It completed the Phase 2 mono trial but not Phase 2 combination trial, so still in Phase 2.
Here's the link to the second Ph2 study: Study Details | A Study of IMU-131 (HER-Vaxx) in Combination With Chemotherapy or Pembrolizumab in Patients With Metastatic HER2/Neu Over-Expressing Gastric Cancer (nextHERIZON) | ClinicalTrials.gov
* yes, I know it's frustrating for it to need more than one Ph2 trail but a few years ago LC was banging on about how combination are the future, so perhaps it shouldn't be a surprise it needs both Ph2 mono and combo to complete Ph2. At least with PD1-Vaxx, they moved straight into combo in the Ph1 with nine arms being in combo with Atezolizumab, and the Vaxinia Ph1 has arms with Pembrolizumab. So, combination therapy for HER-Vaxx is clearly not in response to the HER-Vaxx result &/or lack of licencing but rather what is now needed when running trials and unfortunately the HER-Vaxx mono trial was designed and run before combinations became the benchmark and consequently a combo trial needed to be run to capture that data.
However, I don't disagree the lack of a licencing deal for any of the drugs and/or near-term timeframes for commercial outcomes is the main reason for the low share-price. Hopefully Vaxinia can get accelerated approval into biliary tract cancer or another indication otherwise we're most likely looking at possibly 2027 for Azer-cel to enter the market (if it can obtain FDA registration) as being the most likely driver to catapult the SP.
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