A recent Biospace article covers a news release from 4D Pharma in Leeds, England. 4D has announced the first worldwide clinical confirmation of a biotherapeutic product.
MRx0518 has been combined with the anti-PD1 therapy Keytruda® (pembrolizumab) in patients with advanced malignancies.
The participants in the trial had initially responded to other therapies but then their disease advanced on PD-1/PD-L1 inhibitors.
When PD-1 binds to PD-L1 it prevents the immune cells (T cells) from killing cancer cells. Keytruda is a monoclonal antibody (made by identical immune cells) shown to block the interchange between PD-1 and PD-L1.
Keytruda’s companion, MRx0518, stimulates the immune system. Then the immune cells and cytokines, which are secreted by cells in the immune system, attack the tumors.
Originally, biological medicines were taken from human secretions and tissues in small amounts. Currently scientists are preparing medicinal products by genetically engineering bacteria such as fungi, yeast or even from plants and animals.
The newly developed medicinal products contain cytokines such as interleukin, interferon or growth factors which are secreted by cells in the immune system. Cytokine therapy is of vital importance in current cancer research.
The medicinal products also include proteins, regulatory peptides and products extracted from other specific cell lines.
Results from Keytruda After Seven Therapies
One patient with stage IV non-small cell lung cancer had previously received seven different therapies during a three-year period but showed minimal response.
When treated with Keytruda combined with MRx0518, the patient had a fifty-one percent reduction in the tumors that had been targeted. The patient is in his forty-first week of treatment.
An Ongoing Clinical Trial Phase I/II
4D Pharma’s announcement is an update to previously published interim data from its ongoing clinical trial held in conjunction with Merck’s subsidiary MSD.
Patients who are participating in the trial have been diagnosed with either melanoma, renal cell carcinoma, bladder cancer or non-small cell lung cancer.
MD Anderson researchers at the University of Texas are conducting this live biotherapeutic study and compiling trial results. All patients involved in the clinical trial had already received various therapies but with minimal positive results. All approved treatment options had been exhausted for these patients.
About Checkpoint Inhibitors
Checkpoint inhibitors are molecules that act like breaks on the immune system allowing T cells to attack tumors.
Although checkpoint therapies alone often produce anti-tumor responses, not all patients will benefit. Also, even the patients who are responsive eventually succumb to the progression of the disease.
4D Pharma has interpreted current trial data as evidence of positive results when MRx0518 is combined with checkpoint inhibitor therapy. The combination is seen as reducing tumors in patients who have thus far been resistant to therapy (refractory).
About 4D Pharma
The company was founded in 2014 and is a leader in Live Biotherapeutics, a class of novel and emerging drugs. The FDA classifies these drugs as biological products containing live organism. These organisms are used for preventing, treating and curing disease.
4D’s bacteria can be delivered orally and are usually found in a healthy human gut.
The company is looking forward to larger studies adding MRx0518 to the checkpoint therapy. 4D anticipates the combination working longer and more effectively for a larger number of patients.