RARE Daily

Elevation Oncology Emerges with $32.5 Million to Develop Precision Medicines for Tumors with Rare Genetic Drivers

July 21, 2020

Rare Daily Staff

Elevation Oncology has emerged from stealth with $32.5 million in a series A financing, initiation of a mid-stage study, and partnerships with next-generation genomics companies to develop precision medicines for patients with genomically defined tumors.

Aisling Capital led the financing along with a syndicate of investors including Vertex Ventures HC, Qiming Venture Partners USA, Driehaus Capital Management, and BVF Partners.

“At Elevation Oncology, we envision a future in which each unique genomic testing result can be matched with a purpose-built precision medicine and bring clarity to the patient treatment journey,” said Shawn Leland, founder and chief business officer of Elevation. “Focused drug development paired with open collaboration will be instrumental for our industry to fully realize the potential of precision medicine for all patients with cancer.”

Elevation has struck partnership agreements with Ashion Analytics, Strata Oncology, and Tempus to explore innovative models for real-time identification, patient referral, and enrollment of patients with tumors driven by rare genomic alterations.

The company’s lead experimental therapeutic, seribantumab, is a fully human IgG2 monoclonal antibody that binds to human epidermal growth factor receptor 3 (ERBB3 or HER3). HER3 is traditionally activated through binding of its primary ligand, neuregulin-1 (NRG1).  The NRG1 gene fusion is a rare genomic alteration that combines NRG1 with another partner gene to create chimeric NRG1 “fusion proteins.”

Elevation acquired seribantumab in 2019, and the development program builds on prior clinical experience from more than 800 patients demonstrating consistent safety and tolerability. Previous clinical trials with seribantumab did not select for tumors with an NRG1 driver.

Although rare, NRG1 gene fusions are oncogenic drivers that can be found in a variety of solid tumors, including lung, pancreatic, gallbladder, breast, ovarian, colorectal, and neuroendocrine cancers, and sarcomas. Importantly, NRG1 gene fusions are mutually exclusive with other known driver mutations and are considered a unique oncogenic driver event essential for tumor cell survival.

Following recent regulatory approvals of tumor-agnostic treatments associated with oncogenic drivers, Elevation’s study CRESTONE is designed as a registration-enabling phase 2 “basket trial” to evaluate the efficacy and safety of seribantumab in patients with any solid tumor that harbors an NRG1 fusion. The trial is supported by novel preclinical data generated by Elevation that demonstrates the ability of seribantumab to prevent the activation of HER3 signaling in NRG1 fusion models. Elevation expects to release this data in publications and at scientific conferences later this year.

Elevation Oncology’s diagnostic partnerships will enhance traditional patient enrollment in the CRESTONE study through real-time, nationwide identification of NRG1 fusion positive patients within the Ashion, Strata Oncology, Tempus, and other partner networks. Through various partnership models, patients may also be enrolled in CRESTONE through active referral to current strategic sites or “just-in-time” site initiation.

These innovative models address specific challenges encountered by genomically-driven, tumor-agnostic trials such as the rarity of genomic driver alterations and the impracticality of comprehensive clinical site coverage by both geography and organ-system of study. In addition, these models may reduce the burden on patients by minimizing the number of diagnostic tests they may need and maximizing the treatment opportunities available to them, regardless of where they may live. Bringing clinical trials to patients using the “just-in-time” site initiation model can further help to minimize travel and keep patients safe in the face of ongoing travel restrictions due to COVID-19.

“Our development approach to seribantumab sets the stage for our broader vision: the elevation of precision medicine to the forefront of every patient journey through building a collaborative industry-wide ecosystem,” said Steve Elms, chairman and interim CEO of Elevation Oncology, and managing partner of Aisling Capital. “Together with diagnostic developers, clinical researchers, patient advocates, and the Elevation Oncology team, we are looking to build a pipeline of precision oncology medicines that can amplify each other’s efforts towards our shared goal of improving patient outcomes.”

Photo: Shawn Leland, founder and chief business officer of Elevation

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