A Single-arm, Open-label, Dose-finding Clinical Study of TCR-T Cells in Patients With HLA-A2-expressing and NY-ESO-1-positive Recurrent or Metastatic Solid Tumors

New York Esophageal Squamous Cell Carcinoma 1 (NY-ESO-1) is a Cancer-Testis Antigen (CTA) which is expressed in various tumors. After selected the high affinity TCR gene to NY-ESO-1, the researchers insert genes into the cell that expressing a kind of protein that targeting NY-ESO-1. Then the engineered cells are re-infused in the patients with tumors for curing the tumor patient or prolonging life.

开始日期2022-12-01

申办/合作机构

福建省肿瘤医院

100 项与 TCR-T cells(Fujian Cancer Hospital) 相关的临床结果

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100 项与 TCR-T cells(Fujian Cancer Hospital) 相关的转化医学

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项与 TCR-T cells(Fujian Cancer Hospital) 相关的文献（医药）

2024-02-02·Cancer Immunology Research

Lymph Node–Targeted Vaccine Boosting of TCR T-cell Therapy Enhances Antitumor Function and Eradicates Solid Tumors

Article

作者: Steinbuck, Martin P ; Jakubowski, Aniela ; Shields, Jacqueline ; Haqq, Christopher M ; Seenappa, Lochana M ; Drakes, Dylan J ; Abbas, Abdulraouf M ; DeMuth, Peter C

AbstractT-cell receptor (TCR)–modified T-cell therapies have shown promise against solid tumors, but overall therapeutic benefits have been modest due in part to suboptimal T-cell persistence and activation in vivo, alongside potential tumor antigen escape. In this study, we demonstrate an approach to enhance the in vivo persistence and function of TCR T cells through combination with Amphiphile (AMP) vaccination including cognate TCR T peptides. AMP modification improves lymph node targeting of conjugated tumor immunogens and adjuvants, thereby coordinating a robust T cell–activating endogenous immune response. AMP vaccine combination with TCR T-cell therapy led to complete eradication and durable responses against established murine solid tumors refractory to TCR T-cell monotherapy. Enhanced antitumor efficacy was correlated with simultaneous in vivo invigoration of adoptively transferred TCR T cells and in situ expansion of the endogenous antitumor T-cell repertoire. Long-term protection against tumor recurrence in AMP-vaccinated mice was associated with antigen spreading to additional tumor-associated antigens not targeted by vaccination. AMP vaccination further correlated with pro-inflammatory lymph node transcriptional reprogramming and increased antigen presenting–cell maturation, resulting in TCR T-cell expansion and functional enhancement in lymph nodes and solid tumor parenchyma without lymphodepletion. In vitro evaluation of AMP peptides with matched human TCR T cells targeting NY-ESO-1, mutant KRAS, and HPV16 E7 illustrated the clinical potential of AMP vaccination to enhance human TCR T-cell proliferation, activation, and antitumor activity. Taken together, these studies provide rationale and evidence to support clinical evaluation of combining AMP vaccination with TCR T-cell therapies to augment antitumor activity.

2024-02-01·Clinical Pharmacology & Therapeutics

An IQ Consortium Perspective on Best Practices for Bioanalytical and Immunogenicity Assessment Aspects of CAR‐T and TCR‐T Cellular Therapies Development

Review

作者: Jawa, Vibha ; Grudzinska-Goebel, Joanna ; Kasar, Siddha ; Tarcsa, Edit ; Vepachedu, Venkata R ; Ogasawara, Ken ; Dodge, Robert ; Balasubramanian, Nanda ; Mody, Hardik ; Tourdot, Sophie ; Gokemeijer, Jochem ; Herr, Kate ; Yang, Tong-Yuan ; Upreti, Vijay V ; Gupta, Swati ; Xu, Weifeng

