Orum Therapeutics Announces Three Presentations At AACR 2023

BOSTON & DAEJEON, South Korea, March 14, 2023 – Orum Therapeutics, Inc. (“Orum”), a private biotechnology company pioneering the development of tumor-directed targeted protein degraders (TPDs), today announced that it will present new preclinical data for its ORM-5029, ORM-6151, and PD-1-Cbl-b programs in three separate presentations at the American Association for Cancer Research (AACR) Annual Meeting 2023 taking place April 14-19 in Orlando.

ORM-5029 is a potential first-in-class targeted protein degrader therapy currently in a Phase 1 clinical trial for HER2-expressing breast cancer. ORM-6151 is currently in the IND-enabling stage for CD33-positive hematologic malignancies, such as acute myeloid leukemia (AML). Orum’s PD-1-Cbl-b immuno-oncology program utilizes a novel approach designed to deliver proprietary Cbl-b inhibitors specifically to PD-1-expressing exhausted T cells, while blocking PD-1/PD-L1 interaction. This strategy is expected to limit systemic exposure of Cbl-b inhibitors and minimize c-Cbl inhibition that can lead to off-target toxicity.

Presentation Details

Poster Title: Development of RNAscope multiplex-based assay for exploratory pharmacodynamic biomarkers assessment in breast cancer patients from Phase I clinical trial of ORM-5029, a potent GSPT1 degrader

Date and Time: Monday April 17, 9:00 AM - 12:30 PM ET

Session Category: Clinical Research Excluding Trials

Session Title: Biomarkers for Elucidation of Tumor Biology and Metastasis

Session Location: Section 38

Poster Board Number: 21

Abstract number: 2118 

Poster Title: ORM-6151: A first-in-class CD33-antibody enabled GSPT1 degrader for AML

Date and Time: Monday, April 17, 1:30PM - 5:00PM ET

Session Category: Experimental and Molecular Therapeutics

Session Title: Drug Delivery Systems

Session Location: Section 15

Poster Board Number: 3

Abstract number: 2700

Poster Title: A novel antibody-enabled dual precision targeted protein stabilization (TPS²) that augments anti-tumor immune response by targeting CBL-B inhibitor to exhausted T cells while blocking checkpoint molecule, PD-1

Date and Time: Tuesday Apr 18, 9:00 AM - 12:30 PM ET

Session Category: Clinical Research Excluding Trials

Session Title: Immunomodulatory Agents and Interventions

Session Location: Section 40

Poster Board Number: 22

Abstract number: 4436

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 combined with the precise tumor cell delivery mechanisms of antibodies to generate innovative, first-in-class, cell-specific TPDs for the treatment of cancer. Orum 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’s TPS² ™ Approach

Orum’s Dual-precision Targeted Protein Stabilization (TPS²) approach combines novel targeted protein inhibitors with the precise cell delivery mechanism of antibodies to increase the levels of intracellular target proteins in a cell-type-specific manner for oncology and immuno-oncology. The first program applying the TPS² approach is a Cbl-b inhibitor (Cbl-bi) conjugated to anti-PD-1 antibody. By delivering Cbl-bi specifically to exhausted T cells, the conjugate restores effector T cell function where PD-1 checkpoint blockade alone is insufficient, while also enabling T cells to overcome the immunosuppressive mechanisms in a tumor microenvironment.

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 antibody-enabled 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.

Forward-Looking Statements

This press release contains forward-looking statements that are based on the current expectations and beliefs of Orum. Statements in this release regarding matters that are not historical facts, including, but not limited to, statements relating to the successful development and clinical benefits of novel targeted protein degraders and Cbl-b inhibitor immuno-oncology products, the potential for translation of preclinical data to positive clinical results, the potential for filing of Investigational New Drug applications, the commencement and successful completion of clinical trials, the potential for development of other product candidates, and the preferability of Orum’s 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 any global 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.

