IMUNON Announces Six-Month Data Showing Durability of Protection for Next-Generation DNA Vaccine Platform in Phase 1 Clinical Trial in COVID-19
Company's PlaCCine® technology platform demonstrates better durability and other advantages compared to mRNA vaccines
Results further validate PlaCCine as a novel vaccine platform with potential applications in COVID-19 and other infectious diseases with epidemic implications
LAWRENCEVILLE, N.J., May 15, 2025 (GLOBE NEWSWIRE) -- IMUNON, Inc. (NASDAQ: IMNN), a clinical-stage company focused on developing non-viral DNA-mediated immunotherapies and evaluating an adaptation of the platform's potential as a next-generation vaccine, today announced new data from its first Phase 1 proof-of-concept clinical trial of IMNN-101, an investigational DNA plasmid vaccine based on the Company's proprietary PlaCCine® technology platform, for protection against COVID-19. Results in 24 healthy volunteers demonstrated IMNN-101's durability of protection at six months after a single dose targeting the SARS-CoV-2 Omicron XBB1.5 spike antigen variant. IMNN-101 induced up to a 3-fold median increase in the serum neutralizing antibody (NAb) titers from baseline at six months, with initial evidence of a stronger immune response in two higher dose cohorts (2.0 mg and 1.0 mg) compared to a lower dose cohort (0.5 mg). The highest observed increase among the participating volunteers was 8-fold from baseline. IMNN-101 continues to be safe and well tolerated, with no serious adverse effects reported.
'It is very encouraging to see strong evidence supporting the favorable immunogenicity, durability and safety of IMNN-101 at six months in trial participants, all of whom were previously vaccinated or infected multiple times, further validating the significant potential of our PlaCCine technology platform to support development of an effective treatment for COVID-19, new variants and emerging pathogens with epidemic potential,' said Stacy Lindborg, Ph.D., President and Chief Executive Officer of IMUNON. 'Our platform is designed to support development of vaccines with several competitive advantages, including vaccine stability at workable temperatures and ease of manufacturing compared to available mRNA vaccines. We are currently involved in discussions about the further development of our PlaCCine platform for prophylactic vaccines, which we hope will lead to a long-term strategic partnership to advance these promising technologies as efficiently as possible.'
In the Phase 1 trial, designed to demonstrate the advantages of IMUNON's technology compared to approved messenger RNA (mRNA) vaccines, IMNN-101 was administered as a single dose vaccine without a booster dose in study participants who were previously vaccinated against the Omicron XBB1.5 variant. Study participants had high baseline immune characteristics, presumably from prior infection and multiple previous vaccinations against COVID-19, and ongoing infection. Modest increases in T-cell responses were observed in trial participants who received multiple immunizations prior to the study.
'I have seen firsthand how COVID-19 continues to impact patients, especially those with underlying health conditions. While existing vaccines have saved countless lives, there is a need for more updated and widely available options to keep pace with potential variants, and particularly with applications in unaddressed and emerging infectious diseases. Expanding our vaccine toolkit is essential to reduce hospitalizations and prevent long-term complications. These latest data indicate that IMNN-101 may offer a safe, effective and advantageous treatment option for patients in the future,' said Ai-ris Collier, M.D., Co-Director of the Clinical Trials Unit, Center for Virology and Vaccine Research Center, Beth Israel Deaconess Medical Center.
Results from the Phase 1 trial build on data previously announced in February 2025, which showed IMNN-101 induced a persistent 2- to 4-fold increase in serum NAb titers from baseline through Week 4, further increasing NAb titers between Week 2 and Week 4. The immune response was also observed against the XBB1.5 variant and many newer variants following treatment, demonstrating the IMNN-101 vaccine's cross-reactivity. The Phase 1 clinical data of IMNN-101 is consistent with strong evidence of immunogenicity and protection for the PlaCCine platform in rodents and non-human primates, with prior preclinical results showing comparable protection efficiency (>95%) to a commercial mRNA vaccine in non-human primates.
