CD28 inhibitors(T-cell-specific surface glycoprotein CD28 inhibitors), CTLA4 inhibitors(Cytotoxic T-Lymphocyte-Associated Antigen 4 inhibitors), IL-2R modulators(Interleukin-2 receptor modulators)

Therapeutic Areas

NeoplasmsInfectious DiseasesDigestive System Disorders+ [4]

Active Indication

Advanced Malignant Solid NeoplasmBladder CancerColorectal Cancer+ [11]

Inactive Indication-

Originator Organization

Simcere Pharmaceutical Group Ltd.

GI Innovation, Inc.

Active Organization

GI Innovation, Inc.

Inactive Organization

Simcere Pharmaceutical Group Ltd.

Drug Highest PhasePhase 1/2

First Approval Date-

RegulationOrphan Drug (US)

Gene Sequence

Sequence Code 5063

Target: *****

Sequence Code 6077linker

Sequence Code 315647156

Sequence Code 524284409linker

Sequence Code 524284410

Sequence Code 524284411

Sequence Code 524284413Fusion protein

Clinical Trials associated with SIM-323

KCT0009580 / Not yet recruitingPhase 2IIT

Phase 2a, open-label, multi-center study of GI-101A or GI-102 (CD80-IgG4 FC-IL2v) in patients with relapsed/refractory diffuse large B-cell lymphoma following anti-CD19 chimeric antigen receptor T-cell therapy (CARNATION)

Start Date31 Jul 2024

Sponsor / Collaborator

Asan Medical Center

NCT04977453 / RecruitingPhase 1/2

A Phase 1/2, Open-label, Dose-escalation, and Expansion Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Therapeutic Activity of GI-101 As a Single Agent and in Combination with Pembrolizumab, Lenvatinib or Local Radiotherapy in Patients with Advanced or Metastatic Solid Tumors (Keynote B59)

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and therapeutic activity of GI-101/GI-101A as a single agent or in combination with pembrolizumab, lenvatinib or local radiotherapy (RT) over a range of advanced and/or metastatic solid tumors.

Start Date02 Aug 2021

Sponsor / Collaborator

GI Innovation, Inc.

[+1]

100 Clinical Results associated with SIM-323

100 Translational Medicine associated with SIM-323

100 Patents (Medical) associated with SIM-323

Literatures (Medical) associated with SIM-323

01 Jun 1998·Cell biology internationalQ4 · BIOLOGY

A METASTATIC BREAST TUMOR CELL LINE, GI‐101A, IS ESTROGEN RECEPTOR POSITIVE AND RESPONSIVE TO ESTROGEN BUT RESISTANT TO TAMOXIFEN

Q4 · BIOLOGY

Article

Author: Shula Raney ; Joseph J. Morrissey

The progression of human breast cancer is often associated with a loss of estrogen dependence for growth, a resistance to estrogen antagonists such as tamoxifen, and the metastatic spread of the disease to secondary sites. Cell lines developed from such advanced breast tumors are often metastatic in athymic mice, show a loss of estrogen receptor mRNA and protein (ER−), and do not respond to 17β‐estradiol. However many advanced human breast tumors do express significant amounts of ER transcript, especially when analyzed by more sensitive methods of detection including RT‐PCR and Ribonuclease Protection Assay (RPA). No metastatic, ER+breast tumor cell line has previously existed to examine the role of ER in metastatic progression and acquired drug (tamoxifen) resistance. The GI‐101A cell line was recently developed from a metastatic breast tumor xenograft and is both tumorogenic and metastatic to the lungs and lymph node when injected into athymic mice, a pattern similar to that seen in patients. While Western blot analysis initially indicated that GI‐101A was ER−, analysis of ER mRNA by RT‐PCR and RPA have demonstrated the expression of ER (as well as EGF receptor and neu oncogene) transcripts. Functional ER in GI‐101A was confirmed by a clear growth response to 17β‐estradiol in culture. Optimal 17β‐estradiol concentrations were significantly lower for GI101A than for MCF‐7 (1nmas opposed to ≥10nm), and GI‐101A growth was inhibited at 17β‐estradiol concentrations above 10nm. Unlike MCF‐7 cells, GI‐101A shows constitutive expression of pS2 protein in hormone depleted media with no apparent induction by 17β‐estradiol supplimentation, as well as a resistance to the anti‐estrogen tamoxifen at concentrations up to 10nm. Finally, ER transcripts which likely represent an alternately spliced ER variant which has previously been shown to encode a constitutively active ER protein have been detected in GI‐101A at levels similar to the wild type transcript, and offer a possible mechanism for estrogen independence, tamoxifen resistance, and constitutive pS2 expression.

