Purnovate Collaborates with Medical College of Wisconsin

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Purnovate, Inc. – a subsidiary of Adial Pharmaceuticals, Inc. – has announced their collaboration with the Medical College of Wisconsin, a leading medical school, and Dr. John Auchampach, PhD, Professor and Vice Chair of the Department of Pharmacology and Toxicology. The collaboration aims to further evaluate the Company’s proprietary adenosine analogs as potential treatments for diabetes and non-alcoholic steatohepatitis (NASH).

The company is focused on developing novel molecules to target the adenosine receptors for the treatment of major unmet medical needs. Under the new agreement, Dr. Auchampach and his team will test Purnovate’s adenosine compounds in preclinical models. 

Dr. Julien Dimastromatteo, Purnovate’s Vice President, Research, commented, “We are honored to partner with the Medical College of Wisconsin and Dr. Auchampach, a leading researcher in the field of adenosine, purinergic pharmacology and G-Protein-Coupled receptors. Adenosine analogs have been studied extensively by Dr. Auchampach and others, demonstrating tremendous promise in animal models. However poor biodistribution of historical compounds, likely due to poor solubility, has limited their usefulness as human therapies. Our Purnovate adenosine analog compounds were specifically designed to overcome these solubility and biodistribution challenges, with strong supporting data thus far. As a result, we are encouraged by the therapeutic potential of these compounds and will work to rapidly identify a lead compound to bring forward as a drug candidate.”

The adenosine compounds are meant to provide a safe, oral therapy option to reduce overall body mass and liver fat content while restoring healthier glucose levels. The company believes their compounds could hold significant potential as an alternative therapy for diabetics, pre-diabetics, and overweight individuals.

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.

Tonix Pharmaceuticals Moves TNX-1900 into Phase 2 Studies After FDA Clearance

Sartorius AG to Open Center of Excellence in Michigan

Tonix Pharmaceuticals Holding Corp. has announced the successful FDA clearance of their investigational new drug (IND) for Potentiated Intranasal Oxytocin (TNX-1900). The treatment can be used to prevent migraine headaches for those chronically afflicted.

Tonix is a clinical-stage biopharmaceutical company based in New Jersey who has spent their time repurposing drugs for central nervous system conditions. 

The FDA clearance will allow TNX-1900 to be pushed into a Phase 2 study. The study is expected to qualify for the 505(b)(2) pathway for full FDA approval – a pathway available only to new formulations of an approved drug.

Migraines are a symptom of a neurological condition which manifests in throbbing headaches, light auras, and aversions to lights, smells, and noises. Tonix believes that by engaging and stimulating oxytocin receptors in the trigeminal ganglia, TNX-1900 could prevent migraines. The drug contains magnesium which potentiates the action of oxytocin at oxytocin receptors in animal models. 

Oxytocin is a naturally occurring human hormone with no recognized addiction potential. It has been observed that lowered oxytocin levels in the body can lead to increased migraine headache frequency. Some other chronic pain conditions are also associated with low oxytocin levels.

Tonix has further plans to develop TNX-1900 for craniofacial pain and insulin resistance.

Are you developing new pharmaceuticals 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.

REGENXBIO to Announce Interim Clinical Trial Results

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Maryland-based REGENXBIO is a leading clinical-stage biotechnology company seeking to improve lives through the curative potential of gene therapy. Biotech, as an industry, is expensive and requires lots of capital to support any development and innovation. Earlier this month, REGENXBIO announced a partnership with AbbVie. Now, we can expect a presentation of some of their data from their RGX-314 clinical trials. The partnership with AbbVie allowed REGENXBIO to unlock the full value of its organic pipeline.

They will present their data at the Retina Society 54th Annual Scientific Meeting in Illinois. Their product, RGX-314, is a potential best-in-class, one-time gene therapy for the treatment of wet AMD. The presentation will show interim results at six months of follow up for patients in Cohort 1 (dose level: 2.5×1011 genome copies per eye)

RGX-314 is being investigated as a potential one-time treatment for wet AMD, diabetic retinopathy, and other chronic retinal conditions. RGX-314 consists of the NAV AAV8 vector, which encodes an antibody fragment designed to inhibit vascular endothelial growth factor (VEGF). RGX-314 is believed to inhibit the VEGF pathway by which new, leaky blood vessels grow and contribute to the accumulation of fluid in the retina.

REGENXBIO is advancing research in two separate routes of administration of RGX-314 to the eye, through a standardized subretinal delivery procedure as well as delivery to the suprachoroidal space. REGENXBIO has licensed certain exclusive rights to the SCS Microinjector® from Clearside Biomedical, Inc. to deliver gene therapy treatments to the suprachoroidal space of the eye.

Are you developing new software 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.

