Therapy Acceleration Program
Therapy Acceleration Program
Since 2017, four TAP-supported therapies have been approved by the U.S. Food and Drug Administration (FDA) or included in the National Comprehensive Cancer Network (NCCN) Guidelines:
Currently, there are over 20 active clinical studies with TAP-supported assets, including 6 registration-enabling clinical studies (4 in blood cancer & 2 beyond blood cancer).
TAP Portfolio Assets in Company Sponsored Trials - Blood Cancer Development
NEWEST PARTNER - June 2022
Turku, Finland - Faron Pharmaceuticals is a clinical stage biopharmaceutical company developing novel treatments for medical conditions with significant unmet needs caused by dysfunction of our immune system. The Company currently has a pipeline based on the receptors involved in regulation of immune response in oncology, organ damage and bone marrow regeneration.
Bexmarilimab, a novel anti-Clever-1 humanized antibody, is its investigative precision immunotherapy with the potential to provide permanent immune stimulation for difficult-to-treat cancers through targeting myeloid function. A Phase 1 study in AML (BEXMAB) has been cleared by the FDA and Finnish Medicines Agency and is currently enrolling patients.
NEWEST PARTNER - June 2022
Marseille, France - ImCheck Therapeutics is designing and developing a new generation of immunotherapeutic antibodies targeting butyrophilins, a novel super-family of immunomodulators.
ICT01 is a humanized, anti-BTN3A (also known as CD277) monoclonal antibody that selectively activates γ9δ2 T cells, which are part of the innate immune system that is responsible for immunosurveillance of malignancy and infections. EVICTION (NCT04243499) is a first-in-human clinical trial of ICT01 in patients with various advanced relapsed or refractory solid or hematologic cancers (includes acute myeloid leukemia, acute lymphocytic leukemia, follicular lymphoma, and diffuse large B cell lymphoma patients).
San Diego, CA - Abintus Bio is developing cutting-edge in vivo CAR therapies that allow for powerful CAR T cells to be generated directly in a patient’s body, eliminating the need for time-consuming and costly collection, engineering and re-infusion of patient T cells.
Products are in preclinical development with a goal to explore in blood cancers and solid tumors using this novel technology platform being developed by Abintus.
Heidelberg, Germany - Affimed is a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer by actualizing the untapped potential of the innate immune system using the proprietary ROCK® platform to enable a tumor-targeted approach to recognize and kill a range of hematologic and solid tumors.
AFM13 is bispecific tetravalent engager targeting CD30 on tumor cells and CD16A on NK cells and macrophages. AFM13 is currently in a Phase 2 registration-directed clinical trial in relapsed or refractory CD30-positive peripheral T-cell lymphoma (NCT04101331). The clinical trial recently completed enrollment and topline data is expected in the second half of 2022.
Breda, Netherlands - argenx is a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases and cancer by partnering with leading academic researchers to translate immunology breakthroughs into a world-class portfolio of novel antibody-based medicines.
Cusatuzumab is a first-in-class, high-affinity anti-CD70 monoclonal antibody. Cusatuzumab is currently being investigated in acute myeloid leukemia and higher-risk myelodysplastic syndromes in the CULMINATE (NCT04023526) and ELEVATE (NCT04150887) clinical trials.
San Diego, CA - BioTheryX is a clinical-stage biopharmaceutical company focused on restoring protein homeostasis, including protein degradation and modulation, and multi-kinase inhibition to develop treatments intended to extend and improve the quality-of-life of patients with cancer and other diseases.
BTX-A51 is a small molecule inhibitor of CK1-alpha as well as super enhancer targets (CDK7/CDK9). A clinical study of BTX-A51 in patients with relapsed or refractory AML or high-risk MDS (NCT04243785) is ongoing.
BXT-1188 is a dual target protein degrader specifically engineered to degrade GSPT1 and IKZF1/3. A clinical study of BTX-1188 in patients with advanced hematologic and solid tumor malignancies (NCT05144334) is ongoing.
Berkeley, CA - Caribou is a clinical-stage biotechnology company, co-founded by CRISPR pioneer and Nobel Prize winner Jennifer Doudna, Ph.D., using next-generation CRISPR genome-editing technology to develop “off-the-shelf” (allogeneic) CAR therapies for hard-to-treat blood cancers.
