Last update 07 Nov 2024

MVT-5873

Last update 07 Nov 2024

Overview

R&D Status

Clinical Result

Translational Medicine

Overview

Basic Info

Drug Type

Monoclonal antibody

Synonyms

5B1-(sLeA)-therapeutic, Anti-CA19.9 antibody, anti-sialyl Lewisa antibody

+ [6]

Target

CA19.9

Mechanism

CA19.9 inhibitors(Carbohydrate antigen 19-9 inhibitors)

Therapeutic Areas

NeoplasmsDigestive System DisordersEndocrinology and Metabolic Disease

Active Indication

Pancreatic CancerPancreatic adenocarcinoma

Inactive Indication

Bile Duct NeoplasmsColonic CancerLiver metastases+ [3]

Originator Organization

MabVax Therapeutics, Inc.

Active Organization

Sarah Cannon Research Institute LLC

BioNTech SE

Memorial Sloan Kettering Cancer Center

+ [1]

Inactive Organization

National Cancer Institute

MabVax Therapeutics Holdings, Inc.BioNTech Research & Development, Inc.

Drug Highest PhasePhase 2

First Approval Date-

Regulation-

Gene Sequence

Sequence Code 221485CDR1-LCDR2-L

Sequence Code 1493753CDR1-L

Sequence Code 9849926VH

Sequence Code 9849931VL

Sequence Code 432305210CDR1-H

Sequence Code 546964966CDR1-LCDR3-L

Sequence Code 1038074895CDR2-H

Sequence Code 1038074896CDR3-H

Clinical Trials associated with MVT-5873

NCT06069778 / RecruitingPhase 1/2

A Phase I/Randomized Phase II, Open-label Multicenter Trial to Evaluate the Safety, Tolerability, and Efficacy of mFOLFIRINOX With or Without BNT321 as Adjuvant Therapy Following Curative Resection in Patients With Pancreatic Adenocarcinoma

This trial is designed as a Phase I/randomized Phase II open-label trial of modified(m) FOLFIRINOX ± BNT321 for adjuvant therapy in pancreatic ductal adenocarcinoma (PDAC) patients post R0 or R1 resection.
The Phase I, dose escalation part of this trial will be a limited evaluation of two planned BNT321 dose levels in combination with mFOLFIRINOX chemotherapy (24 weeks) followed by BNT321 monotherapy (24 weeks). Following determination of the combination recommended Phase II dose (RP2D), the Phase II (randomized treatment) part of this trial will be initiated as an open-label 2-arm evaluation of mFOLFIRINOX ± BNT321 (24 weeks) followed by BNT321 monotherapy (24 weeks) in the combination arm only to complete the adjuvant therapy course. Treatment cycles are every 2 weeks (14 days).

Start Date27 Mar 2024

Sponsor / Collaborator

BioNTech SE

NCT04883775 / Active, not recruitingPhase 1IIT

89Zr-DFO-HuMab-5B1 (MVT-2163) Imaging in Pancreatic Cancer or Other CA19-9 Positive Malignancies

The purpose of this study is to see how well the experimental imaging agent 89Zr-DFO-HuMab-5B1 attaches to pancreatic tumors, and to find out whether PET/CT scans done with this imaging agent produce better images of cancer.

Start Date10 May 2021

Sponsor / Collaborator

Memorial Sloan Kettering Cancer Center

[+1]

NCT03801915 / CompletedPhase 2IIT

Perioperative MVT-5873, a Fully Human Monoclonal Antibody Against a CA 19-9 Epitope, for Operable CA 19-9 Producing Pancreatic Cancers, Cholangiocarcinomas, and Metastatic Colorectal Cancers

Background:
Gastrointestinal tumors have a molecule called carbohydrate antigen 19-9 (CA19-9) in the tumors and blood. The agent MVT-5873 was designed to block this molecule. Researchers want to test how safe it is to give this agent to people before and after surgery to remove a tumor. They want to learn the highest dose tolerated. They want to see if getting the agent at surgery helps slow down the disease.
Objective:
To test the safety of giving MVT-5873 at surgery to remove cancer and see if it slows the progression of the disease.
Eligibility:
Adults at least 18 years old with certain cancers and certain blood CA19-9 levels
Design:
Participants will be screened with:
Medical history
Physical exam
Blood and heart tests
Scans
Review of normal activities
Review of tumor sample
Pregnancy test
A few days before surgery, participants will get a dose of the study agent. They will get it through a small plastic tube in a vein over about 2 hours.
Participants will sign a separate consent and have the surgery. A sample of the tumor and normal liver will be removed for research.
For 1-2 weeks after surgery, participants will recover in intensive care then regular care at the hospital. They will be monitored and treated throughout the stay.
After leaving the hospital, participants will get the study agent every week for 1 month. Then they will get it every other week for 2 months. They will repeat screening tests at study visits and at a follow-up visit. That will be about 5 weeks after the last dose.

