GeoVax Announces Positive Interim Data Review for Phase 2 Clinical Trial of COVID-19 Vaccine Booster in Patients with Chronic Lymphocytic Leukemia
GeoVax Labs announced positive interim data from its Phase 2 clinical trial of GEO-CM04S1, a dual-antigen COVID-19 vaccine booster for chronic lymphocytic leukemia (CLL) patients. The Data Safety Monitoring Board's review showed that while the mRNA control arm failed to meet the primary endpoint, GeoVax's vaccine arm should continue enrollment. The study at City of Hope National Medical Center compares two injections of GEO-CM04S1 against an mRNA vaccine control. GEO-CM04S1 uses a modified vaccinia virus vector containing both Spike and Nucleocapsid antigens, potentially offering broader immune response and better protection for immunocompromised CLL patients who typically show insufficient responses to current COVID-19 vaccines.
GeoVax Labs ha annunciato dati intermedi positivi dal suo trial clinico di fase 2 per il GEO-CM04S1, un richiamo vaccinale COVID-19 a doppio antigene per pazienti con leucemia linfocitica cronica (CLL). La revisione del Data Safety Monitoring Board ha mostrato che mentre il braccio di controllo mRNA non ha raggiunto l'obiettivo primario, il braccio vaccinale di GeoVax dovrebbe continuare l'arruolamento. Lo studio presso il City of Hope National Medical Center confronta due iniezioni di GEO-CM04S1 con un vaccino mRNA di controllo. GEO-CM04S1 utilizza un vettore virus vaccinia modificato contenente sia gli antigeni Spike che Nucleocapside, offrendo potenzialmente una risposta immunitaria più ampia e una migliore protezione per i pazienti CLL immunocompromessi che tipicamente mostrano risposte insufficienti ai vaccini COVID-19 attuali.
GeoVax Labs anunció datos interinos positivos de su ensayo clínico de fase 2 para el GEO-CM04S1, un refuerzo de vacuna COVID-19 de doble antígeno para pacientes con leucemia linfocítica crónica (CLL). La revisión de la Junta de Monitoreo de Seguridad de Datos mostró que, aunque el grupo de control con mRNA no alcanzó el objetivo principal, el grupo de la vacuna de GeoVax deberá continuar con la inscripción. El estudio en el City of Hope National Medical Center compara dos inyecciones de GEO-CM04S1 con un control de vacuna mRNA. GEO-CM04S1 utiliza un vector de virus vaccinia modificado que contiene tanto los antígenos Spike como el Nucleocápside, lo que potencialmente ofrece una respuesta inmune más amplia y mejor protección para los pacientes con CLL que son inmunocomprometidos y que normalmente muestran respuestas insuficientes a las vacunas COVID-19 actuales.
GeoVax Labs는 만성림프구백혈병(CLL) 환자를 위한 두 가지 항원 COVID-19 백신 부스터인 GEO-CM04S1의 2상 임상 시험에서 긍정적인 중간 데이터를 발표했습니다. 데이터 안전 모니터링 위원회의 검토 결과, mRNA 대조군이 주요 목표를 달성하지 못한 반면, GeoVax의 백신군은 등록을 계속해야 한다고 나타났습니다. City of Hope National Medical Center에서 실시된 이 연구는 GEO-CM04S1의 두 차례 투여를 mRNA 백신 대조군과 비교합니다. GEO-CM04S1은 스파이크 및 핵단백 항원을 모두 포함하는 수정된 백신 바이러스 벡터를 사용하여, 일반적으로 현재 COVID-19 백신에 대해 충분하지 않은 반응을 보이는 면역 저하된 CLL 환자들에게 더 넓은 면역 반응과 더 나은 보호를 제공할 수 있습니다.
GeoVax Labs a annoncé des données intermédiaires positives de son essai clinique de phase 2 concernant le GEO-CM04S1, un vaccin de rappel COVID-19 à double antigène destiné aux patients souffrant de leucémie lymphoïde chronique (LLC). L'examen du Data Safety Monitoring Board a montré que, bien que le groupe de contrôle mRNA n'ait pas atteint l'objectif principal, le groupe de vaccin GeoVax devrait continuer l'inscription. L'étude menée au City of Hope National Medical Center compare deux injections de GEO-CM04S1 à un contrôle de vaccin mRNA. GEO-CM04S1 utilise un vecteur de virus vaccinia modifié contenant à la fois des antigènes Spike et nucléocapside, offrant potentiellement une réponse immunitaire plus large et une meilleure protection aux patients LLC immunodéprimés qui montrent généralement des réponses insuffisantes aux vaccins COVID-19 actuels.
