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Ha same! In 1 of my 3 trade accounts
2 more cents, I'll be even....lol
Better movement....let's get a buck
Better day even with the market down
Yeah been that way for so long now not fazed.
They are more active than ever before.
Soon.
Maybe soon...
GLTA
Catalysts getting closer here.
Clinical testing of HyBryte™ has yielded consistently positive results. It works by applying fluorescent light to topical synthetic hypericin, and in a Phase 3 study it showed a rapid treatment response in six weeks and sustained responses after twelve and eighteen weeks that produced significant improvement for half of the trial participants. Soligenix anticipates submitting a new drug application (NDA) to the FDA for HyBryte™ to treat CTCL in H2 2022.
The trials have been so effective that Soligenix is now exploring a second disease indication, with synthetic hypericin (SGX302), for the treatment of psoriasis. A Phase 1/2 pilot study was previously conducted to demonstrate proof of concept and a Phase 2a clinical trial is being initiated later this year. According to Fortune Business Insights, the global psoriasis treatment market is projected to reach nearly $40.6 billion in the next five years.
Market way up today....and this continues to get beat down day after day.
SNGX float so low only 43m can definitely blow UP short squeeze!
Been heavily manipulated past 12-18 Months with extremely low volume so it’s about time !
GLTA
Might see a bit of a short squeeze. Possibly.
Watching the LII's. The chart doesn't suggest a short squeeze imo, but it was looking like some short covering. Get this puppy back over the $$!!
Like to see this party get started!! EXCELLENT!!
SNGX +25% pre-market 6/28 with:
Soligenix Receives FDA IND Clearance for Phase 2 Clinical Trial of Synthetic Hypericin in the Treatment of Psoriasis
Mentioned: SNGX
Enrollment on Track to Begin in 4th Quarter of 2022
Soligenix, Inc. (Nasdaq: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today that the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application for a Phase 2a clinical trial titled, "Phase 2 Study Evaluating SGX302 in the Treatment of Mild-to-Moderate Psoriasis." The study is designed to evaluate the safety and efficacy of topically-applied SGX302 (synthetic hypericin) and is expected to begin patient enrollment in the fourth quarter of 2022.
"We are pleased to have received FDA clearance on our SGX302 Phase 2a clinical trial in mild-to-moderate psoriasis," stated Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix. "During the last year, we have made announcements of important development milestones that we have achieved with HyBryte(TM) (synthetic hypericin) in the treatment of early stage cutaneous T-cell lymphoma (CTCL). We have clearly validated synthetic hypericin's biologic activity with the Phase 3 FLASH study in this orphan disease, where we expect to file a New Drug Application (NDA) in the second half of 2022. We are excited to expand synthetic hypericin's development into different cutaneous T-cell diseases such as psoriasis, as a component of our long-term strategy to enhance the value of this unique compound. Psoriasis is an ongoing unmet medical need, with as many as 7.5 million people in the U.S. and 60-125 million people worldwide affected by this incurable disease. Given our promising results with hypericin to date, including a small Phase 1/2 proof of concept clinical trial in mild-to-moderate psoriasis, we are hopeful synthetic hypericin will have a role to play in helping patients suffering from this difficult to treat and chronic disease."
Under this IND, the Phase 2a clinical trial of SGX302 will be a randomized, double-blind, placebo-controlled study that will enroll up to 32 patients age 18 years or older with mild to moderate, stable psoriasis covering 2 to 30% of their body. Patients will receive placebo or SGX302 (randomized 1:1) as a twice weekly treatment for up to 18 weeks. Each treatment will consist of the application of SGX302 followed approximately 24 hours later with visible light activation. Efficacy endpoints will include the extent of lesion clearance and patient reported quality of life indices.
About Synthetic Hypericin
Visible light-activated synthetic hypericin is a novel, first-in-class, photodynamic therapy (PDT) that is expected to avoid much of the long-term risks associated with other PDT treatments. Synthetic hypericin is a potent photosensitizer that is topically applied to skin lesions and taken up by cutaneous T-cells. With subsequent activation by safe, visible light, T-cell apoptosis is induced, addressing the root cause of psoriasis lesions. Other PDTs have shown efficacy in psoriasis with a similar apoptotic mechanism, albeit using ultraviolet (UV) light associated with more severe potential long-term safety concerns. The use of visible light in the red-yellow spectrum has the advantage of deeper penetration into the skin (much more than UV light) potentially treating deeper skin disease and thicker plaques and lesions, similar to what was observed in the positive Phase 3 FLASH (Fluorescent Light Activated Synthetic Hypericin) study in CTCL. Synthetic hypericin or HyBryte(TM) (tradename used in CTCL) was demonstrated in this study to be equally effective in treating both plaque (42% treatment response rate after 12 weeks treatment, p<0.0001 relative to placebo treatment) and patch (37%, p=0.0009) lesions in this orphan disease caused by malignant T-cells. In a published Phase 1/2 proof of concept clinical study using synthetic hypericin, efficacy was demonstrated in patients with CTCL (58.3% response, p=0.04) as well as psoriasis (80% response, p<0.02).
