Soligenix Announced Publication of Pre-Clinical Immunogenicity Studies for a Novel COVID-19 Vaccine

PR Newswire | July 29, 2020

Soligenix, Inc. (Nasdaq: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today publication of pre-clinical immunogenicity studies for its CiVax™ program (heat stable COVID-19 vaccine), demonstrating immunity of both broad-spectrum antibody and cell-mediated, rapid onset immunity is possible using the CoVaccine HT™ (CoVaccine) adjuvant.  The article, authored by collaborators at the University of Hawaiʻi at Mānoa (UHM), is titled, "CoVaccine HT™ adjuvant potentiates robust immune responses to recombinant SARS-CoV-2 spike-S1 immunization," and has been submitted for peer-review to the journal npj Vaccines. An accelerated preprint of the manuscript has been made available here. CiVax™ is the Company's heat stable subunit vaccine candidate for the prevention of COVID-19, the infection caused by SARS-CoV-2.  Ongoing collaborations with Axel Lehrer, PhD, Assistant Professor in the Department of Tropical Medicine, Medical Microbiology and Pharmacology, John A. Burns School of Medicine (JABSOM), UHM have demonstrated the feasibility of developing a broadly immunogenic vaccine for COVID-19.  With significant research dedicated worldwide to the generation of COVID-19 vaccines, it is noteworthy that the essential attributes of a vaccine successful in controlling the ongoing pandemic are believed to include the ability to rapidly stimulate a balanced antibody response, including an enhanced Th1 response, which includes raising significant virus neutralizing antibodies and potent cell-mediated immunity, demonstrated by T-cell activation.  Previous work with the CoVaccine adjuvant, which Soligenix licensed from BTG Specialty Pharmaceuticals, a division of Boston Scientific Corporation, has indicated that CoVaccine has these critical characteristics.  In these results, Lehrer and his colleagues now demonstrate these attributes of CoVaccine, specifically in the context of SARS-CoV-2.  Moreover, these results, using a prototype antigen, also demonstrate a rapid onset of immunity with antibody responses detected within 14 days after the first vaccination.

Spotlight

Remarkable innovations in the technologies that generate ‘omics data have swiftly created such profound efficiencies that the cost of next-generation sequencing (NGS) has fallen below $1,000 per genome. This has led to the creation of vast amounts of data. The challenge of how to harness this rich information, and from it harvest practicable therapeutics, has been thrust to the forefront of advanced analytics.It is anticipated that in the upcoming decade genomics data will require more computing resources than the data demand from astronomy.

Spotlight

Remarkable innovations in the technologies that generate ‘omics data have swiftly created such profound efficiencies that the cost of next-generation sequencing (NGS) has fallen below $1,000 per genome. This has led to the creation of vast amounts of data. The challenge of how to harness this rich information, and from it harvest practicable therapeutics, has been thrust to the forefront of advanced analytics.It is anticipated that in the upcoming decade genomics data will require more computing resources than the data demand from astronomy.

Related News

LifeMine Therapeutics and GSK Enter Drug Discovery and Development Alliance

LifeMine | March 28, 2022

LifeMine Therapeutics Inc., a biopharmaceutical company reinventing drug discovery by mining genetically-encoded small molecules (GEMs) from the biosphere, today announced a strategic R&D collaboration with GlaxoSmithKline (GSK). The collaboration will provide GSK with access to LifeMine’s genomically enabled drug discovery platform to identify novel small molecule leads directed to up to three human targets provided by GSK addressing multiple disease areas. Under the terms of the collaboration, LifeMine will receive an upfront payment of $70 million that includes both cash and an equity investment by GSK in LifeMine in its Series C round of financing. In addition, LifeMine is eligible to receive undisclosed discovery, development and commercial milestone payments for each collaboration product. LifeMine will be also eligible to receive royalties on net sales of any drug from the collaboration that is commercialized by GSK. LifeMine and GSK will collaborate closely on the discovery process, with each company leveraging its core capabilities and equally sharing costs to IND filing. GSK will be responsible for all development and commercialization. This is a transformative collaboration for LifeMine, and marks the first such agreement in genomic drug discovery from fungi, nature’s virtuoso medicinal chemists, We are thrilled to partner with GSK to expand the potential of our drug discovery engine while we continue to advance our own lead programs. We look forward to a productive partnership which we are confident will result in novel therapeutic options for patients.” Gregory Verdine, Ph.D., co-founder, chief executive officer and chief scientific officer of LifeMine. LifeMine aims to bring unparalleled speed, predictability and scalability to small-molecule drug discovery, offering the potential to rapidly advance multiple high-impact precision medicines to solve intractable disease challenges, irrespective of therapeutic area. LifeMine’s Avatar-Rx platform seamlessly integrates high-throughput microbiology, data science and machine learning, genome engineering and automation technologies to search the fungal biosphere for novel GEMs having a predetermined target and biological function. Downstream of GEM discovery, LifeMine’s platform further integrates chemoinformatic-assisted drug optimization and state-of-the art chemical synthesis with biotransformation to advance new product candidates into development. GSK’s drug discovery approach focuses on advanced technologies, including human genetics, functional genomics and machine learning to increase our probability of success, This approach leads to genetically validated targets that are twice as likely to succeed as medicines, but due to their novelty often require innovation to unlock their potential. We are looking forward to teaming up with LifeMine to use their cutting-edge platform, so together we can identify what nature might have already created as chemistry starting points to increase our chances of developing transformational new drugs for patients.” John Lepore, SVP, Head of Research, GSK. About LifeMine Therapeutics LifeMine Therapeutics is reinventing drug discovery by mining genetically-encoded small molecules (GEMs) from the biosphere. Through its proprietary, evolutionarily-derived genomic drug discovery platform, LifeMine aims to bring unparalleled speed, predictability and scalability to small molecule drug discovery. LifeMine has discovered, in genomic space, hundreds of potentially high-impact drug candidates relevant to targets across all major disease areas, and has an initial focus on advancing highly impactful precision medicines in oncology and immune modulation. The Company was founded in 2017 by renowned entrepreneur/scientists Gregory Verdine, Ph.D., and Richard Klausner, M.D., and entrepreneur/company-builder WeiQing Zhou. Headquartered in Cambridge, Mass., and with a second site at Gloucester Harbor, Mass., LifeMine has raised more than $295 million from leading life science investors.

