SIGA Technologies Inc. | July 16, 2022
SIGA Technologies, Inc. a commercial-stage pharmaceutical company focused on the health security market, today announced a collaboration with KaliVir Immunotherapeutics to make TPOXX® available for use with KaliVir’s proprietary oncolytic vaccinia immunotherapy platform. This novel oncolytic platform includes multiple proprietary genetic modifications that can be combined to generate a unique oncolytic virus that has been optimized for systemic delivery and anti-tumor immune stimulation. Under this partnership, SIGA is providing its TPOXX oral capsules to support future clinical programs.
“KaliVir is an innovator in the creation of oncolytic viral immunotherapies, and we are excited to enter into this collaboration with them. TPOXX is a powerful antiviral drug to vaccinia and allows the safe use of higher doses of vaccinia vectors; there is also the potential it could increase immunotherapeutic outcomes. This collaboration helps bring new levels of assurance to physicians, regulators, and especially patients receiving these promising investigational therapies.”
Dr. Phil Gomez, CEO of SIGA
“We are pleased to announce this collaboration with SIGA Technologies,” said Helena Chaye, Ph.D., J.D., CEO of KaliVir. “Pairing oncolytic immunotherapies with an effective antiviral agent is a critical part of the development of new treatments, and we look forward to enhancing our groundbreaking oncolytic immunotherapy programs with the support of SIGA’s TPOXX.”
On July 13, 2018, the U.S. Food and Drug Administration (FDA) approved oral TPOXX for the treatment of smallpox to mitigate the impact of a potential outbreak or bioterror attack. In preclinical studies, TPOXX has been shown to be active against most orthopoxviruses, including vaccinia The unique mechanism of action of TPOXX coupled with published efficacy in animal studies, make it an important addition to development programs focused on vaccinia-based cancer therapies. In 2020, SIGA entered into numerous collaborations, including a partnership with Turnstone Biologics to supply TPOXX to support Turnstone’s clinical oncolytic vaccinia immunotherapy programs. In 2021, SIGA entered into a preclinical research collaboration with Bioarchitech to investigate TPOXX enabling higher doses of vaccinia vectors when used in combination with Bioarchitech’s oncolytic vaccinia-based immunotherapy platform.
ABOUT SIGA TECHNOLOGIES, INC. and TPOXX®
SIGA Technologies, Inc. is a commercial-stage pharmaceutical company focused on the health security market. Health security comprises countermeasures for biological, chemical, radiological and nuclear attacks (biodefense market), vaccines and therapies for emerging infectious diseases, and health preparedness. Our lead product is TPOXX®, also known as tecovirimat and ST-246®, an orally administered and IV formulation antiviral drug for the treatment of human smallpox disease caused by variola virus. TPOXX is a novel small-molecule drug and the US maintains a supply of TPOXX under Project BioShield. The oral formulation of TPOXX was approved by the FDA for the treatment of smallpox in 2018. The full label is available by clicking here. Oral tecovirimat received approval from the European Medicines Agency (EMA) in 2022. The EMA approval includes labeling for oral tecovirimat indicating its use for the treatment of smallpox, monkeypox, cowpox, and vaccinia complications following vaccination against smallpox. The full label is available by clicking here. In September 2018, SIGA signed a contract with the Biomedical Advanced Research and Development Authority (BARDA), part of the office of the Assistant Secretary for Preparedness and Response within the U.S. Department of Health and Human Services, for additional procurement and development related to both oral and intravenous formulations of TPOXX.
ABOUT KALIVIR IMMUNOTHERAPEUTICS.
KaliVir Immunotherapeutics is a privately held biotech company developing cutting-edge, next-generation oncolytic viral immunotherapy programs. The company has developed a unique vaccinia virus-based platform that can generate potent novel oncolytic vaccinia viruses with modifications to maximize viral replication and to enhance intravenous delivery and spread (Vaccinia Enhanced Template “VET” Platform). VET™ platform utilizes the large transgene capacity of the vaccinia virus to deliver therapeutics matched to tumor immunophenotypes to stimulate patients’ immune systems and modify the tumor microenvironment. KaliVir’s oncolytic product candidates are designed to be safe, potent and systemically deliverable to treat cancer patients across multiple tumor types. KaliVir is in the process of advancing multiple therapeutic candidates toward the clinic.
CELL AND GENE THERAPY
Flagship Biosciences, Inc. | September 01, 2022
Flagship Biosciences, Inc., a leader in spatial biology and biomarker analytics services, announced the acquisition of Interpace Pharma Solutions® a division of Interpace Biosciences and provider of cytogenetic, molecular pathology, and genomic profiling solutions. This acquisition follows a growth equity investment in Flagship from Ampersand Capital Partners, BroadOak Capital Partners, and Research Corporation Technologies. The strategic combination of Flagship and IPS creates a full repertoire of biomarker lab and analytic services to advance precision therapeutic development and adds a state-of-the-art laboratory in Research Triangle Park, NC.