This treatment approach avoids the risk of secondary malignancies (including melanoma) inherent with both the frequently used DNA-damaging drugs and other phototherapies that are dependent on UV A or B exposure. The use of synthetic hypericin coupled with safe, visible light also avoids the risk of serious infections and cancer associated with the systemic immunosuppressive treatments used in psoriasis.
The Phase 3 FLASH trial enrolled a total of 169 patients (166 evaluable) with Stage IA, IB or IIA CTCL. The trial consisted of three treatment cycles. Treatments were administered twice weekly in 6-week cycles. In the first double-blind treatment cycle, 116 patients received HyBryte(TM) treatment and 50 received placebo treatment of their index lesions. A total of 16% of the patients receiving HyBryte(TM) achieved at least a 50% reduction in their lesions (using the standard Composite Assessment of Index Lesions Severity [CAILS] score) compared to only 4% of patients in the placebo group after just 6 weeks of treatment (p=0.04). Further treatment with HyBryte(TM) increased the number of treatment successes to 40% and 49% after 12 and 18 weeks, respectively (p<0.0001 for both). Additional analyses also indicated that HyBryte(TM) is equally effective in treating both plaque (42% treatment response rate after 12 weeks treatment, p<0.0001 relative to placebo treatment in Cycle 1) and patch (37%, p=0.0009) lesions of CTCL, a particularly relevant finding given the historical difficulty in treating plaque lesions. This is also relevant to psoriasis where the lesions can be thicker than the patches observed in CTCL.
In a subset of patients evaluated during their third treatment cycle, it was demonstrated that HyBryte(TM) is not systemically available, consistent with the general safety of this topical product observed to date. At the end of Cycle 3, HyBryte(TM) continued to be well tolerated despite extended and increased use of the product to treat multiple lesions.
GLTA!
It's ALIVE! Soligenix Announces Successful Protection using a Bivalent Thermostabilized Filovirus Vaccine
Thu, June 23, 2022, 7:30 AM
Bivalent vaccine provides 100% protection in non-human primates against both Sudan ebolavirus and Marburg marburgvirus
Only subunit (protein) vaccine platform shown to protect against potentially lethal Ebola and Marburg viruses
https://finance.yahoo.com/news/soligenix-announces-successful-protection-using-113000288.html
Bite your tongue.....Let's hope not
This stock seems destined for another reverse stock split.
How does a company not have their filings on their website? Is this even legal?
What are they hiding?
SNGX it's time... Money out of Big market flows to us...
GLTA
$SNGX Pharmaceutical and Biotech Industry Veteran Brings Significant Strategic Development and Commercialization Expertise Launching New Cellular Therapies
https://finance.yahoo.com/news/celularity-appoints-industry-leader-diane-120000446.html
I've looked on the company's website. This may be the first company I've ever seen where I'm not seeing the financials for the company listed on their website. Maybe it's hidden in there somewhere and I'm not seeing it.
The only products I can see even being listed as close have orphan designation....
Soligenix Receives US Patent Allowance For Its Thermostabilized Vaccine Platform
May 23, 2022 (Benzinga)
Soligenix, Inc. (NASDAQ:SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today that the United States Patent and Trademark Office (USPTO) has issued a Notice of Allowance for the patent application titled "Compositions and Methods of Manufacturing Trivalent Filovirus Vaccines." The allowed claims are directed to unique, proprietary compositions and methods directed to combinations of glycoprotein antigens with nanoemulsion adjuvants comprising sucrose fatty acid esters prior to lyophilization. The described vaccine platform has previously been successfully applied to filovirus vaccines (as mono-, bi- and tri-valent candidates for Zaire ebolavirus, Sudan ebolavirus and Marburg marburgvirus) as well as a SARS-CoV-2 vaccine.
The recent news from SNGX on the very positive development progress of HyBryte™ for early-stage cutaneous T-cell lymphoma is quite impressive, especially the latest clinical trial results. This product line holds high promise for the growth of the company's position in major biopharma field.
https://finance.yahoo.com/news/soligenix-moves-forward-treatments-cutaneous-123000857.html
From the news:
At the forefront of the company's pipeline is HyBryte™, a treatment for early-stage cutaneous T-cell lymphoma (CTCL), a condition that affects over 25,000 patients in the United States. The condition, which is also prevalent in Europe and Asia, is caused by the migration of malignant T-cells to the surface of the skin and manifests itself in painful lesions, tumors and plaques.
Clinical testing of HyBryte™ has yielded consistently positive results. It works by applying fluorescent light to topical synthetic hypericin, and in a Phase 3 study it showed a rapid treatment response in six weeks and sustained responses after twelve and eighteen weeks that produced significant improvement for half of the trial participants. Soligenix anticipates submitting a new drug application (NDA) to the FDA for HyBryte™ to treat CTCL in H2 2022.
The trials have been so effective that Soligenix is now exploring a second disease indication, with synthetic hypericin (SGX302), for the treatment of psoriasis. A Phase 1/2 pilot study was previously conducted to demonstrate proof of concept and a Phase 2a clinical trial is being initiated later this year. According to Fortune Business Insights, the global psoriasis treatment market is projected to reach nearly $40.6 billion in the next five years.
