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
Orum Therapeutics Presents Preclinical Data At AACR 2022 Highlighting Novel Dual-Precision Targeted Protein Degrader, ORM-5029, Degrading GSPT1
BOSTON & DAEJEON, South Korea, April 8, 2022 – Orum Therapeutics, a private biotechnology company pioneering the development of tumor-directed targeted protein degraders (TPDs), today presented preclinical data for ORM-5029, a potential first-in-class TPD therapy for HER2-positive cancers, at the American Association for Cancer Research (“AACR”) Annual Meeting 2022. ORM-5029 is one of two lead programs from the company’s Antibody neoDegrader Conjugate (AnDC™) platform based on its Dual-Precision Targeted Protein Degradation (TPD²) approach.
ORM-5029 is designed to selectively deliver catalytic GSPT1 protein degraders to HER2-expressing tumor cells via antibody targeting. 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. The data presented at AACR 2022 describes initial preclinical evaluation of potency, efficacy, and pharmacodynamic (PD) response of ORM-5029.
“Targeted protein degradation holds much therapeutic promise, but classic TPD approaches face clinical development hurdles, including optimizing potency, exposure, and tolerability,” said Peter U. Park, Ph.D., Chief Scientific Officer of Orum Therapeutics. “We believe that we can fulfill the promise of TPD by developing novel small molecule degraders combined with the precise cellular delivery mechanism of antibodies. Compared to either small molecule GSPT1 degraders or standard-of-care antibody drug conjugates, ORM-5029 exhibited superior in vitro and in vivo potency, robust efficacy in low-HER2 settings, and dose-dependent efficacy. These data provide compelling evidence to support our unique approach to targeted protein degradation and continue development of ORM-5029.”
Key data takeaways:
ORM-5029 displays robust efficacy both in vitro and in vivo compared to other small molecule GSPT1 degraders and approved antibody drug conjugates (ADCs)
ORM-5029 exhibits potent activity in HER2-low models both in vitro and in vivo
Dose-dependent efficacy of ORM-5029 correlates with robust and rapid PD modulation of tumor GSPT1 protein levels
Orum’s proprietary payload, SMol006, is a potent degrader with high selectivity for GSPT1 and is compatible with any ADC linker and conjugation technologies.
AACR 2022 is taking place both virtually and in-person at the Ernest N. Morial Convention Center in New Orleans from April 8-13. The poster presentation titled, “ORM-5029: A first-in-class targeted protein degradation therapy using antibody neodegrader conjugate (AnDC) for HER2-expressing breast cancer,” will be available for viewing to registered attendees from Friday, April 8, through Wednesday, July 13, on the AACR Annual Meeting 2022 website. The poster (abstract # 3933) will be presented in person on April 13 from 9:00 am to 12:30 pm in Session PO.ET06.06 – Emerging New Anticancer Agents in Exhibit Halls D-H, Poster Section 22, Poster Number 7.
The poster is available to download https://docsend.com/view/rmxf3edg977qk4r8
About Orum’s AnDC Platform
Orum’s Antibody neoDegrader Conjugate (AnDC™) platform uses the Company’s unique Dual-Precision Targeted Protein Degradation (TPD²™) approach to build novel targeted protein degraders (TPD) 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, neoDegraders are designed to be delivered specifically to cancer cells and degrade the intracellular target protein and cause tumor cell death.
About Orum Therapeutics
Orum Therapeutics is 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 Antibody neoDegrader Conjugate (AnDC) platform, which generates first-in-class antibody drug conjugates. The first therapeutic candidates from the AnDC platform are in development for the treatment of solid tumors and hematologic cancers. Orum is located in Boston, US and Daejeon, South Korea.
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
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 development of other product candidates; the commercialization of product candidates; 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.
