Iovance Biotherapeutics Inc.’s faith in tumor-infiltrating lymphocyte (TIL) therapy lifileucel was further proven by the Jan. 23 acquisition of worldwide rights from Clinigen Ltd. to Proleukin (aldesleukin), an IL-2 product used to promote T-cell activity after infusion of TILs. Terms call for San Carlos, Calif.-based Iovance to pay Clinigen, of Burton Upon Kent, U.K., £166.7 million (US$$206.1 million) right away and a £41.7 million milestone payment upon first approval of lifileucel in advanced melanoma, plus double-digit global royalties for Clinigen.
ABVC Biopharma Inc is headquartered in San Francisco but it has its roots in Taiwan where it is digging into traditional medicine and validating it for the modern world. “There are a number of drugs that can’t be synthesized in the lab,” ABVC CEO Howard Doong told BioWorld, so he is going back to the original source of traditional Chinese medicines to validate them using traditional drug development models.
Long before the U.S. Congress approved a path for importing prescription drugs from Canada to take advantage of their cheaper price, Poornanand Palaparty, an oncologist in Ohio, purchased cancer drugs from a Canadian distributor from 2004 to 2009. Now, nearly a decade after Palaparty pleaded guilty in 2013 to introducing misbranded drugs into the U.S., the FDA is debarring the doctor based on that federal misdemeanor.
Chinese firm Hutchmed Ltd. has out licensed its targeted colorectal cancer drug fruquintinib to Takeda Pharmaceutical Co. Ltd. as it eyes growth opportunities in the U.S., Europe and Japan in a deal totaling up to $1.13 billion. Under the terms of the agreement, Tokyo, Japan-based Takeda will gain an exclusive worldwide license to develop and commercialize the drug in all indications and territories outside of mainland China, Hong Kong and Macau.
Neophore Ltd. announced a £6 million (US$7.4 million) extension to its series B, bringing the total for the round to £21.5 million and enabling it to take forward a second DNA mismatch repair program.
The U.S. FDA granted accelerated approval to Seagen Inc. on Jan. 19 for Tukysa (tucatinib), extending the therapy’s reach beyond HER2-positive metastatic breast cancer, and clearing its way for RAS wild-type, HER2-positive unresectable or metastatic colorectal cancer.
Pulmobiotics Ltd., which was founded in 2019, is developing cell therapy for lung diseases, including lung cancer. But unlike other cell therapies for cancer, this one is based not on harnessing T cells but on engineering bacteria. The team has engineered Mycoplasma pneumoniae to deliver various therapeutic proteins to the lung, depending on the therapeutic indication.
Iaso Biotherapeutics Inc. raised ¥500 million (US$75 million) in a series C1 round as looks for its first drug approval by China after its NDA was accepted for what is claimed to be the first B-cell maturation antigen-targeting CAR T-cell therapy in China.
Shanghai Henlius Biotech Inc. scored NMPA approval for its self-developed anti-PD-1 monoclonal antibody Hansizhuang (serplulimab). It can be used for the first-line treatment of extensive-stage small-cell lung cancer (ES-SCLC) in combination with carboplatin and etoposide.
The accelerated approval by the U.S. FDA of Immunogen Inc.’s landmark antibody-drug conjugate Elahere (mirvetuximab soravtansine-gynx) injected further oomph into the NaPi2b space, where a handful of developers are due to yield important data shortly. In play are such names as Mersana Therapeutics Inc. and Zymeworks Inc., encouraged by historical – if not entirely successful – efforts by giant Roche Holding AG.
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