A Phase I/II Open-Label, Multi-center Study of the Safety and Efficacy of IMCnyeso, an HLA-A* 0201-Restricted, NY-ESO-1 and LAGE-1A-specific soluble T Cell Receptor and Anti-CD3 Bi-specific Molecule, as a Single Agent in HLA-A* 0201 Positive Patients With Advanced NY-ESO-1 and/or LAGE-1A Positive Cancer

Start Date04 Oct 2018

Sponsor / Collaborator

Immunocore Ltd.

NCT03515551 / TerminatedPhase 1/2

A Phase I/II Study of IMCnyeso, HLA- A*0201-Restricted, NY-ESO-1- and LAGE-1A-specific Soluble T Cell Receptor and Anti-CD3 Bispecific Molecule, in HLA-A*0201 Positive Patients With Advanced NY-ESO-1 and/or LAGE - 1A Positive Cancer

IMCnyeso is a bispecific fusion protein designed for the treatment of cancers that express NY-ESO-1 and/or LAGE-1A. This was a first-in-human trial designed to evaluate the safety and efficacy of IMCnyeso in HLA-A*02:01-positive adult participants whose cancer is positive for NY-ESO-1 and/or LAGE-A1.

Start Date15 Jun 2018

Sponsor / Collaborator

Immunocore Ltd.

NCT02737787 / CompletedPhase 1IIT

A Phase I Study of Concomitant WT1 Analog Peptide Vaccine or NY-ESO-1 Overlapping Peptides Vaccine in Combination With Nivolumab in Patients With Recurrent Ovarian Cancer Who Are in Second or Greater Remission

The purpose of this study is to test the safety of a combination of an investigational WT1 vaccine and another drug called nivolumab. This is the first time that the WT1 vaccine and nivolumab are being used in combination. Also, to test the safety of a combination of an investigational NY-ESO-1 vaccine and another drug called nivolumab.

Start Date01 Apr 2016

Sponsor / Collaborator

Memorial Sloan Kettering Cancer Center

100 Clinical Results associated with IMC-nyeso(Immunocore Ltd.)

100 Translational Medicine associated with IMC-nyeso(Immunocore Ltd.)

100 Patents (Medical) associated with IMC-nyeso(Immunocore Ltd.)

187

Literatures (Medical) associated with IMC-nyeso(Immunocore Ltd.)

01 Oct 2023·Cancer immunology, immunotherapy : CII

Oncolytic attenuated measles virus encoding NY-ESO-1 induces HLA I and II presentation of this tumor antigen by melanoma and dendritic cells.

Article

Author: Berland, Laurine ; Tangy, Frédéric ; Boisgerault, Nicolas ; Deshayes, Sophie ; Blanquart, Christophe ; Arbabian, Atousa ; Labarrière, Nathalie ; Chatelain, Camille ; Fradin, Delphine ; Combredet, Chantal ; Grard, Marion ; Idjellidaine, Mohamed ; Fonteneau, Jean-François ; Dehame, Virginie ; Dutoit, Soizic

Antitumor virotherapy stimulates the antitumor immune response during tumor cell lysis induced by oncolytic viruses (OVs). OV can be modified to express additional transgenes that enhance their therapeutic potential. In this study, we armed the spontaneously oncolytic Schwarz strain of measles viruses (MVs) with the gene encoding the cancer/testis antigen NY-ESO-1 to obtain MVny. We compared MV and MVny oncolytic activity and ability to induce NY-ESO-1 expression in six human melanoma cell lines. After MVny infection, we measured the capacity of melanoma cells to present NY-ESO-1 peptides to CD4 + and CD8 + T cell clones specific for this antigen. We assessed the ability of MVny to induce NY-ESO-1 expression and presentation in monocyte-derived dendritic cells (DCs). Our results show that MVny and MV oncolytic activity are similar with a faster cell lysis induced by MVny. We also observed that melanoma cell lines and DC expressed the NY-ESO-1 protein after MVny infection. In addition, MVny-infected melanoma cells and DCs were able to stimulate NY-ESO-1-specific CD4 + and CD8 + T cells. Finally, MVny was able to induce DC maturation. Altogether, these results show that MVny could be an interesting candidate to stimulate NY-ESO-1-specific T cells in melanoma patients with NY-ESO-1-expressing tumor cells.

