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 LLS. The TAP review process is separate from the grant process and each approved project is closely monitored by TAP staff.
For information on how to apply to TAP, please click here.
Clinical Studies Ongoing
Stemline Therapeutics, Inc.
SL-401 in Patients With Acute Myeloid Leukemia (AML) and Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN)
This is a non-randomized, open-label, multi center study. A cycle of therapy is 5 consecutive days every 21 days for 6 or more cycles. Stage 1 will consist of a brief run-in period in which patients with BPDCN (previously untreated and previously treated) and AML (persistent/recurrent and previously untreated) will be treated with SL-401 at 3 dose levels. During Stage 2, two cohorts of BPDCN and AML patients will be treated at the maximum tolerated dose or maximum tested dose in which multiple dose-limiting toxicities are not observed (identified in Stage 1).
ClinicalTrials.gov identifier: NCT02113982
For more information contact:
Shay Shemesh, MS
(646) 502-2310
Trials@stemline.com
Visit the Stemline Therapeutics website for additional information and view this informational video - SL-401: An Encouraging Option for Patients With Blastic Plasmacytoid Dendritic Cell Neoplasm.
Kiadis Pharma
A Phase III, Multicenter, Randomized Controlled Study to Compare Safety and Efficacy of a Haploidentical HSCT and Adjunctive Treatment With ATIR101, a T-lymphocyte Enriched Leukocyte Preparation Depleted ex Vivo of Host Alloreactive T-cells, Versus a Haploidentical HSCT With Post-transplant Cyclophosphamide in Patients With a Hematologic Malignancy
The primary objective of this study is to compare safety and efficacy of a haploidentical T-cell depleted HSCT and adjunctive treatment with ATIR101 versus a haploidentical T cell replete HSCT with post-transplant administration of high dose cyclophosphamide (PTCy) in patients with a hematologic malignancy. An additional objective of the study is to compare the effect of the two treatments on quality of life.
ClinicalTrials.gov identifier: NCT02999854
For more information contact:
Jeroen Rovers, MD PhD
+31 20 3140 250
clinicaltrials@kiadis.com
For more information contact the recruiting sites:
Principal Investigator: Denis Claude Roy, MD PhD
Maisonneuve-Rosemont Hospital (Montreal, Canada)
Principal Investigator: Stephan Mielke, MD PhD
Julius Maximilian University of Würzburg (Würzburg, Germany)
Visit the Kiadis Pharma website for additional information.
Acetylon Pharmaceuticals, Inc.
A Dose-Escalation Study to Determine the Maximum Tolerated Dose, Safety, and Preliminary Antitumor Activity of Oral ACY-241 Alone and in Combination With Pomalidomide and Low Dose Dexamethasone in Relapsed or Relapsed and Refractory Multiple Myeloma (Active, not recruiting)
This is a phase 1a/1b, multicenter, single-arm, open-label, dose escalation study to determine the maximum tolerated dose (MTD) and evaluate the safety and preliminary antitumor activity of ACY-241 for oral administration as monotherapy and in combination therapy with orally administered pomalidomide and low-dose dexamethasone in eligible patients with relapsed or relapsed-and-refractory multiple myeloma (MM).
ClinicalTrials.gov identifier: NCT02400242
For more information contact:
Robert Markelewicz, MD
Acetylon Pharmaceuticals, Inc.
rmarkelewicz@acetylon.com
Visit the Acetylon Pharmaceuticals website for additional information.
Affimed
GHSG-AFM13 An Open-label, Multicenter Phase II Trial With AFM13 in Patients With Relapsed or Refractory Hodgkin Lymphoma
The study is designed:
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to demonstrate efficacy of AFM13 with an optimized treatment schedule
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to decide whether AFM13 warrants further investigation in a phase III clinical trial
ClinicalTrials.gov identifier: NCT02321592
For more information contact:
Michael Fuchs
Department of Medicine, Cologne University Hospital
Cologne, Germany
ghsg@uk-koeln.de
Principal Investigator: Andreas Engert, MD
A Phase 1b Dose Escalation Study to Assess the Safety of AFM13 in Combination With Pembrolizumab in Patients With Relapsed or Refractory Classical Hodgkin Lymphoma (KEYNOTE- 206)
The purpose of this study is to establish a dosing regimen for the combination therapy of AFM13 and pembrolizumab (MK-3475) in patients with relapsed or refractory (R/R) Hodgkin Lymphoma (HL) and to assess the safety and tolerability of this combination therapy.
ClinicalTrials.gov identifier: NCT02665650
For more information contact:
Gudrun Beck
+49 6221 65307 ext 23
g.beck@affimed.com
Visit the Affimed website for additional information.
