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Lisata Therapeutics and Valo Therapeutics Announce Preclinical Research Collaboration

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Lisata Therapeutics (NASDAQ: LSTA) and Valo Therapeutics have announced a preclinical research collaboration to study the combination of Lisata's certepetide with ValoTx's PeptiCRAd platform and a checkpoint inhibitor in a melanoma mouse model. The study aims to build on previous research showing certepetide's synergistic effects with immunotherapies. ValoTx will conduct the research while Lisata provides the certepetide product. The collaboration targets melanoma treatment, which currently has a 35-60% response rate to checkpoint inhibitor therapies and causes approximately 58,000 deaths annually worldwide.

Lisata Therapeutics (NASDAQ: LSTA) e Valo Therapeutics hanno annunciato una collaborazione per la ricerca preclinica per studiare la combinazione del certepetide di Lisata con la piattaforma PeptiCRAd di ValoTx e un inibitore del checkpoint in un modello murino di melanoma. Lo studio mira a costruire sulle ricerche precedenti che mostrano gli effetti sinergici del certepetide con le immunoterapie. ValoTx condurrà la ricerca mentre Lisata fornirà il prodotto certepetide. La collaborazione si concentra sul trattamento del melanoma, che attualmente presenta un tasso di risposta del 35-60% alle terapie con inibitori del checkpoint e causa circa 58.000 decessi all'anno a livello mondiale.

Lisata Therapeutics (NASDAQ: LSTA) y Valo Therapeutics han anunciado una colaboración de investigación preclínica para estudiar la combinación del certepetide de Lisata con la plataforma PeptiCRAd de ValoTx y un inhibidor de puntos de control en un modelo de melanoma en ratones. El estudio tiene como objetivo basarse en investigaciones anteriores que muestran los efectos sinérgicos del certepetide con las inmunoterapias. ValoTx llevará a cabo la investigación mientras que Lisata proporcionará el producto certepetide. La colaboración se enfoca en el tratamiento del melanoma, que actualmente tiene una tasa de respuesta del 35-60% a las terapias con inhibidores de puntos de control y causa aproximadamente 58,000 muertes anualmente en todo el mundo.

Lisata Therapeutics (NASDAQ: LSTA)Valo Therapeutics는 리사타의 젤라테프리드와 발로TX의 PeptiCRAd 플랫폼 및 체크포인트 억제제를 사용한 전임상 연구 협력에 대해 발표했습니다. 이 연구는 젤라테프리드가 면역요법과 함께 나타내는 시너지 효과에 대한 이전 연구를 기반으로 하고자 합니다. 발로TX는 연구를 수행하고 리사타는 젤라테프리드 제품을 제공합니다. 이 협력은 현재 체크포인트 억제제 치료에 대해 35-60%의 반응률을 보이는 흑색종 치료를 목표로 하며, 매년 전 세계에서 약 58,000명이 사망하는 원인입니다.

Lisata Therapeutics (NASDAQ: LSTA) et Valo Therapeutics ont annoncé une collaboration pour la recherche préclinique visant à étudier la combinaison du certepetide de Lisata avec la plateforme PeptiCRAd de ValoTx et un inhibiteur de point de contrôle dans un modèle murin de mélanome. L'étude vise à s'appuyer sur des recherches antérieures montrant les effets synergiques du certepetide avec des immunothérapies. ValoTx effectuera la recherche tandis que Lisata fournira le produit certepetide. La collaboration cible le traitement du mélanome, qui présente actuellement un taux de réponse de 35 à 60 % aux thérapies avec inhibiteurs de points de contrôle et qui cause environ 58 000 décès par an dans le monde.

