< FAQs from the investor meetings in June 2020
We (or “PharmAbcine”) prepared another FAQ to better answer some questions raised during the Q&A session of the investor meeting in the 4th week of June 2020. We recommend viewers to also refer to the previous FAQ as this FAQ only addresses additional questions.
1. What is the current status of the olinvacimab mono-therapy clinical trial that treats patients with bevacizumab (Avastin®)-refractory recurrent glioblastoma multiforme (rGBM)?
We are currently recruiting patients in three regions: Stanford and Florida in the U.S, and Austin in Australia. So far, we were able to recruit five patients in Stanford and five more in Austin. We are looking to recruit a total of 36 patients for this study. However, due to COVID-19 pandemic, there is a delay in patient recruitment.
We started this clinical trial because from our previous phase IIa clinical study in patients with rGBM, we discovered that the mode of actions (MoAs) of bevacizumab and olinvacimab do not overlap with each other completely. In other words, rGBM patients who have become resistant to bevacizumab can be treated with olinvacimab instead, and vice-versa.
2. Can you explain the rumors about “failure in clinical trial” that spread after the ASCO 2020 clinical data release?
There certainly were some rumors. However, they are not well founded due to two reasons.
First, the endpoint of that clinical study was safety, not efficacy; the clinical data showed an excellent safety profile.
Second, the data cutoff was in November 2019. In other words, the interim data is not sufficient yet to evaluate the overall results of the clinical trial. We could not help but had to make this early cutoff to allow our strategic partner Merck to review the abstract before submission.
For these reasons, the rumors are not true.
3. Is PharmAbcine officially “giving up” on olinvacimab + pembrolizumab combo therapy clinical trial targeting rGBM patients?
PharmAbcine is not terminating the rGBM program. The combo clinical trial will be finished in late 2020 as planned. We are, however, reorienting our business strategy. While our partner MSD intended to carry the trial to a next phase, we have decided to call a pause to further rGBM combo trials but shift our gears to metastatic Triple Negative Breast Cancer (mTNBC). This decision is based on data evaluation from prior trials and cost effectiveness.
4. What is the plan for olinvacimab’s mTNBC phase IIa clinical trial?
We have sent the synopsis for the study to Merck and are planning more detailed discussions as we move toward finishing the phase lb study by the late 2020.
We will update our investors as soon as the protocol for the phase IIa clinical study is finalized.
5. What is your development strategy for PMC-403?
PharmAbcine is planning a preclinical trial for PMC-403 in preparation of IND submission and initiation of a global phase I clinical trial in 2022. In June, we have entered into a strategic partnership with Samsung Biologics for the development and manufacturing of PMC-403 to get the full scope of its CDO services from cell line development, process development, cGMP clinical manufacturing, and to IND filing support.
Since PMC-403 has a vessel-normalizing function, its indication may expand to other vascular diseases over time. As for now, PMC-403 is in development for treating age-related macular degeneration (AMD), a common vascular eye disease. It also shows a potential to be developed as a treatment for kidney diseases associated with vascular anomalies.
The antibody might also expand its indication to COVID-19. Recently, Eli Lilly, initiated a clinical trial with their Ang2-neutralizing antibody LY3127804. Neutralizing Ang2 leads to indirect Tie2 activation, which can show promising outcomes from treating symptoms of COVID-19. We believe that PMC-403 might provide better efficacy, as it directly activates Tie2 in a ligand independent manner.
We believe that PMC-403, with its unique characteristics and wide range of potential indications, will be a game changer in the bio market.
6. Are there any Tie2 competitors under development?
Multiple biotech companies work on modulating Tie2 signaling. As of now, PharmAbcine is the only company to own antibody candidates that directly engage and activate Tie2. There are notable competitors on our radar which are Vasomune and Aerpio Pharmaceuticals. In contrast to our approach, Vasomune is targeting Ang-1 with a peptide drug, and Aerpio is developing a small molecule that inhibits VE-PTP to indirectly activate Tie2.
7. How is PMC-309 different from other immune checkpoint inhibitors?
All marketed immune checkpoint inhibitors target just T cells. PMC-309 is a potential First-in-Class candidate targeting VISTA, a key player in a novel inhibitory pathway. It exhibits a unique mechanism, which, in addition to T cells, affects myeloid-derived suppressor cells (MDSCs) that play an important role in immune suppression in TME in certain cancers.
PMC-309 is a promising candidate for combination with anti-PD-1/PD-L1 compounds like pembrolizumab and atezolizumab (Tecentriq®). The PD-1 and VISTA pathways are non-redundant, and combining these two MoAs may result in a huge synergistic effect in tumor growth inhibition.
PMC-309 has two advantages over other VISTA-targeting candidates. It is more specific for VISTA, and it retains high affinity for VISTA at low pH levels in tumor micro-environment (TME). We are hoping that these features increase clinical safety by evading off-target effects while retaining high activity in the tumor site.
8. What are the roles of WINCAL BioPharm, a U.S subsidiary of PharmAbcine?
Through the license agreement with PharmAbcine, WINCAL BioPharm will take advantage of PharmAbcine’s non-oncological assets and focus on development of therapeutics for non-oncological diseases, such as aneurysm, age-related macular degeneration (AMD), and diabetic retinopathy(DR).