A Feasibility Study Following a Phase 2a Design to Demonstrate Successful Local Manufacture of Chimeric Antigen Receptor (CAR) T-Cell Products for the Treatment of B-Cell Lymphoma and B-Acute Lymphoblastic Leukemia

This trial aims to demonstrate the feasibility of this approach to reliably generate product and to safely administer the product to patients who have B-Cell Lymphoma and B-Acute Lymphoblastic Leukemia.

Start Date19 Apr 2022

Sponsor / Collaborator

Allegheny-Singer Research Institute

[+3]

100 Clinical Results associated with Lentigen Technology, Inc.

0 Patents (Medical) associated with Lentigen Technology, Inc.

Literatures (Medical) associated with Lentigen Technology, Inc.

01 Apr 2024·Journal for ImmunoTherapy of Cancer

Armored TGFβRIIDN ROR1-CAR T cells reject solid tumors and resist suppression by constitutively-expressed and treatment-induced TGFβ1

Article

Author: Chand Thakuri, Bal Krishna ; Tran, Ngoc Q ; Steimle, Brittany ; Hu, Peirong ; Tran, Tri Minh ; Nurmukhambetova, Saule ; Schneider, Dina ; Dash, Pradyot ; Lee, Jia-Jye

BackgroundChimeric antigen receptor (CAR) T-cell therapy target receptor tyrosine kinase-like orphan receptor 1 (ROR1) is broadly expressed in hematologic and solid tumors, however clinically-characterized ROR1-CAR T cells with single chain variable fragment (scFv)-R12 targeting domain failed to induce durable remissions, in part due to the immunosuppressive tumor microenvironment (TME). Herein, we describe the development of an improved ROR1-CAR with a novel, fully human scFv9 targeting domain, and augmented with TGFβRIIDN armor protective against a major TME factor, transforming growth factor beta (TGFβ).MethodsCAR T cells were generated by lentiviral transduction of enriched CD4+and CD8+T cells, and the novel scFv9-based ROR1-CAR-1 was compared with the clinically-characterized ROR1-R12-scFv-based CAR-2 in vitro and in vivo.ResultsCAR-1 T cells exhibited greater CAR surface density than CAR-2 when normalized for %CAR+, and produced more interferon (IFN)-γ tumor necrosis factor (TNF)-α and interleukin (IL)-2 in response to hematologic (Jeko-1, RPMI-8226) and solid (OVCAR-3, Capan-2, NCI-H226) tumor cell lines in vitro. In vivo, CAR-1 and CAR-2 both cleared hematologic Jeko-1 lymphoma xenografts, however only CAR-1 fully rejected ovarian solid OVCAR-3 tumors, concordantly with greater expansion of CD8+and CD4+CAR T cells, and enrichment for central and effector memory phenotype. When equipped with TGFβ-protective armor TGFβRIIDN, CAR-1 T cells resisted TGFβ-mediated pSmad2/3 phosphorylation, as compared with CAR-1 alone. When co-cultured with ROR-1+AsPC-1 pancreatic cancer line in the presence of TGFβ1, armored CAR-1 demonstrated improved recovery of killing function, IFN-γ, TNF-α and IL-2 secretion. In mouse AsPC-1 pancreatic tumor xenografts overexpressing TGFβ1, armored CAR-1, in contrast to CAR-1 alone, achieved complete tumor remissions, and yielded accelerated expansion of CAR+T cells, diminished circulating active TGFβ1, and no apparent toxicity or weight loss. Unexpectedly, in AsPC-1 xenografts without TGFβ overexpression, TGFβ1 production was specifically induced by ROR-1-CAR T cells interaction with ROR-1 positive tumor cells, and the TGFβRIIDN armor conferred accelerated tumor clearance.ConclusionsThe novel fully human TGFßRIIDN-armored ROR1-CAR-1 T cells are highly potent against ROR1-positive tumors, and withstand the inhibitory effects of TGFß in solid TME. Moreover, TGFβ1 induction represents a novel, CAR-induced checkpoint in the solid TME, which can be circumvented by co-expressing the TGβRIIDN armor on T cells.

