Tanja Obradovic: Turmoil within the Biotech sector continues as financing remains a challenge
Tanja Obradovic, Vice President of Oncology Scientific Affairs at ICON PLCh, shared a post on LinkedIn:
“Turmoil within the Biotech sector continues as financing remains a challenge. In a latest development USA-based Biotech Checkpoint Therapeutics Inc that is running low on cash despite receiving FDA approval of its PD-L1 inhibitor Unloxcyt (Cosibelimab) in December last year for the treatment of patients with metastatic cutaneous squamous cell carcinoma (mCSCC) or locally advanced (laCSCC) will be taken over by SUN PHARMA.
Launch readiness and market uptake of Cosibelimab remains unclear so it seams that Checkpoint Therapeutics Inc followed in steps of many Biotech companies who missed timely planning window for the medical affairs strategy building. Considering that Cosibelimab is facing competition from Merck Keytruda (Pembrolizumab) and Regeneron’s Libtayo (Cemiplimab) in CSCC that planning was critical.
Key Comparisons in CSCC:
- Cemiplimab received FDA approval for mCSCC and laCSCC with:
- Overall Response Rate (ORR) 21% and 29%, for two indications respectively with high percent of patients with Duration of Response (DOR) ≥6 months of 79%-100%.
- Keytruda holds mCSCC and laCSCC indications with:
- ORR of 35% and 51% with also high percent DOR ≥6 months of 76% and 81%, respectively.
- Cosibelimab was approved on very strong values in:
- ORR of 47% in mCSCC and 48% in laCSCC.
- DOR ≥6 months of 84% and 87%, respectively.
Based on this profile Cosibelimab is performing as expected for PD(L)-1 inhibitor class and may even offer some advantages considering possible stronger effect on natural killer (NK) cells than rivals.
It will be of interest to see next steps in Cosibelimab development strategy under SUN PHARMA leadership that has background in biosimilars and how this acquisition fits within a very active PD(L)-1 inhibitor landscape including impact of PD-1 inhibitor biosimilars post 2028 as well as USA situation considering IRA Act implications upon current leaders.
Making strategic roadmap to viable marketing position for drugs like Cosibelimab is getting more complex.”
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