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Assembly Biosciences, Inc. (NASDAQ: ASMB) is a public clinical-stage biotechnology company dedicated to advancing innovative therapies for serious viral diseases. The company focuses on two key platform programs: the treatment of Hepatitis B virus (HBV) infection and the development of novel oral live biotherapeutics for disorders associated with the microbiome.
In the HBV program, Assembly Biosciences is pioneering a new class of oral therapeutics aimed at increasing cure rates for patients with chronic HBV. The company has developed several drug candidates that inhibit various steps in the HBV lifecycle, including novel core protein allosteric modulators (CpAMs). These small molecules target and modulate the HBV core protein, a crucial component in the virus's replication process.
The microbiome program is designed to address diseases linked to dysbiosis, an imbalance in the microbial community of the gut. Assembly Biosciences employs a robust strain identification and selection process, methods for strain isolation and growth under Good Manufacturing Practices (GMP), and a patent-pending delivery system known as GEMICEL®. This system ensures targeted delivery of live biotherapeutics to specific areas in the gastrointestinal tract.
Recent achievements for Assembly Biosciences include a long-term partnership with Gilead Sciences to accelerate the development of their antiviral pipeline. This collaboration is expected to enhance the company's financial and scientific resources, positioning them to achieve critical milestones and deliver innovative treatments to patients.
Financial results for the third quarter of 2023 highlighted the company's ongoing progress, including the advancement of multiple antiviral candidates targeting herpesviruses, HBV, and hepatitis delta virus (HDV). Assembly Biosciences also announced leadership enhancements, including the appointment of Dr. Anuj Gaggar as Chief Medical Officer.
Looking ahead, Assembly Biosciences plans to have four candidates in clinical studies by the end of 2024. These include the initiation of trials for ABI-5366, a long-acting herpes simplex virus helicase-primase inhibitor, and the development of ABI-6250, an orally bioavailable small molecule for treating chronic HDV.
For more information, visit assemblybio.com.
Assembly Biosciences announced the retirement of John G. McHutchison as CEO effective end of 2022. He will remain on the Board of Directors, chairing the Science & Technology Committee. Jason A. Okazaki, currently the President and COO, has been elected to succeed McHutchison as CEO. Okazaki, who joined Assembly Bio in 2020, played a key role in the company's strategic direction and clinical operations. The Board expresses confidence in Okazaki's leadership to advance the company's mission in developing therapies for hepatitis B virus.
Assembly Biosciences (Nasdaq: ASMB) is set to host a research webcast on August 31, 2022, from 1:30-2:30 PM PT, featuring two innovative small molecule programs targeting viral diseases. Notable speakers include CEO John McHutchison and Nobel laureate Sir Michael Houghton. The first program focuses on a unique antiviral for herpes simplex virus type 2, while the second advances a pan-herpes antiviral for serious viral infections post-transplant. The webcast will be accessible live and via replay on their website.
Assembly Biosciences (ASMB) reported its Q2 2022 financial results, highlighting a cash position of $128.6 million, funding operations until mid-2024. The company initiated a Phase 1b trial for next-generation core inhibitor ABI-H3733 and announced the discontinuation of vebicorvir's development. R&D expenses increased to $17.8 million, while the net loss was $24.5 million, or $0.51 per share. Additionally, a new small molecule interferon-α receptor agonist research program was launched, aiming for improved tolerability in HBV treatments.
Assembly Bio announces the discontinuation of clinical development for vebicorvir (VBR), its first-generation core inhibitor, based on ineffective interim efficacy data from ongoing trials. The focus will shift to next-generation core inhibitors ABI-H3733 and ABI-4334, which have shown significantly higher potency in preclinical studies. The company will undergo organizational restructuring, reducing its workforce by approximately 30%, thus extending its cash runway into the first half of 2024. Initial data from the ABI-H3733 trial is expected in H2 2022.
Assembly Biosciences (Nasdaq: ASMB) reported promising advancements in its investigational HBV core inhibitor programs ABI-H3733, ABI-4334, and vebicorvir (VBR) during the International Liver Congress 2022.
Key data highlights include:
- ABI-H3733 shows improved pharmacokinetics in a new tablet formulation.
- ABI-4334 demonstrates significant potency against HBV cccDNA formation.
- VBR, under Phase 2 studies, exhibits enhanced antiviral effects when combined with entecavir.
Assembly aims to deliver innovative therapies for the 296 million people affected by HBV worldwide.
Assembly Biosciences (ASMB) has announced a new research program focusing on a novel oral interferon-α receptor agonist, aimed at enhancing treatment for hepatitis B. This program will leverage the antiviral mechanisms of interferon-α while minimizing systemic exposure, potentially improving patient tolerability. A live webcast is scheduled for July 26, 2022, featuring key speakers including Professor Edward J. Gane and CEO John McHutchison. The company remains committed to developing curative therapies for the 296 million individuals affected by HBV globally.
Assembly Biosciences, Inc. (Nasdaq: ASMB), a clinical-stage biotechnology firm, announced the acceptance of six abstracts for presentation at the International Liver Congress™ 2022 held from June 22-26. The data covers investigational core inhibitors including vebicorvir and two new candidates, ABI-H3733 and ABI-4334. CEO John McHutchison emphasized the significance of the presentations, which support the company's goal of developing finite therapies for hepatitis B virus (HBV). The posters will be accessible online for conference registrants, showcasing new insights into their drug candidates.
Assembly Biosciences, Inc. (Nasdaq: ASMB) has initiated a Phase 1b trial for its next-generation core inhibitor, ABI-H3733, targeting chronic hepatitis B virus (cHBV) infection. This trial follows a successful Phase 1a study that showed a favorable safety profile and assesses a new tablet formulation designed for once-daily dosing. Approximately 50 treatment-naïve patients will participate in a 28-day, randomized, double-blind study to evaluate the drug's safety and antiviral activity, with results supporting future Phase 2 trial dose selection.
Assembly Biosciences, Inc. (Nasdaq: ASMB) announced a grant of stock options for 16,000 shares to a new employee at an exercise price of $1.87 per share. The options will vest over four years and were given as a material inducement for employment. This grant aligns with the company’s 2017 Inducement Award Plan and adheres to Nasdaq Listing Rule 5635(c)(4). Assembly Bio specializes in innovative therapeutics for hepatitis B virus (HBV), aiming to provide curative treatments for the 296 million people affected globally.
Assembly Biosciences (ASMB) reported its financial results for Q1 2022, highlighting a cash position of $146.5 million, down from $174.6 million at year-end 2021, expected to fund operations into Q4 2023. The company introduced a new small molecule entry inhibitor targeting HBV and HDV, expanding its pipeline. Research and development expenses decreased to $17.2 million from $18.6 million year-over-year, while general and administrative costs also fell to $6.0 million. Net loss narrowed to $23.1 million ($0.48 per share) from $27.2 million ($0.69 per share) in Q1 2021.