ADC Therapeutics nearly went through the entire alphabet before trying, twice, to get off an IPO. Now, that's done, and it’s looking to become a commercial biotech.
Today, the Swiss company said it has sent off a biologics license application (BLA) to the FDA for loncastuximab tesirine, nicknamed “lonca,” an antibody-drug conjugate targeting CD19 in patients with relapsed diffuse large B-cell lymphoma (DLBCL).
It expected to file for approval in the second half of the year and has delivered on that promise, gunning for the DLBCL license, an indication already well-catered for with next-gen CAR-T therapies including Novartis’ Kymriah and Gilead’s Yescarta.
The FDA will look over data for the therapy out of a phase 2 open-label test of 145 patients, which showed patients taking the drug after already having several prior treatments saw an overall response rate of 48.3% and a complete response rate of 24.1%. The tolerability profile “was generally manageable,” the biotech said.
“The completion of our first BLA submission to the FDA is a significant milestone for ADC Therapeutics and takes us one step further in our evolution toward becoming a commercial-stage organization,” said Chris Martin, CEO of ADC Therapeutics.
“We are grateful to the trial participants and investigators and to all our employees for their commitment to this clinical program, and we look forward to working with the FDA to bring Lonca to patients as quickly as possible.”
Following that lead indication, should it be approved, ADC is also developing lonca for other blood cancers including follicular lymphoma, following the same playbook as other biotechs who typically start with DLBCL and work their way through the blood cancer pathway.
It’s also seeking out whether combos can boost its efficacy, with a phase 1/2 trial in the works with Janssen’s Imbruvica (ibrutinib) in patients with relapsed or refractory DLBCL or mantle cell lymphoma and a phase 3 confirmatory clinical trial with fellow Swiss biopharma Roche’s Rituxan (rituximab) in patients with relapsed or refractory DLBCL.
The cancer drug developer reeled in $233 million in its Wall Street debut in May, at the height of the pandemic in the West and after its final series E in 2019, which came after an aborted attempt to list on the NYSE.
Outside of lonca, ADC also aims to finish a phase 2 study of camidanlumab tesirine, or “cami,” which targets CD25 to treat Hodgkin and non-Hodgkin lymphomas. But the Genmab-partnered program hit a snag back in April when the FDA placed a partial clinical hold on the Hodgkin trial due to safety concerns.
Two of the 47 patients in the study were diagnosed with Guillain-Barré syndrome, a rare disorder in which the immune system attacks the nerves. The partial hold was, however, lifted in July, and the company also has plans to use cami in solid tumors.