HBV

HOOKIPA Reports Fourth Quarter and Full Year 2021 Financial Results and Provides 2022 Outlook

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Thursday, March 24, 2022
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As we work to introduce a new class of novel arenaviral immunotherapies, were proud of the progress we made in 2021.

Key Points: 
  • As we work to introduce a new class of novel arenaviral immunotherapies, were proud of the progress we made in 2021.
  • HOOKIPA expects to file an Investigational New Drug (IND) application for HB-300 in the third quarter of 2022.
  • In February 2022, HOOKIPA and Gilead agreed to advance its partnered HIV program, triggering a $54 million commitment from Gilead.
  • Conference call: HOOKIPA will host a conference call and live webcast at 8:30 am EST today to discuss its financial results and provide a corporate update.

Aligos Discontinues Development of its Antisense Oligonucleotide Drug Candidate ALG-020572 in Subjects with Chronic Hepatitis B and Pivots Internal Strategic Emphasis to its Small Molecule Portfolio

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Tuesday, March 22, 2022
Hospital, Drug development, Degenerative disease, Therapy, Partnership, CHB, Institute of Liver and Biliary Sciences, Investment, Forward-looking statement, ALT, SAN, CEO, RNA, HVS, U.S. Securities and Exchange Commission, Hepatitis, Private Securities Litigation Reform Act, Flare, NASH, Sirna, Safety, Liver disease, Doctor of Philosophy, Nasdaq, MBA, COVID-19, Viral hepatitis, PD-L1, GLOBE, HBV, COVID, Fatty liver disease, Terminology, SAE, Hyperlipidemia, CAM, Annual report, Patient, Merck, Security (finance), Pharmaceutical industry, Vaccine, Fine chemical, Jacob Aligo

SOUTH SAN FRANCISCO, Calif., March 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 it has discontinued development of its drug candidate, ALG-020572, which was being studied in subjects with chronic hepatitis B (CHB). Dosing in the first CHB cohort of Study ALG-020572-401 (NCT05001022) was stopped after one subject experienced a serious adverse event (SAE) with significant increase in alanine aminotransferase (ALT) following multiple dosing of 210 mg ALG-020572 that resulted in a brief hospitalization. This is one of four CHB subjects in this first cohort who experienced potentially drug-related ALT flares, which were unexpected based on prior experience in nonclinical studies and single dose safety data in healthy volunteers. In all four CHB subjects, laboratory parameters and symptoms are improving and the hospitalized subject has been discharged.

Key Points: 
  • In all four CHB subjects, laboratory parameters and symptoms are improving and the hospitalized subject has been discharged.
  • We will continue to follow emerging safety and antiviral activity data as these subjects complete their off-treatment follow-up to understand these events further.
  • Aligos CHB portfolio includes a small interfering RNA (siRNA) drug candidate, Class 1 and 2 capsid assembly modulators (CAM-1, CAM-2) and small molecule inhibitors of programmed death ligand 1 (PD-L1).
  • Aligos NASH portfolio includes a small molecule thyroid hormone receptor beta (THR-) agonist, ALG-055009, as well as an oligonucleotide program with undisclosed targets that is partnered with Merck.

HOOKIPA Announces Promotion of Klaus Orlinger, Ph.D. to Chief Scientific Officer

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Tuesday, March 22, 2022
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NEW YORK and VIENNA, Austria, March 22, 2022 (GLOBE NEWSWIRE) -- HOOKIPA Pharma Inc. (NASDAQ: HOOK, HOOKIPA), a company developing a new class of immunotherapeutics based on its proprietary arenavirus platform, today announced that Klaus Orlinger, Ph.D. has been promoted to Chief Scientific Officer.

