A first half of the year progress report from the international advocacy group Alliance for Regenerative Medicine (ARM), finds that the regenerative medicine and advanced therapy sector is in very good shape and has performed well in terms of both clinical development and fundraising despite the challenges posed by the ongoing COVID-19 pandemic.
Biopharma companies that are focused on cell therapies have reported promising clinical trial results in their ability to treat acute respiratory distress syndrome (ARDS), a condition that has shown to be a significant contributor to higher mortality in COVID-19 cases.
Although PDUFA VI still has two years of life left to it, PDUFA VII is already in the birthing process, with the use of real-world data (RWD), AI, and a coming surge of novel cell and gene therapies looking to be prominent features of the next five-year user fee agreement. Politics likely will play a role as well.
BEIJING – U.S.-Taiwan biotech Acepodia Inc., of Burlingame, Calif., and Taipei, has licensed out two of its cell therapy candidates, ACE-1702 and ACE-1655, to Chinese CAR T therapy developer JW Therapeutics (Shanghai) Co. Ltd. to develop and commercialize them in China, Hong Kong and Macau. Acepodia will receive up-front and milestone payments from JW Therapeutics, plus royalties on sales.
BEIJING – Beijing-based Immunotech Biopharm Ltd. made a strong debut as the first pre-revenue cellular immunotherapy firm to trade on the Hong Kong Stock Exchange (HKEX), raising $142 million via its IPO. Trading under the ticker 6978, the company’s share price closed at HK$15.48 (US$2) on July 10, up 40.7% from its offer price at HK$11.
Two California companies – Nkarta Inc. and Poseida Therapeutics Inc. – scored impressive IPOs but with decidedly different post-pricing performance, as Wall Street showed its enthusiasm for the former’s natural killer (NK) cell research by pushing shares (NASDAQ:NKTX) up 166%, to close July 10 at $47.90, an increase of $29.90.
Up-and-coming cell and gene engineering company Sana Biotechnology Inc. raised $700 million in a first round financing, bumping Moderna Inc., which previously had the highest venture capital (VC) financing of a traditional biotech company to date.
Orca Bio Inc.’s $192 million series D brings the company out of stealth and openly into the business of transforming allogeneic cell therapies. The new funding brings Orca’s total capital raised since 2016 to nearly $300 million.
SUZHOU, China – Chinese CAR T therapy developers from early to IPO-ready-stage are confident that they can create a strong presence in the global scene with their innovations, and they are also making strategies that will work best for their home market.
BEIJING – CAR T-cell therapeutics developer Carsgen Therapeutics Co. Ltd., of Shanghai, won IND clearance from the FDA for its first-in-class CT-041 for advanced gastric and pancreatic cancers. The company said it is the first claudin18.2 (CLDN18.2)-targeted CAR T-cell therapy cleared for clinical trials in the world.
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