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DRUG:

nelitolimod (SD-101)

i
Other names: ISS-ODN SD-101, SD-101, SD 101, SD101
Company:
Dynavax, TriSalus Life Sci, UT MD Anderson Cancer Center
Drug class:
TLR9 agonist
2ms
Regional lymph node changes on breast MRI in patients with early-stage breast cancer receiving neoadjuvant chemo-immunotherapy. (PubMed, Breast Cancer Res Treat)
The combination of neoadjuvant paclitaxel and pembrolizumab ± SD101 intratumoral injection was associated with early increases in regional lymphadenopathy on MRI despite decreased breast tumor size. Increased lymphadenopathy was not associated with node positive disease at surgery.
Journal
|
HER-2 (Human epidermal growth factor receptor 2)
|
HER-2 negative
|
Keytruda (pembrolizumab) • paclitaxel • nelitolimod (SD-101)
4ms
Subcutaneous checkpoint inhibition is equivalent to systemic delivery when combined with nelitolimod delivered via pressure-enabled drug delivery for depletion of intrahepatic myeloid-derived suppressor cells and control of liver metastases. (PubMed, J Immunother Cancer)
The SQ route of CPI delivery was equivalent to Sys in combination with nelitolimod, suggesting SQ-CPI may be a rational choice in combination with PEDD of nelitolimod for liver tumor treatment.
Journal • Checkpoint inhibition
|
PTPRC (Protein Tyrosine Phosphatase Receptor Type C) • ITGAM (Integrin, alpha M) • ITGAX (Integrin Subunit Alpha X)
|
nelitolimod (SD-101)
7ms
Incidence and time to onset of immunotherapy-related adrenal insufficiency in the I-SPY2 trial. (ASCO 2024)
Treatment included weekly paclitaxel (T) plus ICI-based tx x 4 cycles, followed by doxorubicin/cyclophosphamide (AC) every 2-3 weeks x 4. 6 completed investigational arms included ICIs: T+pembro x 4, T+pembro x 8 (+/- AC), T+pembro+SD101 (TLR9 agonist), T+durvalumab+olaparib, T+cemiplimab (cemi), and T+cemi+REGN3767 (anti-LAG-3)... The incidence of AI in EBC is higher than has previously been reported in advanced disease, with higher rates observed in those tx with dual immune modulation. No correlation was observed with age; correlation of AI with response predictive subtype and other clinicopathologic features is ongoing and will be presented. Given the high incidence of AI in EBC, close monitoring in the peri/postoperative setting and education of pts and providers is critical, as risk persists even after completion of tx.
PD(L)-1 Biomarker • PARP Biomarker • IO biomarker
|
HER-2 (Human epidermal growth factor receptor 2)
|
MammaPrint
|
Keytruda (pembrolizumab) • Lynparza (olaparib) • Imfinzi (durvalumab) • paclitaxel • doxorubicin hydrochloride • cyclophosphamide • Libtayo (cemiplimab-rwlc) • fianlimab (REGN3767) • nelitolimod (SD-101)
10ms
Haystack Oncology, developer of Haystack MRD, and TriSalus Life Sciences collaborate in connection with the clinical development of TriSalus’ TLR9 agonist in hepatocellular carcinoma, intrahepatic cholangiocarcinoma, and pancreatic adenocarcinoma (PRNewswire)
"Haystack Oncology...has entered a research collaboration with TriSalus Life Sciences to evaluate therapeutic response and provide molecular insights in connection with the clinical development of TriSalus' SD-101, an investigational class C toll-like receptor-9 (TLR9) agonist. SD-101 is delivered via hepatic arterial infusion or pancreatic retrograde venous infusion in their phase 1 and 1b clinical trials using their proprietary Pressure-Enabled Drug Delivery™ (PEDD™) to overcome the challenges associated with intratumoral pressure for patients diagnosed with hepatocellular carcinoma, intrahepatic cholangiocarcinoma, and pancreatic adenocarcinoma."
