[BIO USA] Onconic Therapeutics Aims to Expand Global Phase 2 Nesuparib Trials Within This Year

Preparing for US Clinical Trials with Expansion Planned Within This Year

Onconic Therapeutics has begun preparations for an FDA Investigational New Drug (IND) application, aiming to expand the global phase 2 clinical trial of its next-generation anticancer drug candidate, Nesuparib, within this year.

Onconic Therapeutics announced on the 25th that it participated in the 'BIO International Convention 2026 (BIO USA 2026)', the world's largest bio event held in San Diego, USA, from the 22nd to the 25th (local time). The company held numerous global partnering meetings and delivered a company presentation at 4 p.m. local time on the 23rd.

A representative of Onconic Therapeutics gave a corporate presentation on the 23rd (local time) at the BIO International Convention 2026 (BIO USA 2026), the world's largest biotech event held in San Diego, USA. Onconic Therapeutics

BIO USA is the world's largest pharmaceutical and biotech industry event, organized by the Biotechnology Innovation Organization. It serves as a leading business partnering platform, bringing together global pharmaceutical companies, biotechs, investment institutions, and research organizations.

During the event, CEO John Kim gave an in-person company presentation, introducing the company's core pipeline, research and development capabilities, and global commercialization strategy. He particularly highlighted the clinical development achievements and the potential of the dual-target anticancer drug candidate Nesuparib (JPI-547, Nesuparib) as a next-generation pan-tumor anticancer therapy.

In the presentation, it was also revealed that, leveraging the administrative framework provided by Nesuparib’s FDA orphan drug designation, the company is preparing an FDA IND (Investigational New Drug application) to expand global phase 2 trials within this year. This includes utilizing benefits such as conditional approval and fast-track review, which attracted significant attention from global pharmaceutical companies and investors.

In response to heightened interest and meeting requests from global companies following the release of Nesuparib’s clinical results at ASCO 2026 (American Society of Clinical Oncology) last month, Onconic Therapeutics dispatched its largest-ever delegation, including the business development (BD) team, researchers, and executives. They are currently conducting numerous partnering meetings with global pharmaceutical and biotech companies.

The company reported that the clinical data for Nesuparib, unveiled at ASCO 2026, received strong interest from the global industry, spurring active discussions on business development, particularly regarding the potential for out-licensing (license-out) of Nesuparib technology during the event.

Nesuparib is a first-in-class, dual-target synthetic lethality anticancer drug that simultaneously targets tankyrase and PARP. It is expected to overcome the limitations of existing PARP-based therapies and expand its indications and patient populations as a next-generation synthetic lethality anticancer treatment. Currently, phase 2 clinical development is underway for four indications: pancreatic cancer, endometrial cancer, ovarian cancer, and gastric cancer. The drug has also received FDA orphan drug designation (ODD) for three cancer types.

The phase 1b clinical data for Nesuparib, released at ASCO 2026 last month, increased expectations for its potential in treating metastatic pancreatic cancer. In particular, cases of long-term survival—exceeding 40 months—after achieving complete remission (CR) of target lesions in metastatic pancreatic cancer drew significant attention from several global pharmaceutical companies and investors. Furthermore, the data suggested the possibility of extending overall survival (OS) in metastatic pancreatic cancer, which is considered a refractory cancer, thereby confirming its potential as a next-generation pan-tumor anticancer therapy.

As global business development discussions around Nesuparib rapidly expand, Onconic Therapeutics is accelerating global advancement of Nesuparib by leveraging its overseas business development capabilities and partnership experience demonstrated through the new drug for gastroesophageal reflux disease, Jacuvo. Jacuvo has signed licensing and supply agreements in 27 countries worldwide, and approval procedures are underway in major markets such as China and India, further accelerating its global market entry.

At this year’s BIO USA, the company focused on global business development discussions centered on the out-licensing potential of Nesuparib, while also holding a variety of meetings aimed at securing new growth drivers. Through these efforts, the company actively explored opportunities for new business development and considered the potential for developing next-generation promising technologies.

John Kim, CEO of Onconic Therapeutics, stated, "This BIO USA event provided another opportunity to reaffirm Nesuparib’s global competitiveness and marked significant progress in various global commercialization possibilities, including out-licensing. Based on our accumulated global business development experience and revenue from Jacuvo, we will make Nesuparib’s global collaborations tangible and continue preparing the FDA IND application to expand global phase 2 trials within this year."

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