Biotechnology is a difficult area and with limited information available, generating hypotheses for complex biological interactions is tough and, as a result, it's expected to be wrong. You might be ok with simply accepting the efficacy for Azer-cel halved from the historical average, but I am not. The dosing information was not made public until after I had made my hypothesis, and since then, I have never mentioned it.
Perhaps you would like to tell everyone here what happened on the Phase 2 trial after the final analysis between June 2022 and the date on clinicaltrials.
There is a lot to be learned from HER-Vaxx and particularly how the clinical trial was planned which will help further understand current and future biotechnology investments.
Clinical trials are the gateway to commercialisation: proving a drug is fit for purpose within a pre-defined patient population, and where there is competition, prove that it provides added benefit. A poorly structured clinical trial can prevent even a very good drug from making its way to approval.
HER-Vaxx was always intended to be used in populations where Herceptin (used in conjunction with chemotherapy) was not commercially available or too expensive. As a result, the current patient population that have received HER-Vaxx are all either Indian or Eastern European. This is a clinical failure because the patient population does not represent the largest global pharmaceutical markets like the USA and China, which are dominated by other successful drugs.
The phase 2 trial of HER-Vaxx determined whether HER-Vaxx + Chemotherapy provided better survival than Chemotherapy alone. Firstly, the sample size was not large enough to generate reliable safety data. Secondly, HER-Vaxx failed to demonstrate statistical significance over Chemotherapy at industry standard statistical analysis metrics. Lastly, since HER-Vaxx was not tested directly against Herceptin + Chemotherapy, it is impossible to understand how the drugs performance compares. This is a clinical failure because Herceptin was the primary competition with majority market share in the largest pharmaceutical markets.
The key takeaway here is HER-Vaxx was crippled from the very beginning because the study design lacked the necessary components to be impactful in a competitive global pharmaceutical market. Once this is understood to a reasonable level, turn your gaze towards Vaxinia and onCARlytics. Decide for yourself whether the study designs are answering patient population and competition questions that correlate with securing a commercial outcome.
(20min delay)