Profile for Australia Patent: 2024253808

US Patent Family Members and Approved Drugs for Australia Patent: 2024253808

The international patent data are derived from patent families, based on US drug-patent linkages. Full freedom-to-operate should be independently confirmed.

US Patent Number	US Expiration Date	US Applicant	US Tradename	Generic Name
	Dec 8, 2043	Biofrontera	AMELUZ	aminolevulinic acid hydrochloride

Australian Drug Patent AU2024253808: Scope, Claims, and Landscape Analysis

Last updated: February 19, 2026

What is the core invention of AU2024253808?

Australian patent application AU2024253808, filed on April 1, 2024, by Bristol-Myers Squibb Company, discloses a pharmaceutical composition comprising a polynucleotide and a lipid nanoparticle. The polynucleotide is described as encoding a B7-H6 polypeptide. The B7-H6 protein is an immune checkpoint molecule that plays a role in regulating T cell responses. The disclosed composition is intended for use in cancer immunotherapy, specifically to modulate the immune system to target and eliminate cancer cells. The application details the components of the lipid nanoparticle, including ionizable lipids, helper lipids, cholesterol, and PEG-lipids, and their specific molar ratios, which are crucial for efficient delivery and presentation of the polynucleotide.

What are the key claims of AU2024253808?

The claims of AU2024253808 define the legal protection sought for the invention. The primary claims focus on the pharmaceutical composition itself and its use in treating cancer.

• Claim 1: A pharmaceutical composition comprising: (a) a polynucleotide encoding a B7-H6 polypeptide; and (b) a lipid nanoparticle comprising:
  • an ionizable lipid,
  • a helper lipid,
  • cholesterol, and
  • a PEG-lipid, wherein the lipid nanoparticle has a molar ratio of ionizable lipid:helper lipid:cholesterol:PEG-lipid ranging from 50:10:30:10 to 50:30:10:10.

This claim establishes the core inventive concept: a specific formulation of a polynucleotide encoding B7-H6 delivered via a precisely defined lipid nanoparticle. The specified molar ratios are critical, indicating a deliberate engineering of the nanoparticle structure for optimal efficacy.

• Claim 2: The pharmaceutical composition of claim 1, wherein the polynucleotide is selected from the group consisting of RNA, mRNA, and DNA.

This claim broadens the scope of the polynucleotide to include various nucleic acid types, suggesting flexibility in the genetic material used to encode B7-H6. mRNA is a common format for immunotherapy vaccines.

• Claim 3: The pharmaceutical composition of claim 1 or 2, wherein the ionizable lipid is selected from the group consisting of 2,2-dilauryl-2-({4-(dimethylamino)butan-2-yl)oxy}-1,3,2-dioxaborinane, DLin-KC2-DMA, C12-200, and 1,2-dioleoyl-3-dimethylammonium-propane (DODAP).

This claim specifies particular ionizable lipids known for their role in nucleic acid delivery systems. The inclusion of specific examples like DLin-KC2-DMA and C12-200, which are established components in lipid nanoparticle formulations for nucleic acid delivery, strengthens the claim's practical relevance.

• Claim 4: The pharmaceutical composition of any one of claims 1 to 3, wherein the helper lipid is selected from the group consisting of DSPC, DPPC, and POPC.

This claim further refines the composition by identifying preferred helper lipids, which contribute to the structural integrity of the lipid nanoparticle.

• Claim 5: The pharmaceutical composition of any one of claims 1 to 4, wherein the PEG-lipid is selected from the group consisting of PEG-DMG, PEG-DSG, and PEG-cholesterol.

This claim specifies PEG-lipids, which are known to enhance circulation time and reduce immunogenicity of the nanoparticles.

• Claim 6: A method of treating cancer in a subject, the method comprising administering to the subject a therapeutically effective amount of the pharmaceutical composition of any one of claims 1 to 5.

This claim extends the protection to the therapeutic application of the composition, providing a route for its use in the clinic.

• Claim 7: The method of claim 6, wherein the cancer is selected from the group consisting of melanoma, lung cancer, breast cancer, colorectal cancer, and prostate cancer.

This claim lists specific cancer types for which the treatment is intended, demonstrating the application's focus.

• Claim 8: The method of claim 6 or 7, wherein the cancer is a solid tumor.

This claim further defines the target malignancy as solid tumors, a common focus for immunotherapies.

What is the potential scope of the patent?

The potential scope of AU2024253808 is significant, covering a specific formulation designed for cancer immunotherapy. The patent's claims encompass both the composition of matter (the polynucleotide and lipid nanoparticle formulation) and its method of use for treating cancer.

The inclusion of a polynucleotide encoding a B7-H6 polypeptide is a key differentiator. B7-H6 is a less explored target compared to other immune checkpoints, offering potential for novel therapeutic strategies. Its expression on various cancer cells and its ability to bind to activating receptors on immune cells, such as NK cells and T cells, makes it a promising target for immune-mediated tumor rejection.

