Immunome Presents Compelling Preclinical Data Demonstrating Robust Anti-Tumor Activity for IM-1021
Immunome (NASDAQ: IMNM) presented preclinical data for IM-1021, its ROR1-targeted antibody-drug conjugate, and its proprietary payload HC74 at the 36th EORTC-NCI-AACR Symposium. IM-1021 demonstrated superior efficacy compared to zilovertamab vedotin in mantle cell lymphoma and triple-negative breast cancer models. HC74 showed better potency than deruxtecan across 89 cancer cell lines, with improved hepatocyte clearance and maintained effectiveness in chemotherapy-resistant cells. The company plans to submit an IND application to FDA in Q1 2025.
Immunome (NASDAQ: IMNM) ha presentato dati preclinici per IM-1021, il suo coniugato anticorpale-farmaco mirato a ROR1, e il suo payload proprietario HC74 al 36° Simposio EORTC-NCI-AACR. IM-1021 ha dimostrato un'efficacia superiore rispetto a zilovertamab vedotin in modelli di linfoma a cellule mantellari e cancro alla mammella triplo negativo. HC74 ha mostrato una potenza migliore rispetto a deruxtecan su 89 linee cellulari tumorali, con una migliore clearance epatica e mantenendo l'efficacia nelle cellule resistenti alla chemioterapia. L'azienda prevede di presentare una richiesta IND alla FDA nel Q1 2025.
Immunome (NASDAQ: IMNM) presentó datos preclínicos para IM-1021, su conjugado de anticuerpo-fármaco dirigido a ROR1, y su carga útil propia HC74 en el 36° Simposio EORTC-NCI-AACR. IM-1021 demostró una eficacia superior comparado con zilovertamab vedotina en modelos de linfoma de células del manto y cáncer de mama triple negativo. HC74 mostró mejor potencia que deruxtecan en 89 líneas celulares de cáncer, con una mejor depuración hepatocelular y manteniendo la efectividad en células resistentes a la quimioterapia. La empresa planea presentar una solicitud IND a la FDA en el primer trimestre de 2025.
Immunome (NASDAQ: IMNM)는 36번째 EORTC-NCI-AACR 심포지엄에서 ROR1을 표적으로 한 항체-약물 접합체 IM-1021 및 독점적 페이로드 HC74에 대한 전임상 데이터를 발표했습니다. IM-1021은 맨틀 세포 림프종 및 삼중 음성 유방암 모델에서 zilovertamab vedotin에 비해 우수한 효능을 나타냈습니다. HC74는 89개 암 세포주에서 deruxtecan보다 더 나은 효능을 보여주었으며, 간세포 제거가 개선되고 화학요법 내성 세포에서도 효과를 유지했습니다. 회사는 2025년 1분기에 FDA에 IND 신청서를 제출할 계획입니다.
Immunome (NASDAQ: IMNM) a présenté des données précliniques pour IM-1021, son conjugué anticorps-médicament ciblant ROR1, et sa charge utile propriétaire HC74 lors du 36ème Symposium EORTC-NCI-AACR. IM-1021 a démontré une efficacité supérieure par rapport à zilovertamab vedotin dans des modèles de lymphome à cellules du manteau et de cancer du sein triple négatif. HC74 a montré une meilleure puissance que deruxtecan sur 89 lignées cellulaires cancéreuses, avec une clairance hépatique améliorée et une efficacité maintenue dans les cellules résistantes à la chimiothérapie. L'entreprise prévoit de soumettre une demande IND à la FDA au premier trimestre de 2025.
Immunome (NASDAQ: IMNM) hat beim 36. EORTC-NCI-AACR-Symposium präklinische Daten zu IM-1021, seinem ROR1-zielgerichteten Antikörper-Wirkstoff-Konjugat, und seinem proprietären Wirkstoff HC74 präsentiert. IM-1021 zeigte eine überlegene Wirksamkeit im Vergleich zu zilovertamab vedotin in Modellen für Mantelzell-Lymphom und triple-negativen Brustkrebs. HC74 zeigte eine bessere Potenz als deruxtecan bei 89 Krebszelllinien, mit verbesserter Hepatozyten-Clearance und aufrechterhaltener Wirksamkeit in chemotherapie-resistenten Zellen. Das Unternehmen plant, im ersten Quartal 2025 einen IND-Antrag bei der FDA einzureichen.
