GeoVax Announces Phase 2 Plans for Gedeptin® Cancer Therapy Following Clinical Advisory Committee Review
GeoVax Labs, Inc. (Nasdaq: GOVX) has announced plans for a Phase 2 trial of its Gedeptin® cancer therapy following a clinical advisory committee review. The trial will focus on first-recurrence head and neck cancer, combining Gedeptin with an immune checkpoint inhibitor. This decision comes after reviewing the completed PNP-002 Phase 1b/2a and PNP-001 Phase 1 trials, which demonstrated acceptable safety and efficacy in advanced head and neck squamous cell carcinoma (HNSCC) patients.
The planned Phase 2 trial aims to establish the efficacy of neoadjuvant Gedeptin therapy combined with an immune checkpoint inhibitor. It will involve approximately 6 patients, with pathologic response rate as the primary endpoint. GeoVax anticipates trial activation during the first half of 2025. The company is also pursuing development plans for Gedeptin in additional solid tumor indications in partnership with leading academic oncology centers.
GeoVax Labs, Inc. (Nasdaq: GOVX) ha annunciato piani per un trial di Fase 2 della sua terapia contro il cancro Gedeptin®, dopo una revisione del comitato consultivo clinico. Il trial si concentrerà su cancro alla testa e al collo con prima ricorrenza, combinando Gedeptin con un inibitore del checkpoint immunitario. Questa decisione è stata presa dopo la valutazione dei trial completati PNP-002 Fase 1b/2a e PNP-001 Fase 1, che hanno dimostrato un'accettabile sicurezza ed efficacia nei pazienti con carcinoma squamoso della testa e del collo avanzato (HNSCC).
Il trial di Fase 2 pianificato mira a stabilire l'efficacia della terapia neoadiuvante con Gedeptin combinata con un inibitore del checkpoint immunitario. Coinvolgerà circa 6 pazienti, con il tasso di risposta patologica come obiettivo primario. GeoVax prevede di attivare il trial durante la prima metà del 2025. L'azienda sta anche perseguendo piani di sviluppo per Gedeptin in ulteriori indicazioni di tumori solidi in partnership con centri oncologici accademici di rilievo.
GeoVax Labs, Inc. (Nasdaq: GOVX) ha anunciado planes para un ensayo de Fase 2 de su terapia contra el cáncer Gedeptin® tras una revisión del comité asesor clínico. El ensayo se centrará en el cáncer de cabeza y cuello de primera recurrencia, combinando Gedeptin con un inhibidor de punto de control inmunitario. Esta decisión se toma después de revisar los ensayos PNP-002 de Fase 1b/2a y PNP-001 de Fase 1 completados, que demostraron una seguridad y eficacia aceptables en pacientes con carcinoma de células escamosas de cabeza y cuello avanzado (HNSCC).
El ensayo de Fase 2 planeado tiene como objetivo establecer la eficacia de la terapia neoadyuvante con Gedeptin combinada con un inhibidor de punto de control inmunitario. Involucrará aproximadamente a 6 pacientes, con la tasa de respuesta patológica como objetivo primario. GeoVax anticipa la activación del ensayo durante la primera mitad de 2025. La empresa también está persiguiendo planes de desarrollo para Gedeptin en indicaciones adicionales de tumores sólidos en asociación con destacados centros académicos de oncología.
GeoVax Labs, Inc. (Nasdaq: GOVX)는 임상 자문 위원회의 검토에 따라 Gedeptin® 암 치료제의 2상 시험 계획을 발표했습니다. 이 시험은 첫 재발 두경부암을 대상으로 하며, Gedeptin과 면역 검사 점 inhibitor를 결합할 것입니다. 이 결정은 진행성 두경부 편평세포암(HNSCC) 환자에서 안전성과 효능이 허용 가능한 수준으로 입증된 PNP-002 1b/2a 및 PNP-001 1상 시험을 검토한 후에 내려졌습니다.
계획된 2상 시험은 면역 체크포인트 억제제와 결합된 신보조 Gedeptin 요법의 효능을 확립하는 것을 목표로 합니다. 약 6명의 환자를 포함하며, 병리학적 반응률을 주요 목표로 삼습니다. GeoVax는 2025년 상반기에 시험을 활성화할 것으로 예상하고 있습니다. 회사는 또한 선도적인 학술 종양학 센터와 협력하여 Gedeptin의 추가 고형 종양 적응증 개발 계획을 추진하고 있습니다.
GeoVax Labs, Inc. (Nasdaq: GOVX) a annoncé des projets pour un essai de Phase 2 de sa thérapie contre le cancer Gedeptin® après une revue du comité consultatif clinique. L'essai se concentrera sur le cancer de la tête et du cou en première récidive, combinant Gedeptin avec un inhibiteur de point de contrôle immunitaire. Cette décision fait suite à l'examen des essais PNP-002 Phase 1b/2a et PNP-001 Phase 1, qui ont démontré une sécurité et une efficacité acceptables chez les patients atteints de carcinome squameux de la tête et du cou avancé (HNSCC).
