ADC Therapeutics bumps up series E by $76M, prepares lead drug for 2020 filing

greenlight
ADC Therapeutics is wrapping up the pivotal phase 2 study for ADCT-402, its lead program, in relapsed or refractory diffuse large B-cell lymphoma. (Nadine Doerlé/Pixabay)

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.

Webinar

How ICON, Lotus, and Bioforum are Improving Study Efficiency with a Modern EDC

CROs are often at the forefront of adopting new technologies to make clinical trials more efficient. Hear how ICON, Lotus Clinical Research, and Bioforum are speeding database builds and automating reporting tasks for data management.

RELATED: ADCT says decision to pull HER2 drug doesn’t affect other candidates

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.

RELATED: ASCO: Astellas, Seattle Genetics' ADC banishes 12% of bladder cancers

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.

Suggested Articles

Akoya Biosciences raised $50 million to help boost its commercialization in research, drug development and clinical testing markets.

Eli Lilly is combining the oncology team at Lilly Research Laboratories with Loxo Oncology and putting a trio of Loxo execs at the helm.

The failure of SAGE-217 to beat placebo wiped more than 50% off Sage’s share price as investors digested the implications of the data.