Kiadis abandons lead PhIII program, shifts focus to natural killer cells
Kiadis Pharma announced that it is shifting focus to natural killer cells — and is itself killing off the long-running but deeply troubled Phase III ATIR program that has largely defined the company. It will cut approximately half of its workforce.
Kiadis acquired CytoSen Therapeutics and its natural killer (NK) technology in April. The Netherlands-based Kiadis had been developing a T cell therapy called ATIR101 that was then in Phase III for blood cancer patients, namely acute myeloid leukemia. At the time, it seemed that the Dutch biotech would pair its T cell therapy with the US-based NKs in an intercontinental, multi-cellular effort with implications for transplants and oncology.
“The ATIR T-cell and CSDT002-NK-cell programs each have the potential to make transplants safer and more effective,” Kiadis CEO Arthur Lahr said at the time. “In combination, they have the potential to revolutionize HSCT, making it suitable for an even wider group of patients.”
The big red flag came at the end of October, when Kiadis warned investors it was expecting a rejection from the EMA for ATIR101, which would set it back until at least the next interim analysis in 2021. Today, Kiadis is ending that trial altogether and retiring the compound. Lahr said the decision was “taken in the best interest of patients.”
Jefferies analyst Philippa Gardner was surprised and unimpressed by the news.
“This now shifts the focus to the early-stage NK-cell platform acquired April, to which we do not currently ascribe any value,” she wrote. “An expert event on Friday is now critical for understanding its potential. The restructuring should extend the cash runway, but a lack of catalysts and dent to management credibility remain overhangs.”
Kiadis is now left with two main compounds it acquired from Cytosen. K-NK003 also targets AML. It is headed into the clinic next year, based on early proof-of-concept data from 25 patients. Those patients showed a 69% complete response rate, Kiadis said.
The other drug is K-NK0002, a supplemental treatment to the standard of care for certain stem cell transplants: namely haploidentical hematopoietic stem cell transplantation (HSCT) with post-transplant cyclophosphamide. A Phase I/II trial on 63 patients will begin next year based on proof-of-concept data from 25 patients. The drug reduced long-term relapse rates from 45% to 8% in those patients, Kiadis said.
The Cytosen-acquired platform is based on research from the University of Central Florida that showed how nanoparticles from antigen-presenting cells could be used to stimulate NK cell proliferation.