NetScientific PLC (AIM:NSCI) has hailed progress at portfolio company PDS Biotechnology Corporation (NASDAQ:PDSB), which passed some key data and development milestones for its lead oncology drug candidate.
For the drug, currently called PDS0101, developments in the past quarter include completing the first stage of enrolment for the VERSATILE-002 Phase II combination trial with Keytruda in patients with human papillomavirus (HPV) and or head and neck cancer.
The US Food and Drug Administration (FDA) provided guidance on the regulatory pathway for the trial and, most recently, on a triple combination Phase II trial with the National Cancer Institute, where results showing the median overall survival reached 21 months was also reported during the fourth quarter.
“We look forward to progressing PDS0101 into a registrational trial in 2023,” said Dr Frank Bedu-Addo, PDS chief executive.
PDS also signed an exclusive global licence agreement for PDS0301, a novel, investigational, proprietary investigational tumour targeting, antibody-conjugated IL-12, developed by Merck KGaA, while two pieces were published in the peer-reviewed Viruses journal on the Infectimune platform’s use in recent vaccine studies.
NetScientific CEO Dr Ilian Iliev said: “We are delighted with PDS Biotech's continued development, including the exclusive global agreement with Merck KGaA, Darmstadt, Germany to advance the development of PDS0301, and their continued progress in their preclinical oncology candidates and Infectimune platform."
PDS reported a cash balance of US$73.8mln from the end of December, saying it believed that with the anticipated initiation of one registrational trial in 2023, this was sufficient cash to fund operations and research and development programs into the third quarter of 2024.
It reported a net loss for the calendar year of US$40.9mln, or US$1.43 per share, compared to a net loss of US$16.9mln, or US$0.66 per share the prior year.
The higher net loss was primarily attributed to investment in research and development, including the clinical programs and the acquisition of PDS0301. Research and development expenses were US$29.4mln compared to US$11.3mln.