L'essai de Phase 2 prévu vise à établir l'efficacité de la thérapie néoadjuvante avec Gedeptin combinée à un inhibiteur de point de contrôle immunitaire. Il impliquera environ 6 patients, avec le taux de réponse pathologique comme objectif principal. GeoVax prévoit d'activer l'essai durant la première moitié de 2025. L'entreprise poursuit également des plans de développement pour Gedeptin dans d'autres indications de tumeurs solides en partenariat avec des centres oncologiques académiques de premier plan.
GeoVax Labs, Inc. (Nasdaq: GOVX) hat Pläne für eine Phase-2-Studie seiner Gedeptin®-Krebstherapie nach einer Überprüfung durch den klinischen Beratungsausschuss angekündigt. Die Studie wird sich auf der erste Rückfall von Kopf- und Halskrebs konzentrieren und Gedeptin mit einem immunologischen Checkpoint-Inhibitor kombinieren. Diese Entscheidung folgte der Überprüfung der abgeschlossenen PNP-002 Phase 1b/2a und PNP-001 Phase 1 Studien, die eine akzeptable Sicherheit und Wirksamkeit bei Patienten mit fortgeschrittenem Plattenepithelkarzinom des Kopfes und Halses (HNSCC) zeigten.
Die geplante Phase-2-Studie zielt darauf ab, die Wirksamkeit der neoadjuvanten Gedeptin-Therapie in Kombination mit einem immunologischen Checkpoint-Inhibitor zu bestätigen. Sie wird voraussichtlich etwa 6 Patienten einbeziehen, wobei die pathologische Ansprechraten als primäres Ziel dienen. GeoVax rechnet damit, die Studie in der ersten Hälfte von 2025 zu aktivieren. Das Unternehmen verfolgt außerdem Entwicklungspläne für Gedeptin in weiteren soliden Tumorindikationen in Partnerschaft mit führenden akademischen Onkologiezentren.
- Gedeptin demonstrated acceptable safety and efficacy in completed trials
- Phase 2 trial planned to combine Gedeptin with immune checkpoint inhibitor
- Potential for Gedeptin to be an active therapy against solid tumors
- Development plans for additional solid tumor indications in progress
- Phase 2 trial activation not anticipated until first half of 2025
- patient size (approximately 6) for planned Phase 2 trial
Insights
The announcement of GeoVax's Phase 2 plans for Gedeptin® cancer therapy represents a significant milestone in the company's oncology pipeline. As a Medical Research Analyst, I find several aspects of this development particularly noteworthy:
- The decision to proceed with a Phase 2 trial indicates that the therapy demonstrated acceptable safety and efficacy in earlier trials, which is important for advancing any experimental treatment.
- The planned combination of Gedeptin with an immune checkpoint inhibitor is a strategic move. This approach aligns with the current trend in oncology to leverage synergies between different treatment modalities, potentially enhancing overall efficacy.
- Focusing on first-recurrence head and neck cancer as the target indication is a smart choice. This patient population often has treatment options and success here could open doors for broader applications.
- The use of pathologic response rate as the primary endpoint in a neoadjuvant setting is a strong indicator of the company's confidence in Gedeptin's potential to shrink tumors effectively.
However, investors should note that the anticipated trial activation in the first half of 2025 suggests a relatively long timeline before potential commercialization. This extended development period is typical in oncology but may impact short-term investor expectations.
The mention of pursuing development plans in additional solid tumor indications is promising for long-term growth potential but will require significant resources and successful outcomes in the head and neck cancer trials.
Overall, while this news demonstrates positive progress, it's important to remember that Phase 2 trials still carry substantial risks and success is not guaranteed. Investors should closely monitor upcoming updates throughout 2024 for further insights into Gedeptin's potential.
From a financial perspective, GeoVax's announcement of Phase 2 plans for Gedeptin® presents both opportunities and challenges for investors to consider:
- The advancement to Phase 2 potentially increases the value of GeoVax's oncology pipeline, which could positively impact the company's market valuation. However, this is contingent on successful trial outcomes.
- The planned trial's focus on combining Gedeptin with an immune checkpoint inhibitor could expand the therapy's market potential if successful, as combination therapies often command premium pricing in oncology.
- Investors should be aware that the timeline to trial activation in the first half of 2025 implies continued R&D expenses without immediate revenue generation from this program. This may impact GeoVax's cash burn rate and potentially necessitate additional financing rounds.
- The company's pursuit of additional solid tumor indications suggests a strategy for pipeline expansion, which could diversify risk and increase long-term value proposition. However, this also implies increased development costs in the near term.
