Pharmaceutical – Swanson Reed | Specialist R&D Tax Advisors

Gaining Ground: Arbutus Biopharma and Genevant Sciences in Patent Battle with Moderna

In the ongoing saga of patent disputes surrounding COVID-19 vaccines, Arbutus Biopharma Corporation and Genevant Sciences have made strides in their legal battle against Moderna. With a recent court order clarifying key terms of the patents in question, the two companies are making strides in their quest to claim their share of the profits from Moderna’s Spikevax vaccine.

Arbutus and Genevant initially asserted their patents in 2022, alleging that Moderna utilized their groundbreaking lipid nanoparticle (LNP) delivery platform without proper compensation or licensing. Now, with a joint claim construction brief filed and a detailed court order dissecting the language and scientific intricacies of the patents, the plaintiffs are bolstering their case against Moderna.

Judge Mitchell S. Goldberg’s order largely favors Arbutus and Genevant, rejecting many of Moderna’s proposed constructions and strengthening the plaintiffs’ position. The companies seek compensation for their patented technology, which they argue played a crucial role in the success of Moderna’s COVID-19 vaccine.

While Moderna maintains that its Spikevax technology is the result of independent research and development, Arbutus and Genevant remain steadfast in their commitment to protecting their intellectual property. Interim CEO Michael J. McElhaugh expressed satisfaction with the court’s rulings and emphasized the importance of defending their patents.

The legal battle between the parties is expected to continue for at least two more years, with both sides gearing up for trial. Moderna faces similar lawsuits from other biopharmaceutical companies, underscoring the complexity of intellectual property disputes in the pharmaceutical industry.

Despite the financial success of Spikevax in previous years, sales have been impacted by waning demand and competition from newer boosters. Nevertheless, Arbutus and Genevant’s pursuit of fair compensation for their patented technology remains unwavering.

Are you developing new technology for an existing application? Did you know your development work could be eligible for the R&D Tax Credit and you can receive up to 14% back on your expenses? Even if your development isn’t successful your work may still qualify for R&D credits (i.e. you don’t need to have a patent to qualify). To find out more, please contact a Swanson Reed R&D Specialist today or check out our free online eligibility test.

Who We Are:

Swanson Reed is one of the U.S.’ largest Specialist R&D tax advisory firms. We manage all facets of the R&D tax credit program, from claim preparation and audit compliance to claim disputes.

Swanson Reed regularly hosts free webinars and provides free IRS CE and CPE credits for CPAs. For more information please visit us at www.swansonreed.com/webinars or contact your usual Swanson Reed representative.

Xevant: Pioneering Data Analytics for a More Efficient Pharmacy Benefit Landscape

Xevant, Inc, a company dedicated to revolutionizing the pharmacy benefit landscape, recently announced their commitment to accelerated growth with a significant follow-on investment. This financial backing underscores the growing recognition of their innovative data analytics platform designed to help pharmacy benefit organizations (PBMs) navigate the complexities of the healthcare system.

PBMs play a crucial role in managing prescription drug costs for various stakeholders, including employers, health plans, and individual consumers. However, navigating the intricate world of pharmacy benefits can be challenging due to complex data analysis and reporting requirements.

Xevant addresses this challenge by providing automated data analytics and reporting tools specifically tailored for PBMs. This innovative platform empowers PBMs with the ability to:

Gain deeper insights: Xevant’s technology analyzes vast amounts of data related to drug utilization, pricing, and trends, providing PBMs with a comprehensive understanding of their clients’ needs and opportunities for cost savings.
Make informed decisions: Armed with these insights, PBMs can make data-driven decisions regarding drug formularies, network contracting, and other vital aspects of their operations.
Improve efficiency: Xevant’s platform automates various tasks, streamlining workflows and freeing up valuable time for PBM teams to focus on strategic initiatives.