At the forefront of the company's pipeline is HyBryte™, a treatment for early-stage cutaneous T-cell lymphoma (CTCL), a condition that affects over 25,000 patients in the United States. The condition, which is also prevalent in Europe and Asia, is caused by the migration of malignant T-cells to the surface of the skin and manifests itself in painful lesions, tumors and plaques.
SNGX
SNGX has had MORE than enough time to prove their value. I actually bought some of this stock not due to anyone around here, but due to what I read from real analysts. They obviously were also duped.
Small biotech stocks are the easiest to run as scams. Always waiting for approval of something or other.
Go look at the long term chart on this stock and defend the share price.
SNGX pipeline will prove to be the one that should’ve been owned
Seriously though, what does it truly take for some of you to realize they own a worthless stock?....or at least one that should be?
Is this one of those situations where some of you are stuck with this stock and hope to convince others to take it off your hands for you?
$SNGX The U.S. home medical equipment market, which helps patients adhere to treatment and stay on track with their health,is expected to exceed $20.4 billion by 2027. https://finance.yahoo.com/news/soligenix-moves-forward-treatments-cutaneous-123000857.html
SNGX soon to run UP with a pipeline like this & hitting a market over $20b!
"The U.S. home medical equipment market, which helps patients adhere to treatment and stay on track with their health,is expected to exceed $20.4 billion by 2027".
Soligenix 6/7/2022: Moves Forward with Treatments for Cutaneous T-Cell Lymphoma and Psoriasis
https://finance.yahoo.com/news/soligenix-moves-forward-treatments-cutaneous-123000857.html
GLTA
Very commendable news from SNGX today on the company's important programs to develop key treatments for underserved medical issues including certain cancers and skin conditions as we see described. It is also excellent to see that the trials for these treatments are meeting with high success.
Soligenix Moves Forward with Treatments for Cutaneous T-Cell Lymphoma and Psoriasis
New York, New York--(Newsfile Corp. - June 7, 2022) - PCG Digital -- Rising to the challenge in 2022, late-stage biopharma company Soligenix (NASDAQ: SNGX) continues to move forward with developing and commercializing products to treat rare diseases where there is an unmet medical need.
At the forefront of the company's pipeline is HyBryteT, a treatment for early-stage cutaneous T-cell lymphoma (CTCL), a condition that affects over 25,000 patients in the United States. The condition, which is also prevalent in Europe and Asia, is caused by the migration of malignant T-cells to the surface of the skin and manifests itself in painful lesions, tumors and plaques.
Clinical testing of HyBryteT has yielded consistently positive results. It works by applying fluorescent light to topical synthetic hypericin, and in a Phase 3 study it showed a rapid treatment response in six weeks and sustained responses after twelve and eighteen weeks that produced significant improvement for half of the trial participants. Soligenix anticipates submitting a new drug application (NDA) to the FDA for HyBryteT to treat CTCL in H2 2022.
The trials have been so effective that Soligenix is now exploring a second disease indication, with synthetic hypericin (SGX302), for the treatment of psoriasis. A Phase 1/2 pilot study was previously conducted to demonstrate proof of concept and a Phase 2a clinical trial is being initiated later this year. According to Fortune Business Insights, the global psoriasis treatment market is projected to reach nearly $40.6 billion in the next five years.
Reaching beyond the clinic
Physicians have expressed interest in recommending HyBryte to their patients following regulatory approval, but what about its applicability beyond the clinic? Soligenix has plans to develop HyBryte for home use within 12-18 months of receiving FDA approval, and is looking at expanding its use for other potential disease indications, such as psoriasis.
In arecent interviewwith the Cutaneous Lymphoma Foundation, CEO Susan Thornton explained the significance of the access a home device could provide for CTCL patients: "We know that we have people everywhere geographically, so access is really important and having a company dedicated to making sure patients have access is really, really critical as well."
TheU.S. home medical equipment market, which helps patients adhere to treatment and stay on track with their health,is expected to exceed $20.4 billion by 2027.
Soligenix continues to add value
With a cash runway of about $23 million, not including non-dilutive government funding, Soligenix is well funded to cross the finish line. To date, Soligenix has received $7.6 million in non-operating loss funding and continues to actively pursue non-dilutive funding to offset operating expenses and add value for shareholders. In addition, its management team continues to purchase shares of the company's common stock on the open market, representing a significant alignment of interests.
Zack's research recently issued an update outlining the Company's value proposition and valuated the stock at $4.00 per share.
Disclaimer
This communication was produced by PCG Digital Holdings, LLC, an affiliate of PCG Advisory Inc., (together "PCG"). PCG is not a registered or licensed broker-dealer nor investment adviser. No information contained in this communication constitutes an offer to sell, a solicitation of an offer to buy, or a recommendation of any security. PCG may be compensated by respective clients for publicizing information relating to its client's securities. See www.pcgadvisory.com/disclosures.