CB-010, an allogeneic CD19 CAR-T cell therapy in which PD-1 was genetically disrupted in the CAR-T genome, leading to more durable anti-tumor activity in pre-clinical studies, is being evaluated in a Phase 1 clinical trial for patients with relapsed/refractory B cell non-Hodgkin lymphoma (NCT04637763).
CB-011, an allogeneic BCMA CAR-T cell therapy that is immunologically cloaked for enhanced persistence, is in preclinical development for the treatment of multiple myeloma.
CB-012, an allogeneic CD371 CAR-T cell therapy, is in preclinical development for the treatment of acute myeloid leukemia.
Philadelphia, PA - Carisma is a biopharmaceutical company developing a differentiated and proprietary cell therapy platform focused on engineered macrophages. Carisma is looking at an innovative way to harness yet another part of the human immune system.
Carisma will further develop its proprietary engineered-macrophage platform to support the development of one or more CAR macrophage cell therapy programs for hematological malignancies.
Munich, Germany - Constellation Pharmaceuticals was a clinical-stage biopharmaceutical company developing novel therapeutics that selectively modulate gene expression to address serious unmet medical needs in patients with cancer. MorphoSys acquired Constellation in July 2021 and continues to enroll patients with myeloproliferative neoplasms in multiple clinical studies.
Pelabresib (CPI-0610) is a small molecule inhibitor of bromodomain and extra-terminal (BET) proteins. Pelabresib in combination with ruxolitinib is in a Phase 3 clinical trial (NCT04603495) for myelofibrosis patients that have not been previously treated with Janus kinase inhibitors. In November 2018, the FDA granted CPI-0610 Fast Track Designation for treatment of myelofibrosis.
Foster City, CA - Forty Seven was a clinical-stage immuno-oncology company that was developing therapies targeting cancer immune evasion pathways and specific cell targeting approaches based on technology licensed from Stanford University. Gilead Sciences acquired Forty Seven in March 2020 and continues to develop magrolimab in multiple clinical studies in patients with myelodysplastic syndrome, acute myeloid leukemia, non-Hodgkin lymphoma, and solid tumors.
Magrolimab is a first-in-class monoclonal antibody against the CD47 receptor. Magrolimab is being investigated in multiple Phase 3 clinical studies. One Phase 3 study supported in part by LLS TAP involves magrolimab in combination with azacitidine for the treatment-naive patients with higher risk myelodysplastic syndrome (NCT04313881). In September 2020, the FDA granted magrolimab Breakthrough Therapy Designation for the treatment of newly diagnosed myelodysplastic syndrome.
Palo Alto, CA - Immune-Onc is a clinical-stage cancer immunotherapy company dedicated to the discovery and development of novel myeloid checkpoint inhibitors for cancer patients.
IO-202 is a first-in-class monoclonal antibody that antagonizes LILRB4. IO-202 is in a Phase 1 clinical trial for the treatment of advanced acute myeloid leukemia and chronic myelomonocytic leukemia (NCT0437243). In February 2022, the FDA granted IO-202 Fast Track Designation for treatment of AML.
Waltham, MA - Immunitas is committed to discovering and developing novel, differentiated therapeutics for patients with cancer using a discovery engine that combines deep expertise in single-cell genomics with customized machine learning approaches to elucidate immune cell populations that are key actors in immuno-oncology.
IMT-009 is a first-in-class NK and T cell modulator targeting CD161 that is being developed for the treatment of solid tumors and hematological malignancies and is expected to enter the clinic in 2022.
San Diego, CA - Kura Oncology is a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer with a pipeline that consists of small molecule drug candidates that target cancer signaling pathways.
Ziftomenib (KO-539) is selective small molecule inhibitor of menin. Ziftomenib is currently in a Phase 1/2 clinical trial treating patients with acute myeloid leukemia, including patients with NPM1 mutations or KMT2A rearrangements (NCT04067336).
Watertown, MA - Kymera Therapeutics is a clinical-stage biopharmaceutical company founded with the mission to discover, develop, and commercialize transformative therapies while leading the evolution of targeted protein degradation, a transformative new approach to address previously intractable disease targets.
KT-333 is STAT3 protein degrader. KT-333 is in a Phase 1 clinical trial currently enrolling NHL patients (NCT05225584).
KT-413 is a dual protein degrader of IRAK4 and IMiD substrates. KT-413 is in a Phase 1 clinical trial currently enrolling DLBCL patients (NCT05233033).