About PlaCCine® and IMNN-101
IMNN-101 utilizes the Company's PlaCCine® technology platform, a proprietary composition of a DNA plasmid that regulates the expression of key pathogen antigens and a novel synthetic DNA delivery system. The plasmid-based expression vector accommodates single or multiple antigens through its flexible vector design, offers manufacturing flexibility compared to viral, mRNA or protein vaccines, and the synthetic delivery system protects DNA from degradation and facilitates DNA uptake after injection with acceptable safety.
About the Phase 1 PoC Clinical Trial
This U.S. Phase 1 proof-of-concept (PoC) study enrolled 24 participants to evaluate three escalating doses of IMNN-101 with eight participants at each dose. All participants were treated at DM Clinical Research in Philadelphia. For this study, IMNN-101 has been designed to protect against the SARS-CoV-2 Omicron XBB1.5 variant, in accordance with the FDA's Vaccines and Related Biological Products Advisory Committee's June 2023 announcement of the framework for updated COVID-19 doses. The primary objectives of the study are to evaluate safety and tolerability in healthy adults. Secondary objectives include evaluating IMNN-101's immunogenicity and associated durability.
About IMUNON
IMUNON is a clinical-stage biotechnology company focused on advancing a portfolio of innovative treatments that harness the body's natural mechanisms to generate safe, effective and durable responses across a broad array of human diseases, constituting a differentiating approach from conventional therapies. IMUNON is developing its non-viral DNA technology across its modalities. The first modality, TheraPlas®, is developed for the gene-based delivery of cytokines and other therapeutic proteins in the treatment of solid tumors where an immunological approach is deemed promising. The second modality, PlaCCine®, is developed for the gene delivery of viral antigens that can elicit a strong immunological response.
The Company's lead clinical program, IMNN-001, is a DNA-based immunotherapy for the localized treatment of advanced ovarian cancer that has completed multiple clinical trials including one Phase 2 clinical trial (OVATION 2). IMNN-001 works by instructing the body to produce safe and durable levels of powerful cancer-fighting molecules, such as interleukin-12 and interferon gamma, at the tumor site. Additionally, the Company has completed dosing in a first-in-human study of its COVID-19 booster vaccine (IMNN-101). The Company will continue to leverage these modalities and to advance, either directly or through partnership, the technological frontier of plasmid DNA to better serve patients with difficult-to-treat conditions. For more information, please visit www.imunon.com.
Forward-Looking Statements
IMUNON wishes to inform readers that forward-looking statements in this news release are made pursuant to the 'safe harbor' provisions of the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical fact, including, but not limited to, statements regarding the timing of enrollment of the Company's clinical trials, the potential of any therapies or vaccines developed by the Company to fulfill unmet medical needs, the market potential for the Company's products, if approved, the potential efficacy and safety profile of our product candidates, and the Company's plans and expectations with respect to its development programs more generally, are forward-looking statements. We generally identify forward-looking statements by using words such as 'may,' 'will,' 'expect,' 'plan,' 'anticipate,' 'estimate,' 'intend' and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances). Readers are cautioned that such forward-looking statements involve risks and uncertainties including, without limitation, uncertainties relating to unforeseen changes in the course of research and development activities and in clinical trials, including the fact that interim results are not necessarily indicative of final results; the uncertainties of and difficulties in analyzing interim clinical data; the significant expense, time and risk of failure in conducting clinical trials; the need for IMUNON to evaluate its future development plans; possible actions by customers, suppliers, competitors or regulatory authorities; and other risks detailed from time to time in IMUNON's filings with the Securities and Exchange Commission. IMUNON assumes no obligation, except to the extent required by law, to update or supplement forward-looking statements that become untrue because of subsequent events, new information or otherwise.
