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Ms. Lily Wu, CEO and Co-Founder, PapiVax, Taiwan
In a recent interview, in conjunction with the upcoming 백신 세계 아시아 의회, Ms. Lily Wu, Chief Executive Officer (CEO) and Co-Founder at Papivax Biotech Inc. (PBI) in Taiwan, shares her take on which vaccines should take priority, how she plans to optimize her company’s processes and what we can expect from PBI in the coming year. This interview is part of IMAPAC’s Thursday’s Thought Leader Spotlight series.
| Could you share with us your top 5 indications for which vaccines are pertinent at this point in time? Are there certain indications that you feel should receive greater attention than they currently are?
Vaccines are the most successful healthcare intervention, but they are typically only preventive and require immunizing the whole population. With the advent of molecular testing and advances in our understanding of human immunology, vaccines to treat established infectious diseases and related cancers have enormous potential, and would require only vaccination of those patients that have already acquired the pathogen. One important example is human papillomavirus type 16 (HPV16), a virus that causes 50-60% of all cervical cancers and 80-90% of all HPV-related anogenital (vaginal, vulval, anal, penile) cancers and head and neck cancers (oropharynx). PBI is a small biotechology company that seeks to prevent these cancers by immunotherapy of their precursor lesions (e.g. patients with HPV-16 positive abnormal cytology including Atypical Squamous Cells of Undetermined Significance (ASC-US) or Cannot Exclude High Grade SIL (ASC-H) Cytology or Low-grade Squamous Intraepithelial Lesion (LSIL)) and also as an adjuvant, likely with immune checkpoint blockade, for the management of advanced HPV16-associated cervical and anogenital cancers as well as HPV16-associated head and neck cancers.
The precursor lesions of cervical cancer (HSIL) are effectively treated by ablative therapy such as cold knife conization or Loop Electrosurgical Excision Procedure (LEEP). However, this surgical procedure is associated with elevated rates of cervical incompetence and premature delivery of children, as well as recurrence. The precursor lesions of other anogenital cancers are less successfully treated by ablation with side effects of pain and genital disfigurement or fecal incontinence. There are no defined precursor lesions of oropharyngeal cancer to treat unfortunately.
With the development of routine cervical screening by Pap and/or molecular viral testing, large numbers of women are discovering that they carry a high risk HPV infection including HPV16 but do not yet need ablative therapy (i.e. they have a low grade lesion). Unfortunately, currently there is no medical treatment for these patients except for waiting and re-screening. Patients in this situation not only have a greatly increased potential to develop cervical cancer but also suffer significant psychological stress associated with a sexually transmitted infection. The condition also imposes risks for their sex partners or spread to other anogenital or oral sites, thereby creating significant social-psychological burden for the patients and their partners.
Currently there is not enough attention being paid to these important unmet needs. PBI intends to address these unmet medical issues through the development of innovative therapeutic HPV vaccine technologies.
| In addition, could you share with us 2 areas you are looking to optimize? (with respect to processes, partnerships etc.)
The operation strategy for PBI is to employ streamlined approach for their management and clinical development and to minimize physical infrastructure requirements. Thus, most of our resources are retained for the manufacturing of clinical grade vaccines as well as for early phase clinical testing.
We have developed our own IP strategies through collaboration with and licensing from academic institutions. However, this virtual approach is only suitable for the early development and proof of concept through phase II. Thus, PBI is currently looking for strategic partners who can optimize subsequent clinical development towards licensure.
| Do you have anything exciting coming up in the next year? What should the industry look out for from your organization?
Yes, we have an ongoing double-blind placebo-controlled phase II study in patients with persistent HPV16 infection and low grade cervical disease using PBI’s innovative therapeutic HPV vaccine technology (NCT03911076).
This is the only phase II clinical trial in this group of patients currently. So far, there is no treatment for this group of patients beyond waiting and re-screening. With the increased molecular HPV testing for the screening of HPV-associated pre-cancers, we expect to see significant number of such patients with persistent high risk HPV infections, particularly HPV16. Thus, the successful outcome of our trial will serve as proof-of-concept for treatment of this group of patients to address their important unmet medical needs.
About Ms. Lily Wu
President Lily Wu is an experienced CEO with finance expertise. She has more than 20 years of leadership experience in finance and real estate enterprises. She was also one of the co-founders of Papivax Biotech Inc. (PBI). Ms. Wu was awarded a Master of Business Administration degree from the Executive Master’s Program of Business Administration: Advanced Management Program at Feng Chia University.
PapiVax Biotech Inc. (PBI) is a Taiwan-based biopharmaceutical corporation that focuses on the development of novel therapeutic vaccines for human papillomavirus (HPV)-associated diseases.
This interview is in conjunction with Vaccine World Asia Congress 2020
Join us at the virtual 백신 세계 아시아 총회 2020 conference as Ms. Lily Wu joins us as part of our esteemed speaker panel.
Join us here: https://buff.ly/2Zgnarm