Flagship Biosciences offers cutting-edge spatial biology services, powered by its patented AI image analysis technology that improves the accuracy of tissue-based pathology by delivering thousands of measurements on every cell and enabling the discovery of biomarkers that might be missed using traditional histology methods. Experts in pathology and regulatory strategy, the team at Flagship offers advanced end-to-end biomarker and analytics services to support drug trials, biomarker discovery, and clinical diagnostics. They also offer guidance in the development of companion diagnostics.
To better serve their biopharma and diagnostics clients, Flagship Biosciences will integrate the technologies and services of IPS to support all phases of clinical trials and diagnostic development in immuno-oncology, hematology, solid tumors, and various non-oncology sectors. Flagship Biosciences' expanded services menu will now include advanced molecular biomarker solutions, flow cytometry, cytogenetics, genomics, and bioinformatics solutions. New genomic profiling capabilities will enhance biomarker characterization and improve patient stratification for clinical trials and treatment selection.
"By combining these organizations, we create a single-source provider offering a larger range of biomarker and analytics services while maintaining and expanding the proven expertise of each laboratory. This will allow our customers to gain deeper insights into their clinical projects through multiple biomarker testing paradigms with cohesive data and analytical capabilities, managed in a simplified project workflow."
Trevor Johnson, CEO at Flagship Biosciences
About Flagship Biosciences
Founded in 2009 and headquartered in Broomfield, Colorado, Flagship Biosciences, Inc. is a technology-driven tissue analysis services company delivering the most accurate and informative data available. We are revolutionizing tissue analysis to improve drug development and diagnostics using the power of AI with a consultative approach. Our services and technology dramatically improve on the data and interpretation from traditional pathology methods, eliminating variability associated with typical tissue assessments, and bringing new insights to tissue analysis results. We provide expert scientific consultation for every client. Our team interprets results, contextualizes tissue biology, and identifies the best course for success. For more information, please visit flagshipbio.com and follow us on Twitter and LinkedIn.
About Interpace Pharma Solutions
Based in Research Triangle Park, NC, Interpace Pharma Solutions provides complex molecular analysis services supporting clinical trials and diagnostic development. These services include genomic profiling, biomarker solutions, project and data management, bioinformatics analysis, and biorepository services.
About Ampersand Capital Partners
Founded in 1988, Ampersand is a middle market private equity firm with more than $3 billion of assets under management dedicated to growth-oriented investments in the healthcare sector. With offices in Boston, MA and Amsterdam, Netherlands, Ampersand leverages a unique blend of private equity and operating experience to build value and drive superior long-term performance alongside its portfolio company management teams. Ampersand has helped build numerous market-leading companies across each of the firm's core healthcare sectors.
About BroadOak Capital Partners
BroadOak Capital Partners, with headquarters in Washington, DC, and San Francisco, is a life-sciences focused boutique financial institution that provides direct investment and investment banking services to companies in research tools and consumables, diagnostics, biopharma services, and adjacent markets. BroadOak has led or participated in investments in more than fifty companies across multiple funds and investment vehicles.
About Research Corporation Technologies
Research Corporation Technologies is a Tucson, Arizona based technology investment and management company that provides funding and development for promising life science and biomedical companies. RCT has assets of more than $500 million to advance technology and product development through flexible, long-term investment options.
Co-Diagnostics | July 27, 2022
Co-Diagnostics, Inc. a molecular diagnostics company with a unique, patented platform for the development of molecular diagnostic tests, announced today that it will be disclosing the global expansion of its OEM agreement with Bio Molecular Systems (BMS) at the Company's customer and distributor update today at AACC.
Located in the Gold Coast area of Queensland, Australia, BMS includes the founders and senior personnel from the company responsible for inventing and developing the original Rotor-Gene Real-Time PCR instrument, with a reputation for expertise in developing innovative, versatile, robust, and easy-to-use products.
BMS currently manufactures the magnetic induction PCR instrument that is sold by the Company as the Co-Dx Box™, which includes software that optimized specifically to enhance ease-of-use of the Company's molecular assays. The expanded branding and distribution OEM agreement increases Co-Dx's approved sales territories to 193 countries worldwide.
"We are excited for the opportunities that we believe this expanded agreement will provide the Company to increase the reach of our state-of-the-art products. Co-Dx tests have already been sold to laboratories and distributors in over 50 countries, and with this expanded agreement we expect that even more areas will be able to benefit from Co-Dx's high-quality, affordable molecular testing tools."
Company CEO Dwight Egan
About Co-Diagnostics, Inc.
Co-Diagnostics, Inc., a Utah corporation, is a molecular diagnostics company that develops, manufactures and markets state-of-the-art diagnostics technologies. The Company's technologies are utilized for tests that are designed using the detection and/or analysis of nucleic acid molecules (DNA or RNA). The Company also uses its proprietary technology to design specific tests to locate genetic markers for use in industries other than infectious disease and license the use of those tests to specific customers.