CAR‐T therapies have shown remarkable efficacy against hematological malignancies in the clinic over the last decade and new studies indicate that progress is being made to use these novel therapies to target solid tumors as well as treat autoimmune disease. Innovation in the field, including TCR‐T, allogeneic or “off the shelf” CAR‐T, and autoantigen/armored CAR‐Ts are likely to increase the efficacy and applications of these therapies. The unique aspects of these cell‐based therapeutics; patient‐derived cells, intracellular expression, in vivo expansion, and phenotypic changes provide unique bioanalytical challenges to develop pharmacokinetic and immunogenicity assessments. The International Consortium for Innovation and Quality in Pharmaceutical Development (IQ) Translational and ADME Sciences Leadership Group (TALG) has brought together a group of industry experts to discuss and consider these challenges. In this white paper, we present the IQ consortium perspective on the best practices and considerations for bioanalytical and immunogenicity aspects toward the optimal development of CAR‐T and TCR‐T cell therapies.

2024-02-01·Bulletin du Cancer

La thérapie cellulaire dans tous ses états

Review

作者: Caux, Christophe ; Dougé, Aurore ; Bay, Jacques-Olivier

Immunotherapy strategies have revolutionized the management of a significant number of patients in recent years, whether they are undergoing treatment for hematologic malignancies or solid tumors. This therapeutic class is extensive, ranging from antibodies targeting immune checkpoint molecules to adoptive cell therapy strategies, including bispecific antibodies and anticancer vaccines. All these strategies are currently in active development. Adoptive cell therapy involves the infusion of normal or genetically modified immune cells into a patient with the aim of restoring strong antitumor immunity, primarily associated with the cytotoxicity of T lymphocytes. Currently, there are three major adoptive cell therapy strategies: allogeneic hematopoietic stem cell transplantation, CAR-T cell therapy, and TCR-T cell therapy. The objective of this article is to describe the mechanisms of action of these three strategies as well as their current advantages, limitations and constraints.

项与 TCR-T cells(Fujian Cancer Hospital) 相关的新闻（医药）

2023-11-14

·GlobeNewswire-Health Care

Alaunos Therapeutics Announces Third Quarter 2023 Financial Results, Phase 1 Clinical Data and Continued Exploration of Strategic Alternatives

