Moleculin Announces New Antiviral Drug Candidates Demonstrate In Vitro Activity Against HIV

Moleculin Biotech, Inc | October 07, 2020

Moleculin Biotech, Inc., (Moleculin or the Company), a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting significant unmet needs in the treatment of tumors and viruses, announced preliminary new findings from its research collaboration with the Rega Institute in Leuven, Belgium, that demonstrate its drug candidates, WP1096 and WP1097, are showing significant in vitro activity in a range of infectious diseases.  In addition to activity against SARS-CoV-2, antiviral activity has now been documented for HIV, Zika and Dengue Fever.

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Oncology-related licensing deals vary by clinical phase, regulatory designation and indication.

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Oncology-related licensing deals vary by clinical phase, regulatory designation and indication.

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BUSINESS INSIGHTS

Aptar Expands Pharmaceutical Services Announces Exclusive Collaboration Between Aptar Pharma and Fluidda

Aptar Pharma and Fluidda | September 23, 2022

Nanopharm, an Aptar Pharma company and leader in contract research and development services for orally inhaled and nasal drug products announced an exclusive collaboration with Fluidda, a leader in the field of Functional Respiratory Imaging. The companies will leverage their respective proprietary technology platforms to help accelerate U.S. Food & Drug Administration approvals for orally inhaled generic products via the alternative bioequivalence pathway. Nanopharm was acquired by Aptar in 2019, as part of the company’s strategy to expand its services offerings and partner with pharmaceutical companies earlier in the drug development process. Nanopharm has pioneered the development of the alternative bioequivalence regulatory pathway for U.S. FDA approval of generic OIDPs for Asthma and Chronic Obstructive Pulmonary Disease using its proprietary in vitro and in silico service platform, SmartTrack™. Fluidda’s proprietary in silico platform FRI delivers quantitative predictions of regional drug deposition in disease state lungs using Computational Fluid Dynamics. The FRI platform provides critical information to help understand the availability and activity of the drug at the site of action in the lungs, when complemented by Nanopharm’s local lung physiologically-based pharmacokinetic model platform and its in vitro data. This novel approach is intended to allow pharma companies to file Abbreviated New Drug Application dossiers without the need to perform time-consuming, costly and often unpredictable clinical end-point studies. Similarly, it can support 505(b)(2) filings, by derisking and abbreviating clinical studies. “We are pleased to solidify our relationship with Fluidda and its world-leading FRI technology. A company would have to spend several years to achieve the current combined expertise and experience of Nanopharm and Fluidda. The collaboration between Nanopharm and Fluidda has the potential to revolutionize this arduous regulatory pathway,” Dr. Jag Shur, Vice President, Science & Technology at Nanopharm Having already worked together closely for a number of years, Nanopharm and Fluidda have gained a unique insight into the complex and continually evolving regulatory requirements. This exclusive collaboration deepens the relationship between Fluidda and Nanopharm, benefiting both patients and customers with an uncompromised and holistic approach in developing the scientific rationale to demonstrate bioequivalence using only in vitro and in silico methodologies. The first potential approval of an OIDP using the alternative bioequivalence approach is pending, and, when approved, will further validate Nanopharm’s SmartTrack™ as the go-to solution for alternative bioequivalence studies and should accelerate demand for the companies’ collective services. With momentum building for the transition to new lower global warming potential (GWP) propellants for pMDIs, SmartTrack™ will also help companies to understand and modulate the impact of these new propellants on drug deposition and dissolution in the lungs, giving confidence in the performance of the reformulated product before embarking on any necessary clinical studies. Dr. Jan de Backer, CEO of Fluidda, stated, “Fluidda has already demonstrated the applicability of its FRI platform to provide more objective data for evaluating and administering inhaled drug products accurately. Nanopharm’s unique SmartTrack™ platform provides us with clinically-relevant input data without having to actually go into the clinic, which really adds another level of confidence to the models, and provides an integrated perspective.” Guillaume Brouet, Vice President, Analytical, Regulatory and Scientific Affairs at Aptar Pharma, commented, “Aptar Pharma is delighted to collaborate with Fluidda on this important development, which reinforces our mission to help customers derisk and accelerate their drug product development programs.” About Aptar Aptar Pharma is part of AptarGroup, Inc., a global leader in the design and manufacturing of a broad range of drug delivery, consumer product dispensing and active material science solutions and services. Aptar’s innovative solutions and services serve a variety of end markets including pharmaceutical, beauty, personal care, home care, food and beverage. Aptar Pharma’s analytical, laboratory and regulatory services add value at every stage of the drug development process, accelerating and de-risking the program along the way. Nanopharm, an Aptar Pharma company, is a leading provider of specialized analytical and product development services, with a focus on orally inhaled and nasal drug products. Aptar is headquartered in Crystal Lake, Illinois and has 13,000 dedicated employees in 20 countries. About Fluidda FLUIDDA, founded in 2005, is the world leader in the field of Functional Respiratory Imaging (FRI). This technique combines HRCT scans and Computational Fluid Dynamics technology (CFD), which offers vast improvements by making clinical trials shorter, faster and thus, more cost effective. FRI also helps patients and healthcare providers in offering a unique entry point in personalized medicine, by optimizing diagnosis, monitoring disease progression and the effects of therapy including accurate assessment of the deposition of inhalation medication. Fluidda’s mission is to optimize treatment pathways, reduce healthcare costs and to limit the go-to-market time of respiratory drugs, pulmonology medical devices and therapies. Fluidda has offices in Belgium, the United States and Portugal.

