On November 5, 2024 Galapagos NV (Euronext & NASDAQ: GLPG) reported that it will present new data from its CAR T- and TCR T-cell therapy pipeline at the 66th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition in San Diego, CA, 7-10 December 2024 (Press release, Galapagos, NOV 5, 2024, View Source [SID1234647811]).

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Three abstracts, including one oral presentation, will feature new data from our proprietary cell therapy programs in relapsed/refractory (R/R) non-Hodgkin lymphoma (NHL), and R/R chronic lymphocytic leukemia (CLL) and Richter transformation (RT), in addition to preclinical data in head & neck (H&N) cancer, developed in partnership with Adaptimmune. Galapagos will also host a company showcase, titled: Fresh, Fit, and Fast: Pioneering the Future of Cell Therapy through Decentralized Manufacturing.

"We are committed to advancing breakthrough innovations to expand the reach of cell therapies for patients with rapidly progressing cancers," said Jeevan Shetty, MD, Head of Clinical Development Oncology at Galapagos. "We are excited to present promising new clinical data for our CD19 CAR T-cell therapy candidates, which continue to support the hypothesis that delivering fresh, fit cells quickly could improve outcomes for patients. Additionally, the preclinical proof-of-concept data we will present with our partner Adaptimmune highlight the potential of our innovative approach in treating solid tumors, expanding our reach to critically-ill patients beyond hematological cancers."

The data to be presented are summarized below:

The oral presentation for GLPG5101, our CD19 CAR-T candidate in relapsed/refractory non-Hodgkin lymphoma, including R/R large B-cell lymphoma (DLBCL), mantle cell lymphoma (MCL), follicular lymphoma (FL), and marginal zone lymphoma (MZL), will feature new safety, efficacy, and longer follow-up data for 45 patients in the ongoing Phase 1/2 ATALANTA-1 study (data cut-off: April 25, 2024). The presentation will also demonstrate the feasibility of our decentralized manufacturing platform, delivering a fresh, stem-like early memory cell therapy with a median vein-to-vein time of seven days, robust in vivo expansion, and durable persistence.
The poster presentation for GLPG5201, our CD19 CAR-T candidate in relapsed/refractory chronic lymphocytic leukemia (R/R CLL) and Richter transformation (RT), will include additional safety, efficacy, and translational data from 15 patients (cut-off date: February 21, 2024) in the ongoing Phase 1/2 EUPLAGIA-1 study, consistent with previously disclosed findings. The presentation will also highlight that decentralized manufacturing of GLPG5201, delivered as fresh cells in a median vein-to-vein time of seven days, results in an increase in stem-like early memory phenotypes versus starting material, robust in vivo expansion, and durable persistence.
The poster presentation for uza-cel, a MAGE-A4 directed TCR T-cell therapy candidate in head & neck (H&N) cancer, in partnership with Adaptimmune, will highlight preclinical proof-of-concept data demonstrating that Galapagos’ innovative decentralized cell therapy manufacturing platform can produce uza-cel with features that may result in improved efficacy and durability of response in the clinic compared with the existing manufacturing procedure.
The dates and times for accepted abstracts, presentations and our company showcase are as follows:

