A Phase 2 Clinical Trial of Nalirifox as Neoadjuvant Treatment for Patients With Borderline Resectable Pancreatic Ductal Adenocarcinoma (Nectar Study)

This phase II trial tests how well liposomal irinotecan, oxaliplatin, 5-fluorouracil and leucovorin (NALIRIFOX) before surgery works in treating patients with pancreatic ductal adenocarcinoma that is close to major blood vessels, but is still potentially removable by surgery (borderline resectable). Irinotecan is in a class of antineoplastic medications called topoisomerase I inhibitors. It blocks a certain enzyme needed for cell division and deoxyribonucleic acid (DNA) repair and may kill tumor cells. Liposomal irinotecan is a form of the anticancer drug irinotecan that is contained inside very tiny, fat-like particles. Liposomal irinotecan may have fewer side effects and work better than other forms of the drug. Oxaliplatin is in a class of medications called platinum-containing antineoplastic agents. It damages the cell's DNA and may kill tumor cells. 5-fluorouracil, a type of antimetabolite, stops cells from making DNA and it may kill tumor cells. Leucovorin, a form of folic acid, is used to lessen the toxic effects of substances that block the action of folic acid. It is a type of chemoprotective agent and a type of chemosensitizing agent. Giving NALIRIFOX before surgery may improve the chance of successful surgery and decrease the chance of the cancer returning after surgery in patients with borderline resectable pancreatic ductal adenocarcinoma.

Start Date01 Jun 2025

Sponsor / Collaborator

Roswell Park Comprehensive Cancer Center

NCT06835387

/ RecruitingPhase 2IIT

Phase II Study of NALIRIFOX (Nanoliposomal Irinotecan + Oxaliplatin With Fluorouracil and Folinic Acid) in Advanced Unresectable Small Bowel Tumors

The study regimen will be administered on an outpatient basis and all medications are administered intravenously (IV). Subjects will receive treatment on Day 1 and Day 15 of each 28-day cycle consisting of the following: nanoliposomal irinotecan at 50 mg/m2, followed by oxaliplatin 60 mg/m2, followed by leucovorin at 400 mg/m2 30 minutes after completion of oxaliplatin, followed by 5-FU 2400 mg/m2 60 minutes after leucovorin completion. Subjects will receive up to 6 cycles of NALIRIFOX then based on response and per physician discretion, de-escalated maintenance treatment with NALIRIFOX minus oxaliplatin may continue. Subjects will continue de-escalated maintenance treatment until progression per RECIST 1.1, intolerable toxicity or physician/subject choice to discontinue.

Start Date01 May 2025

Sponsor / Collaborator

Hoosier Cancer Research Network

[+2]

NCT06820762

/ Not yet recruitingPhase 2IIT

Irinotecan Liposome(II) Combined with Ivonescimab As Second-line Treatment for Small Cell Lung Cancer : a Prospective, Single-arm, Multicenter Clinical Study

This study will evaluate the efficacy and safety of irinotecan liposome(II) in combination with Ivonescimab as second line treatment for SCLC.

Start Date28 Feb 2025

Sponsor / Collaborator

ShengJing Hospital

100 Clinical Results associated with Irinotecan Hydrochloride Lioposome

100 Translational Medicine associated with Irinotecan Hydrochloride Lioposome

100 Patents (Medical) associated with Irinotecan Hydrochloride Lioposome

9,071

Literatures (Medical) associated with Irinotecan Hydrochloride Lioposome

01 Jun 2025·Current pharmaceutical biotechnology

Nanotheranostics: A Cutting-edge Technology for Cancer Management

Article

Author: Swain, Shasank Sekhar ; Dash, Shwetapadma ; Sahoo, Sanjeeb Kumar ; Dutta, Sneha ; Khuntia, Auromira

Cancer is the second-leading cause of death in the 21st century, where early detection and appropriate therapeutic interventions are two components essential for effective cancer management. Despite the availability of several conventional diagnostics and therapeutic agents, cancer mortality rates are rising due to an increase in the frequency of recurrence and metastasis in cancer patients. Therefore, tremendous efforts have been expended to address this significant clinical issue and improve therapeutic efficacy. In this regard, nanotheranostic is a multipotential single platform for both cancer diagnosis and treatment through enhanced aqueous solubility and bioavailability of the encapsulated agent, stimulus responsiveness, tumor-specific targeting ability, precise tumor imaging, and real-time drug delivery. Nonetheless, the translational success of nanotheranostic platforms is still in its infancy and requires more extensive research in the context of tumor heterogeneity, safety profile, and regulatory issues, which pose one of the largest technological limitations. The present review summarizes different nanotheranostic platforms and nanotheranostic candidates in clinical trials (AGuIX® , NBTXR3, Ferumoxtran, MM-398, EndoTAG-1, etc.), along with disadvantages and challenges to improving cancer diagnosis and treatment. Overall, the concept, platform, and technical knowledge of nanotheranostics are really helpful to academic and pharmaceutical researchers.

