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Enlivex Receives Notice of Allowance for Japanese Patent Application Covering the Use of Allocetra™ in Patients with Osteoarthritis

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Enlivex Therapeutics (Nasdaq: ENLV) has received a notice of allowance from the Japanese Patent Office for patent application 2022-512861, titled 'THERAPEUTIC APOPTOTIC CELLS FOR TREATMENT OF OSTEOARTHRITIS'. The patent, expected to be formally issued by Q2 2025, will protect Enlivex's intellectual property rights for Allocetra™ in Japan through at least 2040. This development supports the company's global IP strategy and their efforts to develop Allocetra™ as a next-generation cell therapy for osteoarthritis, addressing an unmet medical need with current treatment options.

Enlivex Therapeutics (Nasdaq: ENLV) ha ricevuto una comunicazione di autorizzazione dall'Ufficio Brevetti giapponese per la domanda di brevetto 2022-512861, intitolata 'CELLULE APOPTOTICHE TERAPEUTICHE PER IL TRATTAMENTO DELL'ARTRITE OSTEOARTRITICA'. Il brevetto, che dovrebbe essere formalmente rilasciato entro il secondo trimestre del 2025, proteggerà i diritti di proprietà intellettuale di Enlivex per Allocetra™ in Giappone fino almeno al 2040. Questo sviluppo supporta la strategia globale di proprietà intellettuale dell'azienda e i loro sforzi per sviluppare Allocetra™ come una terapia cellulare di nuova generazione per l'osteoartrite, rispondendo a un bisogno medico non soddisfatto dalle attuali opzioni di trattamento.

Enlivex Therapeutics (Nasdaq: ENLV) ha recibido un aviso de concesión de la Oficina de Patentes de Japón para la solicitud de patente 2022-512861, titulada 'CÉLULAS APOPTÓTICAS TERAPÉUTICAS PARA EL TRATAMIENTO DE LA ARTROSIS'. Se espera que la patente, que será formalmente emitida en el segundo trimestre de 2025, proteja los derechos de propiedad intelectual de Enlivex para Allocetra™ en Japón hasta al menos 2040. Este desarrollo apoya la estrategia global de propiedad intelectual de la compañía y sus esfuerzos para desarrollar Allocetra™ como una terapia celular de próxima generación para la osteoartritis, abordando una necesidad médica no satisfecha con las opciones de tratamiento actuales.

Enlivex Therapeutics (Nasdaq: ENLV)는 일본 특허청으로부터 특허 신청 2022-512861에 대한 허가 통지를 받았습니다. 이 신청의 제목은 '관절염 치료를 위한 치료적 아폽토시스 세포입니다'. 이 특허는 2025년 2분기 내에 공식적으로 발급될 예정이며, 최소 2040년까지 일본에서 Allocetra™에 대한 Enlivex의 지적 재산권을 보호할 것입니다. 이 개발은 회사의 글로벌 지식 재산 전략을 지원하며, 관절염에 대한 차세대 세포 요법으로 Allocetra™를 개발하기 위한 노력을 강조합니다. 현재의 치료 옵션으로는 충족되지 않는 의료적 필요를 해결하고자 합니다.

Enlivex Therapeutics (Nasdaq: ENLV) a reçu un avis de délivrance de l'Office des brevets japonais pour la demande de brevet 2022-512861, intitulée 'CELLULES APOPTOTIQUES THÉRAPEUTIQUES POUR LE TRAITEMENT DE L'ARTHROSE'. Le brevet, qui devrait être officiellement délivré au deuxième trimestre 2025, protègera les droits de propriété intellectuelle d'Enlivex pour Allocetra™ au Japon jusqu'au moins 2040. Ce développement soutient la stratégie mondiale de propriété intellectuelle de l'entreprise et ses efforts pour développer Allocetra™ comme une thérapie cellulaire de nouvelle génération pour l'arthrose, répondant à un besoin médical non satisfait par les options de traitement actuelles.

Enlivex Therapeutics (Nasdaq: ENLV) hat vom Japanischen Patentamt eine Erlaubnis für den Patentantrag 2022-512861 erhalten, der den Titel 'THERAPEUTISCHE APOPTOTISCHE ZELLEN ZUR BEHANDLUNG VON ARTHROSE' trägt. Das Patent, das voraussichtlich im zweiten Quartal 2025 formell erteilt wird, wird die geistigen Eigentumsrechte von Enlivex für Allocetra™ in Japan bis mindestens 2040 schützen. Diese Entwicklung unterstützt die globale IP-Strategie des Unternehmens und dessen Bemühungen, Allocetra™ als eine Therapie der nächsten Generation für Arthrose zu entwickeln und somit ein unerfülltes medizinisches Bedürfnis anzugehen, das von den aktuellen Behandlungsoptionen angesprochen wird.

Positive
  • Patent protection in Japan secured until 2040
  • Strengthens IP portfolio in key global market
  • Expands commercial opportunities for Allocetra™ in Japan
Negative
  • None.

Insights

The Japanese patent allowance for Allocetra™ in osteoarthritis treatment represents a modest strategic advancement for Enlivex. While patent protection in Japan through 2040 strengthens the company's IP portfolio, several key considerations temper the immediate impact:

The Japanese osteoarthritis market is significant due to its aging population, but Allocetra™ remains in early clinical development stages without proven efficacy. The patent merely secures future commercialization rights rather than validating the treatment's effectiveness.

