Whom You Know: Elevation Oncology Receives Fast Track Designation from the FDA for EO-3021 for the Treatment of Adult Patients with Advanced or Metastatic Gastric or Gastroesophageal Junction Cancer Expressing Claudin 18.2

Thursday, September 26, 2024

Elevation Oncology Receives Fast Track Designation from the FDA for EO-3021 for the Treatment of Adult Patients with Advanced or Metastatic Gastric or Gastroesophageal Junction Cancer Expressing Claudin 18.2

Elevation Oncology, Inc. (Nasdaq: ELEV), an innovative oncology company focused on the discovery and development of selective cancer therapies to treat patients across a range of solid tumors with significant unmet medical needs, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation (FTD) to EO-3021, a differentiated antibody drug conjugate (ADC), for the treatment of patients with advanced or metastatic gastric and gastroesophageal junction (GC/GEJ) cancer expressing Claudin 18.2 that has progressed on or after prior therapy.

"We are delighted to receive Fast Track designation for EO-3021, which marks an encouraging recognition of the unmet medical need in patients with Claudin 18.2-expressing tumors, as well as the potential for EO-3021 to deliver improved therapeutic outcomes," said Joseph Ferra, President and Chief Executive Officer of Elevation Oncology. "This designation is based on nonclinical and initial clinical data from our ongoing Phase 1 clinical trial. As we announced in August, early results showed a confirmed overall response rate of 42.8% in a Claudin 18.2-enriched subset of gastric and GEJ cancer. In addition, we observed differentiated tolerability, with minimal MMAE-associated toxicities, including no neutropenia or peripheral neuropathy/hypoesthesia. We are grateful for the opportunity to potentially expedite the delivery of EO-3021 and look forward to advancing through monotherapy dose expansion and reporting additional data from our ongoing trial in the first half of 2025, and to initiating the combination portion of our study later this year."

Fast Track is a process designed by the FDA to facilitate the development and expedite the review of therapeutic candidates intended to treat serious or life-threatening conditions, for which nonclinical or clinical data demonstrate the potential to address unmet medical needs. Therapeutic candidates that receive FTD may be eligible for more frequent interactions with the FDA to discuss the candidate's development plan. Therapeutic candidates with Fast Track designation may also be eligible for priority review and accelerated approval if supported by clinical data.

About EO-3021

EO-3021 is a differentiated, clinical-stage antibody drug conjugate (ADC) with best-in-class potential comprised of an immunoglobulin G1 (IgG1) monoclonal antibody (mAb) that targets Claudin 18.2 and a monomethyl auristatin E (MMAE) payload with a cleavable linker that is site-specifically conjugated to Glutamine 295 providing a drug-to-antibody ratio (DAR) of 2. Claudin 18.2 is a specific isoform of Claudin 18 that is normally expressed in gastric epithelial cells. During malignant transformation, the tight junctions may become disrupted, exposing Claudin 18.2 and allowing them to be accessible by Claudin 18.2 targeting agents. Elevation Oncology is evaluating EO-3021 in a Phase 1 trial (NCT05980416) in patients with advanced, unresectable or metastatic solid tumors likely to express Claudin 18.2 including gastric, gastroesophageal junction, pancreatic or esophageal cancers.

Elevation Oncology has the exclusive rights to develop and commercialize EO-3021 in all global territories outside Greater China.

About Elevation Oncology, Inc.

Elevation Oncology is an innovative oncology company focused on the discovery and development of selective cancer therapies to treat patients across a range of solid tumors with significant unmet medical needs. We are leveraging our antibody-drug conjugate (ADC) expertise to advance a novel pipeline, initially targeting two clinically validated targets in oncology, Claudin 18.2 and HER3. Our lead candidate, EO-3021, is a potential best-in-class ADC designed to target Claudin 18.2 and is currently being evaluated in a Phase 1 trial (NCT05980416) in patients with advanced, unresectable or metastatic solid tumors likely to express Claudin 18.2 including gastric, gastroesophageal junction, pancreatic or esophageal cancers. Additionally, we expect to nominate a development candidate for our second program, a HER3-targeting ADC for the treatment of patients with solid tumors that overexpress HER3, in 2024. For more information, visit www.ElevationOncology.com.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to, anticipated clinical and preclinical development activities, expected timing of announcements of clinical results, potential benefits of Elevation Oncology's product candidates, potential market opportunities for Elevation Oncology's product candidates and the ability of Elevation Oncology's product candidates to treat their targeted indications. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. These forward-looking statements may be accompanied by such words as "aim," "anticipate," "believe," "could," "estimate," "expect," "forecast," "goal," "intend," "may," "might," "plan," "possible," "potential," "will," "would," and other words and terms of similar meaning. Although Elevation Oncology believes that the expectations reflected in such forward-looking statements are reasonable, Elevation Oncology cannot guarantee future events, results, actions, levels of activity, performance or achievements, and the timing and results of biotechnology development and potential regulatory approval are inherently uncertain. Forward-looking statements are subject to risks and uncertainties that may cause Elevation Oncology's actual activities or results to differ significantly from those expressed in any forward-looking statement, including risks and uncertainties related to Elevation Oncology's ability to advance its product candidates, the timing and results of preclinical studies and clinical trials, approvals and commercialization of product candidates, the receipt and timing of potential regulatory designations, Elevation Oncology's ability to fund development activities and achieve development goals, Elevation Oncology's ability to protect intellectual property, Elevation Oncology's ability to establish and maintain collaborations with third parties, and other risks and uncertainties described under the heading "Risk Factors" in documents Elevation Oncology files from time to time with the Securities and Exchange Commission. These forward-looking statements speak only as of the date of this press release, and Elevation Oncology undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date hereof.