03 May 2025·Journal of biomolecular structure & dynamics

Synergy between human DNA ligase I and topoisomerase 1 unveils new therapeutic strategy for the management of colorectal cancer

Article

Author: Maurya, Pooja ; Sashidhara, Koneni V. ; Gupta, Sampa ; Rawat, Rohit Singh ; Krishna, Shagun ; Siddiqi, Mohammad Imran ; Banerjee, Dibyendu

DNA topoisomerase 1 (Topo 1) is a pivotal player in various DNA processes, including replication, repair, and transcription. It serves as a target for anticancer drugs like camptothecin and its derivatives (Topotecan and SN-38/Irinotecan). However, the emergence of drug resistance and the associated adverse effects, such as alopecia, anemia, dyspnea, fever, chills, and painful or difficult urination, pose significant challenges in Topo 1-targeted therapy, necessitating urgent attention. Human DNA Ligase 1 (hLig I), recognized primarily for its role in DNA replication and repair of DNA breaks, intriguingly exhibits a DNA relaxation activity akin to Topo 1. This raised the hypothesis that hLig I might compensate for Topo 1 inhibition, contributing to resistance against Topo 1 inhibitors. To explore this hypothesis, we assessed the efficacy of hLig I inhibition alone and in combination with Topo 1 in cancer cells. As anticipated, the overexpression of hLig I was observed after Topo 1 inhibition in colorectal cancer cells, affirming our hypothesis. Previously identified as an inhibitor of hLig I's DNA relaxation activity, compound 27 (C 27), when combined with Topotecan, demonstrated a synergistic antiproliferative effect on colorectal cancer cells. Notably, cells with downregulated hLig I (via siRNA, inhibitors, or genetic manipulation) exhibited significantly heightened sensitivity to Topotecan. This observation strongly supports the concept that hLig I contribute to resistance against clinically relevant Topo 1 inhibitors in colorectal cancers. In conclusion, our findings offer evidence for the synergistic impact of combining hLig I inhibitors with Topotecan in the treatment of colorectal cancers, providing a promising strategy to overcome resistance to Topo 1 inhibitors.

11 Apr 2025·ACS Pharmacology & Translational Science

PSP205, a Novel Phenyl Sulfonyl Piperidine, Induces Apoptotic Cell Death in Colon Cancer by Modulating Coat Protein Complex-Mediated Vesicle Trafficking

Author: Ljungman, Mats ; Debnath, Bikash ; Roy, Joyeeta ; Samanta, Soma ; Neamati, Nouri

The endoplasmic reticulum (ER) stress and autophagic pathways offer attractive targets for the development of new cancer drugs.Here, we identified a novel Ph sulfonyl piperidine, PSP205, that induces prolonged ER-stress-mediated autophagy and apoptosis in colon cancer cells.Transcriptome anal. of cells exposed to PSP205 unveiled transcriptional upregulation of genes associated with the ER stress response or unfolded protein response (UPR), in addition to vesicle transport.Among the top upregulated genes, DNAJB9, XBP1, PDIA4, HSPA5, SEC24D, and SEC11C are implicated in ER stress.Gene set enrichment anal. revealed the enrichment of gene sets involved in the UPR, mTORC1 signaling, hypoxia, the P53 pathway, apoptosis, and the ER-Golgi-vesicle-mediated transport pathway.Mechanistic studies showed that PSP205 acts on the IRE1-TRAF2-JNK pathway to modulate autophagic flux, leading to macroautophagy, ER-phagy, and deformation of Golgi.Our study also demonstrated that PSP205 decreases the expression of the COPI coat complex subunit beta 2 (COPB2) in the presence of COPB2 siRNA.Furthermore, PSP205 synergistically killed colon cancer cells in combination with proteasome and topoisomerase inhibitors.Cumulatively, our findings suggest that PSP205 targets cancer cells via a novel mechanism, specifically by decreasing the level of COPB2, which has not been extensively studied in the context of cancer therapy development and warrants further investigation.

118

News (Medical) associated with Irinotecan Hydrochloride Lioposome

13 Feb 2025

·www.ipsen.com

Ipsen delivers solid results in 2024, driven by strong performance across all therapeutic areas, and provides guidance for 2025

