September 2026 • PharmaTimes Magazine • 9
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Parsortix study shows promise for ADC target detection
CelLBxHealth has announced the publication of an independent, peer-reviewed study demonstrating that its Parsortix platform can detect antibody-drug conjugate targets on circulating tumour cells taken from patients with triple-negative breast cancer and epithelial ovarian cancer.
The study was conducted by researchers at Trinity College Dublin and St James’s Hospital, Dublin.
They used the Parsortix system to isolate circulating tumour cells from blood samples taken from patients with metastatic triple-negative breast cancer and advanced epithelial ovarian cancer.
The researchers showed that clinically relevant antibody-drug conjugate targets could be detected on Parsortix-enriched circulating tumour cells.
Key findings included detection of TROP-2, the target of the approved antibody-drug conjugate sacituzumab govitecan, on circulating tumour cells from triple-negative breast cancer patients. Importantly, this included cells with low EpCAM expression, a surface marker relied upon by conventional circulating tumour cell platforms.
The study also showed that FRα, the target of the approved antibody-drug conjugate mirvetuximab soravtansine, was detectable on circulating tumour cells from all three ovarian cancer patients assessed. PD-L1, an immune checkpoint marker relevant to combination immunotherapy strategies, was detectable alongside TROP-2 on the same circulating tumour cells.
A key result was the detection of antibody-drug conjugate targets on circulating tumour cells with low EpCAM expression. This is particularly relevant in aggressive cancers such as triple-negative breast cancer.
Vista trial begins dosing in precision cancer vaccine study
Infinitopes has dosed the first patient with ITOP1, its lead investigational therapeutic cancer vaccine, marking the first clinical evaluation of the company’s Precision Immunomics platform.
The approach combines immunopeptidomic antigen discovery with engineered viral vector technologies to identify naturally presented tumour antigens capable of generating durable anti-tumour T-cell responses.
The VISTA study is a multicentre, randomised, double-blind, placebo-controlled phase 1/2a trial conducted with the University of Oxford. It will evaluate ITOP1 in patients with newly diagnosed, surgically resectable oesophageal and gastro-oesophageal junction adenocarcinoma.
Unlike post-surgical vaccination strategies, VISTA investigates treatment while the primary tumour remains in situ, aiming to determine whether earlier immune priming can generate stronger anti-tumour responses.
Current standard of care for resectable disease consists of neoadjuvant FLOT / durvalumab chemoimmunotherapy, surgery and adjuvant chemoimmunotherapy.
In VISTA, ITOP1 is administered between chemoimmunotherapy and surgery, both before and after oesophagectomy, allowing investigators to assess vaccine-induced immune responses throughout first-line treatment.
Professor Mark Middleton, Chief Investigator of the VISTA trial, said: “The first patient dosed in VISTA is an important landmark for our programme and for the wider field of therapeutic cancer vaccines. The neoadjuvant setting provides a fantastic opportunity to study immune responses while the patient’s primary tumour is still there.”
Qnovia has secured a worldwide exclusive licence to a new antimicrobial peptide developed at the University of Virginia, marking its move into a second therapeutic area alongside its smoking cessation programme.
The peptide, known as D8, uses a mechanism distinct from conventional antibiotics and has shown activity against multidrug-resistant bacterial pathogens and biodefence threat agents. Early laboratory and animal testing indicates potential across respiratory, bloodstream, skin and soft-tissue infections.
Sanofi has received European Commission approval to extend the indication of MenQuadfi to infants from six weeks of age, broadening access to protection against invasive meningococcal disease caused by serogroups A, C, W and Y.
The vaccine had previously been authorised in the EU for individuals aged 12 months and older. Invasive meningococcal disease is a rapidly progressing bacterial infection that can lead to death within 24 hours of symptom onset.
Polpharma Biologics has announced that the FDA and EMA have accepted for review the BLA and MAA for PB016, a proposed vedolizumab biosimilar to Entyvio for intravenous use in adults with moderately to severely active ulcerative colitis and Crohn’s disease. The acceptances mark major milestones in the company’s development programme and reinforce its commitment to expanding access to affordable biologic medicines.
Lexeo Therapeutics has secured Regenerative Medicine Advanced Therapy (RMAT) designation from the FDA for LX2020, its investigational AAV-based gene therapy for PKP2 arrhythmogenic cardiomyopathy.
The decision follows interim clinical data from the ongoing HEROIC-PKP2 phase 1/2 trial.
The company said LX2020 now holds RMAT, Orphan Drug and Fast Track designations, strengthening its regulatory position as development continues.
NHS England continues to face significant pressures, with waiting lists still above seven million and cancer targets routinely missed. A&E departments report severe overcrowding, long ambulance delays and rising corridor care.
Staffing shortages persist across nursing, mental health and primary care, contributing to burnout and service disruption. Financial deficits are widening, while maternity and mental health services remain under scrutiny following multiple safety investigations.
NICE has not recommended lecanemab for routine NHS use in Alzheimer’s disease, citing uncertainty over long-term clinical benefit and its very high cost. The decision represents one of the year’s most high-profile negative appraisals, leaving patients without access to the therapy through standard NHS commissioning.