22 Mar 2024·Cancer Research

Abstract 2913: Co-expression of extracellular matrix enzymes heparanase or PH-20 augments the anti-tumor efficacy of folate receptor 1-targeting CAR T cells in an ovarian cancer model

Author: Tran, Ngoc ; Dash, Pradyot ; Hu, Peirong ; Steimle, Brittany L. ; Luo, Kun ; Baysac, Kathleen ; Schneider, Dina ; Nurmukhambetova, Saule ; Liang, Genqing ; Lee, Jia-Jye ; Wang, Xu ; Tran, Tri

AbstractIntroduction: The tumor extracellular matrix (ECM) is a physical barrier which obstructs trafficking of CAR T cells to tumors. We hypothesize that co-expressing ECM remodeling/degrading enzymes heparanase (HPSE) or PH-20 with a CAR directed against folate receptor 1 (FolR1) will overcome the physical tumor microenvironment barrier and improve anti-tumor efficacy of anti-FolR1 CAR in a human ovarian cancer model.Methods: ECM CARs were constructed by combining anti-FolR1 ScFv with a CD8 hinge and transmembrane domain, 4-1BB, and CD3ζ endodomains, followed by a P2A element and full-length HPSE or GPI-anchored PH-20 sequence. CAR T cells were prepared from CD4+ and CD8+ T cells of healthy donors by lentiviral transduction. CAR expression was evaluated by flow cytometry; HPSE and PH-20 expression were measured via ELISA and Western blotting, respectively. CAR-mediated killing and cytokine release were observed in overnight co-culture assays with FolR1-expressing tumor cells. ECM CARs’ migration through CultrexTM and sodium hyaluronate matrices were assessed for HPSE and PH-20 function, respectively. ECM CARs’ efficacy was evaluated in vivo using a FolR1-expressing subcutaneous OV90 ovarian cancer xenograft model in NOD SCID Gamma (NSG) mice, and representative OV90 tumors were harvested at day 7 post-CAR T treatment for immunohistochemical staining.Results: FolR1 expression was confirmed in ovarian cancer cell lines and substrates targeted by HPSE (perlecan, glypican 3, CD138) and PH-20 (hyaluronan) were detected by immunofluorescence in human ovarian tumors’ sections. Lentiviral transduced primary T cells yielded robust expression of FolR1 CAR and ECM enzymes. Anti-FolR1 CAR and ECM CARs secreted pro-inflammatory cytokines IL-2, TNFα, IFNƳ and lysed OVCAR3 tumor cells with similar efficacy. ECM CARs with HPSE or PH-20 exhibited enhanced migration through ECM-rich matrices as compared to anti-FolR1 CAR alone. In vivo, all anti-FolR1 CAR T cells rejected OV90 tumors and extended survival compared to tumor alone or untransduced T cells (UTD). However, ECM CARs co-expressing HPSE or PH-20 accelerated tumor regression as compared to anti-FolR1 CAR alone. Tumor histology revealed CAR T cell infiltration (CD3+, CD8+) in mice treated with anti-FolR1 CARs but not UTD, indicating that anti-FolR1 CARs can effectively infiltrate OV90 tumors. Imaging studies are underway to evaluate the function of ECM CARs in the tumor microenvironment.Conclusions: The anti-FolR1 CARs boosted with ECM enzymes HPSE or PH-20 demonstrated specific lysis of FolR1-expressing cell lines, improved penetration through ECM-rich matrices in vitro, and accelerated tumor regression in an ovarian cancer model in vivo. Therefore, ECM CARs may help improve clinical outcomes in patients with ovarian tumors.Citation Format: Brittany L. Steimle, Peirong Hu, Ngoc Tran, Jia-Jye Lee, Kathleen Baysac, Kun Luo, Xu Wang, Genqing Liang, Saule Nurmukhambetova, Tri Tran, Pradyot Dash, Dina Schneider. Co-expression of extracellular matrix enzymes heparanase or PH-20 augments the anti-tumor efficacy of folate receptor 1-targeting CAR T cells in an ovarian cancer model [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2024; Part 1 (Regular Abstracts); 2024 Apr 5-10; San Diego, CA. Philadelphia (PA): AACR; Cancer Res 2024;84(6_Suppl):Abstract nr 2913.

