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#ADC #ADCPayload #dualPayloads #ADCLinker #breast tumor #antibodies #cancertreatment #medicine #health #medchem Antibody–drug conjugates (ADCs) are a growing class of cancer chemotherapeutics15,16,17,18. Their clinical potential is demonstrated by eleven U.S. Food and Drug Administration (FDA)-approved ADCs and >100 ADCs in clinical trials (clinicaltrials.gov). One key challenge is intratumor heterogeneity. Trastuzumab emtansine (Kadcyla® or known as T-DM1) is not effective at killing cancer cells expressing relatively low levels of HER2, mainly due to intratumor HER2 heterogeneity19. Trastuzumab deruxtecan (Enhertu®) is a newcomer designed to treat HER2 heterogeneous tumors20. #medicalsciences https://lnkd.in/eqHu4GFQ

📢 FDA approves amivantamab in first-line EGFR exon 20 insertion-mutated non-small cell lung cancer indications; converts to traditional approval (The Janssen Pharmaceutical Companies of Johnson & Johnson) ➤ Amivantamab + carboplatin +pemetrexed showed a statistically significant improvement in PFS vs. carboplatin + pemetrexed with a HR of 0.40 (95% CI: 0.30, 0.53; p-value<0.0001). Median PFS was 11.4 months (95% CI: 9.8, 13.7) and 6.7 months (95% CI: 5.6, 7.3) in the respective arms ➤ FDA action converts the May 2021 2nd line accelerated approval to a full approval based on the confirmatory Phase 3 PAPILLON study #oncology #biotech #biotechnology #regulatoryaffairs #pharma #drugdevelopment #oncologytrials #oncologyresearch #cancer #oncology #regulatoryintelligence #regulatoryprecedent #nsclc https://lnkd.in/estqwicD

🧬 Pharma News From The Last Week 🧬 💊US FDA grants full approval for AbbVie ADC for the treatment of ovarian cancer. Elahere is approved for for adult patients with a type of cancer that affects the ovaries, fallopian tube, or walls of the abdomen (See link). 💵 Capstan Therapeutics announced the successful closing of an oversubscribed Series B financing of $175 million, which will support the advancement of the lead program, CPTX230. (https://lnkd.in/demG7KFS) 🔬AbbVie to acquire Landos Biopharma, Inc. Landos’ lead investigational asset is NX-13, a first-in-class, oral NLRX1 agonist. Bolstering their portfolio in inflammatory and autoimmune diseases. (https://lnkd.in/dEj4xZWx) 💉 Molecure first patient in the UK is dosed in the OATD-01 Phase 2 KITE study in pulmonary sarcoidosis. The Phase II clinical trial for OATD-01 is a randomized, double-blind, placebo-controlled, multi-center study to evaluate the safety and efficacy of the oral CHIT1 inhibitor in approximately 100 patients. (https://lnkd.in/dnABPtw5). 💲 Angelini Ventures' investment of €7 million brings the total raised by Nouscom, in its oversubscribed Series C round to €75.8 million. (https://lnkd.in/d24_SVr7) #pharmanews #pharma #biotech 🧬

🚨 Industry News 🚨 The FDA has approved a powerful new combination therapy for the first-line treatment of adults with locally advanced or #metastatic non–small cell lung cancer with #EGFR mutations. The approved combo: Lazertinib (Lazcluze), marking its first FDA approval, and Amivantamab-vmjw (Rybrevant), which was first approved in 2021. This approval, based on the phase 3 MARIPOSA trial, is a significant milestone in the treatment of #NSCLC, offering patients a potential new first-line standard of care with substantial clinical benefits over osimertinib. The trial showed a 30% reduction in the risk of disease progression or death with this combination. As NSCLC treatment evolves, this new option highlights the ongoing advancements in #personalizedmedicine, bringing renewed hope to those facing this challenging diagnosis. https://lnkd.in/dbMKc8bM #LungCancer #PrecisionMedicine #LCSM