Licensing / partnership
|
nelitolimod (SD-101)
11ms
Enrollment closed • Combination therapy • Checkpoint inhibition • Checkpoint block • Metastases • Immuno-oncology
|
Yervoy (ipilimumab) • Opdualag (nivolumab/relatlimab-rmbw) • nelitolimod (SD-101) • relatlimab (BMS-986016)
11ms
TS-PERIO-02: Pressure Enabled Delivery of SD-101 With Checkpoint Blockade for Primary Liver Tumors (clinicaltrials.gov)
P1/2, N=89, Active, not recruiting, TriSalus Life Sciences, Inc. | Recruiting --> Active, not recruiting | Phase classification: P1b/2 --> P1/2
Enrollment closed • Phase classification • Checkpoint inhibition • Checkpoint block • Immuno-oncology
|
FGFR2 (Fibroblast growth factor receptor 2)
|
FGFR2 mutation
|
Keytruda (pembrolizumab) • Opdivo (nivolumab) • Yervoy (ipilimumab) • nelitolimod (SD-101)
11ms
The PERIO-03 Trial: Technical Feasibility and Safety of a Novel Pancreatic Retrograde Venous Immunotherapy Infusion Intervention for Locally Advanced Pancreatic Ductal Adenocarcinoma (SIR 2024)
Materials and The PERIO-03 trial utilizes a uniquely designed occlusive catheter (TriSalus Infusion System (TIS), TriSalus Life Sciences) for the delivery of the immunotherapeutic agent, SD-101, via Pancreatic Retrograde Venous Infusion (PRVI)... Current experience with the novel transvenous immunotherapy delivery intervention in the PERIO-03 study indicates that this PRVI procedure is technically feasible and safe.
Clinical • Metastases
|
nelitolimod (SD-101)
12ms
TLR9 Agonist SD-101, Anti-OX40 Antibody BMS 986178, and Radiation Therapy in Treating Patients With Low-Grade B-Cell Non-Hodgkin Lymphomas (clinicaltrials.gov)
P1, N=15, Active, not recruiting, Ronald Levy | Trial completion date: Oct 2023 --> Oct 2024 | Trial primary completion date: Oct 2023 --> Oct 2024
Trial completion date • Trial primary completion date • Combination therapy
|
nelitolimod (SD-101) • BMS-986178
12ms
TLR9 Agonist SD-101, Ibrutinib, and Radiation Therapy in Treating Patients With Relapsed or Refractory Grade 1-3A Follicular Lymphoma (clinicaltrials.gov)
P1/2, N=21, Completed, Robert Lowsky | Active, not recruiting --> Completed | N=30 --> 21 | Trial completion date: Nov 2023 --> May 2023 | Trial primary completion date: Nov 2023 --> May 2023
Trial completion • Enrollment change • Trial completion date • Trial primary completion date • Combination therapy
|
Imbruvica (ibrutinib) • nelitolimod (SD-101)
1year
Loss of the OX40 Target in Lymphoma Patients after Combining an Anti-OX40 Agonist Antibody with in Situ Vaccination (ASH 2023)
STUDY: Fourteen patients with low-grade lymphoma received low-dose (2Gy x 2) radiotherapy to a single tumor site followed by 5 weekly intratumoral injections of 2 mg CpG-ODN (SD-101, TriSalus Life Sciences) and 3.75 mg anti-OX40 antibody into the same site...This loss was reproduced by in vitro assays where activated blood CD4 T cells exhibited a loss of cell surface OX40 when cultured with BMS-986178... Our observations suggest that treatment with an agonistic anti-OX40 antibody induced a loss of OX40 on the cell surface of effector CD4 T cells in the tumor microenvironment. Fewer molecules of OX40 receptor may have constrained the efficacy of subsequent anti-OX40 infusions and may explain why the clinical responses observed in this study were lower than observed in our past clinical trials of in situ vaccination.
