BEDMINSTER, N.J., Aug. 3, 2022 /PRNewswire/ -- Jubilant Therapeutics Inc., a biopharmaceutical Company advancing small molecule precision therapeutics to address unmet medical needs in oncology and autoimmune diseases, today announced U.S. Food and Drug Administration (US FDA) clearance of the Investigational New Drug application (IND) for JBI-778, an oral, brain penetrant and selective protein arginine methyl transferase 5 (PRMT5) inhibitor, for the treatment of solid tumors with brain metastases and primary brain tumors including high-grade glioma. Jubilant Therapeutics Inc. announces US FDA clearance of& IND for JBI-778, an Oral, Brain Penetrant and Selective PRMT5 Inhibitor,& for treatment of solid tumors with brain metastases and primary brain tumors The Phase I/II trial is an open-label, two-part dose escalation and expansion study designed to define the safety profile, pharmacokinetics, optimal dosing and preliminary activity of JBI-778. The study population in the dose escalation phase will include patients with stable brain metastasis whose disease has failed prior standard therapy. Expansion cohorts will include patients with active brain metastases and high-grade gliomas. Hari S Bhartia, Chairman, Jubilant Therapeutics Inc. shared on the announcement, "JBI-778 will be our second, highly selective oral drug candidate to enter clinical development following JBI-802. These two programs, along with several others partnered or in preclinical development, highlight Jubilant Therapeutics' proven discovery engine and structure-based drug discovery expertise." Syed Kazmi, Chief Executive Officer, Jubilant Therapeutics Inc. said, "JBI-778 was engineered by our drug discovery team to be a PRMT5 substrate-competitive and brain penetrant drug candidate to address primary brain tumors and brain metastases which currently have limited treatment options. The incidence of brain metastasis is increasing due to improved therapies, increased imaging of neurologically asymptomatic patients and patients living longer. Our team has developed a unique capability to optimize brain penetration for precision oncology therapeutics. In addition to JBI-778, we are also advancing an oral brain penetrant PDL1 inhibitor, JBI 2174, which is on the IND-track to potentially treat primary CNS cancers among others." About JBI-778 JBI-778 is a potent and selective brain penetrant inhibitor of protein arginine methyl transferase 5 (PRMT5), which is overexpressed in many cancers. JBI-778 is in development for the treatment of patients with advanced cancer with brain metastasis, and patients with high-grade glioma all of whom have limited treatment options. It has a unique mechanism of action compared to existing PRMT5 inhibitors by being substrate-competitive and S-adenosylmethoinine (SAM) cooperative, combined with a high brain exposure that enables targeting of both primary brain tumors and CNS metastasis. The substrate competitive profile appears to provide enhanced selectivity in the biological system by not interfering with the functions of SAM and shows a good tolerability profile in toxicological studies. About Jubilant Therapeutics Inc. Jubilant Therapeutics Inc. is a clinical stage precision therapeutics Company advancing potent and selective small molecule modulators to address unmet medical needs in oncology and autoimmune diseases. Its advanced discovery engine integrates structure-based design and computational algorithms to discover and develop novel, precision therapeutics against both first-in-class and validated but intractable targets in genetically defined patient populations. The Company's advanced pipeline consists of a first-in-class dual epigenetic modifier, JBI-802, currently in a Phase I/II clinical trial to treat solid tumors, a novel brain-penetrant modulator of PRMT5 for which an IND has been accepted, a brain penetrant PDL1 inhibitor, as well as PAD4 inhibitors for oncology and inflammatory indications. The Company is headquartered in Bedminster, New Jersey and guided by globally renowned key opinion leaders and scientific advisory board members. For more: www.jubilanttx.com

合作First in Class小分子药物

2022-06-22

·GlobeNewswire-Health Care

Aligos Therapeutics Presents 28-Day Safety, Efficacy and Pharmacokinetic Clinical Data for CAM Drug Candidate ALG-000184, First Clinical Data for NASH Drug Candidate ALG-055009 and Nonclinical Data in Other Chronic Hepatitis B Programs at the European Association for the Study of the Liver’s Digital International Liver Congress™ 2022

