DNDi and Atomwise Collaborate to Advance Drug Development Using AI for Neglected Diseases

Atomwise, Inc. | April 16, 2019

A biotech company using artificial intelligence (AI) for drug discovery, and the Drugs for Neglected Diseases initiative (DND i ), a not-for-profit research and development organization working to deliver new treatments for neglected diseases, today announced that promising drug-like compounds have been discovered in a program to develop first-in-class treatments for Chagas disease. The research collaboration is part of Atomwise’s Artificial Intelligence Molecular Screen (AIMS) Awards program. The Centers for Disease Control and Prevention (CDC) estimates that 6-7 million people in the world have Chagas disease. Approximately 30% of those with Chagas disease develop life-threatening cardiac, digestive, or neurological disorders. DND i scientists selected three verified but challenging therapeutic protein targets that would inhibit the action of the parasite that causes Chagas disease. For each disease protein, Atomwise screened millions of compounds using its AI-powered screening technology to predict those that bind and potentially inhibit protein function. This research has delivered drug-like compounds that will now go on to further optimization and then potential drug development. Through the AIMS program, which supports hundreds of researchers at non-profit institutions and universities worldwide, Atomwise provided compounds at no cost to be tested by DND i researchers. “Our partnership with Atomwise has allowed us access to state-of-the-art technology that is more efficient and cost-effective than standard methods,” said Benjamin Perry, Ph.D., Senior Discovery Manager and Research Scientist at DND i. “Ultimately, the next step for this partnership will be to further develop the compounds in active discovery projects and help fill the pipeline of potential treatments for patients with Chagas disease. This win-win collaboration is showing the potential of new technology for neglected disease drug discovery.”

Spotlight

Parrish Galliher, Chief Technology Officer, Upstream, GE Healthcare Life Sciences Xcellerex, talks with BioPharm International about the challenges in biomanufacturing today and the strategies that biopharmas can leverage. He also compares and contrasts fed-batch versus perfusion processing.


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Prime Medicine Expands Leadership Team with Key Appointments to Support Continued Growth and Advancement of Prime Editing Technology and Portfolio

Prime Medicine | July 29, 2022

Prime Medicine, Inc. a biotechnology company committed to delivering a new class of differentiated one-time curative genetic therapies, Prime Editors, to address the widest spectrum of diseases by deploying Prime Editing technology “Prime Medicine is advancing a first-of-its-kind technology intended to expand the number of patients who may benefit from genetic medicines. We are thrilled to welcome Richard, Niamh and Fubao to the team. Together, they bring strong business acumen, extensive clinical and regulatory experience and leadership of successful teams that position us well to achieve our mission. These esteemed leaders have deep expertise across their respective focus areas, each of which is key to the advancement of our novel Prime Editing technology.” Keith Gottesdiener, M.D., Chief Executive Officer of Prime Medicine Richard Brudnick, Chief Business Officer, brings extensive industry experience, including leading successful business development transactions, across multiple stages of development and an array of therapeutic areas. Mr. Brudnick was previously Chief Business Officer and Head of Strategy at Codiak BioSciences and, before that, was Executive Vice President of Business Development and Alliance Management at Bioverativ, Inc., a company he helped found in 2016. Mr. Brudnick joined Bioverativ at the time of its spinoff from Biogen where, over the course of nearly 15 years, he initiated, led and completed numerous transactions, including for several of the company's marketed products and late-stage pipeline, including Tecfidera, Spinraza and its biosimilars joint venture with Samsung. Previously, Mr. Brudnick was the Chief Executive Officer of a regional pharmaceutical distribution business that he sold to a strategic buyer, co-founded two companies, and was a strategy consultant at Bain & Company. Mr. Brudnick earned his undergraduate degree in management science from MIT and his M.S. in management from the Sloan School of Management at MIT. Niamh Alix, Chief Human Resources (HR) Officer, is a human resources leader who brings nearly 20 years of experience helping to grow teams from small, early-stage organizations to global enterprises. She joins Prime from Orchard Therapeutics, where she was Vice President, Global Talent and HR Business Partner. Prior to that, Ms. Alix held multiple global and regional roles at Lonza, including HR Business Partner for Americas, Mexico, and Canada where she led the HR team and people strategy for a 5,000+ employee population across corporate and manufacturing clients, and across multiple scientific platforms including cell and gene therapy. Prior to that, she held senior HR roles of increasing responsibility at Novartis and Bristol Myers Squibb. She holds a master’s degree in HR strategies from Dublin City University and a B.Sc. in management from the Technological University of Dublin. Fubao Wang, Ph.D., SVP, Head of Regulatory, has substantial experience leading product development of genomic medicine products, as well as regulatory strategies and execution for both clinical and commercial-stage products. Before Prime, Dr. Wang served as Senior Vice President, Head of Regulatory Affairs at Asklepios BioPharmaceutical where he built and led the regulatory team to support the development of clinical-stage AAV-based gene therapy products. Earlier, he was Vice President, Head of Regulatory CMC at Sarepta Therapeutics, where he supported the development of AAV gene therapy and RNA products, including the FDA approvals of Vyondys and Amondys. He also served as Associate Vice President, U.S. Site Head, CMC Dossiers at Sanofi to support the BLA approval of Dupixent, a monoclonal antibody product. Prior to that, he held a 16-year tenure at Merck serving in research, development and regulatory roles of increasing responsibility, most recently as director, global and emerging markets regulatory affairs, led and contributed to the discovery and development of a variety of vaccine and biologics products. Dr. Wang holds a Ph.D. in molecular biology from Heidelberg University and completed his postdoctoral work in molecular biology at Stanford University. About Prime Medicine Prime Medicine, Inc. is a biotechnology company committed to delivering a new class of differentiated, one-time, curative genetic therapies to address the widest spectrum of diseases. The company is deploying Prime Editing technology, a versatile, precise, efficient and broad gene editing technology, which is designed to make only the right edit at the right position within a gene. With the theoretical potential to repair approximately 90 percent of known disease-causing genetic mutations across many organs and cell types, medicines based on Prime Editing, if approved, could offer a one-time curative genetic therapeutic option to a broad set of patients.

