BUSINESS INSIGHTS, PHARMACY MARKET
Phio Pharmaceuticals Corp. | December 22, 2022
Phio Pharmaceuticals Corp., today announced it expects to file an IND in the US in the first half of 2023 for a Phase 1b clinical trial of its INTASYL™ compound, PH-762. Phio is a clinical stage biotechnology company whose proprietary INTASYL self-delivering RNAi technology is designed to make immune cells more effective in killing tumor cells. PH-762 has been shown to reduce the expression of PD-1, a protein that inhibits T cells' ability to kill cancer cells. When administered intratumorally in preclinical models PH-762 primes an anti-tumor immune response, and inhibits tumor growth.
Phio is currently conducting a Phase 1b clinical trial of PH-762 for the treatment of advanced melanoma at the Gustave Roussy Institute, one of the largest cancer centers in Europe. Phio expects to commence a US Phase 1b clinical trial early in the 2nd half of 2023. The initial US trial is expected to focus on the treatment of cutaneous squamous cell carcinoma and other selected cutaneous malignancies, following successful regulatory review of the IND.
"Therapeutic interventions for cSCC are limited, and there is increasing unmet medical need. As cSCC tumors comprise approximately 51% of the total incidence of solid tumors in the US, excluding basal cell cancers, we recognize the growing need for alternative therapies for cSCC," said Robert Bitterman, Phio's Principal Executive Officer and Executive Chairman. Mr. Bitterman has over 25 years of executive leadership experience in the pharmaceutical and biologic life science industry with a proven track record in operations, finance and investor relations.
"While monoclonal antibody therapies are available for the treatment of cSCC, mechanistically they only block the interaction between PD-1 and PD-L1 on the cell surface. PH-762 also has the potential to address PD-1 inside the T cell, essentially further enhancing the activity of the T cell to kill the tumor cells," said Dr. James Cardia, Phio's Vice President of Scientific Operations. Dr. Cardia led the team that discovered INTASYL.
"PH-762 has the potential to meet a significant medical need in patients who have failed to respond to mAbs, as well as those with resectable and metastatic solid tumors. Phio is committed to advancing the study of PH-762 to provide a meaningful therapy for patients with a broad range of solid tumors."
Dr. Mary Spellman, Phio's Medical and Clinical Development Advisor
INTASYL compounds are chemically modified siRNAs that are designed to provide efficient, spontaneous cellular uptake and potent, long lasting intracellular activity targeting a broad range of cell types and tissues. INTASYL drugs precisely target specific proteins that reduce the body's ability to fight cancer, without the need for specialized formulations or drug delivery systems. INTASYL has demonstrated preclinical efficacy in both Direct-to-Tumor and Adoptive Cell Therapy applications. In comparison to biologics and cell and gene therapies, INTASYL has a favorable pre-clinical toxicity and safety profile, and a streamlined chemical synthesis that reduces costs and offers substantial convenience to the prescriber and patient. Phio believes that INTASYL is the only self-delivering RNA interference technology focused on immuno-oncology therapeutics.
About Phio Pharmaceuticals
Phio Pharmaceuticals Corp. is a clinical stage biotechnology company whose proprietary INTASYL™ RNAi technology is designed to make immune cells more effective in killing tumor cells. Phio believes that INTASYL is the only self-delivering RNAi technology focused on immuno-oncology therapeutics. INTASYL drugs precisely target specific proteins that reduce the body's ability to fight cancer, without the need for specialized formulations or drug delivery systems.
VIEWS AND ANALYSIS, PHARMACY MARKET
Soligenix, Inc. | December 20, 2022
Soligenix, Inc. 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 patient enrollment has been opened for its Phase 2a study evaluating SGX302 in the treatment of mild-to-moderate psoriasis. 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.
"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. Given our promising published results with hypericin to date, including a small Phase 1/2 proof of concept clinical trial in mild-to-moderate psoriasis, and the Phase 3 FLASH study in cutaneous T-cell lymphoma, where we filed a New Drug Application this month, we are hopeful synthetic hypericin will have a role to play in helping patients suffering from this difficult to treat and chronic disease."
Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix
The Phase 2a clinical trial will target enrollment of up to 42 patients ages 18 years or older with mild to moderate, stable psoriasis covering 2 to 30% of their body. In both Parts A and B, all patients will apply the study drug twice per week and will activate the drug with visible light 24 ± 6 hours later using the supplied visible light devices and according to the manufacturer's instructions. Patients will undergo treatments for a total of 18 weeks and, on completion, will be followed for a 4-week follow-up period in which patients will not receive other psoriasis treatments. In Part A, 5-10 patients will be assigned open-label SGX302 at the time of enrollment. Once the tolerability and response to SGX302 has been established, Part B of the protocol will commence. In Part B, patients will be randomized to double-blind treatment groups at a ratio 1:1 of active drug to placebo ointment.