02 Nov 2023·Blood

A Phase I Clinical Trial of Fully Human Anti-CD19 Chimeric Antigen Receptor T Cells for Relapsed or Refractory Lymphoid Malignancies

Author: Metheny, Leland ; Reese Koc, Jane ; Cooper, Brenda W ; Klisovic, Rebecca B. ; Deng, Changchun ; Ciarrone, Lisa ; Tupta, Rose ; Wu, Darong ; Tomlinson, Benjamin K. ; Schneider, Dina ; de Lima, Marcos ; Van Besien, Koen ; Boughan, Kirsten Marie ; Caimi, Paolo F. ; Gallogly, Molly Megan

Background:Chimeric antigen receptor (CAR) T-cells have revolutionized the standard of care for numerous lymphoid malignancies but continue to present challenges related to toxicity, long-term efficacy, cost, and accessibility. Novel CAR-T cell constructs hold promise for improving desired outcomes. CD19 CAR-T cells with fully humanized chimeric antigen receptors have demonstrated excellent preclinical activity and the potential for lower rates of cytokine release syndrome (CRS) and severe immune effector associated neurotoxicity syndrome (ICANS). To evaluate safety, we conducted a phase 1 clinical trial evaluating fully human Hu19-CD841BBZ CAR-T cells with a 4-1BB costimulatory domain against relapsed or refractory (R/R) CD19-positive lymphoid malignancies, utilizing a single lymphodepletion regimen and local CAR-T cell manufacturing using the Prodigy® Device.Methods:We designed a parallel-group phase I trial with two clinical groups. Group A enrolled subjects with relapsed and refractory CD19+ lymphomas and chronic lymphocytic leukemia (CLL), while Group B comprised patients with acute lymphoblastic leukemia/lymphoma (ALL). The primary endpoint was safety and toxicity assessment, along with the identification of the recommended phase 2 dose in each clinical group. Secondary endpoints included efficacy evaluation. Dose escalation in each group followed a “3 + 3” phase I study design, with three dose levels: 5e5 CAR-T cells/kg, 1e6 CAR-T cells/kg, and 2e6 CAR-T cells/kg. Lymphodepletion consisted of cyclophosphamide 60mg/kg on day -6 and Fludarabine 25mg/m2/day on days -5 to -3. Dose-limiting toxicities included prolonged CRS grade 3 or higher, ICANS grade ≥ 3, and grade ≥ 3 non hematologic toxicities with the exception of self-limited (<7 days) laboratory abnormalities without associated symptoms or clinical consequences.Results:As of 7/1/2023, a total of 13 patients were enrolled in Group A (NHL), and two patients were enrolled in Group B (B-ALL). Three patients in Group A withdrew consent or were withdrawn at the investigator's discretion due to new comorbid conditions before cell collection. Additionally, three patients were unable to receive CAR-T cell infusions due to disease progression, including two with Burkitt lymphoma. Among the remaining patients, 7 in NHL and 2 in B-ALL, received CART cells. The average age was 59 (range: 40-73), and 2 patients were female. In the NHL group, diseases treated included CLL (3), mantle cell lymphoma (2), follicular lymphoma (1), and Waldenstrom's (1). The median number of prior treatments was 4 (range: 3-10).CAR-T cell product manufacturing was successful in all patients to achieve the target dose, with a mean transduction efficiency of 43.8% (29.7% - 54.6%).One potential dose-limiting toxicity, nodular regenerative hyperplasia of the liver, considered possibly related to CAR-T cells, was observed in the NHL group at the 1e6 cells/kg dose level, leading to an expansion of this dose level. Other observed toxicities were as expected and manageable. Six patients experienced CRS, with grades 1-2 in the NHL group. Both patients in the B-ALL arm experienced CRS, one grade 1 and one grade e, with observed severity congruent with known disease burden before receiving CAR-T cells. Two cases of CRS required no intervention, while the remaining cases received tocilizumab (n=4), steroids (n=2), and/or anakinra (n1). There were three occurrences of ICANS, two in Group A and one in Group B. Treatments included corticosteroids (n=3) and anakinra (n=2).Among the 7 NHL patients evaluable for response, 2 achieved complete remission (follicular, mantel cell), three had a partial response (CLL), and one exhibited stable disease (Waldenstrom's). Two NHL patients (CLL and Mantel Cell) had subsequent disease progression. One B-ALL patient evaluable for response achieved a CR but experienced disease progression at one year and subsequently died.Discussion:In this parallel-group phase 1 study, fully human Hu19-CD841BBZ CAR-T cells with a 4-1BB costimulatory domain were successfully manufactured in all patients undergoing leukapheresis. Human CAR-T cells demonstrated preliminary safety and clinical activity in the setting of heavily pre-treated patients with R/R B cell malignancies. A platform of point-of-care manufacture permits access to novel CAR-T cell products, and may facilitate the development of novel immune effector cell products.