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35 minutes ago
- Los Angeles Times
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Joshua Driskell, Managing Partner, Lagerlof, LLP: High-net-worth individuals should prioritize flexibility, tax efficiency and multigenerational planning. With inflation, interest rate fluctuations and potential changes in tax law, building a nimble structure is essential. That includes diversifying asset classes, stress-testing estate plans under higher estate or capital gains tax regimes, and taking advantage of current exemptions before they sunset. Establishing irrevocable grantor trusts, family limited partnerships and charitable vehicles can preserve wealth while achieving strategic goals. Proactive wealth transfers, such as installment sales to defective trusts or GRATs, can lock in valuation discounts and freeze estate value. Most importantly, integrate estate and investment planning with family governance to promote cohesion and legacy continuity. Pujol: In today's environment, high-net-worth individuals should prioritize three things: ownership in assets they understand, tax-efficient structures informed by valuation foresight, and optionality through enhanced liquidity. Long-term capital growth is not about chasing trends or the cliched shiny objects but about staying positioned for the right opportunities. We're seeing a move away from over-diversified portfolios toward intentional ownership, where control, structure and timing drive outcomes. This means more alternatives, a mix of private and public holdings, and tax-minimizing structures. Ownership in assets you'd fight to keep, that's the new diversification. I also like the 'cockroach' approach, which is building portfolios that survive the panoply of circumstances the world is throwing at us by selecting traditional and non-traditional asset classes, making sure that correlation is low. I also think cash yields make liquidity an asset and not a drag on returns; it's strategic capital with a clear purpose of optionality. When opportunities arise, those with dry powder and a defined investment playbook are positioned to act quickly and decisively. The most successful families today follow a clear investment policy that outlines the investment discipline before emotions take over. In this environment, structure and readiness matter more than broad diversification. Ben-Naim: It's not as simple as building your wealth across stocks, bonds and cash anymore. In the past seven to 10 years, we've helped many of our clients increase their alternative asset exposure – ranging from equity and debt investment in commercial real estate, direct lending and hedge funds – from 5% to about 20%, with very positive results due to the less volatile and emotions-driven public market. Our current cycle has also highlighted the importance of hedging strategies. Investors should work closely with their advisors to identify safeguards on the equity market as well as private market entry points that will create protections on the downside, while maintaining participation on the upside. We've seen very positive outcomes as a result of these strategies. Many of our clients who have been allocating funds to private markets have been largely shielded from the recent volatility. Now, they are even taking steps to allocate more funds into these verticals. Q: How should investors rebalance their portfolios in response to shifting interest rates and market volatility? Watson: In today's dynamic environment, rebalancing decisions should be made with a clear understanding of how shifting interest rates and market volatility affect different asset classes. Rather than attempting to time the market or make reactive moves, investors should work closely with a qualified investment advisor who can assess their overall investment time horizon, risk profile and long-term goals. An advisor can provide guidance on when and how to adjust asset allocations, evaluate the impact of interest rate changes on fixed income and equity risk and returns, and implement a disciplined, tax-efficient rebalancing approach. With full visibility into an investor's financial profile, an advisor is able to provide holistic guidance. Professional oversight ensures that adjustments are strategic, not emotional, and aligned with broader financial objectives. Q: What planning opportunities exist when a trust changes from a grantor trust to a non-grantor trust? Driskell: When a trust converts from grantor to non-grantor status – often due to a death or other triggering event – it opens both risks and planning opportunities. 