Start Date13 Nov 2019

Sponsor / Collaborator

National Cancer Institute

100 Clinical Results associated with MVT-5873

100 Translational Medicine associated with MVT-5873

100 Patents (Medical) associated with MVT-5873

Literatures (Medical) associated with MVT-5873

01 Jun 2023·Monoclonal antibodies in immunodiagnosis and immunotherapy

Therapeutic Effects of an Anti-Sialyl Lewis x Antibody in a Murine Model of Acute Lung Injury.

Article

Author: Liu, Wei ; Kawashima, Hiroto ; Liu, Wenxin ; Wei, Zihong ; Abo, Hirohito ; Xiong, Wei

Acute respiratory distress syndrome is a life-threatening acute lung injury (ALI) characterized by the destruction of alveoli leading to pulmonary edema. The infiltration and activation of inflammatory cells and production of inflammatory cytokines are both involved in the pathogenesis of ALI. Here, we show that the infiltration of neutrophils, major inflammatory cells causing ALI, into the lung is mediated by sialyl Lewis x (sLe^x) glycans, which can be efficiently suppressed by a monoclonal antibody (mAb) against these glycans. In fucosyltransferase-IV and -VII double-deficient mice lacking sLe^x expression, neutrophil infiltration into the lung was significantly suppressed compared with that observed in wild-type mice in a lipopolysaccharide (LPS)-induced ALI model. Administration of a highly specific anti-sLe^x mAb F2 3 hours after LPS administration significantly suppressed pulmonary neutrophil infiltration, accompanied by the reduced induction of inflammatory cytokines. It was consistently indicated from ex vivo cell rolling assay that mAb F2 blocked the rolling of mouse neutrophils on P-selectin-expressing cells. Overall, these results indicate that the sLe^x glycan could serve as a therapeutic target against ALI, and also that mAb F2 would be useful for specific targeting of this glycan.

01 Apr 2020·Journal of gastrointestinal oncologyQ4 · MEDICINE

Targeting CA 19-9 with a humanized monoclonal antibody at the time of surgery may decrease recurrence rates for patients undergoing resections for pancreatic cancer, cholangiocarcinoma and metastatic colorectal cancer

Q4 · MEDICINE

Article

Author: Gupta, Shreya ; Khan, Tahsin M ; Sinha, Surajit ; Blakely, Andrew M ; Davis, Jeremy L ; McDonald, James D ; Gamble, Lauren A ; Hernandez, Jonathan M ; Ayabe, Reed I ; Hannah, Cathleen

TRIAL REGISTRATION:

https://clinicaltrials.gov/ct2/show/NCT03801915?term=MVT&rank=3.

01 Dec 2019·Clinical cancer research : an official journal of the American Association for Cancer ResearchQ1 · MEDICINE

Retooling a Blood-Based Biomarker: Phase I Assessment of the High-Affinity CA19-9 Antibody HuMab-5B1 for Immuno-PET Imaging of Pancreatic Cancer

Q1 · MEDICINE

Article

Author: Lewis, Jason S. ; Lyashchenko, Serge K. ; Weber, Wolfgang A. ; Pandit-Taskar, Neeta ; O'Reilly, Eileen M. ; Teng, Rebecca ; Maffuid, Paul W. ; Scholz, Wolfgang ; Carrasquillo, Jorge A. ; Lohrmann, Christian ; Ruan, Shutian ; O'Donoghue, Joseph A.

Abstract:

Purpose::

In patients with cancer who have an abnormal biomarker finding, the source of the biomarker in the bloodstream must be located for confirmation of diagnosis, staging, and therapy planning. We evaluated if immuno-PET with the radiolabeled high-affinity antibody HuMab-5B1 (MVT-2163), binding to the cancer antigen CA19-9, can identify the source of elevated biomarkers in patients with pancreatic cancer.

Patients and Methods::

In this phase I dose-escalating study, 12 patients with CA19-9–positive metastatic malignancies were injected with MVT-2163. Within 7 days, all patients underwent a total of four whole-body PET/CT scans. A diagnostic CT scan was performed prior to injection of MVT-2163 to correlate findings on MVT-2163 PET/CT.

Results::

Immuno-PET with MVT-2163 was safe and visualized known primary tumors and metastases with high contrast. In addition, radiotracer uptake was not only observed in metastases known from conventional CT, but also seen in subcentimeter lymph nodes located in typical metastatic sites of pancreatic cancer, which were not abnormal on routine clinical imaging studies. A significant fraction of the patients demonstrated very high and, over time, increased uptake of MVT-2163 in tumor tissue, suggesting that HuMab-5B1 labeled with beta-emitting radioisotopes may have the potential to deliver therapeutic doses of radiation to cancer cells.