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Love Pharmas Investment in US Biotech Offers Strategic Industry Advantages and Enhanced Shareholder Value

LOVE Pharma | September 09, 2022

Love Pharma Inc. an international mental health and sexual wellness company, remains extremely active in shaping itself into a real competitor in the biotech/pharmaceutical space. The company’s growth and development plan took a major leap forward this week with the announcement that Love Pharma is establishing a “strategic alliance” with Starton Therapeutics a leading clinical-stage biotechnology company in the United States. It’s a relationship that finds Starton ideally aligned with Love Pharma’s mission of improving “quality of life” for its customers. And the benefit to Love Pharma is that Starton is well on its way to transforming standard of care therapies with its proprietary dermal drug delivery technology that allows cancer patients to receive continuous treatment so they can live better, longer. Love Pharma’s investment in Starton Therapeutics is primarily based upon “the company’s interest in innovative drug delivery technology, such as transdermal patches that can reduce side effects, transforming patient outcomes with established, approved medicines allowing for streamlined market entry with long-term IP protections.” A partnership with Starton offers a host of advantages to Love Pharma and its shareholders, including a wealth of experience from industry leaders, proven clinical trials using its proprietary technology, and a “continuous drug delivery” platform that Love Pharma could exploit in the development of its own clinical portfolio—especially in the “addiction” space. The company’s strategic investment certainly makes a lot of sense for the future of this young global brand. “This investment provides our shareholders with exposure to a rapidly developing therapeutics business, which just reported positive data from a phase 1 clinical trial evaluating the pharmacokinetics and safety of the company’s continuous delivery lenalidomide program. Starton is also entering a phase 2 trial, which the U.S. Food and Drug Administration has already cleared an Investigational New Drug application for STAR-OLZ in Chemotherapy Induced Nausea and Vomiting (CINV). Love Pharma’s Chief Executive Officer (CEO), Zachary Stadnyk, said of the relationship “With this investment in Starton, we are building our relationship, forming an alliance, and look to Starton’s expert management team to reduce risk in our own portfolio of clinical pursuits and focus more on the addiction space.” So, what made Starton Therapeutics an attractive investment now? Well, earlier this year, Love Pharma partnered with researchers at Johns Hopkins University. This research initiative aligns with key principles in Love Pharma’s strategy as it aims to develop innovative products that establish new consumer applications based upon science and efficacy. And to further its meticulous plan, the company likely sees a much smoother path forward by expanding its development strategy to include guidance from a vast selection of industry and clinical experts and a highly de-risked avenue into the clinic by way of this strategic alliance with Starton. It's no secret that Love Pharma wants to develop its own clinical portfolio, and specifically, has its eye on developing therapeutic treatments for addiction. Pharmaceutical applications for addiction and recovery treatment are an unmet need and represent a growing market, including in the cannabis space where the Johns Hopkins research initiative is focused. With Starton’s mission of delivering meaningful patient outcomes by leveraging the untapped potential of continuous delivery and dermal technology, it’s obvious that Love Pharma sees this platform technology and its endless opportunities for expansion, as an ideal platform on which it can develop its own therapeutic treatment(s) for addiction. The benefit to partnering with Starton and having access to its platform technology is that the “proof of concept” is complete, and the technology has proven