ADC Therapeutics has expanded its series E by $76 million, bringing the financing to $276 million and its total haul to $531 million. The cash will advance the company’s pipeline of pyrrolobenzodiazepine (PBD)-based antibody-drug conjugates, including an FDA submission for its lead program in 2020.
The cash will carry the Swiss biotech through the end of 2020, CEO Chris Martin, Ph.D., told FierceBiotech. The company is wrapping up the pivotal phase 2 study for ADCT-402 (loncastuximab tesirine), its lead program, in relapsed or refractory diffuse large B-cell lymphoma (DLBCL) and expects to unveil top-line data later this year. It plans to file for FDA approval as a single agent in that particular blood cancer by the end of next year.
ADC is also studying ADCT-402 on its own in non-Hodgkin lymphoma and in combination with Johnson & Johnson and Pharmacyclics' BTK inhibitor Imbruvica for relapsed or refractory DLBCL and mantle cell lymphoma, as well as with the British pharma’s checkpoint inhibitor Imfinzi for follicular lymphoma in addition to DLBCL and mantle cell lymphoma.
The company plans to follow the BLA for ADCT-402 with a filing for ADCT-301, which it’s developing for Hodgkin and non-Hodgkin lymphomas and solid tumors. While ADCT-402 targets CD19, ADCT-301 targets CD25 on regulatory T cells. ADC hopes this mechanism will prove effective in hard-to-treat solid tumors that don’t tend to respond to checkpoint inhibitors, such as head and neck cancer and pancreatic cancer, Martin said. The treatment is designed to knock down regulatory T cells to bring about an immune response to these types of tumors, he said.
Its first filing for ADCT-301, however, will be in a blood cancer. ADC is gearing up for a BLA-enabling phase 2 study for ADCT-301 in relapsed or refractory Hodgkin lymphoma.
The company plans to launch its first product, ADCT-402, in 2021, going it alone in North America and marketing it with partners in the rest of the world, Martin said. It plans to go the same route for ADXT-301.
“We’re recruiting fairly heavily on the commercial and regulatory side of the organization,” he said. ADC’s preclinical and clinical development staff are split between London and New Jersey, with a chemistry, manufacturing and controls team based in California.
“We will be setting up our North American commercial team in the New Jersey offices, so it will be quite a substantial increase in staff, particularly in the North American part of the organization,” Martin said.