Conclusions::

Our study shows that the tumor antigen CA19-9 secreted to the circulation can be used for sensitive detection of primary tumors and metastatic disease by immuno-PET. This significantly broadens the number of molecular targets that can be used for PET imaging and offers new opportunities for noninvasive characterization of tumors in patients.

News (Medical) associated with MVT-5873

27 Jun 2023

·www.prnewswire.com

EXCELLENT CLINICAL DATA FOR SUBB2M/CA15-3 BREAST CANCER TEST

INOVIQ's SubB2M/CA15-3 breast cancer test detects all-stages of breast cancer with excellent accuracy (87%), sensitivity (81%) and specificity (93%) The results of a comprehensive 483-sample case-control study established that INOVIQ's SubB2M/CA15-3 blood test significantly outperformed a leading approved CA15-3 test, demonstrating an area under the curve (AUC) of 0.93 compared to 0.70 INOVIQ is finalizing its planned breast cancer monitoring study and advancing discussions with potential partners and Key Opinion Leaders (KOL's) for its SubB2M platform and tests MELBOURNE, Australia, June 27, 2023 /PRNewswire/ -- INOVIQ Limited (ASX:IIQ) ( INOVIQ or the Company), a developer of next-generation exosome solutions and precision diagnostics, is pleased to announce excellent results from an independent clinical validation study of its SubB2M/CA15-3 test for breast cancer detection. The study showed high accuracy (87%), sensitivity (81%), and specificity (93%) for INOVIQ's SubB2M test, outperforming a leading approved CA15-3 test. CEO Dr Leearne Hinch said: "The outstanding results from this independent clinical validation study of our SubB2M breast cancer test represent a major milestone for INOVIQ. Our SubB2M/CA15-3 blood test detected all-stages of breast cancer with 81% sensitivity and 93% specificity, outperforming a leading CA15-3 test. These positive results support the commercial potential of our simple, cost-effective SubB2M/CA15-3 test for screening and monitoring of breast cancer. INOVIQ intends to present these data and our development plans to potential partners and KOLs to advance commercial discussions for its SubB2M/CA15-3, SubB2M/CA125 and SubB2M multi-cancer tests." Background to SubB2M technology and SubB2M/CA15-3 test INOVIQ's disruptive SubB2M technology is an engineered protein that detects the pan-cancer biomarker Neu5Gc, found in multiple human cancers. SubB2M tests are designed to enhance the sensitivity, specificity and clinical utility of existing tumour marker tests routinely used for cancer detection and monitoring, such as CA15-3 for breast cancer, CA125 for ovarian cancer, PSA for prostate cancer and CA19.9 for pancreatic cancer.[1] CA15-3 tumour marker tests are routinely used to monitor breast cancer treatment response and disease recurrence. However, existing CA15-3 tests have inadequate sensitivity and specificity for early-stage detection and are commonly used as an adjunct to other diagnostic tests for monitoring. The SubB2M/CA15-3 test is initially being developed as an improved monitoring test for breast cancer. INOVIQ engaged US-based contract research organisation, ResearchDx, to undertake assay development and validation of its SubB2M tests (ASX: 5 April 2022). Positive results were previously reported from the analytical validation of the SubB2M/CA15-3 test, demonstrating 78% sensitivity and 80% specificity for detection of breast cancer (ASX: 8 February 2023). The SubB2M/CA15-3 test subsequently underwent further optimisation to improve sensitivity and specificity prior to commencing clinical validation. SubB2M/CA15-3 test clinical validation study method, results and conclusion The objectives of this 483-sample, case-control, clinical validation study were to: 1) evaluate the clinical performance of the SubB2M/CA15-3 test across all stages of breast cancer compared to healthy controls; and 2) to compare the performance of the SubB2M/CA15-3 test to a leading approved CA15-3 test in the same samples in a clinical laboratory setting. The results demonstrated that INOVIQ's SubB2M/CA15-3 breast cancer test provides more accurate detection of breast cancer across all stages. INOVIQ's test demonstrates overall sensitivity and specificity of 81% and 93%, compared to an approved CA15-3 test of 37% sensitivity and 88% specificity (Table 1). The SubB2M test significantly reduces misdiagnoses with lower false positive (7%) and false negative (19%) rates, in this sample set. The study established that INOVIQ's SubB2M/CA15-3 blood test significantly outperformed a leading approved CA15-3 test. The area under the curve (AUC) for INOVIQ's test was 0.93, compared to the Comparator test of 0.70, indicating the superior diagnostic accuracy of the SubB2M test. Analysis of test sensitivity at 95% specificity by breast cancer stage, demonstrates the superior performance of the SubB2M/CA15-3 test compared to a leading CA15-3 test for detection of breast cancer across all stages, in this sample set. The SubB2M/CA15-3 test's performance was confirmed through logistic regression analysis, and these data support its potential use for both screening and monitoring of breast cancer. INOVIQ CSO, Dr Gregory Rice said: "In this large clinical validation study, the SubB2M/CA15-3 test clearly outperformed a leading CA15-3 test at all cut-off points tested. Its impressive performance makes it an ideal blood test for enhancing treatment response monitoring and enabling earlier detection of disease recurrence. Having completed rigorous analytical and clinical validation, the next step involves conducting disease monitoring studies and assessing the test's impact on clinical