In recent years, large pharmaceutical companies have invested heavily in drug innovation, but very few new drugs enter the market each year. People’s Daily Health Client found that since 2022, many pharmaceutical companies have announced that they have failed in drug research and development.
Merck Suspension of Clinical Trials of Combination Therapy for Advanced Prostate Cancer
On March 15th, Merck announced that it will stop its PD-1 products Kerida and PARP Phase 3 clinical trial of the inhibitor lipdrox in combination therapy in metastatic castration-resistant prostate cancer after an interim data analysis found that, compared with the control group abiraterone acetate or enzalutamide Dalian Liprodx did not demonstrate a survival benefit.
Sanofi’s Phase 2 Breast Cancer Trial Fails
Picture from the competition Novi’s official website
On March 14, Sanofi announced the results of a clinical trial of amcenestrant as a second- or multi-line monotherapy for ER+/HER2- advanced or metastatic breast cancer. Results showed that the trial did not meet its primary endpoint: amcenestrant did not improve progression-free survival compared with a physician’s choice of single-agent endocrine therapy, as assessed by an independent central review.
It is understood that Amcenestrant, an optimized oral selective estrogen receptor degrader, reduces the stability of estrogen receptors by binding to estrogen receptors on the surface of breast cancer cells and induces their degradation. The cell’s normal protein degradation mechanism degrades, thereby reducing the level of estrogen receptors and inhibiting the growth of cancer cells.
Beijing Kangchen withdrew the application for clinical trial of teriparatide injection
On the evening of March 14, Kangchen Pharmaceutical issued an announcement that its holding subsidiary Kangchen Bio’s withdrawal of the clinical trial application for teriparatide injection was approved by the State Food and Drug Administration. This medicine is an imported registered product of Kangchen Bio-Agent for the treatment of osteoporosis. It is suitable for the treatment of osteoporosis with high fracture risk in postmenopausal women and osteoporosis with high fracture risk induced by continuous glucocorticoid therapy. It is a blockbuster drug in the field of osteoporosis.
It is understood that the withdrawal is mainly due to the need to further improve the application materials.
Pfizer’s Clostridium difficile vaccine candidate fails to meet expectations
In early March, Pfizer announced that its Clostridium difficile vaccine candidate PF-06425090 was tested in a pivotal The primary endpoint of infection prevention was not met in the phase 3 trial. However, without meeting the expected primary endpoint, Pfizer sought to look for evidence of the efficacy of PF-06425090 in the trial’s secondary endpoint. In terms of secondary endpoints, the experimental vaccine PF-06425090 has been shown to have the potential to reduce disease duration and improve disease severity, Pfizer said.
CAR-T treatment of solid tumors declared failure
On March 1, Celyad Oncology disclosed that in an allogeneic CAR-T therapy CYAD In the Phase Ib clinical trial of -101-002, two deaths were reported. CYAD-101 is an allogeneic CAR-T candidate drug developed by the company targeting NKG2DL, which is mainly evaluated in combination with FOLFOX chemotherapy for the treatment of refractory/metastatic colorectal cancer. The company has suspended the dosing and recruitment of patients in the CYAD-101 clinical trial due to two reported deaths.
Phase IIb/III clinical failure of ultra-long-acting anti-VEGF therapy
On February 23, Kodiak announced that KSI-301 was used to treat previously untreated patients. The company’s shares fell 80% on news that a Phase IIb/III trial in patients with neovascular (wet) age-related macular degeneration failed to meet its primary efficacy endpoint.
KSI-301 is an anti-VEGF therapy developed based on Kodiak’s Antibody Biopolymer Conjugate (ABC) platform. It is a two-component bioconjugate, the first part It is a humanized anti-VEGF monoclonal antibody, and the second part is an optically transparent phosphorylcholine biopolymer, which is used to improve the stability of the drug and the residence time in the eye.
COVID-19 treatment drug SNG001 fails late-stage trial
On February 21, biotech company Synairgen plc said that its COVID-19 treatment drug SNG001 was in late-stage trial The primary or key secondary efficacy endpoints were not met, and the trial results showed that patients who received SNG001 were no more likely to be discharged from the hospital than those who received placebo.
Editor in charge: Lin Jing