AbbVie's Skyrizi wins its first FDA approval, springing blockbuster ambitions

biopharmadive | April 24, 2019

The psoriasis approval for Skyrizi (risankizumab) in the U.S. was expected, following a similar go-ahead from regulators in Japan and a positive recommendation from the European Medicines Agency's Committee for Medicinal Products for Human Use. In Phase 3 studies of the drug, roughly 80% of patients with moderate to severe plaque psoriasis achieved 90% clear skin and slightly more than half reached complete skin clearance using Skyrizi. However, the anti-IL23 antibody is far from alone in the next generation of immunology drugs. Other interleukin inhibitors already on the market include J&J's anti-IL 12/23 Stelara (ustekinumab) as well as the IL-17 inhibitors Cosentyx (secukinumab) and Taltz (ixekizumab), respectively marketed by Novartis and Eli Lilly.

Spotlight

The journey of a healthy cell through oncogenesis and tumorigenesis involves the activation and inactivation of numerous mechanisms and processes acute and chronic, cellular and systemic. Understanding how cancer alters physiological homeostasis and hijacks integral innate mechanisms for its own benefit is critical to the conception and development of novel therapeutic strategies against the disease.

Spotlight

The journey of a healthy cell through oncogenesis and tumorigenesis involves the activation and inactivation of numerous mechanisms and processes acute and chronic, cellular and systemic. Understanding how cancer alters physiological homeostasis and hijacks integral innate mechanisms for its own benefit is critical to the conception and development of novel therapeutic strategies against the disease.

Related News

MEDICAL

HealthMyne's Radiomic Technology Leveraged to Identify Biomarkers That Predict Immunotherapy Treatment Responses

HealthMyne | September 22, 2021

HealthMyne, a pioneer in applied radiomics, announced that peer-reviewed research recently published in the journal Cancers has demonstrated the ability of its radiomics technology to identify biomarkers that predict whether patients with lung adenocarcinoma would benefit from immunotherapy. In the Cancers article, researchers led by Vincenza Granata evaluated HealthMyne's technology as a quantitative imaging decision support tool for radiomic analysis of lung adenocarcinoma in chest CT scans. Researchers analyzed radiomic biomarkers to predict Overall Survival (OS) and Progression Free Survival (PFS) time. To perform the study, researchers selected 74 patients with histologically confirmed lung cancer who underwent immunotherapy and compared them with 50 patients with histologically confirmed lung adenocarcinoma who underwent chemotherapy alone or in combination with targeted therapy. Researchers segmented each patient's lesion leveraging HealthMyne's advanced imaging analytics solution to extract 573 radiometric metrics from the cohort images to predict OS and PFS time. Researchers found that 19 radiomic features were significant for predicting OS and 108 radiomic features for predicting PFS time. Researchers concluded that the study demonstrated the relationship between radiomics and immunotherapeutic response and that specific radiomic features can be used to select patients with lung adenocarcinoma who would benefit from immunotherapy. To maximize the value of research and development investments, drug developers need an accurate and efficient means of selecting and stratifying patients for clinical studies. Numerous examples of peer-reviewed research have shown that radiomics and precision image analysis identifies biomarkers that drive greater personalization of treatment and provides new insights for better decisions. At HealthMyne, we strive to develop innovative radiomic solutions that contribute to the advancement of this critical body of evidence. - Rose Higgins, CEO, HealthMyne. About HealthMyne HealthMyne® is a pioneer in applied radiomics, the cutting-edge field of extracting novel data and biomarkers from medical images. Our FDA-approved and CE marked, AI-enabled solutions allow organizations to easily access and translate groundbreaking radiomic insights into use in research, clinical outcomes, and treatment pathways. By leveraging radiomics, our clients and partners can accelerate the development and delivery of the best possible treatments. HealthMyne's approach is based upon the premise that every cancer patient's story begins with an image. We believe that unleashing the hidden power of imaging data and radiomics will revolutionize personalized care -- ensuring the right treatment every time. Our mission is to advance precision health initiatives through accessible and translatable radiomic data.

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

INDUSTRY OUTLOOK

RegeneRx Licensee Acquired by Korean Biopharmaceutical Group

RegeneRx Biopharmaceuticals, Inc. | September 28, 2021

RegeneRx Biopharmaceuticals, Inc., a clinical-stage drug development company focused on tissue protection, repair and regeneration), announced that GtreeBNT, the licensee for several RegeneRx products, is being acquired by HLB Group, a Korean company that includes six biopharmaceutical and financial subsidiaries in Korea and the U.S. GtreeBNT announced that as part of its acquisition the company would issue approximately US$80 million of new stock and convertible bonds to HLB Group to fund ongoing programs. The new capital should speed up the clinical trials currently in progress and allow the company to focus on new drug approval. RGN-259 will remain a priority for the company. HLB's recommended executives are expected to be appointed at the general meeting scheduled for October 29, 2021. Won Yang, the current CEO of GtreeBNT, is expected to remain as the chief research officer and continue to lead the development of new drugs after the acquisition. RegeneRx has scheduled its 2021 Annual Stockholder Meeting for November 10, 2021 and hopes to have additional details on the acquisition and its effect on GtreeBNT's clinical development activities and timing related to RGN-259 and RGN-137, products developed for the treatment of dry eye syndrome, neurotrophic keratitis, and epidermolysis bullosa. The fact that GtreeBNT will receive a significant capital infusion related to the transaction, we believe, should benefit the development of the products we licensed to the company. As soon as practicable after we receive any new information from the new management related to our products we will update our stockholders. - J.J. Finkelstein, president and chief executive. About RegeneRx Biopharmaceuticals, Inc. RegeneRx is focused on the development of novel therapeutic peptides, including Thymosin beta 4 (Tβ4) and its constituent fragments, for tissue and organ protection, repair, and regeneration. RegeneRx currently has three drug candidates in clinical development for ophthalmic, cardiac/neuro and dermal indications, four active strategic licensing agreements in the U.S., China, and Pan Asia (Korea, Japan, and Australia, among others), and the EU, and has patents and patent applications covering its products in many countries throughout the world.

Read More