Calliditas provides setanaxib patent update
Calliditas Therapeutics announced that the USPTO has issued a patent for setanaxib, used in combination with PD-1 inhibitors to treat solid tumors resistant to PD-1 immunotherapy. The patent will expire in 2039 and complements corresponding applications in other regions, including Europe.
CEO Renee Aguiar-Lucander expressed optimism over the extended product protection and plans for geographical expansion.
Additionally, Calliditas shared positive results from a Phase 2 head and neck cancer trial in May 2024, showing statistically significant improvements in progression-free survival (PFS) and overall survival (OS), aligning with setanaxib's mechanism of action.
- USPTO patent issuance for setanaxib extends until 2039, providing long-term market exclusivity.
- Patent covers combination therapy with PD-1 inhibitors for resistant solid tumors, broadening treatment potential.
- Positive Phase 2 trial results for head and neck cancer show significant improvements in PFS and OS.
- Statistically significant changes in tumor biology align with setanaxib’s mechanism of action.
- Planned geographical expansion of patent protection, including a pending application in Europe.
- Pending patent applications in other regions, such as Europe, indicate potential delays in global market protection.
Insights
The newly issued patent for setanaxib in combination with PD-1 inhibitors for treating solid tumors resistant to immunotherapy is significant. It underscores the potential of integrating setanaxib into cancer treatment regimens, particularly for patients who have not responded to PD-1 inhibitors. The patent expiration in 2039 provides long-term protection for this treatment method, encouraging further investment in related clinical trials and research.
From a clinical perspective, it is essential to understand that solid tumors that exhibit resistance to PD-1 inhibitors pose a substantial challenge in oncology. The combination therapy with setanaxib could offer a new line of treatment, potentially improving patient outcomes significantly. The recent positive topline results from the Phase 2 trial in head and neck cancer, showing improvements in progression-free survival (PFS) and overall survival (OS), lend credence to the therapeutic potential of setanaxib.
This development could lead to more robust and diverse treatment protocols, addressing a critical unmet need in oncology. It also sets the stage for further clinical trials to assess the efficacy and safety of setanaxib in combination with PD-1 inhibitors across various cancer types.
The issuance of a new patent for Calliditas Therapeutics extends the exclusivity of setanaxib until 2039, which is highly beneficial for the company's long-term financial outlook. This patent strengthens Calliditas's intellectual property portfolio, potentially enhancing its market valuation and making it an attractive target for partnerships or acquisitions.
Positive Phase 2 results showing statistically significant improvements in progression-free survival (PFS) and overall survival (OS) add considerable value. These results not only validate the therapeutic potential of setanaxib but also open up opportunities for further late-stage trials. Success in these trials could lead to regulatory approvals and commercialization, translating into substantial revenue streams.
In the short term, investors can expect increased interest and possibly a rise in stock price due to the bolstered market confidence from the patent grant and positive clinical results. Long-term implications include sustained revenue growth and market competitiveness, particularly in the oncology sector.
The patent grant for setanaxib in treating solid tumors resistant to PD-1 inhibitors represents a strategic move by Calliditas to secure a competitive edge in the oncology market. This patent, aligning with positive Phase 2 trial results, positions Calliditas favorably in the oncology landscape, particularly in the niche of overcoming resistance to existing cancer therapies.
The oncology market is highly competitive and driven by innovation. The combination of setanaxib with PD-1 inhibitors could potentially capture significant market share if subsequent trials confirm efficacy and safety. The patent protection until 2039 ensures a prolonged period during which Calliditas can capitalize on this innovation without facing generic competition.
For investors, this strategic patent not only provides a buffer against market competitors but also indicates Calliditas's commitment to advancing its oncology pipeline, potentially resulting in substantial market traction and financial gains in the long run.
The patent covers a method of treating a solid tumor presenting resistance to PD-1 inhibitor immunotherapy by administering setanaxib in combination with a PD-1 inhibitor. The patent will have an expiration date in 2039. Calliditas has corresponding applications and patents in several additional territories around the world, including a pending patent application in
"We are delighted that the product protection of setanaxib in the area of oncology is extended by way of this patent, and we look forward to expanding this to other geographies", said Renee Aguiar-Lucander, CEO.
Calliditas read out positive topline results of its Phase 2 head and neck cancer trial with setanaxib in May 2024. The analysis showed statistically significant improvements in progression-free survival (PFS), as well as in overall survival (OS), with statistically significant changes in tumor biology consistent with the mechanism of action of setanaxib.
For further information, please contact:
Åsa Hillsten, Head of IR & Sustainability, Calliditas
Tel.: +46 76 403 35 43, Email: asa.hillsten@calliditas.com
The information was sent for publication, through the agency of the contact person set out above, on June 18, 2024 at 12:15 p.m. CET.
About Calliditas
Calliditas Therapeutics is a biopharma company headquartered in
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, statements regarding Calliditas' strategy, commercialization efforts, business plans, regulatory submissions, clinical development plans, revenue and product sales projections or forecasts and focus. The words "may," "will," "could," "would," "should," "expect," "plan," "anticipate," "intend," "believe," "estimate," "predict," "project," "potential," "continue," "target," and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties, and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, any related to Calliditas' business and operations, product protection for setanaxib, the safety and efficacy of setanaxib in SCCHN or other potential indications, anticipated timelines and other risks identified in the section entitled "Risk Factors" in Calliditas' reports filed with the Securities and Exchange Commission. Calliditas cautions you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made. Calliditas disclaims any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions, or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements. Any forward-looking statements contained in this press release represent Calliditas' views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date.
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SOURCE Calliditas Therapeutics
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