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< FAQs from the investor meetings as of April 2021 >
We (or “PharmAbcine”) prepared this FAQ (Frequently Asked Questions) to provide answers to questions raised during the Q&A session of the investor meeting in the 1Q of 2021. We recommend viewers to refer to the previous FAQs as this issue only addresses newly raised questions.
1. What is the current development status of the preclinical assets?
Our preclinical assets, including PMC-309, PMC-403, and PMC-402, are getting ready for IND-enabling studies. We are about 7-8 months behind the initial projection. All three molecules were previously scheduled to enter the clinical stage in 2H21. Our revised schedule shows that these assets will enter the clinical stage in 2022.
The COVID-19 pandemic is the single most important reason for such delays. A sharp and unexpected rise in the number of preclinical studies relating to the development of COVID-19 vaccines and therapeutics has created a huge bottleneck, causing serious delays in drug developments of many biotech firms.
Delays are an inevitable part of drug developments, no matter how carefully one plans. PharmAbcine is more susceptible to delays because all of our preclinical assets are first-in-class molecules. Developing a first-in-class drug is like exploring an uncharted world, and delays happen more frequently.
We are doing the best we can to avoid any delays and to shorten our R&D process. We would like to ask our investors for their understanding when delays unfortunately happen.
2. What is the rationale behind the phase II olinvacimab and pembrolizumab combo trial in metastatic Triple-Negative Breast Cancer (mTNBC)?
PharmAbcine intends to do the phase II trial because the Company believes that the olinvacimab-pembrolizumab combo therapy can provide a great therapeutic option for mTNBC patients who do not respond to the existing drugs.
Although the existing drugs have a high response rate of 50+%, they only offer efficacy to those patients with high PD-L1 expression levels. In contrast, the olinvacimab-pembrolizumab combo showed comparable efficacy data regardless of PD-L1 expression level.
The interim result from the phase Ib study showed no serious safety issue with 50% Overall Response Rate (ORR) and 67% Disease Control Rate (DCR) in the high olinvacimab dose cohort.
The data from the phase Ib trial gave us an added confidence for the combo therapy. The Company has already signed a clinical collaboration for the phase II with MSD and will submit an IND filing soon. We aim to start the phase II study within 1H21 in both Australia and Korea.
3. Why does PharmAbcine prefer Australia as the main clinical trial site?
There are at least four reasons we prefer Australia as our main clinical site.
First, Australia offers the best value for money. The Australian government offers tax incentives for those bio tech companies which set up a local operation and conduct clinical studies in Australia. Including the tax incentives, doing a clinical study in Australia is about 20-25% cheaper than in Korea.
Second, the regulatory approval process is much shorter in Australia. Our experiences show that the time it takes to get a regulatory approval in Australia is about one half of that in the US.
Third, most global pharmaceutical companies prefer clinical data obtained in Australia because Australia has the racial diversity needed for a US FDA approval.
Lastly, it is much easier for us to oversee and manage clinical studies performed in Australia because Korea and Australia are in a similar time zone. Australia is only one hour ahead of Korea.
4. What is the significance of PMC-309?
The significance of PMC-309 is that it can provide a new therapeutic option in immuno-oncology with its unique mode of action, pH-independent affinity, and anti-tumor effect.
PMC-309 has a distinctive mechanism whose mode of action does not overlap with that of anti-PD-1/PD-L1 molecules. It targets an immune checkpoint regulator instead of an immune checkpoint. More specifically, it targets VISTA on MDSCs (myeloid-derived suppressor cells), a T cell regulator.
Once PMC-309 binds to VISTA, it indirectly promotes immune responses by inhibiting VISTA pathway between T cells and MDSCs. This unique feature makes PMC-309 an excellent drug candidate for patients who do not respond or have become resistant to the current immunotherapies.
PMC-309’s affinity is pH independent, as it maintains its mechanism even in the hypoxic tumor microenvironment (TME) where many drugs lose their mode of action. This hypoxic environment can cause detrimental effects to the binding mechanism of the molecule lowering the drug’s performance. We expect pH independence of PMC-309 will bring more consistent efficacy.
We believe that PMC-309 can improve low response rates of the existing immuno-oncology drugs through combination therapies. The data from our non-clinical studies showed that PMC-309 and PD-1 drug combo significantly improved tumor growth inhibition compared to mono therapies. This is important because the current immuno-oncology drugs show less than 30% response rate in most oncology indications when used in mono.
5. What is PharmAbcine’s licensing strategy for the first-in-class molecules such as PMC-309, PMC-403, and PMC-402?
The Company’s strategy is to license out its assets in the early stage and enter the clinical stage only when needed.
Many global pharmaceutical companies demand preclinical data after GLP-tox studies. If the data is good in terms of both efficacy and safety, there is a good chance for an early licensing deal. The chance is much higher if the molecule is first-in-class.
Note that all of our preclinical assets are first-in-class and we plan to complete the GLP-tox studies over 2H21-1H22. That said, we will most likely start talking to potential partners as early as 1H22. There are already companies requesting an update when the GLP-tox data is available.
As mentioned earlier, our strategy is to sell our assets as early as possible. However, PharmAbcine will consider a clinical trial only when such a trial significantly increases the value of the asset.