it can address unmet medical needs using already FDA-approved drugs to transform patient outcomes. For Love Pharma and its shareholders, this means much of the hard work is already done. Starton’s proprietary continuous delivery technology can increase efficacy of approved drugs, make them more tolerable, and expand their potential use. Starton uses three different delivery technologies to provide continuous, low-dose delivery as part of its strategic platform that provides a controlled, sustained release over multiple days. Starton uses proven transdermal and subcutaneous technologies to transform approved medicines–establishing superiority or new indications. It is the potential to establish a new indication/use for already approved drugs using the delivery technology, namely in the addiction space that is enticing to Love Pharma. And Love Pharma isn’t stopping there. The company announced that “to further accelerate its planned strategic alliance with Starton, and to bolster the company’s own biotech initiatives in the area, Love Pharma is in discussions with TRPL Laboratory, the lab that develops and supports Starton’s transdermal drug delivery programs and is a global leader in transdermal delivery systems.” Investors in Love Pharma couldn’t ask for a better way to reduce the risk associated with the company developing its own clinical portfolio than by surrounding itself with a plethora of industry and clinical leaders. That expertise begins with Pedro Lichtinger, the CEO and Chairman of the Board at Starton. Lichtinger has spent almost 40-years in the biotechnology arena, including 16 years at Pfizer as President of Global Primary Care and as Pfizer’s President of Europe. Additionally, Love Pharma can draw from the experiences of the former Global Lead, Multiple Myeloma at Celgene, world-renowned scientific leaders in their field leading each program at Dana Farber/Harvard, Mayo Clinic, and Moffitt Cancer Center, and a breadth of operational expertise in regulatory, clinical development, manufacturing, and intellectual property. The company stated that it is currently identifying and assessing disruptive opportunities within the transdermal biotechnology field, which it believes can be a superior delivery system in many cases for new and existing pharmaceutical therapeutic drugs. With its initial investment in Starton, the company believes it can leverage their expertise and proven success to credibly evaluate potential acquisitions in the transdermal field of advanced drug delivery systems. This news should be seen as extremely encouraging by the company’s investors as it could dramatically accelerate Love Pharma’s path to the clinic and the development of its own clinical portfolio. After all, it is these relationships in the biopharma industry that can lead to promising results and real shareholder value. About Love Pharma Inc. With a focus on the global sexual Health and Wellness markets, Love Pharma Inc. was founded in 2020, with a mission to bring to market innovative products that enhance sexual health and wellness while providing an improved quality of life. Love Pharma holds exclusive licenses to produce, market, package, sell, and distribute patent-protected therapeutic and pharmaceutical products throughout Europe, the United Kingdom, and North America. About Starton Therapeutics A clinical-stage biotechnology company focused on transforming standard of care therapies with proprietary dermal technology, so people with cancer can receive continuous treatment to live better, longer. Starton’s proprietary transdermal technology is intended to increase efficacy of approved drugs, to make them more tolerable and expand their potential use. About Stock Market Media Group Stock Market Media Group is a News and Media content development IR firm offering a platform for corporate stories to unfold in the media with press releases, feature news articles, research reports, corporate videos, and radio-style CEO interviews.

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Enable Injections Enhances Board with Addition of John DeFord, Ph.D.

