Elucida Oncology Provides Corporate Update and Outlines Key Upcoming Milestones

• Enrolling third dose level in Phase 1/2 dose escalation study of ELU001, our lead clinical program targeting solid tumors overexpressing folate receptor alpha (FRα)

• Interim Phase 1 data for ELU001 in 1H22 and interim Phase 2 data in 2H22
• Generated pre-clinical proof-of-concept data with ELU001 in pediatric AML
• Established research collaboration with top 10 pharmaceutical company for two additional pipeline candidates

MONMOUTH JUNCTION, N.J., Jan. 05, 2022 (GLOBE NEWSWIRE) -- Elucida Oncology, a clinical-stage biotechnology company developing the next frontier in targeted cancer therapy, today provided a corporate update and announced its strategic priorities and anticipated milestones.

“The past year was one of substantial progress with the advancement of our lead program, ELU001, into the clinic for the treatment of solid tumors overexpressing folate receptor alpha (FRα). Importantly, recent release of pivotal data for an antibody drug conjugate (ADC) also directed at FRα further validated the target and increased our confidence in ELU001,” said Geno Germano, President and CEO of Elucida Oncology.

“Today, I am excited to announce that we have entered into a research collaboration with a major pharmaceutical company for the development of two novel CDCs, which further expands our pipeline of novel drug conjugates. Looking ahead, 2022 could represent another step-change in the evolution of the company, with interim Phase 1 data of ELU001 in the first half of the year and identification of a recommended Phase 2 dose (R2PD) in the second half. We believe our CDC’s greater avidity for the antigen and tumor retention combined with delivery of a larger amount of drug payload could produce efficacy even in patients with lower expression of FRα while rapid renal clearance could translate into a more favorable safety profile, addressing key limitations of ADCs. In addition, we expect our research collaboration to yield preclinical data that could inform the selection of a lead candidate by year-end,” added Mr. Germano.

Strategic Priorities and Milestones

ELU001: Lead CDC clinical candidate for patients with advanced, recurrent, or refractory solid tumors expressing folate-receptor alpha enters third dose level in ongoing Phase 1/2 trial.

• Preliminary safety, efficacy, and translational data from Phase 1 dose escalation trial anticipated in 1H22
• Determine recommended Phase 2 dose (RP2D) and preliminary Phase 2 data in 2H22
• Establish clinical proof of concept in medium as well as high expressing FRα tumors, driving further differentiation from ADCs
• Potential expansion of indications in 2022, including a rare subtype of pediatric AML with poor prognosis, where we have generated encouraging preclinical proof-of-concept data

Pipeline Expansion: Select lead for partnered program and advance multiple wholly owned candidates.

• As part of our research collaboration with a major pharmaceutical company, we will evaluate two novel payloads against a validated target for the treatment of hematological malignancies; anticipate generating preclinical data supporting selection of a lead candidate by end of 2022
• Initiate pre-IND toxicology studies for up to three wholly owned therapeutic candidates in solid and/or liquid tumors by end of 2022

Manufacturing: Scaled manufacturing for ELU001 in anticipation of demand from Phase 2 trials.

• Production of C’Dot and CDC platform was scaled up in 2021 by four orders of magnitude to 50 liters
• The first clinical batch of ELU001 was produced & released, enabling start of Phase 1 trial
• Anticipate further production scale up at qualified CDMOs in 2022
  

Business Development: Elucida continues to focus on executing on numerous business development opportunities available through its CDC platform.

• Anticipate expanding team to broaden internal capabilities and capacity
• Look to unlock value of CDC platform through additional strategic collaborations

About Elucida Oncology:

Elucida Oncology, Inc., is a clinical-stage biotechnology company pioneering the next frontier in targeted cancer therapy with its first-in-class, ultra-small nanoparticle C’Dot drug conjugate (CDC) platform. CDCs are designed to penetrate deeper into tumors and deliver a significantly higher payload compared to antibody drug conjugates (ADCs). This combined with greater avidity for the target antigen, longer retention in tumors with minimal systemic exposure due to rapid renal clearance confers unique Target or Clear® properties. In preclinical studies, this has resulted in enhanced efficacy irrespective of antigen expression levels with reduced off-target toxicity, thereby potentially addressing the limitations of ADCs and other novel drug carriers. For more information on Elucida Oncology, Inc., please visit www.elucidaoncology.com.

Released January 5, 2022