PureTech acquires LYT-100 to treat lymphedema

Pharmatimes | July 17, 2019

PureTech Health has announced that it has acquired and plans to develop a clinical-stage product candidate for the potential treatment of lymphatic and immunofibrotic diseases, including lymphedema.The candidate, LYT-100, demonstrated anti-fibrotic and anti-inflammatory mechanisms in pre-clinical studies and was observed to be well tolerated with a favourable pharmacokinetic profile to support twice daily oral dosing. The oral, small molecule candidate expands PureTech’s internal R&D pipeline and continues its progress in developing new medicines based on insights into the lymphatic system and local modulation of the immune system for the treatment of immune and central nervous system disorders, lymphatic conditions, and cancers. The current standards of care for lymphedema – compression and physical therapy – are cumbersome and non-curative approaches that cannot correct immune cell infiltration or regenerate the dysregulated lymphatics. “Lymphedema is a chronic and incurable secondary disease affecting millions of people, and there has been far too little progress made toward the development of meaningful treatments,” said Joe Bolen, chief scientific officer of PureTech.

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PHARMACY MARKET

AIkido Pharma Reports Improved Manufacturing Process and New United States Patent for Pancreatic Drug

AIkido Pharma Inc. | March 04, 2022

AIkido Pharma Inc.reported an improvement in the manufacturing process for its pancreatic cancer drug, DHA-dFdC, licensed from the University of Texas at Austin. The Company also reported the issuance of an additional U.S. patent covering the drug, and the filing of a continuation patent application intended to expand patent coverage to other facets of the drug. With respect to manufacturing process, the Company reported the successful development of a new means for the scaled production and isolation of the key intermediate compound in the manufacture of DH-dFdC. The Company has now executed a further contract with its contract manufacturing organization, Parimer Scientific, to employ the new process to produce several thousand milligrams of the drug for use in formulation development and stability studies. The Company also reported that the U.S. Patent Office recently issued new U.S. Patent No. 11,219,633, which provides additional intellectual property protection for the drug compound. The term of the patent is expected to continue until May of 2035 with the payment of required maintenance fees. Prior to the patent issuance, the Company authorized the timely filing of a patent continuation application, U.S. Serial No. 17/539,682, in which additional claims related to various aspects of the drug and formulation will be pursued. "This new process significant step forward in the development of our pancreatic cancer drug and should permit production of the drug on a commercial scale at a lower cost. I am also pleased that we can continue to report expansion of the patent estate." Anthony Hayes, CEO of AIkido Richard T. Pace, Owner and Principal Scientist of Parimer Scientific, stated, "The newly developed manufacturing method is a large step forward for this innovative technology. I believe it will reduce cost per unit and at the same time increase batch production volumes." About AIkido Pharma Inc. AIkido Pharma Inc. was initially formed in 1967 and is a biotechnology Company with a diverse portfolio of small-molecule anticancer and antiviral therapeutics. The Company's platform consists of patented technology from leading universities and researchers, and we are currently in the process of developing an innovative therapeutic drug platform through strong partnerships with world renowned educational institutions, including The University of Texas at Austin and University of Maryland at Baltimore. Our diverse pipeline of therapeutics includes therapies for pancreatic cancer, prostate cancer. We are constantly seeking to grow our pipeline to treat unmet medical needs in oncology. The Company is also developing a broad-spectrum antiviral platform that may potentially inhibit replication of multiple viruses including Influenza virus, SARS-CoV (coronavirus), MERS-CoV, Ebolavirus and Marburg virus.

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PHARMACY MARKET

Ultivue Announces Co-Marketing Agreement with Aignostics for Unique Spatial AI-Powered Imaging Solutions for Translational Medicine

