H.C. Wainwright downgraded Advaxis (NASDAQ:ADXS) to “neutral” from “buy” and removed its price target after Amgen terminated a development and collaboration agreement on ADXS-NEO, Advaxis’ personalized neoantigen-targeting therapy. The stock closed at 23 cents on Dec. 17.
In June 2018, the first-in-human Phase 1 study of ADXS-NEO began dosing patients with metastatic microsatellite stable colorectal cancer, metastatic non-small cell lung cancer or metastatic head and neck cancer.
While Amgen did not provide a reason for ending the collaboration, analyst Swayampakula Ramakanth writes that Amgen had likely been receiving real-time updates from the open-label study, which “in our view, raises concerns regarding the manufacturing, dosing and/or clinical efficacy of ADXS-NEO.”
Mr. Ramakanth said Amgen was Advaxis’ only major development partner and that to-date, no clinical data has been presented on ADXS-NEO nor ADXS-HOT, Advaxis’ shared-antigen therapy based on the same platform.
As a result, with the lack of evidence to the contrary, “we believe that Amgen’s withdrawal from the agreement has considerably increased the development risk on ADXS-NEO and potentially ADXS-HOT as well,” he added.
Mr. Ramakanth said that Advaxis’ stock is currently trading near 52-week lows in the range of 20-to-30 cents, and is likely to remain “range-bound until clinical updates from the ADXS-NEO and ADXS-HOT programs are available, which we expect in 2019.”
