BUSINESS INSIGHTS, PHARMACY MARKET
Novo Nordisk & ATLATL | December 06, 2022
Novo Nordisk Research Centre China and ATLATL jointly announce the winners of EntreStar program. Hangzhou DNano MetaBio and Modit Medicine stood out among all participants and won the awards.
The two winners will be given priority access to one of ATLATL’s nation-wide facilities in China, and a prize of CNY 500K RMB each to pay for the ATLATL facilities and services. They are also entitled to mentoring by relevant experts of Novo Nordisk. There will be no strings attached for the two companies.
Founded in 2022, Hangzhou DNano MetaBio Technology has been focusing on the design of nucleic acid nanocarriers with customized functions and great potential in clinical translation. The team has rich experience in nucleic acid structure design, which enables them to accurately regulate the organ-targeting ability and the on-demand drug release performance of the nanocarriers.
“It’s our great honour to participate in EntreStar. We look forward to exploring collaboration opportunities with the community. Meanwhile, it is very much appreciated that we can receive guidance and help from Novo Nordisk’s experts in relevant fields, so that our company can develop in a healthy way.”
Dr. Baoquan DING, President & Chief Scientist of DNano expressed his hopes in the award ceremony,
Modit Medicine Inc., founded in 2022, is a biotech company focusing on RNA editing and therapeutics. The company owns cutting-edge and propriety RNA modification and editing methodologies and is devoted to the development of novel platform technologies. Instead of manipulating DNA sequences, technologies of Modit Medicine Inc. correct genetic errors at the RNA level, thereby providing opportunities for safe, efficacious and innovative therapeutics to treat human rare diseases, cancers, etc.
Dr. Chengqi YI, Founder of Modit Medicine and Boya Professor of Peking University, commented on his participation, “By participating in the EntreStar program, Modit Medicine Inc. hopes to learn from global pharma about their insights on technology platform and marketing strategies in gene therapy, as well as to seek and form potential collaborations with Novo Nordisk. We also appreciate advice and suggestions from ATLATL about useful tips for start-up companies to connect with government and industry.”
Dr. Dan HAN, President of NNRCC, shared her remarks: “We see great potential in the novel concepts proposed by DNano and Modit. By leveraging knowledge and experiences in our global organisation, we hope that Novo Nordisk can help pushing their research projects forward more effectively. As a Novo Nordisk affiliate in China, we partner with brilliant minds via INNOVO® program to facilitate translational research, with EntreStar initiative as its latest addition.”
Dr. Pengcheng ZHU, Founder of ATLATL Innovation Center, commented on the role ATLATL plays: “It is my greatest pleasure to help make the EntreStar winners thrive at ATLATL’s platform, with access to global resources, such as our partners like Novo Nordisk. The ATLATL Innovation Center is a world-class scientific hub for the life sciences. We streamline the elements of R&D to improve resource utilization, and revolutionize the traditional asset-heavy investment model into an asset-light operation model. I am looking forward to collaborating with even more leading biopharmaceuticals and bringing success to these talented people.”
About Novo Nordisk
Novo Nordisk is a leading global healthcare company, founded in 1923 and headquartered in Denmark. Our purpose is to drive change to defeat diabetes and other serious chronic diseases. We do so by pioneering scientific breakthroughs, expanding access to our medicines, and working to prevent and ultimately cure disease. Novo Nordisk employs about 49,300 people in 80 countries and markets its products in around 170 countries.
Novo Nordisk Research Centre China founded in 1997, takes pride in being the first research centre established by a multinational pharmaceutical company in China. With a focus on protein and peptide therapeutics, NNRCC has full capabilities and rich experiences in drug discovery research.
The ATLATL Innovation Center is a world-class scientific hub for global life sciences. ATLATL streamlines the elements of R&D to improve resource utilization and revolutionizes the traditional asset-heavy investment model into an asset-light operation model. This much more time and cost-efficient model originated in Boston and continues to be optimized from 2017 onwards in China. ATLATL provides not only state-of-the-art facilities and professional operational management but also many R&D platforms staffed with scientists and project managers specializing in various fields. By collaborating with leading biopharma ATLATL integrates global resources to stimulate innovative developments. ATLATL currently has R&D platforms in Beijing, Shanghai, Suzhou, etc., leveraging the uniqueness of each site to help innovators quickly reach the next milestone.
Cambrex | November 22, 2022
Cambrex, a leading global contract development and manufacturing organization providing drug substance, drug product, and analytical services across the entire drug lifecycle, today announced that it has entered into a definitive agreement to acquire Snapdragon Chemistry, a leading US-based provider of chemical process development services to a broad range of emerging and established biopharma customers.
Snapdragon specializes in active pharmaceutical ingredient batch and continuous flow process development, utilizing state-of-the-art automation technology and proprietary equipment to solve complex process and analytical development challenges. The team of scientists and engineers apply deep process understanding afforded by data-rich experimentation to design and rapidly execute efficient GMP and non-GMP manufacturing processes. With R&D and manufacturing headquartered in Waltham, Massachusetts, Snapdragon's 74 employees come with strong ties to the local scientific community, with 31 PhD scientists on staff.