04 Sep 1997·Cancer chemotherapy and pharmacologyQ4 · MEDICINE

Sensitivity to camptothecin of human breast carcinoma and normal endothelial cells

Q4 · MEDICINE

Article

Author: Sayed S. Daoud ; Carleton B. Jones ; Mark K. Clements ; Safia Wasi

PURPOSE:

To assess parameters that might determine resistance to the topoisomerase I inhibitor, camptothecin (CPT), the sensitivities of three established human breast cancer cell lines (ER-) and of normal bovine endothelial cells to CPT in the free form and incorporated into liposomes (LCPT), were contrasted with topoisomerase I (topo I) content and activity, and with cell cycle response to CPT treatment.

METHODS:

Drug sensitivities were determined using the tetrazolium dye assay and by 3H-thymidine incorporation. Topo I levels were determined by Western blot analysis, and catalytic activity was determined with a plasmid relaxation assay, using nuclear protein from each cell line. CPT stabilization of cleavable complexes in nuclear extracts was determined using a labeled oligonucleotide with a specific topo I cleavage site. Cell cycle response to CPT was determined by flow cytometric analysis of propidium iodide-stained nuclei.

RESULTS:

CPT was extremely potent against MDA-MB-157 cells with an IC50 value of 7 nM compared with IC50 values of 150 nM for GI 101A and 250 nM for MDA-MB-231 cells. In contrast, CPT inhibited the incorporation of 3H-thymidine at very low doses in GI 101A and MDA-MB-231 cells with IC50 values of 9 nM and 5 nM, respectively; while MDA-MB-157 cells did not stop incorporating 3H-thymidine until very high doses (500 nM) of CPT were used. When incorporated into multilamellar liposomes (LCPT), CPT retained its potency, with IC50 values similar to that of the free drug. No correlation was found between CPT-induced cytotoxicity and any of the topo I parameters determined. Cell cycle analysis, however, showed an accumulation of cells in G2/M phase after 24 h treatment with low doses (5 nM) of CPT in only GI 101A and MDA-MB-231 cells with no arrest in normal endothelial or MDA-MB-157 cells. At higher doses (50 nM), however, a dramatic accumulation of cells in the S phase was observed in MDA-MB-157, MDA-MB-231 and GI 101A cells. In contrast, a G2/M phase block was seen with the normal bovine endothelial cells using the higher doses of CPT.

CONCLUSIONS:

The results suggest that cell cycle regulation plays an important role in determining the effect of CPT on malignant and normal cells. The possible mechanisms explaining the sensitivities of the two cellular compartments to the action of CPT are discussed.

01 Jan 1997·The international journal of biochemistry & cell biologyQ2 · BIOLOGY

Expression of connective tissue growth factor mRNA in the fibrous stroma of mammary tumors

