Erasca to Present Preliminary SEACRAFT-1 Phase 1 Data for Naporafenib Plus Trametinib in RAS Q61X Mutant Solid Tumors as Oral Presentation at 36th EORTC-NCI-AACR Symposium

Rhea-AI Summary

Erasca, Inc. (Nasdaq: ERAS) announced an upcoming oral presentation of preliminary SEACRAFT-1 Phase 1 data for naporafenib plus trametinib in patients with RAS Q61X mutant solid tumors at the 36th EORTC-NCI-AACR Symposium. Naporafenib is a potential first-in-class and best-in-class pan-RAF inhibitor. The presentation, scheduled for October 24, 2024, will be given by Dr. Elisa Fontana from Sarah Cannon Research Institute, London.

Erasca is also evaluating naporafenib plus trametinib in the ongoing SEACRAFT-2 pivotal Phase 3 trial in NRAS-mutant melanoma, where favorable survival was previously demonstrated. The company will host a virtual R&D update for investors on October 24, 2024, at 8:30 AM ET, coinciding with the symposium.

Positive

• Naporafenib is a potential first-in-class and best-in-class pan-RAF inhibitor
• Oral presentation of preliminary SEACRAFT-1 Phase 1 data at a major oncology symposium
• Ongoing SEACRAFT-2 pivotal Phase 3 trial in NRAS-mutant melanoma with previously demonstrated favorable survival

Negative

• None.

Insights

Medical Research Analyst

The presentation of preliminary Phase 1 data for naporafenib plus trametinib in RAS Q61X mutant solid tumors is a significant development in targeted cancer therapy. Naporafenib, as a potential first-in-class and best-in-class pan-RAF inhibitor, represents a novel approach in addressing RAS/MAPK pathway-driven cancers.

Key points to consider:

• The SEACRAFT-1 study focuses on patients with locally advanced unresectable or metastatic solid tumors, a population with high unmet medical need.
• Combining naporafenib with trametinib (an FDA-approved MEK inhibitor) suggests a strategic approach to potentially enhance efficacy and overcome resistance mechanisms.
• The ongoing SEACRAFT-2 pivotal Phase 3 trial in NRAS-mutant melanoma, with previously demonstrated favorable survival in pooled analyses, adds weight to the potential of this combination.

While preliminary data can be promising, it's important to await full results to assess efficacy, safety profile and potential market impact. The upcoming R&D update could provide valuable insights into Erasca's development strategy and the broader implications for RAS-targeted therapies.

Financial Analyst

This news has potential positive implications for Erasca (NASDAQ: ERAS) and its investors:

• As a clinical-stage company, positive data from SEACRAFT-1 could significantly boost investor confidence and potentially the stock price.
• The "first-in-class" and "best-in-class" potential of naporafenib suggests a strong market position if approved, which could translate to substantial revenue opportunities.
• The combination of Phase 1 data presentation and a pivotal Phase 3 trial indicates progress across multiple stages of clinical development, diversifying risk.
• The planned investor R&D update demonstrates transparency and could provide catalysts for stock movement based on additional data or strategic insights shared.

However, investors should note that as a clinical-stage company with a $727 million market cap, Erasca's valuation is highly dependent on clinical success. While promising, early-stage data should be viewed cautiously as many drug candidates fail in later stages. The company's financial runway and potential need for future capital raises are also important considerations.

Naporafenib is a potential first-in-class and best-in-class pan-RAF inhibitor

Erasca is also evaluating naporafenib plus trametinib in the ongoing SEACRAFT-2 pivotal Phase 3 trial in NRAS-mutant melanoma where favorable survival was previously demonstrated in pooled analyses

Erasca to host virtual R&D update for investors on Thursday, October 24, 2024, at 8:30 AM ET

SAN DIEGO, Sept. 25, 2024 (GLOBE NEWSWIRE) -- Erasca, Inc. (Nasdaq: ERAS), a clinical-stage precision oncology company singularly focused on discovering, developing, and commercializing therapies for patients with RAS/MAPK pathway-driven cancers, today announced an oral presentation of preliminary SEACRAFT-1 Phase 1 data for naporafenib plus trametinib (MEKINIST^®) in patients with locally advanced unresectable or metastatic solid tumor malignancies with RAS Q61X mutations at the 36^th EORTC-NCI-AACR (ENA) Symposium on Molecular Targets and Cancer Therapeutics taking place October 23-25 in Barcelona, Spain. Naporafenib is a potential first-in-class and best-in-class pan-RAF inhibitor.

Erasca plans to host a virtual investor event to provide a research and development (R&D) update on naporafenib and the RAS targeting franchise on Thursday, October 24, 2024, at 8:30 AM ET in conjunction with the 36^th ENA Symposium. A live question and answer session will follow the formal presentation. To register for the event, please click here.

