Kiadis updates status of marketing authorization application for ATIR101
Amsterdam, The Netherlands, June 28, 2019 - Kiadis Pharma N.V. ("Kiadis" or the "Company") (Euronext Amsterdam and Brussels: KDS), a clinical-stage biopharmaceutical company, today announced that it has received feedback from the European Medicines Agency (EMA) related to the marketing authorization application (MAA) seeking approval of ATIR101 in hematopoietic stem cell transplant (HSCT). As previously announced, Kiadis submitted responses to the second Day 180 list of outstanding issues for ATIR101 to EMA in May 2019.
As part of the review process, EMA today informed Kiadis that it will convene a Scientific Advisory Group (SAG) in September, comprising of experts in hematology and HSCT to assist EMA in arriving at a determination.
"We appreciate the feedback from EMA and look forward to continuing our interaction with them during the review of our MAA for ATIR101," said Arthur Lahr, CEO, of Kiadis Pharma. "With the SAG meeting now preceding the subsequent CAT and CHMP meetings as part of the EMA approval process, we are changing our guidance to potential EU conditional approval in 2020."
While initial launch in the EU is delayed, Kiadis is on track to complete enrollment in the Phase 3 ATIR101 HSCT study in 2021 to support potential marketing approval in the US. Additionally, the company is also on track to start the Phase 1/2 studies of CSDT002 in HSCT and relapse and refractory acute myeloid leukemia in 2020. With a novel cell-based cancer immunotherapy platform consisting of both T-cell and NK-cell technologies, Kiadis has the opportunity to potentially revolutionize transplants and develop novel cancer cell therapies.
About ATIR101 and CSDT002
Administered as adjunctive immunotherapeutics on top of HSCT, ATIR101 and CSDT002 provide lymphocyte infusions with functional, mature and potent immune cells from a haploidentical family member. The T-cells in ATIR101 and NK-cells in CSDT002 are intended to help fight infections and remaining tumor cells, until the immune system has fully re-grown from stem cells in the transplanted graft. In addition, CSDT002 has shown promise in the treatment of relapse/refractory AML.
In ATIR101, T-cells that would cause GVHD are depleted from the donor lymphocytes, using our photodepletion technology. At the same time, ATIR101 contains potential cancer-killing T-cells from the donor that could eliminate residual cancer cells and help prevent relapse of the disease.
In CSDT002, nanoparticle processing technology enables improved ex vivo expansion and activation of NK-cells supporting multiple high-dose infusions with potent anti-cancer cytotoxicity.
About Kiadis Pharma
Founded in 1997, Kiadis Pharma, is a fully integrated biopharmaceutical company committed to developing innovative therapies for patients with late-stage blood cancers. With headquarters in Amsterdam, the Netherlands, and offices in the US and across Europe, Kiadis Pharma is leveraging the natural strengths of humanity and our collective immune system to source the best cells for life.
Kiadis Pharma is listed on the regulated market of Euronext Amsterdam and Euronext Brussels since July 2, 2015, under the symbol KDS. Learn more at www.kiadis.com.
Forward Looking Statements
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For more information, please contact:
| Kiadis Pharma: |
Sr. Vice President, Corporate Affairs
| Optimum Strategic Communications: |
Mary Clark, Supriya Mathur, Hollie Vile
Tel: +44 203 950 9144
David Brilleslijper (Amsterdam)
Tel: +31 610 942 514