MSD (Merck & Co., Inc) – MRx0518 Oncology clinical collaboration
4D pharma has entered into a clinical collaboration and drug supply agreement with MSD (tradename of Merck & Co., Inc., Kenilworth, N.J., USA), via a subsidiary, to conduct a a Phase I/II multi-center clinical trial to evaluate the safety, tolerability and preliminary clinical benefit of the combination of the combination of Keytruda® (pembrolizumab), an anti-PD-1 therapy marketed by MSD, and 4D pharma's Live Biotherapeutic candidate MRx0518 in patients with advanced solid tumors who had previously shown an initial clinical benefit to anti-PD-1/PD-L1 immune checkpoint inhibitors, but subsequently developed secondary resistance and progressive disease.
In May 2020, 4D pharma announced the successful completion of the Part A safety phase of this study, and in August 2020, announced comprehensive clinical benefit data from Part A of the trial, in which the combination of MRx0518 with Keytruda achieved a disease control rate (DCR) of 42%.
Following successful completion of the Part A safety phase, the Part B cohort expansion phase of the trial is enrolling at multiple sites, and will assess the clinical benefit of the combination of MRx0518 and Keytruda in addition to safety, in up to 120 patients with renal cell carcinoma (RCC), non-small cell lung cancer (NSCLC), bladder cancer, squamous cell carcinoma of the head and neck (HNSCC), triple-negative breast cancer (TNBC), and microsatellite instability-high (MSI-H) tumors. Recruitment is ongoing.
Merck KGaA & Pfizer, Inc. – MRx0518 Oncology clinical collaboration
4D pharma has entered into a clinical trial collaboration and supply agreement with Merck KGaA, Darmstadt, Germany and Pfizer Inc. for Bavencio® (avelumab). Under the collaboration, 4D pharma will evaluate Bavencio in combination with MRx0518 as a first-line maintenance therapy for patients with locally advanced or metastatic urothelial carcinoma that has not progressed with first-line platinum-containing chemotherapy.
Bavencio is the first and only immunotherapy approved as a first-line maintenance treatment for patients with locally advanced or metastatic urothelial carcinoma. Bavencio is co-developed and co-commercialized by Merck KGaA, Darmstadt, Germany and Pfizer Inc.
4D pharma intends to commence a Phase II clinical trial in Q4 2021.
MSD (Merck & Co., Inc) – MicroRx® vaccines collaboration
4D pharma has entered into a research collaboration and option to license agreement with MSD, the tradename of Merck & Co., Inc., Kenilworth, NJ, USA, to discover and develop Live Biotherapeutics (LBPs) for vaccines.
Under the terms of the agreement 4D’s proprietary MicroRx® platform will be paired with MSD’s expertise in the development and commercialization of novel vaccines, to discover and develop LBPs as vaccines in up to three undisclosed indications.
In relation to the collaboration, MSD purchased $5 million in ordinary shares in 4D pharma. In addition to an upfront cash payment, across up to three undisclosed indications 4D is eligible to receive option exercise fees, development and regulatory milestone payments up to a total of $1.0425 billion, plus tiered royalties on annual net sales of any licensed products derived from the collaboration. MSD will be responsible for development, manufacturing and commercialization following the exercise of any of its exclusive options.
The University of Texas MD Anderson Cancer Center – Oncology strategic collaboration
4D pharma and The University of Texas MD Anderson Cancer Center have engaged in a strategic collaboration to evaluate 4D’s Live Biotherapeutic oncology pipeline across a range of cancer settings.
The alliance brings together MD Anderson's translational medicine and clinical research capabilities with 4D’s expertise in the discovery and development of Live Biotherapeutics. The collaboration will initially assess 4D’s lead oncology candidate, MRx0518, as a potential treatment for solid tumors.
To date, 4D pharma has initiated two clinical studies of lead oncology LBP MRx0518 being run by Chief Investigators at the MD Anderson Cancer Center.
The University of Texas MD Anderson Cancer Center is one of the world’s most respected centers devoted exclusively to cancer patient care, research, education and prevention. Find out more at www.mdanderson.org
Imperial College London – Investigator-Lead Clinical trial
A clinical study being conducted in collaboration with Imperial College London to assess the safety and tolerability of MRx0518 neoadjuvant monotherapy in treatment-naïve subjects undergoing surgical resection of a range of solid tumors. Paired patient tumor, blood and stool samples are taken at diagnostic biopsy and surgical resection, with an intervening period of MRx0518 monotherapy treatment of two to four weeks.
The study’s Principal Investigator is Dr. Jonathan Krell, Senior Clinical Lecturer & Consultant Medical Oncologist at Imperial College London.
Biomarker and safety data from the study have been presented at the Society for Immunotherapy of Cancer (SITC) Annual Meeting 2020 and the European Society of Medical Oncology (ESMO) 2021, demonstrating systemic immune and tumor microenvironment modulation following two to four weeks of treatment with MRx0518.
Michael J. Fox Foundation Parkinson’s Progression Markers Initiative (PPMI) – Industry Partner
In December 2020, 4D pharma joined the Parkinson’s Progression Markers Initiative (PPMI) — a landmark longitudinal study to identify objective measures of Parkinson’s disease sponsored by The Michael J. Fox Foundation for Parkinson’s Research (MJFF) — as an industry partner.
4D pharma representatives contribute to the efforts of PPMI by providing feedback on study design and execution through the Industry Scientific Advisory Board (ISAB). In addition, 4D pharma representatives also join a variety of PPMI working groups that provide a forum to discuss PPMI data and address Parkinson’s clinical trial challenges with a consortium of biotech and pharmaceutical companies, and nonprofit organizations.
For more information visit www.michaeljfox.org/news/parkinsons-research-ppmi-clinical-study
Parkinson’s UK – Patient Advisory Board
In early 2021, 4D pharma entered into a collaboration with Parkinson’s UK, a non-profit organization focused on advancing the understanding of Parkinson’s disease and improving treatments, to establish a Patient Advisory Board.
The Patient Advisory Board (PAB) will be comprised of people living with Parkinson’s. Supported by Parkinson’s UK, the PAB will provide valuable patient-centric perspective to 4D pharma as it continues to advance novel Live Biotherapeutics into the clinic to treat neurodegenerative conditions such as Parkinson’s. The PAB will also focus on raising awareness of the issues people with Parkinson’s face with current treatment options.
4D pharma currently expects to commence a clinical trial of novel LBPs in people with Parkinson’s disease in 2022.
For more information on Parkinson's UK visit www.parkinsons.org.uk