8-K: Relay Therapeutics Announces New Clinical Trial Collaboration with Pfizer and Unveils Three New Programs

Relay Therapeutics has announced a clinical trial collaboration with Pfizer to evaluate a combination therapy for breast cancer and has also unveiled three new programs from its pre-clinical pipeline.

Summary

• Relay Therapeutics has entered into a clinical trial collaboration with Pfizer to evaluate the combination of RLY-2608, Pfizer's atirmociclib, and fulvestrant for patients with PI3K-mutated, HR+, HER2metastatic breast cancer, with the trial planned to start by the end of 2024.
• The company also announced three new programs from its pre-clinical pipeline, including two genetic disease programs targeting vascular malformations and Fabry disease, and a precision oncology program focused on an NRAS-selective inhibitor.
• The vascular malformations program, targeting PI3K mutations, is planned to enter clinical development in the first quarter of 2025, addressing an estimated 170,000 patients in the U.S.
• The Fabry disease program, a non-inhibitory chaperone, is expected to enter the clinic in the second half of 2025, targeting approximately 8,000 patients in the U.S.
• The NRAS-selective inhibitor program is also planned to begin clinical development in the second half of 2025, targeting an estimated 28,000 patients in the U.S. annually with mutated NRAS solid tumors.
• Relay Therapeutics' cash runway is expected to fund operations into the second half of 2026, with approximately $750 million in cash, cash equivalents, and investments as of March 31, 2024.
• The company's Dynamo platform has been productive, resulting in eight drug candidates, four Investigational New Drug Applications (INDs), and two programs with clinical proof-of-concept.

Sentiment

Score: 8

Explanation: The document is highly positive due to the new collaboration with Pfizer, the announcement of three new programs, and the strong cash position. The company is making significant progress in its pipeline and has a clear strategy for future growth.

Positives

• The collaboration with Pfizer for the breast cancer trial could accelerate the development of RLY-2608.
• The expansion into genetic diseases with the vascular malformations and Fabry disease programs diversifies Relay's pipeline.
• The development of an NRAS-selective inhibitor addresses a significant unmet need in precision oncology.
• The company has a strong cash position, providing financial stability for ongoing and future research.
• The Dynamo platform has demonstrated its ability to generate multiple drug candidates and advance them into clinical trials.
• The company has shown clinical proof-of-concept for two of its programs.

Negatives

• The clinical trials for the new programs are not expected to start until 2025, which means there will be a delay before any potential revenue.
• The success of the new programs is dependent on the results of future clinical trials, which are subject to risks and uncertainties.
• The company is still in the clinical stage, meaning it is not yet generating revenue from commercialized products.

Risks

• The clinical trials may be delayed or fail to demonstrate the safety and efficacy of the drug candidates.
• The company may face challenges in obtaining regulatory approvals for its drug candidates.
• The company's intellectual property may not be adequately protected.
• The company may face competition from other companies developing similar therapies.
• Global economic uncertainty, geopolitical instability, or public health epidemics could impact the company's operations and clinical trials.

Future Outlook

Relay Therapeutics plans to advance its new programs into clinical trials, with several milestones expected in 2024 and 2025, and expects its current cash runway to fund operations into the second half of 2026.

Management Comments

• Don Bergstrom, M.D., Ph.D., President of R&D at Relay Therapeutics, stated that combining atirmociclib and RLY-2608 will avoid key off-target toxicity.
• Sanjiv Patel, M.D., President and Chief Executive Officer of Relay Therapeutics, expressed excitement about the new programs and their potential to drive the company's growth.

Industry Context

This announcement reflects the growing trend of precision medicine and targeted therapies in oncology and genetic diseases, with a focus on developing more selective and effective treatments with fewer side effects. The collaboration with Pfizer highlights the industry's interest in combination therapies to improve patient outcomes.

Comparison to Industry Standards

• The development of a mutant-selective PI3K inhibitor like RLY-2608 is a significant advancement compared to non-selective PI3K inhibitors, which have shown limited efficacy and significant toxicity, such as Alpelisib.
• The approach of using a non-inhibitory chaperone for Fabry disease is novel compared to existing enzyme replacement therapies and inhibitory chaperones like migalastat, which have limitations in terms of Gal activation and mutational coverage.
• The development of an NRAS-selective inhibitor is a significant step forward from pan-RAS inhibitors and downstream pathway inhibitors, which have shown limited efficacy and significant off-target toxicity.
• The company's Dynamo platform, which integrates computational and experimental techniques, is a leading-edge approach in drug discovery, potentially enabling faster and more efficient development of new therapies.

Stakeholder Impact

• Shareholders will likely view the news positively due to the potential for future growth and revenue.
• Employees may be motivated by the company's progress and expansion into new therapeutic areas.
• Patients with breast cancer, vascular malformations, Fabry disease, and NRAS-mutated tumors may benefit from the development of new therapies.
• The collaboration with Pfizer could lead to increased visibility and potential partnerships.

Next Steps

• Initiate the RLY-2608 + atirmociclib + fulvestrant triplet combination clinical trial by the end of 2024.
• Initiate clinical development of RLY-2608 in vascular malformations in the first quarter of 2025.
• Initiate clinical development of the Fabry disease non-inhibitory chaperone in the second half of 2025.
• Initiate clinical development of the NRAS-selective inhibitor in the second half of 2025.
• Provide data updates for RLY-2608 in breast cancer in the fourth quarter of 2024.
• Provide a tumor agnostic data and regulatory update for lirafugratinib in the second half of 2024.

Key Dates

Keywords

Relay Therapeutics, Pfizer, RLY-2608, Atirmociclib, Breast Cancer, Vascular Malformations, Fabry Disease, NRAS Inhibitor, Precision Medicine, Dynamo Platform, Clinical Trials, Genetic Disease, Oncology