Abstract title Authors (Presenter) Presentation date/time
Galapagos-driven original abstracts
ATALANTA-1: A Phase 1/2 Trial of GLPG5101, a Fresh, Stem-Like, Early Memory CD19 CAR T-Cell Therapy with a 7-Day Vein-to-Vein Time, for the Treatment of Relapsed/Refractory Non-Hodgkin Lymphoma Marie José Kersten, Kirsten Saevels, Evelyne Willems, Marte C. Liefaard, Stavros Milatos, Margot J. Pont, Claire Vennin, Eva Santermans, Anna D.D. Van Muyden, Jeevan Shetty, Esmée P. Hoefsmit, Omotayo Fasan, Maria T. Kuipers, Sébastien Anguille, Joost S.P. Vermaat
  Oral presentation number: 93
Date: Saturday, December 7, 2024
Time: 10:00 PT (session 09:30-11:00 PT)
Session: 704. Cellular Immunotherapies: Early Phase Clinical Trials and Toxicities: CAR-T Cell Therapies for Lymphomas and ALL: New Strategies and Toxicities
Location: Marriott Marquis San Diego Marina, Marriott Grand Ballroom 11-13
EUPLAGIA-1: A Phase 1/2 Trial of GLPG5201, a Fresh Stem-Like Early Memory CD19 CAR T-Cell Therapy with a 7-Day Vein-to-Vein Time, in Patients with Relapsed/Refractory CLL and RT
  Valentin Ortiz-Maldonado, Nuria Martínez-Cibrián, Leticia Alserawan, Sergi Betriu, Ana Triguero, Sandra Blum, Margaux Faes, Marte C. Liefaard, Margot J. Pont, Maike Spoon, Kirsten Van Hoorde, Anna D. D. van Muyden, Julio Delgado, Natalia Tovar Poster presentation number: 3452
Date: Sunday, December 8, 2024
Time: 18:00-20:00 PT
Session: 704. Cellular Immunotherapies: Early Phase Clinical Trials and Toxicities: Poster II
Location: San Diego Convention Center, Halls G-H
Galapagos company showcase
Fresh, Fit, and Fast: Pioneering the Future of Cell Therapy through Decentralized Manufacturing Dr. Jeevan Shetty, M.D., Head of Clinical Development Oncology, Galapagos, Ms. Jacqueline Vink-Korndorffer, Head of Global Cell Therapy Operations, Galapagos Date: Saturday, December 7, 2024
Time: 13:45-14:00 PT
Location: Room 3, Upper Level, San Diego Convention Center
Adaptimmune-driven abstracts
Preclinical Proof of Concept for Decentralized Manufacturing of a MAGE-A4/CD8α–Expressing Autologous T-Cell Therapy for Solid Tumors
  Melissa Herman, Stefania Gobessi, Laurens Sand, Karolin Wagner, Ryan Yuan, Sterenn Davis, Ian Donaldson, Megan Butler, Natalie Bath, Robert Harris, Nathaniel Golden, Alex Tipping, Joseph Sanderson, John Mellors, Phillip Debnam Poster presentation number: 2100
Date: Saturday, December 7, 2024
Time: 17:30-19:30 PT
Session: 711. Cell Collection and Manufacturing of HSPCs, CAR-T Cells, and Other Cellular Therapy Products: Poster I
Location: San Diego Convention Center, Halls G-H

About Galapagos’ cell therapy manufacturing platform
Galapagos’ innovative decentralized cell therapy manufacturing platform has the potential for the administration of fresh, fit cells within a median vein-to-vein time of seven days, greater physician visibility, and improved patient experience. The platform consists of an end-to-end xCellit workflow management and monitoring software system, a decentralized, functionally closed, automated manufacturing platform for cell therapies (using Lonza’s Cocoon) and a proprietary quality control testing and release strategy.

On November 5, 2024 Delta-fly Pharma reported that it is excited to share latest development status (Press release, Delta-Fly Pharma, NOV 5, 2024, View Source [SID1234647771]).

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As informed dated October 28th, an interim analysis for the Phase III study of DFP-10917 in R/R AML patients is ongoing. The Phase I/II combination study of DFP-10917 with Venetoclax in AML patients is well ongoing.

Today, we are delighted to talk about an update for development of the drug delivery of DFP-10917 selective to solid tumor, which is namely, DFP-14927 showed nice safety and efficacy in the Phase I study in solid tumor patients. Accordingly, we have moved forward into an expanded Phase I study of DFP-14927 at 3200 mg/m2 weekly dosing in R/R colorectal cancer patients at MD Anderson Cancer Center and UCLA. Efficacy in expanded Phase I study is evaluated by Disease Control Ratio (DCR) and it shall be evaluated by OS in the next registration study for NDA approval.

On November 5, 2024 Nucleai, an AI-powered spatial biology company, reported that it will present two abstracts at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 2024 Annual Meeting (Press release, Nucleai, NOV 5, 2024, View Source [SID1234647770]). The presentations will detail how Nucleai’s AI-driven spatial biomarker analysis provides actionable insights into patient treatment for non-small cell lung cancer (NSCLC) and melanoma, focusing on treatment resistance and patient stratification.

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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Spatial biology examines the organization of cells and proteins in their natural tissue environments, providing insights into disease progression and treatment responses. By mapping the precise spatial arrangement of cellular structures, researchers can gain insights that were previously challenging to achieve. Nucleai’s AI-driven approach enhances this by extracting precise, actionable insights from multiplex immunofluorescence (mIF) datasets. This integration of AI into spatial biology enables biomarker discovery and patient stratification at scale, directly contributing to better response rates in clinical trials, supporting tailored treatment strategies, and optimizing patient outcomes. Unlike other approaches that focus on general research capabilities, Nucleai emphasizes practical applications that enhance clinical trial efficiency, personalize immunotherapy, and address specific treatment challenges such as immune resistance.

First Abstract: Addressing Immunotherapy Resistance in NSCLC

In collaboration with Dr. Arutha Kulasinghe of The University of Queensland and Dr. David Rimm from Yale University, the first abstract profiles the metabolic states of tumor and immune cells in NSCLC patients treated with checkpoint inhibitors.