Ultivue, Inc., | March 10, 2022

Ultivue, Inc., an industry leader in multiplexing tools and novel image analysis solutions for tissue biomarker studies, and Aignostics GmbH, a global leader in Artificial Intelligence (AI) powered precision diagnostics focused on pathology to assist with research, clinical trials and CDx development, announced a partnership to collaborate on the co-development of AI-powered spatial multiplexed immunophenotype solutions for translational research groups and Biopharma. The companies have already been working together since early 2021 to adapt Aignostics’ client platform to support visualization and analysis for some of Ultivue’s products and services, as well as provisioning of results and corresponding reports. The resulting co-developed platform will now be made available to joint clients. Additionally, proof of concept work conducted on the Ultivue 12-plex Immunophenotyping biomarker panel in over 1,000 clinical NSCLC cases has demonstrated encouraging results for the capacity of AI-based analysis of multiplexed images for more consistent and reproducible readouts at scale. These results will be published later this year and respective AI models made available via the platform. The companies are now expanding their relationship under a co-marketing agreement to offer the multiplex immunofluorescence (mIF) platform to their respective biotech and pharma clients, initially for research use, with a GCP-compliant version to follow later this year. Moreover, Ultivue and Aignostics will offer AI-powered image analysis services within the platform via Aignostics “Explainable AI” approach for the consistent and precise analysis of mIF cohorts at scale, for both translational research and clinical trial research services in Ultivue’s CLIA accredited clinical research laboratory. “We are excited to extend our workflow offering to include mIF AI for highly automated image analysis by partnering with Aignostics,” says Florian Leiss, VP Digital Health at Ultivue. “Improved viewing capabilities enable us to interactively explore the interplay of mIF-labeled cell populations in the histological context of same-slide H&E.” “We believe that development of Ultivue’s assays with our AI-powered image analysis will create insights from data at scale that are unprecedented in spatial biology today. We are excited to start offering this approach to our clients for translational science and clinical trials,” Viktor Matyas, CEO of Aignostics Besides offering research and development services to its clients, Ultivue and Aignostics will also develop products for standardized analysis of certain Ultivue products, paving the way for more widespread use of these technologies in both clinical trials and clinical routine. About Ultivue Ultivue provides researchers and scientists in translational medicine with multiplex biomarker assays for tissue phenotyping and digital pathology. Its proprietary InSituPlex® technology enables advanced exploration and interrogation of tissue samples for precision medicine research. These highly customizable solutions coupled with our scientific consultative approach strengthen and accelerate biomarker discovery and drug development programs. About Aignostics Aignostics, a Berlin based company with offices in the US, is a digital pathology company dedicated to novel precision diagnostics through the use of a proprietary “Explainable AI” platform in pre-clinical and translational research and clinical trials. The use of such technology is expected to be crucial to implementation of AI-powered algorithms in routine diagnostics in order to verify (explain) the model’s decision outputs. Additionally, through its close alignment to Charité and TU Berlin amongst other collaborators, only Aignostics offers the combination of data access, sample testing and pathology expertise to develop digital pathology algorithms spanning multi-modal biomarker assay detection systems such as H&E, IHC and mIF, amongst others.

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BUSINESS INSIGHTS

PhaseBio Pharmaceuticals to Participate in the Cowen 42nd Annual Health Care Conference

PhaseBio Pharmaceuticals, Inc. | February 25, 2022

PhaseBio Pharmaceuticals, Inc. a clinical-stage biopharmaceutical company focused on the development and commercialization of novel therapies for cardiovascular diseases, today announced that Chief Executive Officer Jonathan P. Mow will participate in a panel discussion during Cowen’s 42nd Annual Health Care Conference taking place virtually on Tuesday, March 8, 2022 from 12:50 pm – 1:50 pm ET. Interested parties can access the live and archived webcasts of the virtual session on the “Events and Presentations” page of the “Investors” section of the company’s website at www.phasebio.com. The webcast replay will be available for 90 days after the conclusion of the live presentation. About PhaseBio PhaseBio Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company focused on the development and commercialization of novel therapies for cardiovascular and cardiopulmonary diseases. PhaseBio’s pipeline includes: bentracimab (PB2452), a novel reversal agent for the antiplatelet therapy ticagrelor; pemziviptadil (PB1046), a once-weekly VIP receptor agonist for the treatment of pulmonary arterial hypertension; and PB6440, an oral agent for the treatment of resistant hypertension. PhaseBio’s proprietary elastin-like polypeptide technology platform enables the development of therapies with potential for less-frequent dosing and improved pharmacok

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BUSINESS INSIGHTS

Bruker Acquires Optimal Companies for Pharma PAT Software and Biopharma Manufacturing Automation Expertise and Technologies

