Any biotechnology company must prove its scientific worth and initial market value by moving from preclinical to first-in-human testing. In preclinical testing the basic mechanism of a drug’s action is proven in laboratory animals. Those mice, rats, and other animals with similar biological mechanisms to humans are the bridge between the test tube and real-life patients. Translational research depends on this transition from preclinical to clinical (human) studies. These first-in-human tests are a marker of progress and can be one of the biggest paradigm-shifting events in a biotech company’s journey.
FIH Studies Creates Binary Moves in Stocks:
Synlogic Inc (NASDAQ: SYBX) gained in January on publication of Phase I data and supporting preclinical data. Synlogic was able to affirm that it’s bacterial engineering technology performed as intended in human subjects. Its momentum was compounded by the multiple expected applications for its innovations after clearing this hurdle and more.
Organovo Holdings, Inc (NASDAQ: ONVO) is another low-flying public company moving toward FIH trials in 2019 Investors are watching closely. Institutional investors such as Vanguard Group Inc have increased their stake in Organovo on the heels of its first-in-human trial success. Its 3D bioprinting technology for treating pediatric liver diseases is seen as promising, and dosing and tissue design improvements are moving along.
Solid Biosciences Inc (NASDAQ: SLDB) is an example of a company whose shares took a dive based on negative first-in-human trial results– SLDB shares fell 73% in premarket trading on February 5. Solid Biosciences meant to achieve improvement in Duchenne muscular dystrophy patients through gene therapy, but an early-stage test showed that the company’s lead product did not manage to raise levels of a type of the key protein dystrophin that helps keep muscles intact. This was a crucial test for this company and it failed.
Propanc Biopharma Inc. (OTCQB: PPCB), an Australian biotechnology company,is moving its cancer drug PRP closer to human trials after a decade of development. PRP induces cell differentiation, which causes cancer cells to become benign. PRP has
the potential to change cancer cells from a highly motile and invasive cell type that can wreak havoc, back to a normally functioning cell by using proenzymes. These proenzymes have been shown to stop the spread of cancer in pre-clinical research. The company will pursue a licensing partner who can help the company further refine the pro enzymes, which are naturally derived, so that they achieve optimal effect as clinical trials progress.
Best Foot Forward for FIH Trials
Propanc is currently developing bioanalytical assays and is actively engaged in fine-tuning its manufacturing activities to make PRP. Propanc is currently completing its engineering phase to enter full-scale GMP manufacture of its drug product for human trials.
To date, Propanc has established proof of concept in animals, completed a full pre-clinical development program which established a safe starting dose for humans. It is rapidly expanding its IP portfolio with patents as it publishes several peer-reviewed scientific publications.
In addition, Propanc has conducted several scientific advisory meetings with regulators and achieved orphan drug designation for pancreatic cancer. Beyond just this one product, Propanc’s CEO James Nathanielsz has recently discussed development of backup compounds to PRP that add to the company’s R&D depth.
The Wealthy Venture Capitalist is a series of industry-focused investment articles focused on showing everyday Investors new opportunities in rapidly growing, little-known stocks in three of the markets hottest sectors— healthcare, tech and consumer products.
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