FY 2024 total sales growth of 9.9% at CER1, or 8.7% as reported, with growth driven by strong performance across all therapeutic areas, including a 67.4% increase in the Rare Diseases portfolio, 9.2% in Neuroscience, and 7.3% in Oncology; Somatuline® (lanreotide) sales grew by 5.6%, while all other products, excluding Somatuline, achieved double-digit sales growth at 12.2% FY 2024 core operating income of €1,109m, growing 10.8% as reported, with core operating margin of 32.6% of total sales Continued pipeline expansion in 2024, with significant regulatory approvals, addition of several preclinical therapies with global rights and innovative modalities, and a late-stage asset Four key regulatory and clinical milestones expected in 2025, including the Proof-of-Concept data readout for the Long-Acting Neurotoxin (LANT) Financial guidance2 for 2025 including total sales growth greater than 5.0%3 at CER, and core operating margin greater than 30.0% of total sales, based on accelerated sales growth of the ex-Somatuline portfolio and assuming negative impact on Somatuline sales due to increased generic competition in the U.S. and Europe PARIS, FRANCE, 13 February 2025 – Ipsen (Euronext: IPN; ADR: IPSEY), a global specialty-care biopharmaceutical company, today presents its financial results for the full year 2024. “Ipsen delivered solid results and advanced its pipeline in 2024, laying a strong foundation for sustained growth,” said David Loew, Chief Executive Officer, Ipsen. “With the successful global rollout of Iqirvo and Bylvay, and the U.S. launch of Onivyde, alongside multiple business development deals adding several innovative assets, we are well positioned to execute our strategic roadmap. This year, we look forward to achieving key milestones, including the first data readout for the Long-Acting Neurotoxin (LANT), and further expand and progress our pipeline across all three therapeutic areas to bring promising new medicines to patients.” Pipeline Progress Significant regulatory milestones were achieved in 2024, including FDA approval of Onivyde® (irinotecan) for first-line pancreatic ductal adenocarcinoma (PDAC), along with accelerated U.S. approval and European approval for Iqirvo® (elafibranor), respectively. Additionally, Kayfanda® (odevixibat) was approved for Alagille syndrome (ALGS) in the E.U. The company also opted-in for the CABINET Phase III study of Cabometyx® (cabozantinib) in patients with advanced neuroendocrine tumors (NETs), with study results presented at the 2024 European Society for Medical Oncology (ESMO) Congress and published in the New England Journal of Medicine. An IND application was filed for IPN01194, an ERK inhibitor, advancing the potential medicine into clinical development with a Phase I/IIa trial in advanced solid tumors. Ipsen improved further the depth and breadth of its pipeline by adding five preclinical innovative therapies with global rights and new modalities, and an ex-U.S. licensing agreement with DayOne Biopharmaceuticals for the late-stage oncology asset tovorafenib, an oral RAF inhibitor for pediatric low-grade glioma. Two global licensing agreements for Antibody Drug Conjugate (ADC) in oncology with Sutro Biopharma and Foreseen Biotechnology were signed. An extension of the oncology partnership with Marengo Therapeutics to include TriSTAR, a next-generation precision T-cell engager was completed, as well as more recently, in the fourth quarter, a global licensing agreement with Biomunex for a preclinical novel T-cell engager (TCE). A collaboration with Skyhawk Therapeutics to develop RNA-modulating small molecules for rare neurological diseases was also signed during the year. Ipsen executed several divestments in 2024, including the sale of Increlex® (mecasermin injection) to Eton Pharmaceuticals and the sale of its rare pediatric disease Priority Review Voucher. Environmental, Social and Governance Ipsen took important steps in 2024 in delivering its ambitious sustainability strategy. The company continued to integrate sustainability across its operations. From reducing its environmental footprint to advancing patient access and fostering a strong workplace culture, the company increased its commitment to driving progress for patients, employees, communities, and the planet. Our sustainability efforts were recognized across multiple environment initiatives. The company achieved a 45% reduction in Scopes 1 & 2 greenhouse gas emissions and a 25% reduction in Scope 3, fully in line with its 2030 targets (versus 2019 baseline). Significant efforts were made to engage suppliers and third parties in Ipsen’s sustainability roadmap including the first-ever “Ipsen Supplier Sustainability Day”. Following an intensive transformation project, 99.8% of Ipsen’s global electricity now comes from renewable sources. Through the Fleet for Future project, the company continues to advance sustainable transportation, with 43% of its total company’s fleet now electric vehicles as of 2024. We remain committed to gender balance in leadership, with women now representing 55% of the Global Leadership Team. 2025 Upcoming Milestones Ipsen anticipates several key milestones across its portfolio in 2025, including: Cabometyx (CABINET trial) – Regulatory decision in Europe for advanced neuroendocrine tumors (NETs), including pancreatic (pNETs) and extra-pancreatic (epNETs) neuroendocrine tumors Tovorafenib (FIREFLY-1 trial) – Regulatory submission in Europe for pediatric low-grade glioma Fidrisertib (FALKON trial) – Readout of the pivotal Phase IIb trial in fibrodysplasia ossificans progressiva (FOP) LANT88(LANTIC trial) – Proof-of-concept data readout, evaluating its potential in aesthetics These milestones reinforce Ipsen’s commitment to advancing innovative therapies and expanding treatment options for patients worldwide. 