Veltucyn (veltuzumab) / Gilead - LARVOL DELTA

Biologics in Systemic Lupus Erythematosus: Recent Evolutions and Benefits. (PubMed, Pharmaceutics) - "Biotechnology progress enables targeted biologic therapies for SLE, reducing disease activity and improving patients' quality of life."

Journal • Review • Glomerulonephritis • Immunology • Inflammatory Arthritis • Lupus • Lupus Nephritis • Nephrology • Systemic Lupus Erythematosus • CD20 • IFNAR2

Immunotherapy in indolent Non-Hodgkin's Lymphoma. (PubMed, Leuk Res Rep) - "Other than that, a resistance mechanism to rituximab emerged by inducing a failure in the apoptosis mechanism...Here came the development of 90Y-ibritumomab tiuxetan and 131I-tositumomab. After it, humanized anti-CD20 emerged ofatumumab, IMMU106 (veltuzumab) in 2005, and ocrelizumab which are considered as second generation anti-CD20 and 3 generation anti-CD20 include AME-133v (ocaratuzumab), PRO131921 and GA101 (obinutuzumab). Also multiple other agents emerged targeting different surface cell antigens like CD52 (alemtuzumab), CD22 (unconjugated epratuzumab and calicheamicin conjugated CMC-544 [inotuzumab ozogamicin]), CD80 (galiximab), CD2 (MEDI-507 [siplizumab]), CD30 (SGN-30 and MDX-060 [iratumumab], Brentuximab vedotin), CD40 (SGN-40), and CD79b (Polatuzumab). Other agents include MAB targeting T-Cells like mogamulizumab, Denileukin Diftitox and BiTEs or bispecific T cell engagers like Mosunetuzumab, Glofitamab, and Epcoritamab...Another important aspect in..."

Journal • Allergy • Chronic Lymphocytic Leukemia • Follicular Lymphoma • Hematological Disorders • Hematological Malignancies • Immune Modulation • Indolent Lymphoma • Inflammation • Leukemia • Lymphoma • Lymphoplasmacytic Lymphoma • Marginal Zone Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Waldenstrom Macroglobulinemia • CD22 • CD40 • CD52 • CD79B • TNFRSF8

Epitope Mapping of Rituximab Using HisMAP Method. (PubMed, Monoclon Antib Immunodiagn Immunother) - "Specific anti-CD20 monoclonal antibodies (mAbs), such as rituximab, ofatumumab, veltuzumab, and ocaratuzumab, have been developed. In this study, we tried to determine the binding epitope of rituximab for CD20 using histidine-tag insertion for epitope mapping (HisMAP) method. The results showed that two regions of CD20 (-PANPSE- and -CYSIQ-) are important for rituximab-binding for CD20."

Journal • Hematological Malignancies • Immunology • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

Systematic Review of Safety and Efficacy of Second- and Third-Generation CD20-Targeting Biologics in Treating Immune-Mediated Disorders. (PubMed, Front Immunol) - "Following rituximab, second- and third-generation anti-CD20 mAbs have been developed and tried in immune-mediated diseases, including obinutuzumab, ocrelizumab, ofatumumab, ublituximab, and veltuzumab...Veltuzumab was tested in patients with immune thrombocytopenia resulting in improved platelet counts. https://www.crd.york.ac.uk/prospero/, identifier CRD4201913421."

Review • CNS Disorders • Glomerulonephritis • Hematological Disorders • Immunology • Infectious Disease • Inflammatory Arthritis • Lupus • Multiple Sclerosis • Neuromyelitis Optica Spectrum Disorder • Rare Diseases • Renal Disease • Rheumatoid Arthritis • Rheumatology • Systemic Lupus Erythematosus • Thrombocytopenia • Thrombocytopenic Purpura • Vasculitis

Study of Veltuzumab and 90Y-Epratuzumab in Relapsed/Refractory, Aggressive NHL (clinicaltrials.gov) - P1/2; N=0; Withdrawn; Sponsor: Immunomedics, Inc.; N=70 ➔ 0; Active, not recruiting ➔ Withdrawn

Clinical • Enrollment change • Trial withdrawal • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Hematological Malignancies • Lymphoma • Mantle Cell Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • CD19 • CD20

Corporate Presentation (Immunomedics) - Veltuzumab / Immunomedics; Anticipated top-line results in H2 '13 from VELVET trial