Orum Therapeutics Announces Formation Of Scientific Advisory Board
BOSTON, US & DAEJEON, South Korea, April 4, 2022 -- Orum Therapeutics, a biotechnology company pioneering the development of tumor-directed targeted protein degraders to treat cancer, today announced the formation of its scientific advisory board (SAB). The SAB is comprised of a distinguished group of academic and industry experts who will advise the Orum Therapeutics team on the development of Orum’s novel targeted protein degraders (TPD) that use Orum’s TPD²™ approach, which combines the power of protein degradation with the precise tumor cell delivery mechanism of an antibody.
“We are proud to have experienced leaders in drug discovery and clinical development joining our SAB,” said Peter U. Park, Ph.D., Chief Scientific Officer of Orum Therapeutics. “We look forward to meeting regularly and fully leveraging the team’s diverse breadth of experiences as we progress the first molecule from our Antibody neoDegrader Conjugate platform, ORM-5029, into the clinic and continue to expand our pipeline in dual-precision protein degradation and broader protein homeostasis. With our scientific advisors’ guidance, we believe that we can bring first-in-class, dual-precision therapeutics to cancer patients quickly.”
Appointed members of the newly formed Orum Therapeutics SAB include the following:
Julie M. Cherrington Ph.D., is an experienced life science executive with extensive insight in bringing drugs into the clinic and through to commercialization. She has been a key contributor to the successful development of multiple FDA-approved products, including SUTENT®, PALLADIA®, VISTIDE®, VIREAD®, and HEPSERA®. Dr. Cherrington previously served as President and CEO of several oncology companies and currently serves on the Board of Directors for Mirati Therapeutics, Vaxart, Syncona Ltd., MycRx, Kisoji Biotechnology, and Sardona Therapeutics.
Sara Hurvitz, M.D., is Professor of Medicine at the University of California, Los Angeles (UCLA), Co-director of the Santa Monica-UCLA Outpatient Oncology Practice, Medical Director of the Clinical Research Unit of the Jonsson Comprehensive Cancer Center at UCLA, and Director of Breast Oncology. She has an active clinical practice specializing in the treatment of women with breast cancer. In addition, Dr. Hurvitz is a leader of multiple clinical trials testing new targeted therapies, including ENHERTU® for HER2 breast cancer, and preclinical evaluation of novel breast cancer targets.
Maria Koehler, M.D., Ph.D., is Chief Medical Officer of Repare Therapeutics and has more than 20 years of experience in both large, multinational pharmaceutical and biotechnology companies. Dr. Koehler served as an independent Board Member for Celyad Oncology and now serves as Board of Director for IKENA and Silverback Therapeutics. Her industry experience includes leading the development of IBRANCE®
Zoran Rankovic, Ph.D., is Director, Chemistry Centers at Jude Children’s Research Hospital. Prior to joining St. Jude, he served as director in medicinal chemistry at large pharmaceutical companies, where he led teams that delivered clinical candidates over a range of therapeutic areas. At St. Jude, Dr. Rankovic directs a multidisciplinary team that focuses on targeted protein degradation. He has published over 90 scientific papers, patents, and book chapters on drug discovery topics.
Roland B. Walter, M.D., Ph.D., M.S., is Professor at the Fred Hutchinson Cancer Center and a Professor of Medicine at the University of Washington. Dr. Walter specializes in treating acute myeloid leukemia (AML). His research seeks to develop new and improved antibody-based therapies in the laboratory that effectively kill AML cells, including treatments that eradicate the AML stem cells, and then to bring these therapies to patients.
About Orum Therapeutics
Orum Therapeutics is 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 includes the Antibody neoDegrader Conjugate (AnDC™) platform, which generates first-in-class antibody drug conjugates. The first therapeutic candidates from the AnDC platform are in development for the treatment of solid tumors and hematologic cancers. Orum is located in Cambridge, Massachusetts, and Daejeon, South Korea. For more information, visit www.orumrx.com.
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
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 successful development and clinical benefits of novel targeted protein degraders, the frequency of SAB meetings, the commencement of first-in-human studies, the potential for development of other product candidates, the speed with which such candidates are brought to market, 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.