Kiadis Pharma announced that The Leukemia & Lymphoma Society (LLS) is making an equity investment of approximately $1 million to fund the company’s ongoing Phase 2 study of ATIR101 as an adjunctive treatment to stem cell therapy in certain blood cancers, and to support its preparations for further clinical testing.
“We are pleased to be partnering with the world’s largest voluntary health agency focused on blood cancers. We see this as another validation of our innovative product candidate ATIR101. The extensive network and expertise of The Leukemia & Lymphoma Society will be extremely valuable to us as we prepare to set up the pivotal Phase III study later this year. The fact that LLS is investing into Kiadis Pharma with equity is also a strong sign of confidence in what we do and our goal remains to be to bring this important product to patients as quickly as possible,” Kiadis’ CEO, Manfred Rüdiger, PhD, said in a press release.
ATIR101 (Allodepleted T-cell ImmunotheRapeutics) is being tested in 15 patients with a partially matched (haploidentical) family member serving as a donor for allogeneic hematopoietic stem cell transplantation (HSCT) — currently seen as a potentially effective treatment for blood cancers. The ongoing Phase 2 trial is looking into the repeated dosing of ATIR101 as an adjunctive treatment to a T-cell depleted HSCT in adults with acute myeloid leukemia (AML) or acute lymphoblastic leukemia (ALL).
The treatment is a lymphocyte infusion (DLI) from a haploidentical family member providing the patient with T-cells to help fight infections, eliminate residual cancer cells and prevent relapse, known as the Graft-versus-Leukemia (GVL) effect. ATIR101 essentially is intended to buy time until the recipient’s immune system is able to fully re-establish itself using the stem cells in the transplanted graft. Haploidentical donors are used to reduce the risk of Graft-versus-Host-Disease.
At the ASH2015 annual meeting, researchers presented promising interim data on this novel therapeutic approach. ATIR101 has been granted Orphan Drug Designations both in the U.S. and Europe, and Kiadis is planning to further develop its lead candidate and move it into a randomized, controlled Phase 3 clinical study later in 2016.
“Stem cell transplantation is one of the most effective curative treatments for blood cancer patients, but it comes with great risk of life-threatening infection and graft versus host disease (GVHD). Kiadis Pharma’s ATIR101 shows promise in fighting these infections by boosting the patient’s immune system whilst also reducing GVHD. LLS is enthusiastic about supporting this program which we hope will improve outcomes for patients with blood cancers,” Louis J. DeGennaro, PhD, LLS president and CEO, said.
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