Jazz Pharmaceuticals to Present Pan-RAF Inhibitor Pre-Clinical Data at American Association for Cancer Research (AACR) 2022 Annual Meeting

Rhea-AI Summary

Jazz Pharmaceuticals (Nasdaq: JAZZ) announced the upcoming presentation of pre-clinical data on JZP815, a next-generation pan-RAF kinase inhibitor, at the AACR 2022 Annual Meeting from April 8-13, 2022. The data indicates that JZP815 effectively inhibits mutant A, B, and CRAF kinases, showcasing anti-tumor activity in cancer models. This investigational drug aims to address unmet needs in solid tumors. Jazz plans to submit an IND for JZP815 within the year, continuing its focus on precision oncology.

Positive

• JZP815 demonstrated selective inhibition of mutant A, B, and CRAF kinases.
• The pre-clinical data exhibited anti-tumor activity in RAS- and RAF-mutant models.
• Jazz plans to submit an IND for JZP815 within the year, indicating progress toward clinical trials.

Negative

• JZP815 is still in pre-clinical stages and not yet approved for use.
• The potential risks and uncertainties surrounding registration with the FDA and initiating clinical trials.

DUBLIN, March 8, 2022 /PRNewswire/ -- Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced that pre-clinical data on JZP815, an investigational, next-generation pan-RAF kinase inhibitor, will be presented as a poster at the American Association for Cancer Research (AACR) 2022 Annual Meeting from April 8-13, 2022.

"Together with our pre-clinical collaboration partner, Redx Pharma, we look forward to presenting at AACR our first pre-clinical data on JZP815, which demonstrated that it selectively and potently inhibits mutant A, B and CRAF kinases, and demonstrated anti-tumor activity in RAS- and RAF-mutant xenograft models," said Rob Iannone, M.D., M.S.C.E., executive vice president, global head of research and development of Jazz Pharmaceuticals. "The pan-RAF inhibitor program is part of a novel class of next generation precision oncology therapies that has the potential to benefit cancer patients with high unmet needs in multiple different solid tumors. We look forward to progressing JZP815 to the clinic to further evaluate the benefit it may have for appropriate patients."

The Jazz presentation abstract – titled, "JZP815, a potent and selective pan-RAF inhibitor, demonstrates efficacy in RAF and RAS mutant tumor pre-clinical models" – and the AACR 2022 Annual Meeting details are available here.

Activation of the mitogen-activated protein kinase (MAPK) pathway by oncogenic mutations in RAS and RAF is a frequent driver of cancer. Targeting specific components of the pathway can be a precise and rational route to deliver benefits to cancer patients with high unmet needs. The RAF kinase proteins (ARAF, BRAF, CRAF) are core pathway components that mediate MAPK signaling. Mutations in these critical signaling proteins leads to constitutive activation of the MAPK pathway and tumor growth.

JZP815 is an investigational, pre-clinical stage, next-generation pan-RAF kinase inhibitor that was discovered and developed using state-of-the-art screening methodologies and medicinal chemistry. JZP815 is not currently approved for use anywhere in the world.

Jazz acquired JZP815 from Redx Pharma, and the two companies are collaborating on this pre-clinical research. Jazz plans to submit an IND for JZP815 this year. JZP815 is part of Jazz's growing early-stage R&D pipeline focused on precision oncology in solid tumors.

About Jazz Pharmaceuticals plc
Jazz Pharmaceuticals plc (NASDAQ: JAZZ) is a global biopharmaceutical company whose purpose is to innovate to transform the lives of patients and their families. We are dedicated to developing life-changing medicines for people with serious diseases—often with limited or no therapeutic options. We have a diverse portfolio of marketed medicines and novel product candidates, from early- to late-stage development, in neuroscience and oncology. Within these therapeutic areas, we are identifying new options for patients by actively exploring small molecules and biologics, and through innovative delivery technologies and cannabinoid science.  Jazz is headquartered in Dublin, Ireland and has employees around the globe, serving patients in nearly 75 countries. For more information, please visit www.jazzpharmaceuticals.com and follow @JazzPharma on Twitter.

Caution Concerning Forward-Looking Statements 
This press release contains forward-looking statements, including, but not limited to, statements related to Jazz Pharmaceuticals' belief in the potential of JZP815 to provide a potentially new therapeutic option for multiple solid tumor types; progressing JZP815 to the clinic and other statements that are not historical facts. These forward-looking statements are based on Jazz Pharmaceuticals' current plans, objectives, estimates, expectations and intentions and inherently involve significant risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, effectively registering JZP815 with FDA and initiating clinical trials; launching and commercializing new products; obtaining and maintaining adequate coverage and reimbursement for the company's products; delays or problems in the supply or manufacture of the company's products; and other risks and uncertainties affecting the company, including those described from time to time under the caption "Risk Factors" and elsewhere in Jazz Pharmaceuticals' Securities and Exchange Commission filings and reports (Commission File No. 001-33500), including Jazz Pharmaceuticals' Annual Report on Form 10-K for the year ended December 31, 2021 and future filings and reports by Jazz Pharmaceuticals. Other risks and uncertainties of which Jazz Pharmaceuticals is not currently aware may also affect Jazz Pharmaceuticals' forward-looking statements and may cause actual results and the timing of events to differ materially from those anticipated. The forward-looking statements herein are made only as of the date hereof or as of the dates indicated in the forward-looking statements, even if they are subsequently made available by Jazz Pharmaceuticals on its website or otherwise. Jazz Pharmaceuticals undertakes no obligation to update or supplement any forward-looking statements to reflect actual results, new information, future events, changes in its expectations or other circumstances that exist after the date as of which the forward-looking statements were made.

Media Contact:
Kristin Bhavnani
Head of Global Corporate Communications
Jazz Pharmaceuticals plc
CorporateAffairsMediaInfo@jazzpharma.com 
Ireland +353 1 637 2141
U.S. +1 215 867 4948

Investors:
Andrea N. Flynn, Ph.D.
Vice President, Head, Investor Relations
Jazz Pharmaceuticals plc
investorinfo@jazzpharma.com
Ireland +353 1 634 3211
U.S. +1 650 496 2717

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SOURCE Jazz Pharmaceuticals plc

FAQ

What is JZP815 and what are its potential benefits?

JZP815 is a next-generation pan-RAF kinase inhibitor aimed to provide therapeutic options for cancers with RAS and RAF mutations, showing pre-clinical anti-tumor activity.

When will the pre-clinical data on JZP815 be presented?

The data will be presented at the AACR 2022 Annual Meeting from April 8-13, 2022.

What are the next steps for JZP815?

Jazz Pharmaceuticals plans to submit an IND for JZP815 later this year to advance it into clinical trials.

What types of cancers could JZP815 potentially treat?

JZP815 targets solid tumors, specifically those driven by RAS and RAF mutations.

Is JZP815 currently approved for use?

No, JZP815 is still in the pre-clinical stage and is not yet approved for use.