Therapy Acceleration Program

A strategic initiative to accelerate the development of innovative blood cancer treatments, supportive care and diagnostics.

The Therapy Acceleration Program® (TAP) identifies and funds innovative projects related to therapies, supportive care or diagnostics that have the potential to change the standard of care for patients with blood cancer, especially in areas of high unmet medical need.

TAP funding assists both clinical investigators and companies in gaining critical clinical proof of concept data that better enables them to obtain the resources they need or a partner to complete the testing, registration and marketing of new treatments, supportive care and diagnostics for leukemia, lymphoma and myeloma.

TAP funding is different from the traditional grant at LLS. The TAP review process is separate from the grant process and each approved project is closely monitored by TAP staff. 

Latest News

  • Kiadis Pharma N.V. announced on April 4 2016 positive results on the primary endpoint of its single dose Phase II trial (NCT01794299/EudraCT 2012-004461-41) with its lead product ATIR101™ at the 42nd Annual Meeting of the European Society of Blood and Marrow Transplantation (EBMT) in Valencia, Spain. The data confirms that ATIR101™ can be safely infused, does not cause grade III-IV Graft-versus-Host-Disease (GVHD) and shows a significant reduction in Transplant Related Mortality (TRM) and a significant improvement in Overall Survival (OS) in comparison to a historical control group of patients undergoing a T-cell depleted haploidentical donor transplantation only. Based on the positive results from this Phase II trial, the Company will proceed with the development of ATIR101™ as an adjunctive immuno-therapeutic treatment to a haploidentical HSCT for patients with acute leukemia, initiating a randomised Phase III trial in the second half of 2016.

Kiadis previously entered into a partnership with The Leukemia & Lymphoma Society (LLS) under which LLS is investing via its Therapy Acceleration Program® (TAP) through an equity investment of approximately $1 million for the Phase II development investigating the repeated dosing of ATIR101™. This ongoing Phase II trial (CR-AIR-008; NCT02500550) is set up to enroll patients in the United States as well as other countries, including Canada, Belgium and the United Kingdom.

  • Celator Pharmaceuticals, Inc. announced on March 14th 2016 positive results from the Phase 3 trial of VYXEOS™ (cytarabine: daunorubicin) Liposome for Injection (also known as CPX-351) in patients with high-risk (secondary) acute myeloid leukemia (AML) compared to the standard of care regimen of cytarabine and daunorubicin known as 7+3. The trial met its primary endpoint demonstrating a statistically significant improvement in overall survival. The median overall survival for patients treated with VYXEOS in the study was 9.56 months compared to 5.95 months for patients receiving 7+3, representing a 3.61 month improvement in favor of VYXEOS.  The hazard ratio (HR) was 0.69 (p=0.005) which represents a 31 percent reduction in the risk of death versus 7+3.   The percentage of patients alive 12 months after randomization was 41.5% on the VYXEOS arm compared to 27.6% on the 7+3 arm.  The percentage of patients alive 24 months after randomization was 31.1% on the VYXEOS arm compared to 12.3% on the 7+3 arm. Based on these results the company expects to submit a New Drug Application (NDA) for VYXEOS with the U.S. Food and Drug Administration (FDA) later this year and submit a Marketing Authorization Application (MAA) with the European Medicines Agency (EMA) in the first quarter of 2017. The study was conducted in partnership with The Leukemia & Lymphoma Society® (LLS) through its Therapy Acceleration Program (TAP), which has supported the clinical development of VYXEOS beginning in Phase 2.

  • Valor Biotherapeutics, LLC announced on January 8th 2016 that the first patient was dosed in a phase 1 clinical study of its lead product candidate, IGN002, a novel investigational treatment for non-Hodgkin lymphoma (NHL).  Valor, a joint venture between ImmunGene and Caliber Biotherapeutics, has partnered with The Leukemia & Lymphoma Society (LLS) on the pre-clinical development, manufacturing, and initial proof-of-concept clinical study of IGN002. Data from pre-clinical studies of IGN002 were presented at the American Society of Hematology meeting in December 2015.

  • Kite Pharma, Inc. announced on December 7th 2015 clinical results and biomarker data for the phase 1 portion of Kite's ZUMA-1 trial of KTE-C19 in patients with refractory, aggressive non-Hodgkin lymphoma (NHL). KTE-C19 is an investigational therapy in which a patient's T cells are genetically modified to express a chimeric antigen receptor (CAR) designed to target the antigen CD19, a protein expressed on the cell surface of B cell lymphomas and leukemias. 

