A Phase Ib/II Open-Label, Dose-Escalation, Safety, Pharmacokinetic, Pharmacodynamic and Efficacy Study of Bemcentinib Plus Pacritinib In Patients With Advanced Lung Adenocarcinoma

This is a Phase Ib/II, open-label, single institution dose-escalation, safety, pharmacokinetics, pharmacodynamic and efficacy study.

Start Date27 Dec 2024

Sponsor / Collaborator

University of Texas Health Science Center At San Antonio

[+1]

NCT05469178

/ TerminatedPhase 1/2

Phase 1b/2a Safety and Tolerability Study of Bemcentinib With Pembrolizumab/Carboplatin/Pemetrexed in Subjects With Untreated Advanced or Metastatic Non-squamous Non-small Cell Lung Cancer (NSCLC) Without/With a STK11 Mutation

The primary purpose of this study is to determine the safety and tolerability of the combination of bemcentinib with chemo-immunotherapy (CIT) to identify the recommended phase 2 dose (RP2D) when administered as first line (1L) treatment in participants with locally advanced (Stage IIIb/IIIC) or metastatic (Stage IV) non-squamous NSCLC with no actionable mutations and to determine the anti-tumor activity of the combination of bemcentinib with CIT when administered as 1L treatment in participants with locally advanced (Stage IIIb/IIIc) or metastatic (Stage IV) non-squamous NSCLC with serine/threonine kinase 11 (STK11) mutation and no actionable mutations.

Start Date06 Mar 2023

Sponsor / Collaborator

BerGenBio ASA

CTIS2022-500363-12-00

/ Not yet recruitingPhase 2IIT

Efficacy and Safety of AXL-Inhibitor bemcentinib for the Treatment of Moderate COVID-19 (AXL-SolidAct) - AXL-SolidAct

Start Date27 Sep 2022

Sponsor / Collaborator-

100 Clinical Results associated with Bemcentinib

100 Translational Medicine associated with Bemcentinib

100 Patents (Medical) associated with Bemcentinib

235

Literatures (Medical) associated with Bemcentinib

13 Mar 2025·ACS Medicinal Chemistry Letters

A Hybrid Energy-Based and AI-Based Screening Approach for the Discovery of Novel Inhibitors of AXL

Article

Author: Zhao, Jingyi ; Pan, Youlu ; Ying, Xiaojun ; Li, Long ; Lv, Xinting ; Huang, Wenhai ; Wang, Linjun ; Chi, Xinglong ; Pan, Zhichao ; Kang, Youkun

AXL, part of the TAM receptor tyrosine kinase family, plays a significant role in the growth and survival of various tissues and tumors, making it a critical target for cancer therapy. This study introduces a novel high-throughput virtual screening (HTVS) methodology that merges an AI-enhanced graph neural network, PLANET, with a geometric deep learning algorithm, DeepDock. Using this approach, we identified potent AXL inhibitors from our database. Notably, compound 9, with an IC₅₀ of 9.378 nM, showed excellent inhibitory activity, suggesting its potential as a candidate for further research. We also performed molecular dynamics simulations to explore the interactions between compound 9 and AXL, providing insights for future enhancements. This hybrid screening method proves effective in finding promising AXL inhibitors, and advancing the development of new cancer therapies.

01 Mar 2025·INTERNATIONAL JOURNAL OF BIOCHEMISTRY & CELL BIOLOGY

Bemcentinib enhances sensitivity to estrogen receptor inhibitors in breast cancer cells

Article

Author: Jin, Hyeon-Ok ; Ahn, Se Hee ; Kim, Gyeongmi ; Park, In-Chul ; Park, Chan Sub ; Kim, Hyunggee ; Park, Ki Soo ; Kim, Hyun-Ah ; Kim, Selim ; Seong, Min-Ki ; Jang, Se-Kyeong

