The U.S. FDA has approved the country’s first-ever respiratory syncytial virus (RSV) vaccine, Arexvy, from GSK plc. The adjuvanted vaccine also is the first for older adults anywhere on the planet. GSK now has a head start to vaccinate the U.S. market, but other big companies, such as Sanofi SA and especially Pfizer Inc., are in late-stage development and will pose challenges in the coming year. The vaccine was approved for preventing lower respiratory tract disease caused by RSV in patients ages 60 and older. The BLA was under priority review and the approval was announced on its May 3 PDUFA date. Pfizer Inc.’s PF-0692831/RSVpreF, an RSV vaccine for treating lower respiratory tract disease caused by RSV, has a priority BLA with a May 31 PDUFA date.

Phase III data with Elahere send Immunogen stock on a rocket ride

Shares of Immunogen Inc. (NASDAQ:IMGN) soared 124%, rising $7.61 to trade at $12.81 midday on word of positive top-line data from the phase III trial called Mirasol testing the safety and efficacy of Elahere (mirvetuximab soravtansine-gynx) compared to chemotherapy in patients with folate receptor alpha-positive platinum-resistant ovarian cancer who have received one to three prior lines of therapy. The drug was granted accelerated approval in November of last year. Based on the Mirasol findings, Waltham, Mass.-based Immunogen will submit a marketing authorization application in Europe and an sBLA in the U.S. for conversion to regular approval.

Lilly’s donanemab hits endpoints in phase III Alzheimer’s study

The U.S. FDA’s January rejection of Eli Lilly and Co.’s application seeking accelerated approval of amyloid beta-targeting Alzheimer’s candidate, donanemab, looks to be a minor blip in the drug’s development. Top-line data disclosed May 3 from the phase III study known as Trailblazer-ALZ 2 showed donanemab met its endpoints, slowing cognitive and functional decline in people with early symptomatic disease. With those results in hand, Lilly plans to seek full FDA approval, with a BLA filed as early as this quarter, following close behind Biogen Inc. and Eisai Co. Inc.’s Leqembi (lecanemab), which won accelerated approval and has a decision on full approval expected by July 6, 2023.

As USTR calls foul over trade secrets theft, FDA accused of the same

While the U.S. continues to call out other countries for weak enforcement of intellectual property rights, trade secrets theft and forced technology transfers in the life sciences sector, some companies in the sector claim similar things are happening in the U.S. In its latest Special 301 Report, released last week, the Office of the U.S. Trade Representative (USTR) noted “the growing need for trading partners to provide effective protection and enforcement of trade secrets.” One type of threat the USTR noted stems from regulators failing to protect confidential information submitted for regulatory approval purposes. But that’s what the FDA allegedly did when it took and misused Vanda Pharmaceuticals Inc.’s trade secrets and confidential information in its review and approval of generics referencing two of the company’s drugs, Vanda claimed in a complaint filed May 2 in the U.S. Court of Federal Claims.

LSX World Congress: Capital supply in Europe altering investor sentiment, but still growing 

The IPO market in Europe is firmly shut and not a single company went public in the first quarter of 2023. The impact of this is trickling down to limit access to venture capital for biotechs. “Your existing investors might have to manage reserves quite significantly, and then on the other side, new investors might have a different appetite for investing,” said Juliette Audet, partner at Forbion. “From an investor perspective we see the current market as, you’re probably going to need one more round of financing than you used to, maybe, three years ago,” she told delegates at the LSX World Congress in London on May 3.

CBMG licenses CAR T therapies to Janssen in $245M deal

Cellular Biomedicine Group Inc. (CBMG) licensed a pair of candidates for the treatment of non-Hodgkin lymphoma to Janssen Biotech Inc. for development outside greater China. The candidates are anti-CD19 and CD20 bispecific CAR T-cell therapy C-CAR039 and anti-CD20 CAR T-cell therapy C-CAR066. Janssen Biotech, a subsidiary of Johnson & Johnson, will develop and commercialize the two candidates, while Shanghai-based CBMG will receive $245 million up-front and milestone payments linked to clinical development, regulatory filings, commercialization and sales. The two companies will also negotiate an option for Janssen to commercialize the products in China. 

Morphic looks for $240M to advance oral integrin lead for UC

Buoyed by the progress it has made with its lead integrin therapy for moderate to severe ulcerative colitis, MORF-057, which significantly reduced disease activity in a phase IIa trial, Morphic Therapeutic Inc. is now looking to raise $240 million in a public offering to further advance the candidate through the clinic.

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