OncoPep
A Phase 1b Study of PVX-410, a Multi-Peptide Cancer Vaccine, and Durvalumab (Anti-PDL1) With and Without Lenalidomide for Patients With Smoldering Multiple Myeloma (Active, not recruiting)
This research study is studying a targeted therapy as a possible treatment for Smoldering Multiple Myeloma. The vaccine in combination with Lenalidomide is being used to hopefully provide immunity against Myeloma. Durvalumab is a check point inhibitor which is being combined here to further augment the immune activity of the vaccine. It is a monoclonal antibody known to take the brakes off the immune system to restore immunity. Lenalidomide in previously studied trials has demonstrated an increase in immune activity. It is the hope of the investigators the combination of the vaccine, Lenalidomide, and Durvalumab will augment immunity even further.
ClinicalTrials.gov identifier: NCT02886065
For more information contact the recruiting sites:
Massachusetts General Hospital
Boston, MA 02115
(617) 726-0711
Principal Investigator: Noopur Raje, MD
Visit the OncoPep website for additional information.
Forty Seven
A Phase 1b/2 Trial of Hu5F9-G4 in Combination With Rituximab in Patients With Relapsed/Refractory B-cell Non-Hodgkin's Lymphoma
This Phase 1b/2 trial will evaluate Hu5F9-G4 in combination with rituximab. Hu5F9-G4 is a monoclonal antibody which is designed to block a protein called CD47, which is widely expressed on human cancer cells. Blocking CD47 with Hu5F9-G4 may enable the body's immune system to find and destroy the cancer cells. Rituximab is a monoclonal antibody drug that is used for treatment of non-Hodgkin's lymphoma and other types of cancer.
The major aims of the trial are: (Phase 1b) to investigate the safety and tolerability of sequential dose cohorts and to determine a recommended Phase 2 dose for Hu5F9-G4 in combination with rituximab, and (Phase 2) to evaluate the efficacy of Hu5F9-G4 in combination with rituximab in patients with indolent lymphoma or diffuse large B-cell lymphoma as measured by the overall response rate.
ClinicalTrials.gov identifier: NCT02953509
For more information contact:
Mark Chao, MD PhD
650-352-4150
medical@fortyseveninc.com
For more information contact the recruiting sites:
City of Hope
Duarte, CA 91010
Brianna Phye
brbrophy@coh.org
Sarah Cannon Research Institute
Nashville, TN 37203
Ian Flinn, MD
(615) 329-7274
Visit the Forty Seven website for additional information.
Constellation Pharmaceuticals
A Phase 1 Study of CPI-0610, a Small Molecule Inhibitor of BET (Bromodomain and Extra-terminal) Proteins, in Patients With Progressive Lymphoma (Active, not recruiting)
The purpose of this study is to investigate the first in human, open-label, sequential dose escalation and expansion study of CPI-0610 in patients with progressive lymphoma. CPI-0610 is a small molecule inhibitor of bromodomain and extra-terminal (BET) proteins.
ClinicalTrials.gov identifier: NCT01949883
Contact: Debbie Johnson 617-714-0531 - debbie.johnson@constellationpharma.com
For more information contact the recruiting sites:
Colorado Blood Cancer Institute
Denver, Colorado,80218
Contact: Juli Murphy
(720) 754-4890
Principal Investigator: Michael B Maris, MD
Massachusetts General Hospital
Boston, Massachusetts, 02114
Contact: Jeremy Abramson, MD
(617) 724-4000
Principal Investigator: Jeremy Abramson, MD
The Ohio State University James Cancer Hospital
Columbus, Ohio, 43210
Contact: Kristie Blum, MD
(614) 293-7807
Principal Investigator: Kristie Blum, MD
Sarah Cannon Research Institute
Nashville, Tennessee, 37203
Contact: Sarah Cannon Research Institute
(877) 691-7274
Principal Investigator: Ian Flinn, MD, PhD
A Phase 1 Study Evaluating CPI-0610 in Patients With Acute Leukemia, Myelodysplastic Syndrome, Myelodysplastic/Myeloproliferative Neoplasms and Myelofibrosis
The purpose of this study is to investigate the open-label, sequential dose escalation and expansion study of CPI-0610 in patients with previously treated Acute Leukemia, Myelodysplastic Syndrome, Myelodysplastic/Myeloproliferative Neoplasms, and Myelofibrosis. CPI-0610 is a small molecule inhibitor of bromodomain and extra-terminal (BET) proteins.
ClinicalTrials.gov identifier: NCT02158858
Contact: Debbie Johnson 617-714-0531 - debbie.johnson@constellationpharma.com
For more information contact the recruiting sites:
Horizon Oncology Center
Layfayette, IN, 47905
(765) 446-5111
info@horizonbioadvance.com
Principal Investigator: Wael Harb, MD
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
(617) 724-1124
afathi@partners.org
Principal Investigator: Amir Fathi, MD
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10065
(212) 639-3314
Principal Investigator: Eytan Stein, MD
University of Pennsylvania - Perelman Center for Advanced Medicine
Philadelphia, Pennsylvania, United States, 19104
Contact: Jessica McGraw (215) 662-4610 Jessica.Mcgraw@uphs.upenn.edu
Principal Investigator: James Mangan, MD
A Phase 1 Study Evaluating CPI-0610 in Patients With Previously Treated Multiple Myeloma
The purpose of this study is to investigate the open-label, sequential dose escalation and expansion study of CPI-0610 in patients with previously treated multiple myeloma. CPI-0610 is a small molecule inhibitor of bromodomain and extra-terminal (BET) proteins.
