Delving into the Latest Updates on DI-Leu16-IL2 with Synapse

This is an open-label extension study enrolling participants experiencing clinical benefit following 6 cycles of DI-Leu16-IL2 while enrolled in the Alopexx Oncology Dose-Escalation AO-101 study (NCT01874288). Participants will be permitted to continue to receive DI-Leu16-IL2 at the same dose, schedule, and route of administration they received during Study AO-101 (Main Study). Prior pre-treatment (for example, Rituximab) will continue as before.

Start Date04 Nov 2014

Sponsor / Collaborator

Alopexx Oncology, LLC

NCT01874288 / TerminatedPhase 1/2

A Phase I/II Study of De-immunized DI-Leu16-IL2 Immunocytokine Administered Subcutaneously in Patients With B-cell Non-Hodgkin Lymphoma (NHL)

This dose-escalation study is designed for determining the safety, tolerability, pharmacokinetics (PK), biological, and clinical activity of DI-Leu16-IL2 administered to participants with cluster of differentiation 20 (CD20) positive NHL that have failed standard rituximab-containing therapy.

Start Date25 Nov 2013

Sponsor / Collaborator

Alopexx Oncology, LLC

100 Clinical Results associated with DI-Leu16-IL2

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100 Translational Medicine associated with DI-Leu16-IL2

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100 Patents (Medical) associated with DI-Leu16-IL2

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4

Literatures (Medical) associated with DI-Leu16-IL2

01 Jul 2015·Clinical Lymphoma Myeloma and LeukemiaQ4 · MEDICINE

Three Newly Approved Drugs for Chronic Lymphocytic Leukemia: Incorporating Ibrutinib, Idelalisib, and Obinutuzumab into Clinical Practice

Q4 · MEDICINE

Review

Author: Burger, Jan A ; Wierda, William G ; Sanford, David S ; O'Brien, Susan M ; Keating, Michael J

Three agents have received Food and Drug Administration (FDA) approval for treatment of chronic lymphocytic leukemia (CLL) within the past year. Ibrutinib and idelalisib block B-cell receptor signaling through inhibition of Bruton tyrosine kinase and phosphatidylinositol 3-kinase δ molecules respectively, interfering with several pathways required for leukemia cell survival. Idelalisib has shown efficacy in the relapsed setting and is currently approved by the FDA for use in combination with rituximab. Ibrutinib has been studied in patients with relapsed CLL and as frontline therapy. In the relapsed setting, these agents produce durable remissions, and might be preferable to re-treatment with chemoimmunotherapy for many patients. Ibrutinib is also effective treatment for patients with deletion 17p and is approved by the FDA as frontline therapy in this patient group, although it does not appear to completely abrogate this adverse prognostic factor. These agents have a unique side effect profile and longer follow-up is required to further understand tolerability and rare adverse effects. Obinutuzumab is a type-2 monoclonal anti-CD20 antibody which results in direct and antibody-dependent cell-mediated cytotoxicity of leukemia cells. It is approved by the FDA for use in combination with chlorambucil, and has shown efficacy in the frontline setting in patients unfit for more intensive chemoimmunotherapy. It produces increased response rates and minimal residual disease negativity compared with chlorambucil/rituximab and is associated with an advantage in progression-free survival but not yet overall survival. These agents underscore our advancement in the understanding of the biology of CLL and will improve outcomes for many patients with CLL.

01 Feb 2010·Current opinion in molecular therapeutics

TRU-015, a fusion protein derived from an anti-CD20 antibody, for the treatment of rheumatoid arthritis.

Review

Author: Rubbert-Roth, Andrea

TRU-015, being developed by Trubion Pharmaceuticals Inc and Pfizer Inc, is an intravenously administered anti-CD20 IgG fusion protein for the treatment of rheumatoid arthritis. TRU-015 depletes B-cells from the peripheral blood in vitro, and can mediate complement-and antibody-dependent cellular cytotoxicity. TRU-015 was well tolerated in patients with rheumatoid arthritis in phase I and II clinical trials, and demonstrated an efficacy profile similar to other biological agents approved for rheumatoid arthritis. At the time of publication, phase II trials were ongoing in patients with rheumatoid arthritis. TRU-015 could represent a novel therapy for the treatment of rheumatoid arthritis, although the efficacy, safety profile and advantages of this compound compared with existing therapeutic options would need to be established in phase III trials. In addition, this agent also may be useful to the treatment of B-cell neoplasms and autoimmune diseases.

