Prometheus News - LARVOL Sigma

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||||||||||  Proleukin (aldesleukin) / Merck (MSD), Novartis, Iovance Biotherap
Trial completion, Metastases:  TIL Therapy for Metastatic Renal Cell Carcinoma (clinicaltrials.gov) -  Nov 22, 2024
P1, N=5, Completed,  Sponsor: Inge Marie Svane
Unknown status --> Completed

||||||||||  Proleukin (aldesleukin) / Merck (MSD), Novartis, Iovance Biotherap
Trial completion date, Trial primary completion date, Metastases:  Gene and Vaccine Therapy in Treating Patients With Advanced Malignancies (clinicaltrials.gov) -  Nov 17, 2024
P2, N=6, Active, not recruiting,  Sponsor: Jonsson Comprehensive Cancer Center
Unknown status --> Completed Trial completion date: Nov 2025 --> Nov 2026 | Trial primary completion date: Nov 2024 --> Nov 2025

|||||||||| tulisokibart (MK-7240) / Merck (MSD)
Review, Journal: TL1A: A model for a precision medicine approach in the treatment of Crohn's disease and ulcerative colitis. (Pubmed Central) - Nov 16, 2024
Precision medicine provides a strategy to account for disease heterogeneity and diverse etiology to select for patients most likely to respond to a given therapeutic. In this chapter we present an example of the development of a novel antibody therapeutic, Tulisokibart, as a model for a Precision Medicine approach to the successful treatment of patients with IBD.

|||||||||| Rencarex (girentuximab) / Heidelberg Pharma, Esteve, Merck (MSD)
Journal: [89Zr]Zr-girentuximab PET-CT imaging to diagnose, characterize, and differentiate clear-cell renal cell carcinoma. (Pubmed Central) - Nov 16, 2024
In this chapter we present an example of the development of a novel antibody therapeutic, Tulisokibart, as a model for a Precision Medicine approach to the successful treatment of patients with IBD. In the phase 3 ZIRCON trial, [89Zr]Zr-girentuximab positron emission tomography-computed tomography (PET-CT) detected the presence of clear-cell renal cell carcinoma (ccRCC) with a sensitivity of 86% and a specificity of 87% in patients with an indeterminate renal mass undergoing nephrectomy.1 This imaging technique could be a promising tool that could revolutionize the management of small renal masses (SRMs) and ccRCC.

||||||||||  Proleukin (aldesleukin) / Merck (MSD), Novartis, Iovance Biotherap
New P2 trial, Tumor mutational burden, Metastases:  A Phase II Study of Adjuvant Immunotherapy Targeting KRAS G12D, KRAS G12V, or TP53 R175H for Participants With Advanced Gastrointestinal Malignancies (clinicaltrials.gov) -  Nov 15, 2024
P2, N=65, Not yet recruiting,  Sponsor: National Cancer Institute (NCI)

||||||||||  tulisokibart (MK-7240) / Merck (MSD)
Enrollment closed:  Pharmacokinetic (PK) Characterization of Subcutaneous Tulisokibart (MK-7240-010) (clinicaltrials.gov) -  Nov 12, 2024
P1, N=60, Active, not recruiting,  Sponsor: Merck Sharp & Dohme LLC
In the phase 3 ZIRCON trial, [89Zr]Zr-girentuximab positron emission tomography-computed tomography (PET-CT) detected the presence of clear-cell renal cell carcinoma (ccRCC) with a sensitivity of 86% and a specificity of 87% in patients with an indeterminate renal mass undergoing nephrectomy.1 This imaging technique could be a promising tool that could revolutionize the management of small renal masses (SRMs) and ccRCC. Recruiting --> Active, not recruiting

||||||||||  IDP-023 / Indapta Therap
New P1 trial:  IDP-023 g-NK Cells Plus Ocrelizumab in Patients With Progressive Multiple Sclerosis (clinicaltrials.gov) -  Nov 6, 2024
P1, N=34, Not yet recruiting,  Sponsor: Indapta Therapeutics, INC.

