Positive feedback from MHRA provides alignment on the preclinical, manufacturing, clinical & regulatory pathway for ZI-MA4-1 and supports planned CTA submission

“Receiving positive scientific advice from the MHRA is an important milestone as we prepare to bring ZI-MA4-1 into the clinic,” said Namir Hassan, CEO of Zelluna. “With the involvement of world-class investigators and centres such as The Christie and The Royal Marsden, we are building strong momentum towards initiating a UK-based trial that could generate the first safety and efficacy data in 2026. This progress showcases the talent and dedication of our team, and our shared commitment to advancing a novel, scalable and accessible “off the shelf” cell therapy for patients with solid tumours.”

Share:

More News

“The positive outcome of our pre-IND interactions with the FDA reinforces the development pathway for MaaT034 and supports its continued advancement toward the clinic. It also represents an important step in MaaT Pharma’s expansion into immuno-oncology, highlighting the broader potential of our first in class co-cultivated microbiome donor-independent platform across

“Patients with metastatic RAS G12D non-squamous NSCLC, occurring in approximately 4% of cases, represent an underserved population, with no approved targeted treatment options. Initial clinical data evaluating zoldonrasib in combination with standard of care pembrolizumab and platinum doublet chemotherapy in patients with previously untreated metastatic RAS G12D non-squamous NSCLC showed

“At Georgiamune, we are focused on uncovering novel mechanisms that control immune-cell function and translating that biology into first-in-class medicines across autoimmune disease and oncology,” said Samir N. Khleif, M.D., Founder and Chief Executive Officer of Georgiamune. “GIM-621 is one of multiple programs to emerge from that work, alongside three

“Our team’s outstanding execution has enabled us to rapidly advance three programs into the clinic in 2026 and make significant progress in developing next-generation IO, ADC and combination therapies. Together with our partner, Kelun-Biotech, we have achieved seven IND clearances to date, and by mid-2027, we expect more than 2,000