15 Mar 2007·Cancer ResearchQ1 · MEDICINE

Combining Adoptive Cellular and Immunocytokine Therapies to Improve Treatment of B-Lineage Malignancy

Q1 · MEDICINE

Article

Author: Forman, Stephen J. ; Singh, Harjeet ; Pfeiffer, Timothy ; Colcher, David ; McNamara, George ; Gillies, Stephen D. ; Raubitschek, Andrew ; Jensen, Michael C. ; Olivares, Simon ; Serrano, Lisa Marie ; Al-Kadhimi, Zaid ; Cooper, Laurence J.N. ; Smith, David D.

AbstractCurrently, the lineage-specific cell-surface molecules CD19 and CD20 present on many B-cell malignancies are targets for both antibody- and cell-based therapies. Coupling these two treatment modalities is predicted to improve the antitumor effect, particularly for tumors resistant to single-agent biotherapies. This can be shown using an immunocytokine, composed of a CD20-specific monoclonal antibody fused to biologically active interleukin 2 (IL-2), combined with ex vivo expanded human umbilical cord blood–derived CD8+ T cells, that have been genetically modified to be CD19 specific, for adoptive transfer after allogeneic hematopoietic stem-cell transplantation. We show that a benefit of targeted delivery of recombinant IL-2 by the immunocytokine to the CD19+CD20+ tumor microenvironment is improved in vivo persistence of the CD19-specific T cells, and this results in an augmented cell-mediated antitumor effect. Phase I trials are under way using anti-CD20-IL-2 immunocytokine and CD19-specific T cells as monotherapies, and our results warrant clinical trials using combination of these two immunotherapies. [Cancer Res 2007;67(6):2872–80]

100 Deals associated with DI-Leu16-IL2

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
B-Cell Lymphoma	Phase 2	US	Alopexx Oncology, LLC	25 Nov 2013
Non-Hodgkin Lymphoma	Phase 2	-	Provenance Biopharmaceuticals Corp.	-
Non-Hodgkin Lymphoma	Phase 2	-	Merck Serono SA	-

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Clinical Result

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02151903 (CTgov)	Phase 1/2	B-Cell Lymphoma	5	DI-Leu16-IL2 (DI-Leu16-IL2 1.0 mg/m^2)	(sabwzbczsw) = iswtjkchfw eunnpzdqns (radzfcwttd, ddiiamjzzn - wururrbapf) View more	-	27 Nov 2020
				DI-Leu16-IL2 (DI-Leu16-IL2 2.0 mg/m^2)	(sabwzbczsw) = lskqzvyrdx eunnpzdqns (radzfcwttd, nbblrnmotq - ulxfgoplig) View more
NCT01874288 (DI-Leu16-IL2, CTgov)	Phase 1/2	B-Cell Lymphoma	24	DI-Leu16-IL2 (DI-Leu16-IL2 0.5 mg/m^2)	jqjinpxndt(qpukmqynfu) = yebsilvzme uacpfzvkus (xlmzywsiup, tjfugiinbc - oxdrnnrfln) View more	-	24 Nov 2020
				DI-Leu16-IL2 (DI-Leu16-IL2 1.0 mg/m^2)	jqjinpxndt(qpukmqynfu) = eregcklaou uacpfzvkus (xlmzywsiup, uijuouumiv - ukqijquwha) View more
NCT01874288 (ASCO2016)	Phase 1/2	B-cell lymphoma recurrent	18	DI-Leu16-IL2	pfmmopsers(bzkniuksgd) = DLT occurred in 2 pts at 6 mg/m2 with delayed (8-10 days) grade 3 cytokine release syndrome, suggesting effector cell expansion as the cause. ewvrogljxm (skimyrkfzz ) View more	Positive	20 May 2016