indatuximab ravtansine (BT-062) / Grifols - LARVOL DELTA

Identification of Exosome-Associated Biomarkers in Diabetic Foot Ulcers: A Bioinformatics Analysis and Experimental Validation. (PubMed, Biomedicines) - "Transcription factor and miRNA predictions uncovered regulatory circuits, and DGIdb-driven drug repurposing followed by molecular docking identified Indatuximab ravtansine and heparin as high-affinity SDC1 binders... We present five exosome-associated genes as novel DFU biomarkers with diagnostic potential and mechanistic links to immune modulation and vesicular transport. These findings lay the groundwork for exosome-based diagnostics and therapeutic targeting in DFU management."

Biomarker • Journal • Diabetes • Immune Modulation • Immunology • Infectious Disease • Metabolic Disorders • IL17A • SDC1

Syndecan‑1 expression is an independent favourable prognostic marker in oesophageal adenocarcinoma and represents a potential therapeutic target. (PubMed, Oncol Lett) - "Patients who received neoadjuvant CROSS (carboplatin, paclitaxel and intensity modulated radiotherapy) therapy and had CD138-positive tumours lived significantly longer (P=0.04)...In conclusion, CD138 in cancer is already used as a target for ADCs, such as indatuximab ravtansine, the effectiveness of which depends on the extent of CD138 on tumour cells...Regardless of the favourable prognostic effect of CD138 in EAC, there is an urgent clinical need for personalized therapeutics in relapse. Future clinical trials now need to show how effective the corresponding ADCs are in CD138-positive EACs."

Biomarker • Journal • Esophageal Adenocarcinoma • Esophageal Cancer • Gastrointestinal Cancer • Hematological Malignancies • Multiple Myeloma • Oncology • Solid Tumor • HER-2 • SDC1

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ADC Combined With Immunomodulators Active in R/R Myeloma (MedPageToday) - "'Multiple myeloma remains an incurable disease, and the overall survival for patients who are refractory to currently available therapy is less than 1 year,' wrote Kelly...in The Lancet Haematology....In a commentary accompanying the study...Francesca Gay, MD, PhD...said this suggests there is a synergy between indatuximab ravtansine and lenalidomide that may partially reverse lenalidomide refractoriness....A major limitation of the study, Mina and Gay observed, was the patients' previous treatment exposure."

Indatuximab ravtansine plus dexamethasone with lenalidomide or pomalidomide in relapsed or refractory multiple myeloma: a multicentre, phase 1/2a study. (PubMed, Lancet Haematol) - P1/2 | "Indatuximab ravtansine in combination with immunomodulatory drugs shows preliminary antitumor activity, is tolerated, and could be further evaluated in patients with relapsed or refractory multiple myeloma."

Clinical • Journal • P1/2 data • Hematological Disorders • Hematological Malignancies • Immune Modulation • Inflammation • Multiple Myeloma • Neutropenia • Oncology • Thrombocytopenia • SDC1

Investigational Monoclonal Antibodies in the Treatment of Multiple Myeloma: A Systematic Review of Agents under Clinical Development. (PubMed, Antibodies (Basel)) - "Combination therapy using mAbs such as indatuximab, pembrolizumab, lorvotuzumab, siltuximab or dacetuzumab with chemotherapy agents produced better outcomes as compared to monotherapies. Further clinical trials investigating mAbs targeting CD38 used in combination therapy are warranted."

Clinical • Journal • Review • Hematological Disorders • Hematological Malignancies • Immune Modulation • Inflammation • Multiple Myeloma • Oncology

[VIRTUAL] A Novel CD138-Targeting Monoclonal Antibody Induces Potent Myeloma Killing and Further Synergizes with IMiDs or Bortezomib in in Vitro and In Vivo Preclinical Models of Human Multiple Myeloma (ASH 2020) - "We here developed and determined in preclinical models of human MM the efficacy of VIS832, a novel humanized monoclonal antibody (MoAb) with differentiated CD138 target binding to the anti-CD138 MoAb BB4 within indatuximab ravtansine (BT082)...Evaluation of VIS832-induced ADCC in NK-MM cell co-cultures determined its EC50 values ranged from 2.22 + 0.37 to 15.3 + 2.71 ng/ml, with % maximal lysis of 37.06 + 1.45 % to 97.3 + 3.34 %, across tested MM cell lines (n=12), both sensitive or resistant to current therapies including dexamethasone, IMiDs, and bortezomib...VIS832 induced higher maximal lysis (~3-fold) of all target MM cell lines than CD38-targeting daratumumab (dara), regardless of resistance to lenalidomide and pomalidomide...Taken together, the significant in vivo efficacy of VIS832, coupled with its mechanisms of action and potent in vitro MM cytotoxicity, strongly support clinical development of VIS832, as monotherapy and in combination, to overcome multidrug..."