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BUSINESS INSIGHTS

Glaukos Announces More Than 1 Million iStent® Technologies Implanted Worldwide

Glaukos | September 12, 2022

Glaukos Corporation an ophthalmic medical technology and pharmaceutical company focused on novel therapies for the treatment of glaucoma, corneal disorders and retinal diseases announced a significant milestone as its iStent® family of technologies have now been implanted in more than one million procedures worldwide. This market-leading milestone is a testament to the decades of investment from Glaukos as the corporate founder and pioneer of the now well-established micro-invasive glaucoma surgery (MIGS) marketplace. “One million iStents implanted is a tremendous accomplishment and I’m grateful to Glaukos for their continued dedication, investment and pioneering spirit to advance the development of innovative glaucoma technologies designed to improve the treatment paradigm for the benefit of patients worldwide,” said Ike Ahmed MD, Professor, Department of Ophthalmology and Visual Sciences at John A. Moran Eye Center in Utah, United States and Chief Innovation Officer at Prism Eye Institute in Toronto, Canada. “As one of the early adopters, I have experienced first-hand how iStent, as the first MIGS device, and subsequent generations have fundamentally revolutionized the way we think and treat glaucoma over the last decade. Today, the disease state is more manageable, and we are intervening earlier with micro-invasive surgical options. It’s been an incredible journey thus far and I’m excited to see what the future holds for our glaucoma patients.” “iStent technologies have allowed me to change the way I treat my patients for the better. Before the introduction of iStent and MIGS, we were limited to eye drops, which we know to be problematic for patients, or invasive surgery that carried more risk than needed for mild-to-moderate glaucoma. iStent filled that gap between eye drops and invasive surgery. In my practice today, iStent inject W is my most commonly used surgical option for glaucoma patients undergoing cataract surgery. We now have patient data out past 9 years in my practice showing the iStent is still effective and safe at lowering IOP and reducing medications. I’m eagerly anticipating the exciting future innovations from Glaukos.” John Berdahl, MD, Vance Thompson Vision, South Dakota “I am proud of this tremendous achievement for our company and the MIGS marketplace, reflecting decades of investment and successful advancement of our strategic vision to transform the treatment of chronic, debilitating eye diseases through development of novel, sustainable therapies,” said Thomas Burns, Glaukos chairman and chief executive officer. “I would like to recognize our customers and employees around the world who have poured countless hours into making this market-leading achievement a reality and am grateful for their continued support going forward as we strive to create transformative platform technologies designed to improve the standard-of-care and meet unmet patient needs.” Glaukos is proud to be the corporate pioneer and global market leader in MIGS, with its family of iStent technologies supported by more than 200 peer-reviewed publications, 20 plus years of clinical and commercial experience and more than one million iStent devices implanted worldwide since its inception. The company believes it offers the industry’s most comprehensive offering of minimally-invasive, tissue-sparing glaucoma solutions, supporting its goal to provide a full range of options to fit surgeons’ individual glaucoma treatment algorithms that offer the most favorable short- and long-term benefit-to-risk calculus at every stage of disease progression, from ocular hypertension through refractory disease, and in both combo-cataract and standalone procedures. Glaukos remains dedicated to innovation and bringing customers around the world best-in-class technologies to serve their patients, continuing to invest upwards of 30% of revenue back into R&D, including new product development. A significant number of clinical studies for both current and future products are ongoing, with additional studies commencing in the near future. About Glaukos Glaukos is an ophthalmic medical technology and pharmaceutical company focused on developing and commercializing novel therapies for the treatment of glaucoma, corneal disorders and retinal diseases. Glaukos first developed Micro-Invasive Glaucoma Surgery as an alternative to the traditional glaucoma treatment paradigm, launching its first MIGS device commercially in 2012, and continues to develop a portfolio of technologically distinct and leverageable platforms to support ongoing pharmaceutical and medical device innovations. Products or product candidates for each of these platforms are designed to advance the standard of care through better treatment options across the areas of glaucoma, corneal disorders and retinal diseases. About iStent inject W Trabecular Micro-Bypass System (U.S.) Indication for Use: The iStent inject W Trabecular Micro-Bypass System Model G2-W is indicated for use in conjunction with cataract surgery for the reduction of intraocular pressure (IOP) in adult patients with mild to moderate primary open-angle glaucoma.