Oral Presentation Details

Preliminary results from SEACRAFT-1: An open-label study of naporafenib with trametinib in patients with locally advanced unresectable or metastatic solid tumor malignancies with RAS Q61X mutations

Presenter: Dr. Elisa Fontana, Sarah Cannon Research Institute, London, UK

Date and Time: Thursday, October 24, 2024, at 10:18 AM CEST

Session: Proffered Papers: Advancing patient care through novel clinical trials; Plenary 3; Catalog 2

About Erasca
At Erasca, our name is our mission: To erase cancer. We are a clinical-stage precision oncology company singularly focused on discovering, developing, and commercializing therapies for patients with RAS/MAPK pathway-driven cancers. Our company was co-founded by leading pioneers in precision oncology and RAS targeting to create novel therapies and combination regimens designed to comprehensively shut down the RAS/MAPK pathway for the treatment of cancer. We have assembled one of the deepest RAS/MAPK pathway-focused pipeline in the industry. We believe our team’s capabilities and experience, further guided by our scientific advisory board which includes the world’s leading experts in the RAS/MAPK pathway, uniquely position us to achieve our bold mission of erasing cancer.

Cautionary Note Regarding Forward-Looking Statements
Erasca cautions you that statements contained in this press release regarding matters that are not historical facts are forward-looking statements. The forward-looking statements are based on our current beliefs and expectations and include, but are not limited to: our expectations regarding the potential therapeutic benefits of our product candidates, including naporafenib; the planned advancement of our development pipeline; and our ability to successfully prioritize our pipeline portfolio to focus on existing programs that we believe have the highest probability of success. Actual results may differ from those set forth in this press release due to the risks and uncertainties inherent in our business, including, without limitation: our approach to the discovery and development of product candidates based on our singular focus on shutting down the RAS/MAPK pathway, a novel and unproven approach; we only have one product candidate in clinical development and all of our other development efforts are in the preclinical or development stage; the analysis of pooled Phase 1 and Phase 2 naporafenib plus trametinib data covers two clinical trials with different designs and inclusion criteria, which cannot be directly compared, and therefore may not be a reliable indicator of survival data; due to differences between trial designs and subject characteristics, comparing data across different trials may not be a reliable indicator of data; preliminary results of clinical trials are not necessarily indicative of final results and one or more of the clinical outcomes may materially change as patient enrollment continues, following more comprehensive reviews of the data and more patient data become available; our SEACRAFT trials may not support the registration of naporafenib; our assumptions around which programs may have a higher probability of success may not be accurate, and we may expend our limited resources to pursue a particular product candidate and/or indication and fail to capitalize on product candidates or indications with greater development or commercial potential; potential delays in the commencement, enrollment, data readout, and completion of clinical trials and preclinical studies; our dependence on third parties in connection with manufacturing, research, and preclinical and clinical testing; unexpected adverse side effects or inadequate efficacy of our product candidates that may limit their development, regulatory approval, and/or commercialization, or may result in recalls or product liability claims; unfavorable results from preclinical studies or clinical trials; the inability to realize any benefits from our current licenses, acquisitions, and collaborations, and any future licenses, acquisitions, or collaborations, and our ability to fulfill our obligations under such arrangements; regulatory developments in the United States and foreign countries; later developments with the FDA or EU health authorities may be inconsistent with the feedback received to date regarding our development plans and trial designs; our ability to obtain and maintain intellectual property protection for our product candidates and maintain our rights under intellectual property licenses; our ability to fund our operating plans with our current cash, cash equivalents, and marketable securities; and other risks described in our prior filings with the Securities and Exchange Commission (SEC), including under the heading “Risk Factors” in our annual report on Form 10-K for the year ended December 31, 2023, and any subsequent filings with the SEC. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and we undertake no obligation to update such statements to reflect events that occur or circumstances that exist after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement, which is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.

MEKINIST^® is a registered trademark owned by or licensed to Novartis AG, its subsidiaries, or affiliates.

Contact:
Joyce Allaire
LifeSci Advisors, LLC
jallaire@lifesciadvisors.com

Source: Erasca, Inc.

FAQ

What is the purpose of Erasca's SEACRAFT-1 Phase 1 trial for ERAS?

The SEACRAFT-1 Phase 1 trial evaluates naporafenib plus trametinib in patients with locally advanced unresectable or metastatic solid tumor malignancies with RAS Q61X mutations.

When will Erasca (ERAS) present the SEACRAFT-1 Phase 1 data?

Erasca will present the preliminary SEACRAFT-1 Phase 1 data on October 24, 2024, at the 36th EORTC-NCI-AACR Symposium in Barcelona, Spain.

What is naporafenib and how is it being developed by Erasca (ERAS)?

Naporafenib is a potential first-in-class and best-in-class pan-RAF inhibitor being developed by Erasca. It's being evaluated in combination with trametinib in Phase 1 and Phase 3 trials for various RAS/MAPK pathway-driven cancers.

What is the SEACRAFT-2 trial for Erasca's (ERAS) naporafenib?

SEACRAFT-2 is an ongoing pivotal Phase 3 trial evaluating naporafenib plus trametinib in NRAS-mutant melanoma, where favorable survival was previously demonstrated in pooled analyses.