[Translation] A multicenter phase I/II clinical study evaluating the safety and efficacy of anti-CD74 antibody-drug conjugate BN301 in patients with advanced B-cell non-Hodgkin's lymphoma

Ⅰ期阶段主要目的：1. 评价BN301在晚期B细胞NHL患者中的安全性特征。2. 确定BN301在晚期B细胞非霍奇金淋巴瘤（NHL）患者中的最大耐受剂量（MTD）或II期临床研究推荐剂量（RP2D） Ⅱ期阶段主要目的：评价BN301在DLBCL（队列A）以及其他B细胞NHL（队列B）受试者中的抗肿瘤活性（ORR）

[Translation]

The main objectives of the Phase I stage: 1. Evaluate the safety characteristics of BN301 in patients with advanced B-cell NHL. 2. Determine the maximum tolerated dose (MTD) or recommended dose for Phase II clinical studies (RP2D) of BN301 in patients with advanced B-cell non-Hodgkin lymphoma (NHL) The main objectives of the Phase II stage: Evaluate the anti-tumor activity (ORR) of BN301 in subjects with DLBCL (cohort A) and other B-cell NHL (cohort B)

Start Date16 Dec 2022

Sponsor / Collaborator

BioNova Pharmaceuticals (Shanghai) Ltd.Startup

[+2]

NCT05611853

/ TerminatedPhase 1/2

A Multicenter Phase 1/2 Clinical Study to Evaluate the Safety and Efficacy of BN301，An Anti-CD74 Antibody Drug Conjugate, in Patients With Advanced B-cell Non-Hodgkin's Lymphoma

Phase 1/2 trial to study the safety, pharmacokinetics and preliminary efficacy of BN301 given intravenously every 3 weeks.

Start Date25 Nov 2022

Sponsor / Collaborator

BioNova Pharmaceuticals (Shanghai) Ltd.Startup

NCT03424603

/ CompletedPhase 1

A Phase 1 Open-Label, Safety, Pharmacokinetic and Preliminary Efficacy Study of STRO-001, an Anti-CD74 Antibody Drug Conjugate, in Patients With Advanced B-Cell Malignancies

First-in-human Phase 1 trial to study the safety, pharmacokinetics and preliminary efficacy of STRO-001 given intravenously every 3 weeks.

Start Date22 Feb 2018

Sponsor / Collaborator

Sutro Biopharma, Inc.

100 Clinical Results associated with Bezetabart debotansine

100 Translational Medicine associated with Bezetabart debotansine

100 Patents (Medical) associated with Bezetabart debotansine

290

Literatures (Medical) associated with Bezetabart debotansine

01 Jan 2025·CHROMATOGRAPHIA

An UPLC Method for Determination of Structural Analogues of DM1: the Payload of Trastuzumab Emtansine (T-DM1)

Author: Yin, Daquan ; Yao, Junliang ; Zhu, Yang

Abstract: DM1, a derivative of maytansine, is the payload of trastuzumab emtansine (T-DM1).In this work, a new gradient reverse-phase ultra-performance chromatog. (RP-UPLC) method was proposed for anal. of five structural analogs (DM1-2, AP-3, DM1-4D, DM1-3D, and DM1-3L) of DM1.The chromatog. separation was accomplished by using a Waters BEH Ph column (50 x 2.1 mm, 1.7 μm), at the wavelength of 252 nm.Validation of the method was carried out according the ICH guidelines in terms of specificity, accuracy, precision, linearity and robustness.The developed method was proved to be convenient and reliable for quant. determination of the DM1 analog impurities.It can also be used for the related substances determination in DM1 bulk samples.

01 Dec 2024·Advanced Biology

Assessing Novel Antibody‐Based Therapies in Reconstructive 3D Cell Models of the Tumor Microenvironment

Article

Author: Trindade, Gonçalo ; Ramella Gal, Isabella ; Domenici, Giacomo ; Freitas, Catarina ; Duarte, Nádia ; Lopes, Nuno F. ; Brito, Catarina ; Rebelo, Sofia P. ; Miret Minard, Joan

Abstract:

Targeted, combinatorial, and immunomodulatory therapies, such as antibody‐drug conjugates (ADCs) and immunomodulatory antibodies (Abs), are powerful weapons against tumor cells and immune cells within the tumor microenvironment (TME). Therefore, the evaluation of such therapies should be conducted in pre‐clinical models able to recapitulate the complex cellular and molecular crosstalk of the TME. To build‐in critical hallmarks of the TME, a breast cancer heterotypic 3D cell model (3D‐3) is devised using a microencapsulation strategy with an inert biomaterial (alginate) and agitation‐based cultures. Both stromal and immune components are added to multicellular tumor spheroids, therefore fostering cancer‐associated fibroblasts (CAFs) and tumor‐associated macrophages (TAMs) immunomodulatory interactions. The potential of the methodology to assess Ab‐based therapies is then addressed by employing a series of anti‐HER2‐based ADCs. ADCs induced tumor‐cell specific cytotoxicity toward HER2+ breast cancer spheroids while sparing HER2‐negative CAFs. In addition, an immunomodulatory blocking Ab against colony‐stimulating factor 1 receptor (CSF1R) decreases the expression of immunosuppressive and anti‐inflammatory markers in TAMs, like what is previously observed upon in vivo α‐CSF1R administration. Collectively, the human TME‐based 3D‐3 cell model is a suitable tool to evaluate the anti‐tumor and immunomodulatory potential of novel antibody‐based therapies directed against TME targets, such as cancer cells and macrophages.

20 Nov 2024·BIOCONJUGATE CHEMISTRY

eSOMA-DM1, a Maytansinoid-Based Theranostic Small-Molecule Drug Conjugate for Neuroendocrine Tumors

Article

Author: Beekman, Savanne ; de Ridder, Corrina ; Li, Le ; Stuurman, Debra ; Piet, Amber ; Seimbille, Yann ; Chapeau, Dylan

Background: The main challenges of conventional chemotherapy lie in its lack of selectivity and specificity, leading to significant side effects. Using a small-molecule drug conjugate (SMDC) ensures specific delivery of a cytotoxic drug to the tumor site by coupling it to a targeting vector. This promising strategy can be applied to neuroendocrine tumors (NETs) by choosing a targeting vector that binds specifically to somatostatin receptor subtype 2 (SSTR2). Additionally, incorporation of a bifunctional chelate into the molecule enables complexation of both diagnostic and therapeutic radionuclides. Thus, it facilitates monitoring of the distribution of the SMDC in the body and allows for the implementation of combination therapy. In our study, we designed eSOMA-DM1, a SMDC combining the SSTR2-targeted octreotate peptide and the cytotoxic agent DM1 via a chelate-bridged linker (N₃-Py-DOTAGA). This approach warrants conjugation of the targeting vector and the drug at opposite sites to avoid undesired steric hindrance effects. Methods: Synthesis of the DM1 moiety (4) involved a three-step synthetic route, followed by the conjugation to the cyclic peptide, N₃-Py-DOTAGA-d-Phe-cyclo[Cys-Tyr-d-Trp-Lys-Thr-Cys]-Thr-OH, through a copper-free click reaction, resulting in eSOMA-DM1. Subsequent labeling with [¹¹¹In]InCl₃ gave a high radiochemical yield and purity. In vitro assessments of eSOMA-DM1 binding, uptake, and internalization were conducted in SSTR2-transfected U2OS cells. Ex vivo biodistribution and fluorescence imaging were performed in H69-tumor bearing mice. Results: eSOMA-DM1 exhibited an IC₅₀ value for SSTR2 similar to the gold standard DOTA-TATE. The uptake of [¹¹¹In]In-eSOMA-DM1 in U2OS.SSTR2 cells was 1.2-fold lower than that of [¹¹¹In]In-DOTA-TATE. Tumor uptake in H69-xenografted mice was higher for [¹¹¹In]In-eSOMA-DM1 at all-time points compared to [¹¹¹In]In-DOTA-TATE. Prolonged blood circulation led to increased accumulation of [¹¹¹In]In-eSOMA-DM1 in highly vascularized tissues, such as the lungs, skin, and heart. Excretion through the kidneys, liver, and spleen was also observed. Conclusion: eSOMA-DM1 is a SMDC developed for NET showing promising characteristics in vitro. However, the in vivo results obtained with [¹¹¹In]In-eSOMA-DM1 suggest the need for adjustments to optimize its distribution.