News (Medical) associated with Lentigen Technology, Inc.

02 Aug 2024

·www.fiercepharma.com

FDA signs off on Adaptimmune's Tecelra as the first engineered cell therapy for a solid tumor

Patients with a certain type of synovial sarcoma have a new treatment option for the first time in more than a decade as the FDA has approved Adaptimmune's Tecelra, which is the first engineered T-cell therapy for a solid tumor. Adaptimmune has won accelerated FDA approval for Tecelra (afami-cel), a treatment for metastatic or unresectable synovial sarcoma.Tecelra’s approval comes with several firsts. It’s the first engineered cell therapy for a solid tumor, the first TCR-T therapy to enter the market, and the first new treatment in the indication in more than a decade.It also is the initial approval for the 16-year-old company, which has attracted and lost partnerships with several pharma giants—including GSK, Astellas and most recently Roche—who were drawn to the potential of Adaptimmune’s unique engineered T-cell receptor (TCR) platform. It enables the engineering of T-cells to target and destroy many types of solid tumor cancers.As the first engineered T-cell therapy for solid tumors, Tecelra marks a significant milestone, not only for the company but also for the advancement of cell therapy.“It’s the first product where we use a lentiviral vector to insert our engineered T-cell receptor into the cell,” John Lunger, Adaptimmune’s chief patient supply officer, explained in an interview. Iovance’s Amtagvi (lifileucel), which was approved by the FDA in February for melanoma, was the first T-cell treatment for solid tumors. The difference with Tecelra is that it is engineered.Amtagvi uses immune cells, called tumor-infiltrating lymphocytes (TILs), which are collected from a patient’s tumor, as opposed to CAR-T cell therapies, which are collected from a patient’s circulating blood.“Ninety percent of cancer is solid tumors,” Lunger said. “The idea of a company like ourselves, going after solid tumors using cells, we’re finally getting to that place where we’re demonstrating this can actually work.”The list price for the one-time therapy is $727,000. The addressable patient population in the US is roughly 400 per year, Lunger said. Tecelra’s endorsement covers adults with advanced MAGE-A4+ synovial sarcoma of certain human leukocyte antigen (HLA) types who have received prior chemotherapy. Patients undergo companion diagnostic screening for their genetic HLA types and MAGE-4A expression.Sarcomas are rare solid tumor cancers that develop in the bones and soft tissues including fat, muscle, nerves and blood vessels, which often strike young adults. Of the roughly 13,400 new soft tissue sarcomas diagnosed annually in the US, 5 to 10% are of the synovial type. The five-year survival rate is 20%, with most patients going through multiple lines of therapy, Adaptimmune said.The approval is based on results of the SPEARHEAD-1 study of 44 patients, in which afami-cel provided a 43% overall response rate, with 4.5% seeing the disappearance of their cancer. For those who respond to Tecelra, the median treatment-free interval seen in the trial was 17 months.“We’ve also seen for those responders about a 70% chance that they’re still alive after two years and that data is still developing,” Lunger said.There were no treatment deaths in the study, though Tecelra can cause serious side effects including cytokine release syndrome and neurotoxicity.“From the patient experience, when you compare what we have with a one-time therapy to the usual standard of care—which is chemotherapy, radiation and surgery—it’s extraordinary,” Lunger said.As part of the accelerated approval, a confirmatory trial will be required. Adaptimmune, which is based in Oxford, England, plans to have six to 10 designated treatment centers in operation by the end of this year, growing to 30 across the US by the end of 2025.Adaptimmune went public in 2015 but found itself in dire straits in April when Genentech—in cost-cutting mode—exited a $3 billion partnership in which it was developing two allogenic T-cell therapies directed at up to five targets.But seven weeks later, Galapagos stepped up, signing a $665 million deal for the rights to uza-cel, a MAGE-4A TCR T-cell therapy which Adaptimmune has in phase 2 for ovarian cancer. The Belgian biotech wants to take uza-cel into head and neck cancer and potentially other solid tumors.The Galapagos deal, which includes $100 million up front, will help fund Adaptimmune’s launch of Tecelra.Adaptimmune manufactures drug product for Tecelra in Philadelphia and farms viral vector production out to Miltenyi Biotec’s subsidiary Lentigen, which is based in Maryland. Adaptimmune handles all the manufacturing itself for uza-cel, performing viral vector production at one of its two sites in the UK.“This approval represents a much-needed new option for people diagnosed with this sarcoma and an important milestone for the use of cell therapies in solid tumor cancers,,” Sandra D’Angelo, a sarcoma medical oncologist at Sloan Kettering Cancer Center, and the principal investigator of the SPEARHEAD trial, said.

