Akari Therapeutics plc has established a strategic partnership with Wuxi XDC Cayman Inc. to accelerate the development of Akari’s novel PH1 payload. Akari’s lead program, AKTX-101, is initially targeting metastatic urothelial cancer.
Avenzo Therapeutics Inc. has obtained IND clearance by the FDA for AVZO-103 (formerly VAC-103), a nectin-4/TROP2 bispecific antibody-drug conjugate (ADC).
Corbus Pharmaceuticals Inc. has placed its chips on “bets where somebody else is ahead of us,” CEO Yuval Cohen said. “The idea is to have a de-risked asset” that proves better in the clinic. At the 2025 American Society of Clinical Oncology Genitourinary (ASCO GU) Cancers Symposium in San Francisco, Corbus offered data from the U.S. and U.K. first-in-human dose-escalation study – the Western trial – with Nectin-4-targeting antibody-drug conjugate (ADC) CRB-701 (SYS-6002).
Mixed results for three of Bicycle Therapeutics plc’s zelenectide pevedotin development programs preceded a strong drop in the company’s stock. Bicycle shares (NASDAQ:BCYC) dropped 31.3% on Dec. 13 to close at $13.81 each, the stock’s lowest price in the past 12 months.
Nectin-4 is a cell-adhesion molecule overexpressed in several tumor types, including breast, ovarian, lung, colorectal, pancreatic and urothelial cancer. Enfortumab vedotin (EV), an anti-Nectin-4 antibody-drug conjugate (ADC) has shown a good objective response rate in pretreated patients with advanced urothelial carcinoma. However, this effect has been linked to on-target skin toxicity.
Despite an outcome that TD Cowen analyst Tyler Van Buren called ”fantastic,” shares of Tyra Biosciences Inc. (NASDAQ:TYRA) closed Oct. 25 at $21.93, down $6.68, or 23%, as Wall Street digested new phase I/II data with FGFR3 inhibitor TYRA-300 in metastatic urothelial cancer from the Surf301 phase I/II study in progress.
Shares of Corbus Pharmaceuticals Inc. (NASDAQ:CRBP) doubled on opening Jan. 26 and ended the day up a whopping 249% as investors got a look at data from a first-in-human study testing next-generation Nectin-4-targeted antibody-drug conjugate (ADC) CRB-701. Licensed from CSPC Pharmaceutical Group for $7.5 million up front in February 2023, CRB-701 has IND clearance from the U.S. FDA, and Corbus plans to start its own clinical testing in the first quarter of 2024.
Researchers from Flare Therapeutics Inc. presented the discovery of a first-in-class covalent peroxisome proliferator-activated receptor γ (PPARγ) inverse agonist, FX-909, being developed for the treatment of urothelial cancer (UC). Synthesis and optimization of covalent lead series of agonists of the PPARγ lineage transcription factor led to the discovery of FX-909 as the lead covalent PPARγ inverse agonist with powerful repressive conformational biasing activity.
As Seagen Inc. preps for a merger, the U.S. FDA awarded accelerated approval to the company’s big-selling Padcev (enfortumab vedotin). The approval is for a combination therapy with Merck & Co. Inc.’s Keytruda (pembrolizumab) as a first-line treatment for adults with locally advanced or metastatic urothelial cancer who are not eligible for cisplatin-containing chemotherapy.
Flare Therapeutics Inc. has announced a US$123 million series B financing to support its work targeting novel transcription factors for cancer and other diseases.