PCG Digital
info@pcgadvisory.com
646-863-6341
To view the source version of this press release, please visit https://www.newsfilecorp.com/release/126632
$SNGX News Out! Soligenix Moves Forward with Treatments for Cutaneous T-Cell Lymphoma and Psoriasis https://finance.yahoo.com/news/soligenix-moves-forward-treatments-cutaneous-123000857.html?soc_src=social-sh&soc_trk=tw&tsrc=twtr via @YahooFinance
Ms. Parks, commented, “I am very excited to join Celularity’s Board of Directors and to help guide one of the most promising and innovative approaches to cellular therapeutics. I look forward to bringing my commercial experience and passion to Celularity, and to partnering with its incredibly talented management team to deliver potentially life-changing therapies to patients in need.”
SNGX
Green in power hour Jedi!
SNGX
$SNGX Soligenix, Inc. (Nasdaq: SNGX) Board Member Diane Parks Appointed to Celularity (Nasdaq: CELU) Board of Directors https://finance.yahoo.com/news/celularity-appoints-industry-leader-diane-120000446.html
$SNGX NEWS! Key Binding Characteristics of Dusquetide to Important Intracellular Protein Identified
Wed, June 1, 2022, 7:30 AM
Paper published in the Journal Structure
PRINCETON, N.J., June 1, 2022 /PRNewswire/ -- Soligenix, Inc. (Nasdaq: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today a publication describing the binding of its Innate Defense Regulator (IDR), dusquetide, to the p62 protein. Dusquetide has demonstrated anti-infective, anti-tumor and anti-inflammatory actions in multiple animal models by modulating the body's own innate immune system. Dusquetide previously demonstrated significant benefits in reducing the duration of severe oral mucositis (SOM) in a Phase 2 clinical trial and reduction in SOM rates in the per protocol population in a Phase 3 study. In addition to the reduction of SOM, an acceleration in the clearance of tumor response and an increase in overall survival were also observed in the Phase 2 clinical study as an ancillary benefit to treating oral mucositis in patients receiving chemo-radiation for their head and neck cancer (HNC). This was corroborated by more recent findings confirming dusquetide's anti-tumor activity in xenograft models of breast cancer.
Based on the biological proof of principle shown both nonclinically and clinically with dusquetide, a novel synthetic peptide that modulates the body's innate immune system, Soligenix continues to explore product opportunities, both in the reduction of oral mucositis in HNC and as a potential anti-cancer treatment. Dusquetide binds to p62 or SQSTM-1, a scaffold protein implicated in a number of intracellular signaling networks implicated in tumor cell survival, including autophagy. This recent publication elaborates on the direct interaction of dusquetide with p62, as well as some of the direct downstream consequences of that interaction, consistent with its observed anti-infective, anti-tumor and anti-inflammatory activities. This information advances the understanding of dusquetide's novel mechanism of action and supports the development of analogs related to dusquetide.
"Soligenix continues to pursue potential product opportunities with our new chemical entity dusquetide," stated Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix. "With the supportive data from the Phase 2 and 3 oral mucositis trials, and the nonclinical anti-tumor efficacy demonstrated, we will continue to pursue potential partnership opportunities for this novel molecule and its potential analogs."
About Dusquetide
Dusquetide (the active ingredient in SGX942) is an innate defense regulator (IDR), a new class of short, synthetic peptides. It has a novel mechanism of action whereby it modulates the body's reaction to both injury and infection towards an anti-inflammatory, anti-infective and tissue healing response. IDRs have no direct antibiotic activity but, by modulating the host's innate immune system responses, increase survival after infections caused by a broad range of bacterial Gram-negative and Gram-positive pathogens. It also accelerates resolution of tissue damage following exposure to a variety of agents including bacterial pathogens, trauma and chemo- and/or radiation therapy. Preclinical efficacy and safety has been demonstrated in numerous animal disease models including mucositis, colitis, macrophage activation syndrome (MAS) as well as bacterial infections, including melioidosis. Potential anti-tumor activity has been demonstrated in in vitro and in vivo xenograft studies.
SGX942 has demonstrated safety and tolerability in a Phase 1 clinical study in 84 healthy human volunteers. Positive efficacy results were demonstrated in an exploratory Phase 2 clinical study in 111 patients with oral mucositis due to CRT for HNC, including potential long-term ancillary benefits. The Phase 3 multinational, placebo-controlled, randomized study evaluated the impact of dusquetide on the duration of SOM in 268 subjects with squamous cell carcinoma of the oral cavity and oropharynx, receiving CRT. While the Phase 3 clinical study did not achieve the required level of statistical significance (p≤0.05) in its primary endpoint of median duration of SOM, a clinically meaningful reduction was observed, including a statistically significant reduction in the duration of SOM in the per-protocol population (p=0.049), consistent with the findings in the Phase 2 trial.
SGX942 has received Fast Track Designation from the FDA for the treatment of oral mucositis as a result of radiation and/or chemotherapy treatment in HNC patients, as well as Promising Innovative Medicine designation in the United Kingdom by the Medicines and Healthcare products Regulatory Agency for the treatment of severe oral mucositis in HNC patients receiving CRT. In addition, products containing the same active ingredient, dusquetide, have been granted Fast Track Designation as an adjunctive therapy with other antibacterial drugs, for the treatment of melioidosis and Orphan Drug Designations in the treatment of MAS and the treatment of acute radiation syndrome.