#ScientificSaturday 🔬Enzalutamide ― is a medication used to treat advanced prostate cancer, particularly castration-resistant prostate cancer. It works by inhibiting the androgen receptor, blocking the action of male hormones like testosterone that prostate cancer cells need to grow. Typically administered orally, enzalutamide is used when other hormone therapies are no longer effective and may cause side effects such as fatigue, back pain, and hot flashes. It's often part of a combined treatment approach that may include chemotherapy or radiation therapy. ❗The FDA approval of enzalutamide (Xtandi) for nonmetastatic castration-sensitive prostate cancer (nmCSPC) marks a significant advancement in prostate cancer treatment, offering an effective alternative to standard hormonal therapy. The phase 3 EMBARK trial demonstrated that enzalutamide combined with leuprolide significantly improved metastasis-free survival (MFS) compared to leuprolide alone, leading to its FDA approval on November 17, 2023. This decision was based on the trial's findings, which showed a 58% improvement in MFS with the enzalutamide combination. The safety profile of enzalutamide was consistent with previous studies, with no new safety signals. The approval signifies a shift in the treatment paradigm for nmCSPC, highlighting the benefit of intensifying standard androgen deprivation therapy (ADT) with an androgen receptor pathway inhibitor (ARPI) like enzalutamide to delay disease progression. BioPharma Services Inc. has previously completed multiple clinical trials on Enzalutamide. Trust our world-class Pharmacokinetic team with your next #Phase1, BA/BE or Human Abuse Liability (#HAL) drug development project. Read the full blog here: 👇 https://hubs.li/Q02ggtkD0 Discover our Services: 👇 https://hubs.li/Q02ggv_y0 #clinicalresearch #biopharma #drugdevelopment #drugresearch #cro #clinicaltrials

[Clinical Trials] 09/19 Aligos Therapeutics Reports Significant Reduction in Liver Fat in phase 2a Study of ALG-055009 on Metabolic-Dysfunction Associated Steatohepatitis Patients same day : ( ↓ NASDAQ: ALGS | -20.54% ) 09/19 Laekna Therapeutics Shares End of Study Results for phase Ib Clinical Trial of LAE002 in Advanced Breast Cancer, Begins Phase III Trial AFFIRM-205 09/18 Transcenta Holding's Cancer Treatment TranStar102 Reports Median Progression-Free Survival of 14.2 Months in CLDN18.2 Expressing Patients, Presented at ESMO Congress 2024 09/18 Genentech's phase III trial of Xofluza shows significant reduction in influenza transmission in households [Deals] 09/19 Basilea Pharmaceutica bags initial $29M from BARDA under multi-year agreement for antifungal and antibacterial development 09/19 Tiziana Life Sciences Secures $4M NIH Grant for Alzheimer's Research, Prepares for First-in-Human Clinical Trials for Nasal Anti-CD3 Treatment [Regulatory] 09/19 FDA grants Rare Pediatric Disease and Orphan Drug designations to Longboard Pharmaceuticals' bexicaserin for Dravet syndrome treatment same day : ( ↑ NASDAQ: LBPH | +2.2% ) 09/19 FDA rejects Vanda Pharmaceuticals' application for gastroparesis medication, asks for further studies same day : ( ↓ NASDAQ: VNDA | -8.28% ) View the full newsletter contents for free via the link in the comments.