Active dermatologic assessment of treated lesions for adverse events will be performed immediately before and during light treatments. Patients will be assessed for overall disease status through 4 weeks of follow-up. Efficacy endpoints will include the extent of lesion clearance and patient reported quality of life indices. Routine safety laboratories also will be collected.
About Synthetic Hypericin
Visible light-activated synthetic hypericin is a novel, first-in-class, photodynamic therapy 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 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 potentially treating deeper skin disease and thicker plaques and lesions, similar to what was observed in the positive Phase 3 FLASH study in CTCL. Synthetic hypericin or HyBryte™ was demonstrated in this study to be equally effective in treating both plaque and patch 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.
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 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™ treatment and 50 received placebo treatment of their index lesions. A total of 16% of the patients receiving HyBryte™ 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™ 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™ 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™ is not systemically available, consistent with the general safety of this topical product observed to date. At the end of Cycle 3, HyBryte™ continued to be well tolerated despite extended and increased use of the product to treat multiple lesions.
Psoriasis is a chronic, non-communicable, itchy and often painful inflammatory skin condition for which there is no cure. Psoriasis has a significantly detrimental impact on patients' quality of life, and is associated with cardiovascular, arthritic, and metabolic diseases, as well as psychological conditions such as anxiety, depression and suicide. Many factors contribute to development of psoriasis including both genetic and environmental factors. The lesions develop because of rapidly proliferating skin cells, driven by autoimmune T-cell mediated inflammation. Of the various types of psoriasis, plaque psoriasis is the most common and is characterized by dry, red raised plaques that are covered by silvery-white scales occurring most commonly on the elbows, knees, scalp, and lower back. Approximately 80% of patients have mild-to-moderate disease. Mild psoriasis is generally characterized by the involvement of less than 3% of the body surface area (BSA), while moderate psoriasis will typically involve 3-10% BSA and severe psoriasis greater than 10% BSA. Between 20% and 30% of individuals with psoriasis will go on to develop chronic, inflammatory arthritis (psoriatic arthritis) that can lead to joint deformations and disability. Studies have also associated psoriasis, and particularly severe psoriasis, with an increased relative risk of lymphoma, particularly CTCL. Although psoriasis can occur at any age, most patients present with the condition before age 35.
Treatment of psoriasis is based on its severity at the time of presentation with the goal of controlling symptoms. It varies from topical options including PDT to reduce pain and itching, and potentially reduce the inflammation driving plaque formation, to systemic treatments for more severe disease. Most common systemic treatments and even current topical photo/photodynamic therapy such as UV A and B, carry a risk of increased skin cancer.
Psoriasis is the most common immune-mediated inflammatory skin disease. According to the World Health Organization Global Report on Psoriasis 2016, the prevalence of psoriasis is between 1.5% and 5% in most developed countries, with some suggestions of incidence increasing with time. It is estimated, based upon review of historic published studies and reports and an interpolation of data that psoriasis affects 3% of the U.S. population or more than 7.5 million people. Current estimates have as many as 60-125 million people worldwide living with the condition. The global psoriasis treatment market was valued at approximately $15 billion in 2020 and is projected to reach as much as $40 billion by 2027.
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™ as a novel photodynamic therapy utilizing safe visible light for the treatment of cutaneous T-cell lymphoma. 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 into psoriasis, our first-in-class innate defense regulator technology, dusquetide for the treatment of inflammatory diseases, including oral mucositis in head and neck cancer, and proprietary formulations of oral beclomethasone 17,21-dipropionate for the prevention/treatment of gastrointestinal disorders characterized by severe inflammation including pediatric Crohn's disease.
BUSINESS INSIGHTS, VIEWS AND ANALYSIS
Biodex Medical Systems | November 30, 2022
Mirion Technologies, Inc. announced that it has entered into a definitive agreement to sell the physical medicine assets of Biodex Medical Systems, Inc. to Salona Global Medical Device Corporation for $5 million in cash at closing and up to an additional $3 million in deferred cash payments. The deferred cash payments are contingent on the performance of the assets during the 12-month period following closing. The assets generated approximately $18 million in revenue with estimated gross margins of 30% during the most recent trailing twelve-month period.
“Divesting the physical medicine assets of Biodex enables Mirion Medical to focus on our strategic priorities and better aligns the group with Mirion’s mission of harnessing our unrivaled knowledge of ionizing radiation for the greater good of humanity. We are pleased to see the physical medicine business in the hands of an owner whose core mission and strategy is better aligned with investing in the future of the product line and finding valued employees the right home for their skills and contributions,”
Mike Rossi, President of Mirion Medical
Mirion Technologies is a leading provider of detection, measurement, analysis and monitoring solutions to the nuclear, defense, medical and research end markets. The organization aims to harness its unrivaled knowledge of ionizing radiation for the greater good of humanity. Many of the company's end markets are characterized by the need to meet rigorous regulatory standards, design qualifications and operating requirements. Headquartered in Atlanta (GA – USA), Mirion employs around 2,800 people and operates in 13 countries.