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It is always good to engage advisors early to create trusts, wills and governance structures that reflect your values and intentions. Avoiding these pitfalls requires proactive planning, trusted advice and the discipline to think generationally, not just transactionally. Q: How do you advise clients to balance risk and reward when pursuing long-term growth? Ben-Naim: In my experience, more than 80% of portfolio performance comes from asset allocation. The other 20% comes from the strategic selection of managers. These should be top-tier professionals and sponsors who have long-demonstrated success. Your advisor should not only provide guidance on the makeup of your portfolio but also serve as a reliable conduit, connecting you to well-vetted sponsors – hedge funds, private equity firms and other alternative investment opportunities that can provide buffers in downcycles, participation in bull markets and demonstrate confident returns in five-to-seven-year cycle. For us at IDB, this network of sponsors and managers is of critical importance. We've found that our clients respond incredibly well to our ongoing introductions to high-performance opportunities from both our broker-dealer partner IDB Capital, our joint venture IDB Lido Wealth and outside partners. Pujol: Don't chase high risk, high reward; engineer low risk, high conviction through long-term thinking. At Objective, we believe true risk isn't just about market volatility, it's often about overpaying for uncertain outcomes or fads. Long-term growth starts with disciplined entry and should correlate with what you want to own five years down the line. Valuation at entry isn't just for compliance, it's the defense and roadmap for future position adjustments. We often guide clients to model three – cases, low, base and high – because if you only plan for the base case, you've handicapped your understanding of potential outcomes. 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Tools like Donor-Advised Funds (DAFs), Trust Accounts and strategic charitable giving offer flexible and tax-efficient ways to support causes they care about. These options allow clients to create lasting impact while maintaining control over their giving strategy, making philanthropy a key part of their overall financial and legacy planning. Q: What are the latest trends in estate planning that individuals and families should be aware of? Driskell: Several emerging trends are reshaping estate planning. First, many families are accelerating wealth transfers ahead of the 2026 estate tax exemption sunset. Tools like SLATs, IDGTs and GRATs are increasingly popular for capturing today's favorable tax climate. Second, planners are focused on trust design that balances asset protection with beneficiary flexibility, including directed trusts and decanting statutes. Third, digital assets – from crypto to intellectual property – require new planning considerations. Finally, estate plans increasingly incorporate non-tax goals, such as family harmony, stewardship and values-based legacy planning. Tailored education and engagement for the next generation is also a growing priority to reduce conflict and enhance readiness for wealth transfer. Q: What estate planning tools are most effective for minimizing tax burdens across generations? Pujol: Standard structuring tools still work, but their true power lies in how and when they're used. For example, gifting pre-appreciated assets during downturns or before liquidity events allows wealth to grow outside the estate at a compressed tax cost. Planning with discount studies for minority positioning can allow you to apply discounts for lack of marketability and control, reducing the taxable value of gifted interests while preserving real economic value. Certain traditional trust structures, including those based on annuity techniques, remain effective planning tools. Their impact can be significantly enhanced by aligning transfers with existing tax benefits, such as Qualified Small Business Stock treatment. When minority interests are gifted at trough valuations and supported by appropriate discounts for lack of marketability and/or control, substantial equity can be shifted into tax-efficient vehicles at reduced reported values. Capture step-ups early may save IRS bills later. This clearly shows compliance valuation is not just part of the plan, it's a real economic multiplier. With early planning, millions in future value can be transferred before massive tax consequences. Driskell: Irrevocable trusts are a cornerstone of multigenerational tax planning. Grantor trusts, such as Intentionally Defective Grantor Trusts (IDGTs), allow parents to sell appreciating assets without triggering income tax, removing future growth from the estate. Spousal Lifetime Access Trusts (SLATs) offer access to income while locking in the current exemption amount. Generation-skipping trusts minimize estate tax exposure across multiple generations. Qualified Personal Residence Trusts (QPRTs) and Grantor Retained Annuity Trusts (GRATs) are useful for freezing asset values. Family Limited Partnerships (FLPs) and valuation discounts further enhance tax efficiency. Coordinating these strategies with lifetime gifts and charitable giving can significantly reduce long-term tax burdens. Q: In what ways should wealth managers prepare clients for potential ripple effects from trade restrictions between major economies? Watson: Wealth managers should prepare clients for potential ripple effects from trade restrictions by helping them assess and adjust their