HOUSTON, TX / ACCESS Newswire / September 9, 2026 / BrYet US, Inc. (“BrYet”) – a biotechnology innovator focused on developing potentially curative therapies for advanced cancers – today announced AIFA approval of a first-in-kind cGMP manufacturing line for ML-016, the company’s lead clinical-stage cancer therapeutic. AIFA is the national public body that regulates medicines for human use in Italy, where BrYet’s manufacturing subsidiary is located.
The milestone clears an important manufacturing and regulatory hurdle for ML-016 and enables the production of clinical-grade drug product for BrYet’s upcoming clinical program in Australia. The ML-016 clinical supply manufactured on the newly qualified line was produced to the specifications required by the Australian regulatory authorities. Shipment of the clinical material to Australia is expected to begin shortly, supporting initiation of the approved clinical trial.
“Establishing a validated cGMP manufacturing process for ML-016 marks a critical milestone in our path toward the clinic,” said Lorenzo Pradella, CEO of BrYet Europe. “With this foundation in place, we are advancing ML-016 toward clinical evaluation for patients with difficult-to-treat primary and metastatic cancers of the lung and liver-an important step in our effort to address cancers where significant unmet need remains.”
“We engineered a customized, multipurpose pilot production line embedded with single-use technologies, specifically designed for our unique manufacturing process,” said Giuliana Crema, BrYet Europe CMC Project Manager. “Securing regulatory approval for such an innovative setup represents a challenging major achievement that validates our approach to supply lyophilized, terminally sterilized ML-016 for clinical studies.”
The manufacturing line was established in partnership with NerPharMa, a leading oncology contract development and manufacturing organization (CDMO).
“We are extremely proud of this achievement and of the strong collaboration with BrYet,” said Damien Parisien, CEO of NerPharMa and Benta Europe. “This milestone demonstrates what our teams can achieve together, and NerPharMa is fully committed to doing everything possible to maintain the success of this partnership and support BrYet as ML-016 advances into clinical development.”
“We are very grateful to our partners at NerPharMa for their support qualifying and validating the manufacturing line,” said Dr. Mauro Ferrari, President & CEO of BrYet. “This achievement reflects the momentum we are building at BrYet as we advance ML-016, establish the capabilities needed to bring its potential to patients, and look toward building out our pipeline of novel therapeutics. We believe our approach could represent a major advance in the treatment of truly devastating cancers.”
About ML-016
ML-016 is comprised of an amino acid polymer conjugated to doxorubicin with a formulation that includes BrYet’s proprietary Si-PlateloidTM technology, designed to target the vascular endothelium of blood vessels in the tumor microenvironment. The amino acid-drug conjugate is released into the tumor, where it forms exosome-like vesicles.
These “exosomoids” are designed to be preferentially taken up by cancer cells including those that have previously been resistant to therapy. Through the mechanisms of cellular trafficking, the exosomoid vesicles are intended to be transported to late-stage endosomes and lysosomes, where the increased acidity releases the cytotoxic agent into the cell nucleus.
BrYet has received Australian approval to begin its first-in-human clinical study of ML-016. The broadly scoped Phase I/II trial will enroll patients with any primary or metastatic cancer involving the lungs or liver, with the first patient dose expected to be administered in late 2026.
About BrYet US, Inc.
BrYet US, Inc. is a privately held biotechnology company developing potentially first-in-class therapies for patients suffering from cancers for which there is no current curative treatment. BrYet Europe is a wholly-owned subsidiary of BrYet US that is focused on manufacturing ML-016, BrYet’s lead asset.
ML-016 is being developed for cancers of the lungs and liver, including advanced primary malignancies and metastatic spread from primary cancer that originates in other organs or tissue of the body. The company’s fundamental belief is that upon localization in the lungs and liver, these cancers acquire molecular transport phenotypes that are conserved regardless of site of origin and are largely independent of molecular mutations and their continued evolution. BrYet designs multi-component new chemical entities and formulations, which are directed against the fundamental aspects of these cancer-associated, organ-specific transport phenotypes.
The company’s proprietary platforms include the Si-PlateloidTM and the mathematical formalism for designing the multi-component drugs, termed Transport Oncophysics. BrYet believes that similar approaches may provide advances against other forms of presently incurable cancers, as well as other pathologies of the lungs and liver. For more information about BrYet, please visit the company’s website: https://bryetpharma.com
About NerPharMa
NerPharMa is an Italian-based Contract Development and Manufacturing Organization (CDMO) specializing in the formulation and production of active pharmaceutical ingredients (APIs) and finished dosage forms. Known for its expertise in handling high-potency compounds and complex manufacturing requirements, NerPharMa provides integrated services from clinical-stage development to full-scale commercial production.
NerPharMa is part of Benta. Benta is an international healthcare group delivering integrated pharmaceutical manufacturing, CDMO services, and strategic healthcare solutions across global markets.
Safe-Harbor Statement
This press release contains forward-looking statements concerning BrYet and its business. These statements are based on the beliefs of, assumptions made by, and information currently available to the company’s management. When used in this document, the words “expects,” “anticipates,” “estimates,” “intends,” “believes,” “plans,” “predicts,” “should,” “could,” “will,” and similar expressions are intended to identify forward-looking statements.
Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ from expectations. Factors that could contribute to these differences include the results of studies and clinical trials, regulatory approvals, challenges in clinical trials, the ability to retain employees, research and development expenses, reliance on third parties, intellectual property issues, competition, future funding needs, economic conditions, and other industry-specific risks. You should not place undue reliance on these statements, which are current as of the date of this press release. BrYet does not plan to update these statements unless legally required.
Contact Information:
BrYet US, Inc.
2450 Holcmbe Blvd. Ste 1520
Houston, Texas 77021
info@bryetpharma.com
SOURCE: BrYet US Inc
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