A Phase 2 Switch Maintenance Study of MRx0518 and Avelumab in Patients With Unresectable Locally Advanced or Metastatic Urothelial Carcinoma Who Did Not Progress on First-Line Platinum-Containing Chemotherapy

This is an open-label, switch maintenance study of MRx0518 and Avelumab in patients with unresectable locally advanced or metastatic urothelial carcinoma (UC) whose disease did not progress after 4 to 6 cycles of first-line platinum-containing chemotherapy and who have residual measurable disease according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1). Up to 30 patients will be enrolled.
Patients enrolled in this study will be treated with IV Avelumab every 2 weeks and MRx0518 daily during the treatment period. Patients will receive the study treatment until disease progression (PD), patient withdrawal, or unacceptable toxicity.

Start Date01 Mar 2022

Sponsor / Collaborator

4D Pharma Plc

NCT04193904 / TerminatedPhase 1

A Safety and Preliminary Efficacy Study of the Oral Live Biotherapeutic MRx0518 With Hypofractionated Preoperative Radiation for Resectable Pancreatic Cancer

This is a single center, open-label, phase I study to evaluate the safety and preliminary efficacy of MRx0518 with preoperative hypofractionated radiation in 15 patients with resectable pancreatic cancer.
Subjects will take MRx0518 daily for one week prior to the start of radiation therapy, throughout radiation and until surgical resection of the tumour.

Start Date20 Dec 2019

Sponsor / Collaborator

4D Pharma Plc

NCT03934827 / Active, not recruitingPhase 1IIT

A First in Human, Phase 1 Safety Study in Two Parts to Determine the Safety, Tolerability and Anti-cancer Immune-modulatory Effects of MRx0518 in Patients With Solid Tumour Awaiting Surgical Removal of the Tumour.

The primary objective is to determine the safety and tolerability of the novel compound, MRx0518 in patients with solid tumours at 30 days post-surgery.
20 participants will receive open label MRx0518 in a preliminary safety phase. After successful evaluation by the Independent Safety Monitoring Committee (IDMC), a further 100 participants will be recruited to receive MRx0518/Placebo.

Start Date10 Apr 2019

Sponsor / Collaborator

Imperial College London

[+1]

100 Clinical Results associated with MRx-518

100 Translational Medicine associated with MRx-518

100 Patents (Medical) associated with MRx-518

Literatures (Medical) associated with MRx-518

Scientific ReportsQ3 · CROSS-FIELD

The flagellin of candidate live biotherapeutic Enterococcus gallinarum MRx0518 is a potent immunostimulant

Q3 · CROSS-FIELD

ArticleOA

Author: Stroobach, Eline ; Minter, Beverley ; Mulder, Imke E ; Holt, Amy ; Raftis, Emma J ; Hennessy, Emma ; Lauté-Caly, Delphine L ; Panzica, D Alessio ; Sparre, Christina ; Cowie, Philip

AbstractMany links between gut microbiota and disease development have been established in recent years, with particular bacterial strains emerging as potential therapeutics rather than causative agents. In this study we describe the immunostimulatory properties ofEnterococcus gallinarumMRx0518, a candidate live biotherapeutic with proven anti-tumorigenic efficacy. Here we demonstrate that strain MRx0518 elicits a strong pro-inflammatory response in key components of the innate immune system but also in intestinal epithelial cells. Using a flagellin knock-out derivative and purified recombinant protein, MRx0518 flagellin was shown to be a TLR5 and NF-κB activator in reporter cells and an inducer of IL-8 production by HT29-MTX cells.E. gallinarumflagellin proteins display a high level of sequence diversity and the flagellin produced by MRx0518 was shown to be more potent than flagellin fromE. gallinarumDSM100110. Collectively, these data infer that flagellin may play a role in the therapeutic properties ofE. gallinarumMRx0518.

News (Medical) associated with MRx-518

23 Aug 2022

·www.prnewswire.com

Bladder Cancer Clinical Trial Pipeline Insights Featuring 100+ Companies | DelveInsight

