AbbVie Expands Immunology Portfolio in the U.S. with FDA Approval of SKYRIZI™ (risankizumab-rzaa) for Moderate to Severe Plaque Psoriasis

pipelinereview | April 24, 2019

AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) approved SKYRIZI™ (risankizumab-rzaa), an interleukin-23 (IL-23) inhibitor, for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.3 In clinical trials, SKYRIZI produced high rates of durable skin clearance – most people (82 and 81 percent) treated with SKYRIZI achieved 90 percent skin clearance (PASI 90) at one year, with the majority (56 and 60 percent) achieving complete skin clearance (PASI 100).1 "The complex nature of psoriasis and the variability or loss of treatment response over time can prevent some patients from achieving their treatment goals," said Kenneth B. Gordon, M.D., a principal investigator for the ultIMMa-1 pivotal trial and professor and chair of dermatology at the Medical College of Wisconsin. "In clinical trials, risankizumab demonstrated high levels of skin clearance that persisted through one year. I'm pleased the dermatology community now has a new option that can help patients achieve and maintain a high level of treatment response."

Spotlight

To protect against such a fate, a suite of DNA-repairing proteins is on standby for when breaks occur. One of them is the evolutionarily conserved enzyme Dna2, which helps prepare broken DNA strands for repair by other proteins and also degrades excess pieces of DNA produced during replication.

Spotlight

To protect against such a fate, a suite of DNA-repairing proteins is on standby for when breaks occur. One of them is the evolutionarily conserved enzyme Dna2, which helps prepare broken DNA strands for repair by other proteins and also degrades excess pieces of DNA produced during replication.

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INDUSTRIAL IMPACT

SIGA Announces Oncology Collaboration with KaliVir Immunotherapeutics

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.

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MEDICAL

CellCarta expands it proteomics portfolio with the acquisition of next-generation immuno-MRM assays from Precision Assays

CellCarta | May 23, 2022

CellCarta, a leading global provider of precision medicine laboratory services, announced today the acquisition of the commercial rights to the antibody panels and assays from Precision Assays, a leader in next-generation targeted proteomics testing solutions. A spin-off from Fred Hutchinson Cancer Center ("Fred Hutch"), Precision Assays develops and deploys high-end multiplex quantitative immuno-MRM mass spectrophotometry-based assays for its pharmaceutical and biotech industry clients. The acquisition from Precision Assays of its large spectrum of targeted mass spectrometry assays characterized according to the National Cancer Institute's Clinical Proteomic Tumor Analysis Consortium (CPTAC) Tier 2 guidelines greatly expands CellCarta's capabilities in off-the-shelf multiplex protein quantification offerings ready for deployment in immuno-oncology clinical and pre-clinical studies. Precision Assays' large portfolio of robust assays characterized according to CPTAC guidelines and its established proof of concept data will enable CellCarta to confidently support its clients' exploratory studies and therapeutic development strategies, offering them key solutions to address important clinical challenges and move their immuno-oncology programs forward. Given CellCarta's expertise in protein quantitation, these immuno-MRM panels can further be validated to support secondary and primary clinical endpoints." Lorella Di Donato, Chief Operating Officer of CellCarta, Immunology and Proteomics Divisions. Based on technology licensed from Fred Hutch, Precision Assays' platform is uniquely positioned to fully capture the unique advantages of multiplex protein quantification using targeted mass spectrometry. Founder Dr. Amanda Paulovich, a professor in the Clinical Research Division at Fred Hutch who holds the Aven Foundation Endowed Chair, is an internationally recognized pioneer in targeted mass spectrometry and a clinically trained oncologist. Dr. Paulovich has set best-in-class standards to support precision medicine studies in cancer-specific protein expression analysis in a variety of matrices from FFPE cancer tissue biopsies to clinical serum-based samples. Precision Assays is one of the few CROs to offer large and immuno-oncology relevant multiplex off-the-shelf panels and is at the forefront of targeted-mass spec proteomics-based research. As a global CRO with expertise in targeted mass spectrometry and specializing in biomarker testing to support precision medicine, CellCarta is an ideal partner to deploy and industrialize our platform to support discovery, translational and clinical research, especially in precision medicine and immuno-oncology." Paulovich About CellCarta CellCarta is a leading provider of specialized precision medicine laboratory services to the biopharmaceutical industry. Leveraging its integrated analytical platforms in immunology, histopathology, proteomics and genomics, as well as related specimen collection and logistics services, CellCarta supports the entire drug development cycle, from discovery to late-stage clinical trials. The company operates globally with 11 facilities located in Canada, USA, Belgium, Australia, and China.

