BioSpace Global Roundup, May 30

Global Connection

Orchestra BioMed, Inc. – Orchestra BioMed presented two-year clinical data from the European Moderato I study of BackBeat Cardiac Neuromodulation Therapy for hypertension at the EuroPCR Conference in Paris. Data showed a strong safety profile of BackBeat CNT and its ability to immediately, substantially and chronically lower blood pressure in patients with persistent hypertension despite two or more anti-hypertensive medications and an indication for a pacemaker, the company said. In the Moderato I study, BackBeat CNT demonstrated a 14.2 mmHg reduction in 24-hour ambulatory systolic blood pressure at three months as well as a substantial and sustained 23.4 mmHg reduction in office cuff systolic blood pressure out to two years, the study shows.

Advicenne -- Advicenne, a France-based pharmaceutical company specializing in the development of adult and pediatric therapeutic products for the treatment of orphan diseases, plans to list its shares on the regulated market of Euronext Brussels. The ordinary shares of Advicenne are currently listed on the Euronext Paris stock exchange and would also be admitted to trading on Euronext Brussels as part of the proposed secondary listing. The company would benefit from a cross listing on the two largest Euronext markets for companies in the life sciences sector. The cross listing would have no impact on current shareholders and Euronext Paris remains Advicenne's primary listing venue.

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Vetter – Germany-based Vetter, a global operating Contract Development and Manufacturing Organization, announced a milestone in environmental sustainability. All German sites of the company will be supplied with only CO2 neutral energy from certified renewable energy sources. This action underlines the CDMO’s commitment to climate and environmental protection as an important element of its corporate responsibility. Within the next ten years Vetter plans to offset the company-wide use of natural gas, making it completely CO2 neutral. Unavoidable CO2 emissions are offset by investments in high-quality climate protection projects, the company said in its announcement. “The supply of our German sites with green electricity is an important part of our company-wide program for environmental protection, energy management, and occupational health and safety,” Managing Director Thomas Otto said.

Prestige BioPharma -- Singapore-based Prestige said the European Medicines Agency accepted its Marketing Authorization Application for HD201, the company’s biosimilar to Roche’s Herceptin. HD201 is indicated for the treatment of adult patients with HER2-overexpressing breast cancer as well as HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma. If the biosimilar is approved, it would attempt to carve out market share in competition with other Herceptin biosimilars, such as Herzuma (Celltrion), Kanjinti (Amgen), Ontruzant (Merck Sharp & Dohme). HD201 is Prestige’s first biosimilar to receive a positive Committee for Medicinal Products for Human Use opinion for marketing authorization from the EMA. Based on this achievement, Prestige will continue to move forward with other eight biosimilars and innovative biologics in its portfolio, which are currently at different stages of development, from nonclinical development to advanced clinical stages. The positive top-line results from the Phase I / Phase III global clinical trial of HD201 confirm that HD201 is exceptionally biosimilar to Herceptin in terms of clinical response and PK, in addition to a comparable safety profile to the range previously observed in other trastuzumab biosimilar trials.

Nanobiotix – France-based Nanobiotix announced the launch of a new subsidiary, Curadigm, which is focused on “redefining the therapeutic balance between bioavailability, toxicity, and efficacy across the pharmaceutical industry.” With its Nanoprimer technology, Curadigm hopes to address the body’s use of only a small portion of medicine administered, while the remainder is cleared from the body without effect, or results in toxicity issues. The nanoprimers, have been designed with specific physico-chemical properties that allow them to transiently occupy the liver cells responsible for therapeutic clearance. Injected prior to the therapeutic, the nanoprimer increases systemic bioavailability allowing for increased accrual in the target tissue and therapeutic action. The company will be a wholly-owned subsidiary of Nanobiotix and operate in France and in the U.S. with a dedicated team committed to growth and potential financing opportunities.

Expedeon AG – The Heidelberg, Germany-based Expedeon said the TGR BioSciences CaptSure DIY ELISA technology will complement the company’s product offering. TGR BioSciences was acquired by Expedeon last year. CaptSure DIY ELISA is designed to significantly reduce time and improve flexibility and sensitivity for ELISA assay development. It will enhance Expedeon’s offering for the immunoassay market at a critical time in the company’s growth and development, the company said. Expedeon has an established foothold in the immunology and biochemistry markets through its acquisition of Innova Biosciences, and existing customers within the molecular and cellular biology space. CaptSure DIY ELISA is expected to be widely adopted by both existing and new users within academic, industrial and diagnostics development market segments. Unlike standard ELISA systems, the CaptSure DIY ELISA kit comprises a ready-to-go assay plate, pre-coated with the CaptSure antibody, which is specific for the CaptSure peptide, the company added.

Ayala Pharmaceuticals, Inc. – Israel-based Ayala completed a $30 million Series B financing round led by Novartis. The funds from the financing round will be used to advance the clinical development of lead product candidate AL101, a pan-Notch inhibitor that is currently being evaluated for adenoid cystic carcinoma (ACC). The company intends to advance the Phase II study in ACC and initiate a Phase II clinical trial in triple negative breast cancer. The U.S. Food and Drug Administration’s Office of Orphan Products Development recently granted Orphan Drug Designation to AL101 for the potential treatment of ACC. AL101 and AL102, the company’s gamma-secretase inhibitors, are both in clinical studies. AL102 is being studied in hematologic tumors and in collaboration with Novartis in multiple myeloma.

Synaptive Medical – Canada-based Synaptive Medical received a grant from the Canadian government for a targeted commercialization initiative that leverages progress in artificial intelligence facilitated data processing and outstanding research and business expertise in Image-Guided Therapy.

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