Soligenix has a strong intellectual property position in the IDR technology platform, including composition of matter for dusquetide and related analogs. Dusquetide was developed pursuant to discoveries made by Professors B. Brett Finlay, PhD and Robert Hancock, PhD of the University of British Columbia, Canada. Soligenix has received partial funding from NIH for its oral mucositis clinical studies. The Phase 2 study was supported with a Phase I SBIR grant (#R43DE024032) award, with the Phase 3 study being supported by a Phase II SBIR grant (#R44DE024032) award.
In addition, a high level review of the IDR technology platform is available here.
About Soligenix, Inc.
Soligenix is a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need. Our Specialized BioTherapeutics business segment is developing and moving toward potential commercialization of HyBryte™ (SGX301 or synthetic hypericin) as a novel photodynamic therapy utilizing safe visible light for the treatment of cutaneous T-cell lymphoma (CTCL). With a successful Phase 3 study completed, regulatory approval is being sought and commercialization activities for this product candidate are being advanced initially in the U.S. Development programs in this business segment also include expansion of synthetic hypericin (SGX302) into psoriasis, our first-in-class innate defense regulator (IDR) technology, dusquetide (SGX942) for the treatment of inflammatory diseases, including oral mucositis in head and neck cancer, and proprietary formulations of oral beclomethasone 17,21-dipropionate (BDP) for the prevention/treatment of gastrointestinal (GI) disorders characterized by severe inflammation including pediatric Crohn's disease (SGX203).
Our Public Health Solutions business segment includes active development programs for RiVax®, our ricin toxin vaccine candidate, and SGX943, our therapeutic candidate for antibiotic resistant and emerging infectious disease, and our vaccine programs targeting filoviruses (such as Marburg and Ebola) and CiVax™, our vaccine candidate for the prevention of COVID-19 (caused by SARS-CoV-2). The development of our vaccine programs incorporates the use of our proprietary heat stabilization platform technology, known as ThermoVax®. To date, this business segment has been supported with government grant and contract funding from the National Institute of Allergy and Infectious Diseases (NIAID), the Defense Threat Reduction Agency (DTRA) and the Biomedical Advanced Research and Development Authority (BARDA).
For further information regarding Soligenix, Inc., please visit the Company's website at https://www.soligenix.com and follow us on LinkedIn and Twitter at @Soligenix_Inc.
This press release may contain forward-looking statements that reflect Soligenix, Inc.'s current expectations about its future results, performance, prospects and opportunities, including but not limited to, potential market sizes, patient populations and clinical trial enrollment. Statements that are not historical facts, such as "anticipates," "estimates," "believes," "hopes," "intends," "plans," "expects," "goal," "may," "suggest," "will," "potential," or similar expressions, are forward-looking statements. These statements are subject to a number of risks, uncertainties and other factors that could cause actual events or results in future periods to differ materially from what is expressed in, or implied by, these statements, such as experienced with the COVID-19 outbreak. Soligenix cannot assure you that it will be able to successfully develop, achieve regulatory approval for or commercialize products based on its technologies, particularly in light of the significant uncertainty inherent in developing therapeutics and vaccines against bioterror threats, conducting preclinical and clinical trials of therapeutics and vaccines, obtaining regulatory approvals and manufacturing therapeutics and vaccines, that product development and commercialization efforts will not be reduced or discontinued due to difficulties or delays in clinical trials or due to lack of progress or positive results from research and development efforts, that it will be able to successfully obtain any further funding to support product development and commercialization efforts, including grants and awards, maintain its existing grants which are subject to performance requirements, enter into any biodefense procurement contracts with the U.S. Government or other countries, that it will be able to compete with larger and better financed competitors in the biotechnology industry, that changes in health care practice, third party reimbursement limitations and Federal and/or state health care reform initiatives will not negatively affect its business, or that the U.S. Congress may not pass any legislation that would provide additional funding for the Project BioShield program. In addition, there can be no assurance as to the timing or success of any of its clinical/preclinical trials. Despite the statistically significant result achieved in the HyBryte™ (SGX301) Phase 3 clinical trial for the treatment of cutaneous T-cell lymphoma, there can be no assurance that a marketing authorization from the FDA or EMA will be successful. Notwithstanding the result in the HyBryte™ (SGX301) Phase 3 clinical trial for the treatment of cutaneous T-cell lymphoma and the Phase 1/2 proof-of-concept clinical trial of SGX302 for the treatment of psoriasis, there can be no assurance as to the timing or success of the clinical trials of SGX302 for the treatment of psoriasis. Further, there can be no assurance that RiVax® will qualify for a biodefense Priority Review Voucher (PRV) or that the prior sales of PRVs will be indicative of any potential sales price for a PRV for RiVax®. Also, no assurance can be provided that the Company will receive or continue to receive non-dilutive government funding from grants and contracts that have been or may be awarded or for which the Company will apply in the future. These and other risk factors are described from time to time in filings with the Securities and Exchange Commission, including, but not limited to, Soligenix's reports on Forms 10-Q and 10-K. Unless required by law, Soligenix assumes no obligation to update or revise any forward-looking statements as a result of new information or future events.
