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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 (Nasdaq: ASMB) announced its participation in the AASLD The Liver Meeting from November 12-15, 2021, featuring significant clinical data on its HBV core inhibitor program. The company will present findings from three studies: one oral presentation and two poster presentations, including a late-breaking poster on the preclinical candidate ABI-4334. The results aim to enhance the understanding of HBV and demonstrate the potential of core inhibitors for treating chronic HBV infection.
Assembly Biosciences (ASMB) and Antios Therapeutics announced a clinical collaboration to assess a triple combination treatment for chronic hepatitis B (HBV). The Phase 2a ANTT201 trial will evaluate the safety and efficacy of Antios’ ATI-2173, Assembly Bio’s vebicorvir (VBR), and tenofovir disoproxil fumarate in ten treatment-naive patients. The study aims to provide a functional cure for HBV, which affects approximately 270 million people globally, offering hope for improved treatment options.
Assembly Biosciences (Nasdaq: ASMB) announced its participation in two upcoming conferences focused on hepatitis B virus (HBV). The Science of HBV Cure Meeting 2021 will feature Dr. William Delaney presenting on novel capsid inhibitors on October 12. Additionally, CEO Dr. John McHutchison will participate in the H.C. Wainwright 2nd Annual HBV Conference on October 13. These engagements highlight Assembly Bio's commitment to advancing therapies for the estimated 270 million people living with HBV worldwide.
Assembly Biosciences, Inc. (Nasdaq: ASMB) announced the grant of stock options to two new employees, allowing the purchase of 16,000 shares at an exercise price of $3.46, the closing price on October 1, 2021. These options have a ten-year term, vesting over four years, and are granted as inducements for accepting employment. The grants comply with Nasdaq Listing Rule 5635(c)(4) and are approved by the independent Compensation Committee. Assembly Bio focuses on developing innovative treatments for hepatitis B virus (HBV).
Assembly Biosciences (ASMB) announced the discontinuation of its ABI-H2158 development after observing elevated alanine transaminase (ALT) levels in a Phase 2 trial, indicating drug-induced hepatotoxicity. Patient safety remains a priority, and the company will focus on advancing ongoing triple combination studies and developing other core inhibitor candidates. The Phase 2 study for ABI-H2158 involved 88 patients, with some suffering significant ALT elevations. The FDA has placed the drug on clinical hold. Assembly Bio aims to extend its cash runway into late 2023 while progressing promising pipeline assets.
Assembly Biosciences, Inc. (Nasdaq: ASMB) has selected a new core inhibitor candidate, ABI-4334, optimized for potency, to advance into clinical development targeting hepatitis B virus (HBV). The company is executing preclinical work with plans to initiate clinical studies in 2022. ABI-4334 shows promising preclinical results, including single-digit nanomolar potency against new virus production and cccDNA formation. The candidate demonstrates pan-genotypic activity, an improved resistance profile, and favorable pharmacokinetics, aiming to offer a finite and curative HBV therapy.
Assembly Biosciences (ASMB) reported its Q2 2021 financial results, highlighting a cash position of $199.1 million. However, revenues plummeted to $0, down from $39.4 million in Q2 2020, due to the termination of its microbiome collaboration with Allergan. R&D expenses decreased to $16.7 million from $23.3 million, while general and administrative costs fell to $6.9 million from $9.5 million. The net loss was $23.6 million, or $0.55 per share, compared to net income of $7.3 million, or $0.21 per share, in the previous year. The company aims to advance its HBV clinical programs.
Assembly Biosciences, Inc. (Nasdaq: ASMB) announced the promotions of Jason Okazaki to Chief Operating Officer and Michael Samar to Chief Financial Officer. Okazaki, with 20 years of business and legal experience, has been with Assembly Bio since 2020, while Samar has over 20 years in finance and operations since joining the company in 2017. CEO John McHutchison praised their contributions toward achieving long-term objectives in developing therapies targeted at hepatitis B virus (HBV). The company aims to provide curative treatments for the 270 million HBV-infected individuals globally.
Assembly Biosciences Appoints Dr. Michael Houghton to Board
Assembly Biosciences, Inc. (Nasdaq: ASMB) has appointed Sir Michael Houghton, PhD, a Nobel Prize-winning virologist, to its board of directors. Dr. Houghton, renowned for discovering the hepatitis C virus, brings over 40 years of drug development experience. His expertise is expected to enhance Assembly Bio's efforts towards finite and curative therapies for hepatitis B virus (HBV), targeting over 250 million individuals globally. CEO John McHutchison emphasized the potential impact of Dr. Houghton’s insights on the company's innovative therapeutic pipeline.
Assembly Biosciences (ASMB), a clinical-stage biotechnology company, announced the grant of stock options to three new employees for a total of 21,520 shares at an exercise price of $3.82. The options have a ten-year term and will vest over four years. This grant is part of Assembly Bio's 2020 Inducement Award Plan and aims to support the hiring of new talent as part of their commitment to developing innovative therapeutics for hepatitis B virus (HBV). The approval was made by the Compensation Committee, consisting of independent directors.
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