Gaithersburg, MD - NexImmune is a clinical-stage biotechnology company developing a novel approach to immunotherapy designed to orchestrate a targeted immune response by directing the function of antigen-specific T cell using a proprietary Artificial Immune Modulation (AIM™) nanoparticle technology platform.
NEXI-001 is donor-derived multi-antigen-specific CD8+ T cell therapy. NEXI-001 is in a Phase 1 clinical trial to treat patients with advanced acute myeloid leukemia or myelodysplastic syndrome who relapse following an allogeneic hematopoietic cell transplantation (NCT04284228).
NEXI-002 is a patient-derived multi-antigen-specific CD8+ T cell therapy. NEXI-002 is in a Phase 1 clinical trial for patients with relapsed/refractory multiple myeloma who have failed ≥3 prior lines of therapy (NCT04505813).
Cambridge, MA - OncoPep is developing targeted immunotherapeutics to prevent the progression of cancer, prolong survival and restore the quality of life of patients.
PVX-410 is a multi-peptide therapeutic vaccine being evaluated in smoldering multiple myeloma and triple negative breast cancer. PVX-410 is currently being tested in combination with citarinostat (small molecule inhibitor of HDAC) and lenalidomide in patients with smoldering multiple myeloma (NCT02886065).
Krakow, Poland - Ryvu Therapeutics is a clinical-stage drug discovery and development company focusing on novel small molecule therapies that address emerging targets in oncology using a proprietary discovery engine platform.
RVU120 is a highly selective first-in-class CDK8/CDK19 small molecule inhibitor. RVU120 is currently in a Phase 1 clinical trial in patients with acute myeloid leukemia or high-risk myelodysplastic syndrome (NCT04021368).
South San Francisco, CA - Sutro Biopharma is a clinical-stage drug discovery, development and manufacturing company that uses precise protein engineering and rational design to advance next-generation oncology therapeutics.
STRO-001 is a CD74-targeting antibody-drug conjugate. STRO-001 is currently being investigated in a Phase 1 clinical trial of patients with advanced B-cell malignancies, including multiple myeloma and non-Hodgkin lymphoma (NCT03424603).
Medford, MA - Travera was founded in 2017 to commercialize a breakthrough measurement technology and biomarker developed in the Manalis Laboratory in the Koch Institute for Integrative Cancer Research at the Massachusetts Institute of Technology. A new measurement tool called the Suspended Microchannel Resonator (SMR) makes exquisitely precise measurements of the effects of cancer drugs on cancer cells.
Travera is studying the use of its SMR tool to measure the mass accumulation rate as a predictive biomarker in patients with relapsed and/or refractory multiple myeloma by working with prominent academic institutions to enroll study participants (NCT03777410).
Needham, MA - Verastem Oncology is a biopharmaceutical company committed to the development and commercialization of new medicines to improve the lives of patients diagnosed with cancer. In September 2020, Verastem sold duvelisib to Secura Bio where the company continues development in patients with peripheral T-cell lymphoma (PTCL).
Duvelisib (COPIKTRA) is a marketed oral small molecule inhibitor of phosphoinositide 3-kinase (PI3K), and the first FDA-approved dual inhibitor of PI3K-delta and PI3K-gamma for chronic lymphocytic leukemia or small lymphocytic lymphoma. Duvelisib continues to be clinically studied in PTCL with enrollment of the Phase 2 registration-directed PRIMO study recently being completed (NCT03372057).
In December 2021, the National Comprehensive Cancer Network (NCCN) added duvelisib to the Clinical Practice Guidelines in Oncology (NCCN Guidelines) for PTCL based on interim data from the Phase 2 study, supported in part by LLS TAP.
Boston, MA - X4 Pharmaceuticals is a late-stage clinical biopharmaceutical company and a leader in the discovery and development of novel therapies for the treatment of diseases resulting from dysfunction of the CXCR4 pathway, with a focus on rare diseases and those with limited treatment options.
Mavorixafor is a first-in-class small molecule antagonist of chemokine receptor CXCR4. Mavorixafor is currently being evaluated in a global Phase 3 clinical trial in patients with WHIM syndrome (NCT03995108), and in combination with ibrutinib in patients with Waldenström’s macroglobulinemia (NCT04274738).