Compugen Ltd. has entered another collaboration, this time licensing a preclinical antibody program against an IL-18 binding protein with Gilead Sciences Inc. Compugen will handle ongoing preclinical development and a phase I study of COM-503 to treat tumors, then Gilead receives to sole right to further continue developing the asset. Compugen is getting an up-front $60 million and is eligible for a $30 million milestone payment should the IND clear in 2024. Compugen also is eligible for $758 million in development, regulatory and commercial milestones, putting the deal value at $848 million. Compugen also has a collaboration with Astrazeneca plc to develop a PD-1/TIGIT bispecific antibody. Compugen stock (NASDAQ:CGEN) was sharply higher at midday, with shares trading at $1.77 each, a rise of 142%.

Phase I/II data show AMT-130 worthy in HD, Uniqure says 

Shares of Uniqure NV (NASDAQ:QURE) were trading at $7.10, down 88 cents, or 11%, on word of updated interim data including up to 30 months of follow-up from 39 patients enrolled in the ongoing U.S. and European phase I/II trials of gene therapy AMT-130 for the treatment of Huntington’s disease (HD). Uniqure, with offices in Lexington, Mass., and Amsterdam, said AMT-130 showed encouraging evidence of preserved neurological function in HD and merits further investigation.

China’s new NRDL adds 126 new drugs and cuts prices by 61.7% on average

Chinese patients will soon have wider access to newly approved cancer drugs following the publication of the 2024 National Reimbursement Drug List (NRDL) that added 126 new drugs to the list. Price cuts to drugs averaged 61.7%. The additions and cuts are in line with the previous year. China is providing more access to innovative drugs, and the process is more mature and more predictable than ever before, Justin Wang, partner, head of China at LEK Consulting, told BioWorld.

GC Biopharma scores FDA nod for immunoglobulin therapy Alyglo

South Korea’s GC Biopharma Corp. has gained U.S. FDA approval for its immune-deficiency plasma drug, Alyglo (immune globulin intravenous, human-stwk; IVIG-SN 10%), five months after refiling its BLA, five months after refiling its BLA and before its PDUFA date of Jan. 13, 2024. With the FDA’s approval, Alyglo is now indicated for adult patients ages 17 and older with primary immunodeficiency and other immune-related conditions like congenital agammaglobulinemia, common variable immunodeficiency, Wiskott-Aldrich syndrome and severe combined immunodeficiencies.

Top Trends of 2023: Daiichi Sankyo and Merck’s $22B mega-deal sets a new record

October marked a milestone in biopharma history, with Daiichi Sankyo Co. Ltd. and Merck & Co. Inc.’s $22 billion deal the largest in BioWorld’s records going back to 2014. Tokyo-based Daiichi is granting rights to three of its DXd antibody-drug conjugate candidates for the treatment of multiple solid tumors: ifinatamab deruxtecan, patritumab deruxtecan and raludotatug derutecan. The companies will co-develop and co-commercialize the three candidates worldwide, excluding Japan, where Daiichi retains exclusive rights.

Top Trends of 2023: Radiopharma continues to gather speed

Radiopharmaceuticals continued to be a hot commodity in 2023, with new entrants entering the space and a flurry of deals continuing to spark interest. Although radiopharmaceuticals have been used for a long time for diagnostics, radiopharma therapies are entering a new era in which they are becoming widely accepted as a key tool in the oncology armamentarium, potentially providing patients with a big bump in efficacy with fewer side effects and less damage to healthy tissue.

EMA lays out plan to maximize AI benefits, manage risks 

With the use of artificial intelligence (AI) increasing in both biopharma R&D and the regulatory science used to evaluate new drug candidates in member states, the EMA has laid out a five-year workplan to ensure that the European medicines regulatory network remains at the forefront in benefiting from AI in medicines regulation. The 2023-2028 workplan released this week sets out a collaborative, coordinated strategy to maximize AI benefits to stakeholders while managing its risks.

BioWorld Insider Podcast: Six biopharma executives consider a tough 2023 and are hopeful for a better 2024

One aspect of 2023 our group of executives completely agreed on: the past year was tough financially. And they all foresee a more vibrant year ahead for the market. Giving all of them hope were technological breakthroughs such as artificial intelligence, game changing weight loss drugs, the surging fascination with ADCs and hope for lower interest rates. But uncertainty looms about the upcoming general election in the U.S. and ground-shifting gene therapies. In a preview of the annual Biotech Showcase conference, an investor conference for private and micro- to mid-cap biotech companies Jan. 8-10 in San Francisco, BioWorld spoke with Dave Bearss, CEO of Halia Therapeutics Inc., Vimal Mehta, CEO of Bioxcel Therapeutics Inc., Paul Lammers, CEO at Triumvira Immunologics Inc., Chris Pirie, COO of HDT Bio Corp., Thijs Spoor, CEO of Perspective Therapeutics Inc., and Shelley Hartman, CEO of Aegle Therapeutics Corp. They offered insights brought about by years of hard-won experience.

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