VIEWS AND ANALYSIS
Enteris BioPharma | September 13, 2022
Enteris BioPharma, Inc., a biotechnology company developing innovative drug products based on its proprietary delivery technologies, and a wholly-owned subsidiary of SWK Holdings Corporation announced the publication of a new white paper in Drug Development & Delivery entitled, "Key Considerations in Oral Delivery of Peptides – Factors to Consider While Evaluating Oral Administration."
The paper, authored by John Vrettos, PhD, Director of Formulation Development for Enteris BioPharma, and Kalpana Ramakrishnan, PhD, Manager of Business Development for Enteris BioPharma, explores the barriers to developing oral delivery of peptides and how pharmaceutical companies can overcome them. Oral administration of peptides offers several advantages while treating chronic conditions such as diabetes and obesity as they are less invasive and more cost effective compared to injections.
"Molecule size, potency, and solubility are some of the key physicochemical properties that determine a peptide's suitability for oral delivery. The healthcare industry is in need of enabling drug delivery technologies with the capability to overcome barriers in oral delivery of peptides. Importantly, orally delivered medications may encourage patient compliance compared with more invasive approaches to administering drugs. Approximately 75% of peptides are delivered by injective routes, including subcutaneous injections which can be painful and difficult to incorporate into a daily routine."
Dr. Vrettos
Dr. Vrettos continued, "Enteris' Peptelligence® platform offers a 'triple-action' solution comprised of our enteric coating, protease inhibitor, and permeation enhancer. When combined, these technologies have demonstrated an ability to improve the solubility and permeation of orally delivered peptides. These properties can potentially enable oral delivery of some peptide drugs for the first time, and we are excited to share our knowledge on oral delivery of peptides through this informative whitepaper."
Peptelligence is a novel formulation technology designed to enhance the oral delivery and bioavailability of selected drugs by enhancing the permeation of such compounds that are typically injected, including peptides and BCS class III and IV small molecules, and preventing their breakdown in the digestive tract.
About Enteris BioPharma
Enteris BioPharma, Inc. is a wholly-owned subsidiary of SWK Holdings Corporation offering total integrated contract development and manufacturing services for innovative formulation solutions utilizing its proprietary drug delivery technologies, Peptelligence® and ProPerma®, and contract manufacturing (CMO) services using non-proprietary technologies. The company's proprietary technologies have been the subject of numerous feasibility studies and active development programs, some of which are in clinical development. Additionally, Enteris BioPharma is advancing an innovative internal product pipeline of drug products that address significant unmet clinical needs for which there is no satisfactory treatment option.
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BUSINESS INSIGHTS
SmartSkin Technologies and PDA | October 06, 2022
SmartSkin Technologies and Parenteral Drug Association, Inc. announced a partnership to integrate SmartSkin’s data collection technologies with PDA’s aseptic processing and visual inspection training.
SmartSkin is recognized by leading pharmaceutical brands as an innovator. Its technology helps the industry adapt faster and improve production quality by providing timely data from the container’s perspective inside the production process — from the washer to warehousing. This previously unavailable information enables data-driven decisions, improving efficiency, lowering costs, and reducing waste.
Built on a reputation of scientifically reliable and compliant industry best practices, PDA's hands-on aseptic processing and visual inspection training courses provide new and experienced pharmaceutical professionals with practical information and implementable solutions related to these critical manufacturing operations.
“PDA’s training curriculum is widely acknowledged as the gold standard for the pharmaceutical industry. We have been working closely with them for the past several months and are thrilled to have our technology included as part of their training. We have been working hard to understand all aspects of sterile products, aseptic processing, and how to improve quality in pharmaceutical manufacturing. PDA training will ensure industry professionals understand what is now possible.”
SmartSkin CEO, Evan Justason
“We are always looking to integrate new technologies into our training courses to provide meaningful hands-on experience to our attendees. Smartskin’s technology to protect the integrity of containers across the fill-finish process will enhance the aseptic processing and visual inspection training courses, making them even more unique and valuable,” said PDA VP of Education, David Talmage.
SmartSkin discussed manufacturing and quality assurance issues at the 2022 PDA/FDA Joint Regulatory Conference in Washington earlier this month and showcased its latest product innovations to PDA and FDA members. SmartSkin will also be attending the upcoming PDA Universe of Pre-Filled Syringes and Injection Devices show in Palm Springs, CA, October 18-19.