Q2 · BIOLOGY

Article

Author: Gary R. Grotendorst ; Ken S. Frazier

Desmoplasia, the formation of highly cellular, excessive connective tissue stroma associated with some cancers, shares many features with the wound healing response. Since connective tissue growth factor (CTGF) has previously been demonstrated to play a role in wound repair, we wanted to determine if it might be involved in the pathogenesis of stromal demoplasia in mammary cancer. We assayed 11 human invasive mammary ductal carcinomas by Northern blot and 7 out of 11 were positive for both CTGF expression and transforming growth factor-beta 1 (TGF-beta 1, a principal CTGF inducer). One specimen was positive only for TGF-beta 1. The remaining 3 tumors lacked significant stromal involvement and were negative for either factor. In every case we assayed, in which there was marked connective tissue involvement, both CTGF and TGF-beta 1 messages were found. We also assayed 3 murine mammary tumor models. The GI-101 xenograft model had marked stroma and was positive for both factors in-vivo, but positive for only TGF-beta 1 mRNA expression in culture where fibroblasts were absent. The DMBA murine tumor lacked significant stroma and was negative for CTGF and TGF-beta 1 expression by Northern blot, while the stromal rich DMBA-MMTV tumor contained multifocal desmoplasia and was positive for both factors. We performed in-situ hybridization for CTGF and TGF-beta 1 on the GI-101 and DMBA-MMTV tumors. CTGF message was observed only in the fibroblasts of the stroma, while TGF-beta 1 mRNA hybridization was present in tumor epithelial cells and leukocytes. These results suggest that cancer stroma formation involves induction of similar fibroproliferative growth factors (TGF-beta 1 and CTGF) as wound repair.

News (Medical) associated with SIM-323

26 Aug 2024

·www.businesswire.com

GI Innovation Announces New Clinical Trial Collaboration and Supply Agreement to Evaluate GI-102 in Combination with KEYTRUDA® (pembrolizumab) in Patients with Immunotherapy-Resistant Liver Cancer, Melanoma, and Renal Cell Carcinoma

SEOUL, South Korea--( BUSINESS WIRE )--The South Korean biotech company GI Innovation announced today that it has signed a clinical trial collaboration and supply agreement with MSD (a tradename of Merck& Co., Inc., Rahway, NJ, USA) to evaluate the combination of GI-102 and MSD’s anti-PD-1 therapy, KEYTRUDA® (pembrolizumab) in patients with immunotherapy-resistant liver cancer, melanoma, and renal cell carcinoma. This agreement marks GI Innovation’s second clinical trial collaboration with MSD, following a previous collaboration for GI-101A. The Phase 2 clinical trial including GI-102 in combination with KEYTRUDA will enroll patients with resistance or non-response to immuno-oncology treatments, leaving them with no further treatment options. GI Innovation is focused on three indications with significant market potential and potential likelihood of success: metastatic liver cancer, melanoma, and renal cell carcinoma. The company has already demonstrated strong anti-cancer efficacy with a 42.9% overall response rate (ORR) in a monotherapy trial of GI-102 in melanoma patients who failed to respond to standard-of-care treatment (3 partial responses out of 7 patients). Complete tumor regression was previously observed in 60% of mice treated with GI-102 monotherapy in a preclinical liver cancer model. Fourteen hospitals in South Korea and world-renowned sites in the U.S. have agreed to join the trial, including the Mayo Clinic (campuses in Rochester, Florida, and Arizona), Cleveland Clinic and Memorial Sloan Kettering Cancer Center. In South Korea, the trial will take place at leading hospitals including Samsung Medical Center, Asan Medical Center, Seoul National University Hospital, Severance Hospital of Yonsei University, and St. Vincent’s Hospital. "We are pleased to enter into another clinical trial collaboration and supply agreement with MSD, a world leader in immuno-oncology. We aim to maximize the therapeutic value of GI-102 by combining it with KEYTRUDA, MSD’s anti-PD-1 therapy”, said Dr Myung-Ho Jang, GI Innovation’s Chief Scientific Officer. KEYTRUDA® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway NJ, USA.