Read More

INDUSTRIAL IMPACT

BioLife Solutions Closes Acquisition of Sexton Biotechnologies

BioLife Solutions, Inc. | September 06, 2021

BioLife Solutions, Inc., a leading developer and supplier of class-defining bioproduction products and services for cell and gene therapies and the broader biopharma market, today announced that it has closed its acquisition of Sexton Biotechnologies. Sexton's bioproduction tools portfolio includes proprietary closed vials for cell therapy final dose packaging, human platelet lysate (HPL) media, a bio-defined replacement for fetal bovine serum or human serum used in cell manufacturing, and automated cell processing machines. These class-defining products are currently embedded in more than 50 ongoing clinical trials of new cell and gene therapies. Sexton was spun out of Cook Regentec in 2019 with seed funding from BioCrossroads, BioLife Solutions, Casdin Capital and Cook Regentec. Mike Rice, BioLife Solutions Chairman and CEO, commented, "Our team has identified and closed six acquisitions in the last two and a half years, assembling a portfolio of class-defining bioproduction tools and services for the cell and gene therapy and broader biopharma markets. We welcome Team Sexton to BioLife and look forward to the contributions of Sexton's consumable products to our growing revenue base." About Sexton Biotechnologies Sexton Biotechnologies is a revenue-stage, biotechnology company focused on the development and sales of bioproduction tools for cell and gene therapy. The company was founded in 2019 as a spin out of Cook Regentec, a life science incubator/accelerator. Sexton develops purpose-built cell and gene therapy (CGT) tools and media to enable flexible automation and scaling of cell manufacturing processes to increase the probability of positive clinical outcomes and reduce time-to-market, failure points and labor costs. Sexton's portfolio includes the fluid handling system Signata CT-5, CellSeal platform of cryo-storage tools and fill/finish systems, and human platelet lysate growth supplements. About BioLife Solutions BioLife Solutions is a leading supplier of cell and gene therapy bioproduction products and services. Our portfolio includes our proprietary CryoStor® freeze media and HypoThermosol® shipping and storage media, ThawSTAR® family of automated, water-free thawing products, evo® cold chain management system, Custom Biogenic Systems® high-capacity cryogenic freezers, Stirling Ultracold ULT freezers, and SciSafe biologic materials storage.

Read More

INDUSTRIAL IMPACT

Navrogen Inc. and Tavotek Biotherapeutics Announce Strategic Collaboration to Improve Therapeutic Efficacy of Antibody Pipeline Agents

Navrogen Inc. | August 18, 2021

Navrogen Inc. a biopharmaceutical company specialized in developing therapies for cancer and immune-related disorders, and Tavotek Biotherapeutics, a biotech company focusing on novel multi-specific antibodies in immuno-oncology and autoimmune diseases, announced today that they have entered into a strategic collaboration to identify and develop experimental monoclonal antibodies (mAbs) for the treatment of various cancer indications. Under the agreement, Navrogen and Tavotek will collaborate on the development of future Tavotek oncology assets while utilizing Navrogen's proprietary screening technology to identify mAb leads that are susceptible to Humoral Immuno-Oncology (HIO) factors. HIO is a process by which tumors produce factors that suppress a patient's humoral immune response against malignant tissues as well as diminish therapeutic response of immune-mediated anti-cancer therapies. Working with Navrogen's HIO platform technologies and its expertise in patient tumor screening methods, the teams will identify and/or engineer HIO-refractory antibodies that are effective across a wide range of HIO-positive cancers leading to innovative treatment options for patients with limited therapeutic options. About Navrogen™ Inc Navrogen is a biopharmaceutical company focused on the discovery of tumor-produced Humoral Immuno-Oncology (HIO) factors that are associated with suppressed humoral immunity, poor prognosis and limited therapeutic response of immune-mediated anti-cancer therapies. The company's mission is to develop first-in-class agents that can overcome the immunosuppressive effects of HIO factors by employing its proprietary screening and engineering technologies as well as diagnostic assays that can identify patients whose tumors produce HIO factors to advise physicians on therapeutic options. About Tavotek Biotherapeutics Tavotek is a biopharmaceutical company focused on discovering, acquiring, developing, and commercializing therapeutic medicines for patients suffering from debilitating diseases with significant unmet medical needs. Tavotek has a rich pipeline of product candidates at various stages of development for cancer, autoimmune conditions, and inflammatory diseases.

Read More