Immunome Provides Pipeline Update in Advance of Presentation at the 43rd Annual J.P. Morgan Healthcare Conference
Immunome (NASDAQ: IMNM) announced key pipeline updates ahead of its presentation at the 43rd Annual J.P. Morgan Healthcare Conference. The company expects topline data from the Phase 3 RINGSIDE study of varegacestat, a daily oral gamma secretase inhibitor for desmoid tumors, in H2 2025.
The FDA has cleared the IND for IM-1021, a ROR1-targeted ADC, in Q4 2024. The company plans to submit an IND for IM-3050, a FAP-targeted radioligand therapy, by Q1 2025. Additionally, three novel ADC programs for solid tumors - IM-1617, IM-1340, and IM-1335 - are advancing in preclinical development.
Immunome (NASDAQ: IMNM) ha annunciato importanti aggiornamenti sulla sua pipeline in vista della presentazione alla 43ª Conferenza Annuale J.P. Morgan Healthcare. L'azienda prevede di ottenere i dati preliminari dallo studio di fase 3 RINGSIDE su varegacestat, un inibitore gamma secretasi orale da assumere quotidianamente per i tumori desmoidi, nella seconda metà del 2025.
La FDA ha approvato l'IND per IM-1021, un ADC mirato a ROR1, nel quarto trimestre del 2024. L'azienda pianifica di presentare un IND per IM-3050, una terapia radioligandica mirata a FAP, entro il primo trimestre del 2025. Inoltre, tre nuovi programmi di ADC per tumori solidi - IM-1617, IM-1340 e IM-1335 - stanno avanzando nello sviluppo preclinico.
Immunome (NASDAQ: IMNM) anunció actualizaciones clave de su pipeline antes de su presentación en la 43ª Conferencia Anual de Atención Médica J.P. Morgan. La compañía espera datos preliminares del estudio de fase 3 RINGSIDE de varegacestat, un inhibidor de gamma secretasa oral diario para tumores desmoides, en la segunda mitad de 2025.
La FDA ha aprobado el IND para IM-1021, un ADC dirigido a ROR1, en el cuarto trimestre de 2024. La compañía planea presentar un IND para IM-3050, una terapia radioligandica dirigida a FAP, para el primer trimestre de 2025. Además, tres nuevos programas de ADC para tumores sólidos - IM-1617, IM-1340 y IM-1335 - están avanzando en el desarrollo preclínico.
Immunome (NASDAQ: IMNM)는 제43회 J.P. Morgan Healthcare 컨퍼런스 발표를 앞두고 주요 파이프라인 업데이트를 발표했습니다. 이 회사는 varegacestat의 3상 RINGSIDE 연구에 대한 topline 데이터를 2025년 하반기에 기대하고 있습니다. 이는 매일 복용하는 구강용 감마 세크레타제 억제제로, 데스모이드 종양을 대상으로 합니다.
FDA는 IM-1021에 대한 IND를 2024년 4분기에 승인했습니다. 이 회사는 2025년 1분기까지 FAP을 표적으로 한 방사성 리간드 요법인 IM-3050에 대한 IND를 제출할 계획입니다. 또한, IM-1617, IM-1340, IM-1335의 세 가지 신규 ADC 프로그램이 고형 종양에 대해 전임상 개발을 진행하고 있습니다.
Immunome (NASDAQ: IMNM) a annoncé des mises à jour clés de son pipeline avant sa présentation lors de la 43e Conférence Annuelle J.P. Morgan Healthcare. L'entreprise s'attend à des données préliminaires de l'étude de phase 3 RINGSIDE sur varegacestat, un inhibiteur oral de la gamma secrétase à prendre quotidiennement pour les tumeurs desmoïdes, au second semestre 2025.
La FDA a autorisé l'IND pour IM-1021, un ADC ciblant ROR1, au quatrième trimestre 2024. L'entreprise prévoit de soumettre un IND pour IM-3050, une thérapie radioligandique ciblant FAP, d'ici le premier trimestre 2025. De plus, trois nouveaux programmes d'ADC pour les tumeurs solides - IM-1617, IM-1340 et IM-1335 - avancent dans le développement préclinique.
Immunome (NASDAQ: IMNM) gab wichtige Aktualisierungen seiner Pipeline bekannt, vor seiner Präsentation auf der 43. J.P. Morgan Healthcare Konferenz. Das Unternehmen erwartet in der zweiten Hälfte von 2025 die ersten Daten aus der Phase 3-Studie RINGSIDE mit varegacestat, einem täglichen oralen Gamma-Sekretasehemmer für Desmoid-Tumoren.
