This week, we have a conversation with Valerie Vanhooren, CEO and co-founder of Ona Therapeutics about first-in-class ADCs for tackling tumours, and Daniel Schmitt, president and CEO of Actuate Therapeutics, about targeting multiple molecular pathways in cancer that are involved in promoting tumour growth.
Times:
03:22 Ona Therapeutics
24:08 Actuate Therapeutics
Ona Therapeutics
Ona Therapeutics has reached an important milestone in its development, advancing as a clinical-stage company with its lead first-in-class ADC, ONA-255, now progressing through phase 1a clinical development. More than half of the planned patients have already been enrolled in the study.
Alongside this, Ona has appointed oncologist and physician Aleix Prat as chief medical officer. Prat has worked closely with the company and played a key role in the identification and validation of the target underlying ONA-255.
ONA-255 is a first-in-class ADC designed to target treatment-resistant tumour biology through a novel mechanism, with an initial focus on HR+/HER2-negative advanced breast cancer and gastric cancer. The programme represents an important milestone for Ona following its $86.6m series B financing earlier this year.
The company continues to expand its ADC pipeline, with ONA-389 expected to enter the clinic in the second half of 2027
ONA-418 is advancing a dual-linker, dual-payload approach designed to broaden the potential of Ona’s ADC portfolio.
Actuate Therapeutics
Actuate Therapeutics is developing elraglusib, an investigational GSK-3β inhibitor that targets several pathways involved in tumour growth and drug resistance while also modulating anti-tumour immunity.
In metastatic pancreatic cancer, randomised phase 2 results published in Nature Medicine showed that adding elraglusib to standard chemotherapy reduced the risk of death by 38% and roughly doubled 12-month survival. Since then, Actuate has secured FDA clearance for a phase 1/2 study of an oral tablet formulation and is working with both the FDA and EMA on a potential registrational study.
The company recently shared new preclinical data from its work with the Mayo Clinic and Northwestern University showing synergy with Revolution Medicines’ RAS inhibitors zoldonrasib and daraxonrasib, including in chemotherapy-resistant models.
Elraglusib has also produced complete responses in a phase 1 trial in relapsed/refractory Ewing sarcoma, a paediatric cancer with no approved targeted therapies.
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