2025 Financial Guidance Ipsen has set for FY 2025 the following financial guidance, which excludes any impact from potential late-stage (Phase III clinical development or later) business development transactions: Total sales growth greater than 5.0%, at constant currency. Based on the average level of exchange rates in January 2025, a favorable effect on total sales of around 1% from currencies is expected. Core operating margin greater than 30.0% of total sales, which includes additional R&D expenses from anticipated early and mid-stage external-innovation opportunities. Guidance on total sales and core operating margin is based on accelerated sales growth of the ex-Somatuline portfolio and assumes negative impact on Somatuline sales due to increased generic competition in the U.S. and Europe. Consolidated financial statements The Board of Directors approved the consolidated financial statements on 12 February 2025. The consolidated financial statements have been audited and the Statutory Auditors’ report is in the process of being published. Ipsen’s comprehensive audited financial statements will be available in due course on ipsen.com (regulated-information section). Conference call A conference call and webcast for investors and analysts will begin today at 1pm CET. Participants can access the call and its details by registering here; webcast details can be found here. Calendar Ipsen intends to publish its Q1 2025 sales on April 16th, 2025. Notes All financial figures are in € millions (€m), unless otherwise noted. The performance shown in this announcement covers the twelve-month period to 31 December 2024 (FY 2024) and the three-month period to 31 December 2024 (Q4 2024), compared to the twelve-month period to 31 December 2023 (FY 2023) and the three-month period to 31 December 2023 (Q4 2023), respectively, unless stated otherwise. The commentary is based on the performance in FY 2024, unless stated otherwise. About Ipsen We are a global biopharmaceutical company with a focus on bringing transformative medicines to patients in three therapeutic areas: Oncology, Rare Disease and Neuroscience. Our pipeline is fueled by external innovation and supported by nearly 100 years of development experience and global hubs in the U.S., France and the U.K. Our teams in more than 40 countries and our partnerships around the world enable us to bring medicines to patients in more than 100 countries. Ipsen is listed in Paris (Euronext: IPN) and in the U.S. through a Sponsored Level I American Depositary Receipt program (ADR: IPSEY). For more information, visit ipsen.com. Ipsen contacts Investors Media 1 At constant exchange rates (CER), which exclude any foreign-exchange impact by recalculating the performance for the relevant period by applying the exchange rates used for the prior period.2 Excluding any impact from potential late-stage (Phase III clinical development or later) external-innovation transactions.3 Based on the average level of exchange rates in Jan 2024, a favorable effect on total sales of about 1% from currencies is expected. 4 Extract of consolidated results. The Company’s auditors performed a limited review of the condensed consolidated financial statements.5 Including an impairment loss of €279m (or €2,33 /share) related to Sohonos, reflecting lower revised sales following lower patient uptake.6 Dividend related to the current financial year to be paid the following year.7 Decided by the Ipsen S.A. Board of Directors and to be proposed at the annual shareholders’ meeting on 21 May 2025. 8 Long-acting neurotoxin Attachment Ipsen PR_FY 2024 – Results announcement_13022025 FY 2024 total sales growth of 9.9% at CER1, or 8.7% as reported, with growth driven by strong performance across all therapeutic areas, including a 67.4% increase in the Rare Diseases portfolio, 9.2% in Neuroscience, and 7.3% in Oncology; Somatuline® (lanreotide) sales grew by 5.6%, while all other products, excluding Somatuline, achieved double-digit sales growth at 12.2% FY 2024 core operating income of €1,109m, growing 10.8% as reported, with core operating margin of 32.6% of total sales Continued pipeline expansion in 2024, with significant regulatory approvals, addition of several preclinical therapies with global rights and innovative modalities, and a late-stage asset Four key regulatory and clinical milestones expected in 2025, including the Proof-of-Concept data readout for the Long-Acting Neurotoxin (LANT) Financial guidance2 for 2025 including total sales growth greater than 5.0%3 at CER, and core operating margin greater than 30.0% of total sales, based on accelerated sales growth of the ex-Somatuline portfolio and assuming negative impact on Somatuline sales due to increased generic competition in the U.S. and Europe PARIS, FRANCE, 13 February 2025 – Ipsen (Euronext: IPN; ADR: IPSEY), a global specialty-care biopharmaceutical company, today presents its financial results for the full year 2024. “Ipsen delivered solid results and advanced its pipeline in 2024, laying a strong foundation for sustained growth,” said David Loew, Chief Executive Officer, Ipsen. “With the successful global rollout of Iqirvo and Bylvay, and the U.S. launch of Onivyde, alongside multiple business development deals adding several innovative assets, we are well positioned to execute our strategic roadmap. This year, we look forward to achieving key milestones, including the first data readout for the Long-Acting Neurotoxin (LANT), and further expand and progress our pipeline across all three therapeutic areas to bring promising new medicines to patients.” Pipeline Progress Significant regulatory milestones were achieved in 2024, including FDA approval of Onivyde® (irinotecan) for first-line pancreatic ductal adenocarcinoma (PDAC), along with accelerated U.S. approval and European approval for Iqirvo® (elafibranor), respectively. Additionally, Kayfanda® (odevixibat) was approved for Alagille syndrome (ALGS) in the E.U. The company also opted-in for the CABINET Phase III study of Cabometyx® (cabozantinib) in patients with advanced neuroendocrine tumors (NETs), with study results presented at the 2024 European Society for Medical Oncology (ESMO) Congress and published in the New England Journal of Medicine. An IND application was filed for IPN01194, an ERK inhibitor, advancing the potential medicine into clinical development with a Phase I/IIa trial in advanced solid tumors. Ipsen improved further the depth and breadth of its pipeline by adding five preclinical innovative therapies with global rights and new modalities, and an ex-U.S. licensing agreement with DayOne Biopharmaceuticals for the late-stage oncology asset tovorafenib, an oral RAF inhibitor for pediatric low-grade glioma. Two global licensing agreements for Antibody