Biointron的动态

?? Exciting News from Hamlet BioPharma! ?? We're thrilled to announce that our drug candidate, Alpha1H, has shown strong anti-tumor effects in patients with bladder cancer, as detailed in our latest publication in?Cancer Medicine! The study reveals significant dose-dependent effects, with 88% of tumors showing complete or partial responses at higher doses, and a reduction in tumor size by 59% compared to only 5% in the placebo group. Importantly, no significant drug-related side effects were observed. These promising results have earned Alpha1H Fast Track status from the FDA for treating non-muscle invasive bladder cancer. ?? Read the publication here: https://lnkd.in/dYBqCmAK. #BladderCancer #PharmaInnovation #Alpha1H #CancerTreatment #FDAFastTrack #HamletBioPharma #MedicalResearch #Oncology #HealthcareInnovation

Zai Lab (NASDAQ: ZLAB, SEHK: 9688) presented data from the ongoing global Phase 1a/1b study of ZL-1310, a potential best-in-class next-generation antibody-drug conjugate (ADC), at the EORTC-NCI-AACR (ENA) Symposium 2024 in Spain, as an oral presentation during the plenary session. ZL-1310 is being tested in patients with previously treated extensive-stage small cell?lung cancer?(ES-SCLC) after at least one prior platinum-based chemotherapy regimen. "The preliminary results from the ongoing Phase 1 trial of ZL-1310 suggest that this next-generation ADC therapy has the potential to deliver anti-tumor responses in the majority of patients with ES-SCLC, with good tolerability," said Dr. Alex Spira, a medical oncologist at Virginia Cancer Specialists and NEXT Oncology. "This is particularly encouraging given the urgent need for improved treatment options for these patients. These promising data support continued evaluation of ZL-1310 as a monotherapy in the dose-expansion phase of the ongoing Phase 1 clinical trial and in combination." #ZL1310 #SmallCellLungCancer #Phase1Trial #Oncology #ADC #CancerResearch #ENA2024 #ClinicalTrials #LungCancerTreatment #NextGenTherapies #AntibodyDrugConjugate #BiopharmaInnovation #CancerTreatment #PrecisionMedicine #QimingPortfolio #QimingHealthcare Read More: https://lnkd.in/g8MPWZiB

Datopotamab deruxtecan granted breakthrough therapy designation in US for patients with previously treated advanced EGFR-mutated non-small cell lung cancer The FDA granted this BTD based on data from the?TROPION-Lung05?Phase II trial with supporting data from the?TROPION-Lung01?Phase III trial. Results from a pooled analysis of patients with previously treated?EGFRm NSCLC in these studies were?presented?this month at the European Society of Medical Oncology (ESMO) Asia 2024 Congress. This is the first BTD for datopotamab deruxtecan.

Tackling large medical need in microsatellite stable (#MSS) colorectal cancer (#CRC) with improved therapy is persisting challenge. Are we on the verge of breakthrough in immunotherapy option? Possibly and interesting example of strategic navigation in combo therapy development. At #ESMO 2024 #ligufalimab (anti-#CD47 monoclonal antibody) plus #ivonescimab (anti-#VEGF x #PD-1 MAb) combined with chemo yielded ORR of 88% in the first-line CRC patients while chemo plus #ivonescimab alone resulted in an ORR of 82% https://lnkd.in/eVptyQ2w) . This data would argue that in CRC it is likely sufficient to combine #ivonescimab with chemo in order to get to best safety-efficacy profile. No surprise that further development of #ligufalimab in combo with #ivonescimab appears not to be in CRC despite large indication/medical need but in head and neck cancer (#HNSCC) where addition of #ligufalimab doubled ORR when added to #ivonescimab as the new Ph3 trial posted revealed (https://lnkd.in/eWbFe9Jt). Still this is relatively bold move considering small patient sample in the Ph2 but reaching 60% ORR of combo in #PDL-1 positive HNSCC is relatively strong initial signal. #clinical oncology #combination strategy #CRC #HNSCC #Phase3

New molecule developed by #Korea based innovative #biotech TiumBio targeting dual inhibition of transforming growth factor beta receptor 1 (#TGFR1) and vascular endothelial growth factor receptor 2 (#VEGFR2) is rapidly advancing and may bring great news to patients with head and neck squamous cell carcinoma (#HNSCC), biliary tract cancer (#BTC), and colorectal cancer (#CRC). Company just announced dosing of the first patient in Phase 2a trial of #TU2218 in combination with #Keytruda (#Pembrolizumab). https://lnkd.in/eYBip9Je #TU2218 is a first-in-class oral immune-oncology therapy simultaneously targeting transforming growth factor-β (#TGF-β) and vascular endothelial growth factor (#VEGF) that can potentially act to sensitize responses to #PD-1 inhibition in patients. #TU2218 is being investigated as a treatment of solid tumours as a monotherapy (NCT05204862) and in combination with #Keytruda (#Pembrolizumab) (NCT05784688). This rapid movement of the clinical development is a great achievement of the TiumBio oncology team as this very innovative biotech moves pipeline in other areas aside from oncology with most advanced candidate in endometriosis.

On April 30th, The FDA granted full approval?to?#Pfizer?and?#Genmab’s antibody-drug conjugate Tivdak (tisotumab vedotin-tftv) for the treatment of recurrent or #metastatic #cervicalcancer that had progressed on or after #chemotherapy. Originally developed under a partnership between Seagen and Genmab, Tivdak is an?antibody-drug conjugate?(ADC) that targets the cell surface tissue factor protein, which is an important part of the blood coagulation cascade. Its toxic payload is monomethyl auristatin E, a microtubule-disrupting agent that triggers cell death. Pfizer took over Seagen’s half of the deal when it?bought the cancer-focused biotech in March 2023 for $43 billion. Follow our page to learn more about pharmaceutical industry updates! #raslss #oncology #cancer #cervicalcancer

Results from the phase 1/1b trial of Inavolisib plus Palbociclib plus Endocrine therapy in PIK3CA mutated HR Pos HER2 negative metastatic breast cancer now published. No Drug Drug Interaction, most common treatment related adverse events were hyperglycemia, stomatitis, diarrhea. The triplet with fulvestrant backbone yielded a mPFS of 35 months. These data formed the basis for the phase 3 INAVO120 trial that has since demonstrated near doubling of mPFS from 7 to 15 months with the addition of Inavolisib compared to fulvestrant and palbociclib in 1L metastatic setting in PIK3CA mutated endocrine resistant disease. Inavolisib now has BTD and priority review by US FDA is expected by Nov 27 2024. Memorial Sloan Kettering Cancer Center Journal of Clinical Oncology

FDA Approves Enhertu for HER2-Low and -Ultralow Breast Cancer ? The antibody drug conjugate was approved for patients with unresectable or metastatic HER2-low or -ultralow breast cancer with disease progression after endocrine therapy. https://lnkd.in/efRJTBpJ

Major breakthrough in cervical cancer treatment! ?? Pfizer & Genmab's TIVDAK (tisotumab vedotin-tftv) receives full FDA approval for recurrent/metastatic cervical cancer. This marks a significant advancement,?offering improved survival outcomes for patients. #Pfizer #Genmab #ADCs #TIVDAK #FDAApproval #Oncology #CervicalCancer #Cancer #HealthcareInnovation

This Nature article explains the promise of Claudin-1 as a target in oncology! Nice-read of the day!