Circio announces that partner IOVaxis Therapeutics has exercised the option for an exclusive license to mutant RAS cancer vaccine TG01 in China

  • The option exercise grants IOVaxis an exclusive license to develop and commercialize mutant RAS vaccines TG01/TG02 in Greater China and Singapore
  • IOVaxis will make an immediate down payment of USD 300.000 on the agreed option exercise fee of USD 3.000.000
  • Circio has granted IOVaxis a six-month payment extension on the remainder of the option exercise fee
  • IOVaxis intends to initiate its first TG01 clinical trial in pancreatic cancer during 2024

Oslo, Norway 19 March 2024 – Circio Holding ASA (OSE: CRNA) announces that following approval of the investigational new drug (IND) application by the Chinese National Medical Products Administration (NMPA) on 1 March 2024, IOVaxis Therapeutics of Nantong, China, has on 15 March 2024 exercised its option to license mutant RAS cancer vaccines TG01 and TG02. The license grants IOVaxis exclusive rights to develop and commercialize the TG vaccines in Greater China and Singapore.

Under the license agreement between the parties, Circio is entitled to receive a milestone payment of USD 3m following the exercise of the license option. The total deal includes up to USD 10m in clinical development milestones, as well as royalties and commercial milestones on future sales.

Due to an ongoing process by IOVaxis to secure capital to cover both the milestone payments and the planned phase 1/2 TG01 clinical program and a re-evaluation around the TG01 intellectual property and data protection rights in China, IOVaxis has requested a six-month payment extension of the option fee and a discussion around certain commercial terms. The parties have agreed that IOVaxis will pay USD 300.000 of the option fee to Circio immediately, and that the remaining balance will be due on 15 September 2024. If the payments are not made by the agreed dates, the exclusive license will expire on 15 September 2024.

Dr. John Wang, CEO of IOVaxis Therapeutics, said: “Our substantially expanded IND-package has now been approved by the NMPA, and we are very eager to bring TG01 into the clinic as rapidly as possible to provide a much-needed targeted therapeutic option to patients in China with RAS-mutated pancreatic cancer. The IND-approval was also a critical milestone for our ongoing investor dialogues to secure the required capital for the planned TG01 development program in China and Singapore, and we are very grateful for the flexibility shown by the Circio team to grant an extension to allow further discussions between the parties and with our investors to take place”.

Dr. Erik Digman Wiklund, CEO of Circio Holding ASA, added: “The partnership with IOVaxis is an important component of our aim to bring TG01 development forward through strategic collaborations in multiple settings and geographies. Dr. Wang and his team have shown strong commitment to get the IND approved, which required a substantial investment of time and resources by IOVaxis to develop a broad additional pre-clinical data package. We are very pleased to have such a dedicated partner and expect that the IND approval will make their fundraising successful. We look forward to taking our partnership to the next stage and initiate clinical development in China, which will be the first time TG01 is tested in an Asian patient population”.

For further information, please contact:
Erik Digman Wiklund, CEO
Phone: +47 413 33 536

Renate Birkeli, Investor Relations
Phone: +47 922 61 624

About Circio

Building next generation RNA therapeutics

Circio Holding ASA is a biotechnology company developing novel circular RNA and immunotherapy medicines.

Circio has established a unique circular RNA (circRNA) platform to develop novel circRNA medicines for rare disease, vaccines, and cancer. The proprietary circVec technology is based on a modular genetic cassette design for efficient biogenesis of multifunctional circRNA from DNA and viral vectors, which can be deployed for many purposes. The circVec platform has demonstrated enhanced and more durable protein expression than classic mRNA vector systems, and has the potential to become the new gold-standard for DNA and virus-based therapeutics in the future. The circRNA R&D activities are being conducted by the wholly owned subsidiary Circio AB based at the Karolinska Institute in Stockholm, Sweden.

In addition, Circio is developing a cancer vaccine, TG01, targeting KRAS driver mutations. TG01 is currently being tested in three clinical trials: RAS-mutated pancreatic cancer and lung and non-resectable pancreatic cancer in US, and multiple myeloma in Norway. These studies are being run through academic collaborative networks, supported by prestigious research grants from Innovation Norway and the Norwegian Research Council, creating read-outs and future optionality for the program at low cost to Circio.

This information is considered to be inside information pursuant to the EU Market Abuse Regulation, and is subject to disclosure requirements pursuant to Section 5-12 of the Norwegian Securities Trading Act. The stock exchange announcement was published by Renate Birkeli, Investor Relations, Circio Holding ASA.