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NuCana Announces Grant of Composition-of-Matter Patent for NUC-7738 in the United States

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NuCana plc (NASDAQ: NCNA) has announced the issuance of a new composition-of-matter patent for NUC-7738 by the United States Patent and Trademark Office (USPTO). This patent (US12,054,510) is a important addition to NUC-7738's intellectual property protection, which now includes over 80 issued patents worldwide.

NUC-7738, a novel anti-cancer agent, is currently in a Phase 2 clinical study combined with pembrolizumab for PD-1 inhibitor resistant melanoma patients. Recent data presented at the ESMO Congress 2024 showed encouraging results, with the majority of patients achieving a progression-free survival of more than 5 months, compared to the current standard of care of 2-3 months.

Hugh S. Griffith, NuCana's CEO, emphasized the importance of this patent in strengthening NUC-7738's intellectual property protection and highlighted its potential to make previously resistant tumors sensitive to PD-1 inhibitor rechallenge.

NuCana plc (NASDAQ: NCNA) ha annunciato l'emissione di un nuovo brevetto per composizione di materia per NUC-7738 da parte dell'Ufficio Brevetti e Marchi degli Stati Uniti (USPTO). Questo brevetto (US12,054,510) è un'importante aggiunta alla protezione della proprietà intellettuale di NUC-7738, che ora include oltre 80 brevetti concessi in tutto il mondo.

NUC-7738, un nuovo agente anti-cancro, è attualmente in uno studio clinico di Fase 2 in combinazione con pembrolizumab per pazienti con melanoma resistenti agli inibitori di PD-1. Dati recenti presentati al Congresso ESMO 2024 hanno mostrato risultati incoraggianti, con la maggior parte dei pazienti che ha raggiunto una sopravvivenza libera da progressione di oltre 5 mesi, rispetto all'attuale standard di cura di 2-3 mesi.

Hugh S. Griffith, CEO di NuCana, ha sottolineato l'importanza di questo brevetto nel rafforzare la protezione della proprietà intellettuale di NUC-7738 e ha messo in evidenza il suo potenziale di rendere sensibili a un nuovo trattamento tumori precedentemente resistenti agli inibitori di PD-1.

NuCana plc (NASDAQ: NCNA) ha anunciado la emisión de una nueva patente de composición de materia para NUC-7738 por parte de la Oficina de Patentes y Marcas de los Estados Unidos (USPTO). Esta patente (US12,054,510) es una adición importante a la protección de propiedad intelectual de NUC-7738, que ahora incluye más de 80 patentes otorgadas en todo el mundo.

NUC-7738, un nuevo agente anticancerígeno, se encuentra actualmente en un estudio clínico de Fase 2 combinado con pembrolizumab para pacientes con melanoma resistente a los inhibidores de PD-1. Datos recientes presentados en el Congreso ESMO 2024 mostraron resultados alentadores, con la mayoría de los pacientes alcanzando una supervivencia libre de progresión de más de 5 meses, en comparación con el estándar actual de cuidados de 2-3 meses.

Hugh S. Griffith, CEO de NuCana, enfatizó la importancia de esta patente para fortalecer la protección de propiedad intelectual de NUC-7738 y destacó su potencial para hacer que tumores previamente resistentes sean sensibles a un nuevo desafío con inhibidores de PD-1.

NuCana plc (NASDAQ: NCNA)는 미국 특허청(USPTO)로부터 NUC-7738에 대한 새로운 물질 조성 특허를 발급받았다고 발표했습니다. 이 특허(US12,054,510)는 NUC-7738의 지적 재산권 보호를 강화하는 중요한 추가 사항이며, 현재 전 세계에서 발급된 80개 이상의 특허를 포함하고 있습니다.

NUC-7738은 새로운 항암제로 현재 PD-1 저항성 멜라노마 환자에 대해 pembrolizumab과 함께 진행 중인 2상 임상 연구에 있습니다. ESMO Congress 2024에서 발표된 최근 데이터는 긍정적인 결과를 보여주었으며, 대다수의 환자가 5개월 이상의 무진행 생존율을 달성하였고, 이는 현재 표준 치료인 2-3개월과 비교됩니다.

NuCana의 CEO인 Hugh S. Griffith는 이 특허가 NUC-7738의 지적 재산권 보호를 강화하는 데 중요한 역할을 하며, 이전에 저항성이 있었던 종양을 PD-1 억제제 재도전에 민감하게 만들 수 있는 잠재력을 강조했습니다.

NuCana plc (NASDAQ: NCNA) a annoncé l'octroi d'un nouveau brevet de composition de matière pour NUC-7738 par l'Office des brevets et des marques des États-Unis (USPTO). Ce brevet (US12,054,510) constitue un ajout important à la protection de la propriété intellectuelle de NUC-7738, qui comprend maintenant plus de 80 brevets délivrés à travers le monde.

