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news.The US Food and Drug Administration (FDA) has granted clearance for PDS Biotechnology's investigational new drug (IND) application to assess Versamune MUC1 plus PDS01ADC for the treatment of unresectable, metastatic colorectal carcinoma (mCRC).
The trial will assess the combo in individuals with recurrent or mCRC. Credit: Louis Reed on Unsplash.
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Versamune is the company’s new investigational MUC1-targeted immunotherapy candidate.
The therapy is intended for individuals who have failed prior treatments.
PDS submitted the application to the US regulator in January this year.
PDS Biotechnology CEO and president Frank Bedu-Addo said: “The IND clearance of Versamune MUC1 marks progress for our Versamune platform and its potential to expand beyond HPV-related cancers.”
The combination will be evaluated in a Phase I/II trial, which will be led by the National Cancer Institute (NCI) under its Cooperative Research and Development Agreement (CRADA) with the company.
This trial will assess the combo in individuals with recurrent or mCRC.
PDS Biotech’s combo of Versamune and cytokines, covered by US Patent #12,201,685, is aimed at overcoming the immune suppression within the tumour and enhancing the anti-tumour immune response.
PDS Biotechnology chief medical officer Kirk Shepard said: “MUC1 is over-expressed in multiple solid tumours including colon, pancreatic, ovarian, breast, and NSCLC, and is associated with drug resistance and poor patient outcomes.
“This results in an unmet need for more effective, safer, better-tolerated targeted treatment options. Versamune MUC1 targets mCRC tumours that are MUC1-positive and will be studied in Proficient Mismatch Repair/Microsatellite Stable mCRC, which accounts for 95% of patients with mCRC.”
Additionally, the company is developing the lead investigational targeted immunotherapy, Versamune HPV, which is being developed in conjunction with a standard-of-care immune checkpoint inhibitor as well as in a triple combo therapy that includes an interleukin 12 (IL-12) fused antibody-drug conjugate (ADC), PDS01ADC, along with a standard-of-care immune checkpoint inhibitor.