Lisata Therapeutics (NASDAQ: LSTA) und Valo Therapeutics haben eine Zusammenarbeit zur präklinischen Forschung angekündigt, um die Kombination des Certepetids von Lisata mit der PeptiCRAd-Plattform von ValoTx und einem Checkpoint-Inhibitor in einem Melanom-Mausmodell zu untersuchen. Die Studie zielt darauf ab, auf früheren Forschungsergebnissen aufzubauen, die synergistische Effekte des Certepetids mit Immuntherapien zeigen. ValoTx wird die Forschung durchführen, während Lisata das Produkt Certepetid bereitstellt. Die Zusammenarbeit fokussiert sich auf die Behandlung von Melanomen, die derzeit eine Ansprechrate von 35-60 % bei Therapien mit Checkpoint-Inhibitoren aufweist und weltweit ungefähr 58.000 Todesfälle pro Jahr verursacht.

Positive
  • Partnership with Valo Therapeutics expands potential applications of certepetide
  • Building on previous successful preclinical work showing synergistic effects
  • Targeting melanoma market with significant unmet medical need
Negative
  • Still in early preclinical stage with uncertain outcomes
  • No immediate revenue potential from the collaboration
  • Competing in a market with existing treatments showing 35-60% response rates

Insights

This preclinical collaboration between Lisata and ValoTx represents an early-stage research initiative with immediate market impact. The study combines certepetide, which modifies the tumor microenvironment, with ValoTx's PeptiCRAd platform and checkpoint inhibitors to potentially enhance melanoma treatment efficacy.

The melanoma treatment market presents a significant opportunity, with current checkpoint inhibitor therapies showing 35-60% response rates. However, this is still an early preclinical stage study and investors should note that drug development typically requires years of clinical trials with no guarantee of success. The collaboration structure, where ValoTx conducts research while Lisata provides the product, suggests minimal financial commitment from Lisata at this stage.

Study will investigate the benefits of combining Lisata's novel product candidate, certepetide, with ValoTx's platform technology, PeptiCRAd, and a checkpoint inhibitor in preclinical tumor models

BASKING RIDGE, N.J. and HELSINKI, Nov. 06, 2024 (GLOBE NEWSWIRE) -- Lisata Therapeutics, Inc. (Nasdaq: LSTA), a clinical-stage pharmaceutical company developing innovative therapies for the treatment of advanced solid tumors and other serious diseases, and Valo Therapeutics Oy (“ValoTx”), a private company developing novel, adaptable immunotherapies for the treatment of cancer, are pleased to announce a preclinical research collaboration to investigate the benefits of combining Lisata's novel product candidate, certepetide, with ValoTx's innovative platform technology, PeptiCRAd, and a checkpoint inhibitor in a melanoma mouse model. Under the agreement, ValoTx will be conducting the research, while Lisata will supply certepetide product.

“Building on previous preclinical work demonstrating certepetide's synergistic effects with immunotherapies, we aim to uncover additional benefits by combining certepetide with ValoTx's PeptiCRAd immunotherapy,” stated Kristen K. Buck, M.D., Executive Vice President of Research and Development and Chief Medical Officer of Lisata. “Given the complementary mechanisms of action of these therapies, including certepetide’s ability to modify the tumor microenvironment making it less immunosuppressive, we believe this approach could ultimately lead to improved patient outcomes by addressing the challenges facing current melanoma treatments, including resistance, recurrence, and metastasis.”

“We are thrilled to partner with Lisata Therapeutics on this promising research collaboration,” stated Sari Pesonen, Ph.D., Chief Executive Officer and Chief Scientific Officer of ValoTx. “The combination of our proprietary PeptiCRAd and Lisata's innovative certepetide tumor targeting and penetration technology has the potential to unlock new frontiers in cancer immunotherapy. Together, we hope to accelerate the development of more effective treatments for patients in desperate need, ultimately translating our preclinical findings into life-changing therapies for cancer patients.”

Melanoma is a serious and potentially life-threatening form of skin cancer. According to the World Health Organization, melanoma is amongst the leading causes of cancer-related deaths globally, responsible for approximately 58,000 deaths annually. Current standard-of-care includes checkpoint inhibitor therapies with an overall response rate of 35-60%. Despite advancements in treatment, there remains a significant unmet need for effective therapies, particularly for patients with advanced or metastatic disease.

