MEDICAL

Debiopharm Announces First Patient Dosed in Investigator-initiated, Randomized Phase II, Open-label Clinical Trial for its Antiviral Alisporivir

Debiopharm | January 18, 2021

Debiopharm , a Swiss biopharmaceutical organization, reported the principal patient dosed in a investigator-initiated, randomized phase II, open-label clinical trial for its antiviral alisporivir (Debio 025). The examination will be led by the AP-HP to assess the adequacy and wellbeing of the cyclophilin inhibitor in the therapy of beginning phase, hospitalized COVID-19 patients who don't need clinical ventilation and have not shown indications of intense respiratory distress syndrome. The essential goal of this 'proof-of-concept' preliminary is to assess the decrease in COVID-19 viral burden in alisporivir treated patients. The secondary objective includes the analysis of clinical and radiological efficacy, wellbeing and decency of the compound in addition to Standard of Care (SOC) contrasted with SOC alone. Patients in the investigational arm will get alisporivir either orally or by means of a nasogastric tube, at the portion of 600mg twice every day for 14 days during the preliminary drove by Prof. Jean-Michel Pawlotsky, virologist, Head of the Biology and Pathology Department of the Henri Mondor Hospital Group, Greater Paris University Hospitals. The trial, upheld by both the hospital group gathering and Debiopharm, will be done in numerous centers in France including the Henri Mondor Hospital Group.

Medical perceptions have indicated that viral infections , for example, COVID-19 can be life-threatening because of an overcompensation of the body's immune defense system. Part of the cyclophilin inhibitor class of antivirals, this macrocyclic cyclophilin inhibitor could end up being an important extra therapy to SOC because of its non-immunosuppressive nature.

Spotlight

This video is part of the Cancer Research Institute’s series “Immunotherapy: 5 Ways to Stop Cancer.” For more information on treating cancer with immunotherapy, visit http://www.cancerresearch.org. A virus to cure cancer? It’s possible! Some viruses can infect cancer cells specifically, and cause them to burst. These are known as oncolytic viruses. One promising oncolytic virus therapy is called T-VEC, and is currently in late-stage clinical testing for melanoma.


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CELL AND GENE THERAPY

Dyadic Announces a NIIMBL Coronavirus Grant Under the White House’s American Rescue Plan

Dyadic International, Inc. | December 23, 2021

Dyadic International, Inc. a global biotechnology company focused on further improving, applying and deploying its proprietary C1-cell protein production platform to accelerate development, lower production costs and improve access to biologic vaccines and drugs at flexible commercial scales, announced it is the recipient of one of thirty-two project grants awarded by the National Institute for Innovation in Manufacturing Biopharmaceuticals funded through the White House’s American Rescue Plan. Under the NIIMBL grant, Dyadic will receive up to $690,000 in funding to engineer the Company’s proprietary and patented C1 thermophilic fungal protein production platform to produce two different antibodies. “We are honored to have been selected by NIIMBL to receive this grant and to further leverage Dyadic’s C1-cell protein production platform to help the nation prevent, prepare for, and respond to coronavirus and other public health threats. The grant provides us with the opportunity, among other attributes, to further demonstrate to academia, industry, and governmental agencies the rapid speed at which we can develop stable C1 expressing cell lines to produce antibodies as compared to traditional cell lines, such as Chinese Hamster Ovary cells. We look forward to moving this project forward in the new year,” Mark Emalfarb, Dyadic’s President and Chief Executive Officer NIIMBL members include large and small companies, academic institutions, non-profits, and federal agency partners who are well-equipped to significantly strengthen the nation’s preparedness and response to public health crises. Through the ARP funding, NIIMBL has selected projects that will Provide testbeds for process development, for next generation manufacturing approaches, and for drug product manufacturing approaches that provide access to industrially relevant equipment and facilities for pre-competitive manufacturing innovation Support the development of significantly improved methods for vaccine production, quality, and distribution, including mRNA and other vaccine platforms Demonstrate rapid scaling for production of coronavirus antigens and medical countermeasures for variants of concern Train a diverse biopharmaceutical manufacturing workforce Demonstrate the concept of mobile Good Manufacturing Practices capabilities to support mRNA vaccine and gene therapy production Dyadic’s project grant is intended to benchmark the speed that the C1 manufacturing platform will have when compared to current state of the art methods, which could lead to a rapid ability to produce medical countermeasures and vaccines in response to future pandemics. About NIIMBL The National Institute for Innovation in Manufacturing Biopharmaceuticals is a public-private partnership whose mission is to accelerate biopharmaceutical innovation, support the development of standards that enable more efficient and rapid manufacturing capabilities, and educate and train a world-leading biopharmaceutical manufacturing workforce, fundamentally advancing U.S. competitiveness in this industry. NIIMBL is part of Manufacturing USA®, a diverse network of federally-sponsored manufacturing innovation institutes, and is funded through a cooperative agreement with the National Institute of Standards and Technology in the U.S. Department of Commerce with significant additional support from its members. Visit NIIMBL.org to view a summary of these projects and to learn more about NIIMBL. About Dyadic International, Inc. Dyadic International, Inc. is a global biotechnology company that is developing what it believes will be a potentially significant biopharmaceutical gene expression platform based on the fungus Thermothelomyces heterothallica, named C1. The C1 microorganism, which enables the development and large-scale manufacture of low-cost proteins, has the potential to be further developed into a safe and efficient expression system that may help speed up the development, lower production costs and improve the performance of biologic vaccines and drugs at flexible commercial scales.