Key Points: 
  • NEW YORK and VIENNA, Austria, March 22, 2022 (GLOBE NEWSWIRE) -- HOOKIPA Pharma Inc. (NASDAQ: HOOK, HOOKIPA), a company developing a new class of immunotherapeutics based on its proprietary arenavirus platform, today announced that Klaus Orlinger, Ph.D. has been promoted to Chief Scientific Officer.
  • Klaus has been instrumental in advancing our novel arenaviral science into the differentiated, versatile platform technology it is today.
  • He has played a key role in translating scientific theory into candidate immunotherapies in clinical development for infectious disease and cancers, as we have grown as an organization, said Joern Aldag, Chief Executive Officer.
  • Klaus deep knowledge of viral technologies paired with his innate curiosity have helped us continually optimize the potential of our arenaviral platform.

VBI Vaccines Announces PreHevbrio™ is Now Available in the United States for the Prevention of Hepatitis B in Adults

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Tuesday, March 29, 2022
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In July 2021, the American Medical Association established a unique Current Procedural Terminology (CPT) code for a 3-antigen (S, Pre-S1, Pre-S2) Hepatitis B (HBV) vaccine.

Key Points: 
  • In July 2021, the American Medical Association established a unique Current Procedural Terminology (CPT) code for a 3-antigen (S, Pre-S1, Pre-S2) Hepatitis B (HBV) vaccine.
  • This is the code PreHevbrio will be reported under and it differentiates PreHevbrio from other approved single-antigen HBV vaccines.
  • PreHevbrio is indicated for prevention of infection caused by all known subtypes of hepatitis B virus.
  • VBI Vaccines Inc. (VBI) is a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease.

Enanta Pharmaceuticals Receives FDA Fast Track Designation for EDP-235, its Oral 3CL Protease Inhibitor Specifically Designed for the Treatment and Prevention of COVID-19

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Tuesday, March 29, 2022
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"Despite the broad availability of vaccines, there remains a need for highly potent, oral treatments specifically designed to target SARS-CoV-2, a virus that continues to persist and mutate globally.

Key Points: 
  • "Despite the broad availability of vaccines, there remains a need for highly potent, oral treatments specifically designed to target SARS-CoV-2, a virus that continues to persist and mutate globally.
  • Receiving Fast Track designation from the FDA underscores EDP-235s potential as a once-daily, oral therapeutic for the treatment and prevention of SARS-CoV-2 infection and as another option in the global fight against the ongoing pandemic, said Jay R. Luly, Ph.D., President and Chief Executive Officer of Enanta Pharmaceuticals.
  • We look forward to working with the FDA to continue to advance EDP-235 as expeditiously as possible."
  • Fast Track designation enables more frequent communication with the FDA and eligibility for FDA programs such as priority review and rolling review, if relevant criteria are met.

Genentech to Present Data Across Broad and Impactful Neuroscience Portfolio at 2022 AAN Annual Meeting

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Friday, March 25, 2022
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If you get infusion reactions, your healthcare provider may need to stop or slow down the rate of your infusion.

Key Points: 
  • If you get infusion reactions, your healthcare provider may need to stop or slow down the rate of your infusion.
  • Signs of infection can happen during treatment or after you have received your last dose of Ocrevus.
  • Progressive Multifocal Leukoencephalopathy (PML): Although no cases have been seen with Ocrevus treatment in clinical trials, PML may happen with Ocrevus.
  • Tell your healthcare provider right away if you have any new or worsening neurologic signs or symptoms.

Brii Bio Presents New Data on BRII-835 (VIR-2218) in Chinese Patients with Chronic Hepatitis B at APASL 2022

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Thursday, March 31, 2022
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DURHAM, N.C. and BEIJING, March 31, 2022 /PRNewswire/ -- Brii Biosciences Limited ("Brii Bio" or the "Company", stock code: 2137.HK) a multi-national company developing innovative therapies for diseases with significant unmet medical needs and large public health burdens, today presented new data from a Phase 2 randomized, double-blind, placebo-controlled trial of BRII-835 (VIR-2218) in Chinese patients with chronic hepatitis B virus (HBV) infection, at the 31st Conference of Asian Pacific Association for the Study of the Liver (APASL) 2022, taking place virtually from March 30 to April 3 in Seoul, South Korea.

