Biopharma and life sciences companies from across the globe provide updates on their businesses and pipelines.
Australia-based Beroni Group is building a new R&D center in China. The Sydney-based company will erect a new state-of-the-art facility that includes new preclinical research labs, manufacturing process development labs and a GMP pilot manufacturing plant, in the Zhuhai National High-Tech Industrial Development Zone.
The facility is the first R&D center for Beroni. It is expected to be used to assist the company with drug development for the Chinese market. Construction on the 44,000 square foot facility is expected to be completed by the end of the second quarter of 2022 and operational in the second half of the year.
When the site is up and running, it will be under the banner of a new company dubbed Beroni Pharmaceutical (Guangdong) Co., Ltd. Beroni will commit $10 million to support the clinical trials in the new R&D facility. The company has an existing pipeline focused on oncology and immunotherapy.
“Establishing a new R&D center in Zhuhai will allow us to expand our R&D capabilities and accelerate our innovative pipeline,” Beroni Chief Executive Officer Jacky Zhang said in a statement. “In the future, we plan to establish additional R&D centers around the world to advance the discovery and development of new innovative product candidates.”
Elsewhere around the globe:
Antiverse – Based in Cardiff, Wales, Antiverse announced a partnership with an unnamed top 20 pharmaceutical company to identify antibody candidates for a target of interest. The partnership will harness Antiverse’s proprietary AI-Augmented Drug Discovery platform.
Cergentis– Netherlands-based Cergentis received ISO/IEC accreditation. The accreditation process demonstrates that Cergentis’ genetic QC services are operated to comply with the stringent quality standards expected by its customers and their stakeholders, the company said.
Ethris GmbH – Germany’s Ethris earned $26.3 Million (€23.3 Million) in a Series B financing round led by Laureus Capital. Proceeds from the round will be used to advance the company’s lead programs ETH47 - a broad anti-viral immune modulator, and ETH42, a protein-replacement therapy for primary ciliary dyskinesia (PCD) - into clinical studies. Additionally, the funds will be used to bolster the company’s manufacturing capabilities.
MEGIN – Finland-based MEGIN announced the sale of its fourth-generation magnetoencephalography (MEG) technology, the TRIUX neo, to the Norman Fixel Institute for Neurological Diseases at University of Florida Health. The TRIUX neo is a highly sensitive technology that can accurately detect and localize neural events that are generated in the brain.
Gandeeva Therapeutics – Based in Vancouver, Gandeeva Therapeutics raised $40 million in Series A funding led by Lux Capital and Leaps by Bayer. The round was also supported by Obvious Ventures, Amgen Ventures, Amplitude Ventures and Air Street Capital. Funds from the raise will be used to advance Gandeeva’s AI-driven cryo-EM platform with the aim to accelerate the discovery, design and development of novel precision medicines.
OSE Immunotherapeutics – France’s OSE announced the U.S. Food and Drug Administration approved an Investigational New Drug application for a clinical trial with VEL-101/FR104, a CD28 antagonist monoclonal antibody fragment. This trial will be sponsored and conducted by Veloxis Pharmaceuticals, Inc. in the United States. Veloxis obtained worldwide rights to the asset from OSE for use with all transplant patients. OSE retains rights to develop FR104 in autoimmune diseases.
Inventiva– Also based in France, Inventiva announced the receipt of a €4 million milestone payment from AbbVie following the inclusion of the first patient with psoriasis in the ongoing Phase IIb clinical trial with cedirogant (ABBV-157), an oral RORg inverse agonist jointly discovered by Inventiva and AbbVie for the treatment of autoimmune diseases.
Microbiome DX – Norway’s Microbiome DX announced it successfully launched the GA-map Dysbiosis Test on a new platform, the Luminex MAGPIX instrument system.
BioMed X – Germany’s BioMed X has extended its collaboration with Merck KGaA, Darmstadt, Germany, in the research project RNA Splicing in Cancer (RSC). The RSC research program was launched at the BioMed X Institute in 2018. Emerging data indicated a critical dependency of several subtypes of cancer on a molecular mechanism called RNA splicing. The team was identifying key molecular mechanisms that generate mRNA splicing abnormalities in cancer. The goal of the extension is to further validate novel potential drug targets based on these results. This research program marks the partners’ fifth joint project in oncology and is already the second program to be extended beyond the originally anticipated four-year timeframe.
Azafaros BV – Based in the Netherlands, Azafaros received Orphan Drug Designation from the FDA for AZ-3102, a novel oral small molecule, in GM2 gangliosidosis including both Sandhoff and Tay-Sachs diseases. The company has successfully completed a Phase 1 clinical trial with AZ-3102 in healthy volunteers. Data will be presented later this month at the 18th Annual WORLD Symposium. AZ-3102 is an orally available azasugar that provides a dual mode of action by inhibiting glucosylceramide synthase and non-lysosomal glucosylceramidase (GbA2) to reduce harmful lipid accumulation. Azafaros plans to initiate a pivotal Phase II study in the second half of 2022.
LAVA Therapeutics – Netherlands-based LAVA announced the dosing of the first patient in the company’s Phase I/IIa clinical trial of LAVA-1207 in patients with metastatic castration-resistant prostate cancer (mCRPC). LAVA-1207 is a Gammabody designed to target the prostate-specific membrane antigen (PSMA) and has demonstrated preclinical proof-of-concept driving antitumor responses in a variety of prostate cancer models.
Cariolis Pharma – Germany’s Cariolis Pharma announced the opening of new ATMP development facilities under biosafety level S2. The new facilities, which are in close proximity to Coriolis’ headquarters in Martinsried, will significantly increase Coriolis’ capabilities for ATMP development. Formulation development for ATMPs, including cell culture activities, particle characterization, particle identification and forensic, analytical ultracentrifugation and a lyophilization development center will be available all under biosafety level 2, for Coriolis’ clients and partners, the company said.
Pharming Group N.V. – Also based in the Netherlands, Pharming Group announced positive results from the Phase II/III registration-enabling study of leniolisib for the treatment of activated phosphoinositide 3-kinase delta (PI3Kδ) syndrome (APDS), which is also known as PASLI (p110δ-activating mutation causing senescent T cells, lymphadenopathy, and immunodeficiency). Leniolisib is a small molecule PI3Kδ inhibitor that was discovered and developed by Novartis and was licensed to Pharming in 2019. APDS is an ultra-rare primary immunodeficiency disease caused by a genetic mutation.
SHINE Europe BV – Another Netherlands-based company, SHINE has secured funding to begin designing an advanced medical isotopes facility in Veendam, the Netherlands. This new facility will leverage SHINE’s innovative production systems to safely produce medical isotopes including molybdenum-99 (Mo-99), the company said. This marks the second such facility for SHINE. It also operates a nuclear facility in Wisconsin. Once SHINE Europe is fully operational, SHINE anticipates the two facilities’ combined output of Mo-99 can serve up to 70% of the global need for Mo-99 used in daily diagnostic imaging.
CRISPR Therapeutics – Switzerland-based CRISPR and ViaCyte, Inc. announced the dosing of the first patient in their Phase I clinical trial of VCTX210 for the treatment of type 1 diabetes (T1D). VCTX210 is an investigational, allogeneic, gene-edited, stem cell-derived product. This immune-evasive cell replacement therapy is designed to enable patients to produce their own insulin.
Cytiva – U.K.-based Cytiva and Netherlands-based NecstGen, a non-profit contract development and manufacturing organization forged a partnership to accelerate the development of new cell and gene therapies.
