• Polytaxel, a novel pain-free anticancer drug, may not require break periods
• A new standard of care, more convenient than docetaxel, is suggested
• Hyundai Bioscience to enter clinical trial on pancreatic cancer in Australia
• Patient-centered chemotherapy to enable outpatients to live normal lives

Hyundai Bioscience announced on November 24th, 2022, that it is collaborating with an Australian cancer hospital for its global Phase 1 clinical trial on pancreatic cancer with Polytaxel, which was developed as so-called 'pain-free' anticancer drug, based on a novel inorganic polymer nanohybrid drug delivery platform technology. Polytaxel is loaded with docetaxel as its active pharmaceutical ingredient, which is known as one of the major chemotherapy drugs. Hyundai Bioscience will file its clinical plan to the Human Research Ethics Commission (HREC) of Australia as soon as its clinical design is confirmed with a local clinical trial institution.

Hyundai Bioscience held a press conference at Ewha Womans University on November 22nd, and unveiled its clinical trial design of Polytaxel along with NOAEL therapy, an innovative cancer therapy that may be administered without recovery break periods.

"The clinical design of Polytaxel has a very unique dosing method compared to the existing standard treatment method of docetaxel," said Park Kwang-Sik, president of Hyundai Bioscience's Bio Division. He said, "Based on the very low toxicity of Polytaxel, a completely new standard treatment to enable pain-free anticancer treatment has emerged."

Hyundai Bioscience's clinical trial design is basically to administer Polytaxel by 7-day interval to two separate groups of patients, twice