DelveInsight's bladder cancer pipeline report depicts a robust space with 100+ active players working to develop 100+ pipeline therapies for bladder cancer treatment. LAS VEGAS, Aug. 23, 2022 /PRNewswire/ -- DelveInsight's ' Bladder Cancer Pipeline Insight 2022 ' report provides comprehensive global coverage of available, marketed, and pipeline bladder cancer therapies in various stages of clinical development, major pharmaceutical companies are working to advance the pipeline space and future growth potential of the bladder cancer pipeline domain. Key Takeaways from the Bladder Cancer Pipeline Report DelveInsight's bladder cancer pipeline report depicts a robust space with 100+ active players working to develop 100+ pipeline therapies for bladder cancer treatment. Leading bladder cancer companies such as CG Oncology, FKD Therapies, Bristol-Myers Squibb, LintonPharm Co., Ltd., ImmunityBio, Inc., Hamlet Pharma AB, Asieris Pharmaceuticals, Pfizer, Taizhou Hanzhong biomedical co. LTD, Protara Therapeutics, CicloMed LLC, enGene, Inc., Emtora Biosciences, Theralase Inc., Vaxiion Therapeutics, Janssen Research & Development, LLC, Astellas Pharma, RemeGen Co., Ltd., UroGen Pharma Ltd., Flame Biosciences, Aura Biosciences, BeiGene, Incyte Corporation, QED Therapeutics, G1 Therapeutics, AN0025, Kyowa Kirin, Inc., Infinity Pharmaceuticals, Shanghai Hengrui Pharmaceutical Co., Ltd., HiberCell, Inc., Ikena Oncology, Genentech, Fusion Pharmaceuticals, GI Innovation,SOTIO Biotech AG, Celon Pharma SA, 4D Pharma PLC, Keythera Pharmaceuticals, Quadriga Biosciences, Inc., NeoTX Therapeutics Ltd., Mirati Therapeutics, NGM Biopharmaceuticals, TransThera Biosciences, Ocellaris Pharma, Palleon Pharmaceuticals, Medicenna Therapeutics, Klus Pharma, Novartis, Toray Industries, Carisma Therapeutics, Avacta Life Sciences Ltd, Seagen Inc., Elevation Oncology, Corvus Pharmaceuticals, ADC Therapeutics S.A., IO Biotech, Byondis B.V., Takara Bio, Seven and Eight Biopharmaceuticals, Dragonfly Therapeutics, InnoCare Pharma, and others are evaluating novel bladder cancer drugs candidate to improve the treatment landscape. Key bladder cancer pipeline therapies in various stages of development include CG0070, ADSTILADRIN, Nivolumab, Catumaxomab, N-803, alpha1H, APL-1202, PF-07225570, HX008, TARA-002, CPX-POM, EG-70, eRapa, TLD-1433, VAX014, Erdafitinib, Enfortumab vedotin, RC48-ADC, TAS 102, UGN-102, FL-101, AU-011, Tislelizumab, Pemigatinib, Infigratinib, Trilaciclib, AN0025, KHK2455, IPI-549, SHR-1501, HC-7366, IK-175, ado-trastuzumab emtansine, FPI-1966, GI-101, SO-C101, CPL304110, MRx0518, KF-0210, QBS10072S, Naptumomab Estafenatox, Sitravatinib, NGM120, TT-00420, OC-001, E-602, MDNA11, A166, Spartalizumab, TRK-950, CT-0508, AVA6000, SEA-TGT, Seribantumab, CPI-006, ADCT-301, IO 102, SYD985, TBI-1301, BDB001, DF1001, ICP-192, and others. In July 2022, The FDA accepted for review a Biologics License Application (BLA) from ImmunityBio, Inc. (NASDAQ: IBRX), for its antibody cytokine fusion protein as a treatment for patients with BCG-unresponsive non-muscle-invasive bladder cancer carcinoma in situ (CIS) with or without Ta or T1 disease. ImmunityBio, a leading clinical-stage immunotherapy company, filed the BLA based on positive results from a series of studies of the investigational treatment, including the ongoing QUILT 3.032 trial. The Prescription Drug User Fee Act (PDUFA) target action date is May 23, 2023. In June 2022, CG Oncology announced the interim data on two ongoing clinical studies to be presented at The American Society of Clinical Oncology (ASCO) 2022 Annual Meeting.The first poster presentation reports on efficacy and safety data from a global Phase 2 study (CORE1) of CG0070 in combination with Merck's anti-PD-1 therapy KEYTRUDA® (pembrolizumab), for the treatment of patients with Non-Muscle-Invasive Bladder Cancer (NMIBC) unresponsive to Bacillus Calmette-Guerin (BCG). The second poster presentation centers on a Phase 1b/2 study (CORE2) of CG0070 in combination with OPDIVO®(nivolumab), as a neoadjuvant immunotherapy for Muscle-Invasive Bladder Cancer (MIBC) in cisplatin-ineligible patients. In May 2022, Asieris Pharmaceuticals announced that the ANTICIPATE Study will be presented at the 2022 American Society of Clinical Oncology (ASCO) annual meeting on June 3-7, 2022, in Chicago. This is a study of taking oral APL-1202 in combination with BeiGene's tislelizumab compared to just taking tislelizumab alone as neoadjuvant therapy (NAC) in patients with muscle invasive bladder