Phase 2Immunotherapy

19 Apr 2023

·www.gi-cell.com

GI Cell speeds up developing of allogeneic NK cell therapies

GI Cell has won approval for phase 1 IND (investigational new drug) for allogeneic NK cell therapy. The company will also push for its combined administration with immunotherapy candidate substance of its affiliate, GI Innovation. GI Cell said Monday that it has obtained approval for the phase 1 clinical trial of its allogeneic NK cell therapy, GIC-102 (T.O.P. NK), from the Ministry of Food and Drug Safety. Large medical institutions, including Korea University Anam Hospital, Seoul National University Hospital, and Asan Medical Center, will conduct the clinical trial beginning in the first half year. In phase 1 clinical trial, GI Cell plans to confirm the safety, drug resistance, and pharmacokinetics/pharmacodynamics of GIC-102 in patients with progressive solid cancers, recurrent/refractory non-Hodgkin lymphoma, and multiple myeloma. According to GI Cell, GIC-102 is a next-generation NK cell therapy that maximizes tumor-targeting function and cancer cell-killing efficiency. Its mass culture with high purity is also possible using immune cell pure expander, GI Cell’s technology to mass-culture immune cells. GI Cell has proved GIC-102’s efficacy in various solid cancers through non-clinical trials using a humanized mouse, particularly its consistent cancer-growth-suppressing efficacy in the mouse transplanted with various types of colorectal cancer cell lines. In phase 1 clinical trial, GI Cell will evaluate not only the administration of GIC-102 alone but also its combined administration with GI Innovation’s double fusion protein, GI-101. GI-101, for which a phase 1/2 clinical trial is underway, is a fusion protein of CD80 that targets immune cells and IL-2v, an IL-2 variation that has overcome the disadvantages of IL-2. “GI-101 proliferates and activates NK cells by uniquely binding to receptors expressed in NK cells and is expected to show superior synergy in various solid cancers, including colorectal cancer, through a combined therapy with T.O.P. NK,” said GI Innovation Chairman Chang Myeong-ho said. “NK cells activated by GI-101 induce the expression of chemokine receptors that help smooth infiltration into tumor cells.” GI Cell CEO Hong Cheon-pyo said, “We have moved one step closer to our goal of providing a new treatment option for patients who do not respond to standard treatments. The combined therapy of T.O.P. NK and GI-101 has shown unparalleled durability and efficacy, so we will go all out to win approval as soon as possible by proving their efficacy in clinical trials.” GI Cell said it has a GMP facility of 3,300 square meters to manufacture and supply clinical samples independently. Besides, the company has won permits to manufacture high-technology biopharmaceutical products and to manage human cells and aims to get permission for a cell disposal facility within the first half of this year.

Cell TherapyPhase 1ImmunotherapyIND

23 Aug 2022

·www.prnewswire.com

Bladder Cancer Clinical Trial Pipeline Insights Featuring 100+ Companies | DelveInsight

