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.
Invenshure | June 03, 2022
Venture studio Invenshure announces the launch of MEKanistic Therapeutics, a biotechnology company redefining precision oncology. Co-inventors and pioneers in the MEK inhibitor field, Judith Sebolt-Leopold, PhD, and Christopher Whitehead, PhD, MBA, have rationally designed a drug that blocks two, key pathways (EGFR and PI3K) used to signal cancer cell growth, with a single molecule. In preclinical studies, this first-in-class dual inhibitor shows unparalleled tumor shrinkage without the toxicity generally associated with current kinase inhibitors.
MEKanistic is using cutting edge computational tools to not only understand how these pathways work, but also design medications that perfectly fit within those sites to inhibit the spread of cancer. We have two unique advantages. First, our lead drug's expanded therapeutic window means dramatically reduced side effects for cancer patients. Second, when it's paired with existing cancer therapies, our drug makes them much more effective, We are excited to partner with Pfizer Global R&D veterans, Drs. Leopold and Whitehead, to propel this important technology forward into clinical trials."
Danny Cunagin, CEO of MEKanistic.
MEKanistic will be launching a round of funding in the coming weeks to support the translation of our lead candidate (MTX-531) towards IND approval later this year with the anticipation of initiation of Phase 1 clinical trials in early 2023.
MTX-531's initial application targets head and neck cancers with 900,000 cases worldwide per year. Ultimately, this drug has possible future applications for colon/rectal, esophageal, pancreatic, and some breast cancers. Our work could potentially impact millions of people each year."
Chief Scientific Officer, Dr. Sebolt-Leopold.
Invenshure is a venture studio that scours university research labs for novel and disruptive technologies ready for commercialization. Invenshure partners with top scientists, physicians, and researchers from the most trusted institutions in healthcare and technology. The company focuses on high-growth sectors including biotech, genomics, healthcare IT, diagnostics, cloud computing technologies, and wireless technologies.
CELL AND GENE THERAPY
Ultima Genomics | June 09, 2022
Olink Holding AB (publ) ("Olink") (Nasdaq: OLK) and Ultima Genomics ("Ultima") today announced that they have entered into a collaboration to enable the use of the Olink® Explore high-throughput proteomics platform with Ultima's sequencing architecture.
Ultima Genomics and Olink are working towards a seamless pairing of the existing Olink® Explore assay and Ultima Genomics' sequencing system, and are collaborating with joint customers to enable larger-scale projects. The companies expect this will be accomplished by offering Ultima-specific library modules, along with an Olink-provided data analysis solution. Initial proof of concept data gathered by the companies shows similar performance to the existing Explore assay, signaling its potential for high-throughput proteomics customers. Additional information will be provided by Ultima during a panel discussion today, June 8, at the Advances in Genome Biology and Technology (AGBT) general meeting in Orlando, Florida.
With the next-generation sequencing market expected to undergo a significant evolution in the months and years ahead, Olink is committed to enabling broad access to its unique and industry-leading Explore technology, As more labs embrace the promise of proteomics, we believe we are approaching an inflection point; and efforts such as our collaboration with Ultima will be a critical factor in developing the market and reaching as many customers as possible."
Jon Heimer, CEO of Olink.
This non-exclusive collaborative framework is a continuation of Olink's strategy it has executed in NGS since 2020 and combines the strengths of both companies' technologies. These efforts are in line with Olink's previously communicated operational planning and are intended to provide customers with options in choosing the sequencing platform that is optimal for their needs.
Olink Holding AB (Nasdaq: OLK) is a company dedicated to accelerating proteomics together with the scientific community, across multiple disease areas to enable new discoveries and improve the lives of patients. Olink provides a platform of products and services which are deployed across major biopharmaceutical companies and leading clinical and academic institutions to deepen the understanding of real-time human biology and drive 21st-century healthcare through actionable and impactful science. The Company was founded in 2016 and is well established across Europe, North America, and Asia. Olink is headquartered in Uppsala, Sweden.
About Ultima Genomics
Ultima Genomics is unleashing the power of genomics at scale. The Company's mission is to continuously drive the scale of genomic information to enable unprecedented advances in biology and improvements in human health. With humanity on the cusp of a biological revolution, there is a virtually endless need for more genomic information to address biology's complexity and dynamic change—and a further need to challenge conventional next-generation sequencing technologies. Ultima's revolutionary new sequencing architecture drives down the costs of sequencing to help overcome the tradeoffs that scientists and clinicians are forced to make between the breadth, depth, and frequency with which they use genomic information. The new sequencing architecture was designed to scale far beyond conventional sequencing technologies, lower the cost of genomic information and catalyze the next phase of genomics in the 21st century.