|||||||||| Orencia (abatacept) / BMS, Proleukin (aldesleukin) / Merck (MSD), Novartis, Iovance Biotherap, Rituxan (rituximab) / Roche
Journal: Where are we now in biological drugs for myositis? (Pubmed Central) - Nov 4, 2024
We review several new emerging biological drugs including B cell depletion therapies, abatacept, janus-kinase inhibitors, and aldesleukin. Encouragingly, some phase II randomized controlled trials have evaluated the efficacy and safety of new biologics in IIM, demonstrating an improvement in clinical and laboratory measures.

|||||||||| Proleukin (aldesleukin) / Merck (MSD), Novartis, Iovance Biotherap, Giazo (balsalazide disodium tablet) / Bausch Health
Journal: Drug-induced noninfectious myocarditis: a disproportionality analysis of the FAERS database. (Pubmed Central) - Oct 29, 2024
Disproportionality analysis revealed that the top 5 drugs by ROR were phendimetrazine tartrate (ROR 104.64), trimethoprim?+?sulfamethoxazole (ROR 67.65), aldesleukin (ROR 52.67), mesalazine (ROR 49.73), and balsalazide disodium (ROR 45.26)...Through comprehensive analysis of the FAERS database, our study identified drugs with a strong signal for myocarditis that are not currently indicated on their labels. The findings suggest that the potential risk of myocarditis associated with these medications is significant and warrants close monitoring in clinical practice.

||||||||||  Young TIL / National Cancer Institute
Trial primary completion date, Metastases:  T Cell Receptor Immunotherapy for Patients With Metastatic Non-Small Cell Lung Cancer (clinicaltrials.gov) -  Oct 29, 2024
P2, N=85, Recruiting,  Sponsor: National Cancer Institute (NCI)
The findings suggest that the potential risk of myocarditis associated with these medications is significant and warrants close monitoring in clinical practice. Trial primary completion date: Oct 2024 --> Oct 2025

||||||||||  Proleukin (aldesleukin) / Merck (MSD), Novartis, Iovance Biotherap, Opdivo (nivolumab) / BMS, Yervoy (ipilimumab) / BMS
Trial completion:  Adoptive Cell Therapy Across Cancer Diagnoses (clinicaltrials.gov) -  Oct 28, 2024
P1/2, N=25, Completed,  Sponsor: Inge Marie Svane
Trial primary completion date: Oct 2024 --> Oct 2025 Unknown status --> Completed

||||||||||  tulisokibart (MK-7240) / Merck (MSD)
New P3 trial:  Extension Study of Long-term Safety and Efficacy of Tulisokibart in Participants With Crohn's Disease or Ulcerative Colitis (MK-7240-011) (clinicaltrials.gov) -  Oct 21, 2024
P3, N=1349, Not yet recruiting,  Sponsor: Merck Sharp & Dohme LLC

||||||||||  Proleukin (aldesleukin) / Merck (MSD), Novartis, Iovance Biotherap
Enrollment change, Trial completion date, Trial primary completion date, Metastases:  Genetically Modified T-Cells Followed by Aldesleukin in Treating Patients with Stage III-IV Melanoma (clinicaltrials.gov) -  Oct 17, 2024
P1, N=34, Active, not recruiting,  Sponsor: M.D. Anderson Cancer Center
Unknown status --> Completed N=15 --> 34 | Trial completion date: Jun 2025 --> Oct 2027 | Trial primary completion date: Jun 2024 --> Oct 2027

||||||||||  tulisokibart (MK-7240) / Merck (MSD)
Enrollment open:  Pharmacokinetic (PK) Characterization of Subcutaneous Tulisokibart (MK-7240-010) (clinicaltrials.gov) -  Oct 8, 2024
P1, N=60, Recruiting,  Sponsor: Merck Sharp & Dohme LLC
N=15 --> 34 | Trial completion date: Jun 2025 --> Oct 2027 | Trial primary completion date: Jun 2024 --> Oct 2027 Not yet recruiting --> Recruiting