Dr. Rimm commented, "The identification of immune and metabolic profiles allows us to pinpoint patients likely to respond to combination therapies, which is key in managing NSCLC more effectively. By understanding these unique profiles, we can better overcome treatment resistance, ultimately leading to improved patient survival outcomes. Nucleai’s AI biomarker platform and scientific expertise were crucial in helping us rapidly analyze the spatial data from multiple patient cohorts and in extracting the most clinically relevant insights."

NSCLC is a leading cause of cancer mortality globally, and the variability in patient response to immunotherapy remains a significant challenge. This abstract’s findings highlight biomarker signatures that could guide the development of combination treatment strategies aimed at overcoming treatment resistance, increasing response rates, and improving overall patient survival metrics in NSCLC treatment.

Link to abstract info: SITC (Free SITC Whitepaper) 2024 Abstract Titles and Publications (#109)

Second Abstract: Integrating Spatial Biomarker Analysis in Melanoma

The second abstract, in collaboration with Dr. Paolo Ascertio and Lunaphore, a Bio-Techne brand, examines the spatial proteomic profile of melanoma patients undergoing immunotherapy as part of the SECOMBIT trial.

"This study demonstrates our shared vision with Nucleai to accelerate predictive spatial biomarkers development and showcases the COMET platform’s unique potential in enabling the design of more effective immunotherapy strategies in advanced cancers such as metastatic melanoma," said Matt McManus, President of Bio-Techne’s Diagnostics & Genomics Segment. "We’re committed to advancing spatial biology in clinical research to push the boundaries of healthcare and ultimately improve patient outcomes." The SECOMBIT study involves characterizing immune cell subtypes, their functional states, and the expression of checkpoint markers, providing specific details that can guide immunotherapy decisions for these patients.

This study illustrates the integration of spatial biomarker analysis using Nucleai’s deep learning platform to accelerate translational research, inform drug development decisions, and ultimately improve patient outcomes by enabling more accurate stratification and effective targeting of immunotherapies. The study presents a framework and an end-to-end high-plex COMET workflow leveraging Lunaphore’s core SPYRE Antibody Panels integrated with custom antibody panels and Nucleai’s AI platform to analyze immune cell subtypes, functional cell states, and checkpoint markers within the tumor microenvironment.

Link to abstract info: SITC (Free SITC Whitepaper) 2024 Abstract Titles and Publications (#117)

Collaborative Impact of Nucleai and Lunaphore (a Bio-Techne brand)

Nucleai and Lunaphore, part of Bio-Techne’s Spatial Biology Division, have collaborated since 2022 to refine biomarker discovery and guide immunotherapy treatment pathways. This collaboration is providing biopharmaceutical companies and clinical research organizations with detailed spatial maps that help predict patient responses more accurately, supporting the development of more targeted treatment strategies.

Avi Veidman, CEO of Nucleai, commented, "Our AI-powered platform is transforming how life science companies and clinicians approach immunotherapy. By working with academic partners and top instrument companies such as Lunaphore, we are developing scalable spatial biomarker solutions that could directly impact clinical trials and diagnostics. Our approach enhances the accuracy of patient selection and reduces risks associated with ineffective treatments, which will ultimately increase the success rates of advanced cancer therapies and improve patient outcomes."

At SITC (Free SITC Whitepaper) 2024, Nucleai and Lunaphore will give attendees an inside look at how their work together is solving one of the most daunting pain points for researchers and clinicians: the time-consuming analysis of billions of data points provided by spatial biology. Attendees will see how AI-powered data analysis combined with the innovative and fully automated COMET can supercharge their existing workflows, extracting meaningful insights that lead to more impactful clinical trials and informed treatment decisions for patients.

With two abstracts focused on the most critical areas of disease research today and an example of how its work with other top companies validates its technology and approach, Nucleai is using SITC (Free SITC Whitepaper) 2024 to provide the most comprehensive look yet at how AI-driven spatial biomarker analysis can improve patient outcomes at every step from diagnosis to treatment.

The abstracts presented by Nucleai demonstrate how spatial biomarker analysis can be effectively integrated into biopharma and CRO workflows, particularly for immunotherapies.

On November 5, 2024 Ankyra Therapeutics, a clinical stage biotechnology company pioneering anchored therapy to treat cancer, reported the first patient dosed in a visceral tumor in Part 2 of their dose escalation Phase 1 study (Press release, Ankyra Therapeutics, NOV 5, 2024, View Source [SID1234647769]). The ANCHOR study is a first-in-human Phase 1 study being conducted in two parts. Part 1 is enrolling patients with superficially accessible tumors and is expected to complete enrollment by December 2024. Part 2 is now open to patients with solid tumors located in deep viscera accessed by interventional radiologic or endoscopic procedures for injection.