TCR-T Library Phase 1/2 trial achieved an 87% disease control rate of eight evaluable patients with metastatic, refractory solid tumors; TCR-T cell therapy was well tolerated in all treated patientshunTR® discovered new HLA class I and class II restricted TCRs that recognize driver mutations, including KRAS and TP53Company continues to explore potential strategic alternatives; cost-savings measures expected to extend cash runaway into the second quarter of 2024 HOUSTON, Nov. 14, 2023 (GLOBE NEWSWIRE) -- Alaunos Therapeutics, Inc. (“Alaunos” or the “Company”) (Nasdaq: TCRT), today announced financial results for the third quarter ended September 30, 2023. As previously announced, the Company is exploring strategic alternatives with Cantor Fitzgerald & Co. as its strategic advisor. Alaunos continues to reduce spend and cost-savings measures taken to date are expected to extend its cash runway into the second quarter of 2024. Operational & Corporate Update Clinical Data from TCR-T Library Phase 1/2 Trial: Eight patients were treated and evaluated in the Company’s TCR-T Library Phase 1/2 Trial. Patients with pancreatic (3), colorectal (4) and non-small cell lung cancer (1) were treated, with certain of the pancreatic and colorectal patients also having lung metastases. Overall, the trial showed the Company’s T cells were well-tolerated in all evaluable participants with no dose-limiting toxicities (DLTs) and no immune effector cell-associated neurotoxicity syndrome (ICANS) were observed. All cytokine release syndrome (CRS) events were within grades 1-3 and were self-limiting or resolved with standard clinical management and, in some cases, a single dose of tocilizumab. One patient with non-small cell lung cancer (NSCLC) achieved an objective partial response with six months progression-free survival. Six other patients achieved best overall response of stable disease. The total overall response rate was 13% and disease control rate was 87% in evaluable patients with advanced, metastatic, refractory solid tumors (see attached figure). Disease control was measured by objective responses and stable disease. Increased secretion of interferon-gamma relative to baseline was detected in all patients’ serum post-cell transfer suggesting recognition of the tumor by the infused TCR-T cells. Persistence of TCR-T cells in peripheral blood was detected in all evaluable patients at their last follow-up, including up to six months in one patient. Infiltration of TCR-T cells into the tumor was also detected in three samples where a fresh biopsy was collected suggesting homing to the tumor microenvironment. All patients have progressed or withdrawn from the trial and long-term follow-up is ongoing for a subset of patients with no further intervention per the treatment protocol. This trial established proof-of-concept that Sleeping Beauty TCR-T cells can result in objective clinical responses and recognize established tumors in vivo. Despite the encouraging TCR-T Library Phase 1/2 Trial data, based on the substantial cost to continue development and the current financing environment, Alaunos announced in August 2023 that it would not pursue any further development of its clinical programs. hunTR® TCR Discovery Platform Identifies Proprietary TCRs: Alaunos has discovered multiple proprietary TCRs targeting driver mutations through its hunTR® TCR discovery platform. In addition to TCRs that recognize KRAS and TP53 mutations similar to those licensed from the National Cancer Institute, the Company identified additional TCRs that bind to other driver mutations and TCRs that are restricted to additional HLAs. Alaunos believes that the hunTR® library has the potential to allow for the treatment of a large patient population. Strategic Alternatives: The Company continues to explore strategic alternatives, which may include but are not limited to, an acquisition, merger, reverse merger, sale of assets, strategic partnerships, capital raises or other transactions. In connection with the strategic reprioritization, the Company has reduced its workforce by approximately 80% to date in order to streamline the organization and to maximize its cash runway. Third Quarter Ended September 30, 2023, Financial Results Collaboration Revenue: Collaboration revenue was $0 for the third quarter of 2023, compared to $2.9 million for the third quarter of 2022. The decrease was due to revenue earned under the Solasia License and Collaboration Agreement in 2022 that did not recur in 2023. Research and Development Expenses: Research and development expenses were $3.7 million for the third quarter of 2023, compared to $7.9 million for the third quarter of 2022, a decrease of approximately 54%. The decrease was primarily due to lower program expenses of $0.8 million as a result of our wind-down of clinical activities, a $0.6 million decrease in employee-related expenses due to our reduced headcount, an accrual adjustment related to our de-prioritized clinical programs of $0.3 million and a $2.5 million milestone payment to MD Anderson in 2022 under the terms of our patent and technology license agreement that did not recur in 2023. General and Administrative Expenses: General and administrative expenses were $3.6 million for the third quarter of 2023, compared to $3.3 million for the third quarter of 2022, an increase of approximately 9%. The increase was primarily due to higher consulting and professional services expenses of $0.9 million related to increased legal costs, partially offset by a $0.4 million decrease in employee-related expenses due to our