By leveraging Xevant’s cutting-edge technology, PBMs can not only reduce costs but also enhance the overall quality of care for their clients. This translates to improved health outcomes, increased affordability, and a more efficient healthcare system for everyone involved.

Xevant’s commitment to innovation extends beyond their initial product offering. They continuously invest in research and development to further enhance their platform and stay at the forefront of the ever-evolving healthcare landscape. This dedication to progress ensures that PBMs can rely on Xevant to provide them with the tools they need to navigate the complexities of the pharmaceutical industry and deliver optimal results for their clients.

Are you developing new technology for an existing application? Did you know your development work could be eligible for the R&D Tax Credit and you can receive up to 14% back on your expenses? Even if your development isn’t successful your work may still qualify for R&D credits (i.e. you don’t need to have a patent to qualify). To find out more, please contact a Swanson Reed R&D Specialist today or check out our free online eligibility test.

Who We Are:

Swanson Reed is one of the U.S.’ largest Specialist R&D tax advisory firms. We manage all facets of the R&D tax credit program, from claim preparation and audit compliance to claim disputes.

Swanson Reed regularly hosts free webinars and provides free IRS CE and CPE credits for CPAs. For more information please visit us at www.swansonreed.com/webinars or contact your usual Swanson Reed representative.

Pioneering Collaborative Research and Development for Healthcare Innovation

In an era where healthcare innovation is paramount, Nature’s Toolbox, Inc. (NTx) has landed another federally funded contract under a government vaccine production program. The contract will see the Rio Rancho-based life sciences startup collaborate with Houston Methodist Hospital and BARDA (Biomedical Advanced Research and Development Authority).

NTx, a prominent player in the field of biotechnology, has recently joined forces with Houston Methodist Hospital, one of the leading medical institutions in the nation, and BARDA, a division of the U.S. Department of Health and Human Services responsible for developing and procuring advanced medical solutions. Together, they are embarking on a journey of research and development that holds the promise of transformative breakthroughs.

At the heart of this partnership lies the pursuit of innovative medical solutions that can tackle some of the most pressing healthcare challenges of our time. As we confront global health crises and increasingly complex medical conditions, the need for cutting-edge therapies and treatments has never been more critical.

NTx, with its deep expertise in biotechnology, is well-positioned to contribute groundbreaking solutions to the collaboration. Their commitment to advancing medical science and improving patient outcomes aligns seamlessly with the missions of Houston Methodist Hospital and BARDA.

While the specific projects and research directions are yet to be disclosed, the collective aim of this partnership is clear: to harness the power of science and technology to enhance our capacity to respond to health emergencies, accelerate the development of life-saving treatments, and ensure a brighter and healthier future for all.

In an era where scientific collaboration is the cornerstone of progress, NTx, Houston Methodist Hospital, and BARDA are setting a shining example of how cooperation between experts in different fields can yield remarkable results. Their commitment to pushing the boundaries of what is possible in healthcare research and development offers a glimpse into the exciting possibilities that lie ahead.

As the partnership unfolds, it is bound to capture the attention of the healthcare community and the world at large. NTx’s dedication to pioneering research and development, coupled with the resources and expertise of Houston Methodist Hospital and BARDA, paints a promising picture of a future where medical innovation knows no bounds.

Are you developing new technology for an existing application? Did you know your development work could be eligible for the R&D Tax Credit and you can receive up to 14% back on your expenses? Even if your development isn’t successful your work may still qualify for R&D credits (i.e. you don’t need to have a patent to qualify). To find out more, please contact a Swanson Reed R&D Specialist today or check out our free online eligibility test.

Who We Are:

Swanson Reed is one of the U.S.’ largest Specialist R&D tax advisory firms. We manage all facets of the R&D tax credit program, from claim preparation and audit compliance to claim disputes.

Swanson Reed regularly hosts free webinars and provides free IRS CE and CPE credits for CPAs. For more information please visit us at www.swansonreed.com/webinars or contact your usual Swanson Reed representative.

