bioSeedin’s Post

🚀 𝑬𝒙𝒄𝒊𝒕𝒊𝒏𝒈 𝑵𝒆𝒘𝒔 𝒊𝒏 𝑶𝒏𝒄𝒐𝒍𝒐𝒈𝒚! 🚀 Merck (MSD) has achieved FDA approval for 𝐖𝐞𝐥𝐢𝐫𝐞𝐠 (𝐛𝐞𝐥𝐳𝐮𝐭𝐢𝐟𝐚𝐧), a breakthrough in treating 𝐚𝐝𝐯𝐚𝐧𝐜𝐞𝐝 𝐫𝐞𝐧𝐚𝐥 𝐜𝐞𝐥𝐥 𝐜𝐚𝐫𝐜𝐢𝐧𝐨𝐦𝐚 (𝐑𝐂𝐂). This oral drug offers hope to patients unresponsive to PD-1/PD-L1 inhibitors and VEGF-TKI, demonstrating superior results in the LITESPARK-005 trial. 🔬 Welireg, acquired through the Peloton Therapeutics purchase, has shown impressive progression-free survival (PFS) at 12 and 18 months, surpassing Novartis' Afinitor. With an objective response rate (ORR) difference of 22%, Welireg stands out as a game-changer in RCC treatment. 📊 While interim results raised questions about overall survival (OS) at ESMO Congress, a final analysis is underway. Nonetheless, this HIF-2α inhibitor marks a significant stride in targeting tumor development in kidney cells. 🌐 Renal cell carcinoma affects 81,800 adults in the US annually. Welireg, despite its potential risks, introduces a vital treatment avenue, reducing the risk of disease progression or death compared to everolimus. 👩⚕️ Dr. Toni Choueiri, LITESPARK-005 study chair, emphasizes the significance: "Belzutifan introduces a meaningful new treatment option for certain patients, addressing the gap in options for those progressing post PD-1/PD-L1 and TKI therapy." --------------------------------------------------------------------------------- 🤔What are your views on this FDA Approved ? --------------------------------------------------------------------------------- #fdaapproval #oncology #oncologytrials #carcinoma #marketresearcher #competitiveintelligence #clinicaltrial

In the latest FDA Roundup, Dr. Richard Pazdur, director of FDA’s Oncology Center of Excellence (OCE), expresses his excitement for the approval of LOQTORZI™ (toripalimab-tpzi): “Today’s approval of Loqtorzi is the first approval in the United States of a drug to treat nasopharyngeal carcinoma. When combined with chemotherapy this drug has demonstrated an improvement in overall survival as well as delaying the progression of disease in patients with metastatic or recurrent, locally advanced disease who had not received prior chemotherapy.” An anti-PD-1 monoclonal antibody developed by Shanghai Junshi Biosciences Co Ltd and TopAlliance Biosciences Inc, LOQTORZI™ has been approved by the FDA for treating all lines of nasopharyngeal carcinoma (NPC). For NPC patients in the US, LOQTORZI™ offers renewed hope as it addresses a previously unmet medical need in the absence of NPC-specific treatments. FDA Roundup: https://lnkd.in/eU-bkith #FDAapproval #FDA #monoclonalantibody #pd1 #nasopharyngealcarcinoma #npc #medicalinnovation #loqtorzi #toripalimab #coherus #junshi #topalliance

Our global partner Compass Therapeutics published a trial in progress paper on ABL001 (CTX-009) in the international journal ‘Future Oncology’. This paper contains information on the research methodology, including study goals, clinical design and primary endpoints of COMPANION-002, a Phase 2/3 Randomized, Controlled Study of CTX-009 in Combination With Paclitaxel Versus Paclitaxel Alone in Adult Patients With Unresectable Advanced, Metastatic or Recurrent Biliary Tract Cancers Who Have Received One Prior Systemic Chemotherapy Regimen. If you want to get more information about COMPANION-002, please see this paper: https://lnkd.in/exMdsUpQ

#PaperSpotlight: On February 7, 2024, researcher Richard E. Kast from IIAIGC Study Center published a new research perspective in Oncoscience (Volume 11), entitled, “IPIAD- an augmentation regimen added to standard treatment of pancreatic ductal adenocarcinoma using already-marketed repurposed drugs irbesartan, pyrimethamine, itraconazole, azithromycin, and dapsone.” “This paper presents the rationale for adding five already approved and marketed generic drugs from general medical practice to the current standard current first line chemotherapy for pancreatic ductal adenocarcinoma (PDAC).” #PressRelease: https://lnkd.in/gbuqptYJ #cancerresearch #pancreaticcancer #PDAC #oncology #openaccess #openscience #peerreviewed #meded #publishing #publication