DelveInsight's bladder cancer pipeline report depicts a robust space with 100+ active players working to develop 100+ pipeline therapies for bladder cancer treatment. LAS VEGAS, Aug. 23, 2022 /PRNewswire/ -- DelveInsight's ' Bladder Cancer Pipeline Insight 2022 ' report provides comprehensive global coverage of available, marketed, and pipeline bladder cancer therapies in various stages of clinical development, major pharmaceutical companies are working to advance the pipeline space and future growth potential of the bladder cancer pipeline domain. Key Takeaways from the Bladder Cancer Pipeline Report DelveInsight's bladder cancer pipeline report depicts a robust space with 100+ active players working to develop 100+ pipeline therapies for bladder cancer treatment. Leading bladder cancer companies such as CG Oncology, FKD Therapies, Bristol-Myers Squibb, LintonPharm Co., Ltd., ImmunityBio, Inc., Hamlet Pharma AB, Asieris Pharmaceuticals, Pfizer, Taizhou Hanzhong biomedical co. LTD, Protara Therapeutics, CicloMed LLC, enGene, Inc., Emtora Biosciences, Theralase Inc., Vaxiion Therapeutics, Janssen Research & Development, LLC, Astellas Pharma, RemeGen Co., Ltd., UroGen Pharma Ltd., Flame Biosciences, Aura Biosciences, BeiGene, Incyte Corporation, QED Therapeutics, G1 Therapeutics, AN0025, Kyowa Kirin, Inc., Infinity Pharmaceuticals, Shanghai Hengrui Pharmaceutical Co., Ltd., HiberCell, Inc., Ikena Oncology, Genentech, Fusion Pharmaceuticals, GI Innovation,SOTIO Biotech AG, Celon Pharma SA, 4D Pharma PLC, Keythera Pharmaceuticals, Quadriga Biosciences, Inc., NeoTX Therapeutics Ltd., Mirati Therapeutics, NGM Biopharmaceuticals, TransThera Biosciences, Ocellaris Pharma, Palleon Pharmaceuticals, Medicenna Therapeutics, Klus Pharma, Novartis, Toray Industries, Carisma Therapeutics, Avacta Life Sciences Ltd, Seagen Inc., Elevation Oncology, Corvus Pharmaceuticals, ADC Therapeutics S.A., IO Biotech, Byondis B.V., Takara Bio, Seven and Eight Biopharmaceuticals, Dragonfly Therapeutics, InnoCare Pharma, and others are evaluating novel bladder cancer drugs candidate to improve the treatment landscape. Key bladder cancer pipeline therapies in various stages of development include CG0070, ADSTILADRIN, Nivolumab, Catumaxomab, N-803, alpha1H, APL-1202, PF-07225570, HX008, TARA-002, CPX-POM, EG-70, eRapa, TLD-1433, VAX014, Erdafitinib, Enfortumab vedotin, RC48-ADC, TAS 102, UGN-102, FL-101, AU-011, Tislelizumab, Pemigatinib, Infigratinib, Trilaciclib, AN0025, KHK2455, IPI-549, SHR-1501, HC-7366, IK-175, ado-trastuzumab emtansine, FPI-1966, GI-101, SO-C101, CPL304110, MRx0518, KF-0210, QBS10072S, Naptumomab Estafenatox, Sitravatinib, NGM120, TT-00420, OC-001, E-602, MDNA11, A166, Spartalizumab, TRK-950, CT-0508, AVA6000, SEA-TGT, Seribantumab, CPI-006, ADCT-301, IO 102, SYD985, TBI-1301, BDB001, DF1001, ICP-192, and others. In July 2022, The FDA accepted for review a Biologics License Application (BLA) from ImmunityBio, Inc. (NASDAQ: IBRX), for its antibody cytokine fusion protein as a treatment for patients with BCG-unresponsive non-muscle-invasive bladder cancer carcinoma in situ (CIS) with or without Ta or T1 disease. ImmunityBio, a leading clinical-stage immunotherapy company, filed the BLA based on positive results from a series of studies of the investigational treatment, including the ongoing QUILT 3.032 trial. The Prescription Drug User Fee Act (PDUFA) target action date is May 23, 2023. In June 2022, CG Oncology announced the interim data on two ongoing clinical studies to be presented at The American Society of Clinical Oncology (ASCO) 2022 Annual Meeting.The first poster presentation reports on efficacy and safety data from a global Phase 2 study (CORE1) of CG0070 in combination with Merck's anti-PD-1 therapy KEYTRUDA® (pembrolizumab), for the treatment of patients with Non-Muscle-Invasive Bladder Cancer (NMIBC) unresponsive to Bacillus Calmette-Guerin (BCG). The second poster presentation centers on a Phase 1b/2 study (CORE2) of CG0070 in combination with OPDIVO®(nivolumab), as a neoadjuvant immunotherapy for Muscle-Invasive Bladder Cancer (MIBC) in cisplatin-ineligible patients. In May 2022, Asieris Pharmaceuticals announced that the ANTICIPATE Study will be presented at the 2022 American Society of Clinical Oncology (ASCO) annual meeting on June 3-7, 2022, in Chicago. This is a study of taking oral APL-1202 in combination with BeiGene's tislelizumab compared to just taking tislelizumab alone as neoadjuvant therapy (NAC) in patients with muscle invasive bladder cancer (MIBC). In March 2022, Protara Therapeutics, Inc. announced