4D hosts virtual R&D event providing updates on clinical programmes in oncology and COVID-19
Leeds, UK, 4D pharma plc (AIM: DDDD), a pharmaceutical company leading the development of Live Biotherapeutics, today announces a virtual R&D event in which Duncan Peyton, Chief Executive Officer, 4D pharma, Prof. Axel Glasmacher, Chairman, 4D pharma, and Dr. Alex Stevenson, Chief Scientific Officer, 4D pharma, provide updates on the company’s clinical programmes in oncology and COVID-19. Covering analysts were invited to participated in a Question & Answer session after the presentation. The presentation slides and a recording are accessible via the “Reports and Presentations” area of 4D’s website at https://www.4dpharmaplc.com .
Clinical update summary: oncology and COVID-19 programmes
· Early data supports proof of concept in metastatic renal cell carcinoma, with potential to expand into additional tumour types
· Continuing positive signals further validate the Company’s single strain Live Biotherapeutic approach
· Further clinical confirmation of expected favorable safety profile of therapeutics developed by the Company
· MRx-4DP0004 has a relevant mechanism of action for COVID-19
· Research Ethics Committee and Health Research Authority approval received
· Clinical site selection and initiations underway
· First patient dosing expected June 2020
Oncology – MRx0518 and Keytruda® Phase I/II Combination Study
The presentation provides additional efficacy results from the ongoing Phase I/II trial of immuno-oncology candidate MRx0518 in combination with Keytruda® in solid tumours. Of the twelve patients who were enrolled in Part A, five are continuing on study treatment.
Two of these five patients had tumours that achieved a partial response (PR). One is a patient with metastatic renal cell carcinoma (mRCC), who has now been on the study for over a year and has received three previous lines of therapy before enrolling on the study. The other is a patient with metastatic non-small cell lung cancer (mNSCLC) with a mutation in Epidermal Growth Factor Receptor (EGFR). This patient has been on the study for 49 weeks and has had seven previous lines of therapy. NSCLC patients harboring EGFR mutations are reported to be less likely to show clinical benefit from PD-1/PD-L1 checkpoint inhibitors.1, 2, 3
Both of these patients’ tumours showing partial responses to the combination of MRx0518 and Keytruda® combined with a PD-1 checkpoint inhibitor had previously shown a response no better than stable disease (SD) to PD-1 checkpoint inhibitor treatment, before developing secondary resistance and progressive disease.
Three further patients taking part in the study have mRCC and have exhibited stable disease (SD). One has been on the study for 44 weeks, one for 15 weeks and the other for 12 weeks.
Seven of the twelve patients who were enrolled in Part A have been withdrawn from treatment. Two patients were withdrawn due to progressive disease determined at the first scheduled restaging scan at nine weeks. Three patients were withdrawn following disease-related serious adverse events (SAE) and an early first restaging scan. Two patients were withdrawn prior to any restaging scan due to SAEs related to disease progression.
Part B of the study is now open to recruitment of an additional 30 patients per tumour type cohort included in the study. Four additional investigational sites will be opened.
COVID-19 – Phase II Clinical Study
In April, 4D pharma announced receipt of expedited clinical trial authorization (CTA) from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) for a Phase II randomized, double-blind, placebo-controlled study in up to 90 patients hospitalized with COVID-19.
The study has now received Research Ethics Committee and Health Research Authority approvals and the Company is in the process of initiating the first clinical sites, with the first subjects expected to be recruited in June. Preliminary data is expected in Q4 2020.
Further summary information on the clinical programmes discussed during the webinar is included below.
1. Lee CK, Man J, Lord S. et al. Clinical and molecular characteristics associated with survival among patients treated with checkpoint inhibitors for advanced non-small cell lung carcinoma: a systematic review and meta-analysis. JAMA Oncol 2018; 4(2): 210-216. doi:10.1001/jamaoncol.2017.4427
2. Lisberg A, Cummings A, Goldman JW. et al. A phase II study of pembrolizumab in EGFR-mutant, PD-L1+, tyrosine kinase inhibitor (TKI) naive patients with advanced NSCLC. J Thorac Oncol 2018; 13(8): 1138-1145 . doi: 10.1016/j.jtho.2018.03.035
3. Borghaei H, Paz-Ares L, Horn L. et al. Nivolumab versus docetaxel in advanced nonsquamous non-small-cell lung cancer. N Engl J Med 2015; 373(17): 1627-1639. doi: 10.1056/NEJMoa1507643
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