|||||||||| HM16390 / Hanmi
Synergistic tumor clearing effect of a novel long-acting IL-2 analog, HM16390, in combination with immune checkpoint inhibitors in a cold tumor syngeneic animal models (Exhibit Halls AB - George R. Brown Convention Center) - Oct 4, 2024 - Abstract #SITC2024SITC_1403;
In contrast, daily aldesleukin did not induce significant immune infiltration compared to HM16390, and TIL infiltration on day 8 was similar to that of vehicle...Anti-PD-1 as monotherapy or in combination with paclitaxel exerted only marginal tumor growth inhibition (TGI) against 4T1 tumor...The limited anti-tumor efficacy of another major CPI, anti-CTLA4 (TGI 50% without cured mice), also demonstrated synergism when combined with HM16390 (TGI 90%, more than 40% of mice cured) in 4T1 mice. Conclusions These studies support that HM16390 could be an ideal combination partner for both anti-PD-1 and anti-CTLA4 antibodies, whose mode of actions are considered different, through significant modulation of the TME toward an immune favorable state.

|||||||||| STK-012 / Synthekine
T cell and immune activation from a phase 1 study of STK-012, a first-in-class IL-2R ?/? selective partial agonist in advanced solid tumors (Exhibit Halls AB - George R. Brown Convention Center) - Oct 4, 2024 - Abstract #SITC2024SITC_1084;
These endpoints correlated with improved outcomes on study. STK-012 demonstrated a PK/PD profile which supports selectivity for antigen-activated T-cells and is distinct from that of aldesleukin and non-?-IL-2 analogues.

|||||||||| DF6215 / Dragonfly Therap
A novel alpha-active IL-2-Fc has expanded therapeutic index and robust monotherapy efficacy in mouse cancer models and strong synergy with PD-1 blockade (Exhibit Halls AB - George R. Brown Convention Center) - Oct 4, 2024 - Abstract #SITC2024SITC_1059;
P1
DF6215 is currently being evaluated in a Phase 1/1b clinical trial in patients with advanced solid tumors (NCT06108479). Ethics Approval All mouse studies were carried out according to protocols established by Explora BioLabs/CRADL IACUC committee.

|||||||||| Rencarex (girentuximab) / Heidelberg Pharma, Esteve, Merck (MSD), evofosfamide (IMGS-101) / ImmunoGenesis
Attacking carbonic anhydrase IX as a gateway to remodeling tumor hypoxia (Exhibit Halls AB - George R. Brown Convention Center) - Oct 4, 2024 - Abstract #SITC2024SITC_588;
CAIX is a cell surface enzyme strongly induced under hypoxia and has been correlated with poorer prognosis and ICB resistance.4 5 Lack of murine cross-reactivity amongst existing human CAIX antibodies like Girentuximab has significantly limited their evaluability in murine tumors...Conclusions Our novel mCAIX binding mAbs induce immune cell mediated cytodepletion in vitro and provide therapeutic benefit against melanoma expressing CAIX in vivo. Furthermore, our mCAIX mAbs bind to the hypoxic T cell suppressive stroma in B16/BL6 melanoma, warranting further studies to assess its therapeutic cooperativity with ICB.

|||||||||| Rencarex (girentuximab) / Heidelberg Pharma, Esteve, Merck (MSD)
P3 data, Journal: [89Zr]Zr-girentuximab for PET-CT imaging of clear-cell renal cell carcinoma: a prospective, open-label, multicentre, phase 3 trial. (Pubmed Central) - Oct 3, 2024
P3
Furthermore, our mCAIX mAbs bind to the hypoxic T cell suppressive stroma in B16/BL6 melanoma, warranting further studies to assess its therapeutic cooperativity with ICB. Our results suggest that [89Zr]Zr-girentuximab PET-CT has a favourable safety profile and is a highly accurate, non-invasive imaging modality for the detection and characterisation of clear-cell renal cell carcinoma, which has the potential to be practice changing.

