- Study to assess safety of MRx0518 with BAVENCIO and effect on progression-free survival at 6 months

- Study sites are open for patient enrolment

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 www.4dpharmaplc.com.

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.

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