02 Jun 2023·Medicine

Involvement of NY-ESO-1 and MAGE-A4 in the pathogenesis of desmoid tumors.

Article

Author: Akagi, Masao ; Nishimura, Shunji ; Kakinoki, Ryosuke ; Shinyashiki, Yu ; Ito, Tomohiko ; Hashimoto, Kazuhiko

The involvement of New York esophageal squamous cell carcinoma-1 (NY-ESO-1) and melanoma-associated antigen A4 (MAGE-A4) in soft-tissue sarcoma pathogenesis has recently been reported; however, their involvement in desmoid tumors (DTs) remains unknown. This study aimed to determine the involvement of NY-ESO-1 and MAGE-A4 in DTs. Immunostaining for β-catenin, NY-ESO-1, and MAGE-A4 was performed on DT biopsy specimens harvested at our institution. The positivity rate for each immune component was calculated. In addition, the correlations between the positivity rates for the immune molecules were investigated. The correlation between the positivity rate and age or longest diameter of each immune molecule was also investigated. β-catenin showed staining mainly in the tumor cell nuclei of DTs. Both NY-ESO-1 and MAGE-A4 showed staining in the nucleus, cytoplasm, and infiltrating lymphocytes of DT cells. The mean positive cell rates for β-catenin, NY-ESO-1, and MAGE-A4 were 43.9 ± 21.7, 30 ± 21.6, and 68.9 ± 20.8, respectively. A strong negative correlation was observed between β-catenin and MAGE-A4 positivity rates (r = -0.64). The positivity rates for NY-ESO-1 and MAGE-A4 showed a moderate positive correlation (r = -0.42). A very strong negative correlation was observed between age and the NY-ESO-1 positivity rate (r = -0.72). A weak negative correlation was observed between age and the MAGE-A4 positivity rate (r = -0.28). A medium negative correlation was observed between the longest tumor diameter and NY-ESO-1 positivity (r = -0.37). NY-ESO-1 and MAGE-A4 may be involved in the DT microenvironment. Thus, NY-ESO-1 and MAGE-A4 may be useful in the diagnosis of DT.

31 Mar 2023·Journal of translational medicine

Treatment with decitabine induces the expression of stemness markers, PD-L1 and NY-ESO-1 in colorectal cancer: potential for combined chemoimmunotherapy.

Article

Author: Uddin, Shahab ; Sahir, Fairooz ; Makni-Maalej, Karama ; Hydrose, Shereena ; Mestiri, Sarra ; Nizamuddin, Parveen B ; Taib, Nassiba ; Merhi, Maysaloun ; Azizi, Fouad ; Raza, Afsheen ; Al-Zaidan, Lobna ; Maccalli, Cristina ; Dermime, Said ; Yoosuf, Zeenath Safira K M ; Almoghrabi, Salam ; Fernandes, Queenie ; Shablak, Alaaeldin ; Inchakalody, Varghese ; Al Homsi, Mohammed Ussama

BACKGROUND:

The mechanism of tumor immune escape and progression in colorectal cancer (CRC) is widely investigated in-vitro to help understand and identify agents that might play a crucial role in response to treatment and improve the overall survival of CRC patients. Several mechanisms of immune escape and tumor progression, including expression of stemness markers, inactivation of immunoregulatory genes by methylation, and epigenetic silencing, have been reported in CRC, indicating the potential of demethylating agents as anti-cancer drugs. Of these, a chemotherapeutic demethylating agent, Decitabine (DAC), has been reported to induce a dual effect on both DNA demethylation and histone changes leading to an increased expression of target biomarkers, thus making it an attractive anti-tumorigenic drug.

METHODS:

We compared the effect of DAC in primary 1076 Col and metastatic 1872 Col cell lines isolated and generated from patients' tumor tissues. Both cell lines were treated with DAC, and the expression of the NY-ESO-1 cancer-testis antigen, the PD-L1 immunoinhibitory marker, and the CD44, Nanog, KLF-4, CD133, MSI-1 stemness markers were analyzed using different molecular and immunological assays.