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INDUSTRIAL IMPACT

Riverside Partners' Portfolio Company Syner-G Acquires IMPACT

Riverside Partners | February 02, 2022

Syner-G BioPharma Group a leading provider of Chemistry, Manufacturing, and Controls technical, regulatory, and compliance consulting services to pharmaceutical and biotechnology clients, today announced the acquisition of Impact Pharmaceutical Services. Based in Research Triangle Park, NC, IMPACT supports the outsourced medical writing, regulatory strategy, and regulatory publishing and submission needs of biotech and pharma companies from pre-IND through post-marketing of drugs and biologics. Syner-G is a portfolio company of Riverside Partners, a Boston-based private equity firm. Both Syner-G and IMPACT have demonstrated strong track records of consistent growth and success in providing customized and highly complementary solutions to support the development of quality of life enhancing and lifesaving therapeutics. The combination will allow the companies to provide an even greater depth and breadth of expertise while delivering the highest levels of scientific rigor and customer service. "We are thrilled to support the combination of Syner-G and IMPACT. Similar to Syner-G, IMPACT has a stellar reputation in the marketplace, a diverse list of clients, and an outstanding team of highly qualified, experienced, and dedicated employees. Together, Syner-G and IMPACT will be able to not only better serve existing clients but also expand their reach and support new customers." Craig Stern, a General Partner at Riverside Partners "This combination is an important milestone for both companies," said David Belluck, a General Partner at Riverside Partners. "By adding IMPACT's complementary service offering and outstanding team, Syner-G is building on its long-standing commitment to provide unparalleled expertise and service to biotech and pharma customers." "This acquisition adds medical writing, overall drug development and regulatory strategy, and regulatory publishing and submission services to Syner-G's capabilities which will allow us to better support our customers as they develop lifesaving and breakthrough therapeutics," added Prabu Nambiar, Founder and CEO of Syner-G. "The combination brings together two excellent companies with very similar organizational histories, operating philosophies, and corporate cultures." "IMPACT's expertise and experience, gained over more than a decade of serving its clients, is a perfect extension of Syner-G's best-in-class CMC capabilities," said Mark Cierpial, Founder and CEO of IMPACT. "We are excited to form this strong partnership and work together to build a leading biopharma services organization." Financial terms of the transaction, which closed in late December, were not disclosed. About Syner-G BioPharma Group Based in Boston, MA, Syner-G is a leading provider of customized science and risk-based CMC and regulatory solutions and services, supporting pharmaceutical and biotechnology companies across small molecule, large molecule, and cell and gene therapy products. With its high customer retention, Syner-G oversees all aspects of CMC and regulatory services throughout the drug development process and post-commercialization. About Impact Pharmaceutical Services Based in Research Triangle Park, NC, IMPACT specializes in medical writing and quality control, drug development consulting, regulatory affairs, regulatory operations, and project and program management for the pharmaceutical and biotech sector. About Riverside Partners Founded in 1989, Riverside Partners is a middle market private equity firm with total capital commitments of $1.6 billion raised since inception. The firm focuses on growth-oriented companies in the technology and healthcare industries. Riverside Partners is particularly experienced at partnering with founders, owners and management teams, and it brings substantial domain expertise and operating experience to its portfolio companies.