reduced headcount and a $0.2 million decrease in insurance fees. Restructuring Costs: Restructuring costs were $0.4 million for the third quarter of 2023, compared to $0 for the third quarter of 2022 due to severance expenses for terminated employees related to our strategic reprioritization announced in August 2023. Property and Equipment and Right-of-Use Asset Impairment: Property and equipment and right-of-use asset impairment charges were $1.0 million for the third quarter of 2023, compared to $0 for the third quarter of 2022 due to changes in the intended use of our property and equipment and lease right-of-use asset following the announcement of our strategic reprioritization in August 2023. Net Loss: Net loss was $8.5 million, or $(0.04) per share, for the third quarter of 2023, compared to a net loss of $8.9 million, or $(0.04) per share, for the third quarter in 2022. Cash, Cash Equivalents and Restricted Cash: As of September 30, 2023, Alaunos had approximately $11.9 million in cash balances. The Company expects to have sufficient cash resources to fund operations into the second quarter of 2024 as a result of its ongoing strategic reprioritization. About Alaunos Therapeutics, Inc.Alaunos Therapeutics is a T-cell receptor (TCR) cell therapy company powered by its hunTR® (human neoantigen T-cell Receptor) discovery platform. hunTR® enables the rapid identification of wholly owned, proprietary TCRs. Using a proprietary high-throughput TCR screening process, hunTR® enables rapid functional validation of TCRs potentially allowing Alaunos to advance new TCRs from the lab to testing in the clinic. For more information, visit www.alaunos.com. Forward-Looking Statements Disclaimer This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts, and in some cases can be identified by terms such as “may,” “will,” “could,” “expects,” “plans,” “anticipates,” “believes” or other words or terms of similar meaning. These statements include, but are not limited to, statements regarding the Company’s ability to successfully implement its strategic reprioritization or realize any or all of the anticipated benefits once implemented and its ability to successfully consummate any strategic transactions; the completion and impact of the reduction in workforce; the planned renewed focus on the hunTR® TCR discovery platform and its success, including its ability to discover additional TCRs and the ability to monetize any newly discovered TCRs; the wind down of the TCR-T Phase 1/2 Library trial; the Company’s expected cash runway; and the results and potential of the TCR-T Phase 1/2 Library trial and the hunTR® discovery platform. Although the management team of Alaunos believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Alaunos, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include, among other things, risks relating to volatility and uncertainty in the capital markets for biotechnology and cell therapy companies; availability of suitable third parties with which to conduct contemplated strategic transactions; whether the Company will be able to pursue a strategic transaction, or whether any transaction, if pursued, will be completed successfully and on attractive terms or at all; whether our cash resources will be sufficient to fund the Company’s foreseeable and unforeseeable operating expenses and capital requirements; changes in the Company’s operating plans that may impact its cash expenditures; the uncertainties inherent in research and development, future clinical data and analysis; the risks associated with reductions in workforce, including reduced morale and attrition of additional employees necessary for the strategic reprioritization; the Company’s exclusive focus on its hunTR® TCR discovery platform; the strength and enforceability of Alaunos’ intellectual property rights; competition from other pharmaceutical and biotechnology companies; and the potential delisting of the Company’s common stock from the Nasdaq Stock Market LLC, as well as risk factors discussed or identified in the public filings with the Securities and Exchange Commission made by Alaunos, including those risks and uncertainties listed in the most recent periodic report filed by Alaunos with the Securities and Exchange Commission. Alaunos is providing this information as of the date of this press release, and Alaunos does not undertake any obligation to update or revise the information contained in this press release whether as a result of new information, future events, or any other reason. Alaunos Therapeutics, Inc.Statement of Operations(In thousands except per share data) For the Three Months EndedSeptember 30(Unaudited) 2023 2022Collaboration revenue$- $2,911 Operating expenses: Research and development$3,656 $7,893 General and administrative 3,578 3,282 Restructuring costs 419 - Property and equipment and right-of-use asset impairment 1,011 - Total operating expenses 8,664 11,175 Loss from operations (8,664) (8,264)Interest expense - (841)Other income, net 188 254 Net loss (8,476) (8,851)Basic and diluted net loss per share$(0.04)$(0.04)Weighted average common shares outstanding, basic and diluted 240,046,026 215,098,995 Alaunos Therapeutics, Inc.Selected Balance Sheet Data(In thousands) September 30,2023(Unaudited) December 31,2022(Audited)Cash and cash equivalents$11,944 $39,058 Restricted cash$- $13,938 Working capital, excluding restricted cash$8,193 $15,695 Total assets$19,440 $64,937 Total stockholders’ equity$13,900 $38,555 A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/004e98ab-3132-430a-8757-7e7dbd38f630

