Lakefront Biotherapeutics NV 6-K, filed Apr 8, 2024
Lakefront Biotherapeutics NV (LKFT)
About this 6-K
Lakefront Biotherapeutics NV filed this 6-K on April 8, 2024.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form 6-K
REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934
For the month of April 2024
Commission File Number: 001-37384
GALAPAGOS NV
(Translation of registrant's name into English)
Generaal De Wittelaan L11 A3 2800 Mechelen, Belgium
(Address of principal executive office)
Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.
Form 20-F [ X ] Form 40-F [ ]
The information contained in this Report on Form 6-K, including Exhibit 99.1,except for the quote of Dr. Jeevan Shetty, included in Exhibit 99.1, is hereby incorporated by reference into the Company's Registration Statements on Form S-8 (File Nos. 333-204567, 333-208697, 333-211834, 333-215783, 333- 218160, 333-225263, 333-231765, 333-249416, 333-260500, 333-268756, and 333-275886).
On April 4, 2024, the Registrant issued a press release, a copy of which is attached hereto as Exhibit 99.1 and is incorporated herein by reference.
(c) Exhibit 99.1. Press release dated April 4, 2024
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
| GALAPAGOS NV | ||
| (Registrant) | ||
| Date: April 8, 2024 | /s/ Annelies Denecker | |
| Annelies Denecker | ||
| Company Secretary | ||
EXHIBIT 99.1
Galapagos showcases innovative approach in hematological cancer care with clinical and translational data presentations at EBMT congress 2024
Two oral presentations and one poster on encore preliminary data from Phase 1/2
CD19 CAR-T studies in non-Hodgkin lymphoma (NHL) and chronic lymphocytic leukemia (CLL) / Richter transformation (RT)
Mechelen, Belgium; 4 April 2024, 22:01 CET – Galapagos NV (Euronext & NASDAQ: GLPG) today announced that four abstracts, including two oral presentations on encore preliminary clinical and translational data for its seven-day vein-to-vein CAR-T product candidates GLPG5101 and GLPG5201, will be presented at the 50th Annual Meeting of the European Society for Blood and Marrow Transplantation (EBMT) to be held in Glasgow, UK, on 14-17 April 2024.
ATALANTA-1 and EUPLAGIA-1 are ongoing Phase 1/2 open-label, multi-center studies designed to assess the safety, efficacy and feasibility of point-of-care manufactured GLPG5101 and GLPG5201 in patients with relapsed/refractory NHL, and relapsed/refractory CLL and RT, respectively. The primary objective of the Phase 1 part of the studies is to evaluate the safety and preliminary efficacy to determine the recommended dose for the Phase 2 part of the study. The primary objective of the Phase 2 part of the studies is to assess the Objective Response Rate (ORR) and the secondary objectives include the analysis of the Complete Response (CR), duration of response, progression free survival, overall survival, safety, pharmacokinetic profile, and feasibility of point-of-care manufacturing. GLPG5101 and GLPG5201 are second generation anti-CD19/4-1BB CAR-T product candidates, administered as a single fixed intravenous dose.
“We are committed to accelerating breakthrough innovations to extend the reach of CAR-T therapies to patients with rapidly progressing cancers,” said Dr. Jeevan Shetty, M.D., Head of Clinical Development Oncology at Galapagos. “We believe that the preliminary safety and efficacy data from our ongoing Phase 1/2 studies with our CD19 CAR-T therapy candidates in patients with relapsed/refractory NHL, CLL and RT, combined with our unique, innovative decentralized manufacturing approach that enables a seven-day vein-to-vein time, support the promise of GLPG5101 and GLPG5201 in addressing the critical needs of patients facing poor prognosis.”