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DIAGNOSTICS

Phenomix Sciences Announces First Obesity Biobanking Registry and Outcomes Study for Precision Nutrition and Obesity

Phenomix Sciences | May 27, 2022

Phenomix Sciences (Phenomix), a precision biotechnology company bringing data intelligence to the treatment of obesity, announces today the launch of its biobanking registry and outcome study. The registry will study variability in obesity by looking at patients' DNA, metabolomics, hormones, patient behavior, assessments, and treatment outcomes. The data collected will supplement the 20 billion unique data points that make up the Phenomix Sciences Obesity Platform. Mayo Clinic is the first to enroll in the registry with its Rochester site set to contribute patient outcomes from 2,000 patients undergoing treatment for obesity to its biobank. The biobanking registry is a critical milestone in Phenomix's mission to conquer obesity by creating unprecedented access to its clinical and molecular information throughout all stages and phenotypes of the disease. Outcomes data generated from the biobanks across the registry will supplement Phenomix's database of biological and clinical data matched to the four obesity phenotypes. Insights generated from the database are being used to develop more predictive tests to identify the right intervention for each patient with obesity. This will allow for a better understanding of variability in patient outcomes when undergoing obesity treatments. Despite the justifiable excitement about new weight management products such as semaglutide and tirzepatide, several clinical studies from Phenomix's founders indicate that patient response varies with underlying phenotype. Thus, for many patients, it will open the door to the most effective and appropriate intervention for their unique phenotype. A growing body of evidence indicates that obesity is not a single disease with a single treatment type, but a constellation of diseases. Obesity's roots lie in individual DNA; however, evidence suggests there is a complicated web connecting obesity to age, race, and gender, education, and socioeconomic status. Understanding a person's obesity phenotype — the combination of genes with environmental and behavioral factors — can help pinpoint the cause of weight gain. Phenomix's phenotypes are based on research from its physician founders, Andres Acosta, MD, PhD and Michael Camilleri, MD of Mayo Clinic, that has demonstrated when patients have been phenotyped and prescribed the right medications, they can achieve up to 16 percent total body weight loss (TBWL). In addition to creating the first biobanking registry of this type, this is the first large scale study to monitor phenotypes in patients with obesity being treated with a variety of treatments. The impact of this biobanking registry and the data it will yield has the potential to change the entire system's approach to obesity, from a treatment recommendation to the way payers determine coverage and how industry combines diagnostics testing with drug therapy. This unique biobanking registry will provide critical and contemporary data on obesity outcomes, impacting every stakeholder in the episode of care, This registry is an important opportunity to make vast strides in how we understand the complexities of obesity treatment. All obesity programs should be seeking the opportunity to participate and contribute to this registry. The more data we have on the variables that contribute to an individual's obesity diagnosis, the more lives we can save by putting the best treatment plan forward. We believe the investment in the biobanking registry will better support obesity centers by providing concrete evidence and insight into how DNA and other factors need to be considered in treatment. Patients can benefit greatly from achieving the desired outcome the first time around, and payers avoid paying for trial-and-error approaches and can reduce overall co-morbid conditions for members." Mark Bagnall, CEO of Phenomix Sciences. About Phenomix Sciences Phenomix Sciences is a biotechnology pioneer on a mission to conquer obesity globally through the science of phenotyping, the understanding of how genes combined with environmental and behavioral factors can inform obesity treatment plans. Mayo Clinic physicians, scientists, and researchers, Andres Acosta, MD, and Michael Camilleri, MD, founded the company under the belief that the key to understanding obesity is unprecedented access to its clinical and molecular information throughout all stages and phenotypes of the disease. Phenomix leverages data intelligence for yielding better accuracy in predicting individual patient response to specific weight loss interventions and reducing the variability in weight loss results for patients.

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