About Certepetide

Certepetide is an investigational drug designed to selectively activate the C-end rule active transport mechanism in a tumor specific manner, resulting in systemically co-administered anti-cancer agents more efficiently penetrating and accumulating in the tumor. Additionally, certepetide has been shown to modify the tumor microenvironment, diminishing its immunosuppressive nature and inhibiting the metastatic cascade. Lisata and its collaborators have amassed significant non-clinical data demonstrating enhanced delivery of various existing and emerging anti-cancer therapies, including chemotherapies, immunotherapies and RNA-based therapeutics. To date, certepetide has also demonstrated favorable safety, tolerability, and clinical activity in completed and ongoing clinical trials designed to demonstrate its ability to enhance the effectiveness of standard-of-care chemotherapy for pancreatic cancer as well as the combination of chemotherapy and immunotherapy in a variety of solid tumors. Certepetide has been awarded Fast Track designation (U.S.) and Orphan Drug Designation for pancreatic cancer (U.S. and E.U.), as well as Orphan Drug Designation for glioma, osteosarcoma, and cholangiocarcinoma (U.S.). Additionally, certepetide has received Rare Pediatric Disease Designation for osteosarcoma (U.S.).

About Lisata Therapeutics

Lisata Therapeutics is a clinical-stage pharmaceutical company dedicated to the discovery, development and commercialization of innovative therapies for the treatment of advanced solid tumors and other major diseases. Lisata’s internalizing RGD, or Arginylglycylaspartic acid, (iRGD) cyclic peptide product candidate, certepetide, is an investigational drug designed to activate a novel uptake pathway that allows co-administered or tethered anti-cancer drugs to selectively target and penetrate solid tumors more effectively. Lisata has already established noteworthy commercial and R&D partnerships based on its CendR Platform® technology. The Company expects to announce numerous milestones over the next 1.5 years and believes that its projected capital will fund operations into early 2026, encompassing anticipated data milestones from its ongoing and planned clinical trials. Learn more about certepetide’s mechanism of action in our short film. For more information on the Company, please visit www.lisata.com.

About PeptiCRAd

The PeptiCRAd platform is a unique immunotherapy technology that uses replication-competent adenoviruses engineered for a multifaceted approach. This virus-based platform can be customized to activate the tumor microenvironment (“TME”) optimally. Its lead candidate, PeptiCRAd-1, encodes two immunostimulatory proteins—CD40L and OX40L—that are directly delivered to the TME. What sets PeptiCRAd apart from other viral immunotherapies is its ability to carry multiple tumor antigens on the virus surface, eliciting broad T-cell and antibody responses against multiple tumor antigens simultaneously. These antigens are easy to mix and match, enabling targeted treatment against the varied tumor antigen profiles in solid tumors. PeptiCRAd can be administered subcutaneously or directly into tumors, depending on disease stage. As a monotherapy, PeptiCRAd has demonstrated an abscopal effect and the induction of protective memory responses upon rechallenge with the previously treated tumor. Currently, PeptiCRAd-1, targeting NY-ESO-1 and MAGE A3-expressing tumors, is in Phase 1 clinical testing with pembrolizumab for triple-negative breast cancer, non-small cell lung cancer, melanoma, and sarcoma.

About Valo Therapeutics

Valo Therapeutics Oy (ValoTx) is an immunotherapy company developing tumor antigen-coated replication-competent viruses as therapeutic vaccines against cancer. The ValoTx lead platform, PeptiCRAd (Peptide-coated Conditionally Replicating Adenovirus), was developed out of the laboratory of Professor Vincenzo Cerullo at the University of Helsinki. It turns oncolytic adenoviruses into powerful activators of systemic anti-tumor cytotoxic T-cell immunity without the need to generate and manufacture multiple genetically modified viruses. PeptiCRAd-1 is the company’s lead product made up of its proprietary virus VALO-D102 coated with MAGE-A3 and NY-ESO-1 peptides. The company is also developing PeptiCHIP, an innovative microchip-based solution that enables rapid, accurate, and standardized tumor neoantigen identification from very small tumor biopsies. Watch our film explaining the PeptiCRAd technology. For more information see our website and follow us on LinkedIn.