News (Medical) associated with Bezetabart debotansine

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

22 Nov 2024

·www.businesswire.com

B-cell Lymphoma Pipeline Insight 2024, with Comprehensive Insights for 295+ Companies and 300+ Pipeline Drugs - ResearchAndMarkets.com

DUBLIN--( BUSINESS WIRE )--The "B-cell Lymphoma - Pipeline Insight, 2024" clinical trials has been added to ResearchAndMarkets.com's offering. This "B-cell Lymphoma- Pipeline Insight, 2024" report provides comprehensive insights about 295+ companies and 300+ pipeline drugs in B-cell Lymphoma pipeline landscape. It covers the pipeline drug profiles, including clinical and nonclinical stage products. It also covers the therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space. Report Highlights The companies and academics are working to assess challenges and seek opportunities that could influence B-cell Lymphoma R&D. The therapies under development are focused on novel approaches to treat/improve B-cell Lymphoma. B-cell Lymphoma Emerging Drugs Chapters This segment of the B-cell Lymphoma report encloses its detailed analysis of various drugs in different stages of clinical development, including phase III, II, II/III I, preclinical and Discovery. It also helps to understand clinical trial details, expressive pharmacological action, agreements and collaborations, and the latest news and press releases. B-cell Lymphoma: Therapeutic Assessment This segment of the report provides insights about the different B-cell Lymphoma drugs segregated based on following parameters that define the scope of the report, such as: Major Players in B-cell Lymphoma There are approx. 295+ key companies which are developing the therapies for B-cell Lymphoma. The companies which have their B-cell Lymphoma drug candidates in the most advanced stage, i.e. Phase III include, Denovo BioPharma. The report covers 300+ products under different phases of clinical development like: Late stage products (Phase III) Mid-stage products (Phase II) Early-stage product (Phase I) along with the details of Pre-clinical and Discovery stage candidates Discontinued & Inactive candidates Route of Administration B-cell Lymphoma pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs such as Intravenous Subcutaneous Oral Intramuscular Molecule Type Products have been categorized under various Molecule types such as Monoclonal antibody Small molecule Peptide Product Type Drugs have been categorized under various product types like Mono, Combination and Mono/Combination. B-cell Lymphoma: Pipeline Development Activities The report provides insights into different therapeutic candidates in phase II, I, preclinical and discovery stage. It also analyses B-cell Lymphoma therapeutic drugs key players involved in developing key drugs. Pipeline Development Activities The report covers the detailed information of collaborations, acquisition and merger, licensing along with a thorough therapeutic assessment of emerging B-cell Lymphoma drugs. B-cell Lymphoma Report Insights B-cell Lymphoma Pipeline Analysis Therapeutic Assessment Unmet Needs Impact of Drugs B-cell Lymphoma Report Assessment Pipeline Product Profiles Therapeutic Assessment Pipeline Assessment Inactive drugs assessment Unmet Needs Key Questions Current Treatment Scenario and Emerging Therapies: How many companies are developing B-cell Lymphoma drugs? How many B-cell Lymphoma drugs are developed by each company? How many emerging drugs are in mid-stage, and late-stage of development for the treatment of B-cell Lymphoma? What are the key collaborations (Industry-Industry, Industry-Academia), Mergers and acquisitions, licensing activities related to the B-cell Lymphoma therapeutics? What are the recent trends, drug types and novel technologies developed to overcome the limitation of existing therapies? What are the clinical studies going on for B-cell Lymphoma and their status? What are the key designations that have been granted to the emerging drugs? Key Players Lisocabtagene maraleucel Hoffmann-La Roche Nektar Therapeutics Miltenyi Biomedicine AVM Biotechnology Lin BioScience Incyte Corporation ADC Therapeutics Genor Biopharma Beijing InnoCare Pharma Tech Co., Ltd. CARGO Therapeutics Chia Tai Tianqing Pharmaceutical Group Co., Ltd. SystImmune LIBO PHARMA Abclon BeiGene Cellectis Iovance Biotherapeutics, Inc. Guangzhou Excelmab Y-mAbs Therapeutics TG Therapeutics Sutro Biopharma AbbVie Aleta Biotherapeutics Janssen Research & Development Lantern Pharma Beijing Immunochina Medical Science and Technology Bantam Pharmaceutical Lin Bioscience SFA Therapeutics neoX Biotech March Biosciences HUTCHMED Key Products Bristol Myers Squibb Glofitamab NKTR-255 Zamtocabtagene autoleucel MB-CART20.1 AVM0703 LBS-007 Parsaclisib Loncastuximab tesirine GB-241 ICP-248 CRG-022 TQB3702 GNC-038 NM-IL-12 AT101 BGB-16673 UCART20x22 IOV-2001 EX103 CD38-SADA TG-1801 STRO-001 ABBV-319 ALETA-001 JNJ-80948543 LP-284 INS19 CAR-T Cells BTM 3566 LBS-007 SFA-001 NXD07 MB-105 HMPL A067 For more information about this clinical trials report visit https://www.researchandmarkets.com/r/qxd94m About ResearchAndMarkets.com ResearchAndMarkets.com is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.

