Relay Therapeutics' Big Second Half of 2024, and New Program Announcements
Taking a Look at Relay Therapeutics (RLAY).
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Relay Therapeutics and the Changing Paradigm in Breast Cancer Treatment
Relay Therapeutics (RLAY) has been on a groundbreaking journey in the treatment of breast cancer, marked by a bold and ambitious development strategy. While some of the biggest news at the ASCO (American Society of Clinical Oncology) conference this past week came from AstraZeneca, with their antibody-drug conjugate (ADC) Enhertu showing significant survival benefits over chemotherapy, Relay's focus remains clear: they are not competing with Enhertu but rather developing next-generation breast cancer treatments.
For more in-depth research on this company, please reference my archive where you’ll find recent quarterly and business updates.
At ASCO, a pivotal study highlighted the benefits of Enhertu in patients with HER2+ breast cancer, who had already undergone treatment with hormone therapy and a CDK4/6 inhibitor, or at least two prior therapies. In this study, doctors had the option to administer Enhertu or chemotherapy. Results showed that patients receiving Enhertu experienced an average of 13 months before death or cancer progression, compared to just 8 months with chemotherapy. This underscores the potential for Enhertu to replace chemotherapy in specific patient populations, though challenges such as side effects and manufacturing hurdles remain (which were not good at all).
So, Relay is taking a similarly ambitious approach with their entire breast cancer pipeline, targeting HR+, HER2- breast cancer across various stages of treatment. Their strategy encompasses adjuvant therapy (post-successful treatment to reduce recurrence) and first-line (1L) metastatic treatment. Key steps in this treatment paradigm include the use of CDK4/6 inhibitors to slow tumor growth, hormone therapy to address hormone receptor-positive (HR+) tumors, and various other agents like PI3K inhibitors depending on the tumor's characteristics.
Relay is working on several promising drug candidates:
RLY-2139: A CDK4 inhibitor that spares CDK6, aiming to reduce side effects while effectively targeting tumor growth.
RLY-1013: An estrogen receptor degrader designed to be more selective than current hormone treatments.
RLY-2608: A pan-selective, mutant-selective PI3K alpha inhibitor that, if successful, could be a game-changer for breast cancer treatment due to its selectivity and potential to be combined with other drugs.
Their Dynamo technology platform has advantages that aim to create well-tolerated treatments, allowing for effective double or triple combination therapies tailored to specific patient populations. Relay's goal is to show that RLY-2608 can live up to its potential, with multiple data readouts expected later this year (huge!).
So, they are exploring new programs which were announced last week:
Alpha-galactosidase A (αGal) chaperone: Targeting Fabry disease, this program uses a chaperone molecule to force mutated proteins into their expected structure, restoring normal function. This oral drug approach contrasts with the gene therapies typically used for Fabry disease.
PI3K-alpha in vascular malformations (VM): Using RLY-2608 to treat VMs, non-cancerous overgrowths of blood vessels driven by PI3K-alpha mutations. With an estimated 170,000 affected individuals in the U.S., this presents a significant opportunity.
NRAS inhibitor: Claiming the first-ever NRAS selective molecule, this program aims to overcome the limitations of pan-RAS inhibitors by sparing KRAS, MEK, and RAF, thus reducing side effects.
The company is positioning itself to make significant strides in the field of oncology, challenging the largest drug developers with its innovative approaches. This bold strategy is not just about developing new drugs but about reshaping the entire treatment landscape for breast cancer and beyond. The industry is witnessing a paradigm shift, and Relay is poised to be at the forefront, building what could be a transformative platform for cancer treatment altogether.
The standout drug we're focused on is RLY-2608 PI3ka, which specifically targets breast cancer—a significant and large market. In the second half of 2024, we're expecting to see efficacy data, the start of a triplet clinical trial, and potentially a new trial in 2025. What sets Relay apart, especially in competition with drugs like Enhertu, is their potential to deliver superior efficacy results. If Relay's data meets or exceeds expectations, it could create major waves in the industry and increase the stock's liquidity. This would also bring new hope for breast cancer treatment and potentially open doors for treating other cancers through Relay’s Dynamo platform. For now, I am holding my position, waiting for the data readouts later this year. If the results are positive, I plan to increase my investment.