portfolios to mitigate risk. First, they should review global diversification to ensure clients are not overly exposed to any single economy, industry or region, especially those directly impacted by trade restrictions and geopolitical crises. This may involve shifting exposure from vulnerable sectors or countries to more resilient ones. They should also consider incorporating alternative assets that may offer protection in times of geopolitical instability, such as commodities or real assets. Additionally, wealth managers can guide clients on cash flow management and ensure liquidity needs are met, as trade restrictions could lead to economic slowdowns or disruptions in supply chains. Lastly, they should help clients stay informed and proactive, adjusting investment strategies in response to evolving trade dynamics and market conditions. Q: What unique considerations should business owners factor into their estate and succession plans? Pujol: Succession isn't a single event, it's a system that needs to be built, maintained and regularly tested. Business owners and family heads should structure continuity plans with updated valuations, clearly defined buy-sell mechanisms, and governance that depends less on future intentions or personalities and more on thoughtful planning. Uncertainty is one of the biggest threats to enterprise value. If business plans aren't baked into legal documents, the business is exposed to potential family disputes, tax inefficiencies and legal ambiguity. Transfers are also easier when numbers have been agreed to in advance. Plan as if you'll leave tomorrow and revisit that plan at least once a year. More families are treating succession planning like an annual checkup. During year-end valuation work, they run liquidation or 'liquidity fire-drill' scenarios to spot issues and test their transition plans. Some are also using structures to manage control and distributions effectively across family members more dynamically. Like outdated software, if a succession plan isn't reviewed and updated regularly, it's more likely to break when you need it most. Driskell: Business owners face unique risks and opportunities in estate planning. Key considerations include ensuring continuity of control, managing valuation and liquidity issues, and minimizing transfer tax liability. Proper use of buy-sell agreements, voting and non-voting share structures, and family-limited partnerships helps preserve operations while transferring economic value. Owners should explore gifting or selling interests to irrevocable trusts while leveraging valuation discounts. Planning for management succession is equally vital – aligning legal structure with leadership readiness. Owners often underestimate the need to separate governance from ownership. Coordinating business succession with estate liquidity planning (via insurance or redemption strategies) ensures family and business stability. Q: What defensive investment strategies are you recommending in light of the geopolitical instability and trade disputes? Ben-Naim: We consistently review our clients' allocations and advise on defensive strategies that can help ensure a buttoned-up portfolio. These strategies can range from diversifying asset classes to withstand major public market fluctuations, tax incentive investing and hedging. When considering geopolitical instability, our diversification philosophy is much the same. Now is an opportunity to really consider your geographic exposures and to look to consistently performing and emerging markets outside of the U.S. to realize opportunities. Of course, not all markets are winners and investing in a new region requires vetting, oftentimes with boots on the ground. But with careful research, you can make intelligent entry points. For example, despite the war, Israel proved to have a very strong public market in the past 18 months. Other markets, including India and Vietnam, are expected to perform with higher GDP growth compared to the U.S. and present an exciting outlook. Q: How do you see AI and automation impacting wealth management in the next 5-10 years? Pujol: AI is beginning to reshape wealth management, but it's not a replacement for advisors, it's another tool in the toolbox. Used well, it can accelerate diligence, surface outliers, stress test assumptions and generate models in seconds. But the truth is clients don't need more spreadsheets; they need clarity, context and judgment. All this comes from the human touch and experience. The advisors who will lead in the next decade are those who treat AI like an enhancement of their own skills, not like a replacement. At Objective, we use AI to flag inconsistencies, improve our communication and stress test our thinking. Then we bring in the human element to synthesize, challenge and advise. AI can compute outcomes, but it's useless without an experienced human interpreter. In the end, it's not about replacing insight, it's about removing noise so advisors can focus on the decisions that actually matter. AI enhances great advisors, but it will never make poor ones great. Watson: AI and automation are set