decision-making in collaboration with KOLs and potential partners in the United States." Dr Mathew Moore, Principal of ResearchDx, added: "These outstanding data clearly improve on existing CA15-3 tumour marker tests routinely used for monitoring breast cancer. The SubB2M/CA15-3 test detects all stages of breast cancer with high accuracy, which could be a game-changer for clinicians and clinical practice for screening of undiagnosed breast cancer and in monitoring diagnosed breast cancer." SubB2M CA15-3 test and next development steps INOVIQ's next step is to conduct a cross-sectional monitoring study to demonstrate the superior performance of the SubB2M/CA15-3 test for treatment response and/or disease recurrence over approved CA15-3 tests. INOVIQ is working with ResearchDx and its clinical advisors to finalise the clinical validation plan. This clinical study is expected to complete by the end of Q2 FY24, with the test then expected to be market-ready. Other SubB2M test development plans INOVIQ is also progressing its development plans for the SubB2M/CA125 test for ovarian cancer. Samples have been sourced and assay development and analytical validation studies are expected to commence in H1 FY24 and complete within 6 months. Clinical validation of this test is now expected to complete in H2 FY24. The research-stage SubB2M multi-cancer test (MCT) on the Nicoya ALTO™ SPR instrument is undergoing further evaluation, with data now expected to report in Q1 FY24. Additional opportunities for development of a potential SubB2M MCT for point-of-care testing on other instrument platforms are also being assessed internally and with potential partners. Authorised by the Company Secretary, Mark Edwards. ABOUT INOVIQ LTD INOVIQ Ltd (ASX:IIQ) ( INOVIQ) is developing and commercialising next-generation exosome solutions and precision diagnostics to improve the diagnosis and treatment of cancer and other diseases. The Company has commercialised the EXO-NET pan-exosome capture tool for research purposes and the hTERT test as an adjunct to urine cytology testing for bladder cancer. Our cancer diagnostic pipeline includes blood tests in development for earlier detection and monitoring of ovarian, breast and other cancers. For more information on INOVIQ, see . About SubB2M platform SubB2M is an engineered protein that preferentially binds to the pan-cancer biomarker Neu5Gc, found in multiple human cancers. INOVIQ is developing SubB2M blood tests for multiple uses, including monitoring breast and ovarian cancers, and for a general health panel. SubB2M may enhance the performance of existing tumour marker tests by binding to multiple Neu5Gc sites on the biomarker that amplify the signal to improve sensitivity, and by increasing the cancer specificity to reduce false positives. About breast cancer and breast cancer monitoring According to the World Health Organisation, breast cancer is the most common cancer globally, with 2.3m new cases, 685k deaths and 7.8m survivors (5-year prevalence) in 2020.[2] The global breast cancer diagnostics market was valued at $4.2b in 2021.[3] The intended use of the SubB2M/CA15-3 breast cancer test is as an aid for monitoring breast cancer treatment response and recurrence in women previously diagnosed with the disease. The American Society of Clinical Oncology (ASCO) 2015 guidelines recommend regular physical examination and mammography for monitoring breast cancer disease progression and recurrence.[4] Existing blood tests for serum tumour markers (CA15.3, CA 27.29 and CEA) are not sensitive or specific for breast cancer relapse, but are suggested for monitoring treatment response of women with metastatic breast cancer or follow-up in symptomatic women. There is a need for faster, more accurate and cost-effective blood tests to improve breast cancer detection and monitoring. INOVIQ's SubB2M/CA15-3 test has the potential to deliver high sensitivity and specificity for earlier detection and monitoring of breast cancer. FORWARD LOOKING STATEMENTS This announcement contains certain 'forward-looking statements' within the meaning of the securities laws of applicable jurisdictions. Forward-looking statements can generally be identified by the use of forward-looking words such as 'may', 'should', 'expect', 'anticipate', 'estimate', 'scheduled' or 'continue' or the negative version of them or comparable terminology. Any forecasts or other forward-looking statements contained in this announcement are subject to known and unknown risks and uncertainties and may involve significant elements of subjective judgment and assumptions as to future events which may or may not be correct. There are usually differences between forecast and actual results because events and actual circumstances frequently do not occur as forecast and these differences may be material. The Company does not give any representation, assurance or guarantee that the occurrence of the events expressed or implied in any forward-looking statements in this announcement will actually occur and you are cautioned not to place undue reliance on forward-looking statements. [1] Sensitivity is the ability of a test to correctly identify women with breast cancer. Specificity is the ability of a test to correctly identify cancer-free women. [2] Global Cancer Observatory: Cancer Today. Lyon, France: International Agency for Research on Cancer. Available: , accessed [5 February 2023]. [3] Grand View Research. Breast Cancer Diagnostics Market Size, Share & Trends Analysis Report, 2021 – 2028. 2020; Available: [4] Sharma, P. Overview of the approach to metastatic breast cancer. UpToDate. 2023. SOURCE INOVIQ Limited