Recent Testimonials by Brand Ambassadors on their Experience with Whom You Know

"I work with Peachy Deegan because she's prolific at what she does. She's a hard worker, she's thoughtful and she's tasteful at what she writes which is very important. Peachy gets the facts correct, and just that alone is worth its weight in gold."

-Edward Tricomi, Master Stylist and Owner of Warren-Tricomi
https://warrentricomi.com/

"No one has yet to express their taste for our cuisine better than Peachy Deegan on Whom You Know. Thank you for transforming our flavor into words, unlike any other before.
Sometimes WHOM YOU KNOW, really makes a difference and Ammos Estiatorio is grateful to know Peachy Deegan!"
-
Dimitris Nakos, Founder and Owner of
Ammos Estiatorio
https://ammosnewyork.com/

“Whom You Know has done an amazing job of featuring our company over many years [seven]. Peachy has worked tirelessly to create a well-curated selection of topics and brands that are clearly of relevance to her growing audience of readers. Her articles are filled with great insights based on first-hand experience. She does her research, knows her business and is a pleasure to work with!”

-David Sasuga, Owner of Fresh Origins Microgreens
www.FreshOrigins.com

"Peachy Deegan has the pulse of the nation and highlights exceptional opinion leaders in more than 23,000 inspiring and entertaining posts. Her 100,000 twitter followers are a true testimony to Peachy’s ability to inspire, motivate and entertain. She is a feminine force to be reckoned with and an exemplary example of an influential voice in today’s world."

-Mica Mosbacher, author of the new book The Hurricane Factor: Stormside Patriots and tv political commentator

"It was an honour to be chosen for Movers and Shakers by Peachy Deegan. The questions in the interview were intelligent and insightful and I thoroughly enjoyed answering them. The reaction to the interview has been overwhelmingly positive and has helped bring my art practice to a wider audience."
-Damien Flood, Internationally Acclaimed Artist
http://www.damienflood.ie/

"We were so fortunate to hit Peachy’s radar. Her review of our Warmies was spot-on and came at a great time in our company’s early history.
Peachy has such a strong relationship with her readers. She provides honest and real comments; she is truly a trusted source in a very large circle
of consumers."
-Scott Wehrs
President
Intelex U.S.A.
http://www.intelexusallc.com/

"We at Primola love working with Whom You Know and are proud to have been a highly-ranked Manhattan restaurant by Peachy Deegan since 2012, and are featured seasonally. We appreciate the fantastic work Peachy does highlighting our cuisine with her sublime writing style and the whole neighborhood of the Upper East side. Also, we are glad that she has started a Made in Italy column! If you have the opportunity to be considered for review, we'd highly recommend working with her."
-Giuliano Zuliani, Owner of Primola Restaurant
https://www.facebook.com/Primola-Canaletto-restaurants-NYC-135616799831091

"
Peachy Deegan is a gem. She is wonderful to feature our Irish brands in 'Whom You Know'! The articles are beautifully and passionately presented, bringing products and brands to life, making both relevant and fun for her many faithful followers to read. I am immensely proud for our hand-crafted products to be included in this venue!"

-
Bill Follett
President, Belleek Group North America
www.Belleek.com

"As you know from my past features, Peachy Deegan and I were in the same class at Boston College prior to either of us becoming entrepreneurs. When we played together on the BC Alumni softball team in Central Park years ago, she mentioned she could not find a great dentist in Manhattan and could often be found networking on her phone in the outfield hiding from the ball. She was my second patient ever in 2006 when I opened my dental practice; I was one of the first sponsors on Whom You Know and the first Mover and Shaker featured in 2009 and have worked with her continuously since. She's even talked her friends that are doctors into being my patients, and they subsequently send their hospital colleagues. I don't know anyone that is as great of a networker and writer as Peachy, nevermind that she is upstanding and always good for her word. Cosmopolitan Dental is so happy to be in the company of the caliber of major brands she works with today, and although she will tell you a million ways to get your teeth dirty between Peachy's Picks, Terrific Takeout and Peachy's Pantry, Peachy Deegan will tell you there is only one way to get your teeth clean!"
-Dr. Garo Nazarian, Founder and Owner of Cosmopolitan Dental
http://cosmopolitandental.com/