Estrogen receptor (ER)-positive breast cancer accounts for a substantial proportion of breast cancer cases and is typically managed using ER inhibitors, such as tamoxifen and fulvestrant. However, the development of resistance to these therapies is a significant clinical challenge, and the improvement of therapeutic strategies is crucial. This study aimed to investigate the potential of bemcentinib, a well-known AXL inhibitor, to enhance the sensitivity of MCF7 breast cancer cells to 4-hydroxytamoxifen (4-OHT) and fulvestrant. Our findings revealed that bemcentinib effectively decreased S6K1 phosphorylation and synergistically induced cell death when used in combination with ER inhibitors. Bemcentinib treatment also unexpectedly activated STAT3, and inhibition of STAT3 enhanced cell death induced by bemcentinib and 4-OHT. Notably, the combination of bemcentinib and 4-OHT effectively induced cell death even in tamoxifen-resistant MCF7 cells (MCF7-TR), highlighting its potential to overcome tamoxifen resistance. Interestingly, AXL knockdown did not enhance the sensitivity to 4-OHT or affect S6K1 signaling in either MCF7 or MCF7-TR cells, suggesting that the sensitizing effect of bemcentinib through S6K1 inhibition may be independent of AXL expression. Our findings suggest that bemcentinib treatment, particularly in combination therapy, could be a promising strategy for improving treatment efficacy and overcoming tamoxifen resistance in ER-positive breast cancer.

21 Feb 2025·SCIENCE

Neuronal FAM171A2 mediates α-synuclein fibril uptake and drives Parkinson’s disease

Article

Author: Zhang, Yi ; Ma, Ling-Zhi ; Yang, Liu ; Han, Si-Da ; Xu, Qian-Hui ; Yang, Zhao-Fei ; Wu, Bang-Sheng ; Lu, Bo-Xun ; Chen, Shu-Fen ; Le, Wei-Dong ; Liu, Yi-Qi ; Zhang, Ya-Ru ; Zhao, Jue ; Guo, Yu ; Yu, Jin-Tai ; Wu, Kai-Min ; Cui, Mei ; Liu, Cong ; Xiao, Yu-Jie ; Chen, Yi-Lin ; Chen, Shi-Dong ; Li, Jia-Yi ; Wang, Ting-Ting ; Li, Wen-Sheng ; Ye, Keqiang ; Wang, Jian ; Feng, Yi-Wei ; Yuan, Peng ; Shu, You-Sheng

Neuronal accumulation and spread of pathological α-synuclein (α-syn) fibrils are key events in Parkinson's disease (PD) pathophysiology. However, the neuronal mechanisms underlying the uptake of α-syn fibrils remain unclear. In this work, we identified FAM171A2 as a PD risk gene that affects α-syn aggregation. Overexpressing FAM171A2 promotes α-syn fibril endocytosis and exacerbates the spread and neurotoxicity of α-syn pathology. Neuronal-specific knockdown of FAM171A2 expression shows protective effects. Mechanistically, the FAM171A2 extracellular domain 1 interacts with the α-syn C terminus through electrostatic forces, with >1000 times more selective for fibrils. Furthermore, we identified bemcentinib as an effective blocker of FAM171A2–α-syn fibril interaction with an in vitro binding assay, in cellular models, and in mice. Our findings identified FAM171A2 as a potential receptor for the neuronal uptake of α-syn fibrils and, thus, as a therapeutic target against PD.

News (Medical) associated with Bemcentinib

06 Mar 2025

·www.prnewswire.com

TEPMETKO Continues to Strengthens its Position as a Leading METex14 Skipping NSCLC Therapy | DelveInsight