临床结果细胞疗法财报临床1期

2023-11-06

·GlobeNewswire-Health Care

TScan Therapeutics Presents Phase 1 Trial Design for Solid Tumor Program at the Society for Immunotherapy of Cancer 38th Annual Meeting

Solid tumor program uses separate screening protocol designed to identify patients in advance of treatment protocol; on track to enroll first patient in study this year Company adds TSC-201-B0702 to ImmunoBank, targeting novel melanoma-associated antigen C2 (MAGE-C2) WALTHAM, Mass., Nov. 06, 2023 (GLOBE NEWSWIRE) -- TScan Therapeutics, Inc. (Nasdaq: TCRX), a clinical-stage biopharmaceutical company focused on the development of T cell receptor (TCR)-engineered T cell therapies (TCR-T) for the treatment of patients with cancer, today announced the presentation of six posters at the Society for Immunotherapy of Cancer (SITC) 38th Annual Meeting. “Solid tumors are notoriously heterogenous, which may contribute to low response rates and limited duration of response following treatment with single-targeting TCR-T cell therapy. TScan’s solid tumor program is designed to deliver multiplexed, enhanced TCR-T cell therapy to effectively address both target heterogeneity and HLA loss,” said Gavin MacBeath, Ph.D., Chief Executive Officer. “TScan has initiated a screening protocol to test for target expression and the presence of HLA genes in patients’ tumors. This information is then used to determine eligibility for enrollment into the treatment protocol and to guide selection of which TCR-Ts to administer to the patient. We have already screened over 30 patients in the screening protocol and expect to enroll the first patient in our treatment protocol this year.” Product Characteristics and Clinical Trial Design for T-Plex, a Multiplexed, Enhanced T cell Receptor-Engineered T cell Therapy for Solid Tumors TScan’s Phase 1 solid tumor clinical trial is designed to assess customized, multiplexed TCR-T as a way to overcome tumor heterogeneity and HLA loss of heterozygosity. First generation TCR-T, targeting single antigens, has shown encouraging response rates (typically 30-50%), but has often shown short durations of response (3-4 months). TScan believes that its approach to multiplexing across targets and HLAs will result in increased response rates and increased duration of response. To make this possible, TScan is prospectively screening patients with melanoma, non-small cell lung cancer (NSCLC), head and neck cancer, cervical cancer, ovarian cancer, and anogenital cancers for target expression and the presence of intact HLA genes. Customized treatment is made possible by the Company’s ImmunoBank, its repository of therapeutic TCRs that recognize diverse targets and are associated with multiple HLA types. TScan continues to prioritize populating the ImmunoBank to increase the number of addressable targets, thereby increasing the percentage of patients that are eligible to receive either singleplexed or multiplexed treatment. In the treatment protocol, each TCR-T is first tested as singleplexed therapy at two different dose levels to assess safety. Once a TCR-T has cleared dose level two, it becomes eligible to be combined with any other TCR-T that has also cleared dose level two. As additional Investigational New Drug Applications (INDs) for TCR-Ts are cleared by the FDA and enter the ImmunoBank, they will be incorporated into the same study and follow the same dose escalation scheme, enabling a rapid path to novel multiplexed therapies. Discovery of novel MAGE-C2 epitopes for TCR-T adoptive cell therapy from expanded T cell clones of TIL therapy products Using TargetScan, TScan has identified a novel B*07:02-restricted epitope in the cancer/testis antigen MAGE-C2 as a promising target for TCR-T therapy. TScan is developing TSC-201-B0702, a TCR-T cell therapy that targets this epitope, with plans to file an IND by the end of the year. TCR-Ts targeting MAGE-C2 could potentially be used to treat up to 50% of melanoma patients, 25% of patients with head and neck cancers, and 50% of patients with NSCLC in the United States. “As we expand the number of TCRs in the ImmunoBank, we expect the number of patients eligible for enrollment in our study to increase, providing a rapid and efficient path to delivering multiplexed therapy,” continued Dr. MacBeath. “In addition to filing an IND for TSC-201-B0702, we also anticipate filing an IND for TSC-204-A0101 by the end of 2023. TSC-204-A0101 targets an epitope on MAGE-A1 specific for the HLA type A*01:01.” For additional information on all six posters presented at the SITC 38th Annual Meeting, visit the “Events and Presentations” section of the Company’s Investor