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Celgene Corporation
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AMG-420 versus bb2121 From Canaccord yesterday....brief clip John Newman, Ph.D. | Analyst | Canaccord Genuity LLC (US) A new challenger? AMG-420 versus bb2121 BiTE generates buzz in multiple myeloma space, but data very limited at this point AMG-420, a bispecific T-cell engager (BiTE), demonstrated efficacy in a small number of patients, with 5/5 patients treated in a high-dose cohort achieving 100% sCR as Best Overall Response, but results are very early. While data seem positive, we remind investors that data is very limited and may not show the whole picture. The sample size is currently small, and we are still missing specific details on safety and duration. Furthermore, observed efficacy could change as sample size grows, just as we saw a significant difference between the 75% CR/CRh rate versus 43% CR/CRh rate for blinatumomab, another BiTE, in 2011 (n=12) and 2014 (n=189), respectively. Additional AMG-420 data is set to read out by YE18, potentially at ASH 2018. The data we currently have is too limited to be conclusive. AMG-420 dosing inconvenient; next-gen BiTE more likely to be competitive The dosing of AMG-420 is similar to Blincyto—a continuous IV infusion over 4 weeks out of 6 weeks constituting one cycle and multiple cycles may be necessary. All else being equal, we think that the dosing is a significant barrier for patients, nurses, and doctors, especially since CAR T products like bb2121 just need to be dosed once. AMGN is working on a once-weekly formulation, which could be more competitive, but the efficacy and safety of such a formulation is still unclear. We believe bb2121 is still in a strong position in terms of dosing, and if efficacy/safety end up being similar between the CAR T and BiTE products, we think there is a distinct competitive advantage for bb2121. Historical evidence suggests CAR T therapy should be more efficacious than BiTE Based on FDA-approved BiTE (Blincyto) and CAR T products (Kymriah, Yescarta) that all target the same receptor (CD19), we find that the CAR T products generally produce higher response rates and longer durations of response in 2 different indications (pediatric r/r ALL and adult r/r DLBCL). The difference between the CAR T and BiTE therapies are stark and are the best comparisons we have currently to our AMG-420/ bb2121 scenario. While the analog is not perfect since the targets differ, we think that it could imply that CAR T therapy is a more efficacious method of cancer treatment. Maintain BUY, $250 PT We maintain our BUY rating on BLUE with a $250 PT given our continued positive expectation for the active programs. We maintain our positive outlook on the bb2121 program and will continue to monitor the progress of AMG-420. Data on AMG-420 is scant and there is not enough information for a proper comparison between the programs. However, based on previous, real-world BiTE and CAR T products, it would imply that bb2121 should perform better than AMG-420. Even if the therapeutic profile is similar between bb2121 and AMG-420, we believe that the single dose necessary for bb2121 will be a significant competitive advantage over the continuous infusion or once weekly dosing of AMG-420 or AMG-701. We may not see a data update at ASH 2018 https://canaccordgenuity.bluematrix.com/sellside/EmailDocViewer?encrypt=bdd2b843-d31d-403b-b1b9-ddbbbf890581&mime=pdf&co=Canaccordgenuity&id=replaceme@bluematrix.com&source=mail (December 1-4, 2018) for the bb2121 program; however, we do expect a readout for bb21217, and potentially H125, the company's next-gen CAR T product. |
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