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Details:
The proceeds will be used to advance its unique, in-house, silica-based, drug delivery technology platform into clinical development, including DST1308 in Chronic Hepatitis B, as well as expanding its in-house manufacturing capability.
Lead Product(s): Entecavir
Therapeutic Area: Infections and Infectious Diseases Product Name: DST1308
Highest Development Status: UndisclosedProduct Type: Small molecule
Partner/Sponsor/Collaborator: DRW Venture Capital LLC
Deal Size: $10.8 million Upfront Cash: Undisclosed
Deal Type: Financing January 16, 2024
Details:
AB-729 is a subcutaneously-delivered RNAi therapeutic specifically designed to reduce all HBV viral antigens, which is thought to be a key prerequisite to enable reawakening of a patient’s immune system to respond to virus.
Lead Product(s): AB-729,Vebicorvir,Entecavir
Therapeutic Area: Infections and Infectious Diseases Product Name: AB-729
Highest Development Status: Phase IIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Assembly Biosciences
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 24, 2022
Details:
AB-729 is an RNA interference (RNAi) therapeutic specifically designed to reduce all HBV viral proteins and antigens, including hepatitis B surface antigen, which is thought to be a key prerequisite to enable reawakening of a patient’s immune system to respond to the virus.
Lead Product(s): AB-729,Vebicorvir,Entecavir
Therapeutic Area: Infections and Infectious Diseases Product Name: AB-729
Highest Development Status: Phase IIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Assembly Biosciences
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 20, 2022
Details:
ABI-H0731 (Vebicorvir), is a first-generation core inhibitors has been shown to be well-tolerated and statistically superior in antiviral activity in hepatitis B virus DNA suppression.
Lead Product(s): Vebicorvir,AB-729,Entecavir
Therapeutic Area: Infections and Infectious Diseases Product Name: ABI-H0731
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 04, 2022
Details:
ABI-H0731, a first-generation hepatitis B virus (HBV) core protein inhibitor, has demonstrated effective antiviral activity in chronic hepatitis B (CHB) patients also exhibited selective inhibition of HBV DNA replication.
Lead Product(s): Vebicorvir,Entecavir,Pegylated-interferon Alpha
Therapeutic Area: Infections and Infectious Diseases Product Name: ABI-H0731
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 01, 2021
Details:
The Phase 2 clinical study for ABI-H2158 is a multi-center, randomized, placebo-controlled trial in treatment-naïve patients with HBeAg positive or HBeAg negative chronic hepatitis B infection without cirrhosis.
Lead Product(s): ABI-H2158,Entecavir
Therapeutic Area: Infections and Infectious Diseases Product Name: ABI-H2158
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 01, 2021
Details:
Trial will evaluate Assembly’s core inhibitor candidate, vebicorvir, with Arbutus’ RNAi therapeutic candidate, AB-729, and standard-of-care NrtI therapy.
Lead Product(s): Vebicorvir,AB-729,Entecavir
Therapeutic Area: Infections and Infectious Diseases Product Name: ABI-H0731
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: BeiGene
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 26, 2021
Details:
Assembly Biosciences is foregoing its plans to initiate Phase 3 registrational studies of vebicorvir (VBR, or ABI-H0731) as a chronic suppressive therapy (CST) to concentrate its research and development efforts on finite and curative HBV therapies.
Lead Product(s): Vebicorvir,GalNAc-RNAi,Entecavir
Therapeutic Area: Infections and Infectious Diseases Product Name: ABI-H0731
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 25, 2021
Details:
In Phase 2 clinical trials, first-generation core inhibitor vebicorvir administered with nucleos(t)ide analogue reverse transcriptase inhibitor therapy has been well-tolerated, has shown statistically superior antiviral activity in HBV DNA suppression to NrtI therapy alone.
Lead Product(s): Vebicorvir,Tenofovir Alafenamide,Entecavir
Therapeutic Area: Infections and Infectious Diseases Product Name: ABI-H0731
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 02, 2020
Details:
Assembly’s novel core inhibitor vebicorvir in combination with standard-of-care NrtI continues to demonstrate a favorable safety and tolerability profile, with no observed treatment-emergent resistance in patients with HBeAg negative chronic HBV infection.
Lead Product(s): Vebicorvir,Entecavir
Therapeutic Area: Infections and Infectious Diseases Product Name: ABI-H0731
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 28, 2020
Details:
Findings from the preclinical study show that APG-1387 is able to clear chronic HBV infection in various mouse models with a unique induction of apoptosis and immunoregulation mechanism.
Lead Product(s): APG-1387,Entecavir
Therapeutic Area: Infections and Infectious Diseases Product Name: APG-1387
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 27, 2020
Details:
F351 was generally well tolerated in this study. In patients treated with placebos, 60 mg/tid F351, 90 mg/tid F351, and 120 mg/tid F351, respectively.
Lead Product(s): Hydronidone,Entecavir
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: F351
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 17, 2020
Details:
U.S. Food and Drug Administration (FDA) has granted Fast Track designation to ABI-H2158 (2158) for the treatment of patients with chronic HBV infection. 2158 is Assembly’s second-generation core inhibitor, which is being evaluated in an ongoing global Phase 2 trial.
Lead Product(s): ABI-H2158,Entecavir
Therapeutic Area: Infections and Infectious Diseases Product Name: ABI-H2158
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 09, 2020
Details:
The international multi-center, randomized, placebo-controlled trial will evaluate 2158 with entecavir versus placebo with entecavir in treatment-naïve patients with HBeAg positive chronic hepatitis B infection without cirrhosis.
Lead Product(s): ABI-H2158,Entecavir
Therapeutic Area: Infections and Infectious Diseases Product Name: ABI-H2158
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 25, 2020
Details:
The global multi-center, open-label Phase II study is designed to evaluate the safety and efficacy of APG-1387 in combination with entecavir in patients with CHB who are treatment-naive or -experienced.
Lead Product(s): APG-1387,Entecavir
Therapeutic Area: Infections and Infectious Diseases Product Name: APG-1387
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 17, 2020
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