Following a discussion that focused more on a new personalized trial strategy rather than the proposed therapy, the U.S. FDA’s Oncologic Drugs Advisory Committee (ODAC) voted 3-6 April 30 that Astrazeneca plc’s camizestrant demonstrated a clinically meaningful benefit in treating patients with HR+/HER2- metastatic breast cancer.
Astrazeneca plc has exercised an option under its collaboration with Pinetree Therapeutics Inc. to obtain an exclusive global license to develop and commercialize PTX-299, a first-in-class bispecific antibody degrader targeting EGFR. The option exercise triggers a $25 million payment to Pinetree.
Taking advantage of new technologies to eliminate the lag time in reporting trial data to the U.S. FDA, the agency is moving toward a real-time clinical trial pilot program that will build on two proof-of-concept trials initiated by Amgen Inc. and Astrazeneca plc.
T-cell engagers (TCEs) drive synthetic antitumor immunity by bypassing endogenous T-cell priming and directly inducing tumor cell killing. In prostate cancer, targeting prostate-restricted antigens such as STEAP2, combined with CD8-guided TCE formats that favor cytotoxic T-cell engagement, offers a strategy to reduce cytokine release while maintaining antitumor activity.
After a hiatus of more than nine months, the U.S. FDA’s Oncologic Drugs Advisory Committee (ODAC) will meet April 30 to discuss two Astrazeneca plc applications – an NDA for camizestrant used in combination with a CDK4/6 inhibitor to treat HR+HER2- locally advanced or metastatic breast cancer and an sNDA for Truqap (capivasertib) to treat metastatic hormone-sensitive prostate cancer that’s phosphatase and tensin homolog deficient.
DNA polymerase θ (POLθ) plays a central role in microhomology-mediated end joining (MMEJ), an error-prone DSB repair pathway. Under normal conditions, MMEJ acts as a backup repair mechanism. However, in HRR-deficient tumors, reliance on POLlθ-driven MMEJ is markedly increased, making POLθ essential for cancer cell survival. Researchers from Astrazeneca plc reported the discovery and characterization of AZD-4956, a POLθ inhibitor that can be used in combination with PARP inhibitors and other DNA-damaging agents.
Syneron Bio is emerging as one of the most heavily backed new entrants in the macrocyclic peptide space, raising more than $250 million in venture funding and securing a multibillion-dollar deal with Astrazeneca plc as it builds a platform spanning several of the most competitive frontiers in drug development.
Syneron Bio is emerging as one of the most heavily backed new entrants in the macrocyclic peptide space, raising more than $250 million in venture funding and securing a multibillion-dollar deal with Astrazeneca plc as it builds a platform spanning several of the most competitive frontiers in drug development.
Ovid Therapeutics Inc. has announced plans to initiate a phase I study of OV-4071, an oral, direct activator of potassium-chloride cotransporter 2 (KCC2), having received Australian Human Research Ethics Committee (HREC) approval and clinical trial notification (CTN) acknowledgement from Australia’s TGA.
Even though case law has established that 340B-covered providers can’t sue drug companies for overcharging on the steeply discounted drugs, the Adventist Health System of West tried a new door into court – as a whistleblower under the False Claims Act.
