Date: 2016-07-11
Type of information: Collaboration agreement
Compound: ATIR101™ (Allodepleted T-cell ImmunotheRapeutics)
Company: Kiadis Pharma (The Netherlands) The Leukemia & Lymphoma Society
Therapeutic area: Cancer - Oncology
Type agreement: collaboration
Action mechanism: cell therapy/immunotherapy product. ATIR™ is a cell based medicinal product candidate enabling stem cell transplantations from mismatched (haploidentical) family donors to patients suffering from blood cancer. Stem cell transplantation is the only potentially curative option for many patients but a matching donor is available for only half of the patients in need. ATIR™ thus has the potential to address this unmet need and to make stem cell transplantations available for patients worldwide. Those T-cells in a haploidentical graft which would cause Graft-versus-Host-Disease (GvHD) are selectively eliminated using proprietary technology to produce ATIR™. ATIR™ is administered as an adjunctive treatment on top of a haploidentical stem cell transplantation enhancing early immune reconstitution without causing GvHD.
Disease: acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL)
Details: * On February 1, 2016, Kiadis Pharma announced that it has entered into a partnership with The Leukemia & Lymphoma Society (LLS) under which LLS will fund the Phase II development of Kiadis Pharma’s lead product, ATIR101™, through an equity investment of approximately $1 million. LLS is investing via its Therapy Acceleration Program (TAP), a strategic initiative to partner directly with biotechnology companies to help accelerate the development of promising therapies, and the funds will be used to finance Kiadis Pharma’s second ongoing Phase II trial in leukemia patients. The Company intends to continue this trial into a randomized controlled Phase III pivotal study that is planned to start later this year. This ongoing phase 2 trial is investigating the repeated dosing of ATIR101™ as an adjunctive treatment to a T-cell depleted haploidentical hematopoietic stem cell transplantation (HSCT) (donor cells from a half-matched related donor) in adult patients with acute myeloid leukemia (AML) or acute lymphoblastic leukemia (ALL). The trial (CR-AIR-008; NCT02500550 / EudraCT 2015-002821-20) is conducted under an IND of the FDA and is set up to enroll patients in the United States as well as other countries, including Canada, Belgium and the United Kingdom.
Financial terms:
Latest news: * On July 11, 2016, Kiadis Pharma announced that its partnership with The Leukemia & Lymphoma Society (LLS), the world’s largest voluntary health agency focused on blood cancers, has been strengthened with a second equity investment by LLS into the development of Kiadis Pharma’s lead product ATIR101™. LLS initially invested approximately US$1 million in February 2016 through an equity investment via its Therapy Acceleration Program (TAP). This second investment will now also be used to finance Kiadis Pharma’s second ongoing Phase II trial in leukemia patients which the Company then intends to continue into a randomized controlled Phase III pivotal study on track to start later this year. The second funding by LLS has taken place through an equity investment of approximately US$750,000 and a total of 67,020 shares will be issued to LLS.