Enable Injections, Inc. | August 12, 2022

Enable Injections, Inc. a company developing and manufacturing the enFuse® platform of investigational wearable drug delivery systems, is pleased to announce the appointment of John DeFord, Ph.D. to the company's Board of Directors, effective July 29, 2022. Enable Injections' enFuse is an innovative drug delivery technology designed to subcutaneously (SC) deliver large volumes of up to 50mL for a wide range of therapies and diseases, dedicated to improving the patient experience. Dr. DeFord brings over three decades of expertise as a global medical technology executive, most recently the executive vice president and chief technology officer for Becton, Dickinson and Company (BD) (BDX), a global medical technology company. Prior to BD, Dr. DeFord served in senior science, technology and leadership roles of increasing responsibility at organizations such as C.R. Bard and Cook Incorporated, with additional experience in venture capital as managing director of Early Stage Partners venture capital fund. He is currently also a member of the board of directors at Nordson Corporation (NDSN), NuVasive (NUVA), and Blue Spark, Inc. DeFord graduated from Purdue University with a bachelor's degree and master's degree in electrical engineering, and a Ph.D. in electrical/biomedical engineering, dedicating his career to innovative medical technologies to save lives, enhance quality of life and improve the patient experience. "Enable Injections is at the forefront of both simplifying the therapeutic delivery of critical medications and enhancing quality of life for the patient. I am excited to join the Board of Directors at this important time in the company's growth and development; and I look forward to working with the management team and Board to help accelerate translation of this important technology to the clinical setting." Dr. DeFord "We are pleased to welcome Dr. DeFord as a new director to Enable's Board," said Mike Hooven, President and CEO of Enable Injections. "We believe adding depth of experience in the global medical technology space such as Dr. DeFord's is key to the strong growth of our business." About Enable Injections Cincinnati-based Enable Injections is a global healthcare innovation company developing and manufacturing drug delivery systems designed to improve the patient experience. Enable's body-worn enFuse® delivers high-volume pharmaceutical and biologic therapeutics via subcutaneous administration, with the aim of improving convenience, supporting superior outcomes, and advancing healthcare system economics.

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Hyfe Joins Forces with Merck to Deploy Its Artificial Intelligence-Powered Cough Detection and Counting Technology

Hyfe, Inc. | July 20, 2022

Hyfe, Inc., the global leader in AI-powered cough detection, tracking and classification, has entered into an agreement with Merck, known as MSD outside the United States and Canada, to integrate its artificial intelligence-powered (AI) cough tracker technology into Merck’s consumer disease educational efforts.. Hyfe’s AI-powered technology passively and remotely monitors the number of times a person coughs and the sound of the cough through any smart device, such as a mobile phone. This data collected over time provides the user with helpful information by revealing patterns and potential triggers like seasonal allergies that may be causing the cough that would otherwise go unnoticed or unaddressed. “The overwhelming majority of people cannot even come close to accurately estimating the number of times they cough per day. In order to help diagnose and treat patients, cough frequency and sound should be monitored and measured with the same accuracy as blood pressure, temperature, heartbeat and other biomarkers that are essential for assessing health and medical conditions.” Peter Small, M.D., chief medical officer of Hyfe, Inc Users of the app will be able to determine when and how long to track their coughing. The AI-powered technology records cough-related sounds and allows the user to compare the frequency and quality of their coughs against their own benchmark. This personalized approach provides users with more detailed information and confidential data about their individual situations to share with their health care providers. Hyfe, Inc. is the global leader in AI-powered cough detection and classification that provides insight into cough patterns and correlations that can greatly improve treatment and prevention. With more than 280 million samples, Hyfe maintains the largest cough dataset in the world enabling the building of powerful models to track, manage and diagnose respiratory illnesses. Hyfe provides platforms and data for pharmaceutical companies, medical researchers, government agencies, health care providers and patients and has partnerships with leading academic institutions including Johns Hopkins University and the University of California at San Francisco. The company was founded in 2020 and is headquartered in Wilmington, Delaware.

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Spotlight

Parrish Galliher, Chief Technology Officer, Upstream, GE Healthcare Life Sciences Xcellerex, talks with BioPharm International about the challenges in biomanufacturing today and the strategies that biopharmas can leverage. He also compares and contrasts fed-batch versus perfusion processing.

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