It's important to note that while positive clinical progress can drive stock performance in biotech, GeoVax will likely need to demonstrate clear efficacy in the Phase 2 trial to maintain investor confidence. The focus on a neoadjuvant setting with a clear endpoint (pathologic response rate) could provide relatively quick insights into Gedeptin's potential, which may be a catalyst for stock movement upon data readout.
Investors should closely monitor:
- Any partnerships or licensing deals related to Gedeptin, which could provide non-dilutive funding
- The company's cash position and burn rate leading up to the trial initiation
- Any updates on the broader pipeline, as diversification can mitigate risk associated with a single asset
While the news is generally positive for GeoVax's long-term prospects, the extended timeline to potential commercialization means that near-term stock performance may be more influenced by other factors in the company's pipeline and overall market conditions.
Company plans Phase 2 trial in first-recurrence head & neck cancer, in combination with immune checkpoint inhibitor
ATLANTA, GA, July 31, 2024 (GLOBE NEWSWIRE) -- GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing immunotherapies and vaccines against cancer and infectious diseases, today announced the next steps for the clinical development of its Gedeptin® cancer therapy, following a clinical advisory committee review.
GeoVax and a specially convened clinical advisory committee have completed a comprehensive review of the recently completed PNP-002 Phase 1b/2a trial, together with the previously completed PNP-001 Phase 1 trial. The Phase 1b/2a trial evaluated the safety and efficacy of repeat cycles of Gedeptin therapy in patients with advanced head and neck squamous cell carcinoma (HNSCC), with tumor(s) accessible for injection and no curable treatment options. The protocol assessed up to five treatment cycles, each consisting of three intratumoral injections of Gedeptin over two days followed by infusion of a prodrug, fludarabine phosphate, once a day for three days. This review concluded that Gedeptin demonstrated acceptable safety and efficacy to support continued development. No new safety signals were identified in the PNP-002 trial in heavily pretreated head & neck cancer patients. The therapy demonstrated sufficient tumor stabilization/reduction activity to support plans to advance clinical development of Gedeptin in an expanded Phase 2 clinical trial.
The primary goal of the planned Phase 2 trial will be to establish efficacy of neoadjuvant Gedeptin therapy combined with an immune checkpoint inhibitor in first-recurrence squamous cell head and neck cancer. This trial is anticipated to be a single cycle trial with surgery to follow in approximately 6 patients with pathologic response rate as the primary endpoint. The Company has initiated the necessary planning activities, including protocol development, manufacturing, and CRO selection with the trial activation anticipated during the first half of 2025.
“Based on the review of the two clinical trials completed with Gedeptin, we believe that this therapy, combined with an immune checkpoint inhibitor, has the potential to represent an active therapy against solid tumors. As such, in alignment with the Gedeptin clinical advisory committee, we have initiated efforts in support of an expanded Phase 2 trial, combining Gedeptin with an immune checkpoint inhibitor as therapy in squamous cell head and neck cancer,” stated J. Marc Pipas, M.D., GeoVax Executive Medical Director, Oncology.
“We are pleased to announce the plans for this novel, expanded Phase 2 clinical trial of Gedeptin, seeking to demonstrate efficacy and safety of Gedeptin and an immune checkpoint inhibitor combination therapy in support of such neoadjuvant therapy. We look forward to activation of this trial and are pursuing development plans in additional solid tumor indications in partnership with leading academic oncology centers. Further updates will be provided during the remainder of 2024,” added David Dodd, GeoVax’s Chairman and CEO.
About Gedeptin®
Gedeptin is a novel patented product/technology for the treatment of solid tumors through a gene therapy strategy known as Gene-Directed Enzyme Prodrug Therapy (GDEPT). In GDEPT, a vector is used to selectively transduce tumor cells with a non-human gene, which expresses an enzyme that converts a nontoxic prodrug into a highly active antitumor compound in situ.
The Phase 1b/2a trial (ClinicalTrials.gov Identifier: NCT03754933) evaluated the safety and efficacy of repeat cycles of Gedeptin therapy in patients with recurrent head and neck squamous cell carcinoma (HNSCC), with tumor(s) accessible for injection and no curable treatment options. The protocol entailed up to five treatment cycles, each consisting of three intratumoral injections of Gedeptin over two days followed by infusion of a prodrug, fludarabine phosphate, once a day for three days. A previously completed Phase 1 dose-ranging study demonstrated that treating a tumor with a single cycle of Gedeptin, followed by fludarabine infusions, was well tolerated, with evidence of a reduction in tumor size in patients with solid tumors.
The current study is being funded in part by the FDA pursuant to its Orphan Products Clinical Trials Grants Program. The FDA has also granted Gedeptin orphan drug status for the intratumoral treatment of anatomically accessible oral and pharyngeal cancers, including cancers of the lip, tongue, gum, floor of mouth, salivary gland, and other oral cavities.
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®, in a multicenter Phase 1/2 clinical trial for advanced head and neck cancers. 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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