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 latecomersProductCompanyIndicationUS statusJemperliGSK/ AnaptysBio1st-line MSI-proficient/MMR-stable endometrial cancer (chemo combo)Approved 1 Aug 20241st-line MSI-H/dMMR endometrial cancer (chemo combo)Approved 31 Jul 20232nd-line dMMR solid tumoursApproved 19 Aug 2021ZynyzIncyte/ MacroGenics2nd-line Merkel cell carcinoma, Pod1um-201 trialApproved (AA) 22 Mar 2023LoqtorziCoherus/ Shanghai Junshi1st-line nasopharyngeal carcinoma (chemo combo), Jupiter-02 trialApproved 27 Oct 20232nd-line nasopharyngeal carcinoma (monotherapy), Polaris-02 trialApproved 27 Oct 2023TevimbraBeiGene2nd-line oesophageal squamous cell carcinomaApproved 14 Mar 20241st-line oesophageal squamous cell carcinomaDecision pending (PDUFA Jul 2024)1st-line gastric or gastroesophageal junction cancersPDUFA Dec 2024UnloxcytCheckpoint (Fortress)Cutaneous squamous cell carcinomaApproved 13 Dec 2024 (following CRL Dec 2023)CamrelizumabJiangsu Hengrui/ Elevar (HLB)1st-line liver cancer (rivoceranib combo), Cares-301 trialCRL May 2024; new PDUFA 20 Mar 2025BalstilimabAgenus2nd-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 ph3Source: OncologyPipeline.