About Biodex Medical Systems
Biodex Medical Systems, Inc. is part of Mirion Medical, Inc., a group of healthcare-focused brands within Mirion Technologies. Mirion Technologies, Inc. uses science and technology to drive treatment innovation across physical medicine, nuclear medicine and medical imaging categories. With a history of manufacturing and engineering excellence that spans more than 60 years, the Biodex™ mission is to provide innovative solutions and customer-driven support to medical facilities and wellness centers around the globe.
Symbio Generrics | November 25, 2022
Symbio Generrics India Private Limited a specialized Active Pharmaceutical Ingredients & Intermediates manufacturing and marketing organization, announced that it has completed an equity capital raise from Ascent Capital, a leading growth-capital focused private equity fund.
Symbio was founded by pharmaceutical professionals, Salim Shaikh and Abhijit Kale. They were soon joined by the third promoter, Akash Puranik; all of whom possess decades of experience in the global pharmaceutical industry. Symbio's journey from a sales and marketing organization to a full-fledged vertically integrated manufacturer of specialized APIs has been exemplary. Through a well-developed customer ecosystem, the highly experienced & skilled team at Symbio has established a global footprint for its APIs. Ascent Capital's sizeable investment in Symbio will further accelerate the company's expansion plans and sets the company enroute to emerge as a top-10 manufacturer of APIs in India.
The funds raised from Ascent will be utilized towards undertaking strategic acquisitions, establishing a best-in-class R&D facility and ramping up manufacturing capacity. The company's R&D Centre is housed in Bengaluru while the manufacturing plant is located at Dobbaspet, Bengaluru. The Company is in the process of acquiring another manufacturing facility in India. The team is focused on building a high-potential generics API portfolio for the global markets and to this effect, will work towards getting US FDA and other SRA approvals for their recently acquired facilities.
"We are glad to be associated with Ascent Capital which has a reputation of partnering with entrepreneurs to build leading businesses in India. The sizeable investment from Ascent Capital will add power to our next growth spurt and enable us to emerge as a top-10 API company in India. We are setting ourselves a medium-term goal of growing rapidly into a sizeable company by leveraging the strength of our team and expanding our horizons to actively serve the global API market."
Commenting on the fund raise, Salim Shaikh, Executive Chairman & Founder of Symbio Generrics
Akash Puranik, Promoter, MD& CEO of Symbio Generrics, says, "The latest feather in our cap is the influx of resources from Ascent Capital. We have carved strategic alliances and relationships spanning over two decades with leading pharmaceutical entities in regulated and semi-regulated markets and are now keen to expand these synergies further in the global arena. With a well-developed infrastructure, both on the manufacturing and R&D front, we are keen to engage with potential partners for CDMO Business."
Mr. Raja Kumar, Founder and MD of Ascent Capital, said, "Ascent Capital has been known to support highly qualified professional teams in niche domains. Continuing with this tradition, we are delighted to partner with the first-generation technocrat founders at Symbio. Collectively, the team at Symbio is one of the best multi-disciplinary teams in the Indian pharma space and has shown an exemplary track record of building global relationships. We look forward to working collaboratively with the Company to ensure that we have another category leader from the Ascent stable, akin to BigBasket, Sequent, Skanray, to name a few."
IC Universal Legal's Chennai team led by Senior Partner, Sameena Chatrapathy represented Symbio as the legal counsel for the fund raise from Ascent Capital as well as the follow-on acquisitions.
Symbio Generrics India Private Limited founded in the year 2010 is a specialized Active Pharmaceutical Ingredients & Intermediates manufacturing and marketing organization with headquarters in Bengaluru. The Company was founded by first generation entrepreneurs coming from a leading pharmaceutical organization, with a combined experience of over 40 years.
About Ascent Capital
Ascent Capital is a leading India-focused Independent Private Equity Fund Manager. The team at Ascent is one of the most experienced investment teams in India with 150+ years of collective experience in Indian PE and capital markets. Thus far, Ascent has helped more than 60 entrepreneurs build leading businesses across diverse sectors such as Technology, Healthcare, Financial Services, Consumer Brands, etc. It typically invests USD 10-30 MM in fast growing businesses, led by outstanding entrepreneurs, that have the potential to emerge as leaders in its segment thereby delivering exceptional exit outcomes. Ascent is backed by marquee investors, who include long term institutional investors like pension funds, foundations, endowments, fund of funds and large corporations - a vote of confidence in the team's ability to excel and deliver results.