Phlow Corp Secures $36M to Expand Domestic CDMO Operations

South Carolina-based medicine supply chain company, Phlow Corp, has secured $36 million in a Series B funding round. The funding will aid the company as they scale their contract manufacturing program. The funding’s primary focus will be on supporting the growth of cdmoX – the company’s manufacturing operations – to meet market demands for customized services.

The company refers to their U.S.-based,next generation contract development and manufacturing organization (CDMO) as cdmoX. This program provides R&D services for Advanced Pharmaceutical Ingredients (API) and Key Starting Materials with the intention of streamlining supply and reducing the exorbitant costs associated with typical development.

This mission addresses a growing pain point in the medical industry. Economic drivers moved the manufacturing of APIs abroad, while recent global events have made the global supply chain unstable. Phlow’s approach brings stability back by creating a resilient and domestic supply chain capable of manufacturing critical medicines and medical countermeasures. The boost in funding from this Series B round will aid in this mission, expanding the company’s reach and improving resilience.

Are you developing new technology for an existing application? Did you know your development work could be eligible for the R&D Tax Credit and you can receive up to 14% back on your expenses? Even if your development isn’t successful your work may still qualify for R&D credits (i.e. you don’t need to have a patent to qualify). To find out more, please contact a Swanson Reed R&D Specialist today or check out our free online eligibility test.

Who We Are:

Swanson Reed is one of the U.S.’ largest Specialist R&D tax advisory firms. We manage all facets of the R&D tax credit program, from claim preparation and audit compliance to claim disputes.

Swanson Reed regularly hosts free webinars and provides free IRS CE and CPE credits for CPAs. For more information please visit us at www.swansonreed.com/webinars or contact your usual Swanson Reed representative.

Plus Therapeutics Awarded $17.6 Million from State of Texas

Plus Therapeutics, Inc. has recently announced it has been awarded a $17.6 million Product Development Research grant by the Cancer Prevention and Research Institute of Texas (CPRIT). This grant will help fund the continued development of their lead investigational targeted radiotherapeutic, Rhenium-186 NanoLiposome (186RNL), for the treatment of patients with leptomeningeal metastases (LM).

This clinical-stage pharmaceutical company has focused their expertise on developing innovative, targeted radiotherapeutics for rare and difficult-to-treat cancers. LM is one of the most devastating and aggressive late-stage cancer complications. It’s this complication that characterizes the primary cancer spreading to the central nervous system. With promising results from Plus Therapeutics, the FDA has granted Fast Track designation to 186RNL for the treatment of LM.

“The Plus team is honored to receive this significant and esteemed award from CPRIT,” said Marc H. Hedrick M.D., President and Chief Executive Officer of Plus Therapeutics. “We expect that the non-dilutive funding from CPRIT will come on-line next month once the award agreement is finalized and this will significantly offset our longer-term, three-year capital requirements for the advancement of our LM program.”

Are you developing new technology for an existing application? Did you know your development work could be eligible for the R&D Tax Credit and you can receive up to 14% back on your expenses? Even if your development isn’t successful your work may still qualify for R&D credits (i.e. you don’t need to have a patent to qualify). To find out more, please contact a Swanson Reed R&D Specialist today or check out our free online eligibility test.

Who We Are:

Swanson Reed is one of the U.S.’ largest Specialist R&D tax advisory firms. We manage all facets of the R&D tax credit program, from claim preparation and audit compliance to claim disputes.

Swanson Reed regularly hosts free webinars and provides free IRS CE and CPE credits for CPAs. For more information please visit us at www.swansonreed.com/webinars or contact your usual Swanson Reed representative.

ARS Pharmaceuticals and Silverback Therapeutics Set to Merge into a Single Entity Focused on EpiPen Alternative

ARS Pharmaceuticals has announced a merger with Silverback Therapeutics. Going forward, the combined company will be called ARS Pharmaceuticals.

