Shares in live biotherapeutics company 4D Pharma (DDDD:AIM) surged 33% to 104p on Wednesday after the release of highly encouraging clinical results in the first part of a trial aimed at treating patients with advanced kidney cancer.
Prof. Jaap Verweij, emeritus professor of medical oncology at Erasmus University Medical Center in Rotterdam and advisor to the company, commented: ‘Having been a clinical investigator on over 150 early stage trials with a wide variety of anti-cancer agents, I believe that these results are extremely encouraging, particularly given the novelty of the approach and the durability of clinical benefit observed’.
EFFICACY AND SAFETY
In a small study of 12 patients, the combination of MRx0518 with KEYTRUDA achieved a disease control rate (DCR) of 42% with five of 12 patients experiencing a clinically meaningful benefit from the combination. This result was far in excess of the 12% threshold agreed with partner MSD.
The combination of efficacy and safety is not an easy goal to achieve, as chief scientific officer Dr. Alex Stevenson explained: ‘To achieve these results while maintaining a very clean safety profile is to our knowledge unparalleled, and particularly significant in oncology where there is all too often the unfortunate trade-off between treatment and quality of life, and patients often elect to interrupt or stop treatment completely due to adverse side effects'.
The next stage will involve enrolling a broader cohort of up to 30 additional patients per tumour type across multiple sites.
WHAT IS MRx0518?
4D pharma is a world leader in the development of live biotherapeutics, a novel and emerging class of drugs defined by the US Federal Drug Administration (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.
MRx0518 is an oral capsule which stimulates the body’s immune system, directing it to produce small proteins and immune cells which are known to attack tumours. It is currently being evaluated in three clinical trials in cancer patients. KEYTRUDA is an antibody used in cancer immunotherapy.
