Anocca has achieved regulatory approval for its first clinical trial, VIDAR-1, a major milestone in the company’s transition to a clinical-stage organisation.

The trial will evaluate advanced pancreatic cancer treatments and begins in Q2, 2025, at leading university hospitals in Sweden, Denmark, Germany and the Netherlands.

The VIDAR-1 programme, a phase 1/2 multi-product umbrella trial, focuses on patients with KRAS-positive advanced pancreatic cancer. Initially, it will investigate Anocca’s ANOC-001 therapy, which targets the KRAS G12V mutation. This therapy, a groundbreaking TCR-T cell solution, is the first non-viral gene-edited treatment approved for trials in Europe. ANOC-001 is manufactured at Anocca’s state-of-the-art cGMP facility.

Reagan Jarvis, co-founder and CEO, said: “This approval is a significant step in Anocca’s development as we transition to a clinical-stage company. ANOC-001 represents the first of many products that will advance to the clinic in the coming years.”

Phase 1 will initially enrol up to 20 patients per product, with additional countries and sites introduced in phase 2. The trial aims to address the unmet needs of pancreatic cancer patients, offering hope for improved outcomes through innovative treatments.

Zahid Bashir, Chief Medical Officer, addsed: “We are excited with the approval of VIDAR-1, as it represents a significant step towards addressing the unmet medical needs in patients with pancreatic cancer.”

Grifols has announced positive results from its phase 2/3 clinical trial evaluating the efficacy and safety of intravenous immunoglobulin (IVIG) to treat post-polio syndrome (PPS). The study showed significant improvement in mobility for patients receiving IVIG compared to placebo.

The trial, conducted over one year, met its primary endpoint of improved physical performance in the two-minute walk distance (2MWD). Patients receiving monthly IVIG infusions demonstrated a statistically significant improvement in 2MWD compared to those on placebo.

IVIG, specifically Flebogamma 5% DIF, was found to be safe and well tolerated, with a similar safety profile to other IVIG treatments. The study involved 191 participants, with the majority experiencing symptoms primarily in their legs.

In addition to improved 2MWD, patients treated with IVIG also showed greater endurance in the six-minute walk distance (6MWD). The treatment demonstrated a 29.16-meter improvement in 6MWD compared to placebo.

PPS can develop decades after an initial polio infection, with symptoms worsening over time. An estimated 12-to-20 million polio survivors worldwide are at risk of developing PPS symptoms, with 25% to 40% likely to be affected.

“There are no medications indicated for PPS, and therapies are limited to supportive measures,” said Dr Jörg Schüttrumpf, Grifols Chief Scientific Innovation Officer.  “These results show a meaningful physical accomplishment, providing patients with more freedom of movement.”