Die FDA hat die IND für IM-1021, ein ROR1-gerichtetes ADC, im vierten Quartal 2024 genehmigt. Das Unternehmen plant, bis zum ersten Quartal 2025 eine IND für IM-3050, eine FAP-gerichtete Radioligandtherapie, einzureichen. Darüber hinaus schreiten drei neuartige ADC-Programme für solide Tumoren - IM-1617, IM-1340 und IM-1335 - in der präklinischen Entwicklung voran.
- FDA clearance of IND for IM-1021 ROR1-targeted ADC
- Phase 3 RINGSIDE study for varegacestat progressing with topline data expected H2 2025
- Three new ADC programs in preclinical development expanding solid tumor pipeline
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Insights
The pipeline update reveals multiple significant developments in Immunome's oncology portfolio. The Phase 3 RINGSIDE study of varegacestat for desmoid tumors represents the company's most advanced clinical program, with topline data expected in H2 2025. This rare tumor indication could provide an accelerated path to market if the data is positive.
The FDA clearance of the IND for IM-1021, a ROR1-targeted ADC, is particularly noteworthy. ROR1 is an attractive target expressed in various cancers with minimal expression in normal tissues, potentially offering a wide therapeutic window. The planned IND submission for IM-3050, a FAP-targeted radioligand therapy, suggests a strategic expansion into the growing radioligand space.
The disclosure of three new ADC programs (IM-1617, IM-1340, IM-1335) demonstrates a robust preclinical pipeline leveraging the current industry momentum in ADC development. This diversified approach across multiple modalities - small molecules, ADCs and radioligands - reduces development risk while maximizing potential market opportunities.
The pipeline update presents a compelling investment thesis. With five clinical-stage programs and multiple preclinical assets, Immunome has built a diversified oncology portfolio that could provide multiple value-creating catalysts over the next 12-24 months.
The appointment of Clay Siegall as CEO adds significant credibility - his track record at Seattle Genetics (now Seagen) in developing successful ADCs is particularly relevant given Immunome's growing ADC pipeline. The company's strategic focus on both validated targets (FAP) and novel approaches (ROR1) balances risk and innovation.
The market opportunity in desmoid tumors, while niche, could provide meaningful revenue with competition. The broader ADC portfolio targets larger commercial opportunities in solid tumors. With a market cap of
- Immunome to present at the 43rd Annual J.P. Morgan Healthcare Conference.
- Topline data for Phase 3 RINGSIDE study of varegacestat (formerly known as AL102) expected in second half of 2025.
- IND for IM-1021, a ROR1-targeted ADC, cleared by the FDA in fourth quarter of 2024.
- Novel solid-tumor ADC programs IM-1617, IM-1340 and IM-1335 are in preclinical development.
Interested parties can access the live audio webcast for this conference from the Investor Relations section of the company’s website at www.immunome.com. The webcast replay will be available after the conclusion of the live presentation for approximately 30 days.
The presentation will cover Immunome’s pipeline of targeted therapeutics, including varegacestat (formerly known as AL102), a once-daily oral gamma secretase inhibitor in the Phase 3 RINGSIDE clinical trial for the treatment of desmoid tumors. Immunome expects to report topline data in the second half of 2025.
Immunome also announced the FDA clearance of its IND submission for IM-1021, a ROR1-targeted ADC. Immunome anticipates submitting an IND for IM-3050, its FAP-targeted radioligand therapy, by the end of the first quarter of 2025.
Immunome additionally disclosed three novel ADCs for solid tumor indications that are in preclinical development: IM-1617, IM-1340 and IM-1335.
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). Our most advanced pipeline programs are varegacestat (formerly AL102), a gamma secretase inhibitor which is currently in a Phase 3 trial for treatment of desmoid tumors, IM-1021, a ROR1 ADC with an active IND, and IM-3050, a FAP-targeted radioligand, which is the subject of an IND expected to be submitted in the first quarter of 2025. Our pipeline also includes IM-1617, IM-1335, and IM-1340, all of which are preclinical ADCs pursuing undisclosed targets with expression in multiple solid tumors. 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 “focused,” “will,” “expects,” “anticipates,” “potential,” “expected” and similar expressions to identify these forward-looking statements. These forward-looking statements include, but are not limited to, Immunome’s expected timing for reporting topline data for varegacestat and submission of an IND for IM-3050; Immunome’s ability to advance its novel ADC programs; 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 September 30, 2024, filed with the SEC on November 13, 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
When will Immunome (IMNM) report Phase 3 RINGSIDE trial results for varegacestat?
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