Forward-Looking Statements

This communication contains “forward-looking statements” that involve substantial risks and uncertainties for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, included in this communication regarding the Company’s clinical development programs are forward-looking statements. In addition, when or if used in this communication, the words “may,” “could,” “should,” “anticipate,” “believe,” “estimate,” “expect,” “intend,” “plan,” “predict” and similar expressions and their variants, as they relate to Lisata or its management, may identify forward-looking statements. Examples of forward-looking statements include, but are not limited to, the potential efficacy of certepetide as a treatment for patients with melanoma and other solid tumors; statements relating to Lisata’s continued listing on the Nasdaq Capital Market; expectations regarding the capitalization, resources and ownership structure of Lisata; the approach Lisata is taking to discover and develop novel therapeutics; the adequacy of Lisata’s capital to support its future operations and its ability to successfully initiate and complete clinical trials; and the difficulty in predicting the time and cost of development of Lisata’s product candidates. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors, including, without limitation: results observed from a single patient case study are not necessarily indicative of final results and one or more of the clinical outcomes may materially change following more comprehensive reviews of the data and as more patient data becomes available, including the risk that unconfirmed responses may not ultimately result in confirmed responses to treatment after follow-up evaluations; the risk that product candidates that appeared promising in early research and clinical trials do not demonstrate safety and/or efficacy in larger-scale or later clinical trials; the safety and efficacy of Lisata’s product candidates, decisions of regulatory authorities and the timing thereof, the duration and impact of regulatory delays in Lisata’s clinical programs, Lisata’s ability to finance its operations, the likelihood and timing of the receipt of future milestone and licensing fees, the future success of Lisata’s scientific studies, Lisata’s ability to successfully develop and commercialize drug candidates, the timing for starting and completing clinical trials, rapid technological change in Lisata’s markets, the ability of Lisata to protect its intellectual property rights; and legislative, regulatory, political and economic developments. The foregoing review of important factors that could cause actual events to differ from expectations should not be construed as exhaustive and should be read in conjunction with statements that are included herein and elsewhere, including the risk factors included in Lisata’s Annual Report on Form 10-K filed with the SEC on February 29, 2024, and in other documents filed by Lisata with the Securities and Exchange Commission. Except as required by applicable law, Lisata undertakes no obligation to revise or update any forward-looking statement, or to make any other forward-looking statements, whether as a result of new information, future events or otherwise.

Lisata Therapeutics Contact:

Investors:
Lisata Therapeutics
John Menditto
Vice President, Investor Relations and Corporate Communications
Phone: 908-842-0084
Email: jmenditto@lisata.com

Media:
ICR Healthcare
Elizabeth Coleman
Senior Associate
Phone: 203-682-4783
Email: elizabeth.coleman@westwicke.com

Valo Therapeutics Contact:

Valo Therapeutics
Matthew Vaughan
Email: info@valotx.com

Scius Communications (for ValoTx):
Katja Stout
Phone: +44 778 943 5990
Email: katja@sciuscommunications.com

Daniel Gooch
Phone: +44 774 787 5479
Email: daniel@sciuscommunications.com


FAQ

What is the purpose of Lisata Therapeutics' (LSTA) collaboration with Valo Therapeutics?

The collaboration aims to study the combined effects of Lisata's certepetide with ValoTx's PeptiCRAd platform and a checkpoint inhibitor in a melanoma mouse model to potentially improve cancer treatment outcomes.

What is the current response rate for melanoma treatments that LSTA aims to improve?

Current checkpoint inhibitor therapies for melanoma have an overall response rate of 35-60%, leaving room for improvement in treatment effectiveness.

How many deaths does melanoma cause annually according to the LSTA press release?

According to the World Health Organization data cited in the press release, melanoma causes approximately 58,000 deaths annually worldwide.

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