About PDA
The Parenteral Drug Association (PDA) is the leading global provider of science, technology, and regulatory information. The PDA creates awareness and understanding of important issues facing the pharmaceutical and biopharmaceutical community and delivers high-quality, relevant education to the industry. Since its founding in 1946 as a nonprofit organization, PDA has been committed to developing scientifically sound, practical technical information and expertise to advance pharmaceutical/biopharmaceutical manufacturing science and regulation, so members can better serve patients.
About SmartSkin Technologies
SmartSkin Technologies, Inc. is based in Fredericton, New Brunswick, Canada. The company’s patented Quantifeel™ solutions fuse innovative sensors, deep analytics and artificial intelligence to provide global manufacturers with actionable data on the forces their containers experience during the filling and packaging process. By identifying previously undetectable adverse or abnormal operating conditions, workers are able to better control the process, preventing product defects and costly downtime. SmartSkin’s technology is in use around the world and has earned a reputation as a world leader in IIoT productivity solutions across multiple industries. SmartSkin was honored with the “Best Manufacturing Innovation” at the 2020 PharmaPack Awards in Paris.
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BUSINESS INSIGHTS
AustinPx | September 28, 2022
AustinPx, Pharmaceutics and Manufacturing, a contract development and manufacturing organization announced the appointment of Elizabeth Hickman as Chief Business Officer. In this role, Ms. Hickman will be responsible for the Company’s CDMO business operations and strategy, including building capabilities and a team to deliver high-value solutions for pharmaceutical customers.
Ms. Hickman is an accomplished business leader with over 15 years of experience with small and multi-billion-dollar CDMOs. Over her career, she has held business development and market strategy positions of increasing responsibility, most recently at West Pharmaceutical Services as Senior Director of Strategic Marketing, Services and Solutions where she was responsible for market expansion of the company’s contract development, testing and manufacturing services. Prior to joining West, Ms. Hickman led sales and marketing at Pharmatek Laboratories, where she helped grow the company’s services and revenues resulting in its successful acquisition by Catalent Pharma Solutions. Following Pharmatek’s acquisition, she continued to excel in market strategy and business development leadership roles with Catalent’s oral drug development business unit. Ms. Hickman has a BA in Microbiology from the University of Texas, Austin and an MBA from San Diego State University.
"Elizabeth brings a sharp skillset and a wealth of CDMO experience to AustinPx," said Tim Scott, President and CEO for AustinPx. "She has a strong history of growing CDMOs as both a strategist and a team-builder. Elizabeth is unique in her ability to foster and create a culture that excels at providing client-centric services, and that is why she is such a tremendous asset for AustinPx. We are very fortunate to have her."
As CBO at AustinPx, Ms. Hickman will focus on the strategic buildout of agile, best in class operations, systems, and teams. She will be responsible for all market strategy and communications, business development, project management, systems optimization, and data-driven processes that drive growth.
"I am excited to be a part of AustinPx and join its impressive team of formulation and manufacturing scientists and operations staff. They are a true scientific powerhouse for our clients. My goal is to build on the Company’s strong foundation to develop a client-centric CDMO that consistently delivers exceptional service from initial engagement to product shipment. Ultimately, my passion is for the patients of our clients – if we can help get their drug candidates to the clinic faster, with better formulations and dosage forms, we can in turn impact more patients around the world."
Elizabeth Hickman
About AustinPx
AustinPx, Pharmaceutics and Manufacturing is a contract development and manufacturing organization providing analytical and formulation development services and cGMP manufacturing for small molecule drugs. We specialize in phase-appropriate development strategies, speed to clinic and market strategies, and bioavailability enhancement of poorly soluble molecules - including our next generation amorphous dispersion platform, KinetiSol® Technology.
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VIEWS AND ANALYSIS
Altamira Therapeutics Ltd | December 01, 2022
Altamira Therapeutics Ltd. a company dedicated to developing therapeutics that address important unmet medical needs, today provided a business update and reported its first half 2022 financial results.
“We continue to make good progress with the transformation of Altamira into an RNA delivery technology company. We are optimistic of reaching an agreement to divest or partner our Bentrio nasal spray for key markets in North America and Europe by year end. Last month, we agreed to divest part or all of our inner ear therapeutics programs to a European family office. Following some delay and under slightly amended terms, we expect that transaction to close in December.
