mAbs

Alcimed worked with a major pharma player to understand the potential receptivity of using life-extended monoclonal antibodies to manipulate the commensal bacteria found in the skin to prevent dermatological inflammation.

Alcimed analyzed the current treatment landscape, the unmet needs in the current standard of care, the lack of innovation in the space, and the receptivity to novel treatment strategies. Using this analysis, Alcimed was able to estimate the potential market sizes for both prophylactic and therapeutic indications across several geographies.

Our client could then select the right therapeutic target to add to their R&D pipeline for further exploration of the approach’s technical feasibility.

Alcimed worked with a major biotech player to conduct an in-depth analysis of the scientific publications related to ADAs for chronic diseases (particularly inflammatory diseases like osteoarthritis or rheumatoid arthritis) to characterize ADAs (etiology, formation mechanism,…) and assess their impacts on the efficacy of a mAb treatment in human and animal health.

Alcimed also identified the solutions to overcome those impacts either after treatment injection or at an early development stage and assessed the perception of ADAs by the scientific community and health authorities.

That understanding and analysis of the better ways to circumvent the potential hurdles associated to ADAs, from a scientific and regulatory prospective, allowed to inform on our client’s development strategy for a veterinary mAb.

As seen before, one current limitation of mAbs is their delivery mode, that can restrict their access. One of our clients, a large biotech player, was developing a new Mab, from formulation to packaging.

On top of scientific and medical considerations, our client wanted to improve the patient and HCP experience with the product itself, during administration notably. We then mapped and characterized the current market standards for secondary packing on high-value injectables including mAbs.

The reception of such secondary packaging from both healthcare providers and patients was assessed to make critical packaging design decisions for a new product for the treatment of moderate-to-severe atopic dermatitis nearing market launch.

Alcimed supported a major pharma player in creating a landscape of the most relevant players with technology platforms for oral delivery of mAbs and prioritized them based on development stage and technology platform.

Based on this landscape Alcimed also defined the strategic value arguments for utilizing oral delivery technologies for mAbs and assembled an expert advisory panel to aid in the adoption of such a strategy.

We could then select the right partners to move forward with, and refine our client’s strategy based on how favorable the environment is for the use of oral delivery for mAbs.

The Alcimed team supports its clients in exploring the development potential of monoclonal antibodies (mAbs) across different therapeutic indications and in monitoring innovation developments to ensure mAbs can be used safely and effectively, with improved delivery options for a larger range of patients, from chronic diseases to the use of bispecific antibodies for tumor targeting. The recent success of COVID-19 mAbs in preventing and resolving severe disease highlights the importance of mAbs in infectious disease, especially for immunocompromised patients and in the context of a global pandemic.

Therapeutic use of mAbs is not new. The first therapeutic use of a mAb was granted approval in 1986 for kidney transplant rejection using an anti-CD3 mouse antibody. Its murine origin caused side effects due to the development of anti-mouse antibodies, which dramatically decreased the safety of the therapy. Nowadays, mAbs can be humanized to prevent this and there are more than 1601 monoclonal antibody therapies on the market. The number of monoclonal antibody therapies is expected to grow rapidly.

Alcimed supported a pharma company to identify the best subpopulation of patients with a specific medical condition to be treated with one of their therapeutic mAbs. To do so, our team first performed a segmentation of patients based on desk research and KOL’s opinions. Subsequently, we defined the most promising subpopulations to be treated with the mAb based on specific criteria and assessments. Finally, we elaborated 2 business case scenarios to predict the business potential of the use of the mAb to target identified subpopulations. Thanks to our work, our client received an extensive and complete overview of different subgroups among patients with the specific medical condition. Moreover, they finally got a clear understanding of the business potential of their mAb if they decided to target the selected subpopulations.

Alcimed supported an industry leader in animal health to map companies offering generative AI solutions to support the discovery and optimization of therapeutic mAbs and to select the most promising ones to partner with. To do so, our team identified and mapped 110 companies worldwide with desk research and external interviews. We then strategically selected the 3 companies that best fit the needs of our client. Thanks to our work, our client now has a clear overview of the current landscape of companies offering AI technologies for mAb therapy discovery and development. Moreover, the client will run parallel trials with each of the 3 recommended companies to test their technology in therapeutic areas of interest.