cancer (MIBC). In March 2022, Protara Therapeutics, Inc. announced that the Company had dosed the first patient in ADVANCED-1, its Phase 1 clinical trial evaluating TARA-002, an investigational cell-based immunopotentiator, for the treatment of non-muscle invasive bladder cancer (NMIBC). In January 2022, Vaxiion Therapeutics, announced the U.S. Food and Drug Administration had cleared the company's Investigational New Drug application (IND) for VAX014 for investigational use in the intralesional treatment of solid tumors refractory to standard treatment options. VAX014 is a first-in-class recombinant bacterial minicell-based oncolytic immunotherapy. In December 2021, LintonPharm Co., Ltd., announced that the first patient had been dosed in the Company's Phase 1/2 clinical trial program for catumaxomab (clinicaltrials.gov: NCT04799847), a monoclonal bispecific antibody being studied for the treatment of Non-Muscle-Invasive Bladder Cancer (NMIBC) unresponsive to Bacillus Calmette-Guerin (BCG). Request a sample and discover the recent advances in bladder cancer treatment @ Bladder Cancer Pipeline Report The bladder cancer pipeline report provides detailed profiles of pipeline assets, a comparative analysis of clinical and non-clinical stage bladder cancer drugs, inactive and dormant assets, a comprehensive assessment of driving and restraining factors, and an assessment of opportunities and risks in the bladder cancer pipeline landscape. Bladder Cancer Overview Bladder cancer usually starts in the cells that line the inside of the bladder. It typically affects adults over the age of 70 and is more common in men. Bladder cancer is the fifth most prevalent type of cancer in the general population and the fourth most common in males. When detected early, bladder cancer usually responds well to bladder cancer treatment. Smoking is among the most common bladder cancer causes. Blood in the urine is usually the first sign of bladder cancer. Other bladder cancer symptoms may include urine pain or burning, as well as a change in urinary habits. This can include frequent urination or the need to urinate but being unable to do so. The tests used for bladder cancer diagnosis include biopsy, cystoscopy, urine cytology, imaging tests, and others. Find out more about bladder cancer drugs in development @ Bladder Cancer Drugs A snapshot of the Bladder Cancer Pipeline Drugs mentioned in the report: Learn more about the novel and emerging bladder cancer pipeline therapies @ Bladder Cancer Clinical Trials Bladder Cancer Therapeutics Assessment The bladder cancer pipeline report proffers an integral view of the bladder cancer emerging novel therapies segmented by stage, product type, molecule type, mechanism of action, and route of administration. Scope of the Bladder Cancer 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: Inhalation, Intranasal, Parenteral, Oral, Intravenous, Subcutaneous, Intramuscular Therapeutics Assessment By Molecule Type: Antibody, Antisense oligonucleotides, Immunotherapy, Monoclonal antibody, Peptides, Protein, Recombinant protein, Small molecule, Stem cell, Vaccine Therapeutics Assessment By Mechanism of Action: Cell death stimulants, Granulocyte macrophage colony stimulating factor agonists, Interleukin-15 receptor agonists, DNA synthesis inhibitors, Cyclin-dependent kinase 4 inhibitors, Cyclin-dependent kinase 6 inhibitors, Gene transference, IFNA2B expression stimulants, Antibody-dependent cell cytotoxicity, Programmed cell death-1 receptor antagonists, T lymphocyte stimulants Key Bladder Cancer Companies: CG Oncology, FKD Therapies, Bristol-Myers Squibb, LintonPharm Co.,Ltd., ImmunityBio, Inc., Hamlet Pharma AB, Asieris Pharmaceuticals, Pfizer, Taizhou Hanzhong biomedical co. LTD, Protara Therapeutics, CicloMed LLC, enGene, Inc., Emtora Biosciences, Theralase Inc., Vaxiion Therapeutics, Janssen Research & Development, LLC, Astellas Pharma, RemeGen Co., Ltd., UroGen Pharma Ltd., Flame Biosciences, Aura Biosciences, BeiGene, Incyte Corporation, QED Therapeutics, G1 Therapeutics, AN0025, Kyowa Kirin, Inc., Infinity Pharmaceuticals, Shanghai Hengrui Pharmaceutical Co., Ltd., HiberCell, Inc., Ikena Oncology, Genentech, Fusion Pharmaceuticals, GI Innovation,SOTIO Biotech AG, Celon Pharma SA, 4D Pharma PLC, Keythera Pharmaceuticals, Quadriga Biosciences, Inc., NeoTX Therapeutics Ltd., Mirati Therapeutics, NGM Biopharmaceuticals, TransThera Biosciences, Ocellaris Pharma, Palleon Pharmaceuticals, Medicenna Therapeutics, Klus Pharma, Novartis, Toray