RESULTS:

DAC treatment significantly upregulated stemness markers in both primary 1076 Col and meta-static 1872 Col cell lines, although a lower effect occurred on the latter: CD44 (7.85 fold; ***p = 0.0001 vs. (4.19 fold; *p = 0.0120), Nanog (4.1 fold; ***p < 0.0001 vs.1.69 fold; ***p = 0.0008), KLF-4 (4.33 fold; ***p < 0.0001 vs.2.48 fold; ***p = 0.0005), CD133 (16.77 fold; ***p = 0.0003 vs.6.36 fold; *p = 0.0166), and MSI-1 (2.33 fold; ***p = 0.0003 vs.2.3 fold; ***p = 0.0004), respectively. Interestingly, in the metastatic 1872 Col cells treated with DAC, the expression of both PD-L1 and NY-ESO-1 was increased tenfold (*p = 0.0128) and fivefold (***p < 0.0001), respectively.

CONCLUSIONS:

We conclude that the upregulation of both stemness and immune checkpoint markers by DAC treatment on CRC cells might represent a mechanism of immune evasion. In addition, induction of NY-ESO-1 may represent an immuno-therapeutic option in metastatic CRC patients. Finally, the combination of DAC and anti-PD-1/anti-PD-L1 antibodies treatment should represent a potential therapeutic intervention for this group of patients.

News (Medical) associated with IMC-nyeso(Immunocore Ltd.)

03 Jun 2024

·www.biospace.com

Adaptimmune to Present Data from Planned Interim Analysis of Pivotal IGNYTE-ESO Trial with Lete-cel at ASCO; Data Continue to Support further Development of Sarcoma Franchise

