For European biotechnology, 2022 was a year of contraction. Disclosed equity investments in European firms engaged in the discovery and development of therapeutics totaled $6.782 billion, down 55% on the previous year’s record-breaking tally of $15.193 billion. Last year’s tally is the worst performance since 2017 and is well below the totals achieved during the two years immediately preceding the onset of the COVID-19 pandemic, which triggered a boom in biotech investing.

The hand of Fate cuts ties to $3B Janssen deal, reprioritizes pipeline and reduces staff

Fate Therapeutics Inc. is making big changes. The company has told Janssen Biotech Inc. it is not interested continuing the collaboration and option agreement cut in 2020 that could have brought Fate up to $3 billion. The deal called for Janssen to contribute antigen binding domains for up to four tumor-associated targets. Fate is also halting four solid tumor natural killer (NK) cell programs to concentrate on two of its NK cell programs and two T-cell programs, all while reducing headcount by more than half, to 220 employees, in the first quarter of 2023. Fate’s stock (NASDAQ:FATE) was taking a beating at midday, with shares trading about 60% lower. Fate is far from alone in making big changes early in the new year. Aeglea Biotherapeutics Inc. is laying off 15% of its staff, as Anaptysbio Inc., Century Therapeutics Inc. and Elevation Oncology Inc. are reprioritizing their pipelines.

Hightide raises $107M series C to advance lead metabolic disease program to phase III

Hightide Therapeutics Inc. closed a $107 million series C round that will advance multiple global development programs for lead candidate HTD-1801, including a phase III trial in type 2 diabetes. Originated by Hightide, of Shenzhen, China, HTD-1801 (berberine ursodeoxycholate, BUDCA) is an orally active ionic salt of berberine and ursodeoxycholic acid. It is in clinical development for chronic liver disease and metabolic disorders, including type 2 diabetes, nonalcoholic steatohepatitis and primary sclerosing cholangitis. The series C capital raise was led by TCM Healthcare Fund of Guangdong, which is managed by China Development Bank Capital. Yuexiu Fund and Yuthai Fund also participated in the round.

Raynovent nets $54M in series C round for COVID-19, influenza A virus

Raynovent Biotech Co. Ltd. has raised ¥370 million (US$54 million) in a series C round to further develop candidates in the field of respiratory and metabolic diseases. Funds will be used to accelerate clinical trials of lead candidates in its pipeline, as well as to prepare for the commercialization of oral pills to treat COVID-19 and influenza A virus. “Our core candidates RAY-1216 and ZSP-1273 are currently in phase III trials. We will speed up the development of the two candidates following this financing,” said Chen Xiaoxin, co-founder and CEO of Raynovent.

EMA moving ahead with clinical trial system despite industry concern

The EMA will require all new clinical trial applications to be submitted via its clinical trials information system (CTIS) after Jan. 31, 2023, despite pharma companies and other users raising concerns about functionality and technical failures they are experiencing with the system. There are “serious defects” in the portal of CTIS that “will lead to a loss of competitiveness of Europe as a research region and to disadvantages for patients,” according to Jens Peters, manager for clinical research at the German pharma industry group Bundesverband der Pharmazeutischen Industries.

Graphite pauses phase I/II study in SCD because of serious adverse event

Shares of Graphite Bio Inc. (NASDAQ:GRPH) plunged 42%, or $1.30, to trade at $1.76 as Wall Street learned that the firm voluntarily paused the phase I/II study called Cedar with nulabeglogene autogedtemcel (nula-cel) for sickle cell disease (SCD) due to a serious adverse event in the first patient dosed. Graphite said the problem likely is due to treatment, and the goal of reaching first proof-of-concept data in SCD for the gene editing autologous hematopoietic stem cell therapy by the middle of this year will not be reached.

Also in the news

Abbvie, ABVC, Acer, Acorda, Aeglea, Alphyn, Anaptysbio, Aribio, Arsenalbio, Astrazeneca, Azafaros, Bluebird, Century, Cingulate, Crown, Cytomx, Domain, Dragonfly, Elevation Oncology, Emergent, Fabre-Kramer, Geron, Harbor, Helix, Homology Medicines, Immune-Onc, In8bio, Inflarx, Innovent, Inspirna, Jubilant, Lantern, Maps, Mendus, Mission, Moderna, Oculis, Onconano, Onquality, Ophirex, Ovid, Qiagen, Quralis, Renibus, Revive, Revolo, Sanofi, Sensei, Sosei Heptares, Surface Oncology, Takeda, Tempero, Tryp, Vaxcyte