCCN疗效标准评价AZD0486的有效性。

[Translation]

Part A: Dose escalation: Evaluate the safety and tolerability of AZD0486 in subjects with Ph(+) or Ph(-) R/R B-ALL aged 16-80 years (inclusive). Part B: Dose optimization: Evaluate the preliminary efficacy of AZD0486 according to NCCN efficacy criteria; Evaluate the safety and tolerability of AZD0486 in subjects with R/R Ph(-) B-ALL aged 12-80 years (inclusive). Part C: Efficacy extension: Evaluate the efficacy of AZD0486 according to NCCN efficacy criteria.

Start Date12 Oct 2024

Sponsor / Collaborator

AstraZeneca Global R&D (China) Co., Ltd.

[+2]

NCT06564038 / Not yet recruitingPhase 1/2

A Phase I/II Open-Label Multi-Centre Master Protocol to Evaluate the Safety and Efficacy of AZD0486 Monotherapy or in Combination With Other Anticancer Agents in Participants With Mature B-Cell Malignancies

The purpose of this study is to assess the safety and efficacy of AZD0486 administered as monotherapy or in combination with other anticancer agents in participants with hematological malignancies.

Start Date13 Sep 2024

Sponsor / Collaborator

AstraZeneca PLC

100 Clinical Results associated with Surovatamig

100 Translational Medicine associated with Surovatamig

100 Patents (Medical) associated with Surovatamig

Literatures (Medical) associated with Surovatamig

01 Jan 2021·mAbsQ2 · MEDICINE

TNB-486 induces potent tumor cell cytotoxicity coupled with low cytokine release in preclinical models of B-NHL

Q2 · MEDICINE

Article

Author: Harris, Katherine E. ; Buelow, Benjamin ; Boudreau, Andrew A. ; Schellenberger, Ute ; Van Schooten, Wim ; Ugamraj, Harshad S. ; Davison, Laura M. ; Iyer, Suhasini ; Prabhakar, Kirthana ; Malik-Chaudhry, Harbani K. ; Pham, Duy ; Ogana, Heather ; Jorgensen, Brett ; Dang, Kevin ; Buelow, Roland ; Trinklein, Nathan D. ; Rangaswamy, Udaya S.

The therapeutic potential of targeting CD19 in B cell malignancies has garnered attention in the past decade, resulting in the introduction of novel immunotherapy agents. Encouraging clinical data have been reported for T cell-based targeting agents, such as anti-CD19/CD3 bispecific T-cell engager blinatumomab and chimeric antigen receptor (CAR)-T therapies, for acute lymphoblastic leukemia and B cell non-Hodgkin lymphoma (B-NHL). However, clinical use of both blinatumomab and CAR-T therapies has been limited due to unfavorable pharmacokinetics (PK), significant toxicity associated with cytokine release syndrome and neurotoxicity, and manufacturing challenges. We present here a fully human CD19xCD3 bispecific antibody (TNB-486) for the treatment of B-NHL that could address the limitations of the current approved treatments. In the presence of CD19+ target cells and T cells, TNB-486 induces tumor cell lysis with minimal cytokine release, when compared to a positive control. In vivo, TNB-486 clears CD19+ tumor cells in immunocompromised mice in the presence of human peripheral blood mononuclear cells in multiple models. Additionally, the PK of TNB-486 in mice or cynomolgus monkeys is similar to conventional antibodies. This new T cell engaging bispecific antibody targeting CD19 represents a novel therapeutic that induces potent T cell-mediated tumor-cell cytotoxicity uncoupled from high levels of cytokine release, making it an attractive candidate for B-NHL therapy.

News (Medical) associated with Surovatamig

08 Dec 2024

·endpts.com

AstraZeneca reveals first clinical data for bispecific T cell engager from TeneoTwo buyout

SAN DIEGO — AstraZeneca is getting ready to step on the gas in the world of bispecific T cell engagers. The company presented some of its first Phase 1 data for its CD3xCD19 bispecific known as AZD0486 — which is being tested in multiple B cell malignancies — at the American Society of Hematology’s annual meeting this weekend. Data come from a larger study where AstraZeneca is testing the program against a broad range of blood cancers, where the company tested four dose levels. Researchers touted results in later-line follicular lymphoma and diffuse large B cell lymphoma (DLBCL). In 27 patients with follicular lymphoma who received any of the three highest doses, AZD0486 induced a 96% objective response rate and an 85% complete response rate, AstraZeneca said. Additionally, in the two middle dose levels, 17 of 19 patients achieved undetectable minimal residual disease — an endpoint where the FDA is proving increasingly receptive toward in other blood cancers — by 12 weeks. In DLBCL, a much harder disease to treat, the responses were less potent, according to last month’s abstract. At the dose expected to move into further studies, nine of 19 patients (47%) responded, with eight of 19 (42%) reaching a complete response. AstraZeneca is expected to break down additional DLBCL results in a presentation Monday evening Pacific time. But most promising about these data is how even patients who had previously taken CAR-T or anti-CD20 therapies were seeing responses, AstraZeneca’s executive VP for oncology R&D Susan Galbraith told Endpoints News . Among 14 individuals who progressed after CAR-T in the study at the target dose level, the ORR was 36% and the complete response rate was 29%. Patients whose cancers progress after taking CAR-T, in particular, have extremely limited treatment options, Galbraith said, but bispecifics as a whole appear to be emerging as a new alternative. “I think that bodes well, not just for an option for those patients, but also the potential for those to be really quite efficacious in the early lines of treatments as well,” she said. “We’ve got work to do to deliver all of that data, but so far, I’m quite excited about potential for this market.” AZD0486 came to AstraZeneca in its buyout of TeneoTwo, acquired in 2022 for up to $1.27 billion, including milestones (AstraZeneca paid only $100 million upfront). TeneoTwo is itself an offshoot from Teneobio, which spun it off after being bought by Amgen in 2021 for $900 million upfront and another $1.6 billion in milestones. The only other approved CD3xCD19 bispecific is Amgen’s Blincyto, which was first approved in 2014. Blincyto has since racked up half a dozen other approvals, but they’ve all come in different settings for acute lymphoblastic leukemia (ALL). In 2023, Amgen reported $861 million in worldwide Blincyto sales. Galbraith said the lack of other such drugs has given AstraZeneca the right opportunity to design their compound in a way where it can best take advantage of the market. There is still the potential for combination therapies, particularly for the DLBCL setting, that have yet to be explored in the clinic. Other companies have taken note recently, with a slew of CD19 bispecific deals announced in recent months. In August, Merck paid $700 million upfront for Curon Biopharmaceutical’s CD3xCD19 compound, and GSK spent $300 million upfront in October for a bispecific from Chimagen Biosciences to test it in autoimmune disease. But Galbraith also believes AZD0486 can be more efficacious, too. “I don’t think you get to the same level of exposure with [Blincyto] as we can achieve with this,” Galbraith said. “And it’s early days yet. But I’m encouraged by the profile that we’re seeing and the potential to have a better CD19 bispecific option for patients in ALL.”

