Ajinomoto Bio-Pharma Services Announces Manufacturing Partnership with CytoDyn for Drug Product Used in COVID-19 Clinical Trials

Ajinomoto Bio-Pharma Services | May 05, 2020

Ajinomoto Bio-Pharma Services ("Aji Bio-Pharma"), a leading provider of biopharmaceutical contract development and manufacturing services, is pleased to announce it has entered into a manufacturing services agreement with CytoDyn Inc., a late stage biotechnology company, for the supply of the investigational new drug, leronlimab (PRO 140), which is currently being used in clinical trial protocols for Mild-to-Moderately Ill and Severely Ill COVID-19 patients. Aji Bio-Pharma provides high quality drug product aseptic fill finish services for CytoDyn. Leronlimab, a novel CCR5 antagonist with the potential for multiple therapeutic indications, has been and is currently being administered to COVID-19 patients at New York City area hospitals as part of an emergency investigational new drug (EIND), granted by the U.S. Federal Drug Administration (FDA) as part of Phase 1, Phase 2 and Phase 2b/3 clinical trials. CytoDyn is currently enrolling patients in two placebo-controlled randomized clinical trials for Phase 2 and Phase 2b/3. "We are very excited to support CytoDyn's efforts to utilize this promising antibody therapeutic in the fight against COVID-19," said Kristin DeFife, Ph.D., Sr. VP of Operations & Site Head at Ajinomoto Bio-Pharma Services.

Spotlight

To create an individualized cancer vaccine, researchers must identify cancer-specific peptides called neoantigens, then use a cell-, protein-, or nucleic acid–based platform to deliver those neoantigens to patients to prime the immune system to attack the tumor.


Other News
INDUSTRIAL IMPACT

Iveric Bio and DelSiTech Enter Exclusive Agreement for Development of Sustained Release Zimura®