Industries, Carisma Therapeutics, Avacta Life Sciences Ltd, Seagen Inc., Elevation Oncology, Corvus Pharmaceuticals, ADC Therapeutics S.A., IO Biotech, Byondis B.V., Takara Bio, Seven and Eight Biopharmaceuticals, Dragonfly Therapeutics, InnoCare Pharma, and others Key Bladder Cancer Pipeline Therapies: CG0070, ADSTILADRIN, Nivolumab, Catumaxomab, N-803, alpha1H, APL-1202, PF-07225570, HX008, TARA-002, CPX-POM, EG-70, eRapa, TLD-1433, VAX014, Erdafitinib, Enfortumab vedotin, RC48-ADC, TAS 102, UGN-102, FL-101, AU-011, Tislelizumab, Pemigatinib, Infigratinib, Trilaciclib, AN0025, KHK2455, IPI-549, SHR-1501, HC-7366, IK-175, ado-trastuzumab emtansine, FPI-1966, GI-101, SO-C101, CPL304110, MRx0518, KF-0210, QBS10072S, Naptumomab Estafenatox, Sitravatinib, NGM120, TT-00420, OC-001, E-602, MDNA11, A166, Spartalizumab, TRK-950, CT-0508, AVA6000, SEA-TGT, Seribantumab, CPI-006, ADCT-301, IO 102, SYD985, TBI-1301, BDB001, DF1001, ICP-192, and others. Dive deep into rich insights for bladder cancer drugs, visit @ Bladder Cancer Treatment Table of Contents For further information on the bladder cancer pipeline therapeutics, reach out @ New Drug for Bladder Cancer Treatment Related Reports Bladder Cancer Market Bladder Cancer Market Insights, Epidemiology, and Market Forecast-2032 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key bladder cancer companies including RemeGen Co., Ltd., Taiho Oncology, Inc., Xennials Therapeutics, Flame Biosciences, among others. Bladder Cancer Epidemiology Forecast Bladder Cancer Epidemiology Forecast to 2032 report delivers an in-depth understanding of the disease, historical and forecasted bladder cancer epidemiology in the 7MM, i.e., the United States, EU5 (Germany, Spain, Italy, France, and the United Kingdom), and Japan. Muscle Invasive Bladder Cancer Pipeline Muscle Invasive Bladder Cancer Pipeline Insight, 2022 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key muscle invasive bladder cancer companies, including SOTIO a.s., Celon Pharma SA, Shanghai PerHum Therapeutics Co., Ltd., 4D Pharma PLC, among others. Muscle Invasive Bladder Cancer Market Muscle Invasive Bladder Cancer Market Insights, Epidemiology, and Market Forecast-2032 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key muscle invasive bladder cancer companies including SOTIO a.s., Celon Pharma SA, Shanghai PerHum Therapeutics Co., Ltd., 4D Pharma PLC, among others. Non Muscle Invasive Bladder Cancer Pipeline Non Muscle Invasive Bladder Cancer Pipeline Insight, 2022 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key non muscle invasive bladder cancer companies, including Theralase Inc., Vaxiion Therapeutics, Janssen Research & Development, LLC, Seagen Inc., among others. Non Muscle Invasive Bladder Cancer Market Non Muscle Invasive Bladder Cancer Market Insights, Epidemiology, and Market Forecast-2032 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key non muscle invasive bladder cancer companies including Theralase Inc., Vaxiion Therapeutics, Janssen Research & Development, LLC, Seagen Inc., among others. Other Trending Reports Persistent Depressive Disorder Market | Gene Therapy for Ocular Rare Disease Market | Congestive Heart Failure Market | CRISPR Therapies Pipeline | Desmoplastic Small Round Cell Tumors Market | India Healthcare Outlook Report | Psychosis Market | Dental Lasers Market | Primary Immune Deficiency Market I Dyslipidemia Market | Lateral Epicondylitis Disease Market | Castration-Resistant Prostate Cancer Market | Metrorrhagia Market | Global Messenger RNA-based Vaccines and Therapeutics Market | Negative Pressure Wound Therapy Systems Market | US Healthcare Outlook Report | Mucinous Cystic Neoplasms Market | Hot Flashes Market | Varicose Veins - Market | Hemostats Market | Injectable Drug Delivery Devices Market | Breast Pumps Market | Physiotherapy Equipment Market | Trastuzumab Biosimilars Insight | Deep Brain Stimulation Devices Market | Retinoblastoma Market | Venous Stenosis Market | Tumor Ablation Market | Substance Abuse Market | Insulin Glargine Biosimilar Insight | Interspinous Spacers Market | Anti-hypertension Market Related Healthcare Blogs Bladder Cancer Highlights From ASCO GU 2022 Non Small Cell Lung Cancer Market Outlook Rare Cancers Market Domain About DelveInsight DelveInsight is a leading Business Consultant, and Market Research firm focused exclusively on life sciences. Connect with us at LinkedIn Contact Us Shruti Thakur [email protected] +1(919)321-6187 Logo: SOURCE DelveInsight Business Research, LLP

