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.​

 

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.

 

Affimed
​GHSG-AFM13 An Open-label, Multicenter Phase II Trial With AFM13 in Patients With Relapsed or Refractory Hodgkin Lymphoma

The study is designed:

• to demonstrate efficacy of AFM13 with an optimized treatment schedule

• 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 Study of PVX-410, a Cancer Vaccine, and Citarinostat +/- Lenalidomide for Smoldering MM (Active, not recruiting)

This research study is a Phase I clinical trial, which tests the safety of an investigational intervention and also tries to define the appropriate dose of the investigational intervention to use for further studies. "Investigational" means that the intervention is being studied.

In this research study, the investigators are studying Smoldering Multiple Myeloma. Smoldering Multiple Myeloma is an early precursor to a rare blood cancer known as Multiple Myeloma, which affects plasma cells. The study will test two different combinations of the study drugs; a combination of the vaccine (PVX-410) along with Citarinostat (CC-96241) and triple combination of the vaccine, Citarinostat, and Lenalidomide.

The vaccine (PVX-410) is a multi-peptide vaccine that contains four synthetic peptides that together are intended to induce a T cell-mediated immune response against the myeloma. The FDA (the U.S. Food and Drug Administration) has not approved PVX-410 as a treatment for any disease.

Citarinostat is an orally active, small-molecule Histone Deacetylase (HDAC) Inhibitor which is being combined here to further augment the immune activity of the vaccine. Citarinostat has not been approved by the FDA as a treatment for any disease.

Lenalidomide is commercially available analogue of thalidomide with immunomodulatory, antiangiogenic, and antineoplastic properties that has demonstrated an increase in immune activity in previous trials. The FDA has approved Lenalidomide as a treatment option for Smoldering Multiple Myeloma. Lenalidomide is being added to the combination of the vaccine and Citarinostat because it is hypothesized that co-administration of lenalidomide along with Citarinostat would further enhance the T cell-mediated immune response induced by PVX-410.

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.

 

Sutro
​Study of STRO-001, an Anti-CD74 Antibody Drug Conjugate, in Patients With Advanced B-Cell Malignancies

This study is a first-in-human Phase 1, open-label, multicenter, dose escalation study with dose expansion to identify the maximum tolerated dose (MTD), the recommended phase 2 doses (RP2D) and to evaluate the safety, tolerability, and preliminary anti-tumor activity of STRO-001 in adult subjects with B-cell malignancies (MM and NHL) who are refractory to, or intolerant of, all established therapy known to provide clinical benefit for their condition (i.e., trial subjects must not be candidates for any regimens known to provide clinical benefit). The study will consist of two parts: Part 1, dose escalation, and Part 2, dose expansion.

During Part 1 (dose escalation), an accelerated dose titration design will be applied to cohorts A (MM) and B (NHL). Doses will be escalated using an N-of-1 until the first instance of a treatment-related, clinically relevant Grade 2 non-hematologic toxicity or a Grade 3 hematologic toxicity of any type is observed during Cycle 1 (first 28 days). Any event meeting these criteria will be reviewed and confirmed by the Safety Evaluation Team (SET). Each dose escalation cohort will be assessed independently. When these criteria are met then the dose is expanded with 2 additional subjects and the standard 3+3 trial design is used for all further dosing cohorts. The dose escalation (Part 1) phase of the study will be complete when the MTD is determined and the recommended dose for Part 2 (dose expansion) is identified. The RP2D will be selected based on the safety, tolerability and exposure of STRO-001, and will be the end of Part 1 of the study. After determination of the RP2D, subjects with MM or NHL will be enrolled into indication specific dose expansion cohorts (Part 2). The accelerated dose titration (N-of-1) design with seamless transformation into a traditional 3+3 design allows for very low starting doses to be evaluated in fewer patients.

ClinicalTrials.gov identifier: NCT03424603

For more information contact Sutro or the recruiting sites:

Shannon Matheny, PhD
1-650-676-4610
STRO-001ClinDev@sutrobio.com

Julee Cheung
1-650-676-4642
STRO-001ClinDev@sutrobio.com

City of Hope Medical Center
Duarte, California, United States, 91010
Contact: Amrita Krishnan, M.D.   
626-256-4673    
akrishnan@coh.org   

Rocky Mountain Cancer Center 
Aurora, Colorado, United States, 80012
Contact: Mary Catherine Jerome   
281-541-9285    
MaryCatherine.Jerome@McKesson.com   
Principal Investigator: John Burke, MD         

Texas Oncology 
Austin, Texas, United States, 78705
Contact: Mary Catherine Jerome   
281-541-9285    
MaryCatherine.Jerome@McKesson.com   
Principal Investigator: Jason Melear, MD         

Virginia Cancer Specialists
Fairfax, Virginia, United States, 22031
Contact: Karin Choquette, MSN/RN   
571-389-0873    
Karin.Choquette@USOncology.com   
Principal Investigator: Alexander Spira, MD, PhD         

Medical College of Wisconsin 
Milwaukee, Wisconsin, United States, 53226
Contact: General Cancer Center Info   
866-680-0505 ext 8900    
cccto@mcw.edu   
Principal Investigator: Nirav Shah, MD         

Visit the Sutro 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.

 

miRagen
miRagen’s lead program targets miR-155, a microRNA that has key roles in the differentiation, function and proliferation of blood and lymph cells. Therapeutic inhibition of miR-155 in lymphoma cells is believed to restore normal function and reduce the aberrant cell proliferation that is characteristic of cancerous cells. miRagen is developing Cobomarsen (MRG-106) to treat patients who suffer from the mycosis fungicides (MF) form of cutaneous T-cell lymphoma (CTCL). MF is the most common form of CTCL. It generally affects the skin, often causing rash and sometimes disfiguring skin lesions and tumors that can progress internally over time.

In addition to MF, elevation of miR-155 has been associated with several other blood cancers and certain solid tumors. There is a potential opportunity to develop a companion diagnostic that could detect and quantify levels of miR-155 in circulating blood or malignant cells. This approach may then allow for the selection of patients with elevated miR-155 levels who may be more likely to benefit from MRG-106 treatment and allow the drug to be used selectively in multiple cancers. There are several types of cancer in which high levels of miR-155 have been discovered, including subsets of diffuse large B-cell lymphoma, acute myeloid leukemia, certain virally induced lymphomas such as HTLV-1 associated lymphoma and Burkitt’s Lymphoma, Down Syndrome-associated acute lymphocytic leukemia, and other types of cancer. miRagen plans to evaluate additional types of lymphoma and leukemia in Phase 1 clinical trials and intend to explore other potential applications for MRG-106 through additional clinical studies in other tumor types.

miRagen is actively enrolling the following clinical trials for patients with certain blood cancers:

• SOLAR, a Phase 2 clinical trial of cobomarsen (MRG-106) in patients with cutaneous T-cell lymphoma (CTCL), mycosis fungoides (MF) subtype
• Phase 1 clinical trial of cobomarsen (MRG-106) in patients with adult T-cell leukemia/lymphoma (ATLL), chronic lymphocytic leukemia (CLL) and diffuse large B-cell lymphoma (DLBCL)

Criteria/How to Apply

When a company seeks funding, it needs to demonstrate the compounds, biologics or diagnostics in development:

• Are highly innovative

• Have therapeutic potential in blood cancer field with near-term probability of providing benefits to patients

A company also needs to demonstrate:

• Competency of its management and scientific staff

• Financial strength

• Freedom to operate, including intellectual property protection

• 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, please click here to download the form.

Send a completed inquiry form and non-confidential presentation to 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.