NUC-7738, un nouvel agent anticancéreux, est actuellement en étude clinique de Phase 2 en combinaison avec le pembrolizumab pour des patients atteints de mélanome résistant aux inhibiteurs de PD-1. Les données récentes présentées lors du Congrès ESMO 2024 ont montré des résultats encourageants, la majorité des patients ayant atteint une survie sans progression de plus de 5 mois, par rapport à l'actuel standard de soins de 2-3 mois.

Hugh S. Griffith, PDG de NuCana, a souligné l'importance de ce brevet pour renforcer la protection de la propriété intellectuelle de NUC-7738 et a mis en avant son potentiel à rendre sensibles à une nouvelle épreuve des tumeurs auparavant résistantes aux inhibiteurs de PD-1.

NuCana plc (NASDAQ: NCNA) hat die Erlass einer neuen Stoffzusammensetzungs-Patents für NUC-7738 durch das US-Patent- und Markenamt (USPTO) bekannt gegeben. Dieses Patent (US12,054,510) ist eine wichtige Ergänzung zum Schutz des geistigen Eigentums von NUC-7738, das nun über 80 erteilte Patente weltweit umfasst.

NUC-7738, ein neuartiger Krebsbekämpfer, befindet sich derzeit in einer Phase-2-Studie, die in Kombination mit Pembrolizumab für Patienten mit PD-1-inhibitorresistentem Melanom durchgeführt wird. Neueste Daten, die auf dem ESMO Congress 2024 präsentiert wurden, zeigten ermutigende Ergebnisse, wobei die Mehrheit der Patienten eine progressionsfreie Überlebenszeit von über 5 Monaten erreichte, verglichen mit dem aktuellen Standard von 2-3 Monaten.

Hugh S. Griffith, CEO von NuCana, betonte die Bedeutung dieses Patents zur Stärkung des geistigen Eigentumsschutzes von NUC-7738 und hob das Potenzial hervor, zuvor resistente Tumore empfindlich auf die Wiederherausforderung mit PD-1-Inhibitoren zu machen.

Positive
  • Granted new composition-of-matter patent for NUC-7738 in the United States
  • NUC-7738 now protected by over 80 issued patents worldwide
  • Encouraging Phase 2 clinical study results for NUC-7738 in combination with pembrolizumab
  • Majority of PD-1 inhibitor resistant melanoma patients achieved progression-free survival of over 5 months, compared to 2-3 months standard of care
Negative
  • None.

Insights

The USPTO's grant of a composition-of-matter patent for NUC-7738 significantly bolsters NuCana's intellectual property portfolio. This type of patent is considered the strongest form of protection for pharmaceutical compounds, potentially extending market exclusivity beyond the drug's data exclusivity period. With over 80 issued patents worldwide for NUC-7738, NuCana has built a robust patent estate, which could deter potential competitors and increase the asset's value for potential partnerships or acquisitions.

The timing of this patent grant is strategic, coinciding with promising Phase 2 clinical data presented at ESMO 2024. The combination of strong IP protection and encouraging clinical results in PD-1 inhibitor resistant melanoma patients could position NUC-7738 as a valuable asset in the competitive oncology market. The reported progression-free survival of over 5 months compared to the 2-3 month standard of care is particularly noteworthy and could translate to significant market potential if confirmed in larger studies.

The clinical data for NUC-7738 in combination with pembrolizumab is intriguing, particularly in the context of PD-1 inhibitor resistant melanoma. The ability to sensitize tumors to PD-1 inhibitor rechallenge by targeting multiple aspects of the tumor microenvironment represents a novel approach with significant potential. The median progression-free survival of over 5 months in this difficult-to-treat population is promising, especially compared to the 2-3 month standard.

However, it's important to note that this is Phase 2 data and larger, randomized trials will be necessary to confirm these results. The mechanism of action, targeting multiple aspects of the tumor microenvironment, could potentially lead to broader applications beyond melanoma. If NUC-7738 continues to show efficacy in overcoming PD-1 inhibitor resistance, it could become a valuable addition to the immunotherapy arsenal, potentially extending the benefit of checkpoint inhibitors to a larger patient population.

EDINBURGH, United Kingdom, Sept. 25, 2024 (GLOBE NEWSWIRE) -- NuCana plc (NASDAQ: NCNA) announced the issuance of a new patent by the United States Patent and Trademark Office (USPTO) covering NUC-7738’s composition of matter. This patent (US12,054,510) is expected to serve as a key component of the intellectual property protection for NUC-7738, which currently consists of over 80 issued patents worldwide. NUC-7738 is a novel anti-cancer agent currently in a Phase 2 clinical study in combination with pembrolizumab in PD-1 inhibitor resistant melanoma patients, for which NuCana presented encouraging data at the ESMO Congress 2024 earlier this month.