- Superior efficacy demonstrated in preclinical models compared to competitor drugs
- HC74 showed 4x better potency than deruxtecan (IC50=5nM vs 20nM)
- 5 out of 8 animals achieved complete responses in triple negative breast cancer model
- Maintained potency in chemotherapy-resistant cell lines
- Clear development timeline with IND submission planned for Q1 2025
- Still in preclinical stage, requiring extensive clinical trials before potential commercialization
- IND submission timeline suggests significant time before potential revenue generation
Insights
The preclinical data for IM-1021 demonstrates significant potential in both liquid and solid tumors. Key findings include superior efficacy compared to zilovertamab vedotin in mantle cell lymphoma and triple-negative breast cancer models, with an impressive
Most notably, HC74's improved pharmacological properties - faster hepatic clearance, higher permeability and lower efflux - suggest better tissue distribution and potentially reduced toxicity compared to existing treatments. These characteristics could translate to an improved therapeutic window in clinical settings. The planned IND submission in Q1 2025 positions the company for a critical regulatory milestone.
- IM-1021 showed superior potency when compared to a competitor in both mantle cell lymphoma and triple-negative breast cancer preclinical models; IND submission expected in 1Q25
- HC74, Immunome’s proprietary TOP1 ADC payload, shows superior potency, desirable ADME properties, and enhanced efficacy in chemo-resistant cell lines when compared to deruxtecan
The poster included preclinical results for IM-1021 in both liquid and solid tumors while also highlighting the enhanced ADME properties of HC74:
- IM-1021 showed superior efficacy compared to zilovertamab vedotin in both the Jeko-1 mantle cell lymphoma model and the MDA-MB-468 triple negative breast cancer model. In the MDA-MB-468 study, 5 out of 8 animals achieved complete responses after three 5 mg/kg doses.
- HC74 demonstrated superior potency (IC50=5nM) compared to deruxtecan (IC50=20nM) in a panel of 89 cancer cell lines.
- HC74 showed faster hepatocyte clearance, higher permeability, and lower efflux than deruxtecan.
- When evaluated in doxorubicin-resistant and vincristine-resistant cell lines, HC74 showed no reduction in potency compared to the parental NCI-H69 cell line.
Immunome expects to submit an IND for the IM-1021 program to the FDA in the first quarter of 2025.
“We believe that transformative ADCs require matching the target with the right combination of antibody, linker, and payload. Based on this data, we continue to believe that IM-1021 is a promising preclinical candidate,” said Immunome’s Chief Scientific Officer Jack Higgins, Ph.D. “HC74’s differentiated profile, including substantial potency in chemo-resistant cell lines, provides intriguing opportunities for clinical development. We look forward to submitting the IM-1021 IND and starting clinical trials upon IND clearance to further validate these findings.”
A copy of the poster is available in the “Events & Presentations” portion of Immunome’s website.
About Immunome, Inc.
Immunome is a clinical-stage targeted oncology company committed to developing first- and best-in-class targeted therapies designed to improve outcomes for cancer patients. We are advancing an innovative portfolio of therapeutics, drawing on leadership that previously played key roles in the design, development, and commercialization of cutting-edge targeted cancer therapies, including antibody-drug conjugate therapies (ADCs.) In addition to a portfolio of discovery-stage ADCs, our pipeline includes AL102, a gamma secretase inhibitor which is currently in a Phase 3 trial for treatment of desmoid tumors, as well as IM-1021, a ROR1 ADC, and IM-3050, a FAP-targeted radioligand, both of which are the subject of INDs expected to be submitted in the first quarter of 2025. For more information, visit www.immunome.com.
Cautionary Statement Regarding Forward-Looking Statements
Statements in this press release that are not purely historical in nature are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. We use words such as “expected,” “expects,” “believe,” “promising,” “look forward” and similar expressions to identify these forward-looking statements. These forward-looking statements include, but are not limited to, Immunome’s expected timing for submission of an IND for IM-1021 and IM-3050; Immunome’s ability to initiate clinical studies for IM-1021; the potential benefits and drug profile of IM-1021 and HC74; and other statements regarding management’s intentions, plans, beliefs, expectations or forecasts for the future. These forward-looking statements are based on Immunome’s current expectations and involve assumptions that may never materialize or may prove to be incorrect; consequently, actual results may differ materially from those expressed or implied in the statements due to a number of factors, including, but not limited to, the risk that Immunome will not be able to realize the benefits of its strategic transactions; the risk that regulatory approvals for Immunome’s product candidates are not obtained, are delayed or are subject to unanticipated conditions; the risk that pre-clinical data may not be predictive of clinical data; the risk that Immunome’s product candidates fail to achieve their intended endpoints; and other risks and uncertainties indicated from time to time described in Immunome’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2024, filed with the SEC on August 12, 2024, and in Immunome’s other filings with the SEC. Except as required by law, Immunome assumes no obligation and does not intend to update any forward-looking statements included in this press release.
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Immunome Contact:
Max Rosett
Chief Financial Officer
investors@immunome.com
Source: Immunome, Inc.
FAQ
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