Drug Conjugate (ADC) in oncology with Sutro Biopharma and Foreseen Biotechnology were signed. An extension of the oncology partnership with Marengo Therapeutics to include TriSTAR, a next-generation precision T-cell engager was completed, as well as more recently, in the fourth quarter, a global licensing agreement with Biomunex for a preclinical novel T-cell engager (TCE). A collaboration with Skyhawk Therapeutics to develop RNA-modulating small molecules for rare neurological diseases was also signed during the year. Ipsen executed several divestments in 2024, including the sale of Increlex® (mecasermin injection) to Eton Pharmaceuticals and the sale of its rare pediatric disease Priority Review Voucher. Environmental, Social and Governance Ipsen took important steps in 2024 in delivering its ambitious sustainability strategy. The company continued to integrate sustainability across its operations. From reducing its environmental footprint to advancing patient access and fostering a strong workplace culture, the company increased its commitment to driving progress for patients, employees, communities, and the planet. Our sustainability efforts were recognized across multiple environment initiatives. The company achieved a 45% reduction in Scopes 1 & 2 greenhouse gas emissions and a 25% reduction in Scope 3, fully in line with its 2030 targets (versus 2019 baseline). Significant efforts were made to engage suppliers and third parties in Ipsen’s sustainability roadmap including the first-ever “Ipsen Supplier Sustainability Day”. Following an intensive transformation project, 99.8% of Ipsen’s global electricity now comes from renewable sources. Through the Fleet for Future project, the company continues to advance sustainable transportation, with 43% of its total company’s fleet now electric vehicles as of 2024. We remain committed to gender balance in leadership, with women now representing 55% of the Global Leadership Team. 2025 Upcoming Milestones Ipsen anticipates several key milestones across its portfolio in 2025, including: Cabometyx (CABINET trial) – Regulatory decision in Europe for advanced neuroendocrine tumors (NETs), including pancreatic (pNETs) and extra-pancreatic (epNETs) neuroendocrine tumors Tovorafenib (FIREFLY-1 trial) – Regulatory submission in Europe for pediatric low-grade glioma Fidrisertib (FALKON trial) – Readout of the pivotal Phase IIb trial in fibrodysplasia ossificans progressiva (FOP) LANT88(LANTIC trial) – Proof-of-concept data readout, evaluating its potential in aesthetics These milestones reinforce Ipsen’s commitment to advancing innovative therapies and expanding treatment options for patients worldwide. 2025 Financial Guidance Ipsen has set for FY 2025 the following financial guidance, which excludes any impact from potential late-stage (Phase III clinical development or later) business development transactions: Total sales growth greater than 5.0%, at constant currency. Based on the average level of exchange rates in January 2025, a favorable effect on total sales of around 1% from currencies is expected. Core operating margin greater than 30.0% of total sales, which includes additional R&D expenses from anticipated early and mid-stage external-innovation opportunities. Guidance on total sales and core operating margin is based on accelerated sales growth of the ex-Somatuline portfolio and assumes negative impact on Somatuline sales due to increased generic competition in the U.S. and Europe. Consolidated financial statements The Board of Directors approved the consolidated financial statements on 12 February 2025. The consolidated financial statements have been audited and the Statutory Auditors’ report is in the process of being published. Ipsen’s comprehensive audited financial statements will be available in due course on ipsen.com (regulated-information section). Conference call A conference call and webcast for investors and analysts will begin today at 1pm CET. Participants can access the call and its details by registering here; webcast details can be found here. Calendar Ipsen intends to publish its Q1 2025 sales on April 16th, 2025. Notes All financial figures are in € millions (€m), unless otherwise noted. The performance shown in this announcement covers the twelve-month period to 31 December 2024 (FY 2024) and the three-month period to 31 December 2024 (Q4 2024), compared to the twelve-month period to 31 December 2023 (FY 2023) and the three-month period to 31 December 2023 (Q4 2023), respectively, unless stated otherwise. The commentary is based on the performance in FY 2024, unless stated otherwise. About Ipsen We are a global biopharmaceutical company with a focus on bringing transformative medicines to patients in three therapeutic areas: Oncology, Rare Disease and Neuroscience. Our pipeline is fueled by external innovation and supported by nearly 100 years of development experience and global hubs in the U.S., France and the U.K. Our teams in more than 40 countries and our partnerships around the world enable us to bring medicines to patients in more than 100 countries. Ipsen is listed in Paris (Euronext: IPN) and in the U.S. through a Sponsored Level I American Depositary Receipt program (ADR: IPSEY). For more information, visit ipsen.com. Ipsen contacts Investors Media 1 At constant exchange rates (CER), which exclude any foreign-exchange impact by recalculating the performance for the relevant period by applying the exchange rates used for the prior period.2 Excluding any impact from potential late-stage (Phase III clinical development or later) external-innovation transactions.3 Based on the average level of exchange rates in Jan 2024, a favorable effect on total sales of about 1% from currencies is expected. 4 Extract of consolidated results. The Company’s auditors performed a limited review of the condensed consolidated financial statements.5 Including an impairment loss of €279m (or €2,33 /share) related to Sohonos, reflecting lower revised sales following lower patient uptake.6 Dividend related to the current financial year to be paid the following year.7 Decided by the Ipsen S.A. Board of Directors and to be proposed at the annual shareholders’ meeting on 21 May 2025. 8 Long-acting neurotoxin Attachment Ipsen PR_FY 2024 – Results announcement_13022025

