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

NCT03118349

/ TerminatedPhase 1

Phase I, Open-Label, Multi-Center, Dose Escalation With Expansion Trial of 177Lu Human Monoclonal Antibody 5B1 (MVT-1075) in Combination With a Blocking Dose of MVT-5873 as Radioimmunotherapy in Relapse/Refractory Subjects With Pancreatic Cancer or Other CA19-9 Positive Malignancies

Open label, nonrandomized, dose-escalation with cohort expansion study of MVT-5873/MVT-1075 in subjects with previously treated, Carbohydrate Antigen 19-9 (CA19-9) positive malignancies (e.g., pancreatic adenocarcinoma).

Start Date01 Jun 2017

Sponsor / Collaborator

BioNTech Research & Development, Inc.

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

08 Nov 2024·ACS Pharmacology & Translational Science

Exploring the Interplay Between Radioimmunoconjugates and Fcγ Receptors in Genetically Engineered Mouse Models of Cancer

Article

Author: McGlone, Shane A. ; Zeglis, Brian M. ; Sarrett, Samantha M. ; Hosny, Meena M. ; Delaney, Samantha ; Sebastiano, Joni ; Bournazos, Stylianos ; Rodriguez, Cindy ; Thau, Sarah

Fcγ receptors (FcγR) are responsible for many of the interactions between immunoglobulins (IgG) and immune cells. In biomedicine, this interplay is critical to the activity of several types of immunotherapeutics; however, relatively little is known about how FcγRs affect the in vivo performance of radiolabeled antibodies. A handful of recent preclinical studies suggest that binding by FcγR-and particularly FcγRI-can affect the pharmacokinetic profiles of ⁸⁹Zr-labeled radioimmunoconjugates, but there are no extant studies in immunocompetent or genetically engineered mouse models of cancer. In the investigation at hand, we synthesized and characterized ⁸⁹Zr-labeled probes based on wild-type and aglycosylated variants of the CA19-9-targeting antibody 5B1 and evaluated their in vivo behavior in several murine models of cancer, including immunocompetent and FcγR-humanized mice. The aglycosylated desferrioxamine (DFO)-bearing immunoconjugate DFO-^N297A5B1 displayed identical binding to CA19-9-expressing cells compared to its wild-type analogue (DFO-5B1) but exhibited dramatically attenuated affinity for several FcγR. Positron emission tomography imaging and biodistribution studies with [⁸⁹Zr]Zr-DFO-5B1 and [⁸⁹Zr]Zr-DFO-^N297A5B1 were subsequently performed in several strains of mice bearing CA19-9-expressing BxPC3 human pancreatic ductal adenocarcinoma and B16F10-FUT3 murine melanoma xenografts. Significant differences in the pharmacokinetics of the two radioimmunoconjugates were observed in tumor-bearing immunocompromised NSG mice, but these differences failed to materialize in immunocompetent C57BL/6 and FcγR-humanized C57BL/6 mice with B16F10-FUT3 xenografts. We hypothesize that these observations are related to the presence or absence of endogenous IgG. NSG mice completely lack endogenous IgG, and thus their mFcγR are free to bind radioimmunoconjugates and alter their pharmacokinetic behavior. In contrast, C57BL/6 and FcγR-humanized C57BL/6 mice both have endogenous IgG that occupy their FcγR (murine for the former and human for the latter), precluding interactions with radioimmunoconjugates. Ultimately, these data suggest that understanding the interplay between radiolabeled antibodies and FcγR is critical during the preclinical evaluation of radioimmunoconjugates.

01 Feb 2021·Molecular imaging and biologyQ3 · MEDICINE

ImmunoPET Imaging of Pancreatic Tumors with 89Zr-Labeled Gold Nanoparticle–Antibody Conjugates

Q3 · MEDICINE

Article

Author: Lewis, Jason S ; Korsen, Joshua A ; Younes, Ali ; Sobol, Nicholas B ; Edwards, Kimberly J

PURPOSE:

Targeted delivery in vivo remains an immense roadblock for the translation of nanomaterials into the clinic. The greatest obstacle is the mononuclear phagocyte system (MPS), which sequesters foreign substances from general circulation and causes accumulation in organs such as the liver and spleen. The purpose of this study was to determine whether attaching an active targeting antibody, 5B1, to the surface of gold nanoparticles and using clodronate liposomes to deplete liver and splenic macrophages could help to minimize uptake by MPS organs, increase targeted delivery to CA19.9-positive pancreatic tumors, and enhance pancreatic tumor delineation.