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Referred to as "anchored therapy" the company has identified a method for prolonged drug retention within the tumor microenvironment. The anchored strategy drives local anti-tumor activity, similar to antibody drug conjugates, while limiting systemic toxicity. The company’s lead asset, ANK-101, is an interleukin-12 (IL-12) physically anchored to aluminum hydroxide. ANK-101 is locally delivered and retained in the tumor microenvironment for several weeks where it mediates recruitment and activation of effector immune cells. In multiple preclinical models, a murine adapted ANK-101 demonstrated increased immune cell infiltration and activation with significant therapeutic activity across multiple tumor types. In addition, a canine version of ANK-101 has been evaluated in an exploratory phase I study in dogs with advanced melanoma. Human ANK-101 is now in Phase 1 clinical trials for solid tumors in the U.S. and Canada.

"The first patient dosed in the Part 2 of our Phase 1 study advances our lead asset into visceral solid tumors and marks a key milestone in our mission to bring novel medicines to patients with cancer," said Joe Elassal, M.D. MBA. Part 2 of the ANCHOR study will assess the safety of ANK-101 and determine the recommended dose for expansion in patients with viscerally injected solid tumors. Secondary objectives include evaluation of pharmacokinetics, immunogenicity, and preliminary clinical activity of the medicine. Enrollment in Part 1 of the ANCHOR trial is ongoing.

"I have been impressed with ANK-101 in Part 1 of the Phase 1 study and expansion of the trial to include visceral lesions will enable us to deliver ANK-101 to a broader group of cancer patients," said Jong Chul Park, MD, Assistant Professor at Harvard Medical School and attending physician at Mass General Cancer Center. He added, "we look forward to advancing this part of the trial and exploring the safety and therapeutic potential of ANK-101 for patients with more advanced disease."

About ANK-101

ANK-101 is an anchored drug complex composed of human interleukin-12 (IL-12) linked to aluminum hydroxide. ANK-101 enables local delivery of functional IL-12 to the tumor microenvironment where it remains biologically active for several weeks but does not diffuse into the systemic circulation, thereby avoiding systemic toxicity. Treatment with ANK-101 in animal models has been associated with recruitment and retention of CD8+ T cells, NK cells and M1 macrophages activating innate and adaptive anti-tumor immunity. ANK-101 is being evaluated for the treatment of advanced solid tumors alone and in combination with anti-PD-1 agents. Phase 1 first-in-human, open-label clinical trial of ANK-101 as a monotherapy (NCT:06171750) consists of dose escalation portions in both superficial and visceral lesions that will evaluate the safety and tolerability of ANK-101, followed by dose expansion cohorts.

On November 5, 2024 NJ Bio, Inc. and Charles River Laboratories, Inc. reported a strategic alliance to offer complementary services to clients including early development and optimization to manufacturing of antibody drug conjugates (ADCs) (Press release, Charles River Laboratories, NOV 5, 2024, View Source [SID1234647768]).

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It is well known that the path of bringing ADCs to market is an intricate and complex field that requires expert navigation skills. It involves development and manufacturing processes of antibodies (Abs), cytotoxic payloads, linkers, linker-payloads, their conjugation to ADCs, and preclinical and clinical validations. The biggest benefit of the Charles River and NJ Bio alliance is that clients can receive seamless complementary services to enhance outcomes and accelerate time-to-market for their ADCs. Today, innovation has become a necessity to improve the safety and efficacy profiles of ADCs. Another advantage of this alliance to clients is Charles River’s ability to discover innovative engineered Abs while NJ Bio will synthesize and manufacture novel linkers, payloads, or linker-payloads to enhance the safety and efficacy of ADCs.

Charles River is a leader in antibody development and preclinical evaluation of ADCs. The Company’s antibody, oncology, immunology and safety assessment experts can support ADC programs from proof-of-concept to clinical candidates, helping drive translational success and accelerating the path to the clinic. Last year, in recognition of Charles River’s leadership in ADC discovery and development, the Company was awarded the Best Contract Research Organization at the World ADC Summit, and is shortlisted for the award again this year.

NJ Bio, Inc., is a contract research organization located in Princeton, NJ specializing in providing integrated chemistry and bioconjugation services. Committed to innovation and quality, NJ Bio assists its clients in achieving their development and manufacturing objectives. NJ Bio has significant expertise in the synthesis and GMP manufacturing of payloads, linkers, linker-payloads, ADCs, TPDs, and oligo-conjugates, and non-oncology related conjugations. NJ Bio has an excellent track record with clients to support early phase discovery, proof-of-concept, process and analytical development, manufacture of pre-clinical batches, and manufacture and release of linkers, payloads, linker-payloads, and ADCs in GMP facility. A testament to NJ Bio’s valued offerings to its clients is being recognized as "Best Contract Research Organization (CRO)" for three consecutive years at the World ADC Summit and it is a contender for a fourth award this November.