Drug Discovery and Development Archives

Innovations in Baculovirus–Insect Cell Expression Systems

The baculovirus–insect cell expression system—insect cells used in conjunction with the baculovirus expression vector system (BEVS)—remains a crucial technology for manufacturing large and complex proteins. This eukaryotic expression system offers inherent safety, ease of scale-up, flexible product design, and versatility for a broad range of proteins. As artificial intelligence and computational technologies advance, aiding in the design of complex protein structures with potential folding challenges, baculovirus–insect cell expression systems will remain essential in facilitating the development and production of innovative medicines to meet unmet patient needs. Sino Biological is significantly expanding in the United States and improving baculovirus–insect cell expression offerings at its Houston, Texas, facility, the Center for Bioprocessing.

Advantages of Baculovirus–Insect Cell Expression Systems

The baculovirus–insect cell expression system is a …

The multi-billion dollar promise of efgartigimod and the broader FcRn inhibitor market

Simplified schematic illustration showing the proposed mechanism of action of FcRn inhibitors. The left side illustrates how IgG molecules enter cells and interact with the neonatal Fc receptors (FcRn), and the right side depicts the impact of FcRn inhibitors on this process. Image by Benff, licensed under [CC BY-SA 4.0], via Wikimedia Commons. Modified from D.D. Patel, J.B. Bussel’s work.

The Fc receptor (FcRn) inhibitor market, led by promising candidates such as efgartigimod, promises to reshape the autoimmune disease treatment landscape. Sales projections for the market top $10 billion, as Driehaus Capital Management estimates. The addressable U.S. patient base spans more than 228,500 individuals across various conditions including myasthenia gravis, warm autoimmune hemolytic anemia (wAIHA) and idiopathic thrombocytopenia purpura (ITP), and more. As the estimated annual treatment cost per patient for targeted…

Moving beyond pilot purgatory: Scaling AI in drug discovery projects

3D representation of the HTLV-1 intasome (a type of nucleoprotein complex) structure as visualized through cryo-electron microscopy. [Adobe Stock]

The topic of AI in drug discovery and development may continue to garner significant attention, but harnessing AI effectively requires a nuanced strategy, and an ability to navigate between details and the bigger picture.

Andrew Anderson, vice president of innovation and informatics strategy at ACD/Labs, likens it to boiling water. “On a small scale, it’s straightforward. But boiling a tanker cart full of water? That’s a different ballgame,” he said.

Thinking through these aspects is vital to address the ‘pilot-purgatory’ problem, which frequently arises in projects involving emerging technology. As a growing number of drug developers launch proof-of-concept AI projects, a significant number are struggling to scale them. “There’s a stru…

Biotech sees new shoots of growth but has thorns left to prune

[Image courtesy of ipopba/Adobe Stock]

Today, Boston-based Ginkgo Bioworks’ recently unveiled a deal with Pfizer on RNA-based drug candidates, reflecting the growing interest in RNA therapies. Additionally, Carlsbad, California–based Ionis Pharmaceuticals inked a pact with Roche focused on RNA-targeted therapies for Alzheimer’s and Huntington’s diseases. This development underscores the resilience of prominent biotech hubs.

According to data from real estate services firm JLL, also released today, San Diego’s life sciences has seen a steady increase in VC funding in recent quarters, accelerating in the first half of 2023. In Q2 2023, VC funding hit $632 million and has exceeded $1 billion in Q3.

Still, that’s far from the investment peak of $1.94 billion in Q1 2021. Following that boom in the early phases of the pandemic, the San Diego life sciences sector saw its VC funding …

The balancing act of biotherapy: Be The Match BioTherapies’ Abby Waters on agility and beyond

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Professionals in the biotherapy world are engaged in a sort of balancing act, juggling the nuances of product development, complex science, leadership dynamics, and patient-centricity. In a recent interview, Abby Waters, Ph.D., senior manager of solution owners at Be The Match BioTherapies, opens up about her decade-long journey navigating these multifaceted challenges. From embracing agile methodologies to driving data-informed decisions, Waters shares insights on leading teams, prioritizing patients, and envisioning the future in this quickly evolving field.

In the interview — part of our Women in Pharma and Biotech series, Waters provided insights on an array of subjects, from adopting the IT-based agile framework to cell-and-gene therapy to the art of hiring and weighing hard and soft skills in the biotherapy domain. She also provided advice on approaching data-driven decisions, and offered per…

Allosteric drugs: A differentiated small molecule approach

Protein misfolding image courtesy of Gain Therapeutics

Over the last decade, drugs that bind to allosteric sites have emerged as an attractive approach in small molecule drug design, offering new possibilities for targeting various diseases, including conditions historically known as “undruggable”. Unlike traditional small molecules that bind to a target protein’s endogenous orthosteric or active site, allosteric small molecules selectively bind and modulate protein function at a distant location on the protein’s surface. This unique mechanism allows for precise and selective control of protein activity, offering potential advantages over conventional small-molecule medicines.

