Biointron Weekly Reports
News?
Coming up this week is the AACR ( American Association for Cancer Research ) Annual Meeting 2024, on April 5-10! We hope you can join us at the San Diego Convention Center in California. The event will gather scientists, clinicians, survivors, patients, and advocates in the cancer research community, to share the latest advances in oncology. Don’t miss out and meet us at Booth #746 or schedule a one-to-one meeting with our team here! ?
In our latest episode of the Antibody Basics video series (Part 6), we cover antibody-drug conjugates (ADCs), the drug modality taking the pharma industry by storm. Watch it now.?
This Week’s News?
Trends – The Complexities of Drug Approvals?
The development and approval of novel antibody drugs represent a significant segment of pharmaceutical innovation, addressing a wide range of diseases from cancer to autoimmune disorders. Since the first monoclonal antibody (mAb) drug was approved in 1986, there has been explosive growth in this area. By 2021, the US FDA had approved its 100th mAb product,?with mAbs now accounting?for nearly a fifth of the agency’s new drug approvals each year.?
Just this past week, two novel antibody-based drugs gained approval. Astellas Pharma 's Vyloy (zolbetuximab) is a monoclonal antibody, developed as a treatment for patients with CLDN18.2 positive, unresectable, advanced or recurrent gastric cancer. Approved by Japan, it is the first and only CLDN18.2-targeted therapy approved in the world. Meanwhile, 默克 's Winrevair (sotatercept), is a recombinant fusion protein made up of the extracellular domain of activin receptor type IIA linked to the Fc portion of human IgG1. Granted FDA approval, the novel drug will treat adults with pulmonary arterial hypertension (PAH) to increase exercise capacity, improve WHO functional class, and reduce the risk of clinical worsening events.
The journey to approval for novel drugs, including antibody therapies, is very complex. There are multiple steps towards clinical trials in addition to stringent regulatory reviews that assess the safety and efficacy of these therapies. The regulatory landscape requires a delicate balance between innovation and patient safety, often extending the time from discovery to market availability. Moreover, the high cost of drug development, along with the need for substantial evidence to demonstrate clinical benefit, adds layers of complexity to bringing new antibody drugs to patients.
On March 1, the FDA published a new guide for recommendations to assist industry and other parties involved in the development of antibody-drug conjugates (ADCs). It details the FDA’s current thinking regarding clinical pharmacology considerations, bioanalytical methods, dosing strategies, dose- and exposure-response analysis, intrinsic factors, QTc assessments, immunogenicity, and drug-drug interactions (DDIs).?
In addition, a revised draft guidance for drug development for early Alzheimer’s disease was published by the FDA on March 12, representing their current thinking regarding the selection of subjects with early AD for enrollment in clinical trials and the selection of endpoints for clinical trials in this population. These guides are extremely helpful in directing pharmaceutical companies towards eventual drug approval. ?
However, the COVID-19 pandemic brought about a remarkable acceleration in vaccine and therapeutic development, showcasing the potential for rapid clinical trials and approvals. This experience has ignited hopes for a more streamlined approach to drug development and regulatory review, potentially benefiting the approval process for antibody drugs. The ability to fast-track clinical trials, without compromising on safety or efficacy, could revolutionize the way new treatments are brought to the market, especially for diseases with unmet medical needs.?
Promotions?
Biointron offers a new choice for your small-scale antibody expression rush needs: RushMab? Small-Scale Antibody Expression Packages.?
领英推荐
?? Designed to be cost-effective and time-saving?
? As fast as 8 days?
?? More than 5000 samples?
?? Explore different packages from Super, Standard, and Mini?
?
Get ready for a fantastic adventure at AACR ( American Association for Cancer Research ) with the “Great Dr.Young Hunt”! Score a pair of AirPods or a Google Speaker by keeping your eyes peeled on our social media channels and around the AACR conference for Dr. Young stickers to collect. Swing by Biointron Booth #746 on the last day with your collection to take home your goodies! For more info click here.? ?
Upcoming Events?
Happening this month is the Festival of Biologics San Diego (FOB) on April 15-17, 2024, at the San Diego Convention Center, CA! Join Biointron at this hub for groundbreaking discussions and innovations in the biologics sector. Our team is eager to meet fellow professionals, thought leaders, and enthusiasts. Find us at Booth #240 or register for a 1-on-1 meeting here.??
New Products?
Learn more about Biointron at www.biointron.com, or contact us at [email protected] and +1 (732) 515-4766.