Cision
Cision
View original content:https://www.prnewswire.com/news-releases/key-binding-characteristics-of-dusquetide-to-important-intracellular-protein-identified-301558732.html
SOURCE Soligenix, Inc.
Good morning $SNGX nice news out!
$SNGX “Having a vaccine platform such as this available has the potential to accelerate worldwide vaccination campaigns addressing future health emergencies..."
https://finance.yahoo.com/news/soligenix-receives-us-patent-allowance-113000570.html
A significant development for SNGX with the patent allowance for thermostabilized vaccines. The issue of transporting vaccines under difficult to maintain temperature conditions is of high importance around the world so it is very good to see SNGX making key progress in this area.
Soligenix Receives US Patent Allowance For Its Thermostabilized Vaccine Platform
May 23, 2022 (Benzinga)
Soligenix, Inc. (NASDAQ:SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today that the United States Patent and Trademark Office (USPTO) has issued a Notice of Allowance for the patent application titled "Compositions and Methods of Manufacturing Trivalent Filovirus Vaccines." The allowed claims are directed to unique, proprietary compositions and methods directed to combinations of glycoprotein antigens with nanoemulsion adjuvants comprising sucrose fatty acid esters prior to lyophilization. The described vaccine platform has previously been successfully applied to filovirus vaccines (as mono-, bi- and tri-valent candidates for Zaire ebolavirus, Sudan ebolavirus and Marburg marburgvirus) as well as a SARS-CoV-2 vaccine.
The candidate filovirus vaccines have been previously shown to protect non-human primates (NHPs) from subsequent infection, and represent the only recombinant subunit vaccines that have demonstrated efficacy against Zaire ebolavirus and other filoviruses in NHPs. Lyophilization of the antigens within monovalent vaccine formulations has also been demonstrated to thermostabilize the antigens at temperatures as high as 40 degrees Celsius (104 degrees Fahrenheit) for up to 12 weeks, enabling storage at ambient temperature. No currently licensed lyophilized vaccine that contains an adjuvant is presented in a single vial format and there are few reports of successfully using nano-emulsions in lyophilized formulations. Previous work has demonstrated the use of a single vial platform to co-lyophilize antigen(s) and a nanoemulsion adjuvant, CoVaccine HT™, maintaining key adjuvant stability characteristics including particle size and colloidal stability, as well as maintaining immunogenicity. This most recent milestone confirms that, in the context of lethal challenge with Sudan ebolavirus, complete protection is maintained with the thermostabilized formulation.
"Filoviruses such as Zaire ebolavirus, Sudan ebolavirus and Marburg marburgvirus are some of the most lethal viruses known, and they are endemic in areas of the world where the power supply and distribution network can be uncertain. There are no vaccines for either Sudan or Marburg viruses, while approved vaccines for Zaire ebolavirus are constrained by cold chain logistics. Availability of a single-vial, heat stable vaccine would significantly enhance global public health preparedness or response to a new outbreak, at its source," stated Axel Lehrer, PhD, Associate Professor, Department of Tropical Medicine, Medical Microbiology and Pharmacology, John A. Burns School of Medicine (JABSOM), University of Hawai?i at Manoa (UHM). "Our work to date has demonstrated the feasibility of rapid and efficient manufacturing, as well as the ability to thermostabilize multiple antigens that can then be stored at temperatures exceeding 100 degrees Fahrenheit. Having a vaccine platform such as this available has the potential to accelerate worldwide vaccination campaigns addressing future health emergencies, including other global pandemics as seen with COVID-19."
"Our next generation combined vaccine platform includes three major components: a robust protein manufacturing process that has been demonstrated on multiple protein antigens, a novel nanoemulsion adjuvant which induces broad immunity and a formulation procedure which enables thermostabilization of the combination of adjuvant and antigen in a single vial," stated Oreola Donini, PhD, Senior Vice President and Chief Scientific Officer of Soligenix. "Elements of this vaccine platform have been utilized in our ricin toxin, filovirus and COVID-19 vaccine candidates, indicating its broad applicability. The ability to package more than one vaccine candidate in a single vial platform further adds to their developability, whether as a multivalent or individual monovalent vaccine, particularly against Sudan ebolavirus and Marburg marburgvirus where there are currently no available vaccines."
Work to date has demonstrated the compatibility of lyophilizing both antigen and adjuvant in the same vial, with reconstitution with sterile water for injection immediately prior to use. This simple delivery format, as well as the compatibility with ambient storage, significantly reduces logistical hurdles when vaccinating large groups of individuals as required for example when addressing a global pandemic or for the deployment of vaccines in outbreaks occurring in remote areas or with unreliable power supply.