Overall response rate of 40% consistent across sarcoma indications; median duration of response ~11 months with patients still in response at time of analysis Interim analysis data reinforces the potential of lete-cel to bolster Adaptimmune's sarcoma franchise by expanding addressable sarcoma patient population Full results from the pivotal IGNYTE-ESO trial are expected in late 2024 Philadelphia, Pennsylvania and Oxford, United Kingdom--(News - June 3, 2024) - Adaptimmune Therapeutics plc (NASDAQ: ADAP), a company working to redefine the treatment of solid tumor cancers with cell therapy, is presenting data from its pivotal IGNYTE-ESO trial of lete-cel (letetresgene autoleucel), an engineered cell therapy targeting NY-ESO-1, in synovial sarcoma (SyS) and myxoid/round cell liposarcoma (MRCLS) at the American Society of Clinical Oncology's (ASCO) annual meeting. Dr. Sandra D'Angelo of the Memorial Sloan Kettering Cancer Center will present "Lete-cel in patients with synovial sarcoma or myxoid/round cell liposarcoma: Planned interim analysis of the pivotal IGNYTE-ESO trial" in an oral session at 11:30 a.m. CDT, Monday, June 3rd, in Hall D2 as part of the Developmental Therapeutics-Immunotherapy track. Dennis Williams, PharmD., Senior Vice President, Late-Stage Development, Adaptimmune: "We're encouraged by the findings from the IGNYTE-ESO trial and the potential of our sarcoma franchise. Our lead cell therapy product, afami-cel, targets MAGE-A4 in synovial sarcoma and the ability to now also target the NY-ESO-1 cancer antigen with lete-cel will enable us to reach a greater number of people impacted by advanced sarcomas. We are eager to continue advancing lete-cel to further realise the promise of engineered TCR T-cell therapies for patients and healthcare providers. We look forward to sharing the full results of the IGNYTE-ESO trial in late 2024. We continue to work toward commercializing afami-cel later this year and lete-cel in 2026." Dr. Sandra D'Angelo M.D., Sarcoma Medical Oncology, Memorial Sloan Kettering Cancer Center, lead author and presenter: "Data from this planned interim analysis support the potential of lete-cel to serve as a novel therapy for people with advanced or metastatic MRCLS or synovial sarcoma. As the current treatment options in these two indications are significantly limited, both represent a greatly unmet medical need for novel, innovative therapies." Lete-cel data at ASCO At the planned interim analysis, 18/45 patients who received a single dose of lete-cel had clinical responses (previously reported). The overall response rate (ORR) of 40% was consistent across both SyS and MRCLS, and markedly greater than historical standard of care outcomes in these indications. The primary endpoint success criterion for efficacy was met by the interim analysis 40% ORR. Responses to lete-cel are durable, with the median duration of response (mDOR) at ~11 months, with 9/18 patients censored from mDOR calculation as their responses were ongoing at the time of the interim analysis. The complete primary analyses from IGNYTE-ESO, including more mature duration of response, are currently in progress with a full dataset anticipated in late 2024. Given the success of the pivotal IGNYTE-ESO trial, Adaptimmune plans to initiate a rolling Biologics License Application (BLA) submission for lete-cel for the treatment of advanced or metastatic MRCLS and synovial sarcoma during 2025. Lete-cel will allow Adaptimmune to bolster its sarcoma franchise by expanding the addressable patient population to NY-ESO-1 positive MRCLS and synovial sarcoma solid tumors. About lete-cel Lete-cel is an engineered TCR T-cell therapy targeting the solid tumor antigen NY-ESO-1. Lete-cel is being investigated for the treatment of synovial sarcoma and myxoid/round cell liposarcoma (MRCLS) in the pivotal IGNYTE-ESO (NCT03967223) trial in patients who received prior anthracycline treatment. About Synovial Sarcoma There are more than 50 different types of soft tissue sarcomas which are categorised by tumors that appear in fat, muscle, nerves, fibrous tissues, blood vessels, or deep skin tissues.1 Synovial sarcoma accounts for approximately 5% to 10% of all soft tissue sarcomas (there are approximately 13,400 new soft tissue cases in the U.S. each year).2 One third of patients with synovial sarcoma will be diagnosed under the age of 30.2 The five-year survival rate for people with metastatic disease is just 20% and most people undergoing standard of care treatment for advanced disease experience recurrence and go through multiple lines of therapy, often exhausting all options.3 About Myxoid/round cell liposarcoma (MRCLS) Myxoid/round cell liposarcoma (MRCLS) is a type of soft tissue sarcoma that is predominantly found in the limbs. MRCLS accounts for approximately 5% to 10% of all soft tissue sarcomas.4 One-third of MRCLS cases will become metastatic with tumors spreading to unusual bone and soft tissue locations. MRCLS commonly presents at an age ranging from 35-55 years and has a poor prognosis because it recurs locally and tends to metastasize quickly and widely. The 5-year survival rate for metastatic MRCLS is only 5%.5 About Adaptimmune Adaptimmune is a fully integrated cell therapy company working to redefine how cancer is treated. With its unique engineered T cell receptor (TCR) platform, the Company is developing personalized medicines designed to target and destroy difficult-to-treat solid tumor cancers and to radically improve the patient's cancer treatment experience. Forward-Looking Statements This release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 (PSLRA). These forward-looking statements involve certain risks and uncertainties. Such risks and uncertainties could cause our actual results to differ materially from those indicated by such forward-looking statements, and include, without limitation: the success, cost and timing of our product development activities and clinical trials and our ability to successfully advance our TCR therapeutic candidates through the regulatory and commercialization processes. For a further description of the risks and uncertainties that could cause our actual results to differ materially from those expressed in these forward-looking statements, as well as risks relating to our business in general, we refer you to our Annual Report on Form 10-K filed with the Securities and Exchange Commission for the year ended 31 December, 2023, our Quarterly Reports on Form 10-Q, Current Reports on Form 8-K, and other filings with the Securities and Exchange Commission. The forward-looking statements contained in this press release speak only as of the date the statements were made and we do not undertake any obligation to update such forward-looking statements to reflect subsequent events or circumstances. Dr. Sandra D'Angelo has financial interests related to Adaptimmune. Adaptimmune Contact Investor Relations Juli P. Miller, Ph.D. - VP, Corporate Affairs and Investor Relations T : +1 215 825 9310 M : +1 215 460 8920 Juli.Miller@adaptimmune.com Media Relations Dana Lynch, Senior Director of Corporate Communications M: +1 267 990 1217 Dana.Lynch@adaptimmune.com ________________________ 1. . 2. Synovial Sarcoma - NCI (cancer.gov). 3. Aytekin MN, et al. J Orthop Surg (Hong Kong). 2020;28(2). 4. . 5. . To view the source version of this press release, please visit

