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About Elevation Oncology (Nasdaq: ELEV)
Elevation Oncology is an innovative biotechnology company dedicated to the discovery and development of selective cancer therapies aimed at addressing significant unmet medical needs in oncology. Based in Boston, the company specializes in leveraging antibody-drug conjugate (ADC) technology to create precision medicines targeting specific biomarkers associated with solid tumors. Its mission is to transform cancer treatment by delivering therapies tailored to the unique genomic profiles of patients.
Core Focus and Pipeline
Elevation Oncology’s lead candidate, EO-3021, is a clinical-stage ADC that targets Claudin 18.2, a protein overexpressed in various solid tumors, including gastric, gastroesophageal junction (GEJ), pancreatic, and esophageal cancers. EO-3021 is designed with advanced site-specific conjugation technology to optimize its safety and efficacy profile. The drug is currently being evaluated in a Phase 1 clinical trial for monotherapy and combination therapies, with promising initial data showing robust anti-tumor activity and minimal toxicity.
The company is also advancing EO-1022, a HER3-targeting ADC for cancers such as breast cancer, EGFR-mutant non-small cell lung cancer, and pancreatic cancer. EO-1022 leverages seribantumab, an anti-HER3 monoclonal antibody, combined with cutting-edge site-specific conjugation and payload delivery technologies.
Innovative Technology and Differentiation
Elevation Oncology employs state-of-the-art ADC technology, including site-specific conjugation to improve stability and minimize off-target effects. This approach enhances the therapeutic index of its ADCs, making them safer and more effective. The company’s focus on biomarker-driven therapies allows for precision targeting, ensuring that treatments are tailored to patient populations most likely to benefit.
EO-3021’s differentiated safety profile, including minimal hematological and peripheral neuropathy-related toxicities, makes it a potentially best-in-class ADC. Additionally, its combinability with other therapies, such as PD-1 and VEGFR2 inhibitors, positions it as a versatile treatment option across multiple lines of therapy.
Regulatory Milestones and Partnerships
EO-3021 has received Fast Track designation from the U.S. Food and Drug Administration (FDA) for advanced gastric and GEJ cancers expressing Claudin 18.2, underscoring its potential to address critical unmet needs. The company has also secured Orphan Drug Designation for gastric and pancreatic cancers, enhancing its regulatory pathway.
Elevation Oncology collaborates with leading pharmaceutical companies, including Lilly and GSK, to supply complementary therapies for combination trials. These partnerships strengthen its clinical development capabilities and expand its potential market reach.
Market Position and Competitive Landscape
Operating within the highly specialized field of ADCs, Elevation Oncology competes with established players like Daiichi Sankyo and AstraZeneca. However, its focus on Claudin 18.2 and HER3, combined with its advanced conjugation technology and biomarker-driven approach, provides a unique competitive edge. The company addresses a growing demand for targeted therapies in oncology, particularly for cancers with limited treatment options.
Commitment to Precision Medicine
Elevation Oncology’s approach aligns with the broader industry trend toward precision medicine, where treatments are tailored to the molecular characteristics of individual tumors. By focusing on clinically validated targets and leveraging cutting-edge ADC technology, the company aims to redefine the cancer treatment paradigm and improve patient outcomes.
Conclusion
With a robust pipeline, innovative technology, and strategic partnerships, Elevation Oncology is well-positioned to make a significant impact in the oncology landscape. Its dedication to addressing unmet medical needs through precision-targeted therapies underscores its potential to transform cancer care for patients worldwide.
Elevation Oncology, Inc. (Nasdaq: ELEV) announced the appointment of David Dornan, Ph.D. as the new Chief Scientific Officer. Dr. Dornan brings nearly two decades of oncology drug development experience, previously serving as CSO at Bolt Biotherapeutics and head of Oncology Research at Gilead. Shawn M. Leland, CEO, expressed confidence in Dr. Dornan's ability to advance the company's scientific strategy and expand its product pipeline. Elevation aims to develop precision medicines for genomically defined cancers, focusing on their lead candidate, seribantumab, currently evaluated in the Phase 2 CRESTONE study.