Key Points: 
  • The data demonstrate that BRII-835 (VIR-2218), an investigational small interfering ribonucleic acid (siRNA) that mediates RNA interference (RNAi), results in dose-dependent reduction in hepatitis B surface antigen (HBsAg) in Chinese patients with chronic HBV infection who received two doses of BRII-835 (VIR-2218).
  • Similar HBsAg reductions were observed in both HBeAg- and HBeAg+ patients.
  • Brii Bio licensed exclusive rights to develop and commercialize VIR-2218 for the greater China territory from Vir Biotechnology, Inc. ("Vir") in 2020.
  • An estimated 780,000 people die each year from complications of chronic HBV, such as liver decompensation and hepatocellular carcinoma.

Qiming's Portfolio Company Rendu Biotechnology Lists on STAR Market

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Wednesday, March 30, 2022
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SHANGHAI, March 29, 2022 /PRNewswire/ -- Qiming Venture Partners' portfolio company Rendu Biotechnology (SESH: 688193), a leader in RNA molecular diagnostics in China, today listed on the Science and Technology Innovation Board (the "STAR Market") of the Shanghai Stock Exchange.

Key Points: 
  • SHANGHAI, March 29, 2022 /PRNewswire/ -- Qiming Venture Partners' portfolio company Rendu Biotechnology (SESH: 688193), a leader in RNA molecular diagnostics in China, today listed on the Science and Technology Innovation Board (the "STAR Market") of the Shanghai Stock Exchange.
  • Qiming Venture Partners is the earliest investor in Rendu Biotechnology and led the company's Series A financing round in 2013.
  • The successful listing of Rendu also marks the third IPO in Qiming's portfolio in 2022.
  • In addition, Rendu Biotechnology launched AutoSAT, the first fully automatic, high-throughput, and full-process integrated platform for nucleic acid detection in China's molecular diagnostic space.

Assembly Biosciences to Highlight New Research Program for HBV/HDV Entry Inhibition in Webcast on March 31, 2022

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Monday, March 21, 2022
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An accompanying slide presentation will also be available.

Key Points: 
  • An accompanying slide presentation will also be available.
  • To register for the live webcast and replay, please visit: https://investor.assemblybio.com/events-presentations .
  • Assembly Bio is a clinical-stage biotechnology company committed to bringing finite and curative therapies to the 296 million people living with hepatitis B virus (HBV) worldwide.
  • Except as required by law, Assembly Bio assumes no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise.

HOOKIPA Pharma to Report Fourth Quarter and Full Year 2021 Financial Results and Provide a Corporate Update on March 24, 2022

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Thursday, March 17, 2022
HBV, Prostate cancer, Cancer, NASDAQ, Arenavirus, Lung, CD8, Gilead, KRAS, HIV, Vaccine

HOOKIPA Pharma Inc. (NASDAQ: HOOK) is a clinical-stage biopharmaceutical company focused on developing novel immunotherapies, based on its proprietary arenavirus platform, that are designed to mobilize and amplify targeted T cells and thereby fight or prevent serious disease.

Key Points: 
  • HOOKIPA Pharma Inc. (NASDAQ: HOOK) is a clinical-stage biopharmaceutical company focused on developing novel immunotherapies, based on its proprietary arenavirus platform, that are designed to mobilize and amplify targeted T cells and thereby fight or prevent serious disease.
  • HOOKIPAs replicating and non-replicating technologies are engineered to induce robust and durable antigen-specific CD8+ T cell responses and pathogen-neutralizing antibodies.
  • HOOKIPAs pipeline includes wholly-owned investigational arenaviral immunotherapeutics targeting HPV16+ cancers, prostate cancer, KRAS-mutated cancers (including colorectal, pancreatic and lung), and other undisclosed programs.
  • In addition, HOOKIPA aims to develop functional cures of HBV and HIV in collaboration with Gilead.