Cell TherapyImmunotherapyASCOClinical ResultClinical Study

02 May 2024

·www.globenewswire.com

Medigene AG Expands Patent Portfolio with European Patent Grant for its NY-ESO-1 – targeted T Cell Receptor

Planegg/Martinsried, May 2, 2024. Medigene AG (Medigene or the “Company”, FSE: MDG1, Prime Standard), an immuno-oncology platform company focusing on the discovery and development of T cell immunotherapies for solid tumors, announces today that the Company has been issued a patent by the European Patent Office protecting its T cell receptor (TCR) targeting NY-ESO-1 (New York esophageal squamous cell carcinoma 1), a well-recognized and validated cancer-testis antigen, which is expressed in multiple tumor types. “We are delighted to announce the protection of our NY-ESO-1-targeted TCR in Europe. This TCR, together with the PD1-41BB costimulatory switch protein (CSP), serves as the main component of our lead program MDG1015. This patent grant adds to similar patents that were also granted in the United States, Japan, South Korea, Taiwan and Australia and reinforces the key technologies of our End-to-End Technology platform and its ability to generate optimal affinity 3S (sensitive, specific and safe) TCRs,“ said Selwyn Ho, CEO at Medigene AG. “Along with our differentiated TCR-T therapies for solid tumors, such as MDG1015, we are also exploring opportunities to expand the application of our potential best-in-class TCRs into other modalities such as T cell engagers (TCE) and TCR natural killer cell (TCR-NK) therapies.” Medigene continually extends and strengthens its patent portfolio with new technologies and expands existing patents into additional jurisdictions. The Company maintains over 20 different patent families worldwide covering applications protecting Medigene’s 3S TCRs as well as its exclusive E2E Platform technologies. --- end of press release --- About Medigene AG Medigene AG (FSE: MDG1) is an immuno-oncology platform company dedicated to developing differentiated T cell therapies for treatment of solid tumors. Its End-to-End Platform is built on multiple proprietary and exclusive technologies that enable the Company to generate optimal T cell receptors against both cancer testis antigens and neoantigens, armor and enhance these T cell receptor engineered (TCR) -T cells to create best-in-class, differentiated TCR-T therapies, and optimize the drug product composition for safety, efficacy and durability. The End-to-End Platform provides product candidates for both its own therapeutics pipeline and partnering. Medigene’s lead TCR-T program MDG1015 is expected to receive IND/CTA approval in the second half of 2024. For more information, please visit https://medigene.com/ About Medigene’s MDG1015 Program MDG1015 is a first-in-class, 3rd generation T cell receptor engineered T cell (TCR-T) therapy targeting NY-ESO-1/ LAGE-1a, a well-recognized and validated cancer testis antigen, which is expressed in multiple tumor types. MDG1015 contains our optimal affinity 3S (sensitive, specific and safe) NY-ESO-1/LAGE-1a TCR combined with our proprietary PD1-41BB costimulatory switch protein that blocks the PD1/PD-L1 inhibitory axis while simultaneously activating the T cell through the well described -41BB pathway further enhancing the activity and persistence of the TCR-T in the hostile tumor microenvironment. The Company expects IND/CTA approval for MDG1015 in the second half of 2024. This press release contains forward-looking statements representing the opinion of Medigene as of the date of this release. The actual results achieved by Medigene may differ significantly from the forward-looking statements made herein. Medigene is not bound to update any of these forward-looking statements. Medigene® is a registered trademark of Medigene AG. This trademark may be owned or licensed in select locations only. Medigene AG Pamela Keck Phone: +49 89 2000 3333 01 E-mail: investor@medigene.com In case you no longer wish to receive any information about Medigene, please inform us by e-mail (investor@medigene.com). We will then delete your address from our distribution list.

