[Special Stock] OnconicThera's New Drug Designated as Orphan Drug by US FDA... Efficacy Surpasses AstraZeneca

Onconic Therapeutics is showing strong performance. The news that it will present preclinical research results related to gastric cancer for its targeted anticancer drug candidate 'Nesuparip' at the American Association for Cancer Research (AACR) 2025, held in Chicago, USA, at the end of next month, appears to have influenced its stock price.

As of 2:27 PM on the 31st, Onconic Therapeutics was trading at 22,900 KRW, up 2,920 KRW (14.61%) compared to the previous trading day.

According to the abstract released by AACR, the research presentation contains results verifying the mechanism of action and antitumor effects of Nesuparip in gastric cancer, an indication for which existing PARP inhibitors have not been approved. Nesuparip is a next-generation synthetic lethality dual-target anticancer drug candidate that simultaneously inhibits PARP and tankyrase (TNKS).

In cell experiments partially disclosed through the abstract on gastric cancer cell growth inhibition, Nesuparip showed 28 times higher antitumor efficacy compared to the PARP inhibitor Olaparib and 13 times higher efficacy compared to the TNKS inhibitor XAV939. In animal experiments using a xenograft mouse model where gastric cancer cells were implanted in mice to test antitumor efficacy, the Nesuparip monotherapy group showed superior anticancer effects compared to the Olaparib monotherapy group. When combined with the standard gastric cancer chemotherapy drug 'Irinotecan,' the anticancer effect was further enhanced compared to Irinotecan monotherapy.

Nesuparip recently received Orphan Drug Designation (ODD) from the U.S. Food and Drug Administration (FDA) for the gastric cancer indication. Onconic Therapeutics expects that this dual inhibition mechanism will enhance anticancer effects compared to existing PARP inhibitors and be effective in anticancer indications that could not be treated with existing PARP inhibitors. The FDA’s approval rate for Orphan Drug Designation (ODD) is only 17.6%. The company explained that Nesuparip’s ODD designation has secured the technology’s reliability. Among new drugs approved by the FDA in 2022, 49% had previously received ODD approval.

An Onconic representative stated, "This year, based on the new drug development capabilities secured through the late-stage clinical trials and approval of 'Jacubo' and the financial liquidity from its launch, we plan to expand the treatment indications through additional Phase 2 clinical development of Nesuparip," adding, "We will strive to establish it as a new treatment option in the global anticancer drug market."