Corvus Pharmaceuticals: A New Immunotherapy Player

| April 4, 2018

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The immune checkpoints are signaling molecules that act to shut down or block an immune response. In a healthy person, this mechanism is a "safety" feature allowing cessation of the immune response once it has performed its task. Cytotoxic T Lymphocyte Antigen 4 (CTLA‐4) and programmed Death 1 (PD1) are the most well‐known checkpoints, but there are many others. Tumor cells have evolved to use these checkpoints to inhibit an immune response, but agents like Yervoy (anti-CTLA-4) and Opdivo or Keytruda (both anti-PD1) have the potential to unleash the immune system's cancer-destroying properties. FDA and EMA approve all of them, but preclinical data suggest that there are many other immune checkpoints or targets that may be modulated to promote an immune response.

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We are Isis Pharma Consulting Ltd and we specialise in the provision of Quality Assurance, Qualified Person and Regulatory Affairs services to pharmaceutical, medical device and healthcare sectors. The company provides highly experienced Qualified Persons dedicated to providing a range of QP solutions for your business. We have QP, RP and Quality Management experience with IMPs, and commercial pharmaceutical manufacturing and also wholesaling and distribution organisations. We are also able to provide highly experienced regulatory personnel with up to date knowledge of current regulatory procedures and agency expectations.

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Advance Your Pharma Supply Chain Planning during a Pandemic

Article | March 20, 2020

One predominant and common element within our pharmaceutical industry, is our devotions to patients. Within supply chain there is always a focus on ensuring the right product is delivered to the right place at the right time in order to ensure patient safety and the continuity of medicinal supplies. With the spread of COVID-19 across 117 countries and counting, every supply chain needs to evaluate their global footprint and develop contingency plans within their end to end operations.

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Merck’s Patient-Centric Clinical Trial Recruiting

Article | March 20, 2020

Everyone in pharma knows that product success depends on the results of clinical trials — but we don’t usually hear from the people who are involved in running them. Recently, four Clinical Research Managers (CRM) from Merck (known as MSD outside the United States and Canada) discussed how Merck is overcoming the barriers to clinical trial recruitment by adopting a patient-centric process — a model that affects their trials top to bottom, from design through implementation. Each of the panel members manages clinical trials, serving as the main point of interaction with the Clinical Research Associates (CRAs) on research requirements, goals, and resources, including recruiting and retention.

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Roche Prepares to Launch COVID-19 Antibody Test System

Article | March 20, 2020

Swiss pharma giant Roche is joining the race to develop a test for COVID-19 antibodies in people who have been exposed to the disease. This morning, Roche announced the development and upcoming launch of its Elecsys Anti-SARS-CoV-2 serology test to detect antibodies in people who have been exposed to the SARS-CoV-2, the virus that causes COVID-19. Roche is eying May for the launch of the test in Europe and is in talks with the U.S Food and Drug Administration for emergency approval of the system. Antibody testing is central to help identify people who have been infected by the virus, especially those who may have been infected but did not display symptoms, the company said. Roche noted that as more information becomes available about immunity levels to COVID-19, society can return to a sense of normal much more quickly. Roche’s test will join a number of other antibody tests that have recently come on the market. Earlier this month the U.S. Food and Drug Administration approved the first blood test for COVID-19 antibodies.

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Coronavirus Pandemic Brings Hundreds Of U.S. Clinical Trials To A Halt

Article | March 20, 2020

Rene Roach fired off a quick email in late March for an update on a colorectal cancer clinical trial for which she hoped to qualify. Worried about the coronavirus, she asked, almost as an afterthought, whether the study had been put on hold because of the pandemic.The answer crushed her: It had been. "That's when COVID-19 shut down everything," says Roach, 50, of Germantown, Md. Roach assumed that there would be workarounds for patients like her, who have stage IV cancer. These patients often depend on clinical trials as their best chance to knock cancer out when other therapies have failed. For now, she's being treated with traditional chemotherapy, but she was counting on the drug cocktail from the clinical trial. She figures if chemo was going to rid her body of cancer for good, it would have done so already.

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ISIS Pharma Consulting

We are Isis Pharma Consulting Ltd and we specialise in the provision of Quality Assurance, Qualified Person and Regulatory Affairs services to pharmaceutical, medical device and healthcare sectors. The company provides highly experienced Qualified Persons dedicated to providing a range of QP solutions for your business. We have QP, RP and Quality Management experience with IMPs, and commercial pharmaceutical manufacturing and also wholesaling and distribution organisations. We are also able to provide highly experienced regulatory personnel with up to date knowledge of current regulatory procedures and agency expectations.

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