Phase 2Clinical ResultImmunotherapyDrug ApprovalCell Therapy

26 Mar 2024

·www.fiercepharma.com

Caring Cross, Brazil's Fiocruz team up to produce cell and gene therapies at a fraction of their cost in the US

Maryland non-profit Caring Cross and Brazil's Fundacao Oswaldo Cruz (Fiocruz) plan to develop and manufacture cell and gene therapies at one-tenth of their cost in the U.S. Maryland non-profit Caring Cross has unveiled a partnership with the Brazilian government that's designed to provide access to advanced cell and gene therapies for diseases like leukemia, lymphoma and HIV infection—and in the process provide a manufacturing model that demonstrates how to reduce the cost of these treatments in the United States and Europe. Caring Cross and Fundacao Oswaldo Cruz (Fiocruz)—a foundation funded by the Brazilian Ministry of Health—plan to develop and manufacture the medicines at a fraction of their cost in the U.S. Co-founded by cell and gene therapy manufacturing trailblazers Boro Dropulic, Ph.D. and Rimas Orentas, Caring Cross’ mission is to organize and support a community of healthcare professionals, scientists, engineers, advocates and business leaders to accelerate the development of advanced medicines and make them available for all patients around the world. The program with Brazil is the first of its kind anywhere in the world, Dropulic and Orentas said in an interview with Fierce Pharma. “We’re pioneering something quite new in terms of teaching an organization, that is directly linked to the Ministry of Health, how to manufacture CAR-T cells and the vectors themselves,” said Dropulic, the executive director of Caring Cross. “We will start first in Rio de Janeiro at the Fiocruz campus—in collaboration with INCA, which is their equivalent of the NCI (National Cancer Institute)—to run clinical trials for leukemia and lymphoma.” Dropulic knows the drill. He founded Lentigen, which developed the lentiviral vector used by Novartis to produce the first FDA-approved cell therapy product, Kymriah, in 2017. Dropulic directed Lentigen’s CDMO business model before launching Caring Cross in 2021. The effort in Brazil will include the development of a product for HIV, which is currently in clinical trials in the U.S. A candidate to cure sickle cell disease and beta thalassemia could enter the clinic later this year. Under the plan, the therapies will be available for free for patients, with an approximate cost of $35,000 per dose covered by the Brazilian public health system. Dropulic and Orentas believe an approved product could be available within three years. Caring Cross aims to slash production costs with its point-of-care manufacturing model. Development and manufacturing can be executed entirely in modular units which are 56 by 13 feet and can be set up anywhere. “When you make these products at the point of care or close to a hospital, you significantly decrease these logistical costs,” Dropulic said. Orentas added that it’s already dawned on the managed care systems in countries such as Spain, Germany and Denmark that the way gene therapies are produced in the U.S. is “not sustainable.” Even with the high cost of doing business in the U.S., Caring Cross believes it could deliver CAR-T therapies for around $80,000, Orentas said. In the U.S., cell and gene therapy prices currently range from hundreds of thousands of dollars to millions of dollars. Caring Cross's Brazilian partner has "biomanufacturing expertise" and "an experienced workforce," Orentas said. Fiocruz is the world’s largest producer of the yellow fever vaccine. It also served as Brazil’s home base for production of its AstraZeneca-partnered COVID vaccine. Meanwhile, through its for-profit CDMO spinout, Vector BioMed, Caring Cross is developing technologies to improve the accessibility of CAR-T and other therapies.