Phase 2Drug ApprovalLicense out/inPhase 3

18 Dec 2024

·www.businesswire.com

Valink Therapeutics Appoints Biopharmaceutical Veteran Martin D. Williams as Chair of the Board of Directors and Names Scientific Advisory Board

BOSTON--( BUSINESS WIRE )--Valink Therapeutics, a biopharmaceutical company focused on discovering and developing innovative bispecific antibody-drug conjugates (bsADCs) to transform the treatment of cancer and other diseases, has appointed Martin D. Williams as Chair of its Board of Directors. The company also named its Scientific Advisory Board, which assembles experts in the discovery, development, manufacture and commercialization of ADCs and bispecific therapeutics. “ We are thrilled to welcome Martin, whose expertise in strategy, development and partnering, and track record of leading multiple U.S. biopharmaceutical companies, will be instrumental to the next stages of Valink. He brings deep experience advancing a wide range of therapeutics from early development through regulatory approval and commercialization and developing industry partnerships that move promising medicines closer to patients. Martin’s career journey, which began in the UK before his move to the U.S. over 30 years ago, mirrors Valink’s roots as a University of Oxford spinout based in the U.S., with a strong UK presence,” said Arne Scheu, DPhil, Co-founder and Chief Executive Officer of Valink. “ Furthermore, I am excited to announce our Scientific Advisory Board, which brings together a distinguished group of advisors who have been at the forefront of ADC and bispecific innovation and development.” Mr. Williams brings to Valink more than 35 years of experience in the global biopharmaceutical business, having closed more than $5 billion worth of corporate transactions, including numerous partnerships, M&A, and public and private financings. He recently served as Chief Executive Officer of Caraway Therapeutics, a venture-backed company developing therapeutics to modulate lysosomal function for neurodegenerative and rare diseases, through the company’s acquisition by Merck & Co. at the end of 2023. Previously, he was President and Chief Executive Officer of Tokai Pharmaceuticals, a clinical-stage oncology company; Chief Business Officer at Dicerna Pharmaceuticals, a leading RNAi company with programs in oncology; and Chief Business Officer and Senior Vice President for commercial and business development at Synta Pharmaceuticals, a clinical-stage public company focused on oncology and inflammation. Earlier in his career, he held various leadership positions and directed the development, commercialization and launch of several flagship brands for GSK, Hoffmann-La Roche and Lederle/Wyeth (now Pfizer), including GSK’s blockbusters Zantac® and Zofran®; Hoffmann La-Roche’s Xenical®; and Lederle/Wyeth’s global anti-infective portfolio, including Zosyn®/Tazocin®. He holds an MBA from Harvard Business School and an MS from the University of Manchester, UK. “ Valink has developed a compelling approach to realizing the unmet potential of ADCs to improve outcomes for patients with cancer and other diseases, which has been restricted by dose-limiting toxicities and the range of suitable targets. Their technology addresses a significant challenge to ADC innovation by enabling rapid and cost-effective generation and screening of bispecific ADCs, unlocking a vast range of target synergy and potentially bringing previously undruggable space within reach,” said Mr. Williams. “ I am excited to work closely with the Valink executive team and Board as the company builds on its discoveries and pursues its clinical aspirations.” Valink also announced the formation of its Scientific Advisory Board, initially consisting of: Sonia Quaratino, MD, PhD is Executive Vice President and Chief Medical Officer at Innate Pharma, a clinical-stage biotech utilizing monoclonal antibodies, multi-specific NK cell engagers and ADCs to develop immunotherapies for cancer. Her career spans over 25 years in basic research, clinical development and translational medicine across academia, biotech and global pharmaceuticals. She has held numerous leadership positions, including serving as CMO at Kymab (until its acquisition by Sanofi) and Georgiamune Inc, and was Professor of Immunology at the University of Southampton. Marc Damelin, PhD is Chief Scientific Officer at Alphina Therapeutics and an expert in oncology drug discovery and development. Previously he served as VP and Head of Biology at Mersana Therapeutics, a clinical-stage biotech developing ADCs to treat cancer. Prior to that he worked for a decade in ADC discovery and development in Pfizer's Oncology Research Unit. Robert Lutz, PhD , Chief Scientific Officer at leading ADC company Iksuda Therapeutics, is a recognized expert in ADC discovery and development. As VP of Translational R&D at ImmunoGen, he was responsible for bringing eight ADC product candidates into development and was the research lead for Kadcyla®, the first ADC to be approved for solid tumor indications. Antoine Awad , Principal Executive Officer of Synlogic, has extensive experience in CMC, bispecific drug development and partnerships. Prior to Synlogic, he held leadership positions at various biotechs, including Merrimack Pharmaceuticals, where he led CMC development, manufacturing and approval of ONIVYDE® for treatment of advanced pancreatic cancer and transitioned to Ipsen Bioscience to lead global commercial manufacturing of ONIVYDE®. Mihriban Tuna, PhD is Chief Executive Officer of Immutrin and Entrepreneur-in-Residence at Cambridge Innovation Capital, a leading UK-based venture company focused on deep tech and life sciences. She previously served as Chief Scientific Officer at Adaptate Biotherapeutics (acquired by Takeda) and SVP, Drug Discovery at F-star Therapeutics, and was an early employee at Domantis Ltd. (acquired by GSK). Alexey A. Lugovskoy, PhD is President and Chief Executive Officer of Diagonal Therapeutics, Entrepreneur-in-Residence at Atlas Ventures and Associate Editor of mAbs . He formerly served as Chief Operating Officer at Dragonfly, Chief Development Officer at Morphic, Vice President of Therapeutics at Merrimack Pharmaceuticals and Associate Director of Drug Discovery at Biogen. He joined Valink’s Board of Directors in 2023, and this additional appointment highlights a close collaboration between the Scientific Advisory Board, Board of Directors and leadership team. About Valink Therapeutics Valink Therapeutics Inc. is a biopharmaceutical company focused on the discovery and development of first-in-class bispecific antibody-drug conjugates (bsADCs) to transform the treatment of cancer and other diseases. Valink’s technology platform utilizes a modular assembly approach to rapidly generate bsADCs with therapeutic potential, testing drugs at unparalleled scale and speed to improve on the payload delivery and selectivity of conventional ADCs. The company is based in Boston, Massachusetts and has research and development operations in London, UK. For more information, visit the company’s website at www.valinktx.com or contact the company at connect@valinktx.com .

Executive ChangeADCAcquisitionDrug Approval

05 Dec 2024

·www.prnewswire.com

MEDSIR showcases the DEMETHER Study: advancing therapeutic de-escalation and more effective treatments for advanced breast cancer