that the Company had dosed the first patient in ADVANCED-1, its Phase 1 clinical trial evaluating TARA-002, an investigational cell-based immunopotentiator, for the treatment of non-muscle invasive bladder cancer (NMIBC). In January 2022, Vaxiion Therapeutics, announced the U.S. Food and Drug Administration had cleared the company's Investigational New Drug application (IND) for VAX014 for investigational use in the intralesional treatment of solid tumors refractory to standard treatment options. VAX014 is a first-in-class recombinant bacterial minicell-based oncolytic immunotherapy. In December 2021, LintonPharm Co., Ltd., announced that the first patient had been dosed in the Company's Phase 1/2 clinical trial program for catumaxomab (clinicaltrials.gov: NCT04799847), a monoclonal bispecific antibody being studied for the treatment of Non-Muscle-Invasive Bladder Cancer (NMIBC) unresponsive to Bacillus Calmette-Guerin (BCG). Request a sample and discover the recent advances in bladder cancer treatment @ Bladder Cancer Pipeline Report The bladder cancer pipeline report provides detailed profiles of pipeline assets, a comparative analysis of clinical and non-clinical stage bladder cancer drugs, inactive and dormant assets, a comprehensive assessment of driving and restraining factors, and an assessment of opportunities and risks in the bladder cancer pipeline landscape. Bladder Cancer Overview Bladder cancer usually starts in the cells that line the inside of the bladder. It typically affects adults over the age of 70 and is more common in men. Bladder cancer is the fifth most prevalent type of cancer in the general population and the fourth most common in males. When detected early, bladder cancer usually responds well to bladder cancer treatment. Smoking is among the most common bladder cancer causes. Blood in the urine is usually the first sign of bladder cancer. Other bladder cancer symptoms may include urine pain or burning, as well as a change in urinary habits. This can include frequent urination or the need to urinate but being unable to do so. The tests used for bladder cancer diagnosis include biopsy, cystoscopy, urine cytology, imaging tests, and others. Find out more about bladder cancer drugs in development @ Bladder Cancer Drugs A snapshot of the Bladder Cancer Pipeline Drugs mentioned in the report: Learn more about the novel and emerging bladder cancer pipeline therapies @ Bladder Cancer Clinical Trials Bladder Cancer Therapeutics Assessment The bladder cancer pipeline report proffers an integral view of the bladder cancer emerging novel therapies segmented by stage, product type, molecule type, mechanism of action, and route of administration. Scope of the Bladder Cancer Pipeline Report Coverage: Global Therapeutic Assessment By Product Type: Mono, Combination, Mono/Combination Therapeutic Assessment By Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III Therapeutics Assessment By Route of Administration: Inhalation, Intranasal, Parenteral, Oral, Intravenous, Subcutaneous, Intramuscular Therapeutics Assessment By Molecule Type: Antibody, Antisense oligonucleotides, Immunotherapy, Monoclonal antibody, Peptides, Protein, Recombinant protein, Small molecule, Stem cell, Vaccine Therapeutics Assessment By Mechanism of Action: Cell death stimulants, Granulocyte macrophage colony stimulating factor agonists, Interleukin-15 receptor agonists, DNA synthesis inhibitors, Cyclin-dependent kinase 4 inhibitors, Cyclin-dependent kinase 6 inhibitors, Gene transference, IFNA2B expression stimulants, Antibody-dependent cell cytotoxicity, Programmed cell death-1 receptor antagonists, T lymphocyte stimulants Key Bladder Cancer Companies: CG Oncology, FKD Therapies, Bristol-Myers Squibb, LintonPharm Co.,Ltd., ImmunityBio, Inc., Hamlet Pharma AB, Asieris Pharmaceuticals, Pfizer, Taizhou Hanzhong biomedical co. LTD, Protara Therapeutics, CicloMed LLC, enGene, Inc., Emtora Biosciences, Theralase Inc., Vaxiion Therapeutics, Janssen Research & Development, LLC, Astellas Pharma, RemeGen Co., Ltd., UroGen Pharma Ltd., Flame Biosciences, Aura Biosciences, BeiGene, Incyte Corporation, QED Therapeutics, G1 Therapeutics, AN0025, Kyowa Kirin, Inc., Infinity Pharmaceuticals, Shanghai Hengrui Pharmaceutical Co., Ltd., HiberCell, Inc., Ikena Oncology, Genentech, Fusion Pharmaceuticals, GI Innovation,SOTIO Biotech AG, Celon Pharma SA, 4D Pharma PLC, Keythera Pharmaceuticals, Quadriga Biosciences, Inc., NeoTX Therapeutics Ltd., Mirati Therapeutics, NGM Biopharmaceuticals, TransThera Biosciences, Ocellaris Pharma, Palleon