$Caring Cross, Brazil's Fiocruz team up to produce cell and gene therapies at a fraction of their cost in the US$

VaccineGene TherapyCell Therapy

12 May 2023

·www.prnewswire.com

Global Stem Cell Partnering Terms and Agreements 2010-2023: Deals, Key Players and Financials

Dublin, May 11, 2023 /PRNewswire/ -- The "Global Stem Cell Partnering Terms and Agreements 2010-2023" report has been added to ResearchAndMarkets.com's offering. The Global Stem Cell Partnering Terms and Agreements 2010-2023 report provides comprehensive understanding and unprecedented access to the stem cell partnering deals and agreements entered into by the worlds leading healthcare companies. Trends in stem cell partnering Partnering agreement structure Partnering contract documents Top deals by value Most active dealmakers Average deal terms for stem cells The report provides a detailed understanding and analysis of how and why companies enter stem cell partnering deals. These deals tend to be multicomponent, starting with collaborative R&D, and proceed to commercialization of outcomes. This report provides details of the latest stem cell agreements announced in the life sciences since 2010. The report takes the reader through a comprehensive review stem cell deal trends, key players, top deal values, as well as deal financials, allowing the understanding of how, why and under what terms, companies are entering stem cell partnering deals. The report presents financial deal term values for stem cell deals, listing by headline value, upfront payments, milestone payments and royalties, enabling readers to analyse and benchmark the financial value of deals. The middle section of the report explores the leading dealmakers in the stem cell partnering field; both the leading deal values and most active stem cell dealmaker companies are reported allowing the reader to see who is succeeding in this dynamic dealmaking market. One of the key highlights of the report is that over 700 online deal records of actual stem cell deals, as disclosed by the deal parties, are included towards the end of the report in a directory format - by company A-Z, stage of development, deal type, therapy focus, and technology type - that is easy to reference. Each deal record in the report links via Weblink to an online version of the deal. In addition, where available, records include contract documents as submitted to the Securities Exchange Commission by companies and their partners. Whilst many companies will be seeking details of the payment clauses, the devil is in the detail in terms of how payments are triggered - contract documents provide this insight where press releases and databases do not. The initial chapters of this report provide an orientation of stem cell dealmaking. Chapter 1 provides an introduction to the report, whilst chapter 2 provides an overview of the trends in stem cell dealmaking since 2010, including details of headline, upfront, milestone and royalty terms. Chapter 3 provides a review of the leading stem cell deals since 2010. Deals are listed by headline value. Where the deal has an agreement contract published at the SEC a link provides online access to the contract. Chapter 4 provides a comprehensive listing of the top 25 most active companies in stem cell dealmaking with a brief summary followed by a comprehensive listing of stem cell deals announced by that company, as well as contract documents, where available. Chapter 5 provides a comprehensive and detailed review of stem cell partnering deals signed and announced since Jan 2010, where a contract document is available in the public domain. Each deal title links via Weblink to an online version of the deal record and contract document, providing easy access to each contract document on demand. Chapter 6 provides a comprehensive and detailed review of stem cell partnering deals signed and announced since Jan 2010. The chapter is organized by specific stem cell technology type. Each deal title links via Weblink to an online version of the deal record and where available, the contract document, providing easy access to each deal on demand. A comprehensive series of appendices is provided organized by stem cell partnering company A-Z, stage of development, deal type, and therapy focus. Each deal title links via Weblink to an online version of the deal record and where available, the contract document, providing easy access to each deal on demand. The report also includes numerous tables and figures that illustrate the trends and activities in stem cell partnering and dealmaking since 2010. In conclusion, this report provides everything a prospective dealmaker needs to know about partnering in the research, development and commercialization of stem cell technologies and products. Key benefits Global Stem