PBA-0405 receives FDA "study may proceed"

We are proud to announce that  Zermatt Consulting has played a significant role in Pure Biologics approval receival from the U.S. Food and Drug Administration (FDA) for an exploratory Investigational New Drug (eIND) for testing PBA-0405 in a Phase 0 clinical study in solid tumour cancer patients.  
 
About PBA-0405: 
PBA-0405 is a fully human IgG1 antibody that targets ROR1, a drug-target found on many solid tumours and B cell malignancies, and rarely on healthy tissues. PBA-0405 has been designed to make tumor cells visible to the immune system. Through a process called afucosylation, PBA-0405 has been engineered to optimally induce tumor killing by so-called cytotoxic immune cells. PBA-0405 is the first ROR1-targeting compound with such mode of action to reach such an advanced stage of research. In preclinical studies, PBA-0405 has shown very promising anti-cancer activity, both in vitro and in vivo, both in a solid tumor model and in a B cell leukemia model. 
 
Phase 0 Study Focus: 
The Phase 0 study will focus on detection of early signs of pharmacodynamic activity of PBA-0405, after a single-dose injection directly in the tumor, including immune-cell activation and tumour cell killing, to confirm the PBA-0405 therapeutic mode of action in a real patient setting. 
 
Study Details: 
In the multi-centre, open label study, performed in the USA, patients with head and neck carcinoma, soft tissue sarcoma and triple negative breast cells cancer will receive a single intra-tumoral injection of PBA-0405. For this, Pure Biologics has partnered with Presage Biosciences, Inc. (Seattle, USA) as CRO to execute the studies. Company aims to complete the Phase 0 clinical study within six months after study initiation.