CollaborateAntibodyGene TherapyBiosimilarFirst in Class

26 May 2022

·www.biospace.com

4D pharma Presents Trial in Progress Poster on Study of MRx0518 in Combination with BAVENCIO® in Patients with Unresectable Locally Advanced or Metastatic Urothelial Carcinoma at the 2022 ASCO Annual Meeting

Study to assess safety of MRx0518 with BAVENCIO and effect on progression-free survival at 6 months Study sites are open for patient enrolment LEEDS, England--(BUSINESS WIRE)-- 4D pharma plc (AIM: DDDD, NASDAQ: LBPS), a pharmaceutical company leading the development of Live Biotherapeutic products (LBPs), a novel class of drug derived from the microbiome, today announced the presentation of a trial in progress poster from the Phase II clinical trial of MRx0518 in combination with BAVENCIO® (avelumab), a PD-L1 blocking antibody, as a first-line maintenance therapy for patients with unresectable locally advanced or metastatic urothelial carcinoma that has not progressed with first-line platinum-containing chemotherapy, at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, IL. “We are continuing to build a strong body of evidence to support MRx0518 as a novel immunotherapy with broad potential to address significant unmet need across multiple oncology indications,” said Dr Alex Stevenson, Chief Scientific Officer at 4D pharma. “MRx0518 has previously demonstrated single agent immuno-modulation of the tumor microenvironment, and this data supports the potential of this combination to significantly enhance and improve outcomes for patients beyond treatment with BAVENCIO alone. Not only are we able to evaluate MRx0518 with a leading immune checkpoint inhibitor, we are also able to assess its potential in earlier treatment settings. We are pleased to be sharing further details on the design of our first-line maintenance study with BAVENCIO for the treatment of locally advanced or metastatic urothelial carcinoma with the oncology medical community at ASCO.” Poster Presentation Details: Poster Title: Trial in progress: A phase II switch maintenance study of live biotherapeutic MRx0518 and avelumab in patients with unresectable locally advanced or metastatic urothelial carcinoma (UC) who did not progress on first-line platinum-containing chemotherapy Presenting Author: Amishi Y. Shah MD, The University of Texas MD Anderson Cancer Center, Houston, TX Session Title: Genitourinary Cancer - Kidney and Bladder Abstract Number: TPS4610 Poster Number: 95a Date and Time: Saturday, June 4, 2022 at 13:15 CDT Highlights from the trial in progress poster include: The multi-center study (NCT05107427) will enroll 30 patients with unresectable locally advanced or metastatic urothelial carcinoma. Patients must have measurable disease after a partial response (PR) or stable disease (SD) on 4-6 cycles of platinum-containing induction chemotherapy. Patients will receive intravenous BAVENCIO (avelumab) every two weeks, in combination with one oral capsule of MRx0518 twice daily, until disease progression, patient withdrawal, or unacceptable toxicity. In addition to assessing the safety of the combination of MRx0518 with BAVENCIO, the study will assess the effect of the combination on progression-free survival (PFS) at 6 months. Secondary objectives are to assess other efficacy measures including objective response rate (ORR), time to response, duration of response (DOR), disease control rate (DCR), PFS, and overall survival (OS). Immunological changes of the microbiome and metabolome will be assessed through biopsies, longitudinal blood sampling and stool and urine samples. The study is being conducted in collaboration with Merck KGaA, Darmstadt, Germany and Pfizer Inc. Study sites are open for patient enrolment. The poster will be available on the “Posters & Publications” section of the 4D pharma website at . About MRx0518 MRx0518 is single strain Live Biotherapeutic Product (LBP) in development for the treatment of cancer. It is delivered as an oral capsule and stimulates the body’s immune system, directing it to produce cytokines and immune cells that are known to attack tumors. It is currently being evaluated in four clinical trials in patients with solid tumors. MRx0518-I-001 is a neoadjuvant monotherapy study in a variety of solid tumors and is being conducted at Imperial College (London, UK). MRx0518-I-002 is in combination with KEYTRUDA® (pembrolizumab) in patients with acquired resistance to prior anti-PD-1/PD-L1 immune checkpoint therapies. The Coordinating Investigator of the study is at The University of Texas MD Anderson Cancer Center, Houston, USA, with multiple additional sites in the US. The study is being conducted in collaboration with MSD, the tradename of Merck & Co., Inc., Kenilworth, NJ, USA. MRx0518-I-003 is in combination with preoperative radiotherapy in resectable pancreatic cancer. MRx0518-004 (AVENU) is a Phase II clinical trial of MRx0518 in combination with BAVENCIO® (avelumab) in the first-line maintenance setting for urothelial carcinoma, conducted in collaboration with Merck KGaA, Darmstadt, Germany and Pfizer Inc. About 4D pharma 4D pharma is a world leader in the development of Live Biotherapeutics, a novel and emerging class of drugs, defined by the FDA as biological products that contain a live organism, such as a bacterium, that is applicable to the prevention, treatment or cure of a disease. 