With increasing biomarker-driven cancer treatments, TEPMETKO benefits from growing adoption in precision oncology. Competition from other MET inhibitors like TABRECTA (capmatinib) exists, but TEPMETKO's once-daily dosing and efficacy profile offer differentiation. LAS VEGAS, March 6, 2025 /PRNewswire/ -- DelveInsight's " TEPMETKO Market Size, Forecast, and Market Insight Report" highlights the details around TEPMETKO, a kinase inhibitor indicated for the treatment of adult patients with metastatic NSCLC harboring MET exon 14 skipping alterations. The report provides product descriptions, patent details, and competitor products (marketed and emerging therapies) of TEPMETKO. The report also highlights the historical and forecasted sales from 2020 to 2034 segmented into 7MM [the United States, the EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan]. EMD Serono's TEPMETKO (tepotinib) Overview TEPMETKO is a kinase inhibitor prescribed for adult patients with metastatic non-small cell lung cancer (NSCLC) carrying MET exon 14 skipping alterations. The active component is Tepotinib (as hydrochloride monohydrate), administered orally. Patients should be cautioned about the heightened risk of severe or fatal interstitial lung disease/pneumonitis, liver toxicity, and potential embryo-fetal toxicity, necessitating effective contraception during and shortly after treatment. Tepotinib specifically targets MET, including variants with exon 14 skipping mutations. It blocks HGF-dependent and independent MET phosphorylation, disrupting MET-driven signaling pathways. Additionally, at clinically relevant concentrations, Tepotinib inhibits melatonin 2 and imidazoline 1 receptors. In vitro studies show that it suppresses tumor cell proliferation, anchorage-independent growth, and migration of MET-dependent cancer cells. In mouse models with MET-driven tumors, including those with MET exon 14 skipping alterations, Tepotinib reduced tumor growth, sustained MET phosphorylation inhibition, and, in one case, decreased metastasis formation. The recommended dose of TEPMETKO is 450 mg taken orally once daily until disease progression or intolerable toxicity occurs. Patients should take it at the same time each day, swallowing tablets whole without chewing, crushing, or splitting them. If a dose is missed and less than eight hours remain until the next scheduled dose, patients should skip it. In cases of vomiting after taking TEPMETKO, the next dose should be taken at the usual time. Learn more about TEPMETKO projected market size for NSCLC @ TEPMETKO Market Potential Non-small cell lung cancer (NSCLC) is the most common type of lung cancer, accounting for 81% of all diagnosed cases. Early detection greatly improves outcomes, but diagnosing NSCLC and other lung cancers is challenging because their symptoms are often mistaken for common illnesses or the long-term effects of smoking. Consequently, 80% of NSCLC cases are already at advanced stages by the time they are identified, making treatment more difficult. Around 80% of EGFR mutations in NSCLC involve either exon 19 deletions or the exon 21 L858R substitution, both of which are classified as sensitizing mutations. Until the last decade, chemotherapy was the primary treatment for advanced and metastatic lung cancer. However, this changed in 2015 with the approval of the first immune checkpoint inhibitor (ICI), KEYTRUDA (pembrolizumab), as a second-line therapy for advanced cases. This was followed by TECENTRIQ (atezolizumab) in 2016. Both therapies were later approved for first-line treatment, broadening their use to a larger patient population. In 2020, the combination of OPDIVO (nivolumab) and ipilimumab also received approval as a first-line treatment for metastatic NSCLC. According to DelveInsight, the NSCLC market size across the 7MM is projected to grow from USD 30 billion in 2024, with a substantial CAGR through 2034. This growth is largely driven by the introduction of emerging therapies during the forecast period (2025–2034). Discover more about the NSCLC market in detail @ Non-small Cell Lung Cancer Market Report Emerging Competitors of TEPMETKO The NSCLC pipeline is very robust with the promising therapies such as Telisotuzumab vedotin (AbbVie), Patritumab deruxtecan (Daiichi Sankyo/AstraZeneca), Datopotamab deruxtecan (Daiichi Sankyo/AstraZeneca), Eftilagimod alpha (Immutep), BNT311/GEN1046 (acasunlimab) (Genmab), V940 (mRNA-4157) + Pembrolizumab (Moderna Therapeutics/Merck), Plinabulin + Docetaxel (BeyondSpring), Olomorasib (LY3537982) (Eli Lilly and Company), Zipalertinib (Cullinan Oncology/Taiho