PROCEDURES:

To produce the antibody-gold nanoparticle conjugate (Ab-AuNP), the Ab was conjugated to p-isothiocyanatobenzyl-desferrioxamine (p-SCN-DFO) and subsequently conjugated to NHS-activated gold nanoparticles. The Ab-AuNP was characterized by transmission electron microscopy (TEM) and atomic force microscopy (AFM). Modified Lindmo assay was performed to assess binding affinity and internalization potential in vitro. The Ab-AuNP was radiolabeled with ⁸⁹Zr and injected into CA19.9-positive BxPc-3 pancreatic orthotopic tumor-bearing mice pretreated with or without clodronate liposomes for PET imaging and biodistribution studies. Inductively coupled plasma-optical emission spectrometry (ICP-OES) analysis was used to confirm delivery of gold nanoparticles to BxPc-3 pancreatic subcutaneous xenografts.

RESULTS:

Mice pretreated with clodronate liposomes in an orthotopic setting demonstrated decreased liver uptake at early time points (12.2 ± 2.3 % ID/g vs. 22.8 ± 3.8 % ID/g at 24 h) and increased tumor uptake at 120 h (13.8 ± 8.0 % ID/g vs. 6.0 ± 1.2 % ID/g). This allowed for delineation of orthotopic pancreatic xenografts in significantly more mice treated with clodronate (6/6) than in mice not treated with clodronate (2/6) or mice injected with gold nanoparticles labeled with a nonspecific antibody (0/5).

CONCLUSIONS:

The combination of clodronate liposomes and an active targeting antibody on the surface of gold nanoparticles allowed for PET/CT imaging of subcutaneous and orthotopic pancreatic xenografts in mice.

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 ; Ayabe, Reed I ; Hernandez, Jonathan M ; Hannah, Cathleen

TRIAL REGISTRATION:

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

News (Medical) associated with MVT-5873

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

09 May 2019

·www.biospace.com

4 Biotech Companies List on the Nasdaq Today

Four biotech companies began trading on the Nasdaq this morning. Here’s a look at today’s launches and one rumored IPO. Four biotech companies began trading on the Nasdaq this morning. Compared to last year’s big-money initial public offerings, it’s been a relatively slow year to date. March, however, marked seven life science IPOs, including Precision BioSciences, GenFit, Hookipa, Turning Point Therapeutics, Shockwave Medical, Silk Road Medical and Precision BioSciences. In April, Codiak BioSciences, Peloton Therapeutics, Bicycle Therapeutics, IDEAYA Biosciences, Karuna Pharmaceuticals, Brainsway, Applied Therapeutics, Guardion Health Sciences and NGM Biopharmaceuticals went public . Prior to today’s announcements, Trevi Therapeutics and TransMedics launched IPOs this month. Here’s a look at today’s launches and one rumored IPO. NextCure . Based in Beltsville, Md., NextCure priced its IPO of 5 million common shares at $15 per share. Shares began trading today under the ticker symbol “NXTC.” The company is focused on immunomedicines to treat cancer and other immune-related diseases. On November 18, 2018, the company completed a Series B financing worth $93 million led by Hillhouse Capital Management and Quan Capital, and included Bay City Capital, Surveyor Capital (a Citadel company), Ping An Ventures, Taiho Ventures, ArrowMark Partners and NS Investment. All existing investors participated, including Canaan Partners, Lilly Asia Ventures, OrbiMed Advisors, Pfizer, Sofinnova Ventures and Alexandria Venture Investments. Eli Lilly and Company also invested $15 million in the financing in connection to an announced discovery and development deal announced November 5, 2018. NextCure’s lead compound is NC318, a first-in-class therapeutic against a novel immunomodulatory target found on a restricted set of myeloid cells in the tumor microenvironment and on certain cancer types that includes lung, ovarian, and head and neck cancers. Cortexyme . Headquartered in South San Francisco, Cortexyme announced on April 16 that it had launched the GAIN Trial, an international Phase II/III study of its COR388 in mild to moderate Alzheimer’s patients. The trial will determine if the drug can slow or stop Alzheimer’s progression by inactivating the toxic proteins, or gingipains, released by P. gingivalis , a bacterium most commonly linked to chronic periodontal disease, but which has been shown to infect the brain and cause Alzheimer’s. The company announced its IPO on May 8, with a public price of $17 per share for 4,412,000 shares of common stock. They began trading today under the ticker symbol “CRTX.” Milestone Pharmaceuticals . Located in Montreal and Charlotte, NC, Milestone Pharmaceuticals is focused on developing etripamil for cardiovascular indications. The company announced the pricing of its upsized IPO yesterday at a price of $15 per share. It is offering 5,500,000 common shares and expects to raise about $82.5 million. They began trading today under the ticker symbol “MIST.” On October 25, 2018, the company completed an $80 million private financing. New investors RTW Investments led the round and was joined by Venrock Healthcare Capital Partners and Boxer Capital of Tavistock Group. Existing investors included Novo Holdings, Forbion, funds managed by Tekla Capital Management, Domain Associates, BDC Capital, Pappas Capital, GO Capital, and Fonds de solidarite FTQ. This round builds on a previous July 2017 Series C financing led by Novo Holdings. The proceeds were used to support the company’s Phase III trial of etripamil for paroxysmal supraventricular tachycardia (PSVT) and to expand the company’s pipeline. Axcella . Headquartered in Cambridge, Mass., Axcella priced its IPO at $20 per share and is offering 3,571,428 shares of common stock. It began trading today under the ticker symbol “AXLA.” It plans to raise $71.4 million. On April 11, Axcella presented new data at The International Liver Congress 2019 for its endogenous metabolic modulator (EMM) composition, AXA1665 in patients with mild and moderate hepatitis insufficiency or loss of liver function. The company’s lead candidate is designed to target several metabolic pathways that intersect key organ systems, including liver, muscle wasting, and gut health. The drug was well-tolerated and increased the basal (fasted) Fischer’s ratio by 40%, decreased plasma ammonia area, and showed a trend toward a leaner phenotype and muscle function. BioNTech . Unlike the four previously described companies that all began trading on the Nasdaq today, BioNTech is maneuvering for a possible future IPO, according to reports. Based in Mainz, Germany, BioNTech announced the acquisition of antibody assets and infrastructure yesterday from San Diego-based MabVax Therapeutics Holding, an oncology company. Under the terms of the deal, BioNTech acquired MabVax’s lead candidate, MVT-5873, in addition to other preclinical antibody assets to expand its existing antibody portfolio and RiboMABS development capabilities. MVT-5873 is currently in Phase I development in pancreatic cancer and has been tested in 35 patients with initial positive interim data announced in February 2018. In addition to the assets, it acquired MabVax’s infrastructure and lab equipment with plans to establish a research facility in San Diego. Bloomberg reported in February that BioNTech was considering a U.S. IPO, possibly as early as this year. In addition to acquiring the new assets, BioNTech has development partnerships with Pfizer and Sanofi. At this time, however, it appears to be a rumor.