4D pharma has developed a proprietary platform, MicroRx®, that rationally identifies Live Biotherapeutics based on a deep understanding of function and mechanism. 4D pharma's Live Biotherapeutic products (LBPs) are orally delivered single strains of bacteria that are naturally found in the healthy human gut. The Company has six clinical programs, namely a Phase I/II study of MRx0518 in combination with KEYTRUDA® (pembrolizumab) in solid tumors, a Phase II clinical trial of MRx0518 in combination with BAVENCIO® (avelumab) in the first-line maintenance setting for urothelial carcinoma, a Phase I study of MRx0518 in a neoadjuvant setting for patients with solid tumors, a Phase I study of MRx0518 in patients with pancreatic cancer, a Phase I/II study of MRx-4DP0004 in asthma, and Blautix® in irritable bowel syndrome (IBS) which has completed a successful Phase II trial. A Phase I study of MRx0005 and MRx0029 in patients with Parkinson’s disease is expected to commence in 2022. Additional preclinical-stage programs include candidates for CNS disease, immune-inflammatory conditions and cancer. The Company has a research collaboration with MSD (Merck & Co., Inc., Kenilworth, NJ, USA), to discover and develop Live Biotherapeutics for vaccines. Forward-Looking Statements This announcement contains "forward-looking statements." All statements other than statements of historical fact contained in this announcement, including without limitation statements regarding the efficacy of Live Biotherapeutics including MRx0518, and the ability of MRx0518 to modify the effects of immune checkpoint inhibitors including avelumab, are forward-looking statements within the meaning of Section 27A of the United States Securities Act of 1933, as amended (the "Securities Act"), and Section 21E of the United States Securities Exchange Act of 1934, as amended (the "Exchange Act"). Forward-looking statements are often identified by the words "believe," "expect," "anticipate," "plan," "intend," "foresee," "should," "would," "could," "may," "estimate," "outlook" and similar expressions, including the negative thereof. The absence of these words, however, does not mean that the statements are not forward-looking. These forward-looking statements are based on the Company's current expectations, beliefs and assumptions concerning future developments and business conditions and their potential effect on the Company. While management believes that these forward-looking statements are reasonable as and when made, there can be no assurance that future developments affecting the Company will be those that it anticipates. All of the Company's forward-looking statements involve known and unknown risks and uncertainties, some of which are significant or beyond its control, and assumptions that could cause actual results to differ materially from the Company's present expectations or projections. The foregoing factors and the other risks that could cause actual results to differ materially include risks relating to the efficacy of its Live Biotherapeutic drug candidates including MRx0518, the risk that the Company changes its expected strategy and plans, risk related to safety of investigational therapeutics, clinical development risk, and those additional risks and uncertainties described in the documents filed by the Company with the US Securities and Exchange Commission ("SEC"). The Company wishes to caution you not to place undue reliance on any forward-looking statements, which speak only as of the date hereof. The Company undertakes no obligation to publicly update or revise any of its forward-looking statements after the date they are made, whether as a result of new information, future events or otherwise, except to the extent required by law. View source version on businesswire.com: Contacts 4D pharma Investor Relations ir@4dpharmaplc.com Singer Capital Markets - Nominated Adviser and Joint Broker Philip Davies / James Fischer (Corporate Finance) +44 (0)20 7496 3000 Tom Salvesen (Corporate Broking) Bryan Garnier & Co. Limited - Joint Broker Dominic Wilson +44 (0)20 7332 2500 Stern Investor Relations Julie Seidel +1-212-362-1200 julie.seidel@sternir.com Image Box Communications Neil Hunter / Michelle Boxall +44 (0)20 8943 4685 neil@ibcomms.agency / michelle@ibcomms.agency Source: 4D pharma plc View this news release online at:

CollaborateAntibodyVaccineImmunotherapyASCO

17 May 2022

·www.biospace.com

4D pharma Presents Late Breaking Abstract from Phase I/II Trial of MRx-4DP0004 for the Treatment of Asthma at the American Thoracic Society (ATS) 2022 International Conference

LEEDS, England--(BUSINESS WIRE)-- 4D Pharma plc (AIM: DDDD, NASDAQ: LBPS), a pharmaceutical company leading the development of Live Biotherapeutic products (LBPs), a novel class of drug derived from the microbiome, today announces the presentation of a late-breaking poster on data from Part A of the Phase I/II trial of MRx-4DP0004 for the treatment of asthma. The poster is being presented at the 2022 American Thoracic Society (ATS) International Conference, May 13-18, 2022 in San Francisco, CA, US. “The clinical results of MRx-4DP0004 treatment to date reinforce 4D pharma’s success in using the MicroRx platform to select single strain LBPs and generate clinical candidates with specific immune-modulating therapeutic functionality. We are proud to share with the asthma medical community our growing body of data supporting the potential of MRx-4DP0004 as a novel oral treatment for asthma. 4D pharma will further bolster these results as we advance the Phase I/II trial into Part B,” said Dr. Alex Stevenson, Chief Scientific Officer of 4D pharma. “The effects of MRx-4DP0004 improving ACQ scores and reducing patients’ reliance on SABA rescue medication are very encouraging. Moving forward into the Part B phase of this trial, 4D pharma aims to evaluate MRx-4DP0004 in asthma patients with more symptomatic disease, expected to provide a greater opportunity to demonstrate improvements.” The Company previously announced topline safety and efficacy data from Part A of the trial, in addition to disclosing that this portion of the trial met the primary endpoint of safety and tolerability. In a late-breaking abstract and poster presentation titled, “Safety, Tolerability and Preliminary Signals of Activity in Adult Patients with Partly Controlled Asthma Treated with Live Biotherapeutic MRx-4DP0004 as an Add-On Maintenance Therapy to Inhaled Corticosteroids (ICS) With or Without Long-Acting Beta Agonists (LABA),” 4D highlighted key safety and efficacy findings: Safety - MRx-4DP0004 was safe and well-tolerated with no treatment-related severe adverse events (AEs) or serious AEs reported. - The frequency of AEs and treatment discontinuations due to AEs were comparable to placebo. Efficacy - A significantly greater proportion of patients receiving MRx-4DP0004 than those receiving placebo experienced a reduction in Asthma Control Questionnaire (ACQ-6) scores from baseline at all time points. At end of treatment 83.3% of subjects receiving MRx-4DP0004 had improved ACQ-6 scores compared to 56.3% of those receiving placebo, p=0.088. - The proportion of MRx-4DP0004-treated patients with improved ACQ-6 scores increased over the treatment period. - A greater proportion of the MRx-4DP0004 arm than the placebo arm experienced a reduction in total weekly use of short-acting beta agonists (SABA) rescue medication at all time points. - At the end of treatment period (day 85), 50% of patients receiving MRx-4DP0004 reduced their use of SABA rescue medication as compared to 18.8% for patients receiving placebo. - At the end of treatment period (day 85), 50% of patients receiving MRx-4DP0004 experienced clinically meaningful improvements in Asthma Quality of Life Questionnaire (AQLQ) scores of ≥0.5 from baseline, compared to 31.3% of patients receiving placebo. - In the 12-week treatment period, there was one instance of asthma exacerbation in the MRx-4DP0004 treatment arm, compared to two instances in the placebo arm. - Mean measures of lung function remained stable from baseline and throughout the treatment period, determined by forced expiratory volume (FEV1), ratio FEV1:forced vital capacity (FVC) and peak expiratory flow (PEF). The Phase I/II trial of MRx-4DP0004 is now progressing into Part B, which will assess clinical and biomarker activity in up to 90 adult patients with partly controlled asthma. Following the successful conclusion of Part A, 4D pharma intends to enroll patients into Part B of the study who are more symptomatic than those enrolled in Part A. 4D pharma expects the more symptomatic patients to give even greater scope for treatment effects to be observed. The primary endpoint of Part B will be the proportion of patients with a reduction in ACQ-6 scores from baseline vs. placebo, which was statistically significant at all time points evaluated in Part A of the trial. About 4D pharma 4D pharma is a world leader in the development of Live Biotherapeutics, a novel and emerging class of drugs, defined by the FDA as biological products that contain a live organism, such as a bacterium, that is applicable to the prevention, treatment or cure of a disease. 4D pharma has developed a proprietary platform, MicroRx®, that rationally identifies Live Biotherapeutics based on a deep understanding of function and mechanism. 4D pharma's Live Biotherapeutic products (LBPs) are orally delivered single strains of bacteria that are naturally found in the healthy human gut. The Company has five clinical programs, namely a Phase I/II study of MRx0518 in combination with KEYTRUDA® (pembrolizumab) in solid tumors, a Phase I study of MRx0518 in a neoadjuvant setting for patients with solid tumors, a Phase I study of MRx0518 in patients with pancreatic cancer, a Phase I/II study of MRx-4DP0004 in asthma, and Blautix® in irritable bowel syndrome (IBS) which has completed a successful Phase II trial. A Phase I study of MRx0005 and MRx0029 in patients with Parkinson’s disease is expected to commence in 2022. Additional preclinical-stage programs include candidates for CNS disease, immune-inflammatory conditions and cancer. The Company has a research collaboration with MSD (Merck & Co., Inc., Kenilworth, NJ, USA), to discover and develop Live Biotherapeutics for vaccines.

