With November PDUFA Date, FDA Could Approve Biotech’s Lead Cell Therapy Soon

Source: Streetwise Reports   08/24/2021

A BTIG report noted that Legend Biotech’s cilta-cel has the potential “to take significant market share within the relapsed-refractory multiple myeloma market and establish a best-in-class profile.”

In an Aug. 23 research note, BTIG analyst Justin Zelin reported Legend Biotech Corp. (LEGN:NASDAQ) Q2/21 financial results and clinical achievements, highlighting likely approval in the near term of its lead therapeutic candidate.

Legend has a PDUFA date of Nov. 29, 2021 with the U.S. Food and Drug Administration concerning cilta-cel in relapsed-refractory multiple myeloma, which means the cell therapy could be approved by the end of this year. Cilta-cel is a bispecific autologous chimeric antigen receptor T cell (CAR-T) therapy targeting BCMA in this indication.

Zelin listed other Q2/21 developments regarding cilta-cel in relapsed-refractory multiple myeloma. They include the European Medicines Agency accepting Legend’s marketing authorization application for cilta-cel, and the Brazilian Health Regulatory Agency accepting Legend’s new drug application.

Legend presented longer follow-up data for cilta-cel, from the CARTITUDE-1 trial, at the annual 2021 American Society of Clinical Oncology and the European Hematology Association conferences. Results showed a 98% overall response rate, an 80% stringent complete response rate (criterion used in assessing multiple myeloma), a 66% 18-month progression-free survival rate, and an 81% 18-month overall survival rate, Zelin indicated.

The New Jersey-based biotech started the Phase 3 CARTITUDE-5 trial, which will evaluate cilta-cel in patients who present with newly diagnosed multiple myeloma but do not qualify for a transplant. In this study, Bortezomib, Lenalidomide, and Dexamethasone plus cilta-cel will be compared to Bortezomib, Lenalidomide, and Dexamethasone plus Lenalidomide and Dexamethasone.

Legend, with its partner Johnson & Johnson (JNJ), established a European manufacturing site in Belgium to support their global commercial launch of cilta-cel planned for not only the European Union but also the U.S. and China. Bluebird bio and Bristol Myers Squibb have had delays in rolling out their competitive product, ABECMA, which bodes well for cilta-cel.

“We expect a stronger launch for cilta-cel given Legend and JNJ’s commercial and manufacturing readiness and reiterate the potential for cilta-cel to take significant market share within the relapsed-refractory multiple myeloma market and establish a best-in-class profile,” Zelin wrote.

He added that the cilta-cel therapy is safe and efficacious, can be delivered on an outpatient basis, and has the added benefit of JNJ’s global in-house manufacturing footprint.

As for Legend’s Q2/21 financial results, Zelin reported, the company recorded a net loss of $91.6 million ($91.6M). This compares to its net loss of $81M in the previous quarter. Q2/21 costs included $83.5M in research and development expenses and $26M in sales, and general and administrative expenses. Including the recent $300M private placement, Legend has $488M in cash, cash equivalents, and investments plus additional time deposits of $174M.

Looking forward clinically to the remainder of this year, Zelin noted that Legend is likely to present updated CARTITUDE-1 and CARTITUDE-2 data at the annual American Society of Hematology meeting and publish LEGEND-2 data as well.

Also, using data from the ongoing CARTIFAN-1 trial, also in multiple myeloma, Legend will submit regulatory information to China’s Center for Drug Evaluation and file a new drug application with Japan’s Pharmaceuticals and Medical Devices Agency.

Meanwhile, Zelin noted, the biotech continues developing other assets in its pipeline and conducting multiple Phase 1 studies in China in multiple hematologic and solid tumor cancers. One such trial is LB1901, an anti-CD4 auto-CAR-T for the treatment of T-cell lymphoma, slated to commence this year.

Overall, Zelin declared, “Legend Biotech represents an undervalued player in the anti-BCMA CAR-T space with a therapy approaching global regulatory approval with more immuno-oncology assets in clinical development.”

BTIG rates the biopharma Buy and assigns to it a $55 per share target price. Legend’s stock is currently trading at about $35.31 per share.

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