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PHARMA TECH

Asahi Kasei Pharma to Sponsor Research for Drug Discovery Research and Technology: Open Innovation 2023

Asahi Kasei | October 17, 2022

Asahi Kasei Pharma, subsidiary of diversified Japanese multinational company Asahi Kasei, is publicly calling for new proposals for drug development research as part of its efforts for open innovation to promote pharmaceutical research and development through enhanced cooperation with universities, research institutes and enterprises around the world. The application period begins at 5:00 a.m. GMT on January 5, 2023 and ends at 8:00 a.m. GMT on February 28, 2023. Asahi Kasei Pharma established its Open Innovation Department in October 2016 with the mission to further strengthen and enhance global licensing and alliance-building activities, and has since funded around 5 proposals per year on average with a total of over 20 funded proposals for state-of-the-art pharmaceutical drug developments as well as collected a wealth of creative new ideas. The Open Innovation team is seeking to fund innovative proposals from researchers around the world for up to US$200,000 per year, per project for this upcoming round in 2023. Asahi Kasei Pharma will then pursue joint research opportunities with the drug discovery researchers together with their parent institutions in hopes to create new innovative drugs for diseases that currently have unmet needs or pioneer new platform technologies for drug discovery. Asahi Kasei Pharma has demonstrated a successful track record in developing new drugs in the realms of autoimmune, renal, neurological, and bone disease, so the organization can provide the greatest contribution from correlating research areas and subjects. "Asahi Kasei Pharma believes that nobody should have to give up what they would like to do because of illness. We believe great science comes from working together, and we are excited for the opportunity to accomplish this mission with researchers all over the world.” Osamu Matsuzaki, Primary Executive Officer and Head of R&D and Business Development at Asahi Kasei Pharma Open Innovation works to establish research collaborations related to innovative drug targets and candidate drug compounds up to the preclinical stage as well as advanced drug discovery technologies. Advancements in exploring a new mechanism of action for treating refractory autoimmune disease is one of the most promising outcomes of the research so far, with many more on the horizon. Asahi Kasei believes that these continued efforts to advance drug discovery and research technology will further contribute to life and living for people around the world. About Asahi Kasei The Asahi Kasei Group contributes to life and living for people around the world. Since its foundation in 1922 with ammonia and cellulose fiber businesses, Asahi Kasei has consistently grown through the proactive transformation of its business portfolio to meet the evolving needs of every age. With more than 46,000 employees around the world, the company contributes to a sustainable society by providing solutions to the world's challenges through its three business sectors of Material, Homes, and Health Care. Its health care operations include devices and systems for acute critical care, dialysis, therapeutic apheresis, transfusion, and manufacture of biotherapeutics, as well as pharmaceuticals and diagnostic reagents.

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