Sosei Group Corporation (“Sosei Heptares” or “the Company”; TSE: 4565) has been notified by Pfizer that it has entered a new oral small molecule GLP-1 receptor agonist into a Phase 1 clinical trial. PF-06954522 was discovered by Pfizer scientists during a multi-target research collaboration in which Pfizer had access to Sosei Heptares’ proprietary StaR® (stabilized receptor) technology. Pfizer recently detailed the entry of PF-06954522 into its Internal Medicine focused clinical pipeline as part of its Q3 2023 results on 31 October 2023.

Dr. Matt Barnes, President of Heptares Therapeutics and Head of UK R&D, commented: “We are delighted to see the progression of PF-06954522 into clinical trials as an output of our research collaboration with Pfizer. We look forward to Pfizer continuing to advance potential medicines for metabolic diseases with large unmet medical need.”

Agreement with Pfizer

Sosei Heptares and Pfizer entered a multi-target drug discovery collaboration in November 2015 to research and develop potential new medicines directed at GPCR targets across multiple therapeutic areas. Many of these targets have clinical or biological validation as key points for therapeutic intervention potentially targeting a range of diseases but have proven difficult to address with conventional discovery approaches because of inherent technical challenges.

To address these challenges, Sosei Heptares and Pfizer scientists worked closely together to leverage their respective complementary expertise in enabling GPCR-focused structure-based drug design (SBDD) and development directed to the GPCR targets selected by Pfizer. Pfizer is responsible for developing and commercializing any potential therapeutic agents (small molecules or biologics) for each target and will have exclusive global rights to any potential
resulting agents.

To date, Sosei Heptares has delivered multiple stabilized receptors (StaR® proteins), X-ray structures and biophysical data on certain programs. Pfizer has nominated three currently active distinct clinical candidates from the collaboration with Sosei Heptares, which are progressing into and through Phase 1 clinical trials:

• PF-06954522 (a GLP-1 receptor agonist)
• PF-07054894 (a CCR6 antagonist targeting Inflammatory Bowel Disease), and
• PF-07258669 (an MC4 receptor antagonist for malnutrition)
  
  

The progress under this partnership has triggered multiple milestone payments to date from Pfizer, with further payments and potential royalties possible under the agreement, provided the criteria under the agreement are satisfied.