-Similar significant reductions of hepatitis B virus (HBV) DNA and HBV RNA observed following 28 days of daily oral ALG-000184 dosing, regardless of HBeAg status, across first four dosing chronic hepatitis B (CHB) patient cohorts-In the first clinical data presentation from our NASH program, preliminary data on multiple ascending doses of ALG-055009 in subjects with hyperlipidemia demonstrated favorable pharmacokinetics, safety, and anti-lipid activity-Presentations include nonclinical data from 2 other CHB programs SOUTH SAN FRANCISCO, Calif., June 22, 2022 (GLOBE NEWSWIRE) -- Aligos Therapeutics, Inc. (Nasdaq: ALGS), a clinical stage biopharmaceutical company focused on developing novel therapeutics to address unmet medical needs in viral and liver diseases, today announced that the company is presenting two posters showcasing preliminary Phase 1 data from its capsid assembly modulator (CAM) program in CHB and its thyroid hormone receptor-beta (THR-b) agonist in nonalcoholic steatohepatitis (NASH) at the European Association for the Study of the Liver Digital International Liver Congress™ 2022 (EASL ILC 2022). ILC 2022 is being held on June 22 - 26 at the ExCeL London Exhibition Centre in London, UK. The company is also presenting nonclinical data from two other drug classes within Aligos’ CHB portfolio: small interfering RNA (siRNA) and a small molecule PD-L1 inhibitor. The posters will be available on the “Scientific Presentation and Publications” page in the “Presentations” section of Aligos’ website at www.aligos.com. “We are pleased to continue demonstrating progress from across our chronic hepatitis B portfolio including small-molecule capsid assembly modulators, small interfering RNA molecules and small-molecule PD-L1 inhibitors. Our team is also proud to announce the first clinical data from our THR-b agonist in NASH,” said Lawrence Blatt, Ph.D., MBA, Chairman and CEO of Aligos. “In the context of CHB, we believe that a multi-part approach that addresses HBV viral replication, HBsAg reduction and host T cell exhaustion may lead to either functional cure or effective chronic suppression for CHB patients. To date, our CAM program has shown dramatic reductions in viral DNA and RNA in CHB patients following 28 days of dosing in several CHB patient cohorts and dosing in additional cohorts is ongoing. We also plan to soon initiate a longer-term study evaluating ALG-000184 in combination with nucleos(t)ide analog therapy in HBeAg positive CHB. With respect to our siRNA program, ALG-125755, a potential best-in-class HBV siRNA, we remain on track to begin dosing in a Phase 1 study in healthy volunteers in the fourth quarter of this year. Meanwhile, on the NASH front, we are encouraged by initial clinical data for ALG-055009 in subjects with hyperlipidemia; additional data from this trial are expected to be released in the third quarter of this year.” Aligos’ ILC 2022 presentations, and their potential implications, are summarized below. Chronic hepatitis B (CHB) ALG-000184: Capsid assembly modulator (CAM)Poster number: SAT365Title: Safety, Pharmacokinetics, and Antiviral Activity of the Class II Capsid Assembly Modulator ALG-000184 in Subjects with Chronic Hepatitis BPresenter: Professor Man-Fung Yuen, MBBS, M.D., Ph.D., DSc, University of Hong Kong, Hong KongSummary: ALG-000184 is currently being evaluated in the ALG-000184-201 trial, a multi-part, double blind, randomized, placebo-controlled Phase 1 study (NCT04536337). Part 3 is ongoing and evaluating multiple cohorts (N=10/cohort; 8 active: 2 placebo) of currently not treated/treatment-naïve CHB subjects, who receive daily oral doses of ALG-000184 for 28 days, after which they are followed up for 8 weeks. Here, authors report preliminary safety, pharmacokinetic and antiviral data for CHB subjects enrolled in the following cohorts in Part 3: Cohort 1: 100 mg drug/placebo in HBeAg negative CHBCohort 2: 50 mg drug/placebo in HBeAg-negative CHBCohort 3: 10 mg drug/placebo in HBeAg-negative CHBCohort 4: 100 mg drug/placebo in HBeAg-positive CHB Key findings were as follows: Similar rapid declines in HBV DNA and HBV RNA were observed at all dose levels, regardless of HBeAg status. Among HBeAg-negative subjects, high rates of DNA and RNA reductions below the lower limit of quantification (LLOQ) were observed, with 100% of subjects

抗体小分子药物siRNA

100 项与 JBI-2174 相关的药物交易

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