The following table provides a summary of Galapagos’ presentations at EBMT 2024:
| Abstract Title | Authors/Presenter | Presentation date/time |
| Galapagos encore abstracts | ||
| Seven-Day Vein-to-Vein Point-of-Care Manufactured CD19 CAR T-Cell Therapy (GLPG5101) in Relapsed/Refractory Non-Hodgkin Lymphoma (NHL): Results from the Phase 1 ATALANTA-1 Trial | Marie José Kersten, Kirsten Saevels, Sophie Servais, Yves Beguin, Joost S.P. Vermaat, Eva Santermans, Stavros Milatos, Maike Spoon, Marte C. Liefaard, Claire Vennin, Margot J. Pont, Anna D.D. van Muyden, Maria T. Kuipers, Sébastien Anguille | Oral
presentation number: OS16-04 Date: 17 April, 12:57-13:06 (session runs 12:30-13:45) Session: Oral Session 16: CAR-T outcomes in ALL |
| Seven-Day
Vein-to-Vein Point-of-Care–Manufactured CD19 CAR T-Cell Therapy (GLPG5201) in Relapsed/Refractory
Chronic Lymphocytic Leukemia Including Richter Transformation: Results from the Phase 1 EUPLAGIA-1
Study | Valentin Ortiz-Maldonado, Nuria Martinez-Cibrian, Julio Delgado, Sergi Betriu, Leticia Alserawan, Ana Triguero, Nadia Verbruggen, Maike Spoon, Marte C. Liefaard, Anna D.D. van Muyden, Natalia Tovar | Oral
presentation number: OS16-05 Date: 17 April, 13:06-13:15 (session runs 12:30-13:45) Session: Oral Session 16: CAR-T outcomes in ALL |
| EUPLAGIA-1: Seven-Day Vein-to-Vein Point-of-Care Manufactured GLPG5201 Anti-CD19 CAR-T Cells Display Early Phenotypes in Relapsed/Refractory CLL, including RT | Esmée
P. Hoefsmit, Sandra Blum, Claire Vennin, Kirsten Van Hoorde, Sergi Betriu, Leticia Alserawan, Julio Delgado, Nadia Verbruggen, Anna D.D. van Muyden, Henriëtte Rozema, Ruiz Astigarraga, Margot J. Pont | Poster
number: A073 Date: 15 April, 18:00-19:00 Session: Printed poster: CAR-based Cellular Therapy - Clinical |
| PAPILIO-1: Phase 1/2, Multicenter, Open-Label Study to Evaluate Feasibility, Safety and Efficacy of Point-of-Care–Manufactured Anti-BCMA CAR T-Cell Therapy (GLPG5301) in Relapsed/Refractory Multiple Myeloma | Niels W.C.J. van de Donk, Sébastien Anguille, Jo Caers, Marte C. Liefaard, Christian Jacques, Anna D.D. van Muyden | Poster
number: P049 Date: 14 April, 08:30-18:00 Session: ePoster: CAR-based Cellular Therapy - Clinical |
About
Galapagos’ decentralized CAR-T manufacturing platform
Galapagos’
decentralized, innovative CAR T-cell manufacturing platform near the point-of-care offers
the potential for the administration of fresh, fit cells with a vein-to-vein time of seven
days, greater physician control and a significantly 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.
About
the ATALANTA-1 study (EudraCT 2021-003272-13)
ATALANTA-1 is an ongoing Phase 1/2,
open-label, multicenter study to evaluate the safety, efficacy and feasibility of point-of-care
manufactured GLPG5101, a CD19 CAR-T product candidate, in patients with relapsed/refractory
non-Hodgkin lymphoma (rrNHL). GLPG5101 is a second generation anti-CD19/4-1BB CAR-T product
candidate, administered as a single fixed intravenous dose. The primary objective of the
Phase 1 part of the study is to evaluate the safety and preliminary efficacy to determine
the recommended dose for the Phase 2 part of the study. Secondary objectives include assessment
of efficacy and feasibility of near the point-of-care manufacturing of GLPG5101. The dose
levels that were evaluated in Phase 1 are 50x106 (DL1) and 110x106 (DL2)
and 250x106 (DL3) CAR+ viable T cells. The primary objective of the Phase 2 part
of the study is to evaluate the Objective Response Rate (ORR), while the secondary objectives
include Complete Response (CR), duration of response, progression free survival, overall
survival, safety, pharmacokinetic profile, and the feasibility of point-of-care manufacturing.
Each enrolled patient will be followed for 24 months.