IO biomarker • Preclinical • Hematological Malignancies • Multiple Myeloma • Oncology • CD38 • SDC1

Biotherapeutic Antibodies for the Treatment of Head and Neck Cancer: Current Approaches and Future Considerations of Photothermal Therapies. (PubMed, Front Oncol) - "There are currently three approved antibodies against HNCs (cetuximab, nivolumab, and pembrolizumab), and 48 antibodies under development...In addition, three antibody drug conjugates (ADCs: telisotuzumab-vedotin, indatuximab-ravtansine, and W0101) and two bispecific antibodies (GBR 1372 and ABL001) have been under development...These conjugates combine the high specificity of antibodies with unique spectral properties of GNPs to generate a treatment approach known as photothermal therapy. This approach can provide promising outcomes due to the ability of GNPs to convert light into heat, which can specifically destroy cancer cells and treat HNC in an effective manner."

Journal • Review • Developmental Disorders • Head and Neck Cancer • Infectious Disease • Oncology • Solid Tumor

Increased Cytoplasmic CD138 Expression Is Associated with Aggressive Characteristics in Prostate Cancer and Is an Independent Predictor for Biochemical Recurrence. (PubMed, Biomed Res Int) - "It is of interest due to a possible prognostic effect in tumors and its role as a target for the antibody-drug conjugate indatuximab ravtansine...In summary, our study indicates the cytoplasmic CD138 expression as a strong and independent predictor of poor prognosis in prostate cancer. Immunohistochemical measurement of CD138 protein may thus-perhaps in combination with other parameters-become clinically useful in the future."

Journal • Basal Cell Carcinoma • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • ERG • Ergosterol-3 • SDC1

VIS832, a novel CD138-targeting monoclonal antibody, potently induces killing of human multiple myeloma and further synergizes with IMiDs or bortezomib in vitro and in vivo. (PubMed, Blood Cancer J) - "We here developed and determined the preclinical efficacy of VIS832, a novel therapeutic monoclonal antibody (MoAb) with differentiated CD138 target binding to BB4 that is anti-CD138 MoAb scaffold for indatuximab ravtansine (BT062)...Specifically, CD38-targeting daratumumab-resistant MM cells were highly susceptible to VIS832 which, unlike daratumumab, spares NK cells...Furthermore, VIS832 acted synergistically with lenalidomide or bortezomib to deplete MM cells. Importantly, VIS832 at a sub-optimal dose inhibited disseminated MM1S tumors in vivo as monotherapy (P < 0.0001), and rapidly eradicated myeloma burden in all mice concomitantly receiving bortezomib, with 100% host survival. Taken together, these data strongly support clinical development of VIS832, alone and in combination, for the therapeutic treatment of MM in relapsed and refractory patients while pointing to its potential therapeutic use earlier in disease intervention."

Journal • Preclinical • Hematological Malignancies • Multiple Myeloma • Oncology

Indatuximab Ravtansine (BT062) Monotherapy in Patients With Relapsed and/or Refractory Multiple Myeloma. (PubMed, Clin Lymphoma Myeloma Leuk) - "Our data support further investigation of indatuximab ravtansine as part of a combination regimen for relapsed and/or refractory MM."

Clinical • Journal • Monotherapy • Fatigue • Hematological Malignancies • Immune Modulation • Inflammation • Multiple Myeloma • Oncology

BT062 in combination with lenalidomide/dexamethasone in patients with multiple myeloma (clinicaltrials.gov) - P1/2, N=49; Not yet recruiting; New P1 trial

New trial • Multiple Myeloma

Biotest: Press and Analyst Conference FY 2015 (Biotest) - "BT-062 phase I/IIa study no. 983 in Multiple Myeloma"; "Results of BT-062 with Pomalidomide / Dexamethasone: A total of 17 patients were enrolled; 2 patients were replaced (not evaluable for efficacy), 11/15 = 73% showed a response ( ≥ PR) to treatment, 8 patients are on treatment without progressive disease for more than 8 months"

P1/2 data • Hematological Malignancies • Multiple Myeloma • Oncology

Biotest: Q3 FY 2015 Results (Biotest) - Anticipated final data from P1/2 trial (NCT01001442) in multiple myeloma in 2016

Anticipated P1/2 data • Multiple Myeloma • Oncology

Biotest: Annual Report 2014 (Biotest) - Anticipated final clinical study result from P1/2 trial (NCT01001442) for monotherapy in multiple myeloma in Q2 2015

Anticipated P1/2 data • Multiple Myeloma • Oncology

ImmunoGen, Inc. announces clinical data presentations at upcoming 55th ASH annual meeting and exposition (Immunogen Press Release) - "...There will be an oral presentation on SAR650984, the CD38-targeting therapeutic antibody developed by ImmunoGen and licensed to Sanofi as part of a broader collaboration between the companies....There also will be an oral presentation on BT062, the CD138-targeting antibody-drug conjugate (ADC) in development through the Company's collaboration with Biotest....In addition to these two oral presentations, there also will be a poster presentation on SAR3419, the CD19-targeting ADC also in development through the Company's collaboration with Sanofi."

