US and UK authorities give Swiss biotechs green light to accelerate cancer therapies

iOnctura, a clinical-stage biotechnology company developing breakthrough therapies for patients suffering from cancer. The startup received the innovative medicine designation, the Innovation Passport, for the startup’s drug candidate, roginolisib. Roginolisib is a first-in-class, non-ATP-competitive, allosteric modulator of PI3Kd, which prevents tumor proliferation and breaks immune tolerance in patients with solid and haematological tumors. The Innovation Passport is the entry point to the Innovative Licensing and Access Pathway (ILAP), which aims to accelerate time to market and, thereby, patient access to novel treatments in the UK. Reserved for innovative therapies for life-threatening or seriously debilitating conditions, ILAP provides applicants with a toolkit to support all stages of the design, development, and approval process.

Laevoroc awarded Orphan Drug Designation
Zug-based Laevoroc is developing LR 09, a novel, rationally-designed form of the small molecule drug, Ulodesine, a purine nucleoside phosphorylase (PNP) inhibitor that was originally developed for the treatment of autoimmune and inflammatory disorders. The decision to develop LR 09 for the treatment of relapse after stem cell transplantation follows the achievement of complete remission in a three-year-old patient using a pharmacologically analogous PNP inhibitor whose US development was later discontinued, and the discovery that inhibition of PNP activates (instead of suppressing) the immune system. Laevoroc Immunology acquired the commercial rights to LR 09 for new indications in 2021 and has raised USD 1.1 million in seed capital.

The US Food and Drug Administration (FDA) has granted Orphan Drug Designation for LR 09. “Receiving the FDA’s Orphan Drug Designation for LR 09 is a significant milestone for Laevoroc, bringing us one step closer to delivering a potential cure to patients who suffer a relapse after allogeneic transplantation,” said Thomas Mehrling, haematologist-oncologist, co-founder, and CEO of Laevoroc.

Ymmunobio to accelerate treatment for liver cancer
Ymmunobio's CEACAM Antibody YB-200 for the treatment of hepatocellular carcinoma (HCC) or liver cancer has obtained the FDA Orphan Drug Designation. Liver cancer is responsible for over 12,000 deaths annually in the United States. YB-200 belongs to a novel class of CEACAM1 antibodies with dual action: it acts as a checkpoint inhibitor and has a direct immune agonistic effect on immune cells. The antibody is currently in preclinical development and will bring hope to many patients upon success.

The FDA grants Orphan Drug Designation is awarded to medicines intended for the treatment, diagnosis or prevention of rare diseases or disorders that affect fewer than 200,000 people in the US.

(Press release/RAN)