Pharma), Ceralasertib (AZD6738) (AstraZeneca), TEDOPI (EP-2101; IDM 2101; OSE-2101) (OSE Immuno-therapeutics), Sigvotatug vedotin (PF08046047) (Pfizer), ANKTIVA (N-803) (ImmunityBio), Aumolertinib/Almonertinib/HS-10206 (Jiangsu Hansoh Pharmaceutical), Niraparib (GSK), Savolitinib (AstraZeneca/Hutchison MediPharma), TRODELVY (Gilead Sciences), Pyrotinib (Jiangsu HengRui Medicine), Ociperlimab (BGB-A1217) (BieGene), Volrustomig (AstraZeneca), Gotistobart (BNT316/ONC-392) (OncoC4/BioNTech), Ivonescimab (AK112/SMT112) (Akeso Biopharma/Summit Therapeutics), ZYNYZ (retifanlimab/INCMGA00012) (Incyte/Macrogenics), Divarasib (GDC-6036) (Roche/Genentech), Tiragolumab (RG6058) (Roche), Sacituzumab Tirumotecan (Merck and Kelun-Biotech), JEMPERLI (dostarlimab/TSR-042) (GSK and AnaptysBio), Zongertinib (BI-1810631) (Boehringer Ingelheim), BAY 2927088 (Bayer), Serplulimab (HLX10) (Shanghai Henlius Biotech), Rilvegostomig (AZD2936) (AstraZeneca), MK-1084 (Merck, Taiho Pharmaceutical, and Astex), Domvanalimab (Arcus Biosciences and Gilead Sciences), OPDUALAG (nivolumab and relatlimab) (Bristol-Myers Squibb), Belrestotug + JEMPERLI (iTeos Therapeutics and GSK), Firmonertinib (ArriVent BioPharma), Sunvozertinib (DZD9008) (Dizal Pharmaceutical), Cobolimab (GSK), Livmoniplimab (AbbVie), Fianlimab (REGN3767) (Regeneron Pharmaceuticals), BNT327/PM8002 (Biotheus/BioNTech), HS-20117 (Hansoh BioMedical), IO102-IO103 + Pembrolizumab (IO Biotech), Naptumomab estafenatox (NeoTX Therapeutics/Active Biotech), FF-10832 (FUJIFILM Corporation), BNT116 (BioNTechSE/Regeneron Pharmaceuticals), CAN-2409 (Candel Therapeutics), Mecbotamab Vedotin (BA3011/CAB-AXL-ADC) (BioAtla), Bemcentinib (BGB 324/BGB-3234/R-428) (BerGenBio/Rigel Pharmaceuticals), DOVBLERON (taletrectinib/AB-106/IBI-344) (Nuvation Bio/Innovent Biologics/Daiichi Sankyo/Nippon Kayaku), Lifileucel (Iovance Biotherapeutics), IBI363 (Innovent Biologics), Sotevtamab (AB-16B5) (Alethia Biotherapeutics), Avutometinib (VS6766) (Verastem Oncology), Vebreltinib (APL-101) (Apollomics), LP-300 (Lantern Pharma), JNJ-90301900 (Johnson & Johnson Innovative Medicine), AMG 193 (Amgen), Luveltamab tazevibulin (Sutro Biopharma), PRT3789 (Prelude Therapeutics), Disitamab vedotin (Seagen), PADCEV (enfortumab vedotin) (Astellas Pharma), RP1 (Replimune), TIVDAK (tisotumab vedotin) (Seagen), Zanidatamab (Jazz Pharmaceuticals), Utidelone injectable (UTD1) (Beijing Biostar Pharmaceuticals), REGN5093-M114 (Regeneron Pharmaceuticals), SLC-391 (SignalChem Lifesciences), fulzerasib (GenFleet), Davutamig (REGN5093) (Regeneron Pharmaceuticals), TAS3351 (Taiho Oncology), H002 (RedCloud Bio), JIN-A02 (J INTS BIO), FWD1509 (Forward Pharma), Sabestomig (AZD7789) (AstraZeneca), Sasanlimab (Pfizer), Selvigaltin (GB1211) (Galecto Biotech), Vepafestinib Helsinn (Healthcare/Taiho Pharmaceutical), EP0031 (A400/ KL590586) (Ellipses Pharma/Kelun-Biotech), Pamvatamig (MCLA-129) (Merus), Zidesamtinib (NVL-520) (Nuvalent), NVL-655 (Nuvalent), RMC-4630 (Revolution Medicines), REQORSA (quaratusugene ozeplasmid) (Genprex), PDC*lung01 (PDC*line Pharma), Evalstotug (BA3071) (BioAtla and BeiGene), PT-112 (Promontory Therapeutics), MRT-2359 (Monte Rosa Therapeutics), GAIA-102 (GAIA BioMedicine), Rigosertib (Traws Pharma), HMBD-001 (Hummingbird Bioscience), PLB1004 (Avistone Biotechnology), ANS03 (Avistone Biotechnology), MYTX-011 (Mythic Therapeutics), A166 (Sichuan Kelun-Biotech Bio-pharmaceutical), Atamparib (BN-2397) (Ribon Therapeutics), DELTACEL (KB-GDT-01) (Kiromic BioPharma), Carotuximab (ENV-105) (Kairos Pharma), YL202 (MediLink Therapeutics), and others. To know more about the number of competing drugs in development, visit @ TEPMETKO Market Positioning Compared to Other Drugs Key Milestones of TEPMETKO In February 2024, the FDA granted traditional approval to TEPMETKO for adult patients with metastatic NSCLC harboring MET exon 14 skipping alterations. In February 2022, the EC approved TEPMETKO as monotherapy for the treatment of adult patients with advanced NSCLC harboring alterations leading to METex14 skipping who require systemic therapy following prior treatment with immunotherapy and/or platinum-based chemotherapy. In February 2021, Merck announced that the US FDA has approved TEPMETKO following priority review for the treatment of adult patients with metastatic NSCLC harboring MET exon 14 skipping alterations. This indication was approved under accelerated approval based on ORR and DOR. In October 2020, TEPMETKO received ODD for treating NSCLC with MET genomic tumor aberrations In March 2020, EMD Serono (the biopharmaceutical business of