Clinical ResultMicrobial therapyCollaborateVaccine

100 Deals associated with MRx-518

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Metastatic urothelial carcinoma	Phase 2	US	4D Pharma Plc	01 Mar 2022
Urothelial Carcinoma of the Urinary Bladder	Phase 2	US	4D Pharma Plc	01 Mar 2022
Solid tumor	Phase 2	GB	4D Pharma Plc	26 May 2019
Solid tumor	Phase 2	US	The University of Texas MD Anderson Cancer Center	26 May 2019
Bladder Cancer	Phase 2	US	4D Pharma Plc	10 Jan 2019
Melanoma	Phase 2	US	4D Pharma Plc	10 Jan 2019
Non-Small Cell Lung Cancer	Phase 2	US	4D Pharma Plc	10 Jan 2019
Renal Cell Carcinoma	Phase 2	US	4D Pharma Plc	10 Jan 2019
Ovarian Cancer	Phase 1	GB	4D Pharma Plc	10 Apr 2019
Urethral Neoplasms	Phase 1	GB	4D Pharma Plc	10 Apr 2019

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ASCO_Breakthrough2023 Manual	Phase 1	Pancreatic Cancer	14	MRx518	(ejsvzzwvbb) = rnkmdozalu jfadtidfkl (aqpzsvzkvd ) View more	Positive	03 Aug 2023
NCT03934827 (ASCO2023) Manual	Phase 1	Neoplasms First line	17	MRx-0518	(broylsvjfa) = rgnnnyvgrs vwvopncmpf (dntjdgagqg ) View more	Positive	31 May 2023
NCT03934827 (SITC2022) Manual	Phase 1	Neoplasms First line	17	MRx-0518	(gceyurtvqp) = Analysis of plasma metabolomics on paired pre- and post-treatment samples, at 30-days, demonstrated a significant reduction (P<0.05) in levels of acetic acid, with positive trends (non-significant) identified in 2-methyl butyric acid, butyrate and propionate. Sub-analysis of subjects (n=11) who received MRx0518 for >15 days showed significant (P<0.05) post-treatment increases in 2-methyl butyrate, butyrate, propionate and valerate, with a concordant significant reduction in acetic acid levels. qqxdgxyvbu (uyycpsvfjs )	Positive	10 Nov 2022
NCT05107427 (ASCO2022)	Phase 2	Unresectable Urothelial Carcinoma Maintenance	30	MRx0518 + Avelumab	(bjitjryuny) = gvkqpcqwjl aarxtruzfc (fcylfedimm, 6.8 - 13) View more	-	02 Jun 2022
NCT03637803 (MRx0518-I-002, NEWS) Manual	Phase 1/2	Metastatic Renal Cell Carcinoma	12	MRx0518+Keytruda	(pwxxohplxs) = lcwyiwmhks oxfrlzkulh (nykuhyitrs ) View more	Positive	26 Aug 2020

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