Inotiv, Inc. to Evaluate BioVaxys’ CoviDTH

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BioVaxys Technology Corp. has announced their plans to work with Inotiv, Inc. This comes with BioVaxys Technologies plans to start their in vivo animal toxicology study of CoviDTH in parallel with the preparation of an IND submission. This plan came with a contract announced back in march to have Inotiv, a global contract research organization, evaluate the safety, tolerability, and toxicity of the purified recombinant SARS-CoV-2 s-protein. This protein is a principal constituent of BioVaxys’ CoviDTH- an experimental diagnostic for COVID-19.

The Inotiv study will utilize a purified recombinant s-protein produced by WuXi Biologics, who is BioVaxys’ bioproduction partner. Indiana-based Inotive provides contract research services to start up and emerging pharmaceutical companies, drug development companies, and medical research organizations.

CoviDTH is a low cost, disposable, diagnostic approach to identify a T-cell immune response to the presence of SARS-CoV-2. They had recently published clinical studies which validated the use of the delayed type hypersensitivity (DTH) cutaneous test behind CoviDTH as a feasible and safe in vivo method to assess cellular immune responses in both natural and vaccinated SARS-CoV-2 exposed individuals. They also validated that the DTH response is highly durable, persisting for at least one year after either COVID-19 exposure or vaccine administration.

BioVaxys President and Chief Operating Officer Ken Kovan stated, “Based on the millions of people who have received COVID-19 vaccines that are based on in vivo cellular expression of SARS-CoV-2 s-spike protein, as well as the human DTH studies, we are confident that the toxicology study with Inotiv of the s-protein will likewise confirm the safety profile of CoviDTH.”

Are you developing new software 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.

SAB Biotherapeutics COVID-19 Candidate to Advance to Phase 3 Trials

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SAB Biotherapeutics (SAB) is focused on revolutionizing immunotherapies. They operate as a clinical-stage biopharmaceutical company, utilizing their proprietary immunotherapy platform to produce specifically targeted, high-potency, fully-human polyclonal antibodies. Part of the revolutionary aspect of this technology is that it does not require human donors at all. Recently, SAB received positive news from an independent Data Safety Monitoring Board (DSMB) regarding the safety and efficacy of SAB-185 – their current therapeutic candidate for patients with moderate COVID-19.

SAB-185 has been subjected to a prespecified interim analysis data review, evaluating the safety and efficacy in the Phase 2 portion of the ACTIV-2 trial. The DSMB has given full approval and recommended advancement to Phase 3, a major milestone for their platform.

SAB-185 is a fully-human, specifically-targeted, broadly-neutralizing polyclonal antibody therapeutic candidate for the treatment of non-hospitalized patients with moderate COVID-19. After meeting the predefined graduation criteria, this candidate will move to Phase 3 trials, showing it has true potential to become a valuable therapy. Following Phase 3, if successful, SAB will work on scaling up production to make their therapy as widely available as needed. 

The Phase 3 portion of the ACTIV-2 trial is a randomized, unblinded, active comparator-controlled adaptive platform study that will assess the clinical safety and efficacy of SAB-185 compared to active control monoclonal antibody treatment in people with mild to moderate COVID-19 who are at higher risk for progression to hospitalization, enrolling approximately 600 participants to receive the investigational agent SAB-185 and 600 to receive an active comparator. The primary outcome measures of the Phase 3 trial will include safety and non-inferiority for the prevention of a composite endpoint of either hospitalization or death from any cause through study day 28.

Are you developing new pharmaceuticals? 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.

Nicox SA Announces Phase 2b Results

Wyoming Patent of the Month - August 2021

Nicox SA has recently released the results from their Mississippi Phase 2b clinical trials. This international ophthalmology company has dedicated themselves to the development of treatments to help maintain vision and improve ocular health. 

One of their products in development is the once-daily dosed NCX 4251 – a fluticasone propionate ophthalmic suspension 0.1%. This product was trialed against placebos in patients with acute exacerbations of blepharitis. 

Blepharitis is a condition leading to red, swollen, itchy eyelids which can lead to more serious conditions including conjunctivitis.

The primary measure of this Phase 2b trial looked at the proportion of patients achieving complete cure in all three hallmark signs and symptoms of blepharitis, eyelid redness, debris, and discomfort by day 15. Two separate secondary outcome measures were identified as signs and symptoms of dry eye. 

The Results

The trial did not meet either primary or secondary efficacy endpoints. However, a signal of NCX 4251’s potential efficacy was seen in the trial. NCX 4251 at 0.1% showed a numerical improvement over a placebo outcome for the primary measure. It also showed a statistically significant difference against placebo surrounding the change from baseline in certain symptoms. They intend to further their data analysis to decide which key signs and symptoms should be the focus for future development.

It was also found safe and well tolerated over the 14 day treatment period, with no adverse or serious side events. 

Are you developing new software 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.

MycroDose Therapeutics and HAVN Life Sciences Partner Up in Psychedelic Research

Kansas Patent of the Month - August 2021

MycroDose Therapeutics has announced their plans to partner with HAVN Life Sciences, a  Vancouver based biotechnology company. Each of these companies are focused on research and development of psychedelic compounds. HAVN Life Sciences is specifically focused on the standardized extraction of psychedelic compounds for the creation of APIs. 

