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Business Update
Bempegaldesleukin Fails in PIVOT IO-001 Trial
On March 14, 2022, Bristol Myers Squibb (NYSE:BMY) and Nektar Therapeutics (NASDAQ:NKTR) announced that the Phase 3 PIVOT IO-001 trial of bempegaldesleukin (NKTR-214) in combination with Opdivo (nivolumab) in patients with previously untreated unresectable or metastatic melanoma did not meet the primary endpoint of progression-free survival (PFS) and objective response rate (ORR) as assessed by the blinded independent central review. In addition, since the PIVOT IO-001 trial was unsuccessful, the companies decided to discontinue enrollment and unblind the PIVOT-12 trial in adjuvant melanoma, which is examining bempegaldesleukin in combination with Opdivo compared to Opdivo monotherapy in patients at high risk for recurrence after complete resection of melanoma.
Given the previous underwhelming clinical results for bempegaldesleukin, it is not too surprising that the PIVOT IO-001 trial was unsuccessful. However, we also do not feel that there is any type of read-through for other IL-2 clinical trials, particularly those using an engineered IL-2 such as Medicenna's (NASDAQ:MDNA) MDNA11.
MDNA11 is an engineered version of IL-2 that is designed to have enhanced binding to the IL-2 beta receptor (IL-2Rβ) and to not bind to the IL-2 alpha receptor (IL-2Rα). As the figures below show, MDNA11 shows enhanced binding to IL-2Rβ compared to recombinant human IL-2 (rhIL-2), but displays no binding to IL-2Rα.
MDNA's binding characteristics are in stark contrast to bempegaldesleukin, in which it has decreased affinity to IL-2Rα (but still binds it) and binds to IL-2Rβ with lower affinity than native IL-2. The unique binding characteristics of MDNA11 to the various subunits of the IL-2 receptor will likely lead to a differentiated clinical profile compared to bempegaldesleukin, thus we don't believe that investors should look at the PIVOT IO-001 results as portending a bad outcome for MDNA11.
Medicenna is currently conducting the Phase 1/2 ABILITY Study (A Beta-only IL-2 ImmunoTherapY Study) of MDNA11 in patients with advanced solid tumors. We previously reported on encouraging early data from that trial the company shared in December 2021 and we expect the first efficacy readout from that trial in mid-calendar 2022.
Conclusion
The trial failure for bempegaldesleukin in the PIVOT IO-001 trial does nothing to diminish our enthusiasm for MDNA11 and we are eagerly anticipating the first efficacy data from the ABILITY study a few months from now. We believe that what the results of the PIVOT IO-001 trial show is that further modification of IL-2 beyond pegylation is necessary to enhance its therapeutic effect, and since MDNA11 is the only ‘non-alpha binding, enhanced beta binding' version of IL-2 in development, Medicenna is in a unique position should the molecule deliver the positive results in the clinic that we expect. As we await the first efficacy data from the ABILITY study our valuation remains at $12.
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