Assembly Bio, X4 Reprioritize Pipelines, Slash Headcounts

Biopharma companies Assembly Biosciences and X4 Pharmaceuticals have announced significant layoffs and reprioritization endeavors to let go of underperforming initiatives. 

Assembly Bio Slashing Headcount in Reorganization

Assembly Bio, which is developing drugs targeting hepatitis B (HBV) and other viral diseases, is reorganizing its operations and laying off 30% of its full-time staff in a bid to extend its cash runway into the first half of 2024. 

The clinical-stage biotechnology company announced that it is halting research and development activities for its first-generation core inhibitor vebicorvir (VBR) to focus on next-generation core inhibitors ABI-4334 and ABI-H3733. The latter two demonstrated greater than 35-fold and greater than 900-fold higher potency than VBR in inhibiting the formation of new cccDNA based on preclinical studies. Inhibiting cccDNA is essential to developing curative and finite treatments for HBV and other viral diseases. 

Assembly Bio's decision is based on poor data from two ongoing VBR triple combination trials, Study 203 and Study 204, which did not show any benefit in multiple key viral parameters compared to dual combinations excluding VBR. 

In VBR's place, the company will shift resources toward its ongoing Phase Ib trial for 3733, which will look into the drug's safety, pharmacokinetics and antiviral activity in adults diagnosed with chronic HBV infection. 

The company is expected to release initial data on this study in the second half of the year, as well as initiate a Phase Ia study of 4334 to assess the pharmacokinetics, tolerability and safety of single- and multiple ascending doses.

The priority shift includes the layoff of 70 full-time employees. There will also be changes in the leadership lineup. Current chief medical officer Luisa Stamm, M.D., Ph.D, will leave by the end of July, SVP of development operations Michele Anderson will take over as chief development officer effective August 1, while chief financial officer Michael Samar will be out by August 12. 

Jason Okazaki, the current chief operating officer, will expand his responsibilities and will assume the role of president and chief operating officer beginning August 1. John McHutchison, A.O., M.D. will stay on as chief executive officer. 

"Our strategy remains data-driven, and, while data from our VBR program do not support conducting additional cure-focused clinical trials with this candidate, the work has greatly informed the clinical development programs for our next-generation core inhibitors and contributed to the HBV field," McHutchison said. "The decision to realign our resources and restructure our organization is a difficult one, but refocusing our organization is essential to delivering on Assembly Bio's mission of advancing next-generation compounds for patients suffering from HBV, HDV and other viruses."  

X4 Zeroes in on Neutropenic disorders

X4 Pharmaceuticals is letting go of around 20% of its workforce and discontinuing work on oncology programs to extend its cash runway into the third quarter of 2023. 

Instead, X4 will prioritize developing treatments for chronic neutropenic disorders, with a particular focus on commercializing its lead clinical candidate, mavorixafor, an investigational once-daily oral therapy intended for WHIM (Warts, Hypogammaglobulinemia, Infections, & Myelokathexis) syndrome and other chronic like illnesses.

The safety and efficacy of the drug are being evaluated in a global Phase III trial in patients with WHIM syndrome. It is also being assessed in two Phase Ib studies as a monotherapy for chronic neutropenia disorders and in combination with ibrutinib in people diagnosed with a rare B-cell lymphoma called Waldenström's macroglobulinemia. 

"The sharpening of our strategic focus towards developing treatments for those with chronic neutropenic disorders is intended to maximize the impact to all key stakeholders, including patients and shareholders," Paula Ragan, Ph.D., the president and chief executive officer of X4, said in a statement. 

"Parting with employees who have supported the company to this critical stage in our corporate evolution is a heavy decision; we would like to express our deepest gratitude to each of our X4 colleagues for their important contributions that have positioned X4 for long-term success," Ragan added.