IVERIC bio, Inc. | July 06, 2022

IVERIC bio, Inc. and DelSiTech Ltd, announced an exclusive global license agreement providing Iveric Bio with the right to develop and commercialize new formulations of Zimura® using DelSiTech’s silica-based sustained release technology. As part of Iveric Bio’s lifecycle expansion plan for Zimura, the Company is committed to developing sustained release technologies for the treatment of age-related macular degeneration (AMD). These technologies potentially could address patients being treated for geographic atrophy (GA) and intermediate AMD. “We are thrilled to collaborate with the DelSiTech team on investigating additional sustained release formulations for Zimura with their drug delivery expertise and advanced technology and look forward to evaluating a sustained release formulation in GA and potentially earlier stages of AMD. Previously reported post-hoc analyses from GATHER1 suggest that Zimura may have the potential to impact AMD in early stages before atrophy occurs in patients. We believe Zimura, which is a chemically synthesized RNA aptamer, is amenable to injectable sustained release formulations.” Pravin U. Dugel, MD, President of Iveric Bio “As a leading developer of long-acting controlled release formulations for small molecules and biological entities, we are excited about collaborating with Iveric Bio on bringing innovative solutions to patients living with AMD,” stated Lasse Leino, PhD, Chief Executive Officer of DelSiTech. “We are inspired by the opportunity to leverage our drug delivery technology to potentially help AMD patients early and improve their treatment experience.” “This agreement underscores our commitment to invest in lifecycle initiatives for Zimura,” said Glenn P. Sblendorio, Chief Executive Officer of Iveric Bio. “We are excited about the possibilities to expand Zimura into earlier stages of AMD and potentially allow for a next-generation treatment to help patients with GA.” “We are proud to bring our competencies into this promising alliance and contribute to Iveric Bio’s mission to address unmet needs for patients,” said Dr. Frederic Dargelas, Head of Business Development and Alliance Management for DelSiTech. Under the terms of the license agreement, Iveric Bio will pay DelSiTech an upfront payment of €1,250,000, as well as development and commercial milestones and royalties on net sales of licensed products. In addition to working with DelSiTech, Iveric Bio plans to explore the potential for Zimura in earlier stages of AMD by initiating a clinical trial studying the current formulation of Zimura in patients with intermediate AMD in the fourth quarter of 2022. The development strategy in this indication is subject to global regulatory feedback from the U.S. Food and Drug Administration (FDA) and other regulatory authorities, which Iveric Bio plans to obtain before initiating this trial. About Zimura GATHER1 and GATHER2 Clinical Trials Iveric Bio previously announced that GATHER1, the Company’s first Phase 3 clinical trial for Zimura (avacincaptad pegol) for GA, met its pre-specified primary efficacy endpoint with statistical significance. The most frequently reported ocular adverse events in this trial were related to the injection procedure. The Company expects topline data for GATHER2, the Company’s second Phase 3 clinical trial for Zimura for GA, to be available in the third quarter of 2022, approximately one year after the enrollment of the last patient in the trial plus the time needed for database lock and analysis. If 12-month results from GATHER2 are positive, the Company plans to submit applications with the FDA and the European Medicines Agency for marketing approval of Zimura for GA. There are no FDA or EMA approved treatments available for patients with GA. About Zimura Zimura is an investigational drug product and has not been approved for use anywhere globally. Zimura is designed to target and inhibit the cleavage of complement protein C5 and the formation of its downstream fragments, C5a and C5b. By inhibiting the formation of these fragments, Zimura is believed to decrease or slow the chronic inflammation and cell death associated with the retinal aging process by decreasing the formation of membrane attack complex (MAC) and inflammasome activity, thereby potentially avoiding or slowing the degeneration of retinal pigment epithelial cells. This potential mechanism is the rationale for Zimura as a potential therapy for GA and earlier stages of AMD. About Iveric Bio Iveric Bio is a science-driven biopharmaceutical company focused on the discovery and development of novel treatments for retinal diseases with significant unmet medical needs. The Company is committed to having a positive impact on patients’ lives by delivering high-quality, safe and effective treatments designed to address debilitating retinal diseases including earlier stages of age-related macular degeneration. About DelSiTech DelSiTech Ltd., located in Turku, Finland, is the leading technology specialist in biodegradable silica-based controlled release of small molecule drugs, biologics, and viral vectors. It develops and commercializes its proprietary, drug delivery technology in collaboration with a number of pharma and biotech companies to turn their ideas into novel drug products.

