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Immutep Updates Development Strategy for eftilagimod alfa

Immutep (IMMP) provided an update on its development strategy for eftilagimod alfa. Following the early discontinuation of the TACTI-004 study, Immutep has been conducting a detailed root cause analysis covering clinical, pharmacological and manufacturing aspects. This ongoing root cause analysis has identified structural differences between the efti used in TACTI-004 and the efti used in earlier successful clinical studies. These differences are considered potentially relevant given the markedly different immune activation profile observed in TACTI-004 compared to previous trials and the unexpected clinical outcome of the study. Based on the currently available data from the Root Cause Analysis to date, Immutep believes that the unexpected outcome of TACTI-004 cannot be explained by clinical factors or trial execution factors. The company will provide a further update on completion of the root cause analysis. Based on the findings from the root cause analysis to date, Immutep has contracted a manufacturing run of efti at 200 L scale. Ten GMP batches of efti have previously been manufactured at 200 L scale and used in successful Phase I and Phase II clinical studies of efti, including TACTI-mel, TACTI-002 and INSIGHT-003. In contrast, TACTI-004 was conducted exclusively with efti manufactured at 2,000 L scale. Immutep currently intends to focus the registration-directed clinical development of efti on: HNSCC in patients with CPS less than 1 - based on clinical efficacy data, including mature overall survival data, in a patient population with high unmet need and limited approved treatment options, and for which efti has received Fast Track designation and FDA feedback that the Company considers constructive; and the neoadjuvant setting of STS - based on positive Phase II data, including achievement of the primary endpoint, and for which efti received Orphan Drug Designation from the FDA in April. This focus reflects the compelling clinical data generated to date, the company's interactions with the FDA, regulatory designations obtained, unmet medical need and substantial market potential in these indications. Preparations for the next clinical trials have commenced. Subject to final decisions on strategy and trial design, regulatory interactions, manufacturing timelines, partnering and resources, Immutep is targeting study start during 2H CY27. Immutep's licensing partner, Dr. Reddy's (RDY), has been consulted on and is supportive of this approach. The company is also in preliminary discussions with other parties regarding the proposed development pathway.

Immutep Granted New Patent for Cancer Treatment

Immutep announced the grant of a new patent entitled "Combined Preparations for the Treatment of Cancer or Infection" by the United States Patent and Trademark Office, or USPTO. This patent is the fourth in the series and follows the grant of the United States parent patent, first divisional patent, and second divisional patent announced in December 2020, March 2021 and June 2023, respectively. The claims of the new patent build on the protection provided by the three previously granted patents and are directed to methods for the treatment of cancer by administering eftilagimod alfa in combination with an anti-PD-1 antibody or an anti-PD-L1 antibody, or fragments thereof. The expiry date of the patent is January 20, 2036.