Are Phages the Wave of the Future? Using Viruses to Treat Bacterial Diseases

biospace | May 16, 2018

Researchers with the University of Pittsburgh in Pennsylvania used a genetically modified bacteriophage—a type of virus that infects bacteria—to successfully treat 15-year-old Isabelle Carnell-Holdaway, a British girl with cystic fibrosis who had been fighting a drug-resistant Mycobacterium abscessus infection half her life. Her physician, Helen Spencer, with London’s Great Ormond Street Hospital, was out of options and reached out to Graham Hatfull at U of P. Their approach appeared to work, although they caution that because it was outside a controlled clinical trial, there may be other factors to their patient-specific cocktail. She continues to receive the treatments, which haven’t cured the infection, but appears to have it under control. The research was published in the journal Nature Medicine. Earlier this year, Ella Balasa, a 26-year-old from Richmond, Virginia, made the news when she was apparently successfully treated for a lung infection using a bacteriophage. Balasa has cystic fibrosis, which she was diagnosed with at the age of one year.

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Biomaterials are engineered materials that have been designed to interact with biological systems, for example, when implementing a medical implant or other
devices.

Spotlight

Biomaterials are engineered materials that have been designed to interact with biological systems, for example, when implementing a medical implant or other
devices.

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MEDTECH

Bionaut Labs Closes $43M in Series B Led by Khosla Ventures to Advance First-in-Class Micro-Robotic Technology and Remove Barriers

Bionaut Labs | November 29, 2022

Bionaut Labs, the company that uses microscale robots to revolutionize the treatment of central nervous system diseases and disorders, announced $43.2M in a Series B round of financing led by Khosla Ventures, bringing the company’s total financing raised to date to $63.2 million. Also participating in the round are new investors Deep Insight, OurCrowd, PSPRS, Sixty Degree Capital, Dolby Family Ventures, GISEV Family Ventures, What if Ventures, Tintah Grace and Gaingels, along with all existing investors - Upfront Ventures, BOLD Capital Partners, Revolution VC, and Compound. Many diseases of the brain and central nervous system are hard to treat because it is difficult to deliver therapeutics beyond the blood-brain barrier and reach deep locations in the midbrain with precision. Through magnetic propulsion, Bionauts™ can navigate the depths of the human body to deliver drugs locally, generating efficacy and avoiding side effects and toxicity from systemically delivered drugs. By reaching the midbrain safely through novel routes, Bionaut Labs aims to develop solutions to treat the most debilitating conditions including Parkinson’s disease and Huntington's disease, malignant glioma and hydrocephalus. Funds will be used to advance clinical development of the company’s lead programs against malignant glioma brain tumors and Dandy-Walker Syndrome (a rare pediatric neurological disorder). Funds will also support further development of its proprietary Bionaut™ treatment platform, allowing future expansion of clinical targets and progression through Bionaut’s two accelerated FDA designations. Bionaut Labs will release major pre-clinical data packages from IDE and IND enabling studies in 2023, with the goal of initiating human clinical trials in 2024. “There has been a dearth of innovation around treatments for conditions that cause tremendous suffering, in large part because past failures have discouraged even the best of researchers. Bionaut Labs remains committed to finding new ways to treat these devastating diseases, which are long overdue for a breakthrough.” Michael Shpigelmacher, co-founder and CEO, Bionaut Labs Bionaut Labs is co-founded by two robotics entrepreneurs, Michael Shpigelmacher and Aviad Maizels, who previously co-founded PrimeSense, the company that developed the facial recognition tech behind iPhone’s FaceID. Its leadership and medical team consists of experts across robotics, neuroscience, biology and drug development. “We are extremely excited about the transformative potential Bionaut presents in treating debilitating neurological disorders,” said Vinod Khosla, founder of Khosla Ventures. “Anatomically precise treatment will make traditionally-used methods seem archaic, and Bionaut is at the forefront of this movement.” “Bionaut Labs tackles a complex pharmaceutical problem which many companies have failed to address in the past,” said Giammaria Giuliani, director of the GISEV Family Office. “As pioneers of micro-robotics for CNS treatment, the company enjoys a strong first-mover advantage and carries great promise.” As neurodegeneration continues to grow in prevalence in the aging global population, Bionaut Labs offers unprecedented therapeutic access to the brain and other hard-to-reach locations in the body, diagnosing and treating diseases that were previously unreachable. Bionaut Labs will transform the way the biopharmaceutical industry develops treatments by offering a mechanism to engineer the therapeutic index for optimal efficacy and safety. About Bionaut Labs Bionaut Labs is a biotech company pioneering precision micro-technology with the deployment of microscale robots to remove the barriers of localized treatment and detection of diseases. Magnetic propulsion-controlled Bionauts navigate to deep locations in the human body and brain safely and precisely through non-linear 3D trajectories, making Bionaut Labs the first to access the midbrain through previously inaccessible anatomical routes. Bionauts can perform localized treatment, detection and precise medical procedures to deliver outcomes that were previously unattainable. The FDA has granted Bionaut Labs a Humanitarian Use Device designation for BNL-201, a micro-robot design to treat Dandy Walker Malformation, and an Orphan Drug Designation for BNL 101, a drug-device combination for treatment of malignant glioma.