Clinical
|
CD4 (CD4 Molecule)
|
nelitolimod (SD-101) • BMS-986178
1year
TS-PERIO-02: Pressure Enabled Delivery of SD-101 With Checkpoint Blockade for Primary Liver Tumors (clinicaltrials.gov)
P1b/2, N=89, Recruiting, TriSalus Life Sciences, Inc. | Trial primary completion date: Aug 2023 --> Dec 2023
Trial primary completion date • Checkpoint inhibition • Checkpoint block • Immuno-oncology
|
FGFR2 (Fibroblast growth factor receptor 2)
|
FGFR2 mutation
|
Keytruda (pembrolizumab) • Opdivo (nivolumab) • Yervoy (ipilimumab) • nelitolimod (SD-101)
over1year
Pressure-Enabled Drug Delivery (PEDD) of a class C TLR9 agonist in combination with checkpoint inhibitor therapy in a murine pancreatic cancer model. (PubMed, Surgery)
Pressure-Enabled Drug Delivery of toll-like receptor 9 agonist by Pancreatic Retrograde Venous Infusion with systemic anti-programmed death receptor-1 demonstrated improved pancreatic ductal adenocarcinoma tumor control in a murine pancreatic ductal adenocarcinoma model. These results support study of this combination therapy in pancreatic ductal adenocarcinoma patients and expansion of ongoing Pressure-Enabled Drug Delivery clinical trials.
Preclinical • Journal • Combination therapy • Checkpoint inhibition
|
CD8 (cluster of differentiation 8) • IL6 (Interleukin 6) • CD4 (CD4 Molecule) • CXCL1 (Chemokine (C-X-C motif) ligand 1)
|
nelitolimod (SD-101)
over1year
PERIO-01: Initial safety experience and immunologic effects of a Class C TLR9 agonist using pressure- enabled drug delivery in a phase 1 trial of hepatic arterial infusion of SD-101 +/- checkpoint inhibition in metastatic uveal melanoma (AACR 2023)
For patients who received 2mg SD-101 + ICI with available liquid biopsy data, 4 of 7 demonstrated decreases in circulating tumor cells and 3 of 5 showing ctDNA decreases after the first cycle.In this first-in-human experience, HAI of SD-101 via PEDDTM was well tolerated and associated with encouraging immunologic activity. Evidence of biologic activity with 2 mg of SD-101 with nivolumab is encouraging and patients are currently enrolling at higher SD-101 dose levels + ICI.
Clinical • P1 data • Checkpoint inhibition • Metastases
|
CD8 (cluster of differentiation 8) • IFNG (Interferon, gamma) • IL2RA (Interleukin 2 receptor, alpha) • IL2 (Interleukin 2) • IL18 (Interleukin 18) • IFNA1 (Interferon Alpha 1)
|
Opdivo (nivolumab) • nelitolimod (SD-101)
over1year
Combination treatment with pH modulating drugs and immune checkpoint inhibitors increases TALL-104 cytotoxicity in preclinical co-culture experiments (AACR 2023)
Phase 1 clinical trials are ongoing for treatment of primary liver cancer and uveal melanoma with liver metastases using pressure-enabled drug delivery of SD-101 in combination with systemic immune checkpoint inhibitors (ICIs). Combination PMD and ICI studies are needed to inform drug combinations and dosages in syngeneic murine models of primary liver cancer and CRCLM. Subcutaneous and orthotopic tumor models are expected to demonstrate the efficacy of local PMD treatment with systemic immunotherapy.
Preclinical • Checkpoint inhibition
|
B2M (Beta-2-microglobulin) • CXCL8 (Chemokine (C-X-C motif) ligand 8) • CXCL10 (Chemokine (C-X-C motif) ligand 10) • GDF15 (Growth differentiation factor 15) • CXCL5 (Chemokine (C-X-C motif) ligand 5)
|
nelitolimod (SD-101) • ABIO-0501
2years
Activating Immune Effectors and Dampening Immune Suppressors Generates Successful Therapeutic Cancer Vaccination in Patients with Lymphoma (ASH 2022)
Here we report clinical and immunological results of a phase I/II trial in non-Hodgkin Lymphoma (NCT02927964) in which we combined ISV using intratumoral SD101 (a TLR9 agonist) and low-dose radiation (2 x 2 Gy), and daily oral ibrutinib, a kinase inhibitor that modulates both B and T cells. Notably, our treatment dampened immune suppressors such as TGFß signaling, inhibitory T regulatory 1 cells, and CD8 T cell PD1 expression. These reductions correlated positively with clinical outcomes, suggesting that reversal of negative regulators was as important as induction of immune effectors in producing robust immune responses and clinically meaningful tumor responses.
