Replies to post #233292 on Biotech Values

[DewDiligence]

ASMB—(+10%)—inks deal with BGNE for Greater-China development/commercialization of ASMB’s HBV core inhibitors—$40M up-front cash for ASMB ($500M biobucks):

https://www.globenewswire.com/news-release/2020/07/20/2064219/0/en/Assembly-Biosciences-and-BeiGene-Announce-License-and-Collaboration-Agreement-in-China-for-Assembly-s-Portfolio-of-Three-Clinical-Stage-Core-Inhibitors-for-Chronic-Hepatitis-B-Infe.html

*Includes Taiwan, Hong Kong, Macao.

[DewDiligence]

ASMB, ABUS collaborate on phase-2 HBV trial testing triple combination vs double combinations (plural):

https://www.globenewswire.com/news-release/2020/08/27/2084756/0/en/Assembly-Biosciences-and-Arbutus-Biopharma-Announce-Clinical-Collaboration-Agreement-to-Evaluate-the-Combination-of-Core-Inhibitor-ABI-H0731-with-RNAi-Therapeutic-AB-729-in-Patient.html

A randomized, multi-center, open-label Phase 2 clinical trial will explore the safety, pharmacokinetics, and antiviral activity of the triple combination of HBV core inhibitor ABI-H0731 [from ASMB], RNAi therapeutic AB-729 [from ABUS] and an NrtI [Vemlidy or Baraclude] compared to the double combinations of ABI-H0731 with an NrtI and AB-729 with an NrtI.

This clinical trial is projected to initiate in the first half of 2021 and enroll approximately 60 virologically-suppressed patients with HBeAg negative or positive chronic HBV infection. Patients will be dosed for 48 weeks, with a 24 week follow-up period.

The companies are sharing the cost of the trial, but no other money is changing hands.

Note that ABI-H0731 is not ASMB’s latest-generation core inhibitor (CpAM), and it has shown only modest efficacy as monotherapy—see #msg-156515976 and #msg-152253534.

[DewDiligence]

ASMB—(-37%/AH)—suffers_massive_phase-2_failure in HBV:

https://www.globenewswire.com/news-release/2020/11/05/2121468/0/en/Assembly-Biosciences-Provides-Update-on-the-Ongoing-Phase-2-Extension-Study-of-Vebicorvir-in-Patients-with-Chronic-Hepatitis-B-Virus-Infection.html

Assembly Biosciences…provided an update on the ongoing open-label Phase 2 extension study (Study 211) of vebicorvir (VBR, or ABI-H0731) in patients with chronic HBV infection. A first of its kind, Study 211 is exploring whether sustained virologic response (SVR) could be achieved after discontinuing therapy in virologically-suppressed patients who had received at least 12-18 months of combination treatment with core inhibitor VBR and a nucleos(t)ide analogue reverse transcriptase inhibitor (NrtI). Study patients who met the treatment stopping criteria discontinued therapy and have been assessed monthly for safety and relapse. The study has not achieved meaningful SVR rates as 39 of 41 patients have now relapsed.

I previously posted that ABI-H0731 appeared to have only modest efficacy (#msg-156515976), which is why ASMB has a backup CpAM compound for HBV called ABI-H2158. Today’s failure presumably spells the end of ABI-H0731 as a serious candidate.

Note: ENTA has an HBV CpAM in phase-2 that the CEO says is much more potent than ABI-H0731 (#msg-156787041).