DEM Biopharma Inc. raised $70 million to develop therapies targeting don’t eat me and eat me signals on cancer cells and macrophages. The Cambridge, Mass.-based company’s platform is designed to identify the signals via intercellular CRISPR screening using tumor cells, primary macrophages and other innate effector cells. DEM’s executive chairman is Jan Skvarka, Trillium Therapeutics Inc.’s former CEO. Longwood Fund and Alta Partners led the financing with participation from Insight Partners, Pfizer Ventures, Astellas Venture Management, Emerson Collective, Utokyo Innovation Platform and Alexandria Venture Investments.

Low-dose HD gene therapy cohort in Uniqure phase I/II excites Street

Uniqure NV rolled out safety and biomarker data from 10 patients enrolled in the low-dose cohort of the ongoing phase I/II trial with AMT-130 for the treatment of Huntington’s disease. Six subjects received AMT-130, and four were given an imitation surgical procedure in this randomized, blinded experiment. A mean reduction of 53.8% of mutant HTT turned up in cerebral spinal fluid at 12 months in evaluable patients treated with the drug, which consists of an AAV5 vector carrying an artificial microRNA, specifically tailored to silence the huntingtin gene. Shares of the Amsterdam, the Netherlands-based company (NASDAQ:QURE) were trading midday at $17.72, up $2.33, or 15%.

China stock markets cool down, with fewer biotech IPOs in H1 2022

A tightening of rules for biotech listings on the Shanghai STAR market may have contributed to a visible cool-down in biotech IPOs, with fewer listings in Chinese stock markets in the first half of 2022. That regulatory tightening, along with global market downturns and concerns about the pricing power of biotech firms in China have all led to a freezing of new issues. Just 140 companies across all sectors went public on stock exchanges in mainland China this year to May 31, marking a decrease of 32% compared with the 207 companies that went public during the same period in 2021, according to analytics platform Wind Information Co. Ltd. Several companies also withdrew their IPO applications voluntarily, while nearly 100 were forced to suspend offerings due to factors such as COVID-19 or updates to financial reports.

Newco news: Therorna completes $42M series A to develop circRNA COVID-19 vaccines

Chinese biotech company Therorna Inc. completed a $42 million series A round to develop its circular RNA (circRNA) vaccines and therapies. "The successful completion of this round will play a key role in helping Therorna accelerate the development of a new broad-spectrum COVID-19 vaccine and the discovery of additional novel therapies for a variety of diseases,” Therorna CEO Daniel Tang said. Founded in April 2021 by Wensheng Wei, a professor at the School of Life Sciences at Peking University, the Beijing-based company is developing next-generation vaccines and therapies leveraging its circRNA technology platform. It has established a pipeline of prophylactic and therapeutic drugs that it plans to take to the clinic.

Ten years on, US AIA in need of pruning

It’s been a decade since the America Invents Act (AIA) transformed the U.S. patent landscape from a first-to-invent to a first-inventor-to-file system and added new contours with post-grant opportunities to challenge patents outside of court. While the AIA’s inter partes review process and other post-grant procedures have helped weed out weak patents, they’ve also increased the uncertainty and unpredictability of many patents. Now Congress and the U.S. Patent and Trademark Office (USPTO) are trying to address those unintended consequences. Yesterday, the USPTO released a June 21 memo further clarifying factors the Patent Trial and Appeal Board is to consider when determining whether to institute an AIA post-grant procedure when there is parallel litigation. Meanwhile, the Judiciary Committees in both the Senate and the House held hearings this week on draft legislation aimed at cultivating more certainty and predictability for patents while uprooting the gamesmanship that has grown out of the AIA.

Osivax stays in the hunt for universal flu vaccine with €10M research grant

Osivax SAS secured €10 million (US$10.5 million) in research funding from Bpifrance to maintain the momentum of its putative universal influenza vaccine program, which is currently undergoing phase II trials. The Lyon, France-based company will use the new cash injection to part fund a phase IIb field trial of its vaccine candidate, OVX-836. The study will recruit “several thousand subjects,” co-founder and CEO Alexandre Le Vert told BioWorld. Its precise timing has not been decided as yet, but it is likely to get underway next year.

Against the tide, Australia allows advertising COVID-19 antiviral drugs

In a rare move, Australia’s Therapeutic Goods Administration (TGA) is allowing two prescription-only COVID-19 treatments to be advertised to the public. Pfizer Australia Pty Ltd.’s Paxlovid (nirmatrelvir/ritonavir) and Merck Sharp & Dohme (Australia) Pty Ltd.’s Lagevrio (molnupiravir) were both granted provisional approval in January and are classified as prescription-only medicines. They were subsequently listed on Australia’s government-subsidized Prescription Benefit Scheme (PBS). “Prescription medicines and some over-the-counter medicines, which must be dispensed by a pharmacist, cannot be advertised in Australia,” TGA spokeswoman Sarah Racic told BioWorld. “In some instances, where it is in the public interest to do so, the TGA will provide narrow permissions around what is considered advertising of prescription or pharmacist-only medicines.”

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