Clinical • PD(L)-1 Biomarker • IO biomarker
|
CD8 (cluster of differentiation 8) • PD-1 (Programmed cell death 1) • IL6 (Interleukin 6) • CD47 (CD47 Molecule) • IL4 (Interleukin 4)
|
PD-1 expression • CD8 expression • CD47 expression • IL6 expression
|
Imbruvica (ibrutinib) • nelitolimod (SD-101)
2years
Pembrolizumab +/- SD-101 in Hormone-Naïve Oligometastatic Prostate Cancer With RT and iADT (clinicaltrials.gov)
P2, N=23, Active, not recruiting, Lawrence Fong | Recruiting --> Active, not recruiting | N=42 --> 23 | Trial completion date: Mar 2023 --> Oct 2023 | Trial primary completion date: Mar 2023 --> Oct 2023
Enrollment closed • Enrollment change • Trial completion date • Trial primary completion date • Combination therapy
|
CAST (Calpastatin)
|
Keytruda (pembrolizumab) • abiraterone acetate • prednisone • leuprolide acetate for depot suspension • nelitolimod (SD-101)
over2years
Regional infusion of a class C TLR9 agonist enhances liver tumor microenvironment reprogramming and MDSC reduction to improve responsiveness to systemic checkpoint inhibition. (PubMed, Cancer Gene Ther)
Further, PBMC-derived human MDSCs express TLR9, and treatment with class C TLR9 agonists (ODN2395 and SD101) reduced the expansion of MDSC population. Regional TLR9 agonist infusion along with systemic anti-PD-1 therapy improved control of LM. With effective delivery, TLR9 agonists have the potential to favorably reprogram the liver TME through reduction of MDSCs and favorable macrophage polarization, which may improve responsiveness to systemic CPI therapy.
Journal • Checkpoint inhibition
|
IL6 (Interleukin 6)
|
nelitolimod (SD-101) • ODN2395
almost3years
A Squalene-Based Nanoemulsion for Therapeutic Delivery of Resiquimod. (PubMed, Pharmaceutics)
In vitro and in vivo antitumor immunity of R848 NE were also evaluated in combination with SD-101, a CpG-containing TLR9 agonist...The combination treatment showed a 4-fold increase in systemic TNFa production and a 2.6-fold increase in Cd8a expression in tumor tissues, suggesting strong cell-mediated immune responses against the tumor. The treatment not only demonstrated a strong antitumor immunity by TLR7/8 and TLR9 activations but also induced PD-L1 upregulation in tumors, suggesting a potential therapeutic synergy with immune checkpoint inhibitors.
Journal • PD(L)-1 Biomarker • IO biomarker
|
CD8 (cluster of differentiation 8) • TNFA (Tumor Necrosis Factor-Alpha)
|
nelitolimod (SD-101)
3years
Immune signatures and MammaPrint (ultra) high risk class (MP2) as predictors of response to pembrolizumab combined with the TLR9 agonist SD101 in the neoadjuvant I-SPY 2 TRIAL (SABCS 2021)
Pembrolizumab combined with paclitaxel followed by doxorubicin/cyclophosphamide (P+T->AC) was evaluated in HER2- patients in the neoadjuvant I-SPY 2 TRIAL and graduated in the HER2-, HR+HER2- and triple negative (TN) signatures. Though TN patients are more responsive to Pembro+SD101 and other immunotherapies than HR+HER2- patients, many more immune biomarkers associate with pCR in the latter group. Only tumor-immune signaling signatures associate with pCR in both HR+HER2- and TN subsets. Response in the HR+HER2- subset is higher in MP2 class, high-proliferation, lower-ER tumors.