    • KTE-C19 was successfully manufactured for all leukapheresed subjects

    • KTE-C19 related adverse events consisted predominantly of cytokine release syndrome (CRS) and neurotoxicity, which were self-limited and generally reversible

    • Four complete remissions (CRs) and one partial remission (PR) were observed, representing an overall objective response rate of 71% (5/7)

The Leukemia & Lymphoma Society (LLS) and Kite Pharma, Inc. entered into a partnership to enhance the development of Kite's lead product candidate, KTE-C19, for the treatment of patients with refractory aggressive non-Hodgkin lymphoma (NHL). Under the collaboration, LLS will launch a broad scope educational program focusing on CAR T-cell therapy for the treatment of blood cancers, as well as support outreach for clinical trial enrollment. LLS also will contribute up to $2.5 million, through the Therapy Acceleration Program®, to help fund Kite's ongoing Phase 1/2 clinical study of KTE-C19 (NCT02348216).

  • Stemline Therapeutics, Inc. announced the presentation of positive clinical data, including high response rates, from the lead-in and ongoing expansion stage of its SL-401 pivotal trial in blastic plasmacytoid dendritic cell neoplasm (BPDCN) at the 2015 American Society of Hematology (ASH) Annual Meeting. The data being presented demonstrate that multiple consecutive cycles of SL-401 produced an 86% (12/14) overall response rate (ORR) in BPDCN, with a 100% (9/9) ORR in first-line BPDCN and a 60% (3/5) ORR in relapsed/refractory BPDCN.  Data was presented for the lead-in and initial expansion stage of the ongoing pivotal trial in BPDCN. Patients continue to enroll and additional data will be available throughout 2016. The study (NCT02113982) is sponsored in part by The Leukemia & Lymphoma Society's Therapy Acceleration Program®.

  • OXiGENE, Inc., a biopharmaceutical company developing vascular disrupting agents (VDAs) for the treatment of cancer, announced on October 21st 2015 that it has initiated a phase 1b/2 clinical trial (Study OX1222) of its investigational drug OXi4503 for treatment of acute myeloid leukemia (AML). OXi4503, which has shown significant activity in preclinical studies of AML, is a novel VDA that is designed to reduce blood flow to tumors and to prevent cancer cells from replicating. Study OX1222 is a continuation and expansion of a phase 1 single site clinical trial of OXi4503 conducted by the University of Florida (UF) with support from the Leukemia & Lymphoma Society. OXiGENE is expanding upon the UF study to speed collection of additional safety and efficacy data and to obtain clinical data for OXi4503 in combination with cytarabine, which is an approved treatment for AML.

Clinical Trials in Partnership with LLS

Both TAP and LLS research grant fundings are critical in supporting many active clinical trials at any given time. The ClinicalTrials.gov website provides an updated listing of clinical trials where LLS is listed as a collaborator. ClinicalTrials.gov is a registry and results database of publicly and privately supported clinical studies of human participants conducted around the world. More information about the clinical trials in partnership with LLS TAP can also be found within each TAP division found below.

How TAP Works

The program comprises three divisions, each with designated strategies, to speed the development of blood cancer treatments, supportive care and diagnostics:

TAP Divisions

Academic Concierge Division

The Academic Concierge Division capitalizes on LLS's academic grant-supported portfolio of development-stage projects. This division supports the further development of selected academic projects (with or without prior LLS grant support) to gain clinical proof of concept. Successful projects will potentially be advanced for further clinical development by creating additional partnerships with pharmaceutical...

Biotechnology Accelerator Division

The Biotechnology Accelerator Division identifies companies developing novel anti-cancer therapies, supportive care or diagnostics and co-funds specific projects that will enable a company to partner or raise additional funding to complete the testing, registration and marketing of new therapies or diagnostics for blood cancer indications. TAP funding is different from the traditional grant at ...

Clinical Trials Division

The Clinical Trials Division was created to help patients gain easier access to clinical trials in the community and familiar settings and to address the bottleneck of clinical trials – patient enrollment rate. In June 2013 the Blood Cancer Research Partnership (BCRP) was established together with the Dana-Farber Cancer Institute in Boston with TAP funding. BCRP aims to accelerate the advancemen...