||||||||||  Proleukin (aldesleukin) / Merck (MSD), Novartis, Iovance Biotherap
New P1 trial:  STIL101 for Injection for the Treatment of Locally Advanced, Metastatic or Unresectable Pancreatic Cancer, Colorectal Cancer, Renal Cell Cancer, Cervical Cancer and Melanoma (clinicaltrials.gov) -  Oct 3, 2024
P1, N=12, Not yet recruiting,  Sponsor: City of Hope Medical Center

|||||||||| Rencarex (girentuximab) / Heidelberg Pharma, Esteve, Merck (MSD)
Preclinical efficacy of CAIX-targeting [177Lu]Lu-WT-735-0626 for aggressive renal cell carcinomas (e-Poster Area) - Sep 27, 2024 - Abstract #EANM2024EANM_2490;
We have developed novel CAIX radioligands with exquisite potency, selectivity, in vivo tumor targeting, and normal tissue distribution. Our therapeutic efficacy data evidenced best-in-class potential of [177Lu]Lu-626/729, supporting our current efforts toward the clinical translation of these promising RPT agents in ccRCC and other CAIX-expressing cancers.

|||||||||| Rencarex (girentuximab) / Heidelberg Pharma, Esteve, Merck (MSD)
The Emerging Role of [89Zr]Zr-DFO-Girentuximab PET/ CT in Accurate Characterisation and Staging of ccRCC: early experience with three Patients (Hall Y1-Y3) - Sep 27, 2024 - Abstract #EANM2024EANM_1371;
This modality provides critical information to guide treatment strategies, improving overall clinical management with the advantage of whole-body imaging. In addition, the high specificity of CAIX targeting can identify ccRCC preoperatively, potentially sparing patients with benign renal masses from unnecessary surgery.

|||||||||| Rencarex (girentuximab) / Heidelberg Pharma, Esteve, Merck (MSD)
Development of Girentuximab as a theranostic tool in non-renal indications (Hall F) - Sep 27, 2024 - Abstract #EANM2024EANM_1367;
In addition, the high specificity of CAIX targeting can identify ccRCC preoperatively, potentially sparing patients with benign renal masses from unnecessary surgery. The results support a potential of radiolabelled Girentuximab as a theranostic agent in non-renal cancer indications and demonstrate that in addition to efficient tumour targeting intrinsic tumour radiosensitivity or effects on tumour stroma might play a role in determining tumour responses.

|||||||||| Rencarex (girentuximab) / Heidelberg Pharma, Esteve, Merck (MSD)
Preclinical Evaluation of DNA Damage Response Inhibitors and 225Ac-DOTA-girentuximab Combination Therapy (Hall F) - Sep 27, 2024 - Abstract #EANM2024EANM_1366;
The synergistic effect was evident with 225Ac-DOTA-girentuximab + peposertib, whereas 225Ac-DOTA-girentuximab + lartesertib exhibited an additive effect. Analysis of DDR biomarkers indicated elevated levels of DNA-PK phosphorylation, with phosphorylated ATM showing a comparatively lesser increase.

|||||||||| Rencarex (girentuximab) / Heidelberg Pharma, Esteve, Merck (MSD)
Radiation protection considerations with [89Zr]Zrgirentuximab PET/CT experience in France (Hall Y1-Y3) - Sep 27, 2024 - Abstract #EANM2024EANM_980;
Given the short delay observed between [89Zr]Zr-girentuximab administration and surgery, our on-site measurements represent the upper end of the range of expected dose to staff. With recent positive Phase 3 trial results and potential integration of [89Zr]Zr-girentuximab into clinical practice, appropriate radiation protection procedures are needed.

