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20:05 EDT Innovent, Lilly say TYVYT approved by China NMPA in combo with chemotherapy - Innovent Biologics and Eli Lilly announced that the National Medical Products Administration of China has approved the supplemental New Drug Application for TYVYT in combination with fluorouracil and platinum-based chemotherapy for the first-line treatment of unresectable, locally advanced, recurrent or metastatic gastric or gastroesophageal junction adenocarcinoma. This is the sixth NMPA-approved indication of TYVYT. TYVYT is the first domestic PD-1 inhibitor approved for the first-line treatment of gastric cancer and is currently approved for the first-line treatment in five major types of cancers. In China, TYVYT was approved for the treatment of relapsed or refractory classical Hodgkin's lymphoma in December 2018, first-line treatment of nonsquamous non-small cell lung cancer in February 2021, first-line treatment of squamous NSCLC, and the first-line treatment of hepatocellular carcinoma in June 2021; and the first-line treatment of esophageal squamous cell carcinoma in June 2022. The approval in China was based on the results of a randomized, double-blind, multicenter Phase III clinical trial evaluating sintilimab in combination with chemotherapy, compared to placebo in combination with chemotherapy, for the first-line treatment of unresectable, locally advanced, recurrent or metastatic gastric or gastroesophageal junction adenocarcinoma.

16:49 EDT Madrigal Pharmaceuticals presents late-breaking Phase 3 NASH data - Madrigal Pharmaceuticals announced data from multiple resmetirom abstracts presented at the European Association for the Study of the Liver's International Liver Congress, including a late-breaking presentation of data from the Phase 3 MAESTRO-NAFLD-1 study and three additional oral presentations from the resmetirom clinical development program. Primary and key secondary endpoints from the double-blind, placebo-controlled, 969-patient MAESTRO-NAFLD-1 safety study were achieved; resmetirom was safe and well tolerated and provided significant reductions in liver fat, LDL-C, and other atherogenic lipids vs placebo. Patients treated with resmetirom also achieved significant reductions relative to placebo in ALT, AST, and GGT. For those patients with sufficient baseline liver stiffness, as measured by FibroScan vibration-controlled transient elastography or magnetic resonance elastography, responder analyses showed statistically significant VCTE and MRE responses in the resmetirom groups compared to placebo. Adverse event-related withdrawals were uncommon in the MAESTRO-NAFLD-1 study. The most common adverse event reported with greater frequency in the resmetirom groups vs placebo was generally mild diarrhea or increased stool frequency at the beginning of therapy. 105 patients with well-compensated NASH cirrhosis were enrolled in the open-label arm of the MAESTRO-NAFLD-1 study. Baseline FibroScan VCTE and MRE scores were consistent with F4 fibrosis. Patients with lower MRI-PDFF at baseline had more progressed cirrhosis and greater spleen volumes. Similar to patients with non-cirrhotic NASH, liver volume was greatly elevated compared to normal at baseline. Resmetirom reduced MRI-PDFF and LDL-C and other atherogenic lipids in patients with NASH cirrhosis and reduced FibroScan controlled attenuation parameter, VCTE, and MRE in a significant fraction of patients. The largest reduction in FibroScan VCTE occurred in the more advanced group. Similar improvements were observed in MRE. 73% of patients, independent of baseline cirrhosis severity, had at least 15% reduction in liver volume at Week 52. Spleen volume was also reduced and was strongly correlated with liver volume change and exposure to resmetirom. Reductions in liver enzymes and atherogenic lipids were similar across patient subgroups. Resmetirom was safe and well tolerated. As observed in patients with noncirrhotic NASH, mild GI adverse events were seen at the beginning of therapy. No differences in safety parameters between patients with cirrhosis compared to noncirrhotic NASH patients were noted. No thyroid axis changes or hyper- or hypothyroid symptoms were observed. Abstracts from the resmetirom development program provide new insights to inform noninvasive testing strategies, improve artificial intelligence-based evaluation of treatment response, and better characterize the cost burden of NASH.

