The transaction includes Unloxcyt (cosibelimab-ipdl), which was approved by FDA in December 2024 for treatment of adults with cutaneous squamous cell carcinoma (cSCC).
Hand shaking which print screen on wooden cube block in front of human icon for business deal and agreement concept. | Image Credit: © Dilok - stock.adobe.com
Sun Pharmaceutical Industries (Sun Pharma), a Mumbai-based specialty generics company, has announced an agreement to acquire Checkpoint Therapeutics, of Waltham, Mass., a company that focuses on immunotherapy and targeted oncology (1). The two parties publicly disclosed the agreement in a jointly written press release on March 9 and 10, 2025.
The transaction, which is expected to be completed in the second quarter of 2025, specifies that Sun Pharma will acquire all outstanding shares of Checkpoint, whose stockholders will receive upfront, interest-free cash payments equivalent to $4.10 per share (1).
Included in the acquisition is Checkpoint’s cosibelimab-ipdl treatment, Unloxcyt, a programmed death ligand-1 (PD-L1)-blocking antibody that was approved by FDA in December 2024 for treatment of adults with metastatic cutaneous squamous cell carcinoma (cSCC) or locally advanced cSCC who are not candidates for curative procedures such as surgery or radiation (1,2).
“Combining Unloxcyt, an FDA-approved anti-PD-L1 treatment for advanced cutaneous squamous cell carcinoma, with Sun Pharma’s global presence, means patients with cSCC may soon have access to an important, new treatment option,” Dilip Shanghvi, chairman and managing director of Sun Pharma, said in the press release (1). “The acquisition further bolsters our innovative portfolio in onco-derm therapy.”
The performance of cosibelimab will be a factor in additional payments current Checkpoint stockholders may receive, according to the terms of the acquisition; if it is approved prior to certain deadlines in the European Union pursuant to EU’s centralized approval procedure, or in France, Germany, Italy, Spain, or the United Kingdom, a non-transferable contingent value right will activate, entitling the stockholder to up to an additional $0.70 in cash without interest (1).
Additionally, Checkpoint’s controlling stockholder, Fortress Biotech, has entered into a royalty agreement with Checkpoint and Sun Pharma whereas Fortress may receive future royalty payments based on sales of cosibelimab (1).
“I am proud of the dedication and passion of our team at Checkpoint that allowed us to achieve the first and only FDA-approved anti-PD-L1 treatment for patients with advanced cSCC, and we are excited to enter this transaction with Sun Pharma as the next step to bringing Unloxcyt to cSCC patients in need of a differentiated immunotherapy treatment option,” said James Oliviero, president and chief executive officer of Checkpoint, in the press release. “Sun Pharma is aligned with Checkpoint’s commitment to improving the lives of skin cancer patients, and I believe this transaction will maximize value for our stockholders and provide accelerated access to Unloxcyt in the United States, Europe, and other markets worldwide.”
Both PL-D1 and programmed death receptor-1 (PD-1) inhibitors were mentioned in the UK Medicines and Healthcare products Regulatory Agency (MHRA)’s marketing authorization for Johnson & Johnson’s Balversa (erdafitinib), in November 2024, as a monotherapy in treating adults with unresectable or metastatic urothelial carcinoma, particularly those patients harboring susceptible fibroblast growth factor receptor 3 genetic alterations and who previously received at least one line of therapy containing a PD-1 or PD-L1 inhibitor in the unresectable or metastatic treatment setting (3).
Another treatment for squamous cell carcinomas, meanwhile, received a positive opinion in July 2024 from the European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP), Coherus Biosciences’ Loqtorzi (toripalimab), for nasopharyngeal and esophageal SCCs (4).
1. Sun Pharma. Sun Pharma to Acquire Checkpoint Therapeutics. Press Release. March 10, 2025.
2. FDA. FDA Approves cosibelimab-ipdl for Metastatic or Locally Advanced Cutaneous Squamous Cell Carcinoma. Press Release. Dec. 13, 2024.
3. MHRA. Electronic Medicines Compendium, Balversa Summary of Product Characteristics. products.mhra.gov.uk (accessed November 6, 2024).
4. EMA. Meeting Highlights from the Committee for Medicinal Products for Human Use (CHMP) 22–25 July 2024. Press Release. July 26, 2024.
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