Bruker Corporation | April 06, 2022

Bruker Corporation announced the acquisition of Optimal Industrial Automation and Technologies, a leader in pharma and biopharma process analytical technology pharma manufacturing automation and Quality Assurance (QA) software and systems integration, based in the United Kingdom. The Optimal biopharma tools acquisition strengthens Bruker as a key software and solutions provider for small molecule, biologics and new drug modalities pharma companies. Financial details of the acquisition were not disclosed. Optimal’s 2022 revenue is expected to be approximately $10 million, and Optimal’s revenue growth rate and operating margins are projected to be accretive to Bruker in 2023 and beyond. The Optimal biopharma tools and automation capabilities complement Bruker’s innovative and differentiated high-value NMR, mass spectrometry, SPR, molecular spectroscopy and X-ray scientific instruments, and life-science solutions for biopharma drug discovery and development, as well as for PAT analytical and QA solutions. Together these biopharma tools enable Bruker’s global biopharma customers to bring efficacious and safe medicines to market more quickly. Optimal has a focus on the automation and optimization of batch and continuous processes in the biopharma industry – from R&D to manufacturing. As an integrated PAT solutions provider, Optimal offers development, testing, deployment and support of quality-centric pharmaceutical production systems. Optimal has more than 30 years of experience in successfully delivering regulatory-compliant biopharma solutions, ranging from the development of automated control systems for process control to the market-leading, vendor-agnostic PAT knowledge management software synTQ®. The synTQ PAT software can interface between multiple analytical instruments (spectral and univariate), multi-variate analysis (MVA) packages, manufacturing control systems and a range of adjacent software solutions to ensure quality in real-time. As a 2021 Pharma Innovation Award winner, synTQ is a proven enabler of quality-by-design (QbD) via PAT. For users of synTQ, this can significantly increase productivity and quality, while reducing waste, time-to-manufacture and time-to-market, with proven Optimal use cases tripling biopharma productivity. While remaining a vendor-agnostic biopharma solutions provider, Optimal can integrate bioanalytical technologies such as nuclear magnetic resonance (NMR), mass spectrometry (MS) and FTIR/NIR/Raman systems into innovative drug discovery, development, PAT and quality control workflows. Combining next-generation, high-performance technologies with Optimal solutions eases the transition from development to biopharma manufacturing, while remaining in regulatory compliance. “The acquisition of Optimal is a very exciting step for Bruker as it supports more comprehensive solutions for the biopharmaceutical industry, now adding the capabilities to integrate cutting-edge systems into biopharma manufacturing processes and workflows. We welcome the Optimal team with their strong PAT and automation expertise and, together, are eager to support biotech and pharmaceutical companies in increasing their manufacturing efficiency and flexibility – a global need highlighted by the response to the pandemic crisis.” Dr. Falko Busse, President of the Bruker BioSpin Group Mr. Martin Gadsby, the CEO and Co-Founder of Optimal Industrial Automation and Technologies, added: “We are delighted to become part of the Bruker family. Optimal and Bruker together are a perfect fit – we share the common ethos of innovation with integrity, together with our industry recognition as a high-quality solutions provider delivering tangible benefits to our customers. The whole Optimal team is excited by this new chapter in our history and looks forward to delivering benefits to even more biopharma customers and ultimately to patients around the world.” About Optimal Industrial Technologies and Automation A well-established system integrator with more than 30 years of experience, at Optimal we specialize in automating a client’s R&D or manufacturing system to ensure that their processes remain at the highest level of efficiency. The demands being placed on manufacturers in relation to production costs, product quality and business sustainability are ever increasing, and our primary aim within Optimal is to assist you in being the most competitive supplier of your product to the highest level of quality in the worldwide marketplace, and to ensure that you continue to maintain your lead in the years ahead. We have a rare and wide-ranging skill set covering a multitude of automation technologies, manufacturing processes and industry types, with very specific knowledge in highly regulated environments. In addition, we manufacture the world leading PAT Data Management software package - synTQ® and the widely used integrated Print and Inspect system - synTI®. The combination of our PAT implementation knowledge and synTQ® product together with our automation experience positions us with unique skills that can be leveraged to great advantage by our customers. About Bruker Corporation Bruker is enabling scientists to make breakthrough discoveries and develop new applications that improve the quality of human life. Bruker’s high-performance scientific instruments and high-value analytical and diagnostic solutions enable scientists to explore life and materials at molecular, cellular and microscopic levels. In close cooperation with our customers, Bruker is enabling innovation, improved productivity and customer success in life science molecular research, in applied and pharma applications, in microscopy and nanoanalysis, and in industrial applications, as well as in cell biology, preclinical imaging, clinical phenomics and proteomics research and clinical microbiology.

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