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INDUSTRIAL IMPACT

UNITY Biotechnology Announces Exclusive License Agreement with Jocasta Neuroscience to Continue Development of α-Klotho Program

UNITY | December 21, 2021

UNITY Biotechnology, Inc. a biotechnology company developing therapeutics to slow, halt, or reverse diseases of aging, announced it has signed an exclusive agreement licensing its α-Klotho asset to Jocasta Neuroscience, Inc. for development and commercialization. The α-Klotho protein is a circulating factor associated with improved cognitive performance in preclinical studies. α-Klotho is hypothesized to optimize synaptic neurotransmission of N-methyl-D-aspartate receptors in the brain, effectively combatting the cognitive and synaptic deficits, despite high levels of pathogenic Ab, tau, and phosphorylated tau proteins associated with Alzheimer’s disease. “Since first licensing the α-Klotho asset from UCSF to explore its potential utility in cognitive disorders and other age-related diseases, I’m proud of the team’s hard work in further advancing the program, and we are pleased to now enter into this agreement with Jocasta. This deal allows us to support the continued development of the α-Klotho asset in a capital-efficient manner and share significantly in the upside economics, while focusing UNITY’s resources to advance our lead UBX1325 program, which has several key readouts in 2022.” Anirvan Ghosh, Ph.D., chief executive officer of UNITY Under the terms of the agreement, UNITY will receive an upfront cash payment from Jocasta, as well as additional payments based on development milestones, approval milestones, and sales-based royalties, per indication. In May 2019, the Company exclusively licensed the α-Klotho asset from University of California, San Francisco for certain patents and know-how rights related to α-Klotho. Under the license agreement, Jocasta Neuroscience is, in addition to the payments due to the Company, required to make all payments due to UCSF from UNITY under the UCSF License. About UNITY UNITY is developing a new class of therapeutics to slow, halt, or reverse diseases of aging. UNITY’s current focus is on creating medicines to selectively eliminate or modulate senescent cells and thereby provide transformative benefit in age-related ophthalmologic and neurologic diseases.

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CELL AND GENE THERAPY

Genomics Testing Companies and Laboratories Combine Efforts to Establish the CardioGenomic Testing Alliance

CardioGenomic | March 23, 2022

Several leading genomics companies and laboratories, including Illumina, Fulgent Genetics, Invitae, GeneDx, and PerkinElmer Genomics, have formed the CardioGenomic Testing Alliance (CGTA), a collaborative group aimed at raising awareness and utilization of genomic testing in cardiology. CGTA will inform healthcare providers and other stakeholders to the value of such testing to assure adherence to existing guidelines from professional medical societies, inform medical management and cascade testing, and improve clinical outcomes. The companies forming this coalition believe in extensive clinical utility of cardiogenomic testing. Their combined efforts to increase awareness and utilization of cardiogenomic testing will show the positive outcomes genetic testing can have on patients." Melissa Dempsey, genetic counselor at Illumina and CGTA chairwoman. Genomic testing in cardiology is a powerful tool that can identify those at-risk for specific cardiac conditions, such as arrhythmias, cardiomyopathies, and congenital heart malformations. According to the American Heart Association, "genetic testing is informative and useful for the clinical management of various inherited cardiovascular diseases such as cardiomyopathies, arrhythmic disorders, thoracic aortic aneurysms and dissections, and familial hypercholesterolemia."1 Sudden cardiac arrest can often be the first symptom of an inherited cardiac condition.2 The Sudden Arrhythmia Death Syndromes (SADS) Foundation reports that up to 49% of victims of sudden cardiac death had a significant family history that should have triggered diagnostic testing, and cascade genetic testing reveals an average of 8.9 additional affected family members.3 Genetic testing is one of the essential steps in the diagnosis and treatment of families with SADS conditions." Alice Lara, president of the SADS Foundation. Despite evidence and major professional society recommendations, utilization and awareness of cardiogenomic testing remains low. CGTA will strive to inform healthcare providers about the current guidelines for the appropriate use of genetic testing in cardiology. Working with key stakeholders, CGTA will identify logistical barriers to testing and develop educational resources to address these barriers for providers and for the public.

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Spotlight

This video is part of the Cancer Research Institute’s series “Immunotherapy: 5 Ways to Stop Cancer.” For more information on treating cancer with immunotherapy, visit http://www.cancerresearch.org. A virus to cure cancer? It’s possible! Some viruses can infect cancer cells specifically, and cause them to burst. These are known as oncolytic viruses. One promising oncolytic virus therapy is called T-VEC, and is currently in late-stage clinical testing for melanoma.

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