|||||||||| tulisokibart (MK-7240) / Merck (MSD)
Clinical, P2 data, Journal: Phase 2 Trial of Anti-TL1A Monoclonal Antibody Tulisokibart for Ulcerative Colitis. (Pubmed Central) - Sep 25, 2024
P2
In this short-term trial, tulisokibart was more effective than placebo in inducing clinical remission in patients with moderately to severely active ulcerative colitis. (Funded by Prometheus Biosciences, a subsidiary of Merck; ARTEMIS-UC ClinicalTrials.gov number, NCT04996797.).

|||||||||| Proleukin (aldesleukin) / Merck (MSD), Novartis, Iovance Biotherap, Zinbryta (daclizumab) / Biogen, AbbVie
Journal, Gene Signature: Exploration of the Shared Gene Signatures and Molecular Mechanisms between Chronic Bronchitis and Antineutrophil Cytoplasmic Antibody-associated Glomerulonephritis: Evidence from Transcriptome Data. (Pubmed Central) - Sep 20, 2024
(Funded by Prometheus Biosciences, a subsidiary of Merck; ARTEMIS-UC ClinicalTrials.gov number, NCT04996797.). Our study explores the inflammatory-immune pathways underlying CB-associated ANCA-GN and emphasizes the importance of NETs and lymphocyte differentiation, providing novel insights into the shared pathogenesis and therapeutic targets.

||||||||||  melphalan / Generic mfg.
Trial completion date, Trial termination:  NCI-2018-01758: Genetically Engineered Cells (NY-ESO-1 TCR Engineered T Cells and HSCs) After Melphalan Conditioning Regimen in Treating Patients With Recurrent or Refractory Ovarian, Fallopian Tube, or Primary Peritoneal Cancer (clinicaltrials.gov) -  Sep 18, 2024
P1, N=4, Terminated,  Sponsor: Roswell Park Cancer Institute
Our study explores the inflammatory-immune pathways underlying CB-associated ANCA-GN and emphasizes the importance of NETs and lymphocyte differentiation, providing novel insights into the shared pathogenesis and therapeutic targets. Trial completion date: Jan 2027 --> Jun 2024 | Active, not recruiting --> Terminated; Lack of funding

|||||||||| Rencarex (girentuximab) / Heidelberg Pharma, Esteve, Merck (MSD)
Journal, Heterogeneity: Epidemiological, Phylogenetic, and Resistance Heterogeneity Among Acinetobacter baumannii in a Large U.S. Deep South Healthcare system. (Pubmed Central) - Sep 4, 2024
CG108 and CG499 isolates displayed specific heteroresistance to sulbactam and trimethoprim/sulfamethoxazole, respectively, which resulted in discrepant susceptibility results in microbroth versus agar-based antibiotic susceptibility tests modalities. We report an unusually high degree of CRAb phylogenetic diversity principally driven by emergent U.S. lineages harboring novel resistance elements that must be incorporated into diagnostic, surveillance, and preclinical research efforts.

|||||||||| Rencarex (girentuximab) / Heidelberg Pharma, Esteve, Merck (MSD)
Review, Journal: Molecular imaging for non-invasive risk stratification of renal masses. (Pubmed Central) - Sep 2, 2024
On the other end of the spectrum, carbonic anhydrase IX agents, most notably the monoclonal antibody girentuximab - which can be labeled with positron emission tomography radionuclides such as zirconium-89 - are effective at identifying renal masses that are likely to be aggressive clear cell renal cell carcinomas...The combination of molecular imaging and biopsy in selected patients with other advanced imaging methods, such as artificial intelligence/machine learning and the abstraction of radiomics features, offers the optimal way forward for maximization of the information to be gained from risk stratification of indeterminate renal masses. With the proper application of those methods, inappropriately aggressive therapy for benign and indolent renal masses may be curtailed.