Clinical ResultASCO

02 Jan 2023

·www.prnewswire.com

Propulsion of Pancreatic Cancer Pipeline as Novel and Extensive 170+ Therapies Likely to Enter in the Treatment Domain | DelveInsight

The prevalence of pancreatic cancer has been rising since the past few years, which prompts the growing demand for treatment options. The increasing prevalence of cancer, the robust pipeline, and the growing research and development activities to develop novel therapies to treat Pancreatic Cancer drive the market. The companies developing the potential therapies in the last stage of development include FibroGen, Eli Lilly and Company, CARsgen Therapeutics, and several others. LAS VEGAS, Jan. 2, 2023 /PRNewswire/ -- DelveInsight's ' Pancreatic Cancer Pipeline Insight – 2022 ' report provides comprehensive global coverage of available, marketed, and pipeline pancreatic cancer therapies in various stages of clinical development, major pharmaceutical companies are working to advance the pipeline space and future growth potential of the pancreatic cancer pipeline domain. Key Takeaways from the Pancreatic Cancer Pipeline Report DelveInsight's pancreatic cancer pipeline report depicts a robust space with 150+ active players working to develop 170+ pipeline therapies for pancreatic cancer treatment. Key pancreatic cancer companies such as FibroGen, Innovent Biologics, CARsgen Therapeutics, Ascentage Pharma, NGM Biopharmaceuticals, TME Pharma AG, Lee's Pharmaceutical Limited, ImmunityBio, Inc., Rgene Corporation, CSPC ZhongQi Pharmaceutical Technology Co., Ltd., CanBas Co. Ltd., Jiangsu HengRui Medicine Co., Ltd., Bristol-Myers Squibb, SynerGene Therapeutics, Inc., AbbVie, Silenseed Ltd, Galera Therapeutics, Inc., Helix BioPharma, Golden Biotechnology Corporation, Eli Lilly and Company, Innovent Biologics (Suzhou) Co. Ltd., Panbela Therapeutics, Inc., GlaxoSmithKline, Chia Tai Tianqing Pharmaceutical Group, Roche, Prestige Biopharma Limited, Everfront Biotech Co., Ltd., XBiotech, Inc., Incyte Corporation, Ability Pharmaceuticals SL, Lokon Pharma, HCW Biologics, Amplia Therapeutics Limited, BioLineRx, Ltd., Taiho Pharmaceutical, Sanofi, Scandion Oncology, Nelum, Celldex Therapeutics, Merus N.V., Seagen Inc., GC Cell Corporation, MetiMedi Pharmaceuticals, Lumicell, Nuvation Bio Inc., ENB Therapeutics, BioNTech SE, Bayer, Genentech, Inc., Rise Biopharmaceuticals, Inc., Prestige Biopharma Limited, iOnctura, Shanghai Unicar-Therapy Bio-medicine Technology, Shanghai Hengrui Pharmaceutical Co., Ltd., Hangzhou Neoantigen Therapeutics Co., Ltd., EUSA Pharma, Inc.,Agenus Inc., Arcus Biosciences, Inc.Amgen, Biomea Fusion, and others are evaluating pancreatic cancer drugs to improve the treatment landscape. Promising pancreatic cancer pipeline therapies in various stages of development include Pamrevlumab, Niraparib, CT041, APG-1387, BNT141, ENB003, NUV-868, MCLA-128, LUM015, tisotumab vedotin, OMT-111, tusamitamab ravtansine, SCO-101, NGM120, CDX-301, NLM-001, TAS 102, Olaptesed pegol, BL-8040, Gimatecan, AMP945, N-803, HCW9218, BLEX 404, delolimogene mupadenorepvec, Mitoxantrone Hydrochloride Liposome injection, ABTL0812, CBP501, Pemigatinib, SHR-1701, Fluzoparib, XB2001, Cabiralizumab, EF-009, SGT-53, ABBV-927, PBP1510, Vemurafenib, siG12D-LODER, Penpulimab, GC4711, GSK2256098, L-DOS47, SBP-101, Antroquinonol, LY3214996, Sintilimab, RP72, PBP1510, IOA-289, U87, MVT-5873, SHR-A1904, iNeo-Vac-P01, iNeo-Vac-P01, TQB2858, Siltuximab, AGEN1423, AB680, AMG 199, BMF-219, and others. In December 2022, Targovax ASA announced that it has entered into a collaboration agreement with The University of Kansas Cancer Center (KU Cancer Center) and Agenus Inc. to run a clinical trial testing mutant RAS vaccine TG01 in combination with PD-1 CPI balstilimab in pancreatic cancer following surgery and standard-of-care (SoC) chemotherapy. In December 2022, Bluestar Genomics, Inc. announced the initiation of the New Onset Diabetes Management for Earlier Detection (NODMED) trial, one of the largest clinical studies in pancreatic cancer to date. The trial will use Bluestar Genomics' proprietary epigenomic methods for the detection of the disease. In December 2022, iOnctura BV, a clinical-stage biotech developing novel cancer therapies, had been granted €17.5 million ($18.6 million) funding from the European Investment Council's (EIC) accelerator program to develop IOA-289 for pancreatic cancer.The EIC's funding consists of a grant of €2.5 million ($2.7 million) and €15 million ($16 million) of equity investment. In December 2022, In the Phase I/II CodeBreaK 100 trial, the KRAS G12C inhibitor sotorasib achieved meaningful anticancer activity with an acceptable safety profile in heavily pretreated patients with KRAS G12C-mutated metastatic