Under the Company's Public Health Solutions business segment, ongoing collaborations with Dr. Lehrer, have demonstrated the feasibility of developing thermally-stable subunit protein vaccine formulations for filoviruses. The thermostabilized filovirus vaccine program is continuing to advance with the support of a National Institute of Health (NIH) grant R01-AI132323 (awarded to the University of Hawaii) and a Small Business Innovation Research grant (#1R44AI157593-01; awarded to Soligenix).
Any why would another Big-Pharma not buy this patent or partner with SNGX for use?
GLTA
SNGX should now move back to normal pps..
GLTA
$SNGX NEWS as Soligenix Receives US Patent Allowance for its Thermostabilized Vaccine Platform https://finance.yahoo.com/news/soligenix-receives-us-patent-allowance-113000570.html?soc_src=social-sh&soc_trk=tw&tsrc=twtr via @Yahoo
Good to see this! Further strengthening the pipeline!!
https://finance.yahoo.com/news/soligenix-receives-us-patent-allowance-113000570.html
News Out! May 23, 2022 /PRNewswire/ -- Soligenix, Inc. (Nasdaq: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today that the United States Patent and Trademark Office (USPTO) has issued a Notice of Allowance for the patent application titled "Compositions and Methods of Manufacturing Trivalent Filovirus Vaccines." The allowed claims are directed to unique, proprietary compositions and methods directed to combinations of glycoprotein antigens with nanoemulsion adjuvants comprising sucrose fatty acid esters prior to lyophilization. The described vaccine platform has previously been successfully applied to filovirus vaccines (as mono-, bi- and tri-valent candidates for Zaire ebolavirus, Sudan ebolavirus and Marburg marburgvirus) as well as a SARS-CoV-2 vaccine.
The candidate filovirus vaccines have been previously shown to protect non-human primates (NHPs) from subsequent infection, and represent the only recombinant subunit vaccines that have demonstrated efficacy against Zaire ebolavirus and other filoviruses in NHPs. Lyophilization of the antigens within monovalent vaccine formulations has also been demonstrated to thermostabilize the antigens at temperatures as high as 40 degrees Celsius (104 degrees Fahrenheit) for up to 12 weeks, enabling storage at ambient temperature. No currently licensed lyophilized vaccine that contains an adjuvant is presented in a single vial format and there are few reports of successfully using nano-emulsions in lyophilized formulations. Previous work has demonstrated the use of a single vial platform to co-lyophilize antigen(s) and a nanoemulsion adjuvant, CoVaccine HT™, maintaining key adjuvant stability characteristics including particle size and colloidal stability, as well as maintaining immunogenicity. This most recent milestone confirms that, in the context of lethal challenge with Sudan ebolavirus, complete protection is maintained with the thermostabilized formulation.
"Filoviruses such as Zaire ebolavirus, Sudan ebolavirus and Marburg marburgvirus are some of the most lethal viruses known, and they are endemic in areas of the world where the power supply and distribution network can be uncertain. There are no vaccines for either Sudan or Marburg viruses, while approved vaccines for Zaire ebolavirus are constrained by cold chain logistics. Availability of a single-vial, heat stable vaccine would significantly enhance global public health preparedness or response to a new outbreak, at its source," stated Axel Lehrer, PhD, Associate Professor, Department of Tropical Medicine, Medical Microbiology and Pharmacology, John A. Burns School of Medicine (JABSOM), University of Hawai?i at Manoa (UHM). "Our work to date has demonstrated the feasibility of rapid and efficient manufacturing, as well as the ability to thermostabilize multiple antigens that can then be stored at temperatures exceeding 100 degrees Fahrenheit. Having a vaccine platform such as this available has the potential to accelerate worldwide vaccination campaigns addressing future health emergencies, including other global pandemics as seen with COVID-19."
"Our next generation combined vaccine platform includes three major components: a robust protein manufacturing process that has been demonstrated on multiple protein antigens, a novel nanoemulsion adjuvant which induces broad immunity and a formulation procedure which enables thermostabilization of the combination of adjuvant and antigen in a single vial," stated Oreola Donini, PhD, Senior Vice President and Chief Scientific Officer of Soligenix. "Elements of this vaccine platform have been utilized in our ricin toxin, filovirus and COVID-19 vaccine candidates, indicating its broad applicability. The ability to package more than one vaccine candidate in a single vial platform further adds to their developability, whether as a multivalent or individual monovalent vaccine, particularly against Sudan ebolavirus and Marburg marburgvirus where there are currently no available vaccines."
Work to date has demonstrated the compatibility of lyophilizing both antigen and adjuvant in the same vial, with reconstitution with sterile water for injection immediately prior to use. This simple delivery format, as well as the compatibility with ambient storage, significantly reduces logistical hurdles when vaccinating large groups of individuals as required for example when addressing a global pandemic or for the deployment of vaccines in outbreaks occurring in remote areas or with unreliable power supply.
Under the Company's Public Health Solutions business segment, ongoing collaborations with Dr. Lehrer, have demonstrated the feasibility of developing thermally-stable subunit protein vaccine formulations for filoviruses. The thermostabilized filovirus vaccine program is continuing to advance with the support of a National Institute of Health (NIH) grant R01-AI132323 (awarded to the University of Hawaii) and a Small Business Innovation Research grant (#1R44AI157593-01; awarded to Soligenix).
