US biotech Checkpoint Therapeutics (Nasdaq: CKPT) says it is moving along in its quest to disrupt the ~$25 billion+ immunotherapy market with its anti-PD-L1, cosibelimab, and could be in a position do so as soon as 2022.
Highlights of Checkpoint’s strategy and progress, as expressed in an email to The Pharma Letter, include:
Lower-pricedimmuno-oncology (I-O) therapy: Checkpoint Therapeutics ($CKPT) plans to capture meaningful market share with cosibelimab as a lower-priced alternative to currently available PD-L1s, such a Merck & Co’s (NYSE: MRK) Keytruda (pembrolizumab), Bristol Myers Squibb’s (NYSE: BMY) Opdivo (nivolumab), AstraZeneca’s (LSE: AZN) Imfinzi (durvalumab), Roche’s (ROG: SIX) Tecentriq (atezolizumab), Merck KGaA (MRK: DE) and US partner Pfizer’s (NYSE: PFE) Bavencio (avelumab) and Regeneron (Nasdaq: REGN) and Sanofi’s (Euronext: SAN) Libtayo (cemiplimab-rwlc), which are priced at ~$13,000 per month of therapy.
Through disruptive pricing in the range of ~50% discount to available therapies, Checkpoint is striving to significantly lower the barrier of high out-of-pocket costs patients endure to access premium-priced cancer therapies and challenge the traditional high cost model of the US healthcare system.
With a planned first indication of metastatic cutaneous squamous cell carcinoma (cSCC), the company anticipates top-line pivotal study results in second-half 2021. The US Food and Drug Administration (FDA) has affirmed Checkpoint’s plans to submit for approval in cSCC based on the ongoing pivotal clinical trial. Additionally, the company intends to initiate a Phase III registration-enabling trial of cosibelimab in non-small cell lung cancer this year.
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Cytokinetics is a late-stage biopharmaceutical company focused on discovering, developing and commercializing first-in-class muscle activators as potential treatments for debilitating diseases in which muscle performance is compromised and/or declining.