Worg Pharmaceuticals
Shifting the Paradigm of AIT with PCFiT

Considering the petrifying devastating impact that COVID-19 had on public health, allergic diseases might seem to have become inconsequential. However, the global prevalence of such diseases continues to increase, which severely impairs the quality of life of millions worldwide. The standard care for allergic diseases only helps alleviate the symptoms and has no effect in preventing the progression of allergic symptoms to more severe disease. Practiced for over 100 years, Allergy Immunotherapy or AIT is the only disease-modifying therapeutic intervention. The efficacy of AIT has been established through a significant number of clinical studies and meta-analyses, both alleviating patients’ symptoms and preventing the allergic manifestations. Worg Pharmaceuticals, a clinical-stage biopharmaceutical company, is shifting the paradigm of AIT by developing its advanced technology platform—PCFiT—and the pipeline for AIT. The concept of Peptide/Carrier Vaccines (PCFiT™) is a refined concept of AIT aiming at maximal efficiency and simultaneous reduction of (IgE- and T cell-mediated) therapy-related side effects of AIT.

Worg was established in 2018 in Hangzhou, China and is led by an executive team from China, the U.S., and Europe, which brings in extensive experience in life science executive, pharmaceutical development, clinical trials, regulatory affairs and commercialization. The name “Worg”, which is the reverse of “Grow,” and reflects the company’s business model: from development to research strategy, which enables Worg to grow fast and bring innovative therapies to patients quickly. “We are developing AITs for patients with allergic rhinitis, allergic conjunctivitis, allergic asthma and other allergic disorders to improve their quality of life and offer better solutions than the current symptomatic treatments,” says Andrew Xu, Chairman and CEO of Worg. The company has recently acquired the worldwide rights of a comprehensive pipeline of PCFiT-based allergy vaccines for many inhalant allergens. Further, Worg intends to expand this pipeline through collaborations and internal research with an emphasis on prevalent allergens in worldwide market.

Andrew explains that much attention has been drawn to “Precision Medicine,” an emerging method of individualising therapy to a specific patient profile related to genotype and or phenotype. This approach, and has progressed with the genome sequencing technology, and the cross-application of biological information with big data science. “Our core technology platform PCFiT is a recombinant protein technology, which starts by the selection of major and important allergens that are responsible for allergic rhinitis (AR) and removes IgE binding.

The products are precision medicines based on the allergic sensitization of an individual’s unique profile charaterised by diagnostic tools,” Andrew comments that Worg’s platform offers state-of-the-art treatment in allergy technology with a good safety profile and a very brief treatment cycle leading to better patient compliance.

Worg owns the worldwide exclusive rights of the PCFiT technology platform, which is a third generation technology and the most advanced in the field of AIT. The concept of PCFiT approach built around molecular allergology can be expanded to other therapeutic areas such as oncology, and infectious diseases.

Significant advantages of Worg’s products and technology include:

• Allergy modification and disease prevention

• Beneficial benefit/risk profile demonstrated from early clinical studies

• Convenience to use and patient compliance because of short treatment cycle

• Reproducible manufacturing inherent to recombinant DNA technology

• Potential application to all allergies and expandable to other therapeutic areas

• Exclusive global rights

The uniqueness of Worg also stems from its multinational management team with profound drug development experience and a strong relationship with key opinion leaders in the therapeutic field. Andrew holds more than 25 years of experience in strategy and organization, Merger & Acquisition, capital deployment in the global pharmaceutical business. On the other hand, Rainer Henning, the CSO of Worg, brings over 40 years of experience in the pharmaceutical and biotech industry as a researcher and general management and as a venture capital investor. Richard Jones, CMO of Worg, has over 30 years of experience in clinical research and product development in large pharmaceutical, biotechnology and CRO companies. Worg has the most advanced technology in the AIT area from a technology perspective. The shortened treatment schedule is only 5 to 7 doses which dramatically increases both patient compliance and convenience. This is compared to much longer treatments of more than 30 doses with competitor sub cutaneous products and the long duration of sublingual therapies for 2-3 years.

To illustrate the company’s expertise, Andrew explains that Worg is developing the world’s first recombinant AIT product for grass pollen allergy, WP1048. It has completed three Phase II studies and demonstrated profound improvement of allergy symptoms, which proves the success of the PCF iT technology in the AIT application. “WORG is also leveraging its drug development expertise by actively seeking license-in opportunities of technology platform for global rights and late-stage or commercial assets for the Greater China territories. We are well-funded and have excellent relationships with leading healthcare investment firms in the APAC region,” he says. In addition to that, Worg plans to partner or license out the territory rights of the pipeline in Europe, the U.S., and ROW