The newly combined company will focus their expertise on regulatory approval and commercialization of ARS’s epinephrine nasal spray for severe allergic reactions. The spray, called neffy, is a potential easy-to-use alternative to the EpiPen.

The combined company is expected to have $265 million in cash, cash equivalents and marketable securities upon closing, including $240 million in cash from Silverback. Silverback equity holders will own about 37% of the new company, and ARS’s 63%. The deal is expected to close in the fourth quarter of this year, pending stockholder approval.

Silverback made a name for themselves for their experimental solid tumor therapy following a public offering in late 2020. ARS, which raised $55 million in a Series D round of funding last spring, plans to submit its NDA (new drug application) for neffy to the U.S. Food and Drug Administration by the third quarter of this year. If the spray is approved, the company aims to launch the product in 2023.

The design of this EpiPen alternative would remove the need for needles, making administration less painful in a moment of panic. Less pain means less hesitation means less lives lost.

Are you developing new technology for an existing application? Did you know your development work could be eligible for the R&D Tax Credit and you can receive up to 14% back on your expenses? Even if your development isn’t successful your work may still qualify for R&D credits (i.e. you don’t need to have a patent to qualify). To find out more, please contact a Swanson Reed R&D Specialist today or check out our free online eligibility test.

Who We Are:

Swanson Reed is one of the U.S.’ largest Specialist R&D tax advisory firms. We manage all facets of the R&D tax credit program, from claim preparation and audit compliance to claim disputes.

Swanson Reed regularly hosts free webinars and provides free IRS CE and CPE credits for CPAs. For more information please visit us at www.swansonreed.com/webinars or contact your usual Swanson Reed representative.

Day Three Labs to Study Cannabis as a Treatment for Parkinson’s Disease

Day Three Labs (DTL), is a Colorado-based cannabinoid CPG ingredient manufacturer. With their expertise in the development of these novel cannabis products, the company has set out to evaluate cannabis as a treatment for Parkinson’s Disease.

This mission has come to light after the company announced the world’s first government-sponsored cannabis technology incubator will aid in funding this research.

While the headquarters are in Denver, the research facility is in Israel, where regulations make studying cannabis much easier than in the United States. They are the only company to have passed the first phase of the CanNegev program, a cannabis technology incubator that receives funding from the Israeli government.

With this first phase complete, the company will receive funding and move into phase two. This means initiating the research and data collection for presentation to the Israel Innovation Authority as soon as September.

Through the research program, Day Three Labs plans to study cannabis compounds delivered via its proprietary Unlokt technology as a treatment for Parkinson’s disease symptoms. The funding from CanNegev will enable the company to find the combination of cannabinoids that work best to treat Parkinson’s disease and allow the company to carry the research from the lab to product development.

Parkinson’s Disease affects more than 10 million worldwide. Cannabis has been an approved treatment option in Germany since 2017. However, with the ever growing list of marijuana and cannabis strains and product types, choosing a formulation that is most effective at providing consistent relief is a true challenge. DTL’s research will take advantage of the Unlokt technology which packs cannabis into a natural protein which bypasses the liver, shuttling cannabis directly into the body’s circulation. This allows the cannabinoids and terpenes to be released and absorbed into the bloodstream and should have a beneficial effect.

“Unlokt is a significant leap in technology that will disrupt traditional research and delivery of cannabinoid compounds and beyond,” said Josh Rubin, co-founder and CEO of Day Three Labs. “Utilizing a groundbreaking technology like Unlokt in the adult-use market is revolutionary and game-changing, and creates incredibly enjoyable products, but it only scratches the surface of what this technology is capable of. Our work with CanNegev is just the beginning of the technological advances we are bringing to this fast-growing industry with the hope of eradicating previously untreatable illnesses and conditions and bringing solutions to the cannabis industry that are safer, more efficacious and efficient.”

Are you developing new technology for an existing application? Did you know your development work could be eligible for the R&D Tax Credit and you can receive up to 14% back on your expenses? Even if your development isn’t successful your work may still qualify for R&D credits (i.e. you don’t need to have a patent to qualify). To find out more, please contact a Swanson Reed R&D Specialist today or check out our free online eligibility test.