While allosteric activation and inhibition have proven their clinical utility, scientists are unearthing new methods of developing allosteric therapeutics that can better modulate protein function as determined by disease patholo…

Molecular photoswitches: Illuminating the future of inherited retinal disease treatment

A retina model cross-section labeled with antibodies against recoverin (green), calretinin (red) and PKA (blue). [NIH]

Vision, one of our most valued senses, is a complex orchestration of light-sensing photoreceptors, neurons, and intricate pathways leading to the brain. Central to this native biological system are the photoreceptors – the rods and cones – cells that are responsible for capturing light and initiating visual perception. For many with inherited retinal diseases (IRDs), the degradation of these photoreceptors represents an inevitable descent into darkness. Enter molecular photoswitches, a new class of small molecules poised to revolutionize the field of ophthalmology. Notably, preliminary data coming out of phase 1b clinical trial demonstrates the feasibility of restoring vision for those suffering from inherited retinal disease.

Understanding Molecular Photoswitches

In healthy eyes, rods and cone…

Analysis shows that cariprazine may have cost savings potential for treating MDD

[Cariprazine image courtesy of PubChem]

The Vraylar (cariprazine), which recently scored FDA approval as an adjunctive treatment for Major Depressive Disorder (MDD), could have positive implications for healthcare resource utilization. A new analysis suggests that this atypical antipsychotic, initially developed by Allergan (now AbbVie), could curb healthcare spending of MDD treatment.

In the economic analysis, patients who received cariprazine as their first adjunctive therapy had 45% fewer MH-related hospitalizations and 33% fewer outpatient visits per patient-year than those who received it as a subsequent adjunctive therapy. Additionally, patients starting cariprazine as their first adjunctive therapy also had $2,182 lower total MH-related healthcare costs per patient per year. This was largely a result of significantly lower outpatient visit costs, which were reduced by $1,511 per patient per year, relative…

AI in antibody drug discovery as a tool, not a magic wand

Early in the pandemic, AbCellera entered into a partnership with Lilly to co-develop antibody therapies for COVID-19. The pact eventually led to the development of a number of antibodies, including bamlanivimab, etesevimab and bebtelovimab. Shown here is the antibody bebtelovimab binding to the SARS-CoV-2 spike protein, highlighting key mutations from the omicron variant. The green structures represent the target-binding fragments (Fabs) of bebtelovimab, while the purple structure show the virus’s spike protein, with omicron mutations highlighted in red.

AI in drug discovery is a topic that gets an outsized amount of attention, observes Carl Hansen, CEO of AbCellera, a company specializing in antibody drug discovery. “It’s as if people are saying, ‘AI is here, it’s going to save us. Thank God, we’re finally gonna be able to create drugs,” he said. “To me, that’s implicitly …

The best-selling pharmaceuticals of 2023: Immunology and oncology return to prominence

Note: This feature on the best-selling pharmaceuticals of 2023 will be updated regularly as new data becomes available. Stay tuned for our ongoing coverage of the pharma sector’s sales dynamics.

[Scanrail/Adobe Stock]

In 2023, as the grip of the COVID-19 pandemic began to loosen, the pharma sector returned to relying on immunology and oncology as sales drivers. So far this year, the two segments are on track to be the strongest in the pharma landscape. In the first half of 2023, the immunology and oncology domains drove sales of $31.110 billion and $37.982 billion, respectively, based on a review of financial data from 13 Big Pharma companies. Conversely, the infectious disease segment accumulated sales of approximately $28.587 billion.

Contrasting the boom of prior years, 2023 has seen a pronounced dip in the appetite for SARS-CoV-2 vaccines. For instance, the Pfizer-BioNTech vaccine generated roug…

Early data suggest adjunctive cariprazine could be a promising tool for tackling stubborn anhedonia in MDD

[Cariprazine image courtesy of PubChem]

The dopamine D3 receptor-targeting cariprazine could potentially be a new tool for managing anhedonia, one of the most stubborn symptoms of major depressive disorder (MDD). Characterized by a lack of enjoyment in previously pleasurable activities, anhedonia has been “difficult to address with traditional antidepressants,” said Dr. Vladimir Maletic, coauthor of a poster presented at the U.S. Psych Congress annual meeting held earlier this month in Nashville.

In a post hoc analysis focusing on the adjunctive use of AbbVie’s dopamine D-preferring D3/D2 cariprazine in MDD patients with an inadequate response to one to three antidepressant therapies, patients saw a notable improvement in overall depressive symptoms and, specifically, anhedonia symptoms. This improvement, measured with the Montgomery-Åsberg Depression Rating Scale (MADRS), was observable as early as week 2…

High-profile drugs under the legal spotlight in 2023

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In the wake of the COVID-19 pandemic, the U.S. has witnessed a surge in litigation. One factor driving the uptick in the pharmaceutical sector is the rise of copycat litigation. As mass tort activity amplifies, plaintiff lawyers are treating previously filed lawsuits as templates for new claims. Examples of the trend include steadily increasing nitrosamines litigation and allegations of laminal duct obstruction against the chemotherapeutic agent Taxotere (docetaxel), as Greenberg Traurig has noted. Additionally, plaintiff-affiliated labs are intensifying their efforts to test various products for potentially harmful chemicals.

Amidst this backdrop, the heartburn medication Zantac (ranitidine) has found itself at the center of a litigation storm. Data from X-Ante, a litigation analysis firm, reveals the drug is the most frequent drug target of mass tort TV advertising in 2023 based on estimated ad s…