pancreatic cancer, according to researchers at The University of Texas MD Anderson Cancer Center. The results of the trial, published in the The New England Journal of Medicine, indicate an objective response rate of 21.1% and a median time-to-response of 1.5 months, with 84% of patients experiencing disease control. Median progression-free survival was 4 months, and overall survival was 6.9 months. In December 2022, Oncolytics Biotech® Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to pelareorep in combination with Roche's anti-PD-L1 checkpoint inhibitor atezolizumab, and the chemotherapeutic agents gemcitabine and nab-paclitaxel, for the treatment of advanced/metastatic pancreatic ductal adenocarcinoma (PDAC). This represents pelareorep's second FDA Fast Track designation. In December 2022, RemeGen Co., Ltd. announced that its latest antibody-drug conjugate (ADC), RC118 for injection, has been granted two orphan drug designations (ODD) by the United States Food and Drug Administration (FDA) for gastric cancer (including gastroesophageal junction cancer) and pancreatic cancer. This marks the Company's fourth, having previously been granted ODD twice for Disitamab Vedotin (RC48) and Telitacicept (RC18) earlier this year. In December 2022, Panbela Therapeutics, Inc. announced that the European Medicines Agency (EMA) Committee for Orphan Medicinal Products issued a positive opinion on Panbela's application for orphan designation of ivospemin ( SBP-101) in combination with gemcitabine and nab-Paclitaxel in patients with metastatic pancreatic ductal adenocarcinoma (PDA). In September 2022, Qualigen Therapeutics, Inc. announced the presentation of two posters on QN-302 at the AACR 8th Special Conference on Pancreatic Cancer. The data presented include information on the compound's safety, tolerability, and efficacy in a pancreatic cancer model. The poster included preclinical toxicology data that showed QN-302 does not produce adverse toxicological reactions in mouse models at therapeutic doses. In in vitro tests, QN-302 inhibits acetylcholinesterase (AChE) by 53% and muscarinic receptor (M2) by 70% at 1 µM. Request a sample and discover the recent advances in pancreatic cancer drugs @ Pancreatic Cancer Pipeline Report The pancreatic cancer pipeline report provides detailed profiles of pipeline assets, a comparative analysis of clinical and non-clinical stage pancreatic cancer drugs, inactive and dormant assets, a comprehensive assessment of driving and restraining factors, and an assessment of opportunities and risks in the pancreatic cancer clinical trial landscape. Pancreatic Cancer Overview Pancreatic cancer develops in the pancreas tissues, an abdomen organ located behind the stomach's bottom portion. The pancreas secretes hormones that help control blood sugar and enzymes that aid digestion. Pancreatic cancer is a condition in which malignant (cancer) cells develop in pancreatic tissues. The pancreas can develop tumors in various ways, including malignant and noncancerous tumors. However, the precise causes of pancreatic cancer are unknown. Individuals diagnosed with pancreatic cancer before the tumor develops or spreads have an average life expectancy of pancreatic cancer of 3 to 3.5 years. Pancreatic cancer symptoms may include jaundice, dark urine, weight loss, loss of appetite, fatigue, and others. A pancreatic cancer diagnosis is difficult because symptoms are frequently confused with those of other disorders, such as irritable bowel syndrome. The extent of the cancer determines the treatment of pancreatic cancer options. Pancreatic cancer treatment options may include surgery, chemotherapy, radiation therapy, targeted therapy, or a combination of these. Learn more about the diseases and pancreatic cancer diet @ Pancreatic Cancer Tests A snapshot of the Pancreatic Cancer Pipeline Drugs mentioned in the report: Learn more about the emerging pancreatic cancer treatment options @ Pancreatic Cancer Clinical Trials Pancreatic Cancer Therapeutics Assessment The pancreatic cancer pipeline report proffers an integral view of pancreatic cancer emerging novel therapies segmented by stage, product type, molecule type, mechanism of action, and route of administration. Scope of the Pancreatic 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, Intravenous, Oral, Parenteral, Subcutaneous 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: Connective tissue growth factor inhibitors, Poly(ADP-ribose) polymerase 1 inhibitors, Poly(ADP-ribose) polymerase 2 inhibitors, Immunologic cytotoxicity, T lymphocyte replacements, Growth differentiation factor 15 inhibitors, Endothelin B receptor antagonists, Image enhancers Key Pancreatic Cancer Companies: FibroGen, Innovent Biologics, CARsgen