"The acquisition of Snapdragon will accelerate our growth in the area of continuous flow process development and manufacturing, complementing our recent organic investments in our High Point, North Carolina facility. With R&D and manufacturing capabilities in the heart of Boston's biopharma hub, Snapdragon will continue to focus on solving their customers' most difficult process development challenges."
Tom Loewald, CEO of Cambrex
"We are excited to be joining Cambrex, a company with over 40 years of drug substance development and manufacturing expertise," said Matt Bio, CEO of Snapdragon. "Partnering our best-in-class process development capabilities with Cambrex's larger scale manufacturing facilities in North America and Europe is a natural fit, both for our employees and our customers."
Snapdragon recently opened its second facility, a new 51,000-square-foot facility to manufacture experimental pharmaceutical products for human clinical trials. The new facility expanded the company's capacity for supplying clinical intermediates and drug substances.
The transaction is expected to close following the completion of customary regulatory approvals. This will be Cambrex's second acquisition within a year along with Q1 Scientific, consistent with its strategy to expand its portfolio of specialized solutions for pharmaceutical development and manufacturing.
Cambrex is a leading global contract development and manufacturing organization that provides drug substance, drug product, and analytical services across the entire drug lifecycle. With over 40 years of experience and a growing team of over 2,300 experts servicing global clients from North America and Europe, Cambrex is a trusted partner in branded and generic markets for API and finished dosage form development and manufacturing.
Cambrex offers a range of specialized drug substance technologies and capabilities, including biocatalysis, continuous flow, controlled substances, solid-state science, material characterization, and highly potent APIs. In addition, Cambrex can support conventional dosage forms, including oral solids, semi-solids, and liquids, and has the expertise to manufacture specialty dosage forms such as modified-release, fixed-dose combination, pediatric, bi-layer tablets, stick packs, topicals, controlled substances, sterile, and non-sterile ointments.
VIEWS AND ANALYSIS, PHARMACY MARKET
Vincerx Pharma, Inc. | December 12, 2022
Vincerx Pharma, Inc. a biopharmaceutical company aspiring to address the unmet medical needs of patients with cancer through paradigm-shifting therapeutics, today announced a poster presentation of preclinical data of Vincerx’s proprietary payload and linker technology and VIP943, the Company’s internalizing ADC targeting CD123, at the 64th American Society of Hematology Annual Meeting 2022.
VIP943 is a novel ADC, which binds to the IL3-receptor alpha chain . VIP943 combines the unique payload class of kinesin spindle protein inhibitors with a proprietary legumain-cleavable linker. Vincerx’s CellTrapper™ modification of the KSPi prevents diffusion out of the cell, allowing intracellular accumulation. The nonpermeability of the payload prevents off-target toxicities, leading to favorable efficacy and safety profiles.
“I am truly excited about the preclinical results for VIP943 and our proprietary payload and linker technology presented at ASH,” said Ahmed Hamdy, M.D., Chief Executive Officer of Vincerx. “For the first time, we showed a significant improvement in safety over an approved ADC, demonstrating in non-human primates the benefit of our KSPi payload and CellTrapper technology specifically designed to address some of the well-known challenges of ADCs on the market. The in vivo AML mouse model results also showed improved efficacy and survival for VIP943 in combination with venetoclax and azacitidine. This triple combination resulted in significant tumor regression as demonstrated by five complete responses and significantly prolonged survival time without increased toxicity,” added Dr. Hamdy.
“This ADC is innovative and exciting. The target is well understood and the novel payload that targets myeloid cells suggests this could be a valuable agent for patients with AML.”
Dr. Anthony Tolcher, M.D., Chief Executive Officer, Founder and Director of Clinical Research at NEXT Oncology
“Current standard of care for AML patients is combination therapy with venetoclax and azacitidine, yet most patients eventually relapse with progressive disease. The efficacy and safety data for VIP943 we see in our studies suggest it may be a promising option for treating AML as a monotherapy in relapse/refractory elderly, unfit and high-risk patients as well as in combination with venetoclax and azacitidine. Our results also provide compelling evidence that VIP943 represents a substantial advancement and potential paradigm-shift in ADC technology. We look forward to continuing to advance the IND-enabling studies for VIP943 and expect to file our IND in mid-2023,” concluded Dr. Hamdy.
ABOUT VINCERX PHARMA, INC.
Vincerx Pharma, Inc. is a clinical-stage life sciences company focused on leveraging its extensive development and oncology expertise to advance new therapies intended to address unmet medical needs for the treatment of cancer. Vincerx has assembled a management team of biopharmaceutical experts with extensive experience in building and operating organizations that develop and deliver innovative medicines to patients. Vincerx’s current pipeline derives from an exclusive license agreement with Bayer and includes a clinical-stage and follow-on small molecule drug program and a preclinical stage modular bioconjugation platform, which includes next-generation antibody-drug conjugates and innovative small molecule drug conjugates.
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.