$SNGX: Phase 2a Trial of SGX302 in Psoriasis to Initiate in Second Half of 2022… https://finance.yahoo.com/news/sngx-phase-2a-trial-sgx302-143000280.html?soc_src=social-sh&soc_trk=tw&tsrc=twtr via @Yahoo
AMTX > LOW ~ get in now
SNGX looking UP with avg $6 price target !
"Investors Observer is giving Soligenix, Inc. Common Stock (SNGX) an Analyst Rating Rank of 4, meaning SNGX is ranked higher by analysts than 4% of stocks. The average price target for SNGX is $6 and analyst’s rate the stock as a Hold."
https://www.investorsobserver.com/news/stock-update/do-analysts-agree-wednesday-on-soligenix-inc-common-stock-sngx-stocks-target-price
GLTA
The conference will be held May 23 through 26, 2022 with presentations, one-on-one meetings, and networking. The on-demand presentation will be available Tuesday, May 24 at 7AM ET. To view the presentation, please go to https://journey.ct.events/view/854b33a1-dbee-4dbb-9a35-e3239dfbc75c. The presentation will be archived there for 90 days. For more information about the H.C. Wainwright Global Investment Conference, please refer to the conference website at https://hcwevents.com/globalconference/.
SNGX
PRINCETON, N.J., May 18, 2022 /PRNewswire/ -- Soligenix, Inc. (Nasdaq: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today that the Company will deliver a corporate presentation at the upcoming H.C. Wainwright Global Investment Conference. The conference will be held May 23 through 26, 2022 with presentations, one-on-one meetings, and networking. The on-demand presentation will be available Tuesday, May 24 at 7AM ET. To view the presentation, please go to https://journey.ct.events/view/854b33a1-dbee-4dbb-9a35-e3239dfbc75c. The presentation will be archived there for 90 days. For more information about the H.C. Wainwright Global Investment Conference, please refer to the conference website at https://hcwevents.com/globalconference/.
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Soligenix, Inc. |
Healthcare | Biotechnology | USA |
Soligenix, Inc. (Soligenix) is a late-stage biopharmaceutical company.
The Company is focused on developing and commercializing products to treat rare diseases.
The Company operates through two business segments:
Specialized BioTherapeutics and Public Health Solution. Soligenix’s Specialized BioTherapeutics business segment is developing
a photodynamic therapy (SGX301) utilizing topical synthetic hypericin activated with safe visible fluorescent light for the treatment of cutaneous T-cell lymphoma (CTCL).
The Public Health Solutions business segment includes active development programs for RiVax,
its ricin toxin vaccine candidate and SGX943, its therapeutic candidate for antibiotic-resistant and emerging infectious disease.
CTCL is its innate defense regulator technology, dusquetide (SGX942) for the treatment of oral mucositis in head and neck cancer.
Soligenix has expertise in the development of orphan and unmet medical need indications including preclinical, manufacturing, regulatory and clinical expertise.
Soligenix has expertise in the development of orphan and unmet medical need indications including preclinical, manufacturing, regulatory and clinical expertise.
Preclinical | Phase 1 | Phase 2 | Phase 3 | Market |
---|---|---|---|---|
HyBryte™ for Cutaneous T-Cell Lymphoma (CTCL) | ||||
| | | | |
SGX942 for Oral Mucositis Treatment | ||||
| | | | |
SGX203 for Pediatric Crohn’s Disease | ||||
| | | | |
SGX201 for Radiation Enteritis Treatment | ||||
| | | | |
Orphan and/or Fast Track Designation
Soligenix has a number of Public Health programs, funded entirely by government grants and contracts, which focus on infectious disease and biodefense applications, including our most advanced vaccination program to prevent ricin poisoning.
Proof-of-Concept | IND | Phase 1 | Phase 2/3 | Market |
---|---|---|---|---|
RiVax® to Prevent Ricin Poisoning | ||||
| | | | |
SGX943 for Infectious Disease | ||||
| | | | |
ThermoVax®: Thermostabilized Vaccines for Global Use | ||||
| | | | |
Orphan and/or Fast Track Designation
Preclinical | Phase 1 | Phase 2 | Phase 3 | Market |
---|---|---|---|---|
HyBryte™ for Cutaneous T-Cell Lymphoma (CTCL) almost done [in phase 3] | ||||
| | | | |
SGX942 for Oral Mucositis Treatment almost done [in phase 3] | ||||
| | | | |
SGX203 for Pediatric Crohn’s Disease [phase 2 almost done] | ||||
| | | | |
SGX201 for Radiation Enteritis Treatment [phase 1 going into phase 2] |
Proof-of-Concept | IND | Phase 1 | Phase 2/3 | Market |
---|---|---|---|---|
RiVax® to Prevent Ricin Poisoning | ||||
| | | | |
SGX943 for Infectious Disease | ||||
| | | | |
ThermoVax®: Thermostabilized Vaccines for Global Use | ||||
| | | | |
Orphan and/or Fast Track Designation
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02-07-2021
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