Relations website at ir.tscan.com. About TScan Therapeutics, Inc. TScan is a clinical-stage biopharmaceutical company focused on the development of T cell receptor (TCR)-engineered T cell therapies (TCR-T) for the treatment of patients with cancer. The Company’s lead TCR-T therapy candidates, TSC-100 and TSC-101, are in development for the treatment of patients with hematologic malignancies to eliminate residual disease and prevent relapse after allogeneic hematopoietic cell transplantation. The Company is also developing multiplexed TCR-T therapy candidates for the treatment of various solid tumors. The Company has developed and continues to build its ImmunoBank, the Company’s repository of therapeutic TCRs that recognize diverse targets and are associated with multiple HLA types, to provide customized multiplexed TCR-T therapies for patients with a variety of solid tumors. Forward-Looking Statements This release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, express or implied statements regarding the Company’s plans, progress, and timing relating to the Company’s solid tumor programs, including expanding the ImmunoBank, submitting of INDs, initiating clinical trials, enrolling patients, and reporting data, the Company’s current and future research and development plans or expectations, the structure, timing and success of the Company’s planned preclinical development, submission of INDs, and clinical trials, the potential benefits of any of the Company’s proprietary platforms, multiplexing, or current or future product candidates in treating patients, and the Company’s goals and strategy. TScan intends such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. In some cases, you can identify forward-looking statements by terms such as, but not limited to, “may,” “might,” “will,” “objective,” “intend,” “should,” “could,” “can,” “would,” “expect,” “believe,” “anticipate,” “project,” “target,” “design,” “estimate,” “predict,” “potential,” “plan,” “on track,” or similar expressions or the negative of those terms. Such forward-looking statements are based upon current expectations that involve risks, changes in circumstances, assumptions, and uncertainties. The express or implied forward-looking statements included in this release are only predictions and are subject to a number of risks, uncertainties and assumptions, including, without limitation: the beneficial characteristics, safety, efficacy, therapeutic effects and potential advantages of TScan’s TCR-T therapy candidates; TScan’s expectations regarding its preclinical studies being predictive of clinical trial results; the timing of the initiation, progress and expected results of TScan’s preclinical studies, clinical trials and its research and development programs; TScan’s plans relating to developing and commercializing its TCR-T therapy candidates, if approved, including sales strategy; estimates of the size of the addressable market for TScan’s TCR-T therapy candidates; TScan’s manufacturing capabilities and the scalable nature of its manufacturing process; TScan’s estimates regarding expenses, future milestone payments and revenue, capital requirements and needs for additional financing; TScan’s expectations regarding competition; TScan’s anticipated growth strategies; TScan’s ability to attract or retain key personnel; TScan’s ability to establish and maintain development partnerships and collaborations; TScan’s expectations regarding federal, state and foreign regulatory requirements; TScan’s ability to obtain and maintain intellectual property protection for its proprietary platform technology and our product candidates; the sufficiency of TScan’s existing capital resources to fund its future operating expenses and capital expenditure requirements; and the effect of the COVID-19 pandemic, including mitigation efforts and political, economic, legal and social effects, on any of the foregoing or other aspects of TScan’s business or operations; and other factors that are described in the “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections of TScan’s most recent Annual Report on Form 10-K and any other filings that TScan has made or may make with the SEC in the future. Any forward-looking statements contained in this release represent TScan’s views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date. Except as required by law, TScan explicitly disclaims any obligation to update any forward-looking statements. Contacts Heather SavelleTScan Therapeutics, Inc.VP, Investor Relations857-399-9840hsavelle@tscan.com Joyce AllaireLifeSci Advisors, LLCManaging Director617-435-6602jallaire@lifesciadvisors.com