||||||||||  tulisokibart (MK-7240) / Merck (MSD)
New P1 trial:  Pharmacokinetic (PK) Characterization of Subcutaneous Tulisokibart (MK-7240-010) (clinicaltrials.gov) -  Aug 28, 2024
P1, N=60, Not yet recruiting,  Sponsor: Merck Sharp & Dohme LLC

||||||||||  Proleukin (aldesleukin) / Merck (MSD), Novartis, Iovance Biotherap, Jingzhuda (entinostat) / EOC Pharma, EddingPharm
Trial completion date, Combination therapy, Epigenetic controller, Metastases:  Entinostat in Combination With Aldesleukin in Treating Patients With Metastatic Kidney Cancer (clinicaltrials.gov) -  Aug 27, 2024
P1/2, N=47, Active, not recruiting,  Sponsor: National Cancer Institute (NCI)
With the proper application of those methods, inappropriately aggressive therapy for benign and indolent renal masses may be curtailed. Trial completion date: Jul 2024 --> Jul 2025

|||||||||| tulisokibart (MK-7240) / Merck (MSD)
Long-Term Efficacy and Safety of Intravenous (IV) Tulisokibart in Patients With Ulcerative Colitis (UC): Results From the Open-Label Extension (OLE) Period of the Phase 2 ARTEMIS-UC Study (Exhibit Hall E) - Aug 20, 2024 - Abstract #ACG2024ACG_4858;
Improvements in clinical, endoscopic, and biomarker outcomes observed with tulisokibart were generally maintained through week 50 in both dose groups (Table). A greater proportion of patients achieved clinical and endoscopic outcomes with tulisokibart 250 vs 100 mg.

|||||||||| tulisokibart (MK-7240) / Merck (MSD)
Long-Term Efficacy and Safety of Intravenous (IV) Tulisokibart in Patients With Crohn's Disease (CD): Results from the Open-Label Extension Period of the Phase 2 APOLLO-CD Study (Exhibit Hall E) - Aug 20, 2024 - Abstract #ACG2024ACG_4801;
A greater proportion of participants who were biologic-naive entered the OLE in the tulisokibart 250 vs 100 mg group (44% vs 21%). Improvements in clinical, endoscopic, and biomarker outcomes observed with tulisokibart were generally maintained through week 50 in both dose groups.

||||||||||  Keytruda (pembrolizumab) / Merck (MSD), Amtagvi (lifileucel) / Iovance Biotherap
Trial initiation date:  Efficacy & Safety for LN144 with Pembrolizumab with High Risk Stage IIIb-dResectable Melanoma (clinicaltrials.gov) -  Aug 7, 2024
P1, N=12, Suspended,  Sponsor: James Isaacs, MD
Improvements in clinical, endoscopic, and biomarker outcomes observed with tulisokibart were generally maintained through week 50 in both dose groups. Initiation date: Jun 2024 --> Dec 2024

||||||||||  tulisokibart (MK-7240) / Merck (MSD)
Trial completion date:  A Study to Evaluate the Efficacy and Safety of Tulisokibart (MK-7240) in Participants With Moderate to Severe Crohn's Disease (MK-7240-008) (clinicaltrials.gov) -  Jul 24, 2024
P3, N=1200, Recruiting,  Sponsor: Merck Sharp & Dohme LLC
Initiation date: Jun 2024 --> Dec 2024 Trial completion date: Sep 2029 --> Oct 2032

|||||||||| ANV419 / Anaveon
Journal: Discovery and development of ANV419, an IL-2/anti-IL-2 antibody fusion protein with potent CD8+ T and natural killer cell-stimulating capacity for cancer immunotherapy. (Pubmed Central) - Jul 23, 2024
ANV419 also enhances the NK cell killing capacity and increases tumor growth inhibition when used alongside trastuzumab in a Her-2+ xenograft mouse model...These data support the clinical development of ANV419 in solid tumors and hematological malignancies as monotherapy and in combination with checkpoint inhibitors or agents that induce antibody-dependent cellular cytotoxicity. ANV419 is currently in Phase 1/2 clinical development and may provide cancer patients with a wider therapeutic window than aldesleukin.