Clinical • PD(L)-1 Biomarker • IO biomarker
|
HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1) • ER (Estrogen receptor) • CD8 (cluster of differentiation 8) • LAG3 (Lymphocyte Activating 3) • HAVCR2 (Hepatitis A Virus Cellular Receptor 2) • TIGIT (T Cell Immunoreceptor With Ig And ITIM Domains 2) • STAT1 (Signal Transducer And Activator Of Transcription 1)
|
HER-2 negative
|
MammaPrint
|
Keytruda (pembrolizumab) • paclitaxel • doxorubicin hydrochloride • cyclophosphamide • nelitolimod (SD-101)
3years
Single-institution retrospective analysis of lymph node (LN) change on breast MRI in patients with high risk early-stage breast cancer receiving neoadjuvant chemotherapy with and without immunotherapy on the ISPY-2 TRIAL (SABCS 2021)
This is a retrospective study of the prospective multicenter I-SPY2 adaptive neoadjuvant trial investigating all patients enrolled at UCSF in 3 study arms between Dec 2015 and April 2021: 1) Control (weekly paclitaxel 80 mg/m 2 x 12 weeks followed by AC x 4); 2) weekly paclitaxel + pembrolizumab 200 mg IV every 3 weeks, followed by AC x 4; 3) weekly paclitaxel + every 3 week pembrolizumab + intra-tumoral SD-101 weekly x 4 then every 3 weeks x 2 followed by AC x 4. The addition of immunotherapy to standard neoadjuvant chemotherapy in the I-SPY2 trial was associated with an increase in size of ipsilateral axillary LN and/or development of new LAD on serial breast MRI imaging during the course of neoadjuvant treatment. These changes were not associated with worse pathologic response at surgery and should not be assumed to be due to disease progression. Whether these changes could reflect immunotherapy benefit needs to be investigated in a larger trial with longer follow-up.
Retrospective data • PD(L)-1 Biomarker • IO biomarker
|
HER-2 (Human epidermal growth factor receptor 2) • TLR9 (Toll Like Receptor 9)
|
HR positive • HER-2 negative
|
Keytruda (pembrolizumab) • paclitaxel • nelitolimod (SD-101)
3years
I-SPY 2: I-SPY TRIAL: Neoadjuvant and Personalized Adaptive Novel Agents to Treat Breast Cancer (clinicaltrials.gov)
P2; Trial completion date: Dec 2026 --> Dec 2031 | Trial primary completion date: Dec 2025 --> Dec 2030
Trial completion date • Trial primary completion date • Clinical
|
HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor)
|
ER positive • ER negative
|
TargetPrint®
|
Keytruda (pembrolizumab) • Herceptin (trastuzumab) • Lynparza (olaparib) • carboplatin • Imfinzi (durvalumab) • Nerlynx (neratinib) • Perjeta (pertuzumab) • Kadcyla (ado-trastuzumab emtansine) • doxorubicin hydrochloride • Talzenna (talazoparib) • Verzenio (abemaciclib) • cyclophosphamide • irinotecan • Jemperli (dostarlimab-gxly) • Tukysa (tucatinib) • letrozole • veliparib (ABT-888) • Libtayo (cemiplimab-rwlc) • MK-2206 • ganitumab (AMG 479) • amcenestrant (SAR439859) • metformin • Jivadco (trastuzumab duocarmazine) • Turalio (pexidartinib) • ganetespib (ADX-1612) • Cosela (trilaciclib) • fianlimab (REGN3767) • Oraxol (oral paclitaxel/encequidar) • ladiratuzumab vedotin (SGN-LIV1A) • nelitolimod (SD-101) • patritumab (U3-1287) • trebananib (AMG 386)