MycroDose Therapeutics is one of the few private companies to be granted a Schedule 1 License to research four psychedelic compounds by the DEA.

  1. Psilocybin
  2. MDMA
  3. DMT
  4. LSD

This partnership will be apparent as HAVN Life Sciences will export their naturally derived psilocybin to MycroDose Therapeutics, where it will be used in the development of advanced drug delivery (ADD) systems. These ADD systems will aim to treat mental health and cognitive degenerative diseases.

This is the beginning of the formation of an important supply chain to support the growing field of psychedelic research. This supply chain will be important to beginning the legal and licensed distribution of naturally derived GMP psilocybin throughout the United States. Distribution will include pharmaceutical companies, research institutions, and nonprofits, effectively increasing the body of research and access to naturally derived products in the field.

Are you developing new pharmaceuticals 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.

Scientists Find Potential Non Hormonal Treatment for Endometriosis

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Researchers at the University of Wisconsin, Baylor College of Medicine, Bayer AG, and the University of Oxford have discovered an alternative therapeutic option for the treatment of painful endometriosis without using surgery or hormones. Following a genetic study, these scientists have found a promising new non-hormonal target they intend to further investigate. It seems this target may allow treatment to address the inflammatory and pain components of the disease.

They designed and conducted genetic analyses on humans and rhesus macaques – two species which have spontaneously developed endometriosis – and uncovered the gene NPSR1 (neuropeptide S receptor 1) associated with the disease.

The endometrium is the inner lining of the uterine wall that builds up and sheds periodically during the reproductive lifespan in women. In women suffering from endometriosis, endometrium-like tissue grows outside the uterus leading to inflammation, intense abdominal pain usually associated with menstrual periods, and infertility.

Although the molecular causes of endometriosis are not known, heritability is estimated at about 50% indicating a strong genetic component. Current treatment options are hormone therapy and surgery with a dire need for non-hormonal therapeutics.

The scientists have worked towards therapeutic efficacy by inhibiting NPSR1 in mouse models. Inhibition was achieved using the small molecular inhibitor SHA 68R, and saw a successful reduction of abnormal infiltration of the endometrial tissue outside the uterus. If corroborated in nonhuman primate and human trials, this may lead to a non hormonal drug for endometriosis.

Are you developing new software 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.

Seqirus to Begin Dedicated sa-mRNA Program

Kansas Patent of the Month - August 2021

Seqirus is one of the world’s largest influenza vaccine companies, working to develop new vaccines every single year. Recently, this New Jersey-based company has announced plans to expand and accelerate their capabilities to develop next-gen self amplifying mRNA (sa-mRNA) vaccines. To achieve this goal, they will create a dedicated sa-mRNA program.

Last year the FDA green lit Audenz for the protection against influenza A (H5N1) in the event of a pandemic and won approval for Fluad Quadrivalent just three weeks later. This is the first and only quadrivalent adjuvanted flu vaccine to help protect adults over 65 years of age. Shortly after, their Flucelvax Quadrivalent was approved for a broader set of patients (ages two and up). 

mRNA has been a notably well researched topic, but its implication and authorization of use in vaccines came with research done to fight COVID-19. mRNA based vaccines work by providing instructions to cells to make a protein that stimulates the immune response to fight future infections. Seqirus’ sa-mRNA tech also teaches the body to replicate mRNA, taking it a step further and amplifying the amount of protein made. This development suggests that the future of vaccines may be smaller doses, less negative reaction, and higher efficacy. 

Seqirus is already developing multiple sa-mRNA-based influenza vaccine candidates with promising preclinical results but are hoping their dedicated sa-mRNA program will speed this along. If all goes well, they may even have clinical trials beginning for both seasonal and pandemic influenza vaccine candidates in the second half of 2022.

Are you developing new software 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.

Coeptis Therapeutics, Inc. Acquires CD38 Tech from VyGen-Bio

Minnesota Patent of the Month - June 2021

Coeptis Therapeutics, Inc. is a pharmaceutical company focused on developing innovative technologies to break past traditional therapeutic paradigms. Recently, they have announced to exercise their option to acquire ownership in two technology assets that target CD38 cancers. These technologies come from VyGen-Bio, Inc. – a subsidiary of Vycellix, Inc. 

The first technology – a CD38-GEAR-NK – is a cell therapy product in development to protect CD38-NK (natural killer) cells from destruction. The second is CD38-Diagnostic, an in vitro diagnostic tool to help identify cancer patients who may be appropriate candidates for the anti-CD38 mAB therapy. 

This move follows Coeptis’ entry into two separate exclusive option agreements with VyGen-Bio, Inc. This co-development will help in their treatment of cancers associated with CD38 with the first indication expected to be multiple myeloma. 

Are you developing new software 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.