NorthWest Biotherapeutics Inc (NWBO)

[jondoeuk]

Last year the FDA gave $IMDZ orphan drug designation for LV305 and G305 for the treatment of soft tissue sarcoma. LV305 and G305 are the complementary agents that comprise CMB305 which is their "prime boost" cancer immunotherapy product candidate targeting NY-ESO-1.

A Phase I using LV305 has been completed in STS and other NY-ESO-1+ tumours. The DCR in STS was 63%; mOS not reached. For CMB305 the DCR was 67% in STS; mOS not reached either. For the latter 14 patients with synovial, 9 with MRCL and 2 with spindle (NY-ESO-1+) have been treated to date. Of these 92% were metastatic and the same percentage had prior chemotherapy (52% ≥2 prior lines). Over half (56%) had disease progression at study start. The 12 month OS rate was 83.1% and 18 month OS was 76.2%. Data they presented at ASCO shows the OS is coming up to 27 months. So it's better than standard therapy for both 2nd line STS and synovial sarcoma.

A randomised trial in STS using CMB305 -/+ Atezolizumab is ongoing (NCT02609984). One using G100 (NCT02180698) http://www.oncotherapynetwork.com/bone-and-soft-tissue-cancer-targets/intratumoral-injections-may-change-soft-tissue-sarcoma-microenvironment and another will soon start which combines CMB305 + G100.

Then in the first half of 2018 a potential pivotal trial of CMB305 could happen.