to significantly impact wealth management in the next 5-10 years, likely accelerating the commoditization of basic advisory services. As technology advances, routine tasks such as portfolio rebalancing, tax optimization and risk assessment will become increasingly automated, making them more accessible and efficient at a lower cost. This will force traditional wealth advisors to rethink their value proposition, as many investment-related services will be handled by AI-driven platforms. To remain competitive, advisors will need to expand their offerings beyond just investments, focusing more on personalized financial planning, estate and tax strategies, and holistic wealth management. By integrating AI and automation into their practice, wealth managers can enhance their operational efficiency, but to truly differentiate themselves, they will need to provide high-touch, value-added services that help clients navigate complex financial decisions and life transitions. Q: How can advisors better engage younger generations in the wealth transfer conversation to avoid conflict and ensure legacy continuity? Pujol: If you want heirs to act like stewards instead of recipients, don't just write a will, start a conversation. The earlier families involve younger generations, the more likely wealth becomes a tool for continuity. We've seen families use business valuations, portfolio reviews and cash flow summaries to bring clarity to the 'why' behind the wealth and to tell the full story to their heirs. These tools take emotion out of the equation and turn complex financial decisions into documented, teachable moments. A detailed valuation can start the conversation a trust document cannot. One strategy that works well is forming a Family Investment Committee before the age of 18. You can even give heirs mock capital, or even small portfolios, and let them pitch investments quarterly, benchmarking their results against the real portfolio. Valuation reports and shared KPIs can turn wealth into something they understand and feel responsible for. The more context you provide while living, the fewer misunderstandings arise after you're gone. Driskell: Engaging younger generations early promotes transparency, reduces conflict and builds legacy alignment. Advisors should encourage family meetings to share the purpose behind planning decisions, including family values and long-term goals. Incorporating educational components – like basic financial literacy, investment principles and trust mechanics – empowers beneficiaries and fosters stewardship. Structuring trusts to provide phased access, beneficiary-directed investment input or co-trustee roles can build confidence and responsibility. Additionally, encouraging philanthropy and impact investing can bridge generational gaps. Above all, advisors must create space for open dialogue, ensuring younger family members feel heard and respected. This relational foundation is often more critical than the legal structures themselves. Watson: Advisors can better engage younger generations in the wealth transfer conversation by fostering early, inclusive and values-driven dialogue within families. Rather than treating wealth as a taboo or distant topic, advisors should encourage clients to involve heirs in strategic conversations about family values, financial goals and the purpose behind the wealth. This helps build trust, reduce the risk of conflict and ensures that the next generation feels informed and empowered rather than surprised or unprepared. Advisors can also offer educational resources and facilitate family meetings to bridge knowledge gaps and align expectations. By acting as neutral facilitators and emphasizing transparency, advisors play a key role in preserving both family harmony and the long-term continuity of the legacy. Q: For those concerned that their heirs might abuse their inheritance, what trust strategies are there? Driskell: Discretionary trusts with independent trustees remain a powerful tool to prevent misuse of inherited wealth. These trusts allow the trustee to make distributions based on the beneficiary's needs rather than mandatory rights. Incentive provisions can be included to reward education, employment or sobriety. Spendthrift clauses protect trust assets from creditors and poor financial decisions. Advisors may recommend staggered distributions or milestone triggers to gradually release funds. For families with ongoing concerns, directed trusts or trust protectors can provide oversight and flexibility. Ultimately, thoughtful drafting and selecting a fiduciary who understands family dynamics are key to protecting both wealth and relationships. Q: As a trusted advisor, what advice can you share for longer-term portfolio asset allocation? Ben-Naim: Now more than ever, high-net-worth investors have access to more asset classes, opportunities and strategies. While this is exciting, it's important to understand the implications of your holdings and to allocate your portfolio in a way that will withstand external fluctuations. 