Read More

MEDICAL

HistoSonics Announces Agreement with GE Healthcare

HistoSonics | May 24, 2022

HistoSonics Inc., developer of a completely non-invasive platform using the science of histotripsy, today announced an agreement formalizing ongoing efforts to use GE Healthcare's LOGIQ E10 Series ultrasound imaging platform to power the real time visualization features of HistoSonics' novel sonic beam therapy. As part of the agreement and upon market authorization, HistoSonics will distribute GE Healthcare's LOGIQ E10 Series on a one-to-one basis with its breakthrough liver therapy system. HistoSonics' Edison™ system, currently in development, uses the novel science of histotripsy to non-invasively destroy targeted liver tissue. HistoSonics intends to utilize GE Healthcare's LOGIQ E10 Series, currently the most technologically advanced ultrasound platform for guiding radiology interventions, to provide treating physicians with continuous visualization for key and unique elements of the histotripsy therapy procedure, including planning, monitoring, and immediate post-treatment verification. This agreement is aimed to support HistoSonics' efforts to launch their EdisonTM system leveraging their deep domain expertise along with GE Healthcare's world-class ultrasound imaging technologies, digital infrastructure, data analytics and clinical decision support capabilities. We are very excited to formalize our imaging partnership with GE Healthcare, which is a key part of bringing our transformative therapy platform, and an entirely new treatment option, to the clinic and to patients, We've developed a very collaborative relationship with GE Healthcare and look forward to expanding our efforts to realize the full potential of histotripsy across clinical applications, specialties, and care settings." Josh Stopek, HistoSonics Vice President of R&D. HistoSonics' non-invasive platform combines advanced imaging and proprietary software to deliver patient specific treatments using histotripsy to mechanically destroy and liquify targeted tissues at a sub-cellular level. The company believes the novel mechanism of action of their proprietary technology may offer significant advantages to patients, including precise and predictable treatment zones with equivalent treatment effect throughout the entire treated volume. Early clinical and pre-clinical results also suggest that histotripsy largely preserves critical structures such as the liver capsule, and larger vessels and bile ducts within or adjacent to the treated volume of tissue. Additionally, histotripsy enables the treating physicians to monitor the destruction of tissue under continuous real-time visualization and control, unlike any modality that exists today. The agreement between GE Healthcare and HistoSonics comes as HistoSonics continues enrollment in their U.S. and European #HOPE4LIVER Trials, evaluating the safety and efficacy of histotripsy for the destruction of targeted primary or metastatic liver tumors. Additionally, the company recently was awarded "Breakthrough Device Designation" by the FDA for histotripsy of liver tissue, validating the company's vision that histotripsy has the potential to provide advantages over existing therapies such as surgery, radiation therapy and thermal ablation. About HistoSonics HistoSonics is a privately held medical device company developing a non-invasive platform and proprietary sonic beam therapy utilizing the science of histotripsy, a novel mechanism of action that uses focused ultrasound to mechanically destroy and liquify unwanted tissue and tumors. The company is currently focused on the continued development of its EdisonTM Platform, global clinical studies, and new strategic projects including future clinical applications and platforms. HistoSonics has offices in Ann Arbor, Michigan and Minneapolis, MN.

Read More

MEDICAL

BioCina announces opening of new GMP plasmid DNA manufacturing suite

BioCina | June 14, 2022

BioCina, a leading contract development and manufacturing organization (CDMO) today announced that the company has expanded its CDMO service offering to include the manufacture of plasmid DNA (pDNA) in a new dedicated GMP suite. The suite is equipped with up to 300 L single use fermentation capacity and suitably scaled downstream processing equipment. To complement GMP manufacturing, a broad range of analytical methods have been developed to support in-process, release and stability testing of pDNA products. This is a very important and timely addition that will best enable BioCina to work with its industry partners to further develop RNA vaccines and therapeutics as well as cell and gene therapies. BioCina's decision to expand its service offering into pDNA development and manufacturing was driven by the global increase in demand for GMP grade pDNA fueled by the exponential growth in vaccines and therapies on the RNA platform as well as strong growth in the cell and gene therapy markets. These factors, combined with the CDMO industry's dearth of capacity and access to high-quality cGMP pDNA manufacturing expertise, made this a clear path forward underscored by BioCina's depth of experience in microbial manufacturing. With our extremely strong history of quality in manufacturing, an exemplary regulatory inspection history, and our customer-centric business approach, BioCina is in a strong position to add significant value to companies working in the RNA and gene and cell therapy space that are struggling to find reliable and collaborative outsourcing partners. The addition of GMP pDNA services is a natural extension of our existing traditional biologics offering and provides another avenue for growth by supporting the development and manufacturing of these innovative vaccines and therapies." Ian Wisenberg, Chief Executive Officer of BioCina. With its well established expertise in the production of microbial derived biologics, BioCina is ideally suited to address the increasing global demand for GMP plasmid DNA. Whether used as a raw material in the production of viral vectors or mRNA vaccines, or as the active ingredient for plasmid gene therapy or DNA vaccines, we look forward to partnering with innovators to assist in progressing many exciting therapies." BioCina Chairman, Rick Hancock. About BioCina BioCina Pty Ltd. is a multi-product biologics contract development and manufacturing organization (CDMO), focused on the development and cGMP manufacture of microbial-based biological pharmaceuticals, including proteins, pDNA, mRNA, vaccines and biosimilars, from early development through to commercialization. The BioCina Adelaide facility, formerly the Pfizer/Hospira plant, has a physical footprint of almost 60,000 ft2 for GMP manufacturing, process development, warehouse, and administration. The team has over 35 years of experience and extensive capabilities in microbial process development and manufacturing, with expertise from early process development to commercial manufacturing. BioCina has an enviable history manufacturing biological products approved for commercial use by the US-FDA, EMA and Health Canada, including the manufacturing of API for use in all stages of clinical trials. Licensed for GMP manufacture by the Australian Therapeutic Goods Administration (TGA), BioCina is the only GMP manufacturing facility of its kind in Australia that has successfully passed a US-FDA inspection. BioCina is a Bridgewest Group portfolio company.

