Biopharmaceutical Firms Can Develop Effective HIV Treatment by Monoclonal Antibodies for Drug-Resistant Patients
HIV treatment by monoclonal antibodies may be an effective therapy for patients with drug-resistant HIV. Image source: Flickr CC user NIAID
HIV drug resistance is on the rise worldwide. Despite the success of anti-retroviral treatment (ART) in helping HIV patients manage the disease, rough estimates claim that 10% of patients starting ART and up to 40% of those restarting ART encounter a growing resistance to the drug’s effects.1 The situation arises when patients fail to adhere to their therapy regimen, which circumvents ART’s primary mode of suppressing viral replication and increases the chance of the virus mutating and producing a drug-resistant strain. The ability of HIV replication to rebound even during therapy breaks as short as two days has served as one of the major hurdles in discovering a functional cure for infection.2
When ART can no longer provide a sufficient treatment option for the disease, medical professionals often have to resort to secondary therapies to help HIV patients. But as the incidence of multidrug resistance grows, more people are joining the ranks of patients who remain unresponsive to traditional drugs. Thankfully, life science firms have been working to help this unserved demographic. Similar to the research being conducted in the cancer field, R&D laboratories have been looking at developing an HIV treatment by monoclonal antibodies. Should these biotherapeutics prove effective, other firms will likely adopt similar strategies to develop treatments for unresponsive patients—but their success will depend on efficient discovery and development.
Effective HIV Treatment by Monoclonal Antibodies Depends on Novel Approaches
Last March, a novel monoclonal antibody designed to treat HIV entered late-stage Phase III clinical trials. Specifically targeting HIV drug-resistant patients, the therapy’s primary mode of function reduces viral replication. Current clinical data has demonstrated the biotherapeutic’s ability to improve quality of life in HIV patients by significant levels, leading the FDA to label it a breakthrough therapy because it represents a substantial improvement over existing treatments.3 The therapy’s success hinges on the antibody’s abiity to:
- Act as an HIV-entry inhibitor by binding to the virus’s main receptor
- Block the virus from infecting target cells, the antibody can prevent HIV replication
- Prevent HIV replication reduces viral load in patients to an extent not observed in therapy regimens dependent upon traditional drug cocktails or vaccines
A departure from current HIV therapies, the antibody treats the disease directly, instead of simply alleviating the associated symptoms and conditions. Depending upon the biotherapeutic’s performance in these final clinical trials, FDA approval could pave the way for more biologics tailored toward untreatable patient demographics.
Digital Solutions Can Help Researchers Discover Effective Biotherapeutics for Drug-Resistant Patients
The ability to develop such an effective novel monoclonal antibody depends upon knowledge of disease mechanisms. Armed with the knowledge of how HIV infects cells, researchers were able to design an antibody that binds to the target receptor, thereby blocking viral infection.
But even with this information, the actual process of discovering and developing potential antibody candidates can be a long and involved process. In order to accelerate the R&D cycle and create better biotherapeutic drugs for other conditions and diseases such as HIV, life sciences will need to find ways to streamline the following areas:
- Developing crucial assays: Designing experiments to uncover underlying disease mechanisms and study bio-analytical processes can be involved and complicated. Sharing them with collaborators can be even more so, especially when experimental observations are included. While traditional paper-based systems allow for the recording of unstructured notes, these insights can be difficult to share with colleagues. A digital system that supports both rapid design of experimental assays and management of unstructured data allows scientists the flexibility to analyze freeform information while maintaining efficient workflows.
- Identifying antibody candidates: Uncovering the underlying disease mechanism is only the first step in the process. Once researchers know which receptors and biological pathways are involved, they will need to identify the best candidates for study and potential antibody design. Managing data from the experiments used to discover these candidates can be overwhelming. Adopting platforms that enable the collection and collation of experimental results can boost efficiency by supporting effective sequence analysis and early assessment of antibody developability.
- Optimizing antibody design: Sequence analysis alone is not enough to design novel monoclonal antibodies. R&D laboratories increasingly need to rely upon modeling and simulation tools to predict critical behaviors such as an antibody’s potential physical properties. These tools would allow life science firms interested in developing biotherapeutics for drug-resistant patients—as seen in the case of HIV treatment by monoclonal antibodies—to design therapies to target candidates that block disease progression.
Developing HIV treatment by monoclonal antibodies is only one example of addressing the needs of multidrug-resistant patients. Other disease populations contain demographics that remain unresponsive to existing therapies or for whom current therapies are no longer effective. As life science firms look for other patient populations to help by designing novel biotherapeutics, they will need to ensure their research efforts allow for efficient drug discovery and development.
BIOVIA Biologics is a comprehensive suite of digital processes that enable the discovery and design of innovative biotherapeutic drugs. From tools that support effective and flexible experimental and data management to modeling environments that allow visualization of antibody properties and behavior, the solution helps life sciences R&D laboratories develop therapies for patients with few treatment options. If you’re interested in learning how the Biologics solution can benefit your research laboratory, please contact us to learn more.
- “How to combat the threat of HIV drug resistance,” August 11, 2016, https://www.theguardian.com/global-development-professionals-network/2016/aug/11/hiv-drug-resistance-aids-free-generation ↩
- “Latest HIV Cure Data Expose Resilience of Infection,” July 19, 2016, http://www.medscape.com/viewarticle/866309 ↩
- “Theratechnologies and TaiMed Biologics Sign Exclusive Marketing and Distribution Agreement for Ibalizumab,” March 18, 2016, http://www.marketwired.com/press-release/theratechnologies-taimed-biologics-sign-exclusive-marketing-distribution-agreement-ibalizumab-tsx-th-2107173.html ↩