Anticipated top-line data • Immunology • None • Rheumatoid Arthritis

Immunomedics' CEO discusses F4Q12 results - Earnings Call Transcript (SeekingAlpha) - Immunomedics progressing to out-license epratuzumab & veltuzumab in the cancer indication in certain territories

Licensing / partnership • Hematological Malignancies • Non-Hodgkin’s Lymphoma

Combination Veltuzumab and Fractionated 90Y- Epratuzumab Radioimmunotherapy in Follicular Lymphoma (clinicaltrials.gov) - P1/2; N=5; Active, not recruiting; Sponsor: Weill Medical College of Cornell University; Recruiting ➔ Active, not recruiting; N=20 ➔ 5

Enrollment change • Enrollment closed • Biosimilar • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

Comparison of two dosing schedules for subcutaneous injections of low-dose anti-CD20 veltuzumab in relapsed immune thrombocytopenia. (PubMed) - Haematologica - "In conclusion, subcutaneous injections of veltuzumab were convenient, well-tolerated, and active, without significant safety concerns. Platelet responses and bleeding reduction occurred in all dose groups, and response durability appeared improved with higher doses."

Journal • Biosimilar

Immunomedics announces third quarter fiscal 2012 results and clinical program developments (Immunomedics) - P1/2, N=70; IM-T-hA20/90Y-hLL2-01; Initial clinical experience of 90Y-labeled epratuzumab combined with veltuzumab in pts with aggressive lymphoma will be reported in an oral presentation at the 59th Annual Meeting of the Society of Nuclear Medicine (SNM) on Wed, Jun 13, 2012

Anticipated P1/2 data presentation • Hematological Malignancies • Non-Hodgkin’s Lymphoma

Immunomedics awarded broad patent for anti-CD20 and anti-CD22 combination therapy (Globenewswire) - Immunomedics announced the issuance of US patent 8,105,596, "Immunotherapy of B-cell malignancies using anti-CD22 antibodies"; This patent covers therapeutic compositions comprising any combination of conjugated or unconjugated anti-CD20 and anti-CD22 antibodies, which may be administered separately or concurrently; The patent provides coverage until 2018

Patent issuance • Hematological Malignancies • Non-Hodgkin’s Lymphoma

Study of Veltuzumab and 90Y-Epratuzumab in Relapsed/Refractory, Aggressive NHL (clinicaltrials.gov) - P1/2; N=70; Active, not recruiting; Sponsor: Immunomedics, Inc.; Recruiting -> Active, not recruiting

Enrollment closed • Biosimilar • Hematological Malignancies • Non-Hodgkin’s Lymphoma • Oncology

Lazard Capital Markets Healthcare Conference (Immunomedics) - veltuzumab / Immunomedics; Anticipated updated results from P2 study of subcutaneous veltuzumab in immune thrombocytopenic purpura at ASH meeting in December 2011

Anticipated P2 trial update • Immunology • None

Q2 '11 results (Immunomedics) - Veltucyn (veltuzumab) / Immunomedics; Regulatory approval pending & expected to begin patient enrollment in Q1 ′11 in US

Anticipated enrollment update • Hematological Malignancies • Immunology

Levi & Korsinsky, LLP announces class action involving Immunomedics, Inc. and its board of directors and a deadline of april 28, 2014 to seek a lead plaintiff position (Market Watch) - "...a class action lawsuit has been commenced in the USDC for the District of New Jersey on behalf of investors who purchased Immunomedics...common stock between May 9, 2013 and October 9, 2013...The complaint alleges that the defendants made positive statements about Veltuzumab and its development by Takeda-Nycomed, despite the fact that Takeda-Nycomed and the Company were engaged in a dispute regarding a delay in the antibody’s development."

Corporate lawsuit • Lupus

Dual-targeting immunotherapy of lymphoma: Potent cytotoxicity of anti-CD20/CD74 bispecific antibodies in mantle cell and other lymphomas (Blood) - P=NA, N=NA; The juxtaposition of CD20 and CD74 on MCL cells by the HexAbs resulted in homotypic adhesion and triggered intracellular changes that include loss of mitochondrial transmembrane potential, production of ROS, rapid and sustained phosphorylation of ERKs and JNK, downregulation of pAkt and Bcl-xL, actin reorganization, and lysosomal membrane permeabilization, culminating in cell death

Preclinical-other • Hematological Malignancies

Immunomedics: Annual Report 2013 (Immunomedics) - Anticipated patent expiry in US between 2023 and 2029; Anticipated patent expiry in EU between 2023 and 2029; Anticipated patent expiry in Japan between 2023 and 2029

