Ascletis’ Subcutaneous PD-L1 Antibody ASC22 Demonstrated Potential of Practical Treatment of Continual Hepatitis B as 42.9% of Sufferers with Baseline HBsAg≤100 IU / mL Obtained Sustained HBsAg Loss

–Ascletis offered Part IIb scientific trial outcomes of subcutaneous PD-L1 antibody ASC22 for practical remedy of CHB at oral session of EASL ILC 2022 on June 25, 2022Beijing Time

–The Part IIb scientific trial outcomes additional demonstrated the potential of ASC22 + NAs therapy as a practical remedy for CHB

–On-treatment ALT flares may be used as a predictor or monitor of sufferers’ responses to the CHB therapy

HANGZHOU, China and SHAOXING, China, June 26, 2022 / PRNewswire / – Ascletis Pharma Inc. (HKEX: 1672, “Ascletis”) in the present day broadcasts the most recent Part IIb scientific trial outcomes of subcutaneous PD-L1 antibody ASC22 (Envafolimab) in sufferers with power hepatitis B (CHB) at an oral parallel session of the Worldwide Liver Congress ™ 2022 (ILC 2022) held by the European Affiliation for the Research of the Liver (EASL).

The interim report relies on a randomized, single-blind, multi-center Part IIb scientific trial to evaluate the efficacy and security of ASC22 in therapy of CHB sufferers ( Identifier: NCT04465890). In 1.0 mg / kg ASC22 cohort, 75 CHB sufferers have been randomized to be handled with 1.0 mg / kg ASC22 (n = 60) or placebo (PBO, n = 15) as soon as each 2 weeks (Q2W) plus nucleos

The next units forth the important thing findings from the Part IIb scientific examine on ASC22:

  • 42.9% sufferers with baseline HBsAg ≤100 IU / mL (n = 7) obtained sustained HBsAg loss.
  • ALT flares have been noticed on 21% sufferers in ASC22 group (n = 48) whereas none in PBO group.
  • Sufferers with ALT flares had extra HBsAg discount. Among the many three sufferers with sustained HBsAg loss, two skilled ALT flares.
  • One affected person obtained sustained HBsAg loss beginning at Week 4 after two doses of ASC22 and skilled a transient seroconversion of anti-HBs at Week 28. This affected person stopped NAs therapy three days after 24-week therapy of ASC22, and HBsAg nonetheless remained unfavourable till finish of the examine.
  • Most opposed occasions (AEs) (97.5%) have been Grade 1-2, and no examine drug-related severe opposed occasion (SAE) was reported.

“For the previous years, Ascletis has been devoted to creating remedy for the practical remedy of CHB. ASC22 is essentially the most superior scientific stage immunotherapy on this planet for CHB practical remedy, ie HBsAg loss, via blocking PD-1 / PD-L1 pathway It is a terrific honor that our business main scientific trial end result on immunotherapy has been acknowledged by the reviewers and scientific committee of EASL and accepted as oral presentation in ILC. We’re very inspired by the promising efficacy and security profile that ASC22 has achieved as a possible practical remedy for CHB. We anticipate to additional advance the scientific research to learn extra sufferers. “Stated Dr. Jinzi J. WuFounder, Chairman and CEO of Ascletis.

CHB stays to be a considerably unmet medical want globally, with roughly 86 million folks in China and 1.59 million folks within the US contaminated with hepatitis B virus (HBV) [1]. NAs inhibit solely reverse transcription of HBV RNA into HBV DNA and don’t inhibit the transcription of HBV cccDNA into HBV RNA, thus haven’t any inhibitory impact on HBsAg.

Summary offered at ILC 2022 is as follows:

ALT flares have been linked to HBsAg discount, seroclearance and seroconversion: interim outcomes from a part IIb examine in power hepatitis B sufferers with 24-week therapy of subcutaneous PD-L1 Ab ASC22 (Envafolimab) plus nucleos

Presentation Kind: Oral Presentation

Summary Quantity: OS091

Session: Summary session: Hepatitis B rising therapies

Presenter: Prof. Guiqiang Wang, Director of Infectious Ailments Division and Liver Illness Middle of Peking College First Hospital

Presentation time: June 25, 2022, Saturday, 15: 15-15: 30 (Beijing Time)

* The summary could be accessed at:

[1]Lim JK, Nguyen MH, Kim WR, et al. Prevalence of Continual Hepatitis B Virus An infection in the USA [J]. The American journal of gastroenterology 2020, 115 (9): 1429-38.

About EASL

EASL is the world’s main medical affiliation devoted to liver illnesses analysis. Because the annual flagship occasion with over 10, 000 representatives taking part yearly, ILC is likely one of the most influential congress on hepatology analysis globally the place the advances, greatest practices and newest scientific breakthroughs are shared with the worldwide group. Among the many 1,993 abstracts accepted by ILC this 12 months, complete 9 Chinese language abstracts have been admitted to oral presentation. Ascletis’ ASC22 on CHB practical remedy is the one China biotech-initiated, HBV-related examine that has been chosen for oral presentation at ILC 2022.

About Ascletis

Ascletis is an modern R&D pushed biotech listed on the Hong Kong Inventory Change (1672.HK), overlaying your entire worth chain from discovery and growth to manufacturing and commercialization. Led by a administration crew with deep experience and a confirmed monitor document, Ascletis focuses on three therapeutic areas with unmet medical wants from a worldwide perspective: viral illnesses, non-alcoholic steatohepatitis (NASH) and oncology. By way of glorious execution, Ascletis quickly advances its drug pipeline with an goal of main in international competitors. Thus far, Ascletis has three marketed merchandise, ie ritonavir tablets, GANOVO® and ASCLEVIR®, and 20 drug candidates in its R&D pipeline. Probably the most superior drug candidates embody ASC22 (HBV practical remedy), ASC10 and ASC11 (oral small molecules for COVID-19 therapy), ASC40 (recurrent glioblastoma), ASC42 (PBC, main biliary cholangitis), and ASC40 (pimples).

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