Elevation Oncology (Nasdaq: ELEV) reported its 2021 financial results showcasing substantial growth and strategic advancements. The company raised $106.5 million through an IPO and is progressing in its Phase 2 CRESTONE study of seribantumab, focusing on patients with NRG1 fusions. R&D expenses increased to $23.6 million, driven by clinical trial activities, while net losses mounted to $32 million for the year. Cash reserves stood at $146.3 million, poised to sustain operations into Q2 2023. Initial clinical data from the CRESTONE study is expected in mid-2022.
Elevation Oncology, Inc. (Nasdaq: ELEV) announced its participation in two investor conferences this March. The first is the Cowen 42nd Annual Health Care Conference on March 8 at 12:50 p.m. ET, focusing on tumor-agnostic development. The second is the Oppenheimer 32nd Annual Healthcare Conference on March 16 at 12:40 p.m. ET. Both presentations will be available via live webcast on the company's Investor Relations website. Elevation Oncology is dedicated to developing precision medicines for genomically defined cancers.
Elevation Oncology (Nasdaq: ELEV) has shared its 2021 achievements and 2022 expectations. In 2021, key milestones included advancements in seribantumab in the Phase 2 CRESTONE study, a successful IPO raising $106.5 million, and strategic partnerships aimed at identifying new genomic targets. For 2022, the company plans to present initial data from the CRESTONE study and expand its pipeline. As of September 30, 2021, the company anticipates cash reserves of $155.2 million will support operations into Q2 2023.
Elevation Oncology, Inc. (Nasdaq: ELEV) announced participation by CEO Shawn M. Leland in a pre-recorded fireside chat at the H.C. Wainwright BIOCONNECT Virtual Conference on January 10, 2022. The company focuses on precision medicines for patients with genomically defined cancers, with its lead candidate, seribantumab, targeting NRG1 fusions in solid tumors. The presentation will be available on-demand from 7:00 a.m. ET on the company's investor relations website.
Elevation Oncology, a clinical-stage biopharmaceutical company, announced that Shawn M. Leland, the CEO, will present at the 40th Annual J.P. Morgan Healthcare Conference on January 12, 2022, at 9:45 a.m. ET. The presentation will be held virtually, and interested parties can access a live webcast and replay via the company's Investor Relations website.
Elevation Oncology focuses on developing precision medicines for cancers driven by specific genomic alterations, including their lead candidate, seribantumab.
Elevation Oncology, Inc. (Nasdaq: ELEV) will present a corporate overview and engage in one-on-one meetings at the Piper Sandler 33rd Annual Virtual Healthcare Conference from November 29 to December 2, 2021. An on-demand replay of the presentation will be available starting November 22, 2021, at 10:00 am ET on their Investor Relations website. The company focuses on precision medicines for genomically defined cancers, with lead candidate seribantumab targeting NRG1 fusions in a Phase 2 study. For more details, visit their official site.
Elevation Oncology (Nasdaq: ELEV) reported its third-quarter 2021 financial results, showcasing a net loss of $12.3 million, up from $3.0 million in Q3 2020. Cash and cash equivalents stood at $155.2 million, expected to sustain operations into Q2 2023. The CRESTONE Study for seribantumab has commenced enrollment across the US, Canada, and Australia. Notable clinical data presented indicated a 90% reduction in cancer biomarker CA19-9 in a case study of a patient with NRG1 fusion. The company anticipates completing patient enrollment in mid-2022 and presenting initial clinical results.
Elevation Oncology announced the promotion of Valerie M. Jansen, M.D., Ph.D., to the position of Chief Medical Officer, effective immediately. Jansen, previously the Vice President of Clinical Development, has significantly contributed to the company's vision and clinical programs, including the Phase 2 CRESTONE study targeting NRG1 fusions with the therapeutic seribantumab. The company aims to develop precision medicines for patients with genomically defined cancers, emphasizing the importance of genomic testing to improve treatment outcomes.
Elevation Oncology (Nasdaq: ELEV) announced a case series presentation at the AGITG 2021 Annual Scientific Meeting, highlighting its MoST study. This presentation was recognized as one of the 'Best of the Best.' A patient with treatment-refractory metastatic pancreatic cancer demonstrated lasting response to seribantumab, showing a 90% reduction in the cancer biomarker CA19-9 and a maximum tumor reduction exceeding 50% after over 9 months of treatment. The CRESTONE study, which explores seribantumab's efficacy in NRG1 fusion-positive tumors, is currently enrolling patients.
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