over3years
Current status of intralesional agents in treatment of malignant melanoma. (PubMed, Ann Transl Med)
This review focuses on the current status of IT agents currently under clinical trials in melanoma. Reviewed therapies include T-VEC, T-VEC with immune checkpoint inhibitors including ipilimumab and pembrolizumab or other agents, RP1, OrienX010, Canerpaturev (C-REV, HF10), CAVATAK (coxsackievirus A21, CVA21) alone or in combination with checkpoint inhibitors, oncolytic polio/rhinovirus recombinant (PVSRIPO), MAGE-A3-expressing MG1 Maraba virus, VSV-IFNbetaTYRP1, suicide gene therapy, ONCOS-102, OBP-301 (Telomelysin), Stimulation of Interferon Genes Pathway (STING agonists) including DMXAA, MIW815 (ADU-S100) and MK-1454, PV-10, toll-like receptors (TLRs) agonists including TLR-9 agonists (SD-101, CMP-001, IMO-2125 or tilsotolimod, AST-008 or cavrotolimod, MGN1703 or lefitolimod), CV8102, NKTR-262 plus NKTR-214, LHC165, G100, intralesional interleukin-2, Daromun (L19IL2 plus L19TNF), Hiltonol (poly-ICLC), electroporation including calcium electroporation and plasmid interleukin-12 electroporation (pIL-12 EP), IT ipilimumab, INT230-6 (cisplatin and vinblastine with an amphiphilic penetration enhancer), TTI-621 (SIRPαFc), CD-40 agonistic antibodies (ABBV-927 and APX005M), antimicrobial peptide LL37 and other miscellaneous agents.
Review • Journal
|
TYRP1 (Tyrosinase Related Protein 1) • CD40 (CD40 Molecule) • MAGEA3 (MAGE Family Member A3)
|
Keytruda (pembrolizumab) • Yervoy (ipilimumab) • Imlygic (talimogene laherparepvec) • bempegaldesleukin (NKTR-214) • vidutolimod (CMP-001) • Fibromun (onfekafusp alfa) • ONCOS-102 • cavrotolimod (AST-008) • cisplatin/vinblastine/SHAO-FA (INT230-6) • nelitolimod (SD-101) • ADU-S100 • CV8102 • Cavatak (gebasaxturev) • Hiltonol (poly-ICLC) • LHC165 • NKTR-262 • Nidlegy (darleukin/fibromun) • OrienX010 • Telomelysin (suratadenoturev) • canerpaturev (TBI-1401) • giloralimab (ABBV-927) • lefitolimod (MGN1703) • sotigalimab (PYX-107) • tilsotolimod (IMO-2125) • ulevostinag (MK-1454)
over3years
[VIRTUAL] Evaluation of intra-tumoral (IT) SD-101 and pembrolizumab (Pb) in combination with paclitaxel (P) followed by AC in high-risk HER2-negative (HER2-) stage II/III breast cancer: Results from the I-SPY 2 trial. (ASCO 2021)
Treatment included weekly P x 12 in combination with IT SD-101 2 mg/ml (1 ml for T2 tumors, 2 ml for >T3 tumors) weekly x 4, then q3 weeks x 2, and IV Pb q3 weeks x 4, followed by doxorubicin/cyclophosphamide (AC) q2-3 weeks x 4 (SD-101+Pembro 4) . The SD-101+Pembro 4 regimen was active but did not meet the pre-specified threshold for graduation in I-SPY 2 . pCR/RCB 1 analysis suggests improved response in the HR+/HER-negative signature compared to control . The clinical significance of these findings needs to be weighed against the potential risk of immune-related toxicities.