Back to 1992, when being approved as the first immunotherapy and used for treatment of metastatic renal cancer, IL-2 has long been seen as a shining beacon for drug developers. However, various failure in the past years have led many to question whether it is merely an elusive and unattainable unicorn. But failure sometimes could also present opportunity. In drug development, we never lack courageous and tirelessly venturing warriors. Hanmi Pharmaceuticals, bringing their lead molecule, HM16390, is definitely one of them. As their novel IL-2 analog liked with human IgG4, Hanmi Pharmaceuticals has two posters introducing it in the Late-Breaking Research Poster session at the upcoming AACR 2024 conference (April 5-10) in San Diego. Based on the their public preclinical result, HM16390, by tuning its affinity to IL-2Rα and IL-2Rβ respectively, shows effective anti-tumor efficacy while possessing good safety profile. Check link for more detail: https://www.aacr.org https://lnkd.in/g9wfHzGj Additionally, the 2024 Annual Conference of our society, featuring numerous novel modalities of biologics, will convene in Cambridge, MA, USA on Saturday, May 11, 2024. Registration for the conference is now open via the following link. https://lnkd.in/ecmFPA4v #antibodydiscovery #immunotherapy #oncology #annualmeeting #annualconference #aacr #cancer

In the latest FDA Roundup, Dr. Richard Pazdur, director of FDA’s Oncology Center of Excellence (OCE), expresses his excitement for the approval of LOQTORZI™ (toripalimab-tpzi): “Today’s approval of Loqtorzi is the first approval in the United States of a drug to treat nasopharyngeal carcinoma. When combined with chemotherapy this drug has demonstrated an improvement in overall survival as well as delaying the progression of disease in patients with metastatic or recurrent, locally advanced disease who had not received prior chemotherapy.” An anti-PD-1 monoclonal antibody developed by Shanghai Junshi Biosciences Co Ltd and TopAlliance Biosciences Inc, LOQTORZI™ has been approved by the FDA for treating all lines of nasopharyngeal carcinoma (NPC). For NPC patients in the US, LOQTORZI™ offers renewed hope as it addresses a previously unmet medical need in the absence of NPC-specific treatments. FDA Roundup: https://lnkd.in/eU-bkith #FDAapproval #FDA #monoclonalantibody #pd1 #nasopharyngealcarcinoma #npc #medicalinnovation #loqtorzi #toripalimab #coherus #junshi #topalliance

📅 Save the Date: Join LifeSci Events and Cidara Therapeutics for a virtual research and development day on September 21st at 12:00 PM EDT! Reserve your seat: https://lnkd.in/ePs2dP7J 🌟 Featured Speakers: – Jorge Villacian, MD & Penny Heaton, MD from Janssen Pharmaceuticals will present Phase 2a data on CD388 (JNJ-0953), a promising drug candidate aimed at the universal prevention of seasonal flu. – Stephen Schoenberger, PhD of La Jolla Institute for Immunology will shed light on the unmet needs in cancer immunotherapy. – Ezra Cohen, MD, CMO at Tempus, will discuss the emerging significance of drug-Fc conjugates (DFCs) in precision oncology. The leadership team from Cidara will also share exciting updates on its Cloudbreak® pipeline focusing on oncology DFCs, and offer insights into clinical development considerations for DFCs targeting solid tumors. 🎤 Live Q&A: Stay tuned for a live Q&A session where you can get your questions answered by these industry leaders! #InfluenzaPrevention #CancerImmunotherapy #DrugDevelopment #Pharmaceuticals #InfectiousDiseases #Oncology #PrecisionMedicine #LifeSciEvent #LifeSciences

2seventy bio and Bristol Myers Squibb "are expanding their Abecma treatment site footprint to help more patients access the treatment, 2seventy said. Part of that push will include renewed physician education—especially on treatment sequencing and the emerging data supporting the use of BCMA-directed CAR-Ts before other BCMA-targeted therapies. Further, 2seventy wants to help doctors recognize the significance of Abecma’s real-world safety and efficacy." The former is anticipating FDA's decision for Abecma which could potentially move it to 3L use, as it is currently approved as 5L therapy. 2Seventy will also pass along their R&D assets to Regeneron #2SeventyBio #Biotech #Pharma #BMS #BristolMyersSquibb #CART #CellTherapy #AdvancedTherapeutics #Abecma #Innovation #Cancer #Oncology #Healthcare

Didn’t get a chance to talk to us at #ASH2023? Read the first part of our latest blog series “Old biomarkers, new tricks” which discusses our insights from the December meeting! Leila Luheshi, VP Pharma Partnering, describes the potential of menin inhibitors for acute leukemia, including the use of IVDR approved FISH probes in clinical trials. Read Part 1 of this series here: https://lnkd.in/gCxMefme

https://lnkd.in/gZ-4nBx7 Key Insights: • MARIPOSA marks the third RYBREVANT® Phase 3 study to readout this year following PAPILLON and MARIPOSA-2 • It received accelerated approval from the USFDA in May 2021 for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) that has specific EGFR exon 20 insertion mutations, as determined by an FDA-approved test Visit MedicoInsights to explore key insights #NSCLC #cancer #knowledge #lymphoma  #HealthTrends #Insights #HealthIndustry #HealthInnovation #latestnews #HealthcareAnalytics #NewsUpdate #HealthcareNetworking #pharma #pharmaceuticals #pharmanews #pharmaindustry #pharmainnovation #update #medicoinsights #news #pharma #health #dailynews