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In Brief This Week: Orgenesis, Veracyte, Scorpion, Viracta, Tempus, Labcorp

NEW YORK – Orgenesis, a Germantown, Maryland-based biotech with a point-of-care cell and gene therapy platform, this week said that its joint venture with Theracell Advanced Biotechnology has been designated "priority investment of strategic national importance" and that it can receive up to €32 million ($36.1 million) in grant funding from the government of Greece. The two companies announced in 2019 that they were forming a JV to leverage each other's technical, regulatory, and commercial expertise to implement Orgenesis' point-of-care strategy and bring cell and gene therapies to Greece, Cyprus, the Balkans, and Turkey. With this latest "priority investment" designation in Greece, the licensing and approval of the JV will be fast-tracked, which in turn may expedite patients' access to cell and gene therapies. Theracell can also put the grant funding toward developing its cell and gene therapies and manufacturing them at point-of-care clinical sites using Orgenesis' mobile good manufacturing practice-designated facilities, called Orgenesis Mobile Processing Units and Labs.

Veracyte said this week that the Swedish Medical Technologies Product Council has recommended its Prosigna breast cancer assay for immediate reimbursement and clinical use in all Swedish healthcare regions without legal restrictions beginning Nov. 22. In addition to Sweden, Prosigna had a recent reimbursement approval in Germany. The assay is also endorsed by guidance from the UK's National Institute for Health and Care Excellence, and reimbursed in Spain, Denmark, Switzerland, and Israel. This milestone supports Veracyte's efforts in Europe and other countries to enable local genomic testing on its nCounter Analysis System.

Scorpion Therapeutics this week revealed its two lead programs: STX-H1047-PI3Ka, which targets cancers with PI3Ka mutations, and STX-EGFR-EXON20, which targets tumors with EGFR exon 20 mutations. STX-H1047-PI3Ka is in preclinical studies for solid tumors with PI3Ka mutations, and STX-EGFR-EXON20 is being evaluated in preclinical studies to treat non-small cell lung cancers with EGFR exon 20 mutations. Both candidates are designed to selectively target mutant forms of PI3Ka and EGFR and avoid off-target effects associated with wild-type inhibition in normal cells. Boston-based Scorpion expects to submit investigational new drug applications with the US Food and Drug Administration for both drugs in 2023.

San Diego-based Viracta Therapeutics this week said the US Food and Drug Administration has granted orphan drug status to the combination of nanatinostat and valganciclovir (Nana-val) as a treatment for Epstein-Barr virus-positive diffuse large B-cell lymphoma. The company is currently exploring the activity of Nana-val in patients with various subtypes of relapsed or refractory EBV-positive lymphoma in the NAVAL-1 trial. Viracta aims to enroll around 140 patients at clinical trial sites now open in the US, Europe, and Asia. The agency grants orphan drug status to treatments for rare diseases, and the designation provides sponsors tax credits, trial design assistance, exemption from certain regulatory application fees, and seven years of market exclusivity upon regulatory approval.

Tempus said this week that it is expanding an existing strategic collaboration with Janssen Research & Development to include artificial intelligence-based work to aid the discovery and development of oncology treatments.

Labcorp and ConcertAI this week announced a collaboration to optimize precision oncology clinical trials. The partnership aims to launch cancer trials that minimize the burden on physicians, improve patient recruitment and retention, and ensure equitable access to research. Labcorp will use ConcertAI's artificial intelligence and real-world data platforms to design more effective and inclusive trials.

In Brief This Week is a selection of news items that may be of interest to our readers but had not previously appeared in Precision Oncology News.