Therapeutics, Ascentage Pharma, NGM Biopharmaceuticals, TME Pharma AG, Lee's Pharmaceutical Limited, ImmunityBio, Inc., Rgene Corporation, CSPC ZhongQi Pharmaceutical Technology Co., Ltd., CanBas Co. Ltd., Jiangsu HengRui Medicine Co., Ltd., Bristol-Myers Squibb, SynerGene Therapeutics, Inc., AbbVie, Silenseed Ltd, Galera Therapeutics, Inc., Helix BioPharma, Golden Biotechnology Corporation, Eli Lilly and Company, Innovent Biologics (Suzhou) Co. Ltd., Panbela Therapeutics, Inc., GlaxoSmithKline, Chia Tai Tianqing Pharmaceutical Group, Roche, Prestige Biopharma Limited, Everfront Biotech Co., Ltd., XBiotech, Inc., Incyte Corporation, Ability Pharmaceuticals SL, Lokon Pharma, HCW Biologics, Amplia Therapeutics Limited, BioLineRx, Ltd., Taiho Pharmaceutical, Sanofi, Scandion Oncology, Nelum, Celldex Therapeutics, Merus N.V., Seagen Inc., GC Cell Corporation, MetiMedi Pharmaceuticals, Lumicell, Nuvation Bio Inc., ENB Therapeutics, BioNTech SE, Bayer, Genentech, Inc., Rise Biopharmaceuticals, Inc., Prestige Biopharma Limited, iOnctura, Shanghai Unicar-Therapy Bio-medicine Technology, Shanghai Hengrui Pharmaceutical Co., Ltd., Hangzhou Neoantigen Therapeutics Co., Ltd., EUSA Pharma, Inc.,Agenus Inc., Arcus Biosciences, Inc., Amgen, Biomea Fusion, and others. Key Pancreatic Cancer Pipeline Therapies: Pamrevlumab, Niraparib, CT041, APG-1387, BNT141, ENB003, NUV-868, MCLA-128, LUM015, tisotumab vedotin, OMT-111, tusamitamab ravtansine, SCO-101, NGM120, CDX-301, NLM-001, TAS 102, Olaptesed pegol, BL-8040, Gimatecan, AMP945, N-803, HCW9218, BLEX 404, delolimogene mupadenorepvec, Mitoxantrone Hydrochloride Liposome injection, ABTL0812, CBP501, Pemigatinib, SHR-1701, Fluzoparib, XB2001, Cabiralizumab, EF-009, SGT-53, ABBV-927, PBP1510, Vemurafenib, siG12D-LODER, Penpulimab, GC4711, GSK2256098, L-DOS47, SBP-101, Antroquinonol, LY3214996, Sintilimab, RP72,PBP1510, IOA-289, U87, MVT-5873, SHR-A1904, iNeo-Vac-P01, iNeo-Vac-P01, TQB2858, Siltuximab, AGEN1423, AB680, AMG 199, BMF-219, and others. Dive deep into rich insights for pancreatic cancer research; visit @ New Treatment for Pancreatic Cancer Table of Contents For further information on pancreatic cancer prevention, reach out @ Pancreatic Cancer Drug Treatment Related Reports Pancreatic Cancer Epidemiology Pancreatic Cancer Epidemiology Forecast – 2032 report delivers an in-depth understanding of the disease, historical, and forecasted pancreatic cancer epidemiology in the 7MM. Pancreatic Cancer Market Pancreatic Cancer Market Insight, Epidemiology, and Market Forecast – 2032 report delivers an in-depth understanding of the market trends, market drivers, market barriers, and key pancreatic cancer companies, including FibroGen, NeoImmuneTech, NOXXON Pharma, Silenseed Ltd., Amgen, NGM Biopharmaceuticals, among others. Advanced Pancreatic Cancer Market Advanced Pancreatic Cancer Market Insight, Epidemiology, and Market Forecast – 2032 report delivers an in-depth understanding of the market trends, market drivers, market barriers, and key advanced pancreatic cancer companies, including AstraZeneca, Merck Sharp & Dohme LLC, Bayer, Roche, among others. Advanced Pancreatic Cancer Pipeline Advanced Pancreatic 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 advanced pancreatic cancer companies, including FibroGen, NeoImmuneTech, NOXXON Pharma, Silenseed Ltd., Amgen, NGM Biopharmaceuticals, among others. Metastatic Pancreatic Cancer Market Metastatic Pancreatic Cancer Market Insight, Epidemiology, and Market Forecast – 2032 report delivers an in-depth understanding of the market trends, market drivers, market barriers, and key metastatic pancreatic cancer companies, including Takeda Oncology, Salspera, Eli Lilly and Company, among others. Metastatic Pancreatic Cancer Pipeline Metastatic Pancreatic 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 metastatic pancreatic cancer companies, including Takeda Oncology, Salspera, Eli Lilly and Company, among others. Other Trending Oncology Reports Follicular lymphoma | Indolent lymphoma | Severe Toxicities In Lymphoma | Marginal Zone Lymphoma | Vulvar Squamous Cell Carcinoma | Cholangiocarcinoma | Metastatic Cutaneous Squamous cell Carcinoma | Nasopharyngeal Carcinoma | Ductal Carcinoma in Situ | Oncolytic Virus Cancer Therapy | Cancer Cachexia | Intratumoral Cancer Therapies | Brain Cancer Related Healthcare Blogs Upcoming Oncology Drugs Oncology Market Outlook Future of Oncology Market Related Cases Studies Competitive Intelligence Market Assessment Product Assessment Epidemiology Assessment Related Healthcare Services Healthcare Business Consulting Healthcare Competitive Intelligence Services Healthcare Asset Prioritization Services 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