Anticipated patent expiry • Non-Hodgkin’s Lymphoma

VELVET, a dose range finding trial of veltuzumab in subjects with moderate to severe rheumatoid arthritis (clinicaltrials.gov) - P2, N=300; Sponsor: Nycomed; Active, not recruiting -> Terminated (Trial re-design; no safety issues identified)

Trial termination • Immunology • Rheumatoid Arthritis

Immunomedics provides clinical updates on subcutaneous injections of veltuzumab in autoimmune disease and cancer (ASH 2012, Immunomedics) - P1, N=22; NCT00546793; "Results from 18 assessable patients were presented...The overall disease control rate was 83%, with 12 patients having stable disease (SD) and 3 patients (17%) reporting a partial response as their best responses...Despite cumulative doses ranging from 320 to 5120 mg, similar disease control rates were observed across all 3 dose levels (80 vs. 160 vs. 320 mg) and dosing schedules (cohort 1 vs. 2)."

P1 data • Hematological Malignancies • Non-Hodgkin’s Lymphoma

Immunomedics provides clinical updates on subcutaneous injections of veltuzumab in autoimmune disease and cancer (ASH 2012, Immunomedics) - P1, N=22; NCT00546793; "Results from 18 assessable patients were presented...The overall disease control rate was 83%, with 12 patients having stable disease (SD) and 3 patients (17%) reporting a partial response as their best responses...Despite cumulative doses ranging from 320 to 5120 mg, similar disease control rates were observed across all 3 dose levels (80 vs. 160 vs. 320 mg) and dosing schedules (cohort 1 vs. 2)."

P1 data • Hematological Malignancies • Non-Hodgkin’s Lymphoma

Humanized anti-CD20 antibody, veltuzumab, in refractory/recurrent non-Hodgkin's lymphoma: phase I/II results (J Clin Oncol) - P1/2, N=55; Veltuzumab appeared safe and active at all tested doses, encouraging further study, including dose levels less than those typically used with rituximab

P1/2 data • Hematological Malignancies

Wells Fargo Securities Healthcare Conference (Immunomedics) - Anticipated initiation of pts enrollment for P2 VELVET trial for rheumatoid arthritis in H2 2012

Anticipated enrollment status • Rheumatoid Arthritis

Immunomedics announces first quarter fiscal 2012 results and clinical program developments (Market Watch) - P2; P1/2; N=86; N=36; NCCTG-N0489; OSU-09024; The multicenter P2 trial conducted by the North Central Cancer Treatment Group with epratuzumab + rituximab + CHOP chemotherapy as upfront therapy for DLBCL, which showed a high rate of durable complete responses, was published in the October 13th, 2011 issue of Blood; Results from an Ohio State University-sponsored P1 study of milatuzumab and veltuzumab in pts with relapsed and refractory B-cell NHL will be presented on Monday, December 12, 2011, at the 53rd ASH Annual Meeting

Anticipated P1/2 data presentation • P2 data • Hematological Malignancies

Immunomedics reports updated clinical results on potential new treatment regimens for non-Hodgkin lymphoma (ASH 2012, Immunomedics) - P1/2, N=70; NCT01101581; "Results from 18 patients with various types of aggressive NHL who had failed 1 or more prior standard therapies were reported at the conference...The overall objective response rate among 17 patients who have had treatment response assessments was 53%, including one DLBCL patient (6%) with a CR continuing 12 months later. The combination is active in all NHL subgroups and across 90Y dose levels. At the maximum tolerated dose of 6 mCi/m2 x 2, 5 of 6 patients (83%) achieved PRs."

P1 data • Hematological Malignancies • Non-Hodgkin’s Lymphoma

Immunomedics reports updated clinical results on potential new treatment regimens for non-Hodgkin lymphoma (ASH 2012, Immunomedics) - P1/2, N=70; NCT01101581; "Results from 18 patients with various types of aggressive NHL who had failed 1 or more prior standard therapies were reported at the conference...The overall objective response rate among 17 patients who have had treatment response assessments was 53%, including one DLBCL patient (6%) with a CR continuing 12 months later. The combination is active in all NHL subgroups and across 90Y dose levels. At the maximum tolerated dose of 6 mCi/m2 x 2, 5 of 6 patients (83%) achieved PRs."

P1 data • Hematological Malignancies • Non-Hodgkin’s Lymphoma