Vaccinex Reports Improved Immunity Correlating with Clinical Benefit of Pepinemab Combination Treatment at Society for Immunotherapy of Cancer’s Annual Meeting
Vaccinex (NASDAQ: VCNX) announced new biomarker data showing that pepinemab enhanced clinical activity of immune checkpoint inhibitors in HPV-negative head and neck cancer (HNSCC). Data from two studies, the Phase 2 KEYNOTE-B84 and a neoadjuvant treatment study, demonstrated that pepinemab combination treatments induced mature lymphoid aggregates correlating with clinical benefit in immunotherapy resistant tumors. The findings will be presented at the Society for Immunotherapy of Cancer's Annual Meeting on November 8th, 2024.
The research suggests pepinemab can overcome limitations of immune checkpoint inhibitors, particularly in patients who typically don't benefit from immune checkpoint monotherapy.
Vaccinex (NASDAQ: VCNX) ha annunciato nuovi dati sui biomarcatori che mostrano come pepinemab abbia migliorato l'attività clinica degli inibitori del checkpoint immunitario nel cancro testa-collo (HNSCC) negativo per HPV. I dati di due studi, il Fase 2 KEYNOTE-B84 e uno studio di trattamento neoadiuvante, hanno dimostrato che i trattamenti combinati con pepinemab hanno indotto aggregati linfocitari maturi correlati a benefici clinici in tumori resistenti all'immunoterapia. I risultati saranno presentati alla Society for Immunotherapy of Cancer's Annual Meeting l'8 novembre 2024.
La ricerca suggerisce che pepinemab può superare le limitazioni degli inibitori del checkpoint immunitario, in particolare nei pazienti che generalmente non traggono beneficio dalla monoterapia con checkpoint immunitario.
Vaccinex (NASDAQ: VCNX) anunció nuevos datos sobre biomarcadores que muestran que pepinemab mejoró la actividad clínica de los inhibidores de puntos de control inmunitario en cáncer de cabeza y cuello (HNSCC) negativo para VPH. Los datos de dos estudios, el Fase 2 KEYNOTE-B84 y un estudio de tratamiento neoadyuvante, demostraron que los tratamientos combinados con pepinemab inducen agregados linfocitarios maduros que correlacionan con beneficios clínicos en tumores resistentes a la inmunoterapia. Los hallazgos se presentarán en la Reunión Anual de la Sociedad para la Inmunoterapia del Cáncer el 8 de noviembre de 2024.
La investigación sugiere que pepinemab puede superar las limitaciones de los inhibidores de puntos de control inmunitario, particularmente en pacientes que normalmente no se benefician de la monoterapia con puntos de control inmunitario.
Vaccinex (NASDAQ: VCNX)는 pepinemab가 HPV 음성 두경부 암(HNSCC)에서 면역 체크포인트 억제제의 임상 활성을 강화한다는 새로운 바이오마커 데이터를 발표했습니다. 2개의 연구, 즉 Phase 2 KEYNOTE-B84와 신항암 치료 연구의 데이터는 pepinemab 복합 치료가 면역 요법에 저항하는 종양에서 임상적 이점과 관련된 성숙 림프 집합체를 유도했다는 것을 보여주었습니다. 이 결과는 2024년 11월 8일에 암 면역요법 학회의 연례 회의에서 발표될 예정입니다.
연구 결과는 pepinemab가 면역 체크포인트 억제제의 한계를 극복할 수 있음을 시사하며, 특히 일반적으로 면역 체크포인트 단일 요법에서 혜택을 보지 못하는 환자들에서 그 효과가 기대됩니다.
Vaccinex (NASDAQ: VCNX) a annoncé de nouvelles données sur les biomarqueurs montrant que pepinemab a amélioré l'activité clinique des inhibiteurs de points de contrôle immunitaire dans le cancer de la tête et du cou (HNSCC) négatif pour le VPH. Les données de deux études, la Phase 2 KEYNOTE-B84 et une étude de traitement néoadjuvant, ont démontré que les traitements combinés avec pepinemab induisaient des agrégats lymphoïdes matures en corrélation avec un bénéfice clinique dans les tumeurs résistantes à l'immunothérapie. Les résultats seront présentés lors de la Réunion Annuelle de la Société pour l'Immunothérapie du Cancer le 8 novembre 2024.
La recherche suggère que pepinemab peut surmonter les limitations des inhibiteurs de points de contrôle immunitaire, en particulier chez les patients qui ne bénéficient généralement pas de la monothérapie par point de contrôle immunitaire.