Merck KGaA), announced that the MHLW approved TEPMETKO for the treatment of patients with unresectable, advanced, or recurrent NSCLC with METex14 skipping alterations. In September 2019, the US FDA granted BTD for tepotinib in patients with metastatic NSCLC harboring METex14 skipping alterations who progressed following platinum-based cancer therapy Discover how TEPMETKO is shaping the NSCLC treatment landscape @ TEPMETKO NSCLC TEPMETKO Market Dynamics TEPMETKO competes in a growing but highly specialized market where MET-targeted therapies are gaining traction due to their efficacy in addressing MET-altered tumors. The market for MET inhibitors is expanding as precision oncology advances and molecular diagnostics become more widely available, enabling better identification of patients who would benefit from targeted treatments like TEPMETKO. A key factor shaping TEPMETKO's market dynamics is competition. It directly competes with Novartis' TABRECTA (capmatinib), another MET inhibitor approved for the same indication. While TEPMETKO offers the advantage of once-daily dosing compared to TABRECTA's twice-daily regimen, both drugs have similar efficacy profiles, making physician and patient preference an important differentiator. Additionally, broader competition from next-generation MET inhibitors and combination therapies in clinical trials could impact TEPMETKO's long-term market position. Regulatory approvals and market access play a crucial role in TEPMETKO's adoption. The drug has been approved in multiple regions, including the U.S., Europe, and Japan, but reimbursement and pricing strategies vary by market. Payer policies, along with the cost-benefit analysis of MET inhibitors compared to other targeted therapies, influence prescription trends. Furthermore, real-world evidence and post-marketing studies will be critical in demonstrating TEPMETKO's sustained effectiveness and safety, which could support expanded indications and increased market penetration. Looking ahead, the MET inhibitor market is expected to grow with advances in biomarker-driven therapy, further refining patient selection. TEPMETKO's success will depend on continued clinical development, potential label expansions, and strategic partnerships to strengthen its competitive edge. As new entrants emerge, Merck KGaA's ability to differentiate TEPMETKO through combination strategies or enhanced formulations may determine its long-term sustainability in this evolving landscape. Dive deeper to get more insight into TEPMETKO's strengths & weaknesses relative to competitors @ TEPMETKO Market Drug Report Table of Contents Related Reports Non-small Cell Lung Cancer Market Non-small Cell Lung Cancer Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key NSCLC companies including Daiichi Sankyo, AstraZeneca, Gilead Sciences, BieGene, AbbVie, Roche, Merck, Novartis, Pfizer, Takeda Pharmaceuticals, Eli Lilly, BerGenBio, GlaxoSmithKline, Duality biologics, among others. Non-small Cell Lung Cancer Pipeline Non-small Cell Lung Cancer Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key non-small cell lung cancer companies, including BridgeBio Pharma, Daiichi Sankyo, EMD Serono, Merck, BridgeBio Pharma, Abbvie, Pfizer, Eli Lilly and Company BioNTech SE, Shenzhen TargetRx, Taiho Pharmaceutical, Chong Kun Dang, Bristol Myers Squibb, Innovent Biologics, Xuanzhu Biopharmaceutical, Bayer, GeneScience Pharmaceuticals, InventisBio, Apollomics, Imugene, Ono Pharmaceutical, Pierre Fabre, Jiangsu Hengrui Medicine Co., Bristol-Myers Squibb, Surface Oncology, Inhibrx, Sinocelltech, Mirati Therapeutics, REVOLUTION Medicines, Yong Shun Technology Development, Iovance Biotherapeutics, Galecto Biotech, among others. C-MET Metastatic Non-small Cell Lung Cancer Market C-MET Metastatic Non-small Cell Lung Cancer Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key C-MET mNSCLC companies, including Novartis, Merck, EMD Serono, AbbVie, Regeneron Pharmaceuticals, Mythic Therapeutics, Apollomics, Johnson & Johnson Innovation, Haihe Biopharma, among others. C-MET Non-small Cell Lung Cancer Pipeline C-MET Non-small Cell Lung Cancer Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key C-MET non-small cell lung cancer companies, including AbbVie, Janssen Research & Development, Beijing Pearl Biotechnology Limited Liability Company, Novartis, among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Contact Us Shruti Thakur [email protected] +14699457679 Logo: SOURCE DelveInsight Business Research, LLP WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Drug ApprovalImmunotherapyPriority Review