GeoVax Labs gab positive Zwischenwerte aus seiner Phase-2-Studie für den GEO-CM04S1, einen COVID-19-Impfschutz mit zwei Antigenen für Patienten mit chronischer lymphatischer Leukämie (CLL), bekannt. Die Überprüfung durch das Data Safety Monitoring Board ergab, dass der mRNA-Kontrollarm das primäre Ziel nicht erreichte, während der Impfarm von GeoVax die Einschreibung fortsetzen sollte. Die Studie am City of Hope National Medical Center vergleicht zwei Injektionen von GEO-CM04S1 mit einem mRNA-Impfstoffkontrollarm. GEO-CM04S1 verwendet einen modifizierten Vacciniavirus-Vektor, der sowohl Spike- als auch Nukleokapsid-Antigene enthält, was potenziell eine breitere Immunreaktion und besseren Schutz für immunocompromittierte CLL-Patienten bieten könnte, die typischerweise unzureichende Reaktionen auf die derzeitigen COVID-19-Impfstoffe zeigen.
- Interim data shows GEO-CM04S1 performing better than mRNA control vaccine
- DSMB recommends continuation of GeoVax's vaccine arm while control arm fails primary endpoint
- Vaccine demonstrates potential effectiveness in immunocompromised population
- Pending BARDA-funded 10,000-participant Phase 2b trial adds development momentum
- None.
Insights
The interim data review for GeoVax's Phase 2 trial reveals promising developments in their COVID-19 vaccine booster program. The key differentiator of GEO-CM04S1 is its dual-antigen approach, targeting both Spike (S) and Nucleocapsid (N) proteins, while current mRNA vaccines only target the S protein. This broader coverage could be particularly significant for CLL patients, who typically show poor immune responses to conventional vaccines.
The DSMB's decision to continue the experimental arm while noting the control arm's failure to meet endpoints suggests superior performance of GEO-CM04S1. The MVA vector platform's ability to induce strong T cell responses, even in immunosuppressed patients, represents a potential breakthrough for immunocompromised populations who remain vulnerable to COVID-19 despite current vaccination options.
This positive interim data represents a significant milestone for GeoVax, potentially opening doors to a specialized market segment in immunocompromised patients. The BARDA-funded upcoming 10,000-participant Phase 2b trial adds substantial credibility and could significantly reduce development costs. For a small-cap company (
GEO-CM04S1 Improved Immune Response vs mRNA Vaccine
ATLANTA, Nov. 19, 2024 (GLOBE NEWSWIRE) -- GeoVax Labs, Inc. (Nasdaq: GOVX), a biotechnology company developing immunotherapies and vaccines against cancers and infectious diseases, today announced the completion of an interim data review by the Data Safety Monitoring Board (DSMB) for the ongoing Phase 2 clinical trial of GEO-CM04S1, GeoVax’s dual-antigen next-generation COVID-19 vaccine, as a booster vaccine for patients with chronic lymphocytic leukemia (CLL).
Based on the interim analysis of immune responses from the patients enrolled to date, the DSMB determined that, while the mRNA control arm of the study failed to meet the predetermined primary endpoint, the study should continue enrollment of the experimental arm utilizing GeoVax’s Next-Generation GEO-CM04S1 vaccine. The Phase 2 trial is an investigator-initiated clinical study (ClinicalTrials.gov Identifier: NCT05672355) being conducted at City of Hope National Medical Center. The study is examining the use of two injections of GEO-CM04S1, three months apart, to assess immune responses in CLL patients, with an mRNA vaccine as the control arm. Thus far, participants have been randomized 1:1 to receive two boosters with either the GEO-CM04S1 or the mRNA control vaccine.
“This is very exciting news,” commented David Dodd, GeoVax President and CEO, “The outcome of the DSMB interim review appears to support our view of GEO-CM04S1 as a potentially superior COVID-19 vaccine booster within the CLL patient population. Within the CLL and other immune-compromised patient populations, more robust and durable protective immunity is needed, as provided by potential next-generation vaccines such as GEO-CM04S1 that induce both strong T cell and antibody responses.”
