Checkpoint's latecomer could draw interest
The FDA approval of Unloxcyt, the eleventh PD-(L)1 blocker, looks likely to have come too late to save its developer, Checkpoint Therapeutics. But the product might appeal to bigger players that have missed the checkpoint inhibitor bandwagon, especially as it could be picked up for a bargain price. Checkpoint had just $4.7m in cash at the end of September; despite raising another $9.2m in November through the exercise of warrants, a solo launch looks out of the question. Potential buyers could include Novartis, which has had two ill-fated bites at the checkpoint cherry: first with the in-house spartalizumab, and then with the BeiGene-originated tislelizumab (which, after Novartis handed back rights, was approved as Tevimbra). Pfizer is another big player to lack an approved checkpoint inhibitor, but its subcutaneous contender sasanlimab is already in phase 3, so looks a less likely contender. Other large groups with low-key anti-PD-(L)1 assets, largely being tested in combos, include AbbVie (budigalimab), Johnson & Johnson (cetrelimab) and Boehringer (ezabenlimab). And Sanofi is a free agent here after handing Regeneron full rights to Libtayo in 2022, but might not want to re-enter the PD-(L)1 fray, and in any case has moved away from oncology in recent years.
Selected anti-PD-(L)1 latecomers
Product | Company | Indication | US status |
---|---|---|---|
Jemperli | GSK/ AnaptysBio | 1st-line MSI-proficient/MMR-stable endometrial cancer (chemo combo) | Approved 1 Aug 2024 |
1st-line MSI-H/dMMR endometrial cancer (chemo combo) | Approved 31 Jul 2023 | ||
2nd-line dMMR solid tumours | Approved 19 Aug 2021 | ||
Zynyz | Incyte/ MacroGenics | 2nd-line Merkel cell carcinoma, Pod1um-201 trial | Approved (AA) 22 Mar 2023 |
Loqtorzi | Coherus/ Shanghai Junshi | 1st-line nasopharyngeal carcinoma (chemo combo), Jupiter-02 trial | Approved 27 Oct 2023 |
2nd-line nasopharyngeal carcinoma (monotherapy), Polaris-02 trial | Approved 27 Oct 2023 | ||
Tevimbra | BeiGene | 2nd-line oesophageal squamous cell carcinoma | Approved 14 Mar 2024 |
1st-line oesophageal squamous cell carcinoma | Decision pending (PDUFA Jul 2024) | ||
1st-line gastric or gastroesophageal junction cancers | PDUFA Dec 2024 | ||
Unloxcyt | Checkpoint (Fortress) | Cutaneous squamous cell carcinoma | Approved 13 Dec 2024 (following CRL Dec 2023) |
Camrelizumab | Jiangsu Hengrui/ Elevar (HLB) | 1st-line liver cancer (rivoceranib combo), Cares-301 trial | CRL May 2024; new PDUFA 20 Mar 2025 |
Balstilimab | Agenus | 2nd-line cervical (monotherapy); MSS colorectal cancer (botensilimab combo) | Monotherapy cervical filing pulled 2021; AA plan for bot-bal in MSS CRC abandoned Jul 2024, looking for partner to fund ph3 |
Source: OncologyPipeline.
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