Who We Are:

Swanson Reed is one of the U.S.’ largest Specialist R&D tax advisory firms. We manage all facets of the R&D tax credit program, from claim preparation and audit compliance to claim disputes.

Swanson Reed regularly hosts free webinars and provides free IRS CE and CPE credits for CPAs. For more information please visit us at www.swansonreed.com/webinars or contact your usual Swanson Reed representative.

UNH FInds Repurposed Drug Could Inhibit Enzyme used in COVID-19 Replication

Researchers at the University of New Hampshire have recently found that an existing drug compound could be successfully repurposed and used to block the activity of an enzyme of the coronavirus.

“The goal was to slow or prevent the spread of the virus by using a strategic therapeutic that could possibly disrupt key steps in the viral life cycle at the molecular level, like the first contact with a healthy cell or the first step in replicating within an infected cell,” said Harish Vashisth, associate professor of chemical engineering.

They published their first-of-its-kind study in the journal PROTEINS: Structure, Function, and Bioinformatics. The researchers targeted this key enzyme, the main protease enzyme Mpro, which has become a primary target of intense research and therapeutic development due to its role in the virus’s replication.

They explored the inhibiting properties of a derivative of the existing compound – Thiadiazolidinones (TDZD). TDZD is already being studied as a potential treatment of neurological disorders like Parkinson’ Disease. Using molecular dynamics simulations combined with laboratory experiments, the researchers determined that the TDZD compound was able to inhibit the Mpro enzyme. Preventing the enzyme for working could prevent the virus’s ability to develop defenses at the cellular level.

This research was supported by grants from the National Institutes of Health under award numbers R35GM138217, P20GM113131, and the National Science Foundation under award number OIA-1757371. The content is solely the responsibility of the authors and does not necessarily represent the official views of the funders.

Are you developing new technology for an existing application? Did you know your development work could be eligible for the R&D Tax Credit and you can receive up to 14% back on your expenses? Even if your development isn’t successful your work may still qualify for R&D credits (i.e. you don’t need to have a patent to qualify). To find out more, please contact a Swanson Reed R&D Specialist today or check out our free online eligibility test.

Who We Are:

Swanson Reed is one of the U.S.’ largest Specialist R&D tax advisory firms. We manage all facets of the R&D tax credit program, from claim preparation and audit compliance to claim disputes.

Swanson Reed regularly hosts free webinars and provides free IRS CE and CPE credits for CPAs. For more information please visit us at www.swansonreed.com/webinars or contact your usual Swanson Reed representative.

MindImmune Therapeutics Secures $12.4M in Series A Funding

Hawaii Patent of the Month - November 2021

MindImmune Therapeutics, Inc. is at the forefront of discovering mechanisms of neuroinflammation that may be targeted for breakthrough therapeutics for brain disease. With such ground-breaking research, it’s no surprise that the company has raised $12.4 million in Series A financing.

Their research is focused on the science around blocking aberrant immune system activity. This activity is an effector of nervous system disease, and blocking it may have positive impacts around the cause of symptoms and progression in many devastating neurodegenerative and neuropsychiatric disorders.

Collectively, the co-founders bring over a century of experience in drug discovery. The founders are experts in neuropharmacology, neuroscience, and pharmaceutical drug discovery and development.

MindImmune’s scientists are bridging knowledge of both the nervous and immune systems in an effort to discover previously unrecognized immune effector mechanisms underlying brain disease. To support this endeavor, the company has decided to actualize their knowledge in the form of a facile drug discovery engine. Their flagship program may herald a breakthrough therapeutic for Alzheimer’s disease.