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CELL AND GENE THERAPY, INDUSTRIAL IMPACT

Aldevron Launches Type-V CRISPR Nuclease, Eureca-V™ MAD7®

Aldevron | January 20, 2023

Aldevron®, a worldwide leader in the custom development and production of plasmid DNA, RNA, and proteins for the biotech sector, recently announced the launch of Eureca-V™ nuclease. Eureca-V™, licensed from Inscripta®, is the wild-type MAD7® CRISPR Type-V nuclease at research grade, with GMP to follow. The launch of Aldevron's Eureca-V nuclease at advanced therapies week expands the toolkit of accessible CRISPR nucleases for therapeutic, diagnostic, and agricultural workflows. In addition, a pass-through license for research use is conveyed with the purchase of Eureca-V nuclease, allowing customers to thoroughly examine the product without committing to a long-term licensing agreement. Vice President and General Manager of Aldevron's Protein Business Unit, Tom Foti, said, "The availability of Eureca-V drives forward the entire genomics medicine industry and enhances Aldevron's position as a supplier of choice for CRISPR drug substances and drug products." He added, "We are proud to work alongside our partners at Inscripta to bring the innovative, off-the-shelf catalog product to market now as well as provide a clear path to GMP in 2023." (Source – Cision PR Newswire) Eureca-V at the research grade level ensures the acceleration of CRISPR translational research. In addition, the product will assist academic and commercial scientists seeking a wild-type Type-V CRISPR nuclease that targets T-rich regions of the genome. Venkata Indurthi, Chief Scientific Officer at Aldevron, expressed, "We are thrilled to offer Eureca-V product at research grade starting today, and later this year, our clients can expect a smooth transition to our GMP product." He further added, "Aldevron's extensive history in CRISPR nucleases allows researchers to develop therapies that will eventually address global health issues." (Source – Cision PR Newswire) It will be the third GMP CRISPR nuclease by Aldevron and the first Type-V nuclease available as a GMP catalog product. It is a leader in supplying vital raw materials and reagents used for cell and gene therapy manufacturing. The company's portfolio of CRISPR nucleases is applied globally in preclinical and clinical research applications. About Aldevron Aldevron is a pioneer in advancing biological science. Its custom development and manufacturing services have provided scientists all across the world with the components they need to accelerate research and create labs for revolutionary science and breakthrough discoveries. The company aims to deliver products and services that contribute significantly to global biological research. It seeks to be the partner of choice forproducing high-quality plasmid DNA, proteins, enzymes, and other biologicals to support its clients' goals.