Read More

INDUSTRIAL IMPACT

Providence Therapeutics Signs Licensing Agreement with SickKids for Immunotargeting Technology

Providence Therapeutics | July 13, 2022

Providence Therapeutics, Canada's premier mRNA medicines company, is pleased to announce that it has entered into an exclusive licensing agreement with The Hospital for Sick Children of Toronto, ON, for an immunotargeting technology platform. This platform provides an innovative approach to generating adjuvant-free vaccines and works by targeting Antigen Presenting Cells of the immune system via the MHC Class II molecules on their surface. This can result in an enhanced immune response to antigens which are coupled to the targeting monoclonal antibody (mAb). The technology builds on the earlier pioneering work done by Dr. Brian Barber, Professor Emeritus of Immunology at the University of Toronto, and has been extensively refined in the laboratory of Dr. Jean-Philippe Julien, Senior Scientist in the Molecular Medicine program at SickKids. The versatile technology platform can generate both monovalent and multivalent therapeutics, in a varied field of applications, including vaccines. With additional features, such as incorporating T-cell epitopes with the aim of generating a broader and longer immune response, the technology can engage both the humoral and cellular components of the immune system. Providence Therapeutics, an emerging specialty Biopharma, has successfully developed a robust, scalable, and effective mRNA medicine platform as exemplified by the clinical success of PTX-COVID19-B. The company is currently applying this platform to a variety of other infectious diseases and to an emerging oncology pipeline. The immunotargeting technology will enable the development team at Providence to explore the development of a new generation of unique mRNA medicines and vaccines by combining both platforms synergistically, potentially offering a multivalent dimension which will be new and unique in the field. "We are very excited to be working with a prestigious institution like SickKids. The immunotargeting technology is an excellent addition to our existing world class mRNA platform and will be important in enhancing the depth and scope of our portfolio of development programs." Brad Sorenson, CEO of Providence Therapeutics "We are excited to identify and potentially develop further novel applications for our immunotargeting technology, which provides an alternative to the use of adjuvants in vaccines," says Dr. Jean-Philippe Julien, the co-inventor of the technology. "This opportunity, emerging from Drs. Julien and Barber's research, is an example of how SickKids Industry Partnerships & Commercialization is working to support promising research and provide access to the robust research and clinical innovation ecosystem at SickKids," says Ihor Boszko, Executive Director, SickKids Industry Partnerships & Commercialization. The financial terms of the License are not being disclosed, but does include a provision for development of the technology through future sponsored research at SickKids. The company is committed to commercializing the technology and has an option for licensing of additional related technologies from the PI's laboratory in the future. About Providence Therapeutics Providence is a leading Canadian clinical stage biotechnology company pioneering mRNA therapeutics and vaccines with operations in Calgary, AB and Toronto, ON. In response to a worldwide need for a COVID-19 vaccine, Providence expanded its focus beyond oncology therapies and devoted its energy and resources to develop a world-class mRNA vaccine for COVID-19, PTX-COVID19-B, which is currently in the planning stages for a Phase 3 booster study to begin before the end of the year. Providence is focused on serving the needs of Canada, and other countries that may be underserved by large pharmaceutical programs.

Read More

Spotlight

To create an individualized cancer vaccine, researchers must identify cancer-specific peptides called neoantigens, then use a cell-, protein-, or nucleic acid–based platform to deliver those neoantigens to patients to prime the immune system to attack the tumor.

Resources