In a June 10, 2021 research note, H.C. Wainwright & Co. analyst Joseph Pantginis provided an update on Targovax ASA's (TRVX:OSL) lead immune activator ONCOS-102, a genetically modified oncolytic adenovirus, it is assessing in several indications.
Regarding ONCOS-102 in malignant pleural mesothelioma, the biotech just announced the median overall survival at 24 months demonstrated in its Phase 1/2 study, and according to Pantginis, the result "provides the rationale for moving the asset to late stage development" in this tumor type.
This open-label study, the analyst reiterated, is testing ONCOS-102 in combination with standard of care pemetrexed/cisplatin as a firstline treatment in malignant pleural mesothelioma. Of the 31 enrolled patients, 20 received the combination treatment whereas the other 11 only received chemotherapy.
In the randomized group of eight patients, median overall survival was between 21.9 and 25 months. The same metric was lower, 13.5 months and 12–16 months, respectively, in the study's chemotherapy-only cohort and historically in patients treated per standard of care.
"Importantly, positive tumor responses and survival outcome were associated with evidence of broad and powerful immune activation assessed in tumor biopsies pre- and post-ONCOS-102 treatment (day 36)," Pantginis pointed out. Patients who received combination treatment, when compared to those who only got the standard of care treatment, demonstrated increased T-cell infiltration and a "shift towards pro-inflammatory immune cells."
Now, Pantginis relayed, Targovax is working to determine the best approach to advance ONCOS-102 in malignant pleural mesothelioma, including the next study's design, scope and timelines. In doing so, the company is talking with key opinion leaders and considering the change taking place in the current malignant pleural mesothelioma treatment landscape. Now, following approval by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency, the combination of ipilimumab and nivolumab is replacing pemetrexed/cisplatin as the firstline standard of care.
In addition, ONCOS-102, in combination with Keytruda, was shown in a recent study to reactivate cyclin kinase inhibitor (CKI)-resistant refractory melanoma. Thus, Targovax is looking at the potential for ONCOS-102 in CKI-resistant malignant pleural mesothelioma as well, "expanding on the demonstrated ability of ONCOS-102 to bring benefit to the majority of patients who still progress after checkpoint inhibitor treatment," Pantginis wrote.
As for ONCOS-102 in PD-1 refractory melanoma, Targovax is currently finalizing the design of a registrational, open-label trial of combination ONCOS-102 and Keytruda. Targovax expects to meet with the FDA in August 2021 and potentially dose the first patient in H2/22.
"Recall that a Phase 2 study, with a single arm with a target population of approximately 100 patients, is expected to be sufficient to seek accelerated approval (with parallel confirmatory trial) and registration," Pantginis wrote. Most likely, Targovax will not have to conduct a randomized trial.
In terms of ONCOS-102 plus Keytruda for melanoma, Targovax recently announced updated immune response data. They showed that ONCOS-102 induced a "broad and powerful" immune response in that T cells in the tumor increased, even in patients whose cancer previously was refractory to the oncolytic virus therapy, T-VEC.
"We believe these data continue to build confidence in ONCOS-102's median overall survival and in its development potential in melanoma and beyond," wrote Pantginis.
Pantginis also addressed Targovax's pipeline. He indicated that ONCOS-102 in melanoma and mesothelioma comprises the bulk of H.C. Wainwright's valuation on Targovax but that the immuno-oncology company is also pursuing novel assets alone or via a collaborative partnership. They include ONCOS-211, a next generation ONCOS, with Leidos; ONCOS plus target tyrosine kinase Inhibition, with Papyrus Therapeutic; and ONCOS in combination with TG-mutant RAS peptides, with Valo Therapeutics.
H.C. Wainwright has a rating of Buy and a price target of NOK17 per share on Targovax. In comparison, its current share price is NOK8.25, suggesting the stock has twobagger potential.
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