Combination therapy
|
HER-2 (Human epidermal growth factor receptor 2)
|
HER-2 negative
|
MammaPrint
|
Keytruda (pembrolizumab) • paclitaxel • doxorubicin hydrochloride • nelitolimod (SD-101)
over3years
I-SPY 2: I-SPY TRIAL: Neoadjuvant and Personalized Adaptive Novel Agents to Treat Breast Cancer (clinicaltrials.gov)
P2, N=4000, Recruiting, QuantumLeap Healthcare Collaborative | Phase classification: P1 --> P2
Phase classification
|
HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor)
|
ER positive • ER negative
|
MammaPrint • TargetPrint®
|
Keytruda (pembrolizumab) • Herceptin (trastuzumab) • Lynparza (olaparib) • carboplatin • Imfinzi (durvalumab) • Nerlynx (neratinib) • Perjeta (pertuzumab) • Kadcyla (ado-trastuzumab emtansine) • doxorubicin hydrochloride • Talzenna (talazoparib) • Verzenio (abemaciclib) • cyclophosphamide • irinotecan • Jemperli (dostarlimab-gxly) • Tukysa (tucatinib) • letrozole • veliparib (ABT-888) • Libtayo (cemiplimab-rwlc) • MK-2206 • ganitumab (AMG 479) • amcenestrant (SAR439859) • metformin • Jivadco (trastuzumab duocarmazine) • Turalio (pexidartinib) • ganetespib (ADX-1612) • Cosela (trilaciclib) • fianlimab (REGN3767) • Oraxol (oral paclitaxel/encequidar) • ladiratuzumab vedotin (SGN-LIV1A) • nelitolimod (SD-101) • patritumab (U3-1287) • trebananib (AMG 386)
4years
[VIRTUAL] Intratumoral CpG, Local Radiation, and Oral Ibrutinib Combine to Produce Effective in Situ Vaccination in Patients with Low-Grade B-Cell Lymphoma (ASH 2020)
Introduction: Local treatment with intratumoral CpG (a toll-like receptor 9 agonist, SD-101) and low-dose radiation can elicit antitumor immune responses and global tumor reduction in patients with low-grade lymphoma (Frank, Cancer Discov, 2018). Early data suggest that the combination of oral ibrutinib, intratumoral CpG, and local low-dose radiation is safe and can generate systemic antitumor immune responses and systemic tumor shrinkage in low-grade lymphoma.
Clinical
|
CD8 (cluster of differentiation 8) • IL2 (Interleukin 2) • GZMB (Granzyme B) • ITK (IL2 Inducible T Cell Kinase)
|
Imbruvica (ibrutinib) • nelitolimod (SD-101)
4years
I-SPY 2: I-SPY TRIAL: Neoadjuvant and Personalized Adaptive Novel Agents to Treat Breast Cancer (clinicaltrials.gov)
P1, N=4000, Recruiting, QuantumLeap Healthcare Collaborative | Phase classification: P2 --> P1
Clinical • Phase classification • PARP Biomarker • PD(L)-1 Biomarker
|
HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor)
|
ER positive • ER negative
|
Keytruda (pembrolizumab) • Herceptin (trastuzumab) • Lynparza (olaparib) • carboplatin • Imfinzi (durvalumab) • Nerlynx (neratinib) • Perjeta (pertuzumab) • Kadcyla (ado-trastuzumab emtansine) • doxorubicin hydrochloride • Talzenna (talazoparib) • irinotecan • Jemperli (dostarlimab-gxly) • Tukysa (tucatinib) • veliparib (ABT-888) • Libtayo (cemiplimab-rwlc) • MK-2206 • ganitumab (AMG 479) • metformin • Jivadco (trastuzumab duocarmazine) • Turalio (pexidartinib) • ganetespib (ADX-1612) • Cosela (trilaciclib) • fianlimab (REGN3767) • Oraxol (oral paclitaxel/encequidar) • ladiratuzumab vedotin (SGN-LIV1A) • nelitolimod (SD-101) • patritumab (U3-1287) • trebananib (AMG 386)
4years
Study of SD-101 in Combination With Localized Low-dose Radiation in Patients With Untreated Low-grade B-cell Lymphoma (clinicaltrials.gov)
P1/2, N=29, Terminated, Dynavax Technologies Corporation | Completed --> Terminated; The sponsor terminated the trial early because there was sufficient data to make a decision about SD-101 in the lymphoma development program.