For a small-cap company ($30.8M), successful development and commercialization will require substantial capital investment and likely strategic partnerships. The patent protection may help attract potential partners but doesn't address immediate development challenges or funding needs.

Nes-Ziona, Israel, Oct. 30, 2024 (GLOBE NEWSWIRE) -- Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the “Company”), a clinical-stage macrophage reprogramming immunotherapy company, today announced that the Japanese Patent Office issued a notice of allowance for patent application number 2022-512861 titled “THERAPEUTIC APOPTOTIC CELLS FOR TREATMENT OF OSTEOARTHRITIS”. Once issued, the resulting patent will provide Enlivex with added intellectual property (IP) protection through at least 2040. The Company expects that this new patent will be formally issued in Japan by the end of the second quarter of 2025.

Oren Hershkovitz, Ph.D., Chief Executive Officer of Enlivex, commented, “this notice of allowance demonstrates our commitment to protecting Allocetra’s™ commercial opportunities in key geographies around the world. We also believe that it highlights the successful execution of our global IP strategy. Going forward, we will continue to pursue multiple layers of patent protection in key global markets as we work to develop Allocetra™ as a next generation cell therapy for osteoarthritis, which is an unmet medical need that currently has poor treatment alternatives.”

ABOUT KNEE OSTEOARTHRITIS1

Osteoarthritis is by far the most common form of arthritis, affecting more than 32.5 million Americans and more than 300 million individuals worldwide. About half of knees with ACL injuries develop osteoarthritis within 5 to 15 years. 78 million Americans are projected to have osteoarthritis by the year 2040. Symptomatic knee osteoarthritis is particularly prevalent and disabling, with 40% of men and 47% of women developing knee osteoarthritis in their lifetimes. Osteoarthritis accounts for over one million hospitalizations annually in the United States, primarily for total joint replacement. The burden of osteoarthritis is enormous, and the need for treatments that reduce pain and attendant disability for persons with osteoarthritis is critical. There are currently no medications approved by either the U.S. Food and Drug Administration (FDA) or the European Medicines Agency (EMA) that have been demonstrated to arrest, slow or reverse progression of structural damage in the joint.

ABOUT ENLIVEX

Enlivex is a clinical stage macrophage reprogramming immunotherapy company developing Allocetra™, a universal, off-the-shelf cell therapy designed to reprogram macrophages into their homeostatic state. Resetting non-homeostatic macrophages into their homeostatic state is critical for immune system rebalancing and resolution of life-threatening conditions. For more information, visit https://enlivex.com/.

ENLIVEX CONTACT
Shachar Shlosberger, CFO
Enlivex Therapeutics, Ltd.
shachar@enlivexpharm.com 

INVESTOR RELATIONS CONTACT
Dave Gentry, CEO
RedChip Companies Inc.
1-407-644-4256
ENLV@redchip.com                                                

Safe Harbor Statement:  This press release contains forward-looking statements, which may be identified by words such as “expects,” “plans,” “projects,” “will,” “may,” “anticipates,” “believes,” “should,” “would”, “could,” “intends,” “estimates,” “suggests,” “has the potential to” and other words of similar meaning, including statements regarding the timing and receipt of intellectual property protection for ALLOCETRATM programs and market opportunities for ALLOCETRATM programs. All such forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.  Investors are cautioned that forward-looking statements involve risks and uncertainties that may affect Enlivex’s business and prospects, including the risks that Enlivex may not succeed in generating any revenues or developing any commercial products; that the products in development may fail, may not achieve the expected results or effectiveness and/or may not generate data that would support the approval or marketing of these products for the indications being studied or for other indications; that ongoing studies may not continue to show substantial or any activity; and other risks and uncertainties that may cause results to differ materially from those set forth in the forward-looking statements. The results of clinical trials in humans may produce results that differ significantly from the results of clinical and other trials in animals. The results of early-stage trials may differ significantly from the results of more developed, later-stage trials. The development of any products using the ALLOCETRATM product line could also be affected by a number of other factors, including unexpected safety, efficacy or manufacturing issues, additional time requirements for data analyses and decision making, the impact of pharmaceutical industry regulation, the impact of competitive products and pricing and the impact of patents and other proprietary rights held by competitors and other third parties.  In addition to the risk factors described above, investors should consider the economic, competitive, governmental, technological and other factors discussed in Enlivex’s filings with the Securities and Exchange Commission, including in the Company’s most recent Annual Report on Form 20-F filed with the Securities and Exchange Commission.  The forward-looking statements contained in this press release speak only as of the date the statements were made, and we do not undertake any obligation to update forward-looking statements, except as required under applicable law.




1 Source: The Arthritis Foundation; Disease modification in osteoarthritis; pathways to drug approval, Katz et. Al., Osteoarthritis and Cartilage Open (2) (2020)



FAQ

When will Enlivex's (ENLV) Japanese patent for Allocetra in osteoarthritis treatment be issued?

The patent is expected to be formally issued in Japan by the end of the second quarter of 2025.

How long will Enlivex's (ENLV) Japanese patent protection for Allocetra last?

The patent will provide intellectual property protection through at least 2040.

What is the Japanese patent application number for Enlivex's (ENLV) Allocetra osteoarthritis treatment?

The Japanese patent application number is 2022-512861.

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