26 Feb 2025

·endpts.com

Harbour BioMed inks deal up to $395M; ORIC refines plans for two drugs

Plus, news about Idorsia, Enveda, Zymeworks, BerGenBio and Ignota Labs: Harbour BioMed does another deal: The Shanghai-based biotech’s subsidiary, called HBM Alpha Therapeutics, inked a pact with an undisclosed company for up to $395 million in upfront fees and biobucks, plus the potential for a minority stake. The undisclosed partner also gets exclusive ex-China global rights to an antibody known as HAT001/HBM9013 for congenital adrenal hyperplasia (CAH) and other rare endocrine disorders. HBMAT raised a seed round of undisclosed size in January 2023, and Harbour did a NewCo deal for an anti-TSLP antibody with Windward Bio last month. — Kyle LaHucik ORIC ‘refines’ development plans for two drugs: The ORIC-944 program is set to start a Phase 3 trial in the first half of 2026 looking at patients with metastatic castration-resistant prostate cancer. Its ORIC-114 candidate is expected to begin registrational trials sometime in 2026 in the first-line lung cancer setting. Its stock $ORIC was up about 13% on Wednesday morning. — Max Gelman Idorsia’s big updates: The Swiss drugmaker said an undisclosed party opted not to move forward with a deal for the global rights to Idorsia’s experimental hypertension drug, called aprocitentan, but it will keep the $35 million exclusivity fee that it got in December. Meanwhile, Idorsia and Viatris adjusted the terms of their collaboration for selatogrel and cenerimod, with Idorsia contributing $100 million less toward development while losing $250 million in potential milestone payments from Viatris. It is also restructuring its debt and getting new funding . — Kyle LaHucik Sanofi backs Enveda with $20M: The French pharma giant is joining the Series C of the Colorado biotech, which mines plant chemistry to find new drugs. The Series C now totals $150 million, up from the $130 million disclosed in November . — Kyle LaHucik Zymeworks’ $14M milestone: The company received the payment from GSK from a bispecific antibody deal they inked in 2016 and then expanded in 2019. — Jaimy Lee BerGenBio discontinues lung cancer study, to seek strategic alternatives: The company was evaluating whether bemcentinib, an AXL kinase inhibitor, could treat patients with first-line non-squamous non-small cell lung cancer in combination with standard of care. Patients also needed to have a mutation of the STK11 gene. In a statement, CEO Olav Hellebø said the results were not strong enough for BerGenBio to obtain additional financing and is now looking for a merger, sale or other transaction. — Max Gelman Ignota Labs closes £5.5M seed round: The startup’s goal is to “turn around failed drugs” using AI, acquiring assets from bigger companies that stopped being developed and then testing them in new clinical trials. Its first asset is a PDE9A inhibitor, which the company says has potential in cardiovascular, metabolic and neurodegenerative diseases. — Max Gelman