About
the EUPLAGIA-1 study (EudraCT 2021-003815-25)
EUPLAGIA-1 is an ongoing Phase 1/2 open-label,
multi-center study evaluating the safety, efficacy and feasibility of point-of-care manufactured
GLPG5201, a CD19 CAR-T product candidate, in patients with relapsed/refractory chronic lymphocytic
leukemia (rrCLL) and small cell lymphocytic lymphoma (rrSLL), with or without Richter transformation
(RT). GLPG5201 is a second generation anti-CD19/4-1BB CAR-T product candidate, administered
as a single fixed intravenous dose. Patients with CD19+ rrCLL or rrSLL with ≥2 lines
of prior therapy are eligible to participate, and patients with RT are eligible regardless
of prior therapy. The primary objective of the Phase 1 part of the study is to evaluate the
safety and preliminary efficacy to determine the recommended dose for the Phase 2 part of
the study. The dose levels that were evaluated in the Phase 1 part of the study are 35x106
(DL1) and 100x106 (DL2) CAR+ viable T cells. The primary objective of the
Phase 2 part of the study is to assess the Objective Response Rate (ORR) and the secondary
objectives include the analysis of the Complete Response (CR), duration of response, progression
free survival, overall survival, safety, pharmacokinetic profile, and feasibility of point-of-care
manufacturing.
About
Galapagos
We are a biotechnology company with operations in Europe and the US dedicated
to developing transformational medicines for more years of life and quality of life. Focusing
on high unmet medical needs, we synergize compelling science, technology, and collaborative
approaches to create a deep pipeline of best-in-class small molecules, CAR-T therapies, and
biologics in oncology and immunology. With capabilities from lab to patient, including a
decentralized, point-of-care CAR-T manufacturing network, we are committed to challenging
the status quo and delivering results for our patients, employees and shareholders. For additional
information, please visit www.glpg.com or follow us on LinkedIn or X
(formerly Twitter).
Contact
| Media
inquiries: Marieke Vermeersch +32 479 490 603 media@glpg.com Jennifer Wilson + 44 7539 359 676 media@glgp.com | Investor
inquiries: Sofie Van Gijsel +1 781 296 1143 ir@glpg.com Sandra Cauwenberghs +32 495 58 46 63 ir@glpg.com |
Forward-looking
statements
This press release includes forward-looking statements within the meaning
of the Private Securities Litigation Reform Act of 1995, as amended. These statements are
often, but are not always, made through the use of words or phrases such as “anticipate,”
“expect,” “plan,” “estimate,” “will,” “continue,”
“aim,” “intend,” “future,” “potential,” “could,”
“indicate,” “forward,” as well as similar expressions. Forward-looking
statements contained in this release include, but are not limited to, statements regarding
preliminary, interim and topline data from the EUPLAGIA-1 and ATALANTA-1 studies and other
analyses related to Galapagos’ CD19 CAR-T program, statements related to Galapagos’
plans, expectations and strategy with respect to the EUPLAGIA-1 and ATALANTA-1 studies, and
statements regarding the expected timing, design and readouts of the EUPLAGIA-1 and ATALANTA-1
studies, including the expected recruitment for such trials. Forward-looking statements involve
known and unknown risks, uncertainties and other factors which might cause Galapagos’
actual results to be materially different from those expressed or implied by such forward-looking
statements. These risks, uncertainties and other factors include, without limitation, the
risk that preliminary or interim clinical results may not be replicated in ongoing or subsequent
clinical trials; the risk that ongoing and future clinical studies with GLPG5201 and GLPG5101
may not be completed in the currently envisaged timelines or at all, the inherent uncertainties
associated with competitive developments, clinical trial and product development activities
and regulatory approval requirements (including that data from the ongoing and planned clinical
research programs may not support registration or further development of GLPG5201 and GLPG5101
due to safety, efficacy or other reasons), Galapagos' reliance on collaborations with third
parties (including its collaboration partner Lonza) and that Galapagos’ estimations
regarding its GLPG5201 and GLPG5101 development programs and regarding the commercial potential
of GLPG5201 and GLPG5101 may be incorrect, as well as those risks and uncertainties identified
in Galapagos’ Annual Report on Form 20-F for the year ended 31 December 2022 filed
with the U.S. Securities and Exchange Commission (SEC) and its subsequent filings with the
SEC. All statements other than statements of historical fact are statements that could be
deemed forward-looking statements. The forward-looking statements contained herein are based
on management’s current expectations and beliefs and speak only as of the date hereof,
and Galapagos makes no commitment to update or publicly release any revisions to forward-looking
statements in order to reflect new information or subsequent events, circumstances or changes
in expectations.