Jazz and Redx Tout IND Acceptance while Omega Seeks First

Cancer Research

European biotech companies Jazz Pharmaceuticals and Redx Pharma announced Wednesday that the Investigational New Drug (IND) application for their drug candidate, JZP815, has been accepted by the U.S. Food and Drug Administration.

JZP815’s IND clearance comes after its impressive preclinical data, which was presented at the American Association for Cancer Research conference. Jazz is now planning a Phase I clinical trial to assess the potential of JZP815 as a therapy for various difficult-to-treat cancers. Once it pushes through, JZP815 will be Redx’s fifth candidate to enter the clinic.

"We're excited to advance JZP815, a precision pan-RAF inhibitor with a differentiated mechanism of action, into a clinical trial program,” Rob Iannone, M.D., M.S.C.E., executive vice president, global head of research and development at Jazz Pharmaceuticals, said in a statement.

“The JZP815 program exemplifies our continued progress in expanding our early-stage oncology pipeline, and in developing therapies with the potential to address unmet patient need. Redx has an exceptional team of research and development scientists and together we have formed an outstanding collaboration, leveraging the strengths of both companies," he added.

The two companies entered into a partnership in 2019, when Jazz acquired Redx’s pan-RAF inhibitor development program. Under this agreement, Jazz made a $5 million milestone payment to Redx following the IND acceptance. Redx continues to be entitled to other development, regulatory and commercial milestone payments, including tiered royalties.

JZP815 is a pan-RAF kinase inhibitor that targets specific molecules in the MAPK pathway which, when mutated, often play roles in the development of cancer. As an investigational and pre-clinical candidate, JZP815 is currently not approved for use for any indication. It forms part of Jazz’s growing R&D pipeline for solid tumors.

Omega Seeks IND Approval for First-in-Class HCC Candidate

Right on the heels of Jazz and Redx is Massachusetts-based development-stage biotech company Omega Therapeutics. The company announced that it had submitted an Investigational New Drug (IND) application to the FDA in hopes of initiating a clinical trial for OTX-2002, its lead candidate for the treatment of hepatocellular carcinoma (HCC).

OTX-2002 is a first-in-class mRNA therapeutic agent delivered through lipid nanoparticles. It works by pre-transcriptionally suppressing the expression of c-Myc through epigenetic modulation. Discovered and developed through the company’s OMEGA Epigenomic Programming platform, OTX-2002 represents Omega’s mold-breaking approach of targeting, with incredible precision, discrete units in the chromosome and fine-tune the expression of genes in these units—all without altering the native DNA sequence. The company is currently developing a broad pipeline of drug candidates for a wide array of therapeutic areas including oncology, immunology, and multigenic diseases.

“We are excited that this represents the first of many anticipated IND applications and the transition of the company to its next stage," Mahesh Karande, president and chief executive officer of Omega Therapeutics, said in a statement. "This also marks a milestone regulatory submission for the first epigenomic controller, a new class of programmable mRNA therapeutics enabled by our OMEGA platform.”

“We believe our approach to engineering epigenomic controllers has immense potential across a broad range of diseases, including HCC, which carries a 5-year survival rate of only 10%. We look forward to advancing OTX-2002 into the clinic and bringing it one step closer to patients in need," he added.

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