Vaccinex (NASDAQ: VCNX) hat neue Biomarker-Daten veröffentlicht, die zeigen, dass pepinemab die klinische Aktivität von Immun-Checkpoint-Inhibitoren bei HPV-negativem Kopf-Hals-Krebs (HNSCC) verbessert hat. Daten aus zwei Studien, der Phase-2 KEYNOTE-B84 und einer neoadjuvanten Behandlung, zeigen, dass die Kombinationstherapien mit pepinemab reife lymphoide Aggregate induzierten, die mit klinischen Vorteilen in immuntherapieresistenten Tumoren korrelieren. Die Ergebnisse werden auf dem Jahrestreffen der Society for Immunotherapy of Cancer am 8. November 2024 präsentiert.
Die Forschung legt nahe, dass pepinemab die Einschränkungen von Immun-Checkpoint-Inhibitoren überwinden kann, insbesondere bei Patienten, die in der Regel nicht von einer Monotherapie mit Immun-Checkpoint profitieren.
- Pepinemab demonstrated enhanced clinical activity when combined with immune checkpoint inhibitors
- Treatment showed positive results in typically resistant tumor populations
- Evidence of mature lymphoid aggregate formation correlating with durable responses
- None.
Insights
The biomarker data from the Phase 2 KEYNOTE-B84 study reveals a potentially significant breakthrough in treating HPV-negative head and neck cancer. The formation of mature tertiary lymphoid structures in tumors following pepinemab combination treatment represents a meaningful development in immunotherapy resistance.
The key technical achievement here is pepinemab's ability to block SEMA4D, which typically inhibits dendritic cell migration and maturation. By addressing this specific resistance mechanism, the treatment could potentially expand the effectiveness of immune checkpoint inhibitors to previously non-responsive patient populations.
However, investors should note that while these biomarker results are promising, they are still from Phase 2 trials. The development pathway requires further validation in larger studies before potential commercialization. The micro-cap status of Vaccinex (
Pepinemab appears to enhance clinical activity of immune checkpoint inhibitors via induction of mature tertiary lymphoid structures in tumors of patients with HPV-negative head and neck cancer.
ROCHESTER, N.Y., Nov. 05, 2024 (GLOBE NEWSWIRE) -- Vaccinex, Inc. (Nasdaq: VCNX), a clinical-stage biotechnology company pioneering a differentiated approach to treating cancer and neurodegenerative disease (NDD) through the inhibition of SEMA4D, today announced that it will present new biomarker data that neoadjuvant treatment with pepinemab enhanced the clinical activity of immune checkpoint inhibitors in poorly immunogenic, HPV-negative, head and neck cancer (HNSCC). In a presentation at Society for Immunotherapy of Cancer’s Annual Meeting (SITC) on November 8th, Vaccinex will present data from the Phase 2 KEYNOTE-B84 study (NCT04815720) for treatment of recurrent and metastatic disease as well as an independent study evaluating neoadjuvant treatment of resectable HNSCC (NCT03690986) showing that pepinemab combination treatments appear to induce mature lymphoid aggregates correlating with clinical benefit within immunotherapy resistant tumor populations, including HPV-negative and PD-L1 low HNSCC.
“Major advances beyond immune checkpoint therapies to expand and extend treatment benefits are needed for cancers whose activity may be limited by other resistance mechanisms, including expression of semaphorin 4D (SEMA4D), which binds receptors on myeloid cells to inhibit the migration and maturation of dendritic cells (DC) that are crucial for priming and expanding T cells in adaptive immune responses.” said Maurice Zauderer, CEO at Vaccinex. “We are very excited to see that pepinemab treatment induced the formation of productive lymphoid structures within treated tumors and that this is associated with enhanced immune interactions and durable responses. We believe that novel modalities such as pepinemab can overcome limitations of ICI, particularly in patients who would not typically benefit from immune checkpoint monotherapy. We look forward to ongoing development of pepinemab combination therapies in metastatic and neoadjuvant settings.”
| Meeting: | SITC 39th Annual Meeting |
| Date: | November 8, 2024 |
| Poster Number: | 747 |
| Poster Title: | Pepinemab a Semaphorin 4D blockade antibody in combination with immune checkpoint therapies induces mature lymphoid aggregates correlating with clinical outcomes |
| Presenter | Crystal Mallow, Vaccinex, Rochester, NY, USA |
About Pepinemab
Pepinemab is a humanized IgG4 monoclonal antibody designed to block SEMA4D, which can trigger collapse of the actin cytoskeleton and loss of homeostatic functions of astrocytes and glial cells in the brain and dendritic cells in immune tissue. Over 600 patients have been enrolled in clinical trials of pepinemab in different indications and pepinemab appears to be well-tolerated and to have a favorable safety profile.