Clinical ResultDrug ApprovalPhase 1AcquisitionImmunotherapy

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

100 Deals associated with Surovatamig

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Follicular Lymphoma	Phase 3	CN	AstraZeneca PLC	07 Aug 2024
Follicular Lymphoma	Phase 3	JP	AstraZeneca PLC	07 Aug 2024
Follicular Lymphoma	Phase 3	AU	AstraZeneca PLC	07 Aug 2024
Follicular Lymphoma	Phase 3	BE	AstraZeneca PLC	07 Aug 2024
Follicular Lymphoma	Phase 3	CA	AstraZeneca PLC	07 Aug 2024
Follicular Lymphoma	Phase 3	FI	AstraZeneca PLC	07 Aug 2024
Follicular Lymphoma	Phase 3	HK	AstraZeneca PLC	07 Aug 2024
Follicular Lymphoma	Phase 3	PL	AstraZeneca PLC	07 Aug 2024
Follicular Lymphoma	Phase 3	KR	AstraZeneca PLC	07 Aug 2024
Follicular Lymphoma	Phase 3	ES	AstraZeneca PLC	07 Aug 2024

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04594642 (ASH2024) Manual	Phase 1	Diffuse Large B-Cell Lymphoma	51	AZD0486 ≥2.4 mg	dpolmnmmhq(brkfxmcvns) = xqmhwqnngu cispstybyt (txpibsduxy ) View more	Positive	09 Dec 2024
NCT04594642 (ASH2024) Manual	Phase 1	Diffuse Large B-Cell Lymphoma	51	AZD0486 7.2 mg	dpolmnmmhq(brkfxmcvns) = kqguzecknm cispstybyt (txpibsduxy ) View more	Positive	09 Dec 2024
NCT04594642 (ASH2024) Manual	Phase 1	Follicular Lymphoma	47	AZD0486 ≤0.8 mg	-	Positive	07 Dec 2024
NCT04594642 (ASH2024) Manual	Phase 1	Follicular Lymphoma	47	AZD0486 2.4 mg	ebifosyamm(vmmsxvbcru) = iphzbonzss woosvprzyw (itvtjyvmld ) View more	Positive	07 Dec 2024
NCT04594642 (EHA2024) Manual	Phase 1	Recurrent Follicular Lymphoma \| Refractory Follicular Lymphoma \| B-cell lymphoma refractory ... CD19 Positive View more	29	AZD0486 0.8 mg	nhwfduckbz(myypzpbgtr) = gwvxboluxu nqxmerzkdd (erpdwzmcxr ) View more	Positive	14 May 2024
NCT04594642 (EHA2024) Manual	Phase 1		29	AZD0486 2.4 mg	nhwfduckbz(myypzpbgtr) = hqrxbnsntq nqxmerzkdd (erpdwzmcxr ) View more	Positive	14 May 2024
NCT04594642 (ASH2023)	Phase 1	B-Cell Lymphoma	62	AZD0486 (formerly TNB-486)	mdeknutmrp(gedfmejmei) = dzkdknmgxs vhxnlbhklj (wjqpsijdrw ) View more	-	09 Dec 2023
NCT04594642 (TNB-486, ICML2023)	Phase 1	Refractory Follicular Lymphoma CD19 \| CD3	17	TNB-486	dnlrccbgoe(ahehsysrba) = ekegnzzokr wwnmylktyo (wnvvrhdnfi ) View more	Positive	09 Jun 2023
NCT04594642 (EHA2023)	Phase 1	Refractory Follicular Lymphoma	17	TNB-486	yokbrbbauf(dgcnjzdnap) = juarebpvfq gpdnexbgek (xkugogudnz ) View more	-	08 Jun 2023
NCT04594642 (ASCO2023) Manual	Phase 1	Refractory Follicular Lymphoma	17	TNB-486	ixirrkyugu(azotawqcjk) = No G3+ CRS occurred (59% G1, 12% G2). jpanlmzwly (qoejazgbjo ) View more	Positive	26 May 2023

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