Thomas Meyer, Altamira Therapeutics’ founder, Chairman and CEO
“Heading towards 2023, we look forward to focusing exclusively on the many emerging opportunities in the fast-growing RNA therapeutics market. We are increasingly well positioned to advance our RNA delivery technology throughout 2023.”
As Altamira is going through the final stages of a major corporate transformation, management intends to hold its next investor call upon finalization of its partnering / divestiture projects. On that call, the Company will also provide its outlook for 2023.
RNA delivery platform update
Altamira continued to make solid progress with the development of its patented, peptide-based platform for RNA delivery to extrahepatic tissues. In recent months, the RNA team led by Chief Development Officer Covadonga Pañeda, Ph.D., and Chief Scientific Officer Samuel Wickline, MD, have advanced various projects, including selection and optimization of siRNA sequences, formulation, process development and manufacturing. Starting with project AM-401 for the treatment of KRAS-driven tumors, the Company added a second project, AM-411 for the treatment of rheumatoid arthritis. AM-411 nanoparticles comprise siRNA targeting NF-kB a key checkpoint in RA inflammation.
The Company is developing both AM-401 and AM-411 with the objective of out-licensing the drug products at a later stage. They serve as a “showcase” for the application of Altamira’s RNA delivery technology; the Company’s strategy will be to out-license the technology to pharma and biotech companies for use with their own RNA molecules. In this context, Altamira has been intensifying its efforts to raise awareness about OligoPhore/SemaPhore within science and industry.
In recent months, members of Altamira’s leadership team gave oral presentations at multiple international conferences, highlighting the ability to deliver RNA molecules to extrahepatic tissues and achieve efficient and rapid endosomal release inside target cells. Concurrently, further data on RNA delivered with Altamira’s delivery technology has been published by independent research groups in peer-reviewed scientific journals. Altamira anticipates entering into its first partnering agreements in 2023.
Bentrio Update
Earlier today, Altamira reported that its licensee and distribution partner Nuance Pharma has launched Bentrio nasal spray in Hong Kong to help provide protection against airborne viruses as well as allergens. This will be the first step to distributing Bentrio in the other Nuance-licensed territories which is comprised of mainland China, Macau and South Korea.
As part of its strategy to focus exclusively on RNA delivery, Altamira has been in discussions with several well-established OTC consumer health companies for the partnering of Bentrio. Those discussions intensified following the 510(k) clearance of the product by the FDA and have advanced well, including due diligence by interested parties. The Company anticipates entering into a partnering transaction before year end. In the context of those partnering discussions, Altamira suspended preparations for launching the product in the US on its own as well as pausing major marketing initiatives in Europe. This restraint provides the prospective strategic partner for Bentrio with maximum flexibility to fit the product into its business plan.
Beginning in early October, the Bentrio nasal spray was relaunched in Europe for allergic rhinitis. Previously, the Company had ceased marketing the product for the indication of viral infection in the EU and Switzerland although Bentrio’s mode of action is the same regardless of whether it provides a barrier against airborne virus or allergen particles. This had been demonstrated in various relevant in vitro assays. However, certain countries and regions require specifically clinical performance data to clear Bentrio for this indication, in particular related to COVID-19. Such data are expected to become available through the COVAMID trial.
In September, Altamira announced that it had reached its extended enrollment target of 160 confirmed subjects in its COVAMID clinical investigation to evaluate the safety, tolerability, and efficacy of its Bentrio nasal spray in patients with acute COVID-19. The read-out of top-line data remains on track for the current quarter. The Company plans to seek an expansion of its product label to also include viral infections in those countries requiring supportive clinical data.
In September, the Company also announced that its “NASAR” clinical trial in seasonal allergic rhinitis (SAR) resumed enrollment as the new pollen season started in Australia. The NASAR trial is expected to enroll a total of 100 patients suffering from SAR and is designed to compare the safety and efficacy of Bentrio against a (control) saline nasal spray. The primary endpoint will be the comparison of the reflective Total Nasal Symptom Score under treatment with Bentrio against control.
The NASAR trial was initiated in the fall of 2021. It was suspended in spring 2022 as the pollen season came to an end before the enrollment target could be met. Interim data from the trial were used in support of the 510(k) clearance of Bentrio by the US FDA. Unless an interim analysis performed upon reaching 50% of the enrollment target to check the validity of the statistical powering assumptions requires a change to the target size of 100 patients, the Company expects to complete enrollment into the NASAR trial by year-end or in early 2023 with a read-out of top-line data in late 1Q-23.
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