Our readers will remember well Propanc Biopharma Inc (OTCMKTS:PPCB), a clinical stage biopharmaceutical company, which we featured in "Propanc Biopharma Inc. (OTCMKTS:PPCB) Is Today’s Cancer Focus". Presentation from Propanc Biopharma Inc OTCMKTS:PPCBWe appreciated that the company had received Orphan Drug Designation (ODD) from the FDA for the use of PRP, which treats pancreatic cancer. Thanks to this distinction, the company now receives tax credits up to 50% of R&D costs, R&D grants, waived FDA fees, and protocol assistance. It was a great news and market participants celebrated it. SeeThruEquity, for example, gave a price target of $5.10 while the share price was trading below $1. Hence, we noted that the market expectations were high and we expected a lot from the company as well.We believe that we were not wrong when we wrote that piece. The new share price movements seem to prove this fact.Have a look at the recent share price spike. From $0.1, the share price increased to touch the $0.7 share price level in less than five days. But, that's not the most interesting. Please check out the volume in the following chart: 2 months chart for PPCBMore than 0.5 million shares changed hands some days. We believe that it clearly shows that the market interest in the stock is growing. In this article, we will tell you why.Before we move to the new information, we are revisiting the company's business model for those who are getting to know PPCB in this piece. Propanc Biopharma Inc. is headquartered in Melbourne, Australia.It is focused on "the development of new cancer treatments targeting high-risk patients, particularly cancer survivors, who need a follow-up, non-toxic, long-term therapy designed to prevent the cancer from returning and spreading."The company is working on several candidates, but the most interesting is PR, "an enhanced pro-enzyme formulation designed to enhance the anti-cancer effects of multiple enzymes acting synergistically."Recent DevelopmentsWe received quite a lot of news from the company over the past several months. Some of them didn't get to move the share price, but we believe that they were quite significant. Have a look.On July 18, 2017, the company released a new 4 year joint research partnership with the Jaén University, based in Andalucía, Spain. The objective is to expand Propanc Biopharma's product pipeline by discovering new compounds based on "the mode of action of naturally derived proenzymes, trypsinogen and chymotrypsinogen, which are the key active ingredients" in the candidate product PRP.We appreciate the good relations that the company has with hospital and universities. It shows that the Propanc's R&D team is respected in the industry.In the press release, some information was given about the target market. It is not small. According to GBI Research, the individuals suffering from pancreatic, ovarian and colorectal cancers represent a combined market segment of $14 billion projected in 2020. This means that if Propanc is able to receive FDA approvals for its product PRP, the revenues will not be limited.But, there is more.On July 20, 2017, the company released that it had received notification of acceptance for its lead patent application from the Chinese Patent Office. The share price seemed to react to the new information. Have a look at it: 1 year chart for PPCBWe agree with the reaction of the market. China is a large market. It accounts for more than 20% of the world's population and is growing at a large pace. It is not only that. Chinese middle class seems to be rising as well, which is expected to make the pharmaceutical market grow as well.James Nathanielsz, Propanc Biopharma's Chief Executive Officer, was quoted:
"Acceptance of our first Chinese patent is a significant achievement for our Company, and indicates the strong growth of intellectual property portfolio worldwide." Source
That was not all that was released in July.Only seven days after releasing that patent application in China, a new press release was received by the market. The company announced that it is looking towards clinical trial application in the UK for PRP. Propanc Biopharma's Chief Medical Officer noted that the team is heading towards First-In-Human studies. Additionally, he remarked again the orphan drug designation status from the FDA:
"Given that we recently received orphan drug designation status from the FDA for the treatment of pancreatic cancer and have completed all the required non-clinical safety studies to define a safe starting dose for humans, our immediate focus right now is to enter the clinical development phase." Source
On August 2, 2017, the company noted that a broad safety margin to support a safe starting dose for PRP in First-In-Human studies was confirmed after no treatment related findings were reported by pathologists upon completion of a GLP-compliant 28-day repeat-dose toxicity study with PRP. It is again a great news, which surprisingly did not make the share price increase. We believe that the market is looking for more information from the FDA.Dr Julian Kenyon, Propanc Biopharma's Chief Scientific Officer, was quoted:
"The fact we observed no treatment related findings in the 28-day repeat-dose toxicity study provides strong evidence that PRP is non-toxic compared to standard treatment approaches and concludes the non-clinical development phase of PRP," Source
That was not all. In the same press release, it was noted that the company was also preparing to submit a new Orphan Drug Designation application for the treatment of ovarian cancer, which, management believes, could also qualify. We encourage readers to be very alert, as last time when the Orphan Drug Designation was given to the company, the share price spiked up.Remarkable news came out on October 19, 2017. The company released that key scientific data has been published in a peer reviewed journal, Scientific Reports, demonstrating a combination of two pancreatic proenzymes, trypsinogen and chymotrypsinogen, providing potent anti-tumor efficacy in pancreatic and ovarian cancers. The new information is very significant, as it shows that the PRP formulation could be helpful for the treatment of cancer. Dr Julian Kenyon, Propanc Biopharma's CEO, was quoted:
"We are delighted that our latest scientific paper shows the synergistic effects of our PRP formulation, which is proven to inhibit in vitroangiogenesis, tumour growth, cancer cell migration and invasiveness, and to be an effective and well tolerated in vivo anti-tumor treatment." Source
We needed to wait until December 4, 2017 to receive the news that pushed up the share price.The company noted that it is making significant recent progress towards full scale Good Manufacturing Process (GMP) manufacture of its lead product, PRP, for First-In-Human studies, expected to commence in 2018. It was noted that the activities developed with the European Contract Manufacturing Organization (CMO) experienced in the production of biopharmaceuticals had been successful in developing a process capable of purifying and stabilizing the two active drug substances of the PRP formulation, trypsinogen and chymotrypsinogen, which is an important requirement during the manufacturing process. As a result, the company noted that runs of manufacturing the finished drug product will be commencing prior to full scale GMP manufacture of PRP for human trials. We believe that it was this new information, which made the share price increase. Market participants seem to be expecting the revenues from PRP to come soon.We need to note the words of the Chief Scientific Officer, who said that the First-In-Human studies will commence next year:
"We are delighted with the excellent progress made with our CMO in progressing PRP to its current stage of development and we are excited about our plans to move into First-In-Human studies next year." Source
ConclusionCurrently trading with a market cap of $7 million, PPCB is an exciting story among small caps. We believe that there is a lot to like on this name and we encourage readers to follow closely the new developments. It is what's driving the share price dynamics.We will be updating our subscribers as soon as we know more. For the latest updates on PPCB, sign up below!Disclosure: We have no position in PPCB and have not been compensated for this article.Image courtesy of Yale Rosen via Flickr
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