16:39 EDT Arbutus presents new data on AB-729, AB-836 and AB-101 at EASL ILC - Arbutus Biopharma announced the presentation of new clinical and pre-clinical data from its proprietary compounds at the European Association for the Study of the Liver International Liver Congress. The new clinical data for AB-729, its RNAi therapeutic, continues to support its development as a potential cornerstone agent for the treatment of chronic hepatitis B infection. In addition, when AB-729 and nucleos(t)ide analogues were discontinued in the first five patients who met stopping criteria and consented, there was no evidence of virologic or clinical relapse in at least 8-24 weeks of follow-up, which may lead to a functional cure. AB-836, its oral capsid inhibitor, demonstrated robust antiviral activity, however, two patients in the 200 mg cohort experienced alanine aminotransferase elevations. Based on these observations along with potentially correlated immunological findings, the company plans to conduct a Phase 1 clinical trial in healthy volunteers before progressing this program. Professor Man-Fung Yuen, Deputy Head of Department, Chief of Division of Gastroenterology and Hepatology, Master of Lap Chee, University of Hong Kong, and lead investigator of AB-729-001 clinical trial, presented a poster titled, "Continued suppression of viral markers observed following discontinuation of nucleos(t)ide analogue therapy in chronic hepatitis B subjects with low hepatitis B surface antigen levels after 48 weeks of treatment with AB-729". This presentation focused on the preliminary safety and virology data from those patients in part 3 of the AB-729-001 clinical trial who completed treatment with AB-729 and, after meeting the protocol-defined criteria, elected to stop their NA-therapy. Prof. Yuen reported on the first five of the nine patients that had between 8 and 24 weeks of data following discontinuation of all treatment. The mean HBsAg for the five patients at baseline was 2887 IU/mL compared to 69 IU/mL at the last visit after discontinuing all treatment. All five patients remain off all treatment, and all have HBsAg levels below pre-baseline levels. None of the patients have met clinical or virologic relapse criteria. There were no adverse events reported, no ALT elevations observed, and HBV DNA levels remain either less than the LLOQ or have transiently risen and subsequently decreased without intervention. Prof. Yuen also presented data from a poster titled, "Long-term suppression maintained after cessation of AB-729 treatment and comparable on-treatment response observed in HBeAg+ subjects." In addition, Prof. Yuen presented follow-up data on Cohort G, which included HBV DNA+ patients who began treatment with tenofovir disoproxil fumarate concurrently with AB-729, and Cohorts E, F, I and J, which enrolled HBeAg- and HBV DNA- patients and evaluated different doses and dosing intervals. Prof. Edward Gane, University of Auckland, New Zealand Liver Transplant Unit, Auckland, New Zealand, presented the full data from this trial in a poster titled, "Safety, tolerability, pharmacokinetics, and antiviral activity of the 3rd generation capsid inhibitor AB-836 in healthy subjects and subjects with chronic hepatitis B." AB-836-001 is a Phase 1a/1b clinical trial evaluating the safety and tolerability of multiple doses of AB-836 in patients with cHBV infection. Data from part 3 of the trial showed that the 100mg and 200mg doses of AB-836 provided potent inhibition of HBV replication with mean declines in HBV DNA at Day 28 of 3.04 and 3.55 log10 IU/mL, respectively. From a safety standpoint, there were no deaths or SAEs observed. Two HBeAg+ patients in the 100mg dose cohort had transient Grade 3 ALT elevations that resolved with continued dosing and were not considered treatment emergent adverse events. Two patients in the 200mg cohort had Grade 3 and Grade 4 ALT elevations on the last day of dosing that returned to baseline during follow up which were reported as TEAEs. The Grade 3 and Grade 4 ALT elevations seen in the 200 mg cohort were accompanied by serum IP-10 increases, a cytokine previously described to be associated with potential liver toxicity in the capsid inhibitor space. All patients with ALT elevations were asymptomatic and none had changes in bilirubin or met drug-induced liver injury criteria. There were no other clinically significant lab abnormalities, ECG or vital sign changes observed. Dr. Emily Thi presented data from a poster titled, "Preclinical activity of small-molecule oral PD-L1 checkpoint inhibitors capable of reinvigorating T cell responses from chronic hepatitis B patients." The purpose of this study was to assess the preclinical activity of AB-101 and the compound's ability to reinvigorate patient HBV-specific T-cells. Studies were conducted using a transgenic MC38 tumor mouse model and peripheral blood mononuclear cells from cHBV patients. The data presented showed that once daily oral administration of AB-101 resulted in profound tumor reduction that was associated with T-cell activation. In addition, AB-101 activates and reinvigorates HBV-specific T-cells. This favorable preclinical profile supports further development of AB-101 as a therapeutic modality for cHBV treatment. AB-101 is currently undergoing IND-enabling activities.

16:15 EDT Sinovac Biotech COVID-19 vaccine conditionally registered in South Africa - Sinovac Biotech announced that the South African Health Products Regulatory Authority granted conditional registration to SINOVAC CoronaVac in aged 18 and above adults, based on acceptable safety, quality, and efficacy data submitted. The vaccine is administered intramuscularly in two doses with a 14 to 28-day interval. The CoronaVac was previously authorized for emergency use with conditions by the SAHPRA on July 3, 2021.