ImmunotherapyCell Therapy

11 Mar 2024

·www.biospace.com

Replay’s cell therapy product company Syena announces first patient dosed in Phase 1/2 study of TCR-NK cell therapy for multiple myeloma

Replay’s cell therapy product company Syena announces first patient dosed in Phase 1/2 study of TCR-NK cell therapy for multiple myeloma Phase 1/2 clinical study of NY-ESO-1 TCR/IL-15 NK for relapsed or refractory multiple myeloma commences on track NY-ESO-1 TCR/IL-15 NK is the lead clinical program of Syena, a Replay and MD Anderson cell therapy company based on the scientific discoveries of Professor Katy Rezvani, M.D., Ph.D. Syena is Replay’s first product company to enter clinical development San Diego, California, London, UK, and Houston, Texas, March 11, 2024 – Replay, a genome writing company reprogramming biology by writing, designing, and delivering big DNA, today announced that the first patient has been dosed in the Phase 1/2 study of NY-ESO-1 TCR/IL-15 NK, an engineered T-Cell Receptor Natural Killer (TCR-NK) cell therapy for relapsed or refractory multiple myeloma. NY-ESO-1 TCR/IL-15 NK is being developed by Syena, an oncology-focused product company launched by Replay and The University of Texas MD Anderson Cancer Center,, based on the scientific discoveries of Katy Rezvani, MD, PhD, Professor of Stem Cell Transplantation & Cellular Therapy at MD Anderson. Syena has an exclusive licensing agreement for MD Anderson’s TCR-NK technology platform. This first-in-class engineered cell therapy comprises cord blood-derived natural killer cells that express an affinity-enhanced TCR targeted against the NY-ESO-1 antigen. NY-ESO-1 is highly immunogenic and expressed on numerous cancer cell types. The ability of NY-ESO-1 to elicit humoral and cellular immune responses along with its restricted tissue expression makes it a compelling target for cancer immunotherapy. The Phase 1/2 clinical study will assess the safety and efficacy of NY-ESO-1 TCR/IL-15 NK in patients with relapsed or refractory multiple myeloma. It will be administered following lymphodepletion with standard doses of fludarabine/cyclophosphamide (Flu/Cy). The study will enrol up to 44 patients in total. Adrian Woolfson, Executive Chairman, President, and Co-Founder of Replay, said: “The dosing of the first patient in Syena’s NY-ESO-1 TCR-NK clinical study represents a major step forward in addressing the significant unmet medical need for ‘off-the-shelf’ cell therapies. I am delighted with the rapid progress that we have made to date. NY-ESO-1 is highly expressed in poor-prognosis multiple myeloma, making this a suitable indication for demonstrating proof of concept for Syena’s TCR-NK technology platform. We believe that the use of optimally selected cord blood donors is likely to translate into improved patient outcomes. We are grateful to the patients, clinical sites, and development teams for their ongoing commitment and efforts to advance this new technology into the clinic.” Lachlan MacKinnon, CEO and Co-Founder of Replay, commented: “This Phase 1/2 clincial study will be key to further understanding the potential of our TCR-NK platform, with Syena making significant strides towards delivering its pioneering first-in-class TCR-NK cell therapy to patients with relapsed or refractory multiple myeloma. We look forward to enrolling further patients and evaluating the safety and efficacy outcomes as the study progresses.” For more information please visit ClinicalTrials.gov and reference identifier NCT06066359. Ends About Replay Replay is a genome writing company, which aims to define the future of genomic medicine through reprogramming biology by writing, designing, and delivering big DNA. The Company has assembled a toolkit of disruptive platform technologies — including a high payload capacity HSV delivery platform — to address the challenges currently limiting clinical progress and preventing genomic medicine from realizing its potential. The Company’s hub-and-spoke business model separates technology development within Replay from therapeutic development in a portfolio of product companies that leverage its technology platforms. The Company recently incorporated a first-in-class engineered TCR-NK cell therapy product company, Syena, using technology developed by Katy Rezvani, MD, PhD, at The University of Texas MD Anderson Cancer Center in Houston, Texas. Replay’s synHSV™ technology, a high payload capacity HSV vector capable of delivering up to 30 times the payload of AAV, is used by Replay’s gene therapy product companies, bringing big DNA treatments to monogenic diseases impacting the skin, and eye. Replay is led by a distinguished team of academics, entrepreneurs, and industry experts. The Company has raised $85 million to date and is supported by an international syndicate of investors including: KKR, OMX Ventures, ARTIS Ventures, Lansdowne Partners and the Bill and Melinda Gates Foundation. Replay is headquartered in San Diego, California. For further information please visit and follow us on LinkedIn and Twitter. About NY-ESO-1 TCR/IL-15 NK NY-ESO-1 TCR/IL-15 NKs are adoptive Natural Killer (NK) cells expressing an affinity-enhanced T-cell receptor (TCR) directed against NY-ESO-1-specific cord blood-derived NK cells. The cells are engineered to express the CD3 and TCR signalling complex and IL-15, and use the same manufacturing method as engineered CAR-NKs, which have demonstrated safety and efficacy in lymphoma (Liu et al, NEJM 2020 and Marin et al Nature Medicine 2024). NY-ESO-1 (New York Esophageal Squamous cell carcinoma 1) is an cancer-testis antigen with re-expression in multiple cancer types, and restricted expression in healthy tissues. This expression pattern and its ability to elicit humoral and cellular immune responses makes it a compelling target for TCR-T cell therapy. TCR-engineered NK cells retain their capacity to target tumor cells through their native receptors. The ability of NK cells to target tumor cells that down-regulate or lack MHC through the ‘missing self’ mechanism, may make disease escape through the most common mechanism of acquired resistance, less likely. IND-enabling studies have confirmed that NY-ESO-1 TCR/IL-15 NK cells do not kill healthy human cell lines derived from organs including the heart, lungs, liver, and kidneys. Contacts: Replay Dr. Adrian Woolfson/Lachlan MacKinnon info@replay.bio ICR Consilium – media relations Amber Fennell/Tracy Cheung/David Daley replay@consilium-comms.com