||||||||||  ICT01 / ImCheck Therap
Trial completion date, Trial primary completion date, Combination therapy, Metastases:  EVICTION-2: Phase 1/2a Study of ICT01 Plus Low Dose SC IL-2 in Patients With Advanced Solid Tumors (clinicaltrials.gov) -  Jul 21, 2024
P1/2, N=100, Recruiting,  Sponsor: ImCheck Therapeutics
ANV419 is currently in Phase 1/2 clinical development and may provide cancer patients with a wider therapeutic window than aldesleukin. Trial completion date: Dec 2024 --> Dec 2025 | Trial primary completion date: Apr 2024 --> Apr 2025

|||||||||| RG6631 / Roche, duvakitug (SAR447189) / Sanofi, tulisokibart (MK-7240) / Merck (MSD)
DISCOVERY AND CHARACTERIZATION OF A NOVEL HIGH-AFFINITY ANTI-TL1A MONOCLONAL ANTIBODY WITH EXTENDED HALF-LIFE FOR THE TREATMENT OF INFLAMMATORY BOWEL DISEASE (Poster Stage 1) - Jul 18, 2024 - Abstract #UEGW2024UEGW_3021;
In human FcRn knock-in mice and in cynomolgus monkeys, these antibodies show an extended half-life consistent with FDA-approved antibodies using the XtendTM technology. These data demonstrate the therapeutic potential of the clinical candidate antibodies in the treatment of TL1A-mediated diseases such as ulcerative colitis and Crohn

|||||||||| tulisokibart (MK-7240) / Merck (MSD)
LONG-TERM EFFICACY AND SAFETY OF TULISOKIBART IN PATIENTS WITH ULCERATIVE COLITIS (UC): RESULTS FROM THE OPEN-LABEL EXTENSION PERIOD OF THE PHASE 2 ARTEMIS-UC STUDY (Strauss 2) - Jul 18, 2024 - Abstract #UEGW2024UEGW_2987;
A trend for higher efficacy with tulisokibart 250 mg vs 100 mg maintenance treatment was observed at week 50. Tulisokibart was well tolerated with no identified safety signals.

|||||||||| CHARACTERIZATION OF TWO NOVEL EXTENDED HALF-LIFE MONOCLONAL ANTIBODY DRUG CANDIDATES TARGETING TL1A FOR THE TREATMENT OF IBD (Poster Stage 1) - Jul 18, 2024 - Abstract #UEGW2024UEGW_2709;
With an extended half-life observed in NHP, both SPY002-091 and SPY002-072 demonstrate therapeutic potential for effective and safe treatment of CD and UC with the advantage of infrequent SC dosing. Further preclinical and clinical studies are warranted to demonstrate this potential.

|||||||||| tulisokibart (MK-7240) / Merck (MSD)
LONG-TERM EFFICACY AND SAFETY OF TULISOKIBART IN PATIENTS WITH CROHN (Lehar 3) - Jul 18, 2024 - Abstract #UEGW2024UEGW_2250;
A trend for higher maintenance efficacy with tulisokibart 250 mg vs 100 mg maintenance treatment was observed at week 50. Tulisokibart was well tolerated with no safety signals identified through 50 weeks of treatment.

|||||||||| Rencarex (girentuximab) / Heidelberg Pharma, Esteve, Merck (MSD)
Retrospective data, Review, Journal: Imaging modalities for characterising T1 renal tumours: A systematic review and meta-analysis of diagnostic accuracy. (Pubmed Central) - Jul 18, 2024
Forest plots of sensitivity and specificity were produced for CT (seven records, 1118 participants), contrast-enhanced ultrasound (seven records, 197 participants), [99mTc]Tc-sestamibi SPECT/CT (five records, 263 participants), MRI (three records, 220 participants), [18F]FDG PET (four records, 43 participants), [68Ga]Ga-PSMA-11 PET (one record, 27 participants) and [111In]In-girentuximab SPECT/CT (one record, eight participants)...[99mTc]Tc-sestamibi SPECT/CT is an emerging tool, but further studies are required to inform its role in clinical practice. The field would benefit from standardisation of diagnostic thresholds for CT, MRI and contrast-enhanced ultrasound to facilitate future meta-analyses.