Phase 1IPOAcquisitionImmunotherapy

07 May 2019

·www.marketscreener.com

BioNTech SE Acquires Mabvax Therapeutics’ Antibody Assets to Expand Portfolio

BioNTech SE announced the acquisition of antibody assets and infrastructure from San Diego-based MabVax Therapeutics Holding Inc. Under the terms of the agreement, BioNTech has acquired MabVax Therapeutics’ lead candidate, MVT-5873, as well as other pre-clinical antibody assets to expand and complement its existing antibody portfolio and proprietary RiboMABS development capabilities. The acquired lead asset is currently in Phase 1 clinical development in pancreatic cancer and has been tested in 35 patients with initial positive interim data announced in February 2018. MVT-5873 is a fully human IgG1 monoclonal antibody targeting sialyl Lewis A (sLea), an epitope expressed in pancreatic and other GI cancers that plays a role in tumor adhesion and metastasis formation. In conjunction with the agreement, BioNTech has purchased MabVax Therapeutics’ infrastructure and laboratory equipment with the intention of establishing a research facility in San Diego. The location is advantageous for BioNTech’s planned US-based clinical trials and will further support production of the Company’s investigational treatments. Financial terms were not disclosed.

Phase 1ADCAcquisitionLicense out/in

100 Deals associated with MVT-5873

R&D Status

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Pancreatic Ductal Adenocarcinoma	Phase 2	United States	BioNTech SE	27 Mar 2024
Advanced Bile Duct Carcinoma	Phase 2	United States	National Cancer Institute	13 Nov 2019
Liver metastases	Phase 2	United States	National Cancer Institute	13 Nov 2019
Metastatic colon cancer	Phase 2	United States	National Cancer Institute	13 Nov 2019
Metastatic Colorectal Carcinoma	Phase 2	United States	National Cancer Institute	13 Nov 2019
Pancreatic Cancer	Phase 2	United States	National Cancer Institute	13 Nov 2019
Small Cell Lung Cancer	Phase 1	United States	MabVax Therapeutics Holdings, Inc.	26 Jan 2019
Non-Small Cell Lung Cancer	Phase 1	United States	MabVax Therapeutics Holdings, Inc.	23 Dec 2018

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02672917 (ASCO 12018 \| ASCO 22018) Manual	Phase 1	Neoplasms \| Pancreatic Cancer CA19-9 Positive	9	gemcitabine+nab-paclitaxel+HuMab-5B1 1 mg/kg	rjqkddorbx(jiepynudnb) = GI toxicity (abdominal pain/cramps/diarrhea/nausea) and G1-2 infusion reactions pzbtnxbeml (cnenfxekcf ) View more	Positive	01 Jun 2018
NCT02672917 (ASCO 12018 \| ASCO 22018) 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)	qkgalcripv(ehsaasnnag) = most were low grade and included GI toxicity (abdominal pain/cramps/diarrhea/nausea) pdcqokszrh (wnjwkgbpog ) View more	Positive	30 May 2017

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