NEW YORK – MeiraGTx this week said that the US Food and Drug Administration has dubbed its investigational Parkinson's treatment AAV-GAD a regenerative medicine advanced therapy. The firm is developing the gene therapy AAV-GAD for treating Parkinson's disease that is inadequately controlled with dopamine replacement medications. AAV-GAD is designed to reprogram dysfunctional brain circuits that control movement by producing the chemical neurotransmitter GABA. For products with RMAT designation, sponsors can meet with regulators frequently, pursue accelerated approval, and undergo priority review.
IASO Biotherapeutics said that equecabtagene autoleucel, a BCMA-targeted autologous CAR T-cell therapy it has developed, has received orphan drug designation from the Saudi Food and Drug Authority as a fourth-line treatment for relapsed or refractory multiple myeloma patients after a proteasome inhibitor and an immunomodulatory agent. The SFDA developed the orphan drug designation to encourage sponsors to develop rare disease treatments, and drugs with this designation are reviewed on an expedited timeline and receive product development assistance from the regulatory body. IASO can now submit a new drug application for equecabtagene autoleucel in Saudi Arabia in its bid to bring this cell therapy to multiple myeloma patients in the Middle East.
Integrated DNA Technologies has launched a new innovation hub, dubbed the "Innovation Nexus," in Redwood City, California. The new site will serve as a collaboration center that enables IDT to innovate with regional customers, forge strategic partnerships, and drive R&D initiatives with biotechnology companies. The Coralville, Iowa-headquartered company said this week that the new site is a pivotal element of its strategic roadmap to acquire emerging and transformative synthesis technologies and drive market growth in precision oncology through next-generation sequencing applications.
Volta Labs said this week that it has inked a multiyear collaboration with the Hartwig Medical Foundation to develop a sample processing platform for the most common cancer diagnostic sequencing applications, including whole-genome sequencing, targeted sequencing, circulating tumor DNA analysis, and RNA profiling. The collaboration expands from the existing partnership between Volta and Hartwig, with the latter adopting the former's Callisto liquid handling platform for an automated hybrid capture workflow. The teams said they are currently developing library preparation for tissue- and ctDNA-based whole-genome sequencing to diagnose tumors and monitoring disease burden.
Bristol Myers Squibb this week announced the closing of its tender offer to acquire 2seventy Bio, which was announced in March. 2seventy said that BMS commenced a tender offer on April 14 to acquire all outstanding shares of common stock at $5.00 per share in an all-cash transaction, and the 2seventy board of directors unanimously recommended shareholders tender their shares. The mandated waiting period for the tender offer expired on May 2, and unless the tender offer is extended, the offer and withdrawal rights will expire at midnight on May 12. Following the completion of this acquisition, 2seventy's common stock will no longer be listed for trading on the Nasdaq.
Cardio Diagnostics this week announced a 1-for-30 reverse stock split, effective with the market opening on May 13. The stock split is part of the company's plan to regain compliance with the minimum bid price requirement for the continued listing on the Nasdaq Capital Market. As a result of the stock split, every 30 shares of the company's common stock issued and outstanding prior to the opening of trading on May 13 will be combined into one issued and outstanding share, with no change in the nominal par value per share of $.00001. Chicago-based Cardio Diagnostics is developing clinical tests for cardiovascular disease using an artificial intelligence-driven "Integrated Genetic-Epigenetic Engine."
In Brief This Week is a selection of news items that may be of interest to our readers but had not previously appeared on Precision Medicine Online.