Fast TrackOrphan DrugClinical ResultImmunotherapy

100 Deals associated with MVT-5873

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Pancreatic adenocarcinoma	Phase 2	US	BioNTech SE	27 Mar 2024
Bile Duct Neoplasms	Phase 2	US	National Cancer Institute	13 Nov 2019
Colonic Cancer	Phase 2	US	National Cancer Institute	13 Nov 2019
Liver metastases	Phase 2	US	National Cancer Institute	13 Nov 2019
Metastatic Colorectal Carcinoma	Phase 2	US	National Cancer Institute	13 Nov 2019
Pancreatic Cancer	Phase 2	US	National Cancer Institute	13 Nov 2019
Small Cell Lung Cancer	Phase 1	US	MabVax Therapeutics Holdings, Inc.	26 Jan 2019
Non-Small Cell Lung Cancer	Phase 1	US	MabVax Therapeutics Holdings, Inc.	23 Dec 2018
Pancreatic Carcinoma	Phase 1	US	BioNTech Research & Development, Inc.	11 Jul 2016

Clinical Result

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Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02672917 (ASCO2018) Manual	Phase 1	Neoplasms \| Pancreatic Cancer CA19-9 Positive	9	gemcitabine+nab-paclitaxel+HuMab-5B1 1 mg/kg	xsullsiteb(abaivdxodg) = GI toxicity (abdominal pain/cramps/diarrhea/nausea) and G1-2 infusion reactions ryzddkegsh (gihpkocepj ) View more	Positive	01 Jun 2018
NCT02672917 (ASCO2018) Manual	Phase 1	Neoplasms \| Pancreatic Cancer CA19-9 Positive	9	gemcitabine+nab-paclitaxel+HuMab-5B1 0.125 mg/kg		Positive	01 Jun 2018
NCT02672917 (ASCO2017)	Phase 1	Neoplasms \| Pancreatic Cancer	25	HuMab-5B1 (MVT-5873)	dwfozgxwmv(khywhlerzj) = most were low grade and included GI toxicity (abdominal pain/cramps/diarrhea/nausea) kcmxtfcmbq (bbltnobsyh ) View more	Positive	30 May 2017

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