FDA Grants Fast Track for INX-315 in Treating CCNE1-Amplified Platinum-Resistant Ovarian Cancer

Incyclix Bio, LLC, a trailblazing company focused on next-generation cell cycle control, has announced a significant milestone in its quest to combat advanced and resistant cancers. The U.S. Food and Drug Administration (FDA) has granted Fast Track designation to INX-315, a novel and highly selective CDK2 inhibitor, specifically targeting CCNE1-amplified platinum-resistant/refractory ovarian cancer. This designation underlines the potential of INX-315 to address pressing needs in patients suffering from recurrent advanced or metastatic cancer.

Patrick Roberts, PharmD, PhD, who serves as the Chief Executive Officer and Co-Founder of Incyclix Bio, expressed his optimism regarding this development. He emphasized that the FDA's decision to grant Fast Track status is a testament to the promising potential of INX-315. The company's preclinical and early clinical data have shown promising results, strengthening the case for INX-315 as a game-changer for patients with CCNE1-amplified, platinum-resistant ovarian cancer. Roberts also highlighted the urgency of addressing this unmet need and expressed eagerness to collaborate with the FDA to expedite the drug's development and availability.

The FDA's Fast Track program is designed to accelerate the development and review process for drugs that treat serious conditions and address unmet medical needs. Drugs with this designation benefit from increased interaction with the FDA, and they may also qualify for Accelerated Approval and Priority Review if certain criteria are met.

Amplification of cyclin E1 and E2 (CCNE) is a known factor in various solid tumors, and it is particularly prevalent in a subset of patients with high-grade serous ovarian cancer (HGSOC). This amplification is associated with resistance to platinum-based chemotherapy, highlighting a critical gap in effective treatments for the most common form of ovarian cancer. INX-315 aims to fill this gap by offering a novel approach through its potent and selective inhibition of CDK2, which is currently being evaluated in the INX-315-01 trial. This ongoing first-in-human Phase 1/2 clinical trial is assessing the safety, tolerability, pharmacokinetics, and preliminary antitumor activity of INX-315 in patients with recurrent advanced or metastatic cancer.

Incyclix Bio is at the forefront of scientific research into cyclin-dependent kinases (CDKs) and their implications in cancer cell cycles. The company is leading efforts to develop precision treatments targeting the aberrant cell proliferation that drives many cancers. INX-315 stands out as the company's lead compound, showcasing its potential to significantly impact the treatment landscape for ovarian, breast, and lung cancers among others.

Situated in Research Triangle Park, North Carolina, Incyclix Bio is led by pioneers in the field of CDK inhibitor discovery and development. The company is committed to advancing its scientific understanding and translating that knowledge into groundbreaking therapies for cancer patients worldwide.

The current clinical trial for INX-315, identified as NCT05735080, continues to evaluate its potential, with a focus on safety and efficacy. While INX-315 is still an investigational drug and not yet approved by the FDA, the Fast Track designation marks a significant step forward in its development journey, promising new hope for patients battling some of the most challenging cancer forms.