BEIJING – Legend Biotech Corp., headquartered in Somerset, N.J., filed with the U.S. SEC last week plans to raise up to $100 million to advance its BCMA-targeting CAR T candidate, LCAR-B38M, by listing on Nasdaq. Legend confidentially submitted a draft registration statement to the regulators in March.

It is not immediately known how many American depositary shares Legend will issue or at what price. Its parent company, HKEX-listed Genscript Biotech Corp., is expected to own a certain portion of its ordinary shares and remain its majority shareholder.

Legend’s chief financial officer, Ying Huang, declined BioWorld’s request for a comment on the company’s IPO plan.

To prepare for the U.S. IPO, Genscript ended Legend’s status as a majority-owned subsidiary in March. In a statement on March 16, Genscript said the spin-off “will enable operational focus and strategy development at both the company and Legend Biotech level,” among other reasons.

“Owing to the significant need for capital resources to support Legend Biotech’s clinical development plans and growth, and increase financial flexibility, Legend Biotech is considering its separate listing,” Genscript added. The proceeds are particularly needed to advance its lead product candidate, LCAR-B38M, a CAR T-cell therapy being co-developed with Janssen Biotech Inc. for treating multiple myeloma and known as JNJ-4528 outside of China.

The need for the IPO is fueled by the encouraging clinical data of LCAR-B38M, which Legend said demonstrated the drug’s potential to deliver deep and durable antitumor responses in relapsed and refractory multiple myeloma patients with a manageable safety profile.

In December 2018, clinical data from a phase I study that enrolled 74 patients across four independent sites showed that those treated with LCAR-B38M had at least 24 months of median follow-up and achieved an overall response rate of 88%, with a complete response rate ranging from 74% to 82%. The biotech further revealed that in the largest site of 57 patients, median overall survival was 36.1 months as of July 31, 2019.

Further encouraging results were found in the phase Ib/II registrational trial of JNJ-4528 in the U.S. and Japan, with all 29 patients treated with the therapy candidate from the phase Ib portion achieving a response, for an overall response rate of 100%. As of April 20, with a median follow-up of 11.5 months, 86% of patients achieved a stringent complete response. The nine-month progression-free survival rate was 86%, and 22 of the 29 patients remained alive and progression-free at the time of data cutoff.

“Overall, the safety profile of LCAR-B38M/JNJ-4528 has been consistent with the safety profile of other CAR T-cell therapies in hematologic malignancies,” said Legend in its document to the U.S. regulators last week. “We anticipate that data from the phase II portion of [the trial] will be presented at a major medical conference in the second half of 2020.”

For now, Legend is recruiting patients for a phase II confirmatory trial to further evaluate LCAR-B38M in advanced relapsed or refractory multiple myeloma in China. The biotech is also building GMP manufacturing facilities to prepare for the launch of LCAR-B38M once marketing approval comes.

LCAR-B38M will also be investigated in global studies, namely a phase II trial in patients with multiple myeloma in various clinical settings, and a randomized phase III trial in around 400 patients with multiple myeloma who have received one to three prior lines of therapy and are refractory to lenalidomide.

In December 2019, LCAR-B38M gained the FDA’s breakthrough therapy designation for treating relapsed or refractory multiple myeloma. It received orphan drug designation in February 2019 and a PRIME designation from the EMA in April 2019.

“This marks an important regulatory milestone,” Legend’s CEO Yuan Xu told BioWorld in a previous interview. He added that the designation had helped expedite the development and review of the therapy to treat multiple myeloma, which is seen as an incurable disease.

The biotech further revealed that it plans to submit a biologics license application to the FDA and a market authorization application to the EMA for LCAR-B38M for relapsed or refractory multiple myeloma, in the second half of this year.

Legend and Janssen entered their partnership in 2017. Janssen paid $350 million up front to gain the worldwide license to jointly develop and commercialize LCAR-B38M in multiple myeloma with Legend. To date, Legend has received four milestone payments totaling $110 million.

Advancing pipeline

Besides its potential blockbuster LCAR-B38M, Legend also has eight product candidates in its pipeline that target various cancers, including non-Hodgkin lymphoma (NHL), acute myeloid leukemia and T-cell lymphoma, of which the first two are currently in investigator-initiated phase I trials in China.

Legend is also developing an allogeneic CAR T product candidate targeting CD20 for the treatment of NHL that is in an investigator-initiated phase I trial in China. The biotech has several product candidates in early preclinical and clinical development for treating solid tumors and infectious diseases.

Genscript said those pipeline programs “require significant resources to support and further clinical development,” which is why Legend is eager to raise capital in the U.S. market.

Positioning itself as a clinical-stage biopharma company specializing in novel cell therapies for oncology and other indications, Legend has yet to make a profit and recorded net losses of $133 million last year.

Prior to Legend’s Nasdaq attempt, Shanghai-based immunotherapy biotech I-Mab Biopharma Co. Ltd. launched a $100 million IPO in January and Shanghai-based Zai Lab Ltd. raised $173 million on the U.S. bourse in 2017.

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