Phase 2ASCOCell TherapyPhase 1

19 Sep 2023

·www.globenewswire.com

Sutro Biopharma Appoints Dr. Hans-Peter Gerber as Chief Scientific Officer

SOUTH SAN FRANCISCO, Calif., Sept. 19, 2023 (GLOBE NEWSWIRE) -- Sutro Biopharma, Inc. (Sutro or the Company) (NASDAQ: STRO), a clinical-stage oncology company pioneering site-specific and novel-format antibody drug conjugates (ADCs), today announced the appointment of Hans-Peter Gerber, Ph.D., as Chief Scientific Officer, effective September 18, 2023. Dr. Gerber brings over 25 years of drug discovery and development experience to Sutro, with extensive scientific background and expertise in ADCs, targeted oncology, and novel biotherapeutic platforms. “Dr. Gerber’s deep experience in the development of ADCs and other novel therapeutics make him an invaluable addition to our management team,” said Bill Newell, Sutro’s Chief Executive Officer. “With a demonstrated track record from target identification and selection of lead compounds to IND and subsequent regulatory filings, he is the ideal CSO for Sutro. As we continue to develop our pipeline, Dr. Gerber is well-positioned to execute on our goal of continuing to identify, design, and develop next-generation cancer drugs that will rapidly progress into the clinic.” “I was impressed by Sutro’s unique ability to design and manufacture precise targeted molecules, addressing current challenges in the development of biotherapeutics, as well as its already promising pipeline,” said Dr. Gerber. “It is an honor to join such a talented team and to have the chance to transform the lives of cancer patients by discovering and developing innovative treatments.” Dr. Gerber began his Biotech career at Genentech in the Department of Molecular Oncology, followed by various management roles at Seattle Genetics and Pfizer. He has a strong track record in leading cross-functional teams, innovative discovery and translational medicine, and contributions to IND filings and BLA submissions. Prior to joining Sutro, Dr. Gerber served as Chief Scientific Officer at Codeable Therapeutics, an ADC startup company focusing on the development of next generation ADCs that induce immunogenic cell death. Previously, he held executive roles at 3T Biosciences and Maverick Therapeutics. He has also served as an advisor for various Biotech startups, VCs, and Pharma companies and is currently a Board member at Athebio AG and Chairman of the Board at T-CURX. With over 100 peer-reviewed publications and 100 issued patents, he has an impressive record of high scientific achievement. He received an MS in Biochemistry and a PhD in Molecular Biology from the University of Zurich, Switzerland. Inducement Grants Under Nasdaq Listing Rule 5635(c)(4) In connection with Dr. Gerber’s appointment as Chief Scientific Officer, the Compensation Committee of Sutro’s Board of Directors granted to Dr. Gerber 175,000 shares of Sutro stock options and 150,000 restricted stock units (RSUs) of Sutro common stock. These grants were made as an inducement material to the Dr. Gerber’s acceptance of employment with Sutro and were approved by the Compensation Committee of Sutro’s Board of Directors in accordance with Nasdaq Listing Rule 5635(c)(4). The RSUs and stock options are subject to the terms and conditions of Sutro’s 2021 Equity Inducement Plan. One-fourth of the total number of shares subject to the RSUs will vest on the one-year anniversary of the Dr. Gerber’s hire date and annually thereafter until fully vested on the fourth anniversary, subject to Dr. Gerber’s continued service with Sutro on each such vesting date. One-fourth of the total number of shares underlying the stock options will vest on the one-year anniversary of Dr. Gerber’s hire date and 1/48th of the total number of shares underlying the stock options will vest each month thereafter until fully vested on the fourth anniversary of Dr. Gerber’s hire date, subject to Dr. Gerber’s continued service with Sutro on each such vesting date. The stock options have a term of ten years and an exercise price equal to the closing price of Sutro’s common stock on the grant date as reported by The Nasdaq Stock Market. About Sutro Biopharma Sutro Biopharma, Inc., is a clinical-stage company developing next-generation cancer therapeutics, principally antibody-drug conjugates (ADCs), designed for greater potency, tolerability and improved safety. Sutro’s cell-free technology, XpressCF®, enables the design and manufacture of homogeneous product candidates with precise and empirically-demonstrated positioning of linker-payloads and consistent drug antibody ratio (DAR). Sutro’s platform has produced six clinical stage candidates to date, including two wholly-owned ADCs—luveltamab tazevibulin, or luvelta, a folate receptor alpha (FolRα)-targeting ADC in clinical studies for ovarian and endometrial cancers, as well as STRO-001, a CD74-targeting ADC in clinical studies for B-cell malignancies. In addition, the Company has a robust pipeline of preclinical and discovery stage candidates including STRO-003, a ROR1-targeting ADC, and STRO-004, a tissue factor-targeting ADC. Sutro has also entered into high-value collaborations with industry partners, including Astellas and Merck (MSD outside of the United States and Canada); and Sutro’s platform technology enabled the formation of Vaxcyte. Sutro is headquartered in South San Francisco. For more information, follow Sutro on Twitter, @Sutrobio, or visit www.sutrobio.com. Forward-Looking Statements This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to, anticipated preclinical and clinical development activities, timing of announcements of clinical results, trial initiation, and regulatory filings, potential benefits of luvelta and the Company’s other product candidates and platform, potential future milestone and royalty payments, and potential market opportunities for luvelta and the Company’s other product candidates. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. Although the Company believes that the expectations reflected in such forward-looking statements are reasonable, the Company cannot guarantee future events, results, actions, levels of activity, performance or achievements, and the timing and results of biotechnology development and potential regulatory approval is inherently uncertain. Forward-looking statements are subject to risks and uncertainties that may cause the Company’s actual activities or results to differ significantly from those expressed in any forward-looking statement, including risks and uncertainties related to the Company’s ability to advance its product candidates, the receipt and timing of potential regulatory designations, approvals and commercialization of product candidates and the Company’s ability to successfully leverage Fast Track designation, the market size for the Company’s product candidates to be smaller than anticipated, the impact of the COVID-19 pandemic on the Company’s business, clinical trial sites, supply chain and manufacturing facilities, the Company’s ability to maintain and recognize the benefits of certain designations received by product candidates, the timing and results of preclinical and clinical trials, the Company’s ability to fund development activities and achieve development goals, the Company’s ability to protect intellectual property, the value of the Company’s holdings of Vaxcyte common stock, and the Company’s commercial collaborations with third parties and other risks and uncertainties described under the heading “Risk Factors” in documents the Company files from time to time with the Securities and Exchange Commission. These forward-looking statements speak only as of the date of this press release, and the Company undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date hereof. ContactEmily WhiteSutro Biopharma (650) 823-7681ewhite@sutrobio.com