The DEMETHER trial, whose principal investigator is Dr. Javier Cortés, explores an innovative therapeutic de-escalation strategy for patients with previously untreated HER2-positive advanced breast cancer. New therapeutic perspectives for brain metastases: the PHENOMENAL and TUXEDO-4 studies in metastatic breast cancer Additionally, a total of five studies are being presented at San Antonio Breast Cancer Symposium 2024, strengthening its global leadership in oncology innovation and research. SAN ANTONIO, Dec. 5, 2024 /PRNewswire/ -- MEDSIR, a leading company dedicated to advancing independent clinical research in oncology on an international level and part of Oncoclínicas & Co, the largest oncology treatment group in Latin America with significant strength in the clinical and outpatient setting, will participate in the prestigious San Antonio Breast Cancer Symposium 2024 (SABCS) with the presentation of five innovative studies, including one of particular significance in advanced breast cancer: the DEMETHER study. These landmark studies demonstrate remarkable progress in the development of more personalized and less invasive therapies, offering the potential to enhance patients' quality of life and redefine the treatment approach for advanced breast cancer. The DEMETHER clinical trial explores an innovative treatment strategy for previously untreated HER2-positive advanced breast cancer. The study employs a dual-phase approach, beginning with an induction phase using trastuzumab deruxtecan (T-DXd), followed by a maintenance phase with subcutaneous administration of trastuzumab and pertuzumab. This strategy aims to prolong progression-free survival, improve overall survival rates at three years, and provide enhanced safety and quality of life compared to standard treatments. By offering an alternative to conventional chemotherapy and prolonged T-DXd administration, DEMETHER aims to redefine therapeutic de-escalation. This strategy seeks to minimize the side effects associated with traditional therapies, thereby significantly improving patients' quality of life. Furthermore, it underscores a commitment to making advanced breast cancer treatments more accessible, less invasive, and patient centered. 23 active centers in 4 countries and several Highly Cited Researchers 2024 The trial is currently being conducted at 23 active centers across the United States, Spain, Italy and Germany. Additionally, the study benefits from the involvement of leading international researchers renowned for their excellence. Among them are several scientists featured in the Highly Cited Researchers 2024 list by Clarivate, including Dr. Javier Cortés, Dr. Hope Rugo, Dr. Nadia Harbeck, Dr. Sara M. Tolaney, and Dr. Peter Schmid, whose expertise and contributions bring exceptional value to the project. The DEMETHER study seeks to further advance personalized medicine, exploring less invasive, safer, and potential more effective alternatives to conventional treatments. "This study reflects the collaborative efforts of international experts, leading centers, the pharmaceutical industry and MEDSIR in designing therapeutic strategies that enhance patients' quality of life through treatment de-escalation." highlights Dr. Javier Cortés, principal investigator of the DEMETHER study. New therapeutic options for patients with metastatic breast cancer: exploring advances in brain metastases with PHENOMENAL and TUXEDO-4 Both the PHENOMENAL and TUXEDO-4 studies presented at SABCS are particularly relevant as they address a critical and historically underserved population: patients with metastatic breast cancer (MBC) and brain metastases (BMs). BMs occur in up to 25% of patients with MBC 1, significantly impacting prognosis and quality of life. These studies stand out by exploring innovative therapeutic strategies tailored to overcome the unique challenges of treating brain metastases. The PHENOMENAL study focuses on nanoliposomal irinotecan, Nal-IRI, to enhance drug delivery to brain tumors while reducing systemic toxicity. Meanwhile, the TUXEDO-4 study investigates the use of T-DXd, a novel antibody-drug conjugate targeting HER2-low tumors, with the goal of achieving meaningful intracranial tumor shrinkage. An innovative therapeutic regimen with the potential to expand treatment options and improve the quality of life for patients with advanced breast cancer The Phase III ADELA study, in collaboration with the MENARINI Group, explores new perspectives in the treatment of advanced ER+ and HER2-negative breast cancer, specifically in patients with mutations in the ESR1 gene whose cancer has progressed after receiving standard first-line of therapy. This gene produces estrogen receptor proteins that can stimulate the growth of this type of breast cancer. ADELA has the potential, if successful, to pave the way for regulatory approval of this therapeutic combination, making it accessible to a broader patient population. In addition to this study, MEDSIR is presenting the PRIMED trial, which evaluates the efficacy of prophylactic administration of granulocyte colony-stimulating factor (G-CSF) and loperamide during the initial treatment cycles of sacituzumab govitecan (SG) therapy to mitigate the incidence of neutropenia and diarrhea, aiming to enhance treatment tolerability and patient safety. The presentation of these results at an event of SABCS 2024's magnitude not only positions MEDSIR as a leader in oncology research excellence but also highlights its ability to lead transformative projects addressing unmet needs in breast cancer treatment. References: Le Rhun E, et al. Ann Oncol. 2021;32(11):1332-1347 About MEDSIR   Established in 2012, MEDSIR prides itself on working closely with its strategic partners to drive innovation in oncology research. Operating in Spain and the United States, the company provides end-to-end clinical trial management, from study design to publication, with an extensive global network of experts and integrated technology to streamline the process. The company offers proof-of-concept support and a strategic approach that enables research partners to benefit from the best of both worlds: industry clinical research and investigator-driven trials.   With the aim of promoting independent research worldwide, MEDSIR has formed a strategic alliance with Oncoclínicas, the leading oncology group in Brazil, which offers outstanding research potential in South America.   For further information:     About Oncoclínicas & CO   Oncoclínicas & Co is the largest group dedicated to cancer treatment in Latin America, with a specialized and innovative model focused on the entire oncology care journey, combining operational efficiency, humanized care, and high specialization through a medical team composed of over 2,700 specialist physicians with an emphasis on oncology. With its mission to democratize cancer treatment, it offers a comprehensive system that integrates outpatient clinics with high-complexity cancer centers. The company operates 145 units across 39 Brazilian cities, allowing high-quality access in all regions it serves, aligned with world-class standards.  Focusing on technology, precision medicine, and genomics, Oncoclínicas performed approximately 635,000 treatments in 2023. It is the exclusive partner in Brazil of the Dana Farber Cancer Institute, affiliated with Harvard Medical School, one of the world's leading cancer research and treatments centers. The company also owns Boston Lighthouse Innovation, a bioinformatics firm based in Cambridge, United States, and holds shares in Medsir, a company dedicated to the development and management of clinical trials for independent cancer research, based in Barcelona, Spain. Recently, Oncoclínicas expanded its operations to Saudi Arabia through a joint venture with the Al Faisaliah Group, bringing its mission to beat cancer to a new continent and providing advanced oncology care on a global scale by combining oncological hyperspecialization with innovative treatment approaches.  The company is part of the IDIVERSA index, launched by B3, highlighting companies committed to gender and racial diversity. For more information, visit:    SOURCE MEDSIR WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

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Approved

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Indication	Country/Location	Organization	Date
Pancreatic adenocarcinoma metastatic	United States	Ipsen SA	15 Feb 2024
Pancreatic adenocarcinoma	European Union	Les Laboratoires Servier SAS	14 Oct 2016
Pancreatic adenocarcinoma	Iceland	Les Laboratoires Servier SAS	14 Oct 2016
Pancreatic adenocarcinoma	Liechtenstein	Les Laboratoires Servier SAS	14 Oct 2016
Pancreatic adenocarcinoma	Norway	Les Laboratoires Servier SAS	14 Oct 2016
Pancreatic Cancer	United States	Ipsen Biopharmaceuticals, Inc.	22 Oct 2015

Developing

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Indication	Highest Phase	Country/Location	Organization	Date
Metastatic Pancreatic Ductal Adenocarcinoma	NDA/BLA	United States	Ipsen SA	14 Jun 2023
Extensive stage Small Cell Lung Cancer	Phase 3	United States	Ipsen SA	25 Apr 2018
Extensive stage Small Cell Lung Cancer	Phase 3	China	Ipsen SA	25 Apr 2018
Extensive stage Small Cell Lung Cancer	Phase 3	Australia	Ipsen SA	25 Apr 2018
Extensive stage Small Cell Lung Cancer	Phase 3	Belgium	Ipsen SA	25 Apr 2018
Extensive stage Small Cell Lung Cancer	Phase 3	Brazil	Ipsen SA	25 Apr 2018
Extensive stage Small Cell Lung Cancer	Phase 3	France	Ipsen SA	25 Apr 2018
Extensive stage Small Cell Lung Cancer	Phase 3	Germany	Ipsen SA	25 Apr 2018
Extensive stage Small Cell Lung Cancer	Phase 3	Hungary	Ipsen SA	25 Apr 2018
Extensive stage Small Cell Lung Cancer	Phase 3	Italy	Ipsen SA	25 Apr 2018

