U.K.-based pharmaceutical company 4d Pharma PLC (DDDD:LON), which is focused on developing a novel class of drug derived from the microbiome known as Live Biotherapeutic products (LBPs), today announced that "in Part B of its signal finding study of MRx0518 in combination with MSD's anti-PD-1 therapy, KEYTRUDA® (pembrolizumab) in patients with solid tumors that have progressed on a prior immune checkpoint inhibitor (ICI), the renal cell carcinoma (RCC) group has met its primary efficacy endpoint ahead of enrollment completion."
4D pharma noted that the ongoing Phase 1/2 study is evaluating MRx0518 in combination with Merck & Co. Inc.'s (MRK:NYSE) (known as MSD in Europe) KEYTRUDA® (pembrolizumab) in heavily pre-treated metastatic patients with solid tumors. The participants in the clinical trial have all previously experienced clinical benefit from prior ICI therapy but subsequently developed progressive disease.
The company advised that "the primary efficacy endpoint for Part B of the study is more than 3 out of 30 patients per tumor group achieving clinical benefit, defined as complete response, partial response, or stable disease for at least 6 months."
The firm indicated during Part B of the study 20 patients with RCC were enrolled as participants. The company noted that 4 of the first 16 evaluable patients showed clinical benefit by achieving 6 months or more of stable disease. To date, Part B of the study has enrolled 47 patients with a final enrollment goal of 120 patients.
In addition to enrolling RCC patients, the trial is also studying the effects of MRx0518 in patients diagnosed with non-small cell lung cancer, bladder cancer, and head and neck squamous cell carcinoma.
4D pharma's Chief Scientific Officer Dr. Alex Stevenson remarked, "Today's results in renal cell carcinoma, meeting the predefined primary efficacy endpoint early in this difficult to treat population, marks another important step forward for MRx0518 and the increasing importance of the microbiome in cancer treatment…Meeting the primary efficacy endpoint for this group is crucial for the future development of MRx0518, and these data are highly informative for our strategy going forward as we determine next steps in RCC."
The company mentioned that it plans to discuss its development strategy going forward with the Genitourinary Cancers Advisory Board and its partners regarding how to best proceed with a possible pivotal study of MRx0518 in patients with ICI-refractory RCC.
The firm stated that that it intends to continue with recruitment of patients in the ongoing combination therapy study of MRx0518 and Keytruda in RCC and the three tumor groups, though it may elect to expand the scope of its investigation into other types of ICI resistance.
4D pharma is headquartered in Leeds, U.K. and claimed to be "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." The company explained that its LBPs are administered orally and represent single strains of bacteria naturally found in healthy human's digestive systems.
4D pharma started the day with a market cap of around $107.1 million with approximately 22.54 million shares outstanding. LBPS ADR shares opened about 45% higher today at $6.765 (+$2.096, +44.89%) over yesterday's $4.669 closing price. The stock has traded today between $5.48 and $8.80 per share and closed for trading at $5.99 (+$1.321, +28.29%).
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