Contacts

Corporate: Kyuri Kim Ph.D., Senior Manager, Business Development, Orum Therapeutics, media@orumrx.com

Media: Jessica Yingling, Ph.D., President, Little Dog Communications Inc., +1-858-344-8091, jessica@litldog.com

Orum Therapeutics Presents Positive Preclinical Data Of ORM-6151, A First-In-Class, CD33-GSPT1 Dual-Precision Targeted Protein Degrader For AML, At ASH 2022

BOSTON & DAEJEON, South Korea, December 10, 2022 – Orum Therapeutics, a private biotechnology company pioneering the development of tumor-directed targeted protein degraders (TPDs), today announced the presentation of positive preclinical data for ORM-6151, a first-in-class, anti-CD33 antibody-enabled GSPT1 degrader for acute myeloid leukemia (AML), at the 64th American Society of Hematology (ASH 2022) Annual Meeting & Exposition taking place December 10-13 in New Orleans and virtually. ORM-6151 is the second drug candidate from Orum’s Dual-Precision Targeted Protein Degradation (TPD2 TM) approach, which combines the catalytic mechanism of TPDs with the precision of tumor-targeting therapeutic antibodies.

The data show that ORM-6151 has picomolar potency and efficacy superior to clinically equivalent doses of CC-90009, a small-molecule GSPT1 degrader, or Mylotarg™, an FDA-approved treatment for AML, in CD33-expressing cell lines and primary relapsed/refractory AML patient blasts. In a clinically relevant animal model of AML, a single treatment of ORM-6151 at doses as low as 1 mg/kg, compared to a clinically equivalent dose of CC-90009, demonstrated superior tumor growth inhibition and correlated with the degree and duration of GSPT1 depletion. ORM-6151 also had robust activity in Mylotarg-resistant cell lines and exhibited minimal cytotoxic activity to healthy hematopoietic progenitor cells compared to CC-90009 or Mylotarg.

“These data demonstrate we can increase the therapeutic index to improve the efficacy and tolerability of targeted protein degrader therapies with our ‘TPD-squared’ approach,” said Peter U. Park, Ph.D., Chief Scientific Officer of Orum Therapeutics. “We believe that ORM-6151 via targeted tumor delivery has the potential to provide an improved therapeutic option in AML that appropriately balances efficacy with safety and tolerability of a clinically validated GSPT1 degradation mechanism. We look forward to continuing development of ORM-6151 with a goal of filing an Investigational New Drug application in the first half of 2023.”

The poster can be viewed in the poster hall and via the virtual meeting platform for registered attendees. Details of the presentation are as follows, and the abstract can be viewed by clicking here.

Title: ORM-6151: A First-in-Class, Anti-CD33 Antibody-Enabled GSPT1 Degrader for AML

Publication Number: 1319

Session Name: 604. Molecular Pharmacology and Drug Resistance: Myeloid Neoplasms: Poster I

Session Date: Saturday, December 10

Presentation Time: 5:30 PM to 7:30 PM CST

Location: Ernest N. Morial Convention Center, Hall D

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 combined with the precise tumor cell delivery mechanisms of antibodies to generate innovative, first-in-class, cell-specific TPDs 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 antibody-enabled 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.

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-6151; the potential for filing an IND application, conducting and successfully completing clinical trials, translation of preclinical data to the clinical context, obtaining favorable trial results, conducting later-phase trials, obtaining regulatory approval of product candidates for sale, and successfully commercializing product candidates; the types of cancer that might be treated by Orum products; and the 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.

Contacts

Corporate: Kyuri Kim Ph.D., Senior Manager, Business Development, Orum Therapeutics, media@orumrx.com

Media: Jessica Yingling, Ph.D., President, Little Dog Communications Inc., +1-858-344-8091, jessica@litldog.com

Orum Therapeutics Announces First Patient Dosed In Phase 1 Clinical Trial Of ORM-5029 In Development To Treat HER2-Expressing Advanced Solid Tumors

ORM-5029 is a first-in-class drug candidate designed to selectively deliver catalytic GSPT1 protein degraders to HER2-expressing tumor cells via antibody targeting

BOSTON & DAEJEON, South Korea, October 31, 2022 – 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.

Contacts

Corporate: Kyuri Kim Ph.D., Senior Manager, Business Development, Orum Therapeutics, contact@orumrx.com

Media: Jessica Yingling, Ph.D., President, Little Dog Communications Inc., +1-858-344-8091, jessica@litldog.com