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Believe, a European tech entity, is navigating its path towards profitability with expected earnings growth of 96.9% annually. Despite current unprofitability, its revenue growth outpaces the French market's average at 13.4% per year compared to 5%. This growth trajectory is supported by strategic moves such as the proposed acquisition by TCMI Inc., EQT X, and Denis Ladegaillerie for a €57.9 million stake, enhancing financial stability and market presence. Moreover, Believe's commitment to R&D aligns with industry demands for continuous innovation, ensuring it remains competitive in the dynamic tech landscape. Get an in-depth perspective on Believe's performance by reading our health report here. Examine Believe's past performance report to understand how it has performed in the past. Simply Wall St Growth Rating: ★★★★★☆ Overview: Comet Holding AG, along with its subsidiaries, delivers X-ray and radio frequency (RF) power technology solutions globally across Europe, North America, and Asia, with a market capitalization of CHF1.79 billion. Operations: The company generates revenue through three main segments: X-Ray Systems (CHF115.89 million), Industrial X-Ray Modules (CHF94.57 million), and Plasma Control Technologies (CHF247.39 million). Comet Holding AG, a Swiss tech firm, is making notable strides with an earnings growth of 37.3% annually, significantly outpacing the local market's average of 10.7%. This robust performance is further underscored by its revenue increase of 12.2% per year, which also surpasses the Swiss market growth rate of 4.2%. Notably, Comet's commitment to innovation is evident in its R&D spending, crucial for maintaining technological leadership in a competitive sector. Recent corporate actions include electing Benjamin Loh as Chairman and approving a dividend increase to CHF 1.50 per share, signaling strong governance and shareholder confidence amidst a promising financial trajectory marked by first-quarter sales surging by 37.5% year-over-year to CHF 111.2 million. Take a closer look at Comet Holding's potential here in our health report. Assess Comet Holding's past performance with our detailed historical performance reports. Dive into all 226 of the European High Growth Tech and AI Stocks we have identified here. Shareholder in one or more of these companies? Ensure you're never caught off-guard by adding your portfolio in Simply Wall St for timely alerts on significant stock developments. Join a community of smart investors by using Simply Wall St. It's free and delivers expert-level analysis on worldwide markets. Explore high-performing small cap companies that haven't yet garnered significant analyst attention. Fuel your portfolio with companies showing strong growth potential, backed by optimistic outlooks both from analysts and management. Find companies with promising cash flow potential yet trading below their fair value. This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned. Companies discussed in this article include ENXTBR:ARGX ENXTPA:BLV and SWX:COTN. Have feedback on this article? Concerned about the content? with us directly. 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Business Upturn
2 hours ago
- Business Upturn
Glenmark Pharmaceuticals to launch Zanubrutinib (BRUKINSA) in India after DCGI approval
Glenmark Pharmaceuticals has announced the launch of zanubrutinib in India following approval by the Drugs Controller General of India (DCGI). The drug will be marketed under the brand name BRUKINSA®, developed by BeiGene (now BeOne Medicines), a global oncology company. This marks the introduction of the first Bruton's tyrosine kinase (BTK) inhibitor in India approved for the treatment of five B-cell malignancies: chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), Waldenström macroglobulinemia (WM), mantle cell lymphoma (MCL), marginal zone lymphoma (MZL), and follicular lymphoma (FL). BRUKINSA is approved in over 70 countries, backed by data from clinical studies such as ALPINE, ASPEN, and SEQUOIA. These trials have demonstrated consistent clinical outcomes across various B-cell cancers. The availability of BRUKINSA in India comes at a time when blood cancers continue to impact a large number of individuals. Estimates suggest that someone is diagnosed with blood cancer every five minutes in India, with annual deaths from the disease numbering around 70,000. The treatment has shown high response rates and the ability to maintain disease control in patients with different types of B-cell malignancies. It also offers dosing flexibility, allowing for once or twice-daily administration. In the ALPINE study, BRUKINSA was compared with ibrutinib in relapsed or refractory CLL and showed a lower rate of serious cardiac events and fewer treatment discontinuations due to cardiac-related issues. With its recent regulatory approval, BRUKINSA will now be available to patients in India who are affected by challenging hematological cancers. Aman Shukla is a post-graduate in mass communication . A media enthusiast who has a strong hold on communication ,content writing and copy writing. Aman is currently working as journalist at