Anticipated clinical data • Anticipated conference • Hematological Malignancies • Oncology

BT062, an antibody-drug conjugate directed against CD138, shows clinical activity in patients with relapsed or relapsed/refractory multiple myeloma (ASH 2011) - Presentation Time: Monday, December 12, 2011: 8:00 AM; P1, N=32; 969; Preliminary data from this study demonstrate an acceptable toxicity profile of BT062; Stabilization of disease was noted in an additional 11 patients, receiving a median of 5 cycles of therapy (range of 4-10); The stable disease or better was noted in 52% of pts

P1 data • Multiple Myeloma

Biotest: Q3 FY 2015 Results (Biotest) - "BT-062 Phase I/IIa Study No. 983 in Multiple Myeloma"; "Results of BT-062 with Pomalidomide / Dexamethasone"; "A total of 17 patients were enrolled"; "13 patients are on treatment without progressive disease"

P1/2 data • Multiple Myeloma • Oncology

Biotest: H1 2014 Results (Biotest) - Anticipated presentation of additional data from P2 trial for multipleim  myeloma at ASH (Dec 06-Dec 09, 2014)

Anticipated P2 data • Multiple Myeloma • Oncology

Indatuximab ravtansine: "11/14 = 79% showed an objective response (≥ PR) to treatment" (Biotest) - Company Presentation

P1/2 data • Multiple Myeloma • Oncology

Biotest: Q3 2014 Results (Biotest) - "ASH abstract: Indatuximab Ravtansine (BT-062)"; "BT-062 is well tolerated with LenDEX (Lenalidomide/Dexamethason)"; "Very good responses in patients with relapsed and / or refractory multiple myeloma and patients who do not respond to standard therapy"; "Overall response rate (ORR) is 78% including: 8% complete remissions, 28% very good partial remissions, 42% partial remissions"

P2 data • Multiple Myeloma • Oncology

Biotest: Press and Analyst Conference FY 2015 (Biotest) - Anticipated data from P1/2 trial (NCT01001442) in r/r MM in Q4 2016

Anticipated P1/2 data • Multiple Myeloma • Oncology

New data from Biotest's monoclonal antibody-drug-conjugate (ADC) BT-062 in the therapy of solid tumors (PipelineReview) - P1/2, N=64; NCT01638936; "Data from combination therapy of BT-062 with lenalidomide or pomalidomide and dexamethasone in multiple myeloma (clinical phase I/IIa study no. 983)...show that...treatment with BT-062 in combination with lenalidomide or pomalidomide and dexamethasone can lead to partial or complete response. The study continues as some patients have been benefitting from the combination treatment for over four years."

P1/2 data • Hematological Malignancies • Multiple Myeloma • Oncology

Prevalence of Syndecan-1 (CD138) Expression in Different Kinds of Human Tumors and Normal Tissues. (PubMed, Dis Markers) - "It is of interest because of a possible prognostic role of differential expression in tumors and its role as a target for indatuximab, a monoclonal antibody coupled with a cytotoxic agent...In summary, the preferential expression in squamous cell carcinomas of various sites makes these cancers prime targets for anti-CD138 treatments once these might become available. Abundant expression in many different normal tissues might pose obstacles to exploiting CD138 as a therapeutic target, however."

Journal • Bladder Cancer • Colorectal Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Germ Cell Tumors • Head and Neck Cancer • Neuroendocrine Tumor • Oncology • Prostate Cancer • Sarcoma • Solid Tumor • Squamous Cell Carcinoma • Thyroid Cancer • Urothelial Cancer

Monoclonal antibodies in relapsed/refractory myeloma: updated evidence from clinical trials, real life studies and meta-analyses. (PubMed, Expert Rev Hematol) - "In particular, updated results of antibodies directed against CD38 (daratumumab and isatuximab), SLAMF7 (elotuzumab), BCMA (GSK2857916/belantamab mafodotin), and PD-1/PD-1L axis (nivolumab and pembrolizumab) will be discussed in detail.Expert opinion: Monoclonal antibodies represent a very effective therapeutic strategy that will open novel and dynamic treatment scenarios for myeloma patients in the coming years. Optimal positioning and selection of different antibodies that are or will be soon available, appropriate combinations and careful evaluation of possible new toxicities should be considered in the future management of these patients."

Clinical • Journal • PD-1