License out/inADC

24 Jan 2025

·www.pharmaceutical-technology.com

Ascentage Pharma raises $126m in first biotech IPO of 2025

Ascentage sold 7,325,000 American Depositary shares at $17.25 each. Credit: Andrey Zhuravlev via Getty Images. China-based biotech Ascentage Pharma has raised $126m in a US initial public offering (IPO), marking the first biotech IPO of 2025. Free Report What’s missing from your IPO industry assessment? IPO activity all but stopped in 2020, as the investment community grew wary of the effects of COVID-19 on economies. No matter how deserving a business was of flotation, momentum was halted by concerns of when a ‘new normal’ of working patterns and trade would set in. Recently, sentiment has changed. Flotations picked up again during the second half of 2021, and now in 2022 the mood is decidedly optimistic. Business leaders have their eyes on fast rebounding economies, buoyant market indices and the opportunity once again to take their businesses public. As a result, global IPOs are expected to hit back this year. With GlobalData’s new whitepaper, ‘IPOs in Consumer and Retail: 5 must-include elements for your prospectus industry report’, you can explore exactly what is needed in the essential literature. GlobalData’s focus lies in the critical areas to get right: Macroeconomic and demographic environment Consumer context Industry environment Competitive environment Route to market Interested to learn more about what to include in your IPO Industry Assessment report? Download our free whitepaper. Thank you. You will receive an email shortly. Please check your inbox to download the Report. Go deeper with GlobalData Reports LOA and PTSR Model - Bemcentinib in Acute Myelocytic Leukemia (AML,... Reports LOA and PTSR Model - Bemcentinib in Lung Adenocarcinoma Data Insights The gold standard of business intelligence. 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Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address. The company sold 7,325,000 American Depositary shares at $17.25 each. Shares for the company began trading today (24 January) on the Nasdaq under the ticker symbol “AAPG”, and are up by as much as 4% since markets opened, as per Bloomberg . The funds will primarily support the development of Ascentage’s cancer drug pipeline, including its lead candidate olverembatinib for the treatment of chronic myeloid leukaemia (CML). Olverembatinib, a tyrosine kinase inhibitor (TKI), is approved and marketed as Nelic in China for the treatment of adult patients with TKI-resistant chronic-phase CML (CP-CML) or accelerated-phase CML (AP-CML) with the T315I mutation, and for those with CP-CML resistant disease or intolerant to first and second generation TKIs. The IPO comes after the company signed a significant licencing agreement with Takeda in 2024. Takeda paid $100m upfront for the option to licence olverembatinib outside China, Hong Kong, Macau, Taiwan, and Russia, and committed to potential milestone payments totalling $1.2bn. The broader IPO market has seen fluctuations in recent years. Following a surge in 2020 and 2021, activity slowed, only to pick up slightly in late 2024. In September 2024, three biotech firms – Bicara Therapeutics, Zenas BioPharma, and MBX Biosciences – raised over $700m collectively in a single day on Nasdaq, reflecting renewed investor interest. Industry sentiment remains optimistic for 2025 , with many expecting IPO activity to increase. A Jefferies survey reported that 64% of respondents anticipate a stronger IPO market this year, with equity raising expected to play a significant role. Ascentage’s listing aligns with this outlook and suggests a favourable environment for biotech funding as the year begins. Ascentage’s olverembatinib is being investigated in the Phase III POLARIS-2 registrational study (NCT06423911) which plans to enrol 285 patients with CML. Beyond olverembatinib, Ascentage has other candidates in its pipeline including lisaftoclax, a treatment for blood cancers. The candidate is in late-stage trials and under regulatory review in China. Free Report What’s missing from your IPO industry assessment? IPO activity all but stopped in 2020, as the investment community grew wary of the effects of COVID-19 on economies. No matter how deserving a business was of flotation, momentum was halted by concerns of when a ‘new normal’ of working patterns and trade would set in. Recently, sentiment has changed. Flotations picked up again during the second half of 2021, and now in 2022 the mood is decidedly optimistic. Business leaders have their eyes on fast rebounding economies, buoyant market indices and the opportunity once again to take their businesses public. As a result, global IPOs are expected to hit back this year. With GlobalData’s new whitepaper, ‘IPOs in Consumer and Retail: 5 must-include elements for your prospectus industry report’, you can explore exactly what is needed in the essential literature. GlobalData’s focus lies in the critical areas to get right: Macroeconomic and demographic environment Consumer context Industry environment Competitive environment Route to market Interested to learn more about what to include in your IPO Industry Assessment report? Download our free whitepaper. Thank you. You will receive an email shortly. Please check your inbox to download the Report. 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Phase 3IPODrug Approval

100 Deals associated with Bemcentinib

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KEGG	Wiki	ATC	Drug Bank
D11438	Bemcentinib	-	DB12411

R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Metastatic Non-Squamous Non-Small Cell Lung Carcinoma	Phase 2	United States	BerGenBio ASA	06 Mar 2023
Metastatic Non-Squamous Non-Small Cell Lung Carcinoma	Phase 2	France	BerGenBio ASA	06 Mar 2023
Metastatic Non-Squamous Non-Small Cell Lung Carcinoma	Phase 2	Greece	BerGenBio ASA	06 Mar 2023
Metastatic Non-Squamous Non-Small Cell Lung Carcinoma	Phase 2	Hungary	BerGenBio ASA	06 Mar 2023
Metastatic Non-Squamous Non-Small Cell Lung Carcinoma	Phase 2	Italy	BerGenBio ASA	06 Mar 2023
Metastatic Non-Squamous Non-Small Cell Lung Carcinoma	Phase 2	Poland	BerGenBio ASA	06 Mar 2023
Metastatic Non-Squamous Non-Small Cell Lung Carcinoma	Phase 2	Spain	BerGenBio ASA	06 Mar 2023
COVID-19	Phase 2	India	BerGenBio ASA	20 Oct 2020
COVID-19	Phase 2	South Africa	BerGenBio ASA	20 Oct 2020
Metastatic Pancreatic Cancer	Phase 2	United States	BerGenBio ASA	03 Jan 2019