About Vaccinex Inc.
Vaccinex, Inc. is pioneering a differentiated approach to treating cancer and slowly progressive neurodegenerative diseases through the inhibition of semaphorin 4D (SEMA4D). The Company’s lead drug candidate, pepinemab, blocks SEMA4D, a potent biological effector that it believes prevents immune infiltration into tumors and triggers damaging inflammation in chronic diseases of the brain. In neurodegenerative diseases, pepinemab is being studied as a monotherapy in the Phase 1/2a SIGNAL-AD study in Alzheimer’s Disease, with ongoing exploration of potential Phase 3 development in Huntington’s disease. In oncology, pepinemab is being evaluated in combination with KEYTRUDA® in the Phase 1b/2 KEYNOTE-B84 study in recurrent or metastatic head and neck cancer (HNSCC) and in combination with BAVENCIO® in a Phase 1b/2 study in patients with metastatic pancreatic adenocarcinoma (PDAC). The oncology clinical program also includes several investigator-sponsored studies in solid tumors including breast cancer and melanoma.
Vaccinex has global commercial and development rights to pepinemab and is the sponsor of the KEYNOTE-B84 study which is being performed in collaboration with Merck Sharp & Dohme Corp, a subsidiary of Merck and Co, Inc. Kenilworth, NJ, USA. Additional information about the study is available at: clinicaltrials.gov.
KEYTRUDA is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co. Inc., Kenilworth, NJ, USA. BAVENCIO®/avelumab is provided by Merck KGaA, Darmstadt, Germany, previously as part of an alliance between the healthcare business of Merck KGaA, Darmstadt, Germany and Pfizer.
Vaccinex’s ActivMAb® Technology is a proprietary poxvirus-based antibody discovery platform. The technology has multiple applications, including discovery of antibodies specific for complex membrane antigens, discovery of antibodies with optimized developability, and protein optimization for expression and activity. Its novel capabilities enable selection of unique antibody drugs against difficult, high-value targets, including multi-pass membrane proteins against which small molecule drugs have demonstrated low efficacy or high toxicity. ActivMAb® and its potential applications for drug discovery against complex membrane protein targets have been described in several publications and is the focus of collaborations with leading biopharmaceutical companies.
Forward Looking Statements
To the extent that statements contained in this presentation are not descriptions of historical facts regarding Vaccinex, Inc. (“Vaccinex,” “we,” “us,” or “our”), they are forward-looking statements reflecting management’s current beliefs and expectations. Such statements include, but are not limited to, statements about expectations and objectives with respect to the results and timing of the SIGNAL-AD clinical trial; our plans, expectations and objectives with respect to the results and timing of the KEYNOTE-B84 clinical trial; the use and potential benefits of pepinemab in R/M HNSCC, lung cancer, metastatic pancreatic adenocarcinoma (PDAC) and other indications; the potential for benefits as compared to single agent KEYTRUDA® or BAVENCIO®; expectations with respect to the collaboration of Merck; the potential to initiate a Phase 3 trial in Huntington’s Disease; and other statements identified by words such as “believe,” “being,” “will,” “appears,” “expect,” “ongoing,” “potential,” “suggest”, and similar expressions or their negatives (as well as other words and expressions referencing future events, conditions, or circumstances). Forward-looking statements involve substantial risks and uncertainties that could cause the outcome of our research and pre-clinical development programs, clinical development programs, future results, performance, or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, uncertainties inherent in the execution, cost and completion of preclinical studies and clinical trials, that interim and preliminary data may not be predictive of final results and does not ensure success in later clinical trials, uncertainties related to regulatory approval, risks related to our dependence on our lead product candidate pepinemab, the possible delisting of our common stock from NASDAQ if we are unable to regain compliance with the NASDAQ listing standards, and other matters that could affect our development plans or the commercial potential of our product candidates. Except as required by law, we assume no obligation to update these forward-looking statements. For a further discussion of these and other factors that could cause future results to differ materially from any forward-looking statement, see the section titled “Risk Factors” in our periodic reports filed with the Securities and Exchange Commission and the other risks and uncertainties described in the Company’s annual year-end Form 10-K and subsequent filings with the SEC.
Investor Contact
Elizabeth Evans, PhD
Chief Operating Officer, Vaccinex, Inc.
(585) 271-2700
eevans@vaccinex.com
FAQ
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