Cell Partnering Terms and Agreements 2010-2023 provides the reader with the following key benefits: In-depth understanding of stem cell deal trends since 2010 Access to headline, upfront, milestone and royalty data Detailed access to actual stem cell contracts entered into by leading biopharma companies Identify most active stem cell dealmakers since 2010 Insight into terms included in a stem cell partnering agreement, with real world examples Understand the key deal terms companies have agreed in previous deals Undertake due diligence to assess suitability of your proposed deal terms for partner companies Report scope Global Stem Cell Partnering Terms and Agreements 2010-2023 is intended to provide the reader with an in-depth understanding and access to stem cell trends and structure of deals entered into by leading companies worldwide. Stem Cell Partnering Terms and Agreements includes: Trends in stem cell dealmaking in the biopharma industry since 2010 Access to headline, upfront, milestone and royalty data Access to stem cell contract documents Leading stem cell deals by value since 2010 Most active stem cell dealmakers since 2010 In Global Stem Cell Partnering Terms and Agreements 2010-2023, the available deals are listed by: Company A-Z Headline value Stage of development at signing Deal component type Specific therapy target Technology type Each deal title links via Weblink to an online version of the deal record and where available, the contract document, providing easy access to each contract document on demand. The Global Stem Cell PartneringTerms and Agreements 2010-2023 report provides comprehensive access to available deals and contract documents for over 700 stem cell deals. Analyzing actual contract agreements allows assessment of the following: What are the precise rights granted or optioned? What is actually granted by the agreement to the partner company? What exclusivity is granted? What is the payment structure for the deal? How are sales and payments audited? What is the deal term? How are the key terms of the agreement defined? How are IPRs handled and owned? Who is responsible for commercialization? Who is responsible for development, supply, and manufacture? How is confidentiality and publication managed? How are disputes to be resolved? Under what conditions can the deal be terminated? What happens when there is a change of ownership? What sublicensing and subcontracting provisions have been agreed? Which boilerplate clauses does the company insist upon? Which boilerplate clauses appear to differ from partner to partner or deal type to deal type? Which jurisdiction does the company insist upon for agreement law? Companies Mentioned Regenetech Regeneus Stempeutics Bakulev Center of Cardiovascular Surgery of Russian Academy of Sciences CNA Development The New York Stem Cell Foundation Arthrex Generex Biotechnology Celltex Therapeutics Viscofan BioEngineering Dana-Farber Cancer Institute Biosafe BioLife Solutions Rockefeller University Montefiore Medical Center Wake Forest University Fast Forward Jain Foundation Promega Lineage Cell Therapeutics Hepregen Histogen Lentigen Philogen Vascugen Shenogen Pharma VistaGen Therapeutics Centogene Spinogenix Transgenomic Biological Industries Procognia Apceth Munich Technical University Lehigh University Monash University Abu Dhabi Stem Cells Center Shanghai Cell Therapy Group Shanghai Jia Fu Medical Apparatus Sinopharm AXM Pharma For more information about this report visit About ResearchAndMarkets.com ResearchAndMarkets.com is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends. Media Contact: Research and Markets Laura Wood, Senior Manager [email protected] For E.S.T Office Hours Call +1-917-300-0470 For U.S./CAN Toll Free Call +1-800-526-8630 For GMT Office Hours Call +353-1-416-8900 U.S. Fax: 646-607-1907 Fax (outside U.S.): +353-1-481-1716 Logo: SOURCE Research and Markets

Cell Therapy

100 Deals associated with Lentigen Technology, Inc.

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Pipeline Snapshot as of 26 Nov 2024

The statistics for drugs in the Pipeline is the current organization and its subsidiaries are counted as organizations,Early Phase 1 is incorporated into Phase 1, Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3

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Drug(Targets)	Indications	Global Highest Phase

MB CART19.1(Miltenyi) ( CD19 )	Marginal Zone B-Cell Lymphoma More	Phase 2
TGFßRIIDN-armored ROR1-CAR-1 T cells (Miltenyi ) ( ROR1 x TGF-β1 )	Pancreatic Cancer More	Preclinical
CD19/CD20/CD22-targeting duoCAR-T(Lentigen) ( CD19 x CD20 x CD22 )	B-Cell Malignant Neoplasm More	Preclinical
US11590169 ( CD123 )	Neoplasms More	Discovery
LG-690	Graft vs Host Disease More	Pending

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