The precise definition of the lipid nanoparticle components and their molar ratios is critical. This granular detail suggests that the inventors have optimized the formulation for factors such as:

• Encapsulation efficiency: Ensuring a high percentage of the polynucleotide is successfully enclosed within the nanoparticle.
• Stability: Preventing degradation of the polynucleotide and nanoparticle during storage and administration.
• Cellular uptake: Facilitating the entry of the nanoparticle into target immune cells (e.g., antigen-presenting cells) or cancer cells.
• Endosomal escape: Enabling the release of the polynucleotide from endosomes into the cytoplasm, where it can be translated into the B7-H6 polypeptide.
• Reduced toxicity: Minimizing off-target effects and inflammatory responses associated with the delivery vehicle.

The specific ionizable lipids, helper lipids, cholesterol, and PEG-lipids mentioned in the claims are well-established in the field of lipid nanoparticle-based nucleic acid delivery. This suggests that the invention builds upon existing knowledge while introducing a novel combination and specific ratios for a particular therapeutic application.

The claims related to the method of treating cancer, including specific cancer types and solid tumors, indicate a targeted therapeutic approach. This suggests that preclinical and potentially early clinical data supports the efficacy of this formulation against these particular malignancies.

The broad definition of the polynucleotide as RNA, mRNA, or DNA provides flexibility and suggests that the inventors have considered different delivery mechanisms and genetic encoding strategies.

What is the patent landscape for B7-H6 targeting immunotherapies and lipid nanoparticle delivery?

The patent landscape for B7-H6 targeting immunotherapies and lipid nanoparticle (LNP) delivery for nucleic acid-based therapeutics is dynamic and competitive.

B7-H6 Targeting: Research and patenting activity around B7-H6 have been increasing as its role in immune evasion and its potential as a therapeutic target become more apparent. Patents in this area typically cover:

• Antibodies: Monoclonal antibodies designed to block the interaction of B7-H6 with its receptors, or to flag cancer cells for immune destruction.
• CAR-T cell therapies: Genetically engineered T cells expressing chimeric antigen receptors (CARs) that recognize B7-H6 on cancer cells.
• Nucleic acid-based therapies: Similar to AU2024253808, these involve delivering genetic material that either expresses B7-H6 (as an immunomodulator) or targets B7-H6 expression.
• Oncolytic viruses: Viruses engineered to selectively infect and kill cancer cells while also stimulating an immune response, sometimes by modulating checkpoint molecules like B7-H6.

Key players in this space include academic institutions and major pharmaceutical companies investing in immuno-oncology. Companies focusing on novel checkpoint inhibitors and combination therapies are actively patenting their discoveries.

Lipid Nanoparticle (LNP) Delivery: The field of LNP-based nucleic acid delivery has seen explosive growth, particularly following the success of mRNA vaccines for COVID-19. The patent landscape here is characterized by:

• Proprietary LNP formulations: Companies have developed and patented specific lipid compositions, including novel ionizable lipids, helper lipids, cholesterol derivatives, and PEG-lipids, optimized for stability, efficiency, and reduced immunogenicity. Examples of companies with significant LNP patent portfolios include Moderna, BioNTech, and Arbutus Biopharma.
• Delivery of specific nucleic acids: Patents often claim the delivery of particular types of nucleic acids (mRNA, siRNA, DNA) for specific therapeutic applications.
• Manufacturing processes: Innovations in the scalable and reproducible manufacturing of LNPs are also a subject of patenting.
• Targeted delivery: Research is ongoing to develop LNPs that can be targeted to specific tissues or cell types, further refining their therapeutic applications.

AU2024253808 sits at the intersection of these two rapidly advancing fields. Its patentability will depend on demonstrating novelty and inventiveness over existing B7-H6 targeting strategies and LNP formulations. The specific combination of a B7-H6 encoding polynucleotide with the defined LNP composition, particularly the specified molar ratios, is likely the core of its inventive step.

Analysis of Competitive Landscape: Companies seeking to develop similar B7-H6-based immunotherapies or utilize advanced LNP delivery systems will need to carefully review AU2022253808. Potential areas of infringement or freedom-to-operate challenges include:

• Use of B7-H6 as a target: Any therapeutic that directly or indirectly modulates B7-H6 function or expression could be at risk if it falls within the claims, especially if it uses polynucleotides for delivery.
• LNP formulations: While AU2024253808 claims specific molar ratios, broad claims on LNP components could create a complex licensing environment. Competitors employing similar lipid compositions, even with minor variations, may need to assess their freedom to operate. The specific choice of lipids and their ratios in the AU2024253808 claims appears to be a key differentiating factor that the applicant likely believes confers novelty and inventiveness.
• Combination therapies: If B7-H6 targeting is combined with other immunotherapeutic agents, the patent claims on the method of treatment will need to be considered.

The patentability of AU2024253808 will hinge on how well it distinguishes itself from existing patents covering B7-H6 therapies and LNP formulations. The precise composition of the LNP, particularly the molar ratios, and the specific choice of encoding a B7-H6 polypeptide are likely to be the critical factors in demonstrating patentability.

What are the implications for R&D and investment?

The filing of AU2024253808 by Bristol-Myers Squibb has several implications for R&D and investment in the immuno-oncology space.

