BLEX 404 is the β-glucan extracted from the dry fruit body of Grifola frondosa (maitake mushrooms). Image Credit: asch_asch / Shutterstock.

US-based ABVC BioPharma has sold the rights to its botanical drug extract therapy, BLEX 404, for the treatment of non-small cell lung cancer (NSCLC) to the dietary supplements company OncoX.

Under the agreement, ABVC will receive an aggregate licence fee of $12.5m as either cash or stocks of OncoX. Furthermore, the company will also be entitled to a milestone-based payment of $1.25m and 5% royalties on net sales of BLEX-404 for up to $12.5m.

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BLEX 404 is the β-glucan extracted from the dry fruit body of Grifola frondosa (maitake mushrooms), which are native to China, Europe and North America. The safety of the maitake mushroom extract has been evaluated in two studies – a Phase I/II trial involving postmenopausal patients with breast cancer following remission and a Phase II trial in patients with myelodysplastic syndrome (MDS). The maitake extract was well tolerated in both trials and immunological response was also observed.

The US Food and Drug Administration (FDA) cleared the investigational new drug application (IND) to start an open-label Phase I/II trial evaluating the safety and tolerability of BLEX 404 in combination with chemotherapy in patients with advanced inoperable or metastatic EGFR-mutated NSCLC in December 2022. As per the licencing agreement, ABVC will bear responsibility for the clinical development of BLEX 404.

ABVC’s portfolio consists of several therapies derived from plant and fungal extracts. The company’s lead assets ABV-1504 and ABV-1505 are plant-based norepinephrine transporter (NET) inhibitors. In November 2023, ABVC signed a global licensing agreement with AiBtl for both ABV-1504 and ABV-1505.

The company is currently conducting an interim analysis of the Phase IIb trial (NCT05202327) of ABV-1504 in patients with attention deficit hyperactivity disorder (ADHD), with the results expected in Q2 this year, as per the ABVC’s 2023 financials. ABVC is also planning an end-of-Phase II meeting with the US FDA to finalise the protocol for the Phase III trial for ABV-1504 in patients with major depressive disorder.

Other oncology therapies in ABVC’s pipeline include ABV-1501 for the treatment of triple-negative breast cancer, ABV-1702 for treating MDA, and ABV-1703 for the treatment of pancreatic cancer. All three therapies contain maitake mushroom extract.