Hugh S. Griffith, NuCana’s Founder and Chief Executive Officer said: “We welcome the USPTO’s decision to grant this important new patent, which further strengthens the intellectual property protection of NUC-7738. This patent issuance follows our recent data presentation at ESMO which supports NUC-7738’s novel mode of action and its ability to make previously resistant tumors sensitive to rechallenge with PD-1 inhibitors by targeting multiple aspects of the tumor microenvironment. The majority of these PD-1 inhibitor resistant metastatic melanoma patients achieved a progression free survival of more than 5 months with NUC-7738 plus pembrolizumab. These results are very encouraging as the median progression free survival in this patient population is 2-3 months with the current standard of care. We look forward to advancing the development of this promising new anti-cancer agent.”

About NuCana

NuCana is a clinical-stage biopharmaceutical company focused on significantly improving treatment outcomes for patients with cancer by applying our ProTide technology to transform some of the most widely prescribed chemotherapy agents, nucleoside analogs, into more effective and safer medicines. While these conventional agents remain part of the standard of care for the treatment of many solid and hematological tumors, they have significant shortcomings that limit their efficacy and they are often poorly tolerated. Utilizing our proprietary technology, we are developing new medicines, ProTides, designed to overcome the key limitations of nucleoside analogs and generate much higher concentrations of anti-cancer metabolites in cancer cells. NuCana’s pipeline includes NUC-3373 and NUC-7738. NUC-3373 is a new chemical entity derived from the nucleoside analog 5-fluorouracil, a widely used chemotherapy agent. NUC-3373 is currently being evaluated in two ongoing clinical studies: a Phase 1b/2 study (NuTide:302) in combination with leucovorin, irinotecan or oxaliplatin, and bevacizumab in patients with metastatic colorectal cancer; and a Phase 1b/2 modular study (NuTide:303) of NUC-3373 in combination with the PD-1 inhibitor pembrolizumab for patients with advanced solid tumors and in combination with docetaxel for patients with lung cancer. NUC-7738 is a novel anti-cancer agent that disrupts RNA polyadenylation, profoundly impacts gene expression in cancer cells and targets multiple aspects of the tumor microenvironment. NUC-7738 is in the Phase 2 part of a Phase 1/2 study (NuTide:701) which is evaluating NUC-7738 as a monotherapy in patients with advanced solid tumors and in combination with pembrolizumab in patients with melanoma.

Forward-Looking Statements
This press release may contain “forward-looking” statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are based on the beliefs and assumptions and on information currently available to management of NuCana plc (the “Company”). All statements other than statements of historical fact contained in this press release are forward-looking statements, including statements concerning the Company’s planned and ongoing clinical studies for the Company’s product candidates and the potential advantages of those product candidates, including NUC-3373 and NUC-7738; the initiation, enrollment, timing, progress, release of data from and results of those planned and ongoing clinical studies; the Company’s goals with respect to the development, regulatory pathway and potential use, if approved, of each of its product candidates; the utility of prior non-clinical and clinical data in determining future clinical results; and the intellectual property protection of the Company’s product candidates, including with respect to the new composition-of-matter patent issued for NUC-7738. In some cases, you can identify forward-looking statements by terminology such as “may,” “will,” “should,” “expects,” “plans,” “anticipates,” “believes,” “estimates,” “predicts,” “potential” or “continue” or the negative of these terms or other comparable terminology. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause the Company’s actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. These risks and uncertainties include, but are not limited to, the risks and uncertainties set forth in the “Risk Factors” section of the Company’s Annual Report on Form 20-F for the year ended December 31, 2023 filed with the Securities and Exchange Commission (“SEC”) on March 20, 2024, and subsequent reports that the Company files with the SEC. Forward-looking statements represent the Company’s beliefs and assumptions only as of the date of this press release. Although the Company believes that the expectations reflected in the forward-looking statements are reasonable, it cannot guarantee future results, levels of activity, performance or achievements. Except as required by law, the Company assumes no obligation to publicly update any forward-looking statements for any reason after the date of this press release to conform any of the forward-looking statements to actual results or to changes in its expectations.

For more information, please contact:

NuCana plc
Hugh S. Griffith
Chief Executive Officer
+44 131-357-1111
info@nucana.com

ICR Westwicke
Chris Brinzey
+1 339-970-2843
chris.brinzey@westwicke.com


FAQ

What new patent did NuCana (NCNA) receive for NUC-7738?

NuCana received a new composition-of-matter patent (US12,054,510) for NUC-7738 from the United States Patent and Trademark Office (USPTO).

How many patents does NuCana (NCNA) now have for NUC-7738?

NuCana now has over 80 issued patents worldwide for NUC-7738.

What clinical trial stage is NUC-7738 currently in for NuCana (NCNA)?

NUC-7738 is currently in a Phase 2 clinical study in combination with pembrolizumab for PD-1 inhibitor resistant melanoma patients.

What were the recent clinical results for NuCana's (NCNA) NUC-7738?

The majority of PD-1 inhibitor resistant metastatic melanoma patients achieved a progression-free survival of more than 5 months with NUC-7738 plus pembrolizumab, compared to the current standard of care of 2-3 months.

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