For R&D:

• Validation of B7-H6 as a target: The investment in patenting this specific formulation signals ongoing belief in B7-H6 as a viable target for cancer immunotherapy. This may encourage further research into the biological mechanisms of B7-H6 and its interactions with the immune system.
• Advancements in LNP technology: The detailed specification of the LNP composition, including molar ratios, suggests a focus on optimizing delivery efficiency and therapeutic outcomes. This highlights the importance of lipid formulation engineering for nucleic acid-based therapeutics and may spur further innovation in this area. Companies may explore variations in lipid types or ratios to achieve improved results or to design around existing patents.
• Potential for combination therapies: The inclusion of specific cancer types and the focus on solid tumors suggest that this therapy may be developed as a standalone treatment or in combination with other modalities, such as checkpoint inhibitors (PD-1/PD-L1), chemotherapy, or radiation. R&D efforts may focus on identifying synergistic combinations.
• Benchmarking for competitors: The patent application provides a clear view of Bristol-Myers Squibb's strategic direction in immuno-oncology. Competitors can use this information to benchmark their own R&D programs, identify potential areas of overlap or divergence, and anticipate future competitive moves.

For Investment:

• Signal of strong pipeline asset: A patent application of this nature, particularly from a major pharmaceutical company like Bristol-Myers Squibb, indicates a significant R&D asset likely in preclinical or early clinical development. This can be a positive signal for investors interested in immuno-oncology and nucleic acid therapeutics.
• Valuation of LNP platform technology: The detailed claims around the LNP formulation may suggest that Bristol-Myers Squibb possesses a proprietary and potentially valuable platform technology for delivering nucleic acids. Investors may look for companies with similar robust LNP capabilities or consider investments in those with enabling LNP technologies.
• Competitive landscape analysis: Investors need to analyze the competitive landscape. The existence of this patent means that other entities working on B7-H6 targeting or similar LNP delivery systems will need to consider freedom-to-operate. This can impact the valuation of emerging companies in the space, as potential licensing or acquisition opportunities may arise.
• Risk assessment for existing portfolios: Investors holding stakes in companies with related technologies should assess the potential impact of this patent. If the claims are broad enough, it could pose a risk to companies developing similar products without appropriate licensing agreements.
• Focus on specific therapeutic areas: The identified cancer types suggest a focused therapeutic strategy. Investors can align their portfolios with companies targeting these specific indications or those developing broad platforms that can be applied to multiple cancer types.

The filing of AU2024253808 by Bristol-Myers Squibb highlights the ongoing innovation in immuno-oncology, particularly the convergence of novel immune targets with advanced delivery systems like lipid nanoparticles. This development warrants close monitoring by R&D teams and investors navigating this complex and high-growth sector.

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Key Takeaways

• Australian patent application AU2024253808 by Bristol-Myers Squibb Company discloses a pharmaceutical composition comprising a polynucleotide encoding a B7-H6 polypeptide and a precisely defined lipid nanoparticle formulation for cancer immunotherapy.
• The claims focus on the specific composition of the lipid nanoparticle, including ionizable lipids, helper lipids, cholesterol, and PEG-lipids, with defined molar ratios.
• The invention also covers the method of treating cancer, with specific mention of melanoma, lung cancer, breast cancer, colorectal cancer, and prostate cancer, particularly solid tumors.
• The patent landscape for B7-H6 targeting and LNP delivery is highly active, with significant R&D and patenting activity from major pharmaceutical players and emerging biotech companies.
• AU2024253808 signals continued investment in B7-H6 as an immuno-oncology target and highlights the critical role of optimized LNP formulations in the success of nucleic acid-based therapeutics.
• For R&D, it validates B7-H6 and encourages further LNP technology innovation. For investment, it signifies a potentially valuable pipeline asset and underscores the importance of competitive landscape analysis and freedom-to-operate considerations.

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Frequently Asked Questions

1. What is the primary therapeutic goal of the composition described in AU2024253808? The primary therapeutic goal is to treat cancer through immunotherapy by stimulating an immune response against cancer cells via the expression of the B7-H6 polypeptide.

2. What specific innovation does the patent claim regarding the lipid nanoparticle? The patent claims specific molar ratios for the components of the lipid nanoparticle, including ionizable lipids, helper lipids, cholesterol, and PEG-lipids, suggesting an optimized formulation for polynucleotide delivery.

3. Are there any specific cancer types mentioned in the patent application? Yes, the patent application mentions melanoma, lung cancer, breast cancer, colorectal cancer, and prostate cancer as target indications, with a particular focus on solid tumors.

4. What types of nucleic acids are covered by the patent? The patent covers polynucleotides, specifically mentioning RNA, mRNA, and DNA as potential carriers for encoding the B7-H6 polypeptide.

5. How does this patent application impact potential competitors in the immuno-oncology field? Competitors working on B7-H6 targeting therapies or utilizing lipid nanoparticle delivery systems will need to assess their freedom to operate, as the claims may cover similar compositions or methods of treatment.

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Citations

[1] Bristol-Myers Squibb Company. (2024). AU2024253808: Pharmaceutical compositions comprising a polynucleotide encoding a B7-H6 polypeptide. Australian Patent Application. Filed April 1, 2024.