Clinical • Trial termination • Combination therapy
|
GBP1 (Guanylate Binding Protein 1)
|
nelitolimod (SD-101)
over4years
Keynote 184: A Trial of Intratumoral Injections of SD-101 in Combination With Pembrolizumab in Patients With Metastatic Melanoma or Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (clinicaltrials.gov)
P1b/2, N=241, Terminated, Dynavax Technologies Corporation | Active, not recruiting --> Terminated; A strategic restructuring including the planned conclusion of clinical oncology development programs and no further sponsoring of the development of SD-101.
Clinical • Trial termination • Combination therapy • PD(L)-1 Biomarker
|
PD-L1 (Programmed death ligand 1)
|
PD-L1 expression
|
Keytruda (pembrolizumab) • nelitolimod (SD-101)
almost5years
I-SPY 2: I-SPY TRIAL: Neoadjuvant and Personalized Adaptive Novel Agents to Treat Breast Cancer (clinicaltrials.gov)
P2, N=4000, Recruiting, QuantumLeap Healthcare Collaborative | N=1920 --> 4000
Clinical • Enrollment change • PARP Biomarker • PD(L)-1 Biomarker
|
HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor)
|
ER positive • ER negative
|
Keytruda (pembrolizumab) • Herceptin (trastuzumab) • Lynparza (olaparib) • carboplatin • Imfinzi (durvalumab) • Nerlynx (neratinib) • Perjeta (pertuzumab) • Kadcyla (ado-trastuzumab emtansine) • doxorubicin hydrochloride • Talzenna (talazoparib) • irinotecan • Jemperli (dostarlimab-gxly) • Tukysa (tucatinib) • veliparib (ABT-888) • Libtayo (cemiplimab-rwlc) • MK-2206 • ganitumab (AMG 479) • metformin • Jivadco (trastuzumab duocarmazine) • Turalio (pexidartinib) • ganetespib (ADX-1612) • Cosela (trilaciclib) • fianlimab (REGN3767) • Oraxol (oral paclitaxel/encequidar) • ladiratuzumab vedotin (SGN-LIV1A) • nelitolimod (SD-101) • patritumab (U3-1287) • trebananib (AMG 386)
almost5years
I-SPY 2: I-SPY TRIAL: Neoadjuvant and Personalized Adaptive Novel Agents to Treat Breast Cancer (clinicaltrials.gov)
P2, N=1920, Recruiting, QuantumLeap Healthcare Collaborative | Trial primary completion date: Dec 2020 --> Dec 2025
Clinical • Trial primary completion date • PARP Biomarker • PD(L)-1 Biomarker
|
HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor)
|
ER positive • ER negative
|
Keytruda (pembrolizumab) • Herceptin (trastuzumab) • Lynparza (olaparib) • carboplatin • Imfinzi (durvalumab) • Nerlynx (neratinib) • Perjeta (pertuzumab) • Kadcyla (ado-trastuzumab emtansine) • doxorubicin hydrochloride • Talzenna (talazoparib) • irinotecan • Jemperli (dostarlimab-gxly) • Tukysa (tucatinib) • veliparib (ABT-888) • Libtayo (cemiplimab-rwlc) • MK-2206 • ganitumab (AMG 479) • metformin • Jivadco (trastuzumab duocarmazine) • Turalio (pexidartinib) • ganetespib (ADX-1612) • Cosela (trilaciclib) • fianlimab (REGN3767) • Oraxol (oral paclitaxel/encequidar) • ladiratuzumab vedotin (SGN-LIV1A) • nelitolimod (SD-101) • patritumab (U3-1287) • trebananib (AMG 386)
almost5years
A pilot study of intratumoral SD-101 (toll-like receptor 9 agonist), nivolumab, and radiotherapy for treatment of chemotherapy-refractory metastatic pancreatic adenocarcinoma. (ASCO-GI 2020)
Clinical trial information: NCT04050085. Research Funding: Private, individual donor, Drug-only support from Bristol-Myers Squibb and Dynavax
Clinical • Tumor Mutational Burden • PD(L)-1 Biomarker • IO biomarker
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TMB (Tumor Mutational Burden)
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Opdivo (nivolumab) • nelitolimod (SD-101)