Faron Pharmaceuticals Limited (AIM:FARN, OTC:FPHAF), a specialist in macrophage reprogramming and anticancer #immunotherapies, has shared its breakthrough research in treating late-stage solid tumours in a peer-reviewed scientific journal. Specifically, the company said comprehensive results from the phase I/II MATINS trial of #bexmarilimab had been published in Cell Reports Medicine. The report underscores the drug's efficacy and safety in patients with advanced, treatment-resistant cancers. The MATINS trial, a first-in-human study, focused on evaluating the safety and anti-tumour effectiveness of bexmarilimab.  The #FaronPharmaceuticals discovery targets a protein called CLEVER-1 found in certain immune cells (macrophages) that usually help #cancer cells evade the body's immune response. More at #Proactive #ProactiveInvestors #AIM #FARN #OTC #FPHAF #Faron #FaronPharma http://ow.ly/6Cej1054V5i

We are thrilled to share the exciting news of the European Commission’s approval of Takeda’s Fruzaqla (fruquintinib) for metastatic colorectal cancer. This significant milestone is based on data from the Phase III FRESCO-2 trial, offering a new monotherapy option for patients who have exhausted current standard therapies. At Lampgen Clinical Research, we are proud to support such groundbreaking advancements by providing expert oncology CRAs. Our team ensures that cancer clinical trials are meticulously monitored with ICH/GCP and industry-standard expertise. As the staffing firm of choice for companies conducting these crucial trials, we remain committed to excellence in every aspect of our service. The approval of Fruzaqla is a testament to the relentless efforts in the oncology community to bring new, effective treatments to patients in need. We are honored to play a role in these developments, helping sponsors and CROs achieve their goals with precision and dedication. #OncologyResearch #ClinicalTrials #CancerTreatment #MetastaticColorectalCancer #OncologyCRAs #ClinicalResearch #Fruzaqla #Takeda #LampgenClinicalResearch #CancerResearch #ICHGCP #PharmaIndustry 🔗 https://lnkd.in/e7MQ8rMd

📃Scientific paper: Development and Challenges of Diclofenac-Based Novel Therapeutics: Targeting Cancer and Complex Diseases Abstract: SIMPLE SUMMARY: Diclofenac is a widely used drug for its anti-inflammatory and pain alleviating properties. This review summarizes the current understanding about the drug diclofenac. The potential applications of diclofenac beyond its well-known anti-inflammatory properties for other diseases such as cancer are discussed, along with existing limitations. ABSTRACT: Diclofenac is a highly prescribed non-steroidal anti-inflammatory drug (NSAID) that relieves inflammation, pain, fever, and aches, used at different doses depending on clinical conditions. This drug inhibits cyclooxygenase-1 and cyclooxygenase-2 enzymes, which are responsible for the generation of prostaglandin synthesis. To improve current diclofenac-based therapies, we require new molecular systematic therapeutic approaches to reduce complex multifactorial effects. However, the critical challenge that appears with diclofenac and other drugs of the same class is their side effects, such as signs of stomach injuries, kidney problems, cardiovascular issues, hepatic issues, and diarrhea. In this article, we discuss why defining diclofenac-based mechanisms, pharmacological features, and its medicinal properties are needed to direct future drug development against neurodegeneration and imperfect ageing and to improve cancer therapy. In addition, we describe various advance molecular mechanisms and fundamental aspects linked with diclofenac which can strengthen and enable the better designing of new derivative... Continued on ES/IODE ➡️ https://etcse.fr/BQlC6 ------- If you find this interesting, feel free to follow, comment and share. We need your help to enhance our visibility, so that our platform continues to serve you.

#GSK blood cancer drug nearly halves risk of death in late-stage trial:- •GSK's #Blenrep, a new tab multiple myeloma drug, has nearly halved the risk of disease progression or death compared to standard-of-care treatments, according to a late-stage study of 302 patients. •GSK oncology executive Hesham Abdullah highlighted the importance of offering a drug like Blenrep that can be administered outpatiently, requires no hospitalization, is available in a community setting, and is not restricted by manufacturing challenges. •The American Society of Clinical Oncology presented data from a trial revealing that Blenrep, which faced setbacks in recent years, had met its main goal of improving PFS over a standard treatment regimen, signaling a comeback. •Multiple myeloma treatments include Johnson & Johnson's, Darzalex, and generic cancer drugs. FDA approved #Carvykti and #Abecma for less severe cases. Eye-related side effects led to 9% discontinuation rate.