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Indication	Highest Phase	Country/Location	Organization	Date
Diffuse Large B-Cell Lymphoma	Phase 2	China	BioNova Pharmaceuticals (Shanghai) Ltd.Startup	25 Nov 2022
Follicular Lymphoma	Phase 2	China	BioNova Pharmaceuticals (Shanghai) Ltd.Startup	25 Nov 2022
Mantle-Cell Lymphoma	Phase 2	China	BioNova Pharmaceuticals (Shanghai) Ltd.Startup	25 Nov 2022
Hematologic Neoplasms	Phase 1	China	BioNova Pharmaceuticals (Shanghai) Ltd.Startup	07 Sep 2022
Multiple Myeloma	Phase 1	United States	Sutro Biopharma, Inc.	22 Feb 2018

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03424603 (ASH 12020 \| ASH 22020) Manual	Phase 1	B-Cell Lymphoma	18	STRO-001	rblinbujzb(majoizqywx) = chills, fatigue, nausea, anemia, headache, pyrexia, infusion reaction, decreased appetite, and abdominal pain occurring in ≥ 20% of patients. dkxlhhlwud (ocfrykyznp ) View more	Positive	05 Nov 2020
STRO-001 (ICML2017)	Not Applicable	Non-Hodgkin Lymphoma CD74	-	STRO-001	oydszfyctl(axvqmkwdxy) = Myelosuppression was observed at the highest dose, with no off-target toxicity vmqsyrdjgd (pideplslsa ) View more	Positive	07 Jun 2017

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