Orum Therapeutics Announces First Patient Dosed in Phase 1 Clinical Trial of ORM-5029 in Development to Treat HER2-Expressing Advanced Solid Tumors

BOSTON & DAEJEON, South Korea

Orum Therapeutics, a private biotechnology company pioneering the development of tumor-directed targeted protein degraders (TPDs), today announced that the first patient has been dosed with ORM-5029 in a Phase 1 clinical trial for patients with HER2-expressing advanced solid tumors. ORM-5029 is one of two lead programs from the company’s GSPT1 platform leveraging the Dual-Precision Targeted Protein Degradation (TPD²) approach, which is designed to leverage antibody drug conjugates (ADCs) to precisely deliver and target intracellular proteins for degradation leading to cancer cell death.

“The initiation of this clinical trial represents a series of firsts for Orum—it’s our first drug candidate from our GSPT1 degrader conjugate platform to enter the clinic, and ORM-5029 is a first-in-class molecule that represents a novel approach to precision targeted protein degraders,” said Sung Joo Lee, Ph.D., CEO of Orum Therapeutics. “In addition to ORM-5029, we are harnessing the power of various protein degraders with the precision of antibodies with the potential to improve the treatment of cancer for more patients.”

The Phase 1 trial (ClinicalTrials.gov Identifier: NCT05511844) is an open label, multicenter, dose escalation and expansion study of ORM-5029 in patients with HER2-expressing advanced solid tumors who are not eligible for standard of care therapy. The study is designed to evaluate the safety, pharmacokinetics, and preliminary anti-tumor activity of ORM-5029 administered intravenously.

“ORM-5029 combines the strengths of targeted protein degraders and ADCs while overcoming the limitations of each modality,” said Olaf Christensen, M.D., Chief Medical Officer of Orum Therapeutics. “Using a GSPT1-degrading payload conjugated to a HER2-detecting antibody is a first-in-class approach for ADCs, differentiating ORM-5029 from ADCs with cytotoxic payloads.”

Dr. Christensen added, “Although important progress has been made for the treatment of HER2-expressing cancers, patients with tumors that are refractory or becoming resistant to approved treatment approaches will need new therapeutic options. The Phase 1 trial will help us to understand the potential clinical impact of ORM-5029 on HER2-expressing advanced tumors.”

Orum’s GSPT1 degrader conjugate platform is designed to deliver potent and differentiated TPDs by combining novel small molecule degraders with the precise cellular delivery mechanism of antibodies. For ORM-5029, Orum developed a proprietary class of GSPT1 degrader molecules, paired them with a HER2-targeting antibody pertuzumab, and screened numerous candidate conjugates to identify a molecule with the desired therapeutic profile. Preclinical data presented at AACR 2022 demonstrate robust potency in vitro and in vivo in low-HER2 settings and dose-dependent efficacy of ORM-5029 compared to either small molecule GSPT1 degraders or standard-of-care ADCs.

About Orum’s GSPT1 Platform Using the TPD² Approach

Orum’s GSPT1 platform uses the Company’s unique Dual-Precision Targeted Protein Degradation (TPD²™) approach to build novel targeted protein degraders (TPDs) combined with the precise tumor cell delivery mechanisms of antibodies to generate innovative, first-in-class, cell-specific TPD for the treatment of cancer. The company has developed new molecular glue degrader payloads to specifically degrade an intracellular target protein within cancer cells via the E3 ubiquitin ligase pathway. Conjugated to antibodies, the payloads are designed to be delivered specifically to cancer cells and degrade the intracellular target protein GSPT1 and cause tumor cell death.

About Orum Therapeutics

Orum Therapeutics is a private, clinical stage biotech pioneering the development of tumor-directed targeted protein degraders by leveraging its TPD² approach to provide dual-precision, antibody-enabled targeted protein degraders for cell-specific delivery. The Company’s proprietary platforms generated using the TPD² approach include the GSPT1 platform, which generates first-in-class antibody drug conjugates. The first therapeutic candidates from the GSPT1 platform are in development for the treatment of solid tumors and hematologic cancers. Orum is located in Boston, US, and Daejeon, South Korea. For more info, please visit www.orumrx.com.

Forward-Looking Statements

This press release contains forward-looking statements that are based on the current expectations and beliefs of Orum Therapeutics, Inc. (“Orum”). Statements in this release regarding matters that are not historical facts, including, but not limited to, statements relating to the potential for clinical efficacy, potency, and tolerability of ORM-5029; the potential for enrolling and dosing additional patients, successfully completing clinical trials, obtaining favorable trial results, conducting later-phase trials, obtaining regulatory approval of product candidates for sale, and successfully commercializing product candidates; the development of other product candidates and the composition thereof; the filing of additional IND applications; the range of potential tumor types that might be treated by Orum products; and the potential market for and preferability of Orum products to others available are forward-looking statements. These forward-looking statements are based on management’s expectations and assumptions as of the date of this release and are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include, without limitation, the uncertain and continually changing impacts and expected duration of the COVID-19 pandemic; the uncertainty of success in research and development activities; risks related to clinical trials, including potential delays, safety issues, or negative results; competition from alternative therapies; the risk that Orum may not be able to maintain and enforce its intellectual property; the risk that product candidates may not be successfully commercialized or adopted; the availability of financing; and risks related to the recruitment and retention of key employees, fluctuating markets and economic conditions, health care reform, prices, and reimbursement rates. The forward-looking statements in this presentation speak only as of the date of this release, and Orum undertakes no obligation to update or revise any of the statements. Orum cautions investors not to place considerable reliance on the forward-looking statements contained in this release.

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