Individuals with CLL, regardless of their treatment status, typically exhibit less predictable and often insufficient immune responses to the currently authorized COVID-19 vaccines; therefore, such patients may be at higher risk of a lethal COVID-19 infection. GEO-CM04S1 uses a modified vaccinia virus (MVA) viral vector backbone, containing both the Spike (S) and Nucleocapsid (N) antigens of the SARS-CoV-2 virus. Inclusion of both the S and N antigens may be more effective at inducing COVID-19 immunity in patients exhibiting poor antibody responses following receipt of an mRNA vaccine containing only the S antigen as MVA also induces strong T cell expansion, even in the background of immunosuppression. By targeting both the S and N protein antigens, GEO-CM04S1 offers the potential to both broaden the specificity of the immune responses as well as protect against the loss of efficacy associated with current vaccines due to the significant sequence variation observed within the S antigen.
Dodd continued, “This ongoing trial is providing important information about the potential use of GEO-CM04S1 in one of many immune-compromised patient populations. It is also complementary to the pending start of a BARDA-funded 10,000-participant Phase 2b clinical trial to evaluate the efficacy of GEO-CM04S1 versus an approved COVID-19 vaccine as a booster in healthy individuals. We look forward to sharing further progress reports on each of these programs.”
About GeoVax
GeoVax Labs, Inc. is a clinical-stage biotechnology company developing novel vaccines for many of the world’s most threatening infectious diseases and therapies for solid tumor cancers. The company’s lead clinical program is GEO-CM04S1, a next-generation COVID-19 vaccine for which GeoVax was recently awarded a BARDA-funded contract to sponsor a 10,000-participant Phase 2b clinical trial to evaluate the efficacy of GEO-CM04S1 versus an approved COVID-19 vaccine. In addition, GEO-CM04S1 is currently in three Phase 2 clinical trials, being evaluated as (1) a primary vaccine for immunocompromised patients such as those suffering from hematologic cancers and other patient populations for whom the current authorized COVID-19 vaccines are insufficient, (2) a booster vaccine in patients with chronic lymphocytic leukemia (CLL) and (3) a more robust, durable COVID-19 booster among healthy patients who previously received the mRNA vaccines. In oncology the lead clinical program is evaluating a novel oncolytic solid tumor gene-directed therapy, Gedeptin®, having recently completed a multicenter Phase 1/2 clinical trial for advanced head and neck cancers. A Phase 2 clinical trial in first recurrent head and neck cancer, evaluating Gedeptin® combined with an immune checkpoint inhibitor is planned to initiate during the first half of 2025. GeoVax has a strong IP portfolio in support of its technologies and product candidates, holding worldwide rights for its technologies and products. The Company has a leadership team who have driven significant value creation across multiple life science companies over the past several decades. For more information about the current status of our clinical trials and other updates, visit our website: www.geovax.com.
Forward-Looking Statements
This release contains forward-looking statements regarding GeoVax’s business plans. The words “believe,” “look forward to,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “could,” “target,” “potential,” “is likely,” “will,” “expect” and similar expressions, as they relate to us, are intended to identify forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our financial condition, results of operations, business strategy and financial needs. Actual results may differ materially from those included in these statements due to a variety of factors, including whether: GeoVax is able to obtain acceptable results from ongoing or future clinical trials of its investigational products, GeoVax’s immuno-oncology products and preventative vaccines can provoke the desired responses, and those products or vaccines can be used effectively, GeoVax’s viral vector technology adequately amplifies immune responses to cancer antigens, GeoVax can develop and manufacture its immuno-oncology products and preventative vaccines with the desired characteristics in a timely manner, GeoVax’s immuno-oncology products and preventative vaccines will be safe for human use, GeoVax’s vaccines will effectively prevent targeted infections in humans, GeoVax’s immuno-oncology products and preventative vaccines will receive regulatory approvals necessary to be licensed and marketed, GeoVax raises required capital to complete development, there is development of competitive products that may be more effective or easier to use than GeoVax’s products, GeoVax will be able to enter into favorable manufacturing and distribution agreements, and other factors, over which GeoVax has no control.
Further information on our risk factors is contained in our periodic reports on Form 10-Q and Form 10-K that we have filed and will file with the SEC. Any forward-looking statement made by us herein speaks only as of the date on which it is made. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law.
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FAQ
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