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT06184698 (ASCO_GI2025) Manual	Phase 2	Metastatic Colorectal Carcinoma Second line	50	Liposomal irinotecan + 5-fluorouracil + leucovorin + bevacizumab	gzddtohzeq(vlgpdyobsm) = qnlzcinmjg najndhkmsu (acrgyxggbb, 9.3 - 36.5) View more	Positive	23 Jan 2025
JPRN-UMIN000043939 (NAPOLEON-2, ASCO_GI2025)	Not Applicable	Pancreatic carcinoma non-resectable	150	Nanoliposomal irinotecan and fluorouracil with folinic acid (NFF)	lyqwrktrgu(mecdujapiv) = lwkbarivuy tqbtgajfoq (vpudoymnnn, 6.6 - 9.2) View more	Positive	23 Jan 2025
JPRN-UMIN000043939 (NAPOLEON-2, ASCO_GI2025)	Not Applicable	Pancreatic Cancer neutropenia	150	Nanoliposomal irinotecan and fluorouracil with folinic acid (NFF)	hflqmfxgte(regiodtkzj) = engeeqolxg jhqkmxlouh (xillnrneai )	Positive	23 Jan 2025
NCT06184698 (IRIS, ESMO_ASIA2024)	Phase 2	Metastatic Colorectal Carcinoma Second line	41	Liposomal irinotecan + 5-FU/LV + bevacizumab	dbhiuhbazu(fyqakbscfp) = pkmtlvnbpv wdmktkagyj (dlmvpbbgts, 9.1%∼51.2%) View more	Positive	07 Dec 2024
NCT03483038 (NEO-Nal-IRI, CTgov)	Phase 2	Pancreatic adenocarcinoma	45	LEUCOVORIN CALCIUM+Liposomal Irinotecan+Oxaliplatin+Fluorouracil	nkmnzhbypf = wvmmwbvkqr ngigdlhwzi (zmkbicolzu, oowojcfrkb - rmikombosc) View more	-	23 Sep 2024
ESMO2024 Manual	Phase 1/2	Metastatic Pancreatic Cancer Second line	120	S-1 and liposomal irinotecan (nal-IRI)	oukdhzehli(mhmheawqnm) = qsgjrptohb buifyyglbu (rtosowpzws ) View more	Negative	16 Sep 2024
ESMO2024 Manual	Phase 1/2	Metastatic Pancreatic Cancer Second line	120	5-fluorouracil5-fluorouracil/leucovorin (5-FU/LV) and nal-IRI	oukdhzehli(mhmheawqnm) = hxbdnnject buifyyglbu (rtosowpzws ) View more	Negative	16 Sep 2024
JPRN-UMIN000048143 (JON 2109-P, ESMO2024) Manual	Phase 3	Pancreatic Cancer Second line	446	S-1 monotherapy	wwrleoagjx(zbrkczqsqx) = uyoijypzde bqmhjsosae (mqnlkjsrbi ) View more	Positive	16 Sep 2024
JPRN-UMIN000048143 (JON 2109-P, ESMO2024) Manual	Phase 3	Pancreatic Cancer Second line	446	Nanoliposomal irinotecan plus 5-fluorouracil/leucovorin regimen	wwrleoagjx(zbrkczqsqx) = kygbqmcdnv bqmhjsosae (mqnlkjsrbi ) View more	Positive	16 Sep 2024
NCT03719924 (OESIRI-PRODIGE 62, ESMO2024) Manual	Phase 2	Esophageal Squamous Cell Carcinoma Second line	106	Nanoliposomal irinotecan (Nal-IRI) + folinic acid/L-folinic acid + 5FU	rnipkqgftn(xejzlmixji) = sqahsdlspu egenssmkzb (qyeswnyjnh, 22.9 - 46.5) Not Met View more	Negative	16 Sep 2024
NCT03719924 (OESIRI-PRODIGE 62, ESMO2024) Manual	Phase 2	Esophageal Squamous Cell Carcinoma Second line	106	Paclitaxel	rnipkqgftn(xejzlmixji) = xmacswyfqf egenssmkzb (qyeswnyjnh, 27.7 - 51.7) Not Met View more	Negative	16 Sep 2024
NCT03043547 (NALIRICC, Pubmed) Manual	Phase 2	Gallbladder Carcinoma \| Bile Duct Neoplasms Second line	100	Nanoliposomal irinotecan + fluorouracil + leucovorin	odtybixfqo(gklmltiftt) = tpixtnvtpr pywkrpwwzf (hbwixwpkay, 1.7 - 3.6) View more	Negative	01 Aug 2024
NCT03043547 (NALIRICC, Pubmed) Manual	Phase 2	Gallbladder Carcinoma \| Bile Duct Neoplasms Second line	100	Fluorouracil + leucovorin	odtybixfqo(gklmltiftt) = mwiarvecig pywkrpwwzf (hbwixwpkay, 1.6 - 3.4) View more	Negative	01 Aug 2024
NAPOLEON-2 (ESMO_GI2024) Manual	Not Applicable	Pancreatic Cancer Second line	87	Nano-liposomal irinotecan, fluorouracil, and folinic acid (NFF)	pgbinreohq(ajcdplsapy) = jnyyocyljd dmonjwmelo (uptwjuljxw, 6.4 - 9.4) View more	Positive	27 Jun 2024

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