Snagging its second U.S. FDA approval since being spun out of Pfizer Inc. in 2017, Springworks Therapeutics Inc. is aiming to position Gomekli (mirdametinib), cleared for neurofibromatosis type 1-associated plexiform neurofibromas (NF1-PN) not amenable to complete resection, as a first-in-class drug for adults and potentially best-in-class option for children. The priority approval, which came after market close Feb. 11, more than two weeks ahead of the Feb. 28 PDUFA date, marks the second MEK1/2 inhibitor to hit the market for NF1-PN, a rare, genetic condition caused by mutations in the NF1 gene in which neurofibromas develop on the peripheral nerve sheath, which can result in severe pain, organ compression, disfigurement and impaired physical function, with a small percentage of the tumors eventually turning malignant.

Xilio inks $2.1B-plus immunotherapy deal with Abbvie

Shares of Xilio Therapeutics Inc. (NASDAQ:XLO) were trading at $1.33, up 67 cents, or 102%, after the firm disclosed a deal with Abbvie Inc. that brings $52 million up front, including a $10 million equity investment, and about $2.1 billion in contingent payments for option-related fees and milestones plus tiered royalties. The pair will develop tumor-activated, antibody-based immunotherapies, including masked T-cell engagers. At the same time, Xilio made public three wholly owned preclinical programs for masked T-cell engagers targeting prostate-specific membrane antigen, claudin 18.2 and six-transmembrane epithelial antigen of prostate.

APAC deals abound: Lilly taps Advancell, Olix; Genome draws Ellipses

Dealmaking in the Asia Pacific (APAC) region took off this week, with the latest showcasing Genome & Co.’s licensing deal with Ellipses Pharma Ltd. for GENA-104, a phase I-ready immuno-oncology asset, under undisclosed terms Feb. 11. Other deals include Eli Lilly and Co.’s back-to-back deals with Olix Pharmaceuticals Inc. and Advancell Co. Ltd., along with Intas Pharmaceuticals Ltd.’s agreement with Bio-Thera Solutions Ltd.

Cancer Index takes hit in 2024 amid regulatory setbacks, failures

The BioWorld Cancer Index (BCI) experienced a steep decline in 2024, closing the year down 17.32%. After peaking in late February with an 11.16% gain, the index steadily trended downward, with only brief recoveries that failed to push it back into positive territory. This marked a sharp contrast to 2023, when the BCI soared 76.26% by year-end. In comparison, 2022 saw the index drop by 41.98%, while 2021 closed with a decline of 36.34%. The BCI’s performance lagged behind broader market indices, as the Nasdaq Biotechnology Index ended the year down just 1.37%, while the Dow Jones Industrial Average climbed 12.88% in 2024. Of the 20 stocks in the BCI, only four posted gains throughout the year, while the remaining 16 saw their share values decline.

Newco news: Biomissile’s multispecific antibodies harness NK cell engagers

Biomissile Pharmaceuticals Co. Ltd. is developing multispecific antibodies that overcome resistance associated with antibody-drug conjugates (ADCs) via its next-generation natural killer (NK) cell engagers. “ADCs are very efficacious, but they do have a drawback with side effects and resistance,” Biomissile co-founder and CEO Chao Tu told BioWorld. “Some solid tumors don't respond at all, and so solving that dilemma is what drives our company.” Biomissile is focusing on a different mechanism to treat solid tumors by bringing immune cells, especially NK cell engagers, to the tumor site rather than toxins.

Also in the news

AI Proteins, Altpep, Ampersand, Astellas, Ausperbio, Biohaven, Bioversys, Bluejay, Bridgebio, Cognito, Convergent, CSL Behring, Greenwich, In8bio, Kala, Lakewood-Amedex, Lipella, Lixte, Lycia, Maxona, Merck, Orchard, Pfizer, Q32, Regeneron, Sionna, Spinogenix, Third Harmonic, Travere