INOVIO Reports FDA Partial Clinical Hold for Planned Phase 2 / 3 Trial of COVID-19 Vaccine Candidate INO-4800

INOVIO | September 28, 2020

INOVIO (NASDAQ:INO), a biotechnology company focused on bringing to market precisely designed DNA medicines to treat and protect people from infectious diseases and cancer, announced that the U.S. Food and Drug Administration (FDA) has notified the company it has additional questions about the company's planned Phase 2/3 trial of its COVID-19 vaccine candidate INO-4800, including its CELLECTRA® 2000 delivery device to be used in the trial. Until the FDA's questions have been satisfactorily addressed, INOVIO's Investigational New Drug Application (IND) for the Phase 2/3 trial is on partial clinical hold. The company is actively working to address the FDA's questions and plans to respond in October, after which the FDA will have up to 30 days to notify INOVIO of its decision as to whether the trial may proceed. This partial clinical hold is not due to the occurrence of any adverse events related to INOVIO's ongoing expanded Phase 1 study of INO-4800, the conduct of which may continue and is not impacted by the FDA's notification. In addition, this partial clinical hold does not impact the advancement of INOVIO's other product candidates in development. INOVIO and its partners are continuing to prepare for a planned Phase 2/3 trial of INO-4800, following resolution of the FDA's partial clinical hold and subject to the receipt of external funding to conduct the trial.


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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.

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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.

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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.

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Biodesix Announces Research Agreement with Top US Cancer Center

Biodesix | June 06, 2022

Biodesix, Inc. (Nasdaq: BDSX), a leading data-driven diagnostic solutions company with a focus in lung disease, today announced that it intends to develop a new novel minimal residual disease (MRD) test as a part of a master sponsored research agreement (MSRA) with Memorial Sloan Kettering Cancer Center (MSK). In addition, the MSRA between MSK and Biodesix also includes the potential future development of other diagnostic tests aimed at improving the treatment of cancer. The initiation of this research program with MSK is a significant milestone for Biodesix. While the initial focus will be on developing a novel MRD test for solid tumors as an addition to our pipeline, Biodesix hopes to co-develop and validate a number of new test concepts under the agreement.” Scott Hutton, CEO, Biodesix. Biodesix will utilize its array of genomics, proteomics, artificial intelligence, and machine learning capabilities with the aim of developing and commercializing oncology biomarker assays in collaboration with MSK. Initially, the teams will collaborate to develop a highly sensitive molecular MRD test on the new ddPCR™ platform, the Bio-Rad QX600™ ddPCR™ System. As part of Bio-Rad's continued growth in oncology and expansion into the field of molecular MRD monitoring, we are pleased that Biodesix is utilizing the advanced multiplexing QX600™ ddPCR™ System that will be launching later this year." Simon May, EVP & President, Life Science Group, Bio-Rad Laboratories. About Biodesix Biodesix is a leading data-driven diagnostic solutions company with a focus in lung disease. The Company develops diagnostic tests addressing important clinical questions by combining multi-omics through the power of artificial intelligence. Biodesix is the first company to offer eight non-invasive tests for patients with lung diseases. The blood based Nodify Lung® nodule risk assessment testing strategy, consisting of the Nodify XL2® and the Nodify CDT® tests, evaluates the risk of malignancy in incidental pulmonary nodules, enabling physicians to better triage patients to the most appropriate course of action. The blood based IQLung™ strategy for lung cancer patients integrates the GeneStrat ddPCR™ test, the GeneStrat NGS™ test and the VeriStrat® test to support treatment decisions across all stages of lung cancer with results in an unprecedented 36-72 hours, expediting time to treatment. Biodesix also leverages the proprietary and advanced Diagnostic Cortex® AI (Artificial Intelligence) platform, to collaborate with many of the world’s leading biotechnology and pharmaceutical companies to solve complex diagnostic challenges in lung disease. Biodesix launched the SARS-CoV-2 ddPCR™ test, the Platelia SARS-CoV-2 Total Ab, and the cPass™ SARS-CoV-2 Neutralization Antibody test (cPass™ Neutralization Test Kit, GenScript, Inc,) in response to the global pandemic and virus that impacts the lung and causes COVID-19

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