ClinicalTrials.gov identifier: NCT02157636
Contact: Debbie Johnson 617-714-0531 - debbie.johnson@constellationpharma.com
For more information contact the recruiting sites:
Mayo Clinic
Scottsdale, Arizona, 85259
Contact: Clinical Trials Office All Mayo Clinic Locations
(507) 538-7623
Principal Investigator: Lief Bergsagel, MD
Massachusetts General Hospital
Boston, Massachusetts, 02114
Contact: Noopur Raje, MD
(617) 724-4000
Principal Investigator: Noopur Raje, MD
University of Pennsylvania - Perelman Center for Advanced Medicine
Philadelphia, Pennsylvania, 19104
Contact: Rita Bhagat, BS, RN, BSN, CCRP - rita.bhagat@uphs.upenn.edu
(215) 614-0548
Principal Investigator: Dan Vogl, MD
Sarah Cannon Research Institute
Nashville, Tennessee,37203
Contact: Salah Nabhan - Salah.Nabhan@scresearch.net
(615) 329-7215
Principal Investigator: Jesus Berdeja, MD
Visit the Constellation Pharmaceuticals website for additional information.
ImmunGene, Inc.
A Phase 1, Open-Label, Dose-Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Multiple Intravenous Doses of IGN002 Administered Weekly to Subjects with Refractory Non-Hodgkin Lymphoma (NHL)
The purpose of this study is to investigate the open-label, sequential dose escalation and expansion study of IGN002 in patients with refractory Non-Hodgkin lymphoma. IGN002, comprises an anti-CD20 monoclonal antibody attached to interferon (IFN) through a stable peptide linker system. CD20 is expressed on Non-Hodgkin lymphoma and other B cell driven hematologic malignancies.
ClinicalTrials.gov identifier: NCT02519270
For more information contact the recruiting sites:
UCLA
Santa Monica, California, 90404
Contact: Doris Quintanilla
310-582-4060
dquintanilla@mednet.ucla.edu
Principal Investigator: John Timmerman, MD
University of Florida
Gainesville, Florida, 32610
Contact: Cathy Spears
352-265-0680 ext 87658
cdspears@ufl.edu
Principal Investigator: Nam Dang, MD
UT MD Anderson Cancer Center
Houston, Texas, 77030
Contact: Chizobam "Chi Chi" Obi
713-794-3074
CIObi@mdanderson.org
Principal Investigator: Loretta Nastoupil, MD
Visit the ImmunGene website for additional information.
Other Active Programs
Selvita S.A.
SEL120 is an ATP-competitive and selective inhibitor of CDK8 and a closely related serine kinase, CDK19. CDK8 is a part of a multi-protein complex that regulates gene expression and is distinct from CDK4 or CDK6, which play a role in cell cycle progression. In laboratory experiments, treatment with SEL120 has been shown to result in the death of AML cells especially with elevated phosphorylation of STAT5 and stem cell characteristics, which is significant because AML stem cells are typically resistant to conventional therapies and thereby mediate relapsed disease. Moreover, the status of phosphorylation of STAT5 may provide a useful biomarker for action of the drug. The molecular mechanism of action involves modulation of various oncogenic transcriptional programs that are critical to the survival of AML cells. This unique mechanism, which does not overlap with existing therapies, may allow the development of highly effective combination therapies that may be required to provide long term control of AML in patients.
SEL120 has shown efficacy in treating AML cells both in vitro and in vivo (mouse models). SEL120 has successfully passed a series of non-GLP toxicity studies in mice and monkeys. Selvita initiated Investigational New Drug (IND)-enabling studies for SEL120 in June 2017, a critical step in getting the U.S. Food and Drug Administration’s permission to begin in human clinical trials.
Visit the Selvita website for additional information.
Criteria/How to Apply
When a company seeks funding, it needs to demonstrate the compounds, biologics or diagnostics in development:
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Are highly innovative
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Have therapeutic potential in blood cancer field with near-term probability of providing benefits to patients
A company also needs to demonstrate:
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Competency of its management and scientific staff
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Financial strength
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Freedom to operate, including intellectual property protection
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Well-designed regulatory and commercialization strategies
TAP builds business alliances and collaborations with companies. The funding TAP provides is not a grant, nor for building the company's infrastructure. It is designed to complement the company resources to accelerate the development of a therapeutic asset, supportive care or diagnostic.
The TAP team reviews all companies that make an inquiry but will only invite those deemed to meet diligence criteria to complete a proposal template and be considered for TAP funding.
To submit an inquiry for initial non-confidential review, contact Dr. Jun Xu, Executive Director, Therapy Acceleration Program®, The Leukemia & Lymphoma Society, 3 International Drive, Suite 200, Rye Brook, NY 10573; jun.xu@lls.org.