Alzheimer’s disease is a chronic inflammatory condition wherein the immune system becomes inappropriately activated. Then the inflammatory response fails to resolve this activation. This inappropriate immune response usually manifests as innate immune first responder cells infiltrating into the brain, where these cells cause damage to synapses. This synaptic damage underlies both the cognitive symptoms and the relentless progression of Alzheimer’s disease.

MindImmune has identified the key innate immune cells that infiltrate the brain in these instances. Armed with this knowledge, the company began developing an antibody therapy to block this infiltration and ameliorate the synaptic attack.

Investors participating in the Series A funding round include Dolby Family Ventures, Pfizer Ventures, the Alzheimer’s Drug Discovery Foundation (ADDF), Trend Venture, RightHill Ventures (an affiliate of the Slater Technology Fund) and several private investors. The funding will go towards supporting the company’s lead program in preclinical development, targeting Alzheimer’s disease as the primary indication.

Are you developing new technology for an existing application? Did you know your development work could be eligible for the R&D Tax Credit and you can receive up to 14% back on your expenses? Even if your development isn’t successful your work may still qualify for R&D credits (i.e. you don’t need to have a patent to qualify). To find out more, please contact a Swanson Reed R&D Specialist today or check out our free online eligibility test.

Who We Are:

Swanson Reed is one of the U.S.’ largest Specialist R&D tax advisory firms. We manage all facets of the R&D tax credit program, from claim preparation and audit compliance to claim disputes.

Swanson Reed regularly hosts free webinars and provides free IRS CE and CPE credits for CPAs. For more information please visit us at www.swansonreed.com/webinars or contact your usual Swanson Reed representative.

PAI Life Sciences Begins Phase 1 Trial for Snail Fever Vaccine

PAI Life Sciences, a Seattle biotech startup, has started a phase 1 trial for their schistosomiasis vaccine. The trial has an expected end date of April 2024. This tropical disease, also called snail fever, is caused by parasitic flatworms that enter human skin when in contact with contaminated water. This infection, if untreated long term, can cause damage to livers and kidneys, infertility, and bladder cancer.

The phase 1 trial will evaluate both safety and immune response in healthy volunteers at Kaiser Permanente Washington Health Research Institute. The study will be conducted as an open-label, dose-escalation trial with a sample size of 45 healthy adults between 18 and 55 years of age. Five treatment groups, each including nine subjects, will receive three intramuscular injections at different doses. One group will receive the vaccine without an adjuvant (which acts to increase immune responses) and four will receive the vaccine with an adjuvant.

Currently, there are drug therapy approaches for treatment of the infection but dependence on these treatment options alone is inadequate. This treatment option has minimal impact on the reduction of disease transmission and, as such, infection rates continue to be high. Beyond this, there is an ever-present risk of the development of drug resistance by the parasite.

If proven effective and safe through clinical trials, this vaccine would build up the arsenal against the disease and contribute to the reduction in infection rates. At present, the vaccine has shown to ameliorate disease, kill adult worms, and reduce fecundity in preclinical animal models. The company is hoping to prove this again in full clinical studies.

The condition “is second only to malaria among parasitic diseases with the greatest devastating economic impact,” said PAI’s vice president Sean Gray.

PAI Life Sciences have focused their expertise on antigens for diagnostics and vaccines. They provide developmental and translational research necessary to bring products from the laboratory to the bedside.

Are you developing new technology for an existing application? Did you know your development work could be eligible for the R&D Tax Credit and you can receive up to 14% back on your expenses? Even if your development isn’t successful your work may still qualify for R&D credits (i.e. you don’t need to have a patent to qualify). To find out more, please contact a Swanson Reed R&D Specialist today or check out our free online eligibility test.

Who We Are:

Swanson Reed is one of the U.S.’ largest Specialist R&D tax advisory firms. We manage all facets of the R&D tax credit program, from claim preparation and audit compliance to claim disputes.

Swanson Reed regularly hosts free webinars and provides free IRS CE and CPE credits for CPAs. For more information please visit us at www.swansonreed.com/webinars or contact your usual Swanson Reed representative.