细胞疗法免疫疗法临床1期AACR会议

2023-10-25

·BioSpace

AGC Biologics Signs TCR-T Cell Services Agreement to Support Medigene’s New Cell Therapy Product

SEATTLE--(BUSINESS WIRE)-- AGC Biologics, a leading global Biopharmaceutical Contract Development and Manufacturing Organization (CDMO), today announced a new service agreement with Medigene AG (Medigene, the “Company”, FSE: MDG1, Prime Standard). Under the agreement, AGC Biologics is providing autologous production for a next-generation-therapy product focused on the treatment of solid cancers, supporting Medigene’s IND filing and clinical trials. With the product currently in the pre-clinical phase, AGC Biologics will perform a process transfer and clinical manufacturing of Medigene’s product candidate at the CDMO’s Cell and Gene Center of Excellence in Milan. “The growth of T cell immunotherapies in recent years has been astonishing. Although complex to manufacture, they offer unique therapeutic effects for patients in need,” said Luca Alberici, General Manager of AGC Biologics Milan. “Intricate cell therapy projects are not unique to our team, and we are eager to take on this challenge and help produce this cell therapy product with Medigene, a company truly focused on innovation in the field of solid tumor treatments.” According to recent industry research from Roots Analysis, T cell immunotherapies are poised for greater than 30 percent growth rate over the next decade, thanks to their unique ability to target cancer cells and promising early clinical data. Being a living therapy, T cell therapies are complex drug products to manufacture at GMP scales. AGC Biologics' Milan location has 30 years of experience in the cell and gene field and expertise with complex advanced cell therapy projects, such as these. The core team has guided three cell therapy products from development to commercial stages and has manufactured hundreds of batches of cell therapies for clinical and commercial usage. “This is a critical first step in ensuring that our lead product candidate MDG1015, a third generation TCR-T therapy combining our optimal affinity TCR targeting NY-ESO-1/LAGE-1a with our PD1-41BB costimulatory switch protein, is ready for GMP clinical evaluation,” said Selwyn Ho, CEO at Medigene. “We are delighted to partner with AGC Biologics as we advance towards MDG1015’s phase I clinical milestone and look forward to its further development and delivering a potentially best-in-class, differentiated TCR-T therapy for patients with solid tumors.” To learn more about AGC Biologics’ global cell therapy services visit , go to and learn more about the CDMO’s viral vector offerings. About AGC Biologics AGC Biologics is a leading global biopharmaceutical Contract Development and Manufacturing Organization (CDMO) with a strong commitment to delivering the highest standard of service as we work side-by-side with our clients and partners, every step of the way. We provide world-class development and manufacture of mammalian and microbial-based therapeutic proteins, plasmid DNA (pDNA), messenger RNA (mRNA), viral vectors, and genetically engineered cells. Our global network spans the U.S., Europe, and Asia, with cGMP-compliant facilities in Seattle, Washington; Boulder and Longmont, Colorado; Copenhagen, Denmark; Heidelberg, Germany; Milan, Italy; and Chiba, Japan. We currently employ more than 2,500 employees worldwide. Our commitment to continuous innovation fosters the technical creativity to solve our clients’ most complex challenges, including specialization in fast-track projects and rare diseases. AGC Biologics is the partner of choice. To learn more, visit . About Medigene AG Medigene AG (FSE: MDG1) is an immuno-oncology platform company dedicated to developing T cell therapies to effectively eliminate cancer. Its End-to-End Platform, built on multiple proprietary and exclusive TCR generation and optimization, as well as product enhancement technologies, allows Medigene to create best-in-class, differentiated T cell receptor engineered T cell (TCR-T) therapies for multiple solid tumor indications that are optimized for safety, efficacy and durability. This platform provides product candidates for both its in-house therapeutics pipeline and partnering. For more information, please visit View source version on businesswire.com: Contacts Nick McDonald nmcdonald@agcbio.com (425) 419-3555 Source: AGC Biologics View this news release online at:

细胞疗法免疫疗法引进/卖出

100 项与 TCR-T cells(Fujian Cancer Hospital) 相关的药物交易

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