ERAS-007 100 mg BID-QW + encorafenib + cetuximab (EC) in EC-naïve patients with BRAFm CRC showed a 50% (3/6) response rate (2 cPR, 1 uPR), reinforcing ERAS-007 as a potential best-in-class ERK inhibitor
Ongoing clinical programs for naporafenib, ERAS-007, ERAS-601, and ERAS-801 in patients with RAS/MAPK pathway-driven tumors continue to offer potential differentiation and near-term catalysts
Strategic pipeline prioritization sharpens focus on existing programs with encouraging signals of activity
Erasca to host investor event today at 4:30 PM Eastern Time
SAN DIEGO, June 05, 2023 (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 promising preliminary Phase 1b data for ERK inhibitor ERAS-007 in patients with metastatic BRAF V600E-mutated (BRAFm) colorectal cancer (CRC) and provided a portfolio update. Erasca will host a virtual investor event to discuss these updates today at 4:30 PM ET. To register for the event, please click here.
“We are pleased that the early ERAS-007 clinical data continue to reinforce its potential to become a backbone for combination therapy,” said Jonathan E. Lim, M.D., Erasca’s chairman, CEO, and co-founder. “Moreover, through our signal-seeking trials, we have tested three biological hypotheses: preventing in-pathway resistance, reversing in-pathway resistance, and targeting adjacent pathways. We believe the encouraging efficacy data for ERAS-007 in combination with encorafenib and cetuximab in EC-naïve patients with BRAFm CRC (preventing in-pathway resistance) provide compelling evidence to continue with further enrollment in this patient population.”
Dr. Lim continued, “Due to a lack of clinical activity, we will not continue exploring ERAS-007 combined with palbociclib in patients with RAS-mutated gastrointestinal malignancies (targeting adjacent pathways) or ERAS-007 combined with osimertinib in patients with post-osimertinib EGFR-mutated non-small cell lung cancer (reversing in-pathway resistance). We have also decided to deprioritize certain discovery programs: ERAS-9 (SOS1), ERAS-11 (MYC), and ERAS-2/3 (RAS switch-II groove targeting), but are pursuing other promising research approaches to target RAS mutations beyond G12C. Further refining our efforts and prioritizing resources will allow us to focus on clinical and research programs with potential therapeutic differentiation and will increase our capacity to realize the many exciting opportunities ahead of us to help patients. We continue to be well positioned to execute on important catalysts over the next 18 months and beyond for our four clinical programs, our pan-RAF inhibitor naporafenib, ERK inhibitor ERAS-007, SHP2 inhibitor ERAS-601, and CNS-penetrant EGFR inhibitor ERAS-801.”
ERAS-007 Development Update
Meaningful activity in patients with EC-naïve BRAFm CRC supports initial focus on and dose expansion of this patient population*:
* Safety data cutoff date was March 23, 2023. Efficacy data cutoff date was May 21, 2023
Across the HERKULES studies, early clinical data reinforce ERAS-007’s potential to be a backbone for combination therapy:
A data-driven prioritization focuses Erasca’s resources on opportunities with the highest probability of success for patients.
Key Upcoming Milestones
Erasca re-affirmed its prior guidance for the following, with respect to anticipated key milestones and clinical trial readouts:
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 what we believe to be 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 ability to execute on important catalysts over the next 18 months and beyond for our four clinical programs; our expectations regarding the potential therapeutic benefits and safety profile of our product candidates, including naporafenib, ERAS-007, ERAS-601, and ERAS-801; and the planned advancement of our development pipeline, including the anticipated timing of the first patient dosing in the SEACRAFT series of trials, the anticipated timing of data readouts for the SEACRAFT-1, HERKULES-3, FLAGSHP-1, and THUNDERBBOLT-1 trials, and other upcoming development milestones, and the planned deprioritization of certain programs. 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: preliminary results of a clinical trial 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 as more patient data becomes available, including the risk that an uPR to treatment may not ultimately result in a cPR to treatment after follow-up evaluations; 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; potential delays in the commencement, enrollment, 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; results from preclinical studies or early clinical trials not necessarily being predictive of future results; we have not conducted any clinical trials of naporafenib and are reliant on data generated by Novartis in prior clinical trials conducted by it; our planned 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; regulatory developments in the United States and foreign countries; 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 ending December 31, 2022, 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.
LifeSci Advisors, LLC
Source: Erasca, Inc.
Source: Erasca, Inc.