Cell TherapyLicense out/inImmunotherapyClinical StudyGene Therapy

100 Deals associated with IMC-nyeso(Immunocore Ltd.)

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	Immunocore Ltd.	15 Jun 2018
Advanced Malignant Solid Neoplasm	Phase 2	CA	Immunocore Ltd.	15 Jun 2018
Advanced Malignant Solid Neoplasm	Phase 2	GB	Immunocore Ltd.	15 Jun 2018
Lung Cancer	Phase 2	BR	Instituto de Investigação e Inovação em Saúde	01 Jul 2012
Ovarian Cancer	Phase 2	BR	Instituto de Investigação e Inovação em Saúde	01 Jul 2012
Melanoma	Phase 2	NZ	Ludwig Institute for Cancer Research Ltd.	01 Sep 2005
Melanoma	Phase 2	GB	Ludwig Institute for Cancer Research Ltd.	01 Sep 2005
Malignant melanoma stage IV	Phase 2	AU	Ludwig Institute for Cancer Research Ltd.	28 Nov 2003
Unresectable Melanoma	Phase 1	US	Ludwig Institute for Cancer Research Ltd.	24 Jan 2014
Unresectable Melanoma	Phase 1	AU	Ludwig Institute for Cancer Research Ltd.	24 Jan 2014