||||||||||  KK-LC-1 TCR therapy - T / Cure Biosci
Trial primary completion date, Gene therapy:  KK-LC-1 TCR-T Cell Therapy for Gastric, Breast, Cervical, and Lung Cancer (clinicaltrials.gov) -  Jul 11, 2024
P1, N=30, Recruiting,  Sponsor: Christian Hinrichs
The field would benefit from standardisation of diagnostic thresholds for CT, MRI and contrast-enhanced ultrasound to facilitate future meta-analyses. Trial primary completion date: Sep 2025 --> Sep 2026

|||||||||| Bavencio (avelumab) / EMD Serono
Intratumoral interleukin-2 in the treatment of cutaneous metastases of Merkel cell carcinoma after secondary loss of efficacy of avelumab (Terminal 2) - Jul 11, 2024 - Abstract #ADO2024ADO_221;
Trial primary completion date: Sep 2025 --> Sep 2026 After discussion in the tumor board, we then decided to inject IL-2 (Proleukin

||||||||||  tulisokibart (MK-7240) / Merck (MSD)
Enrollment open:  A Study to Evaluate the Efficacy and Safety of Tulisokibart (MK-7240) in Participants With Moderate to Severe Crohn's Disease (MK-7240-008) (clinicaltrials.gov) -  Jun 27, 2024
P3, N=1200, Recruiting,  Sponsor: Merck Sharp & Dohme LLC
After discussion in the tumor board, we then decided to inject IL-2 (Proleukin Not yet recruiting --> Recruiting

|||||||||| Rencarex (girentuximab) / Heidelberg Pharma, Esteve, Merck (MSD)
P1 data, Journal: Evaluation of PET/CT imaging with [89Zr]Zr-DFO-girentuximab: a phase 1 clinical study in Japanese patients with renal cell carcinoma (Zirdac-JP). (Pubmed Central) - Jun 12, 2024
Not yet recruiting --> Recruiting This study demonstrates that [89Zr]Zr-DFO-girentuximab administered to Japanese patients with suspected RCC has a favorable safety profile and is well tolerated and has a similar dosimetry profile to previously studied populations.

|||||||||| CLN-617 / Cullinan Oncology
Journal: CLN-617 retains IL-2 and IL-12 in injected tumors to drive robust and systemic immune-mediated antitumor activity. (Pubmed Central) - Jun 6, 2024
P1
We found that IT administration of a murine surrogate of CLN-617, mCLN-617, eradicated established treated and untreated tumors in syngeneic models, significantly improved response to anti-PD1 checkpoint therapy, and generated a robust abscopal response dependent on cellular immunity and antigen cross-presentation. CLN-617 is being evaluated in a clinical trial in patients with advanced solid tumors (NCT06035744).

|||||||||| Proleukin (aldesleukin) / Merck (MSD), Novartis, Iovance Biotherap
Pulmonary safety assessment of cancer immunotherapy on a patient-derived lung-on-chip (PS-5; Poster board no. 11) - May 31, 2024 - Abstract #ERS2024ERS_3771;
CLN-617 is being evaluated in a clinical trial in patients with advanced solid tumors (NCT06035744). Adverse events can occur in the lungs, where drugs such as the first approved immunotherapy Interleukin-2 (IL2, Proleukin

||||||||||  AU-007 / Aulos Biosci
Trial completion date, Trial primary completion date, Metastases:  Study of AU-007, A Monoclonal Antibody That Binds to IL-2 and Inhibits IL-2R? Binding, in Patients With Unresectable Locally Advanced or Metastatic Cancer (clinicaltrials.gov) -  May 31, 2024
P1/2, N=136, Recruiting,  Sponsor: Aulos Bioscience, Inc.
Adverse events can occur in the lungs, where drugs such as the first approved immunotherapy Interleukin-2 (IL2, Proleukin Trial completion date: Jan 2025 --> Sep 2025 | Trial primary completion date: Oct 2024 --> Aug 2025



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