LLS’ Second Investment in Kiadas Pharma Will Help Fund Phase 2 Trial of Leukemia Therapy

LLS’ Second Investment in Kiadas Pharma Will Help Fund Phase 2 Trial of Leukemia Therapy

Kiadis Pharma recently said its collaboration with The Leukemia & Lymphoma Society (LLS) has been strengthened with a second equity investment by LLS to advance Kiadis’ lead product candidate ATIR101.

The second funding by LLS is roughly $750,000. Kiadis will issue 67,020 shares to LLS. The first investment by LLS was about $1 million in February through the society’s Therapy Acceleration Program, a collaborative initiative with biotech companies to help in the development of promising therapies.

The second investment will fund Kiadis Pharma’s ongoing Phase 2 clinical trial in patients with leukemia, which will continue as a randomized controlled Phase 3 pivotal trial planned to begin later this year.

The ongoing study (CR-AIR-008; NCT02500550 / EudraCT 2015-002821-20) is examining ATIR101 given at repeated doses as an adjunctive therapy to a T-cell depleted haploidentical hematopoietic stem cell transplantation (HSCT) in adults with acute lymphoblastic leukemia (ALL) or acute myeloid leukemia (AML). The trial is conducted under the FDA’s investigational new drug designation and will enroll patients in the U.S., Canada, Germany, Belgium, the United Kingdom, and other countries.

Haploidentical family donors are becoming an effective alternative for patients in need of HSCT who lack an HLA-matched donor (HLA is a protein found on most cells and used to match patients with a donor for their bone marrow or cord blood transplant).

To prevent graft-versus-host disease (GVHD), intensive in-vivo or ex-vivo T-cell depletion is often used, resulting in slow immune system reconstitution, frequent and often lethal infectious complications and/or high relapse rates, decreasing overall survival.

To overcome these limitations, Kiadis developed ATIR101, allowing additional donor lymphocytes to be infused post-HSCT without the risk of inducing severe GVHD, and maintaining the ability to react against infections and leukemia cells.

ATIR101 provides for a safe donor lymphocyte infusion (DLI) from a partially matched family member without the risk of causing severe GVHD. The T-cells in ATIR101 help fight infections and residual tumor cells and bridge the time until the immune system has fully regrown from stem cells in the transplanted graft.

“We are delighted that LLS has made another significant contribution to the development of our lead product ATIR101 and invested further in Kiadis Pharma,” Kiadis CEO Manfred Rüdiger, PhD, said in a press release. “This is again 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 Pharma’s ATIR101 shows great promise in fighting life-threatening infections and [GVHD] following stem cell transplantations,” said LLS President and CEO Louis J. DeGennaro, PhD. “LLS is very pleased to be increasing its level of support for this program, which we hope will improve outcomes for patients with blood cancers.”