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT00299728 (CTgov)	Phase 1	Neoplasms	22	NY-ESO-1 Protein Vaccine (Arm A; 100 μg NY-ESO-1 Protein Co-mixed With CpG 7909 and Montanide ISA-51 VG)	btuwapiizy(ezyrqglfsm) = pomoxqusla ctajqajwro (hhopicqhwt, eubcwwnlzt - jwltnxkgjx) View more	-	26 Nov 2021
				NY-ESO-1 Protein Vaccine (Arm B; 400 μg NY-ESO-1 Protein Co-mixed With CpG 7909 and Montanide ISA-51 VG)	btuwapiizy(ezyrqglfsm) = bxosajklem ctajqajwro (hhopicqhwt, gbohaghmzy - ckjmcglrkn) View more
NCT00199849 (CTgov)	Phase 1	Sarcoma \| Esophageal Carcinoma \| Non-Small Cell Lung Cancer ... View more	18	NY-ESO-1 Plasmid DNA Cancer Vaccine (Cohort 1)	nmmetugeez(mwvvfcdsnw) = bhspokexar bxndppmlfv (sniicprnst, mhfilgkzbj - kcavrfqidk) View more	-	08 Oct 2021
				NY-ESO-1 Plasmid DNA Cancer Vaccine (Cohort 2)	nmmetugeez(mwvvfcdsnw) = pzwctfogff bxndppmlfv (sniicprnst, ccpsycgxlt - lspjqamqaj) View more
NCT00292045 (CTgov)	Phase 1	Prostatic Cancer	15	NY-ESO-1 protein/CpG 7909	bymcgytopu(vgygolahir) = oombcrfuzk gvrndcbxhx (hrptubfxpr, hbdjefcieb - rsehoiciia) View more	-	27 Jan 2021
NCT00142454 (CTgov)	Phase 1	Melanoma	9	Imiquimod+NY-ESO-1 protein	hgqjfbqkpd(jygozmfntu) = ockvxcstpg lqcqzgisld (btzlhxqjvh, ymbnhohafi - bskjghwbbw) View more	-	22 Oct 2020
NCT00803569 (CTgov)	Phase 1	Ovarian Cancer \| Primary peritoneal carcinoma \| Fallopian Tube Carcinoma	13	Sargramostim+ALVAC(2)-NY-ESO-1(M)/TRICOM vaccine	ctftwksses(domfsiftqv) = avkqfnnxnb hzkzpsvocy (tlawdssijf, qbmqgjpcqu - rhibzwylkt) View more	-	15 Feb 2019
NCT01810016 (P366, CTgov)	Phase 1	Unresectable Melanoma	8	Arm A (Arm A (Ipi, NY-ESO-1 Protein))	mkhplsezch(lgwkjytlnr) = hyxncegkod jpsrbhzdvc (rvlregkwoa, wmvqfyqufz - oyfrjibseb) View more	-	30 Nov 2018
				Ipi+NY-ESO-1 OLP4 (Arm B (Ipi, NY-ESO-1 OLP4))	mkhplsezch(lgwkjytlnr) = aemjjhiulk jpsrbhzdvc (rvlregkwoa, zvatczdvfa - vlvwglmgcg) View more
NCT00616941 (CTgov)	Phase 1	Primary peritoneal carcinoma \| Ovarian Epithelial Carcinoma \| Fallopian Tube Carcinoma	28	NY-ESO-1 OLP4 (Cohort 1)	ctdjojexlr(jnlsipwnqn) = sxmoluzust ecgoaifgbt (hoehfcfgzs, vfsshkylmo - wjzwktilni) View more	-	27 Jul 2018
				NY-ESO-1 OLP4 + Montanide (Cohort 2)	ctdjojexlr(jnlsipwnqn) = kmvtpugvsw ecgoaifgbt (hoehfcfgzs, echspbtuig - dhucjalhlw) View more
NCT00518206 (CTgov)	Phase 2	Malignant melanoma stage IV	46	ISCOM+NY-ESO-1 protein (Cohort 1: NY-ESO-1 ISCOM)	gqtlopggqy(pgiqtvbndw) = geelyvvfxv fkqvcanbku (zkweibnjpb, zeuwulvxwh - wzhodbkxve) View more	-	23 Jun 2017
				Cyclophosphamide+NY-ESO-1 (Cohort 2: Cyclophosphamide + NY-ESO-1 ISCOM)	gqtlopggqy(pgiqtvbndw) = qidgnhukza fkqvcanbku (zkweibnjpb, flxgwvhokz - oqrbovmpyr) View more
NCT00090493 (UARK 2003-26, CTgov)	Phase 2/3	Multiple Myeloma	4	MAGE-A3+NY-ESO-1 IMMUNOTHERAPY	oigjxjshsd(dsnqrkdpaq) = uhnrbrtykn ndxxspwzbf (qaacslvzlm, bcfirfdmfr - lckjbgjywc) View more	-	24 Jun 2013

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