Pharmaceuticals, Medicenna Therapeutics, Klus Pharma, Novartis, Toray Industries, Carisma Therapeutics, Avacta Life Sciences Ltd, Seagen Inc., Elevation Oncology, Corvus Pharmaceuticals, ADC Therapeutics S.A., IO Biotech, Byondis B.V., Takara Bio, Seven and Eight Biopharmaceuticals, Dragonfly Therapeutics, InnoCare Pharma, and others Key Bladder Cancer Pipeline Therapies: CG0070, ADSTILADRIN, Nivolumab, Catumaxomab, N-803, alpha1H, APL-1202, PF-07225570, HX008, TARA-002, CPX-POM, EG-70, eRapa, TLD-1433, VAX014, Erdafitinib, Enfortumab vedotin, RC48-ADC, TAS 102, UGN-102, FL-101, AU-011, Tislelizumab, Pemigatinib, Infigratinib, Trilaciclib, AN0025, KHK2455, IPI-549, SHR-1501, HC-7366, IK-175, ado-trastuzumab emtansine, FPI-1966, GI-101, SO-C101, CPL304110, MRx0518, KF-0210, QBS10072S, Naptumomab Estafenatox, Sitravatinib, NGM120, TT-00420, OC-001, E-602, MDNA11, A166, Spartalizumab, TRK-950, CT-0508, AVA6000, SEA-TGT, Seribantumab, CPI-006, ADCT-301, IO 102, SYD985, TBI-1301, BDB001, DF1001, ICP-192, and others. Dive deep into rich insights for bladder cancer drugs, visit @ Bladder Cancer Treatment Table of Contents For further information on the bladder cancer pipeline therapeutics, reach out @ New Drug for Bladder Cancer Treatment Related Reports Bladder Cancer Market Bladder Cancer Market Insights, Epidemiology, and Market Forecast-2032 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key bladder cancer companies including RemeGen Co., Ltd., Taiho Oncology, Inc., Xennials Therapeutics, Flame Biosciences, among others. Bladder Cancer Epidemiology Forecast Bladder Cancer Epidemiology Forecast to 2032 report delivers an in-depth understanding of the disease, historical and forecasted bladder cancer epidemiology in the 7MM, i.e., the United States, EU5 (Germany, Spain, Italy, France, and the United Kingdom), and Japan. Muscle Invasive Bladder Cancer Pipeline Muscle Invasive Bladder Cancer Pipeline Insight, 2022 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key muscle invasive bladder cancer companies, including SOTIO a.s., Celon Pharma SA, Shanghai PerHum Therapeutics Co., Ltd., 4D Pharma PLC, among others. Muscle Invasive Bladder Cancer Market Muscle Invasive Bladder Cancer Market Insights, Epidemiology, and Market Forecast-2032 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key muscle invasive bladder cancer companies including SOTIO a.s., Celon Pharma SA, Shanghai PerHum Therapeutics Co., Ltd., 4D Pharma PLC, among others. Non Muscle Invasive Bladder Cancer Pipeline Non Muscle Invasive Bladder Cancer Pipeline Insight, 2022 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key non muscle invasive bladder cancer companies, including Theralase Inc., Vaxiion Therapeutics, Janssen Research & Development, LLC, Seagen Inc., among others. Non Muscle Invasive Bladder Cancer Market Non Muscle Invasive Bladder Cancer Market Insights, Epidemiology, and Market Forecast-2032 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key non muscle invasive bladder cancer companies including Theralase Inc., Vaxiion Therapeutics, Janssen Research & Development, LLC, Seagen Inc., among others. Other Trending Reports Persistent Depressive Disorder Market | Gene Therapy for Ocular Rare Disease Market | Congestive Heart Failure Market | CRISPR Therapies Pipeline | Desmoplastic Small Round Cell Tumors Market | India Healthcare Outlook Report | Psychosis Market | Dental Lasers Market | Primary Immune Deficiency Market I Dyslipidemia Market | Lateral Epicondylitis Disease Market | Castration-Resistant Prostate Cancer Market | Metrorrhagia Market | Global Messenger RNA-based Vaccines and Therapeutics Market | Negative Pressure Wound Therapy Systems Market | US Healthcare Outlook Report | Mucinous Cystic Neoplasms Market | Hot Flashes Market | Varicose Veins - Market | Hemostats Market | Injectable Drug Delivery Devices Market | Breast Pumps Market | Physiotherapy Equipment Market | Trastuzumab Biosimilars Insight | Deep Brain Stimulation Devices Market | Retinoblastoma Market | Venous Stenosis Market | Tumor Ablation Market | Substance Abuse Market | Insulin Glargine Biosimilar Insight | Interspinous Spacers Market | Anti-hypertension Market Related Healthcare Blogs Bladder Cancer Highlights From ASCO GU 2022 Non Small Cell Lung Cancer Market Outlook Rare Cancers Market Domain About DelveInsight DelveInsight is a leading Business Consultant, and Market Research firm focused exclusively on life sciences. Connect with us at LinkedIn Contact Us Shruti Thakur [email protected] +1(919)321-6187 Logo: SOURCE DelveInsight Business Research, LLP