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INDUSTRIAL IMPACT, MEDICAL

Bioasis Technologies Inc. Announces Merger with Midatech Pharma plc

Bioasis Technologies Inc. | December 14, 2022

BIOASIS TECHNOLOGIES INC. a multi-asset rare and orphan disease biopharmaceutical company developing clinical stage programs based on epidermal growth factors and a differentiated, proprietary xB3™ platform for delivering therapeutics across the blood-brain barrier and the treatment of central nervous system disorders in areas of high unmet medical need, today announced that it has entered into a definitive agreement dated December 13, 2022 with Midatech Pharma plc a company focused on the research and development of medicines that would benefit from improved bio-delivery or bio-distributions using proprietary drug delivery technologies, pursuant to which Midatech will acquire 100% of the issued and outstanding common shares in the capital of Bioasis from Bioasis’ shareholders in exchange for ordinary shares of Midatech in the form of American depositary shares. Midatech has also entered into securities purchase agreement with an institutional investor for (i) a registered direct offering of ADSs for gross proceeds of approximately US$400,000 that is expected to be completed on or about December 15, 2022 and a private placement equity financing for gross proceeds of approximately US$9.6M that will be completed concurrently with Midatech’s acquisition of Bioasis. The combination of Bioasis and Midatech will create a multi-asset rare and orphan disease company that will be renamed Biodexa Pharmaceuticals PLC (“Biodexa”). Bioasis and its shareholders are expected to benefit from Biodexa’s capital markets profile in the United States as a NASDAQ-listed company, as well as increased trading liquidity and broadened appeal to global index and generalist investors relative to Bioasis’ status as a TSXV-listed company. Biodexa is expected to have strengthened balance sheet with pro forma cash of approximately C$17.9 million as at June 30, 2022. Biodexa is also expected to benefit from the collective scientific, technical, and operational expertise of both Midatech and Bioasis as well as cost synergies as a result of the elimination of duplicative salaries, administrative and regulatory costs and other public company expenses. Through their ownership of ADSs, current Bioasis securityholders will maintain exposure to the value that is expected to be unlocked as Bioasis and Midatech’s pipeline programs progress through clinical development and the drug delivery technologies secure additional partnerships. Bioasis’ Executive Chair, Deborah Rathjen PhD, commented “As shareholders are aware, in December 2021 we indicated that Bioasis would seek value accretive strategic alternatives and pursue opportunities that have the potential to unlock value and liquidity for shareholders. With this transaction and through the formation of Biodexa, it is anticipated that Bioasis’ pipeline will achieve value accretive milestones whilst continuing to monetize the xB3 platform through additional partnerships. Once the transaction is closed, Bioasis shareholders will have access to the benefits of a NASDAQ listing through their ownership of Biodexa. We are very excited by the prospects for this transaction given the evident synergies between Bioasis and Midatech”. Mr Stephen Stamp, Midatech CEO and incoming Biodexa CEO added “By combining the two groups to create Biodexa Pharmaceuticals, we have the opportunity to reposition the enlarged group as an emerging biotech company focused on the development of therapeutics for rare diseases, supported by Midatech and Bioasis’s enabling drug delivery platforms. We continue to believe there is substantial value to be unlocked from Midatech’s MTX110, particularly in glioblastoma, and to leverage our Q-Sphera technology. In combination with Bioasis’s promising development pipeline we have the opportunity to create a much stronger group.” About Bioasis Bioasis Technologies Inc. is a multi-asset rare and orphan disease biopharmaceutical company developing clinical stage programs based on epidermal growth factors and the xB3™ platform, a proprietary technology for the delivery of therapeutics across the blood brain barrier and the treatment of CNS disorders in areas of high unmet medical need. The delivery of therapeutics across the blood-brain barrier represents the final frontier in treating neurological disorders. The in-house development programs at Bioasis are designed to develop symptomatic and disease-modifying treatments for brain-related diseases and disorders. About Midatech Midatech is a drug delivery technology company focused on improving the bio-delivery and biodistribution of medicines. Midatech combines approved and development medications with its proprietary and innovative drug delivery technologies to provide compelling products that have the potential to powerfully impact the lives of patients. Midatech has developed three in-house technology platforms, each with its own unique mechanism to improve delivery of medications to sites of disease. All of Midatech’s technologies have successfully entered human use in the clinic, providing important validation of the potential for each platform: (i) Q-Sphera™ platform: a disruptive micro-technology used to prolong and control the release of injectable therapeutics over an extended period of time (from weeks to months), (ii) MidaSolve™ platform: an innovative nanotechnology used to solubilize inherently insoluble drugs so that they can be administered in liquid form directly and locally into tumors and (iii) MidaCore™ platform: a gold nanotechnology used for targeting medications to sites of disease. The platform nature of the technologies offers the potential to develop multiple drug assets rather than being reliant on a limited number of programs. Midatech’s technologies are supported by 36 patent families including 120 granted patents and an additional 70 patent applications. Midatech's headquarters and R&D facility is in Cardiff, UK.

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