Clinical Result

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03184571 (BGBC008, AACR2025)	Phase 2	Refractory Lung Carcinoma granzyme B \| cDC1 \| phospho-STAT3	29	Bemcentinib + Pembrolizumab	zclnikbuum(kfsfjbhcmi) = qyyouwwsqz vwkcxlxfss (bovqzjduyd )	Positive	30 Apr 2025
				Bemcentinib (AXL-PD1-STAT3 axis)	zclnikbuum(kfsfjbhcmi) = gnpnpjyqwt vwkcxlxfss (bovqzjduyd )
NCT02424617 (CTgov)	Phase 1/2	Non-Small Cell Lung Cancer	40	Bemcentinib (Phase 1- Run in Arm (Bemcentinib Monotherapy))	dfytgtzbdl = emliyvbezw alneugjevu (kzudehwacn, ionmhtbvde - ticagcceby) View more	-	26 Feb 2025
				Erlotinib+Bemcentinib (Phase 1- Arm A (Bemcentinib + Erlotinib))	dfytgtzbdl = ikygmitxsn alneugjevu (kzudehwacn, sepozyzcfq - ftqvbtpwun) View more
NCT06469138 (8479217, CTgov)	Phase 1	Acute Myeloid Leukemia \| COVID-19 \| Mesothelioma, Malignant ... View more	6	Bemcentinib	tnlxblfqhb(vrcvitpvdo) = sreqlozmwp bojoagciuk (owdfucpufs, 26.8) View more	-	29 Jan 2025
NCT04890509 (CTgov)	Phase 2	COVID-19	115	SOC	azbpwnfhzb(jwsciohpym) = jxcjqrxsmf rboaiqlqtl (hkjpsrfffs, arkzdykuzj - nwckckydwl) View more	-	16 Oct 2024
NCT02488408 (BGBC003, ASH2023)	Phase 1/2	Acute Myeloid Leukemia	32	Bemcentinib + Low-dose Cytarabine	bvglxbcwlj(kozrjobqse) = rjnmmiasjy mwqpedwssb (azbtmuzaqi ) View more	-	09 Dec 2023
NCT03649321 (CTgov)	Phase 1/2	Metastatic Pancreatic Cancer	9	Nab-paclitaxel+gemcitabine+cisplatin+Bemcentinib (Phase 1b)	lbwleeiwga = fnfxykltxk fzihudgtue (uqqjrngcmp, odafjqalgq - ntarnjdmov) View more	-	09 Nov 2023
				Nab-paclitaxel+gemcitabine+Bemcentinib (Phase 2)	lbwleeiwga = oiiwdzwcqg fzihudgtue (uqqjrngcmp, lpyvqfdeje - nrtnggpuhn) View more
NCT03184571 (BGBC008, ESMO 12023 \| ESMO 22023) Manual	Phase 2	Non-Small Cell Lung Cancer Second line	99	Bemcentinib + Pembrolizumab	wenmmrtbal(treazoimjg) = acijjfejvk cofoiklhxu (luggwwukox ) View more	Positive	23 Oct 2023
				Bemcentinib + Pembrolizumab (AXL TPS > 5)	wenmmrtbal(treazoimjg) = tnkqxrdpec cofoiklhxu (luggwwukox ) View more
NCT02872259 (BGBIL006, ESMO 12023 \| ESMO 22023) Manual	Phase 1/2	Metastatic melanoma	68	Bemcentinib+PembrolizumabPem or D/TDabrafenibTrametinib (Bemcentinib+Pembrolizumab or Dabrafenib/Trametinib)	wqbrpksfqi(kgqeqlbbbp) = dgdwppzjel jzwjvufhni (msdwasrxcp ) View more	Negative	21 Oct 2023
				PembrolizumabPem or D/TDabrafenibTrametinib (Pembrolizumab or Dabrafenib/Trametinib)	-
NCT03654833 (MiST3, ASCO 12023 \| ASCO 22023) Manual	Phase 2	Mesothelioma	26	Pembrolizumab+Bemcentinib	xgnvgcqqhd(mbezhagevo) = dfrhazxbvq afcgvmkfzg (yelsfsszar, 29.2 - 63.4) View more	Positive	26 May 2023
NCT02922777 (ASCO2022) Manual	Phase 1	Non-Small Cell Lung Cancer First line	21	Docetaxel+Bemcentinib	evmvlgotdw(ywbejzqcsl) = 60 mg/m2 docetaxel plus 200 mg bemcentinib daily labzaecder (xtjdducfux ) View more	Positive	02 Jun 2022

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