CollaborateAntibodyGene TherapyBiosimilarFirst in Class

100 Deals associated with SIM-323

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Advanced Malignant Solid Neoplasm	Phase 2	US	GI Innovation, Inc.	02 Aug 2021
Advanced Malignant Solid Neoplasm	Phase 2	KR	GI Innovation, Inc.	02 Aug 2021
Bladder Cancer	Phase 2	US	GI Innovation, Inc.	02 Aug 2021
Bladder Cancer	Phase 2	KR	GI Innovation, Inc.	02 Aug 2021
Colorectal Cancer	Phase 2	US	GI Innovation, Inc.	02 Aug 2021
Colorectal Cancer	Phase 2	KR	GI Innovation, Inc.	02 Aug 2021
Esophageal Squamous Cell Carcinoma	Phase 2	US	GI Innovation, Inc.	02 Aug 2021
Esophageal Squamous Cell Carcinoma	Phase 2	KR	GI Innovation, Inc.	02 Aug 2021
Melanoma	Phase 2	US	GI Innovation, Inc.	02 Aug 2021
Melanoma	Phase 2	KR	GI Innovation, Inc.	02 Aug 2021

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04977453 (Keynote-B59, SITC2023)	Phase 1/2	Advanced Malignant Solid Neoplasm	25	GI-101 (CD80-IL2v) + Pembrolizumab	tbpvaiipmw(rmrbsxutga) = 28%, 24% ddahallcig (kzpaqmfxtr ) View more	Positive	02 Nov 2023
NCT04977453 (GII-101-P101, ESMO2023) Manual	Phase 1/2	Advanced Malignant Solid Neoplasm	57	GI-101	skggmujmxz(xrpnpdcpnd) = rbtrnpjfdp kseajoxqla (bsijysuasm ) View more	Positive	23 Oct 2023
				GI-101 (MSS CRC with liver metastasis)	beqfasdwac(wvkgrezxui) = nalvkyxcrb wdncajibro (xbpoaulfbl )
NCT04977453 (GII-101-P101, SITC2022) Manual	Phase 1/2	Metastatic Solid Tumor	25	GI-101	anyvgocwnk(yqxynwjrff) = No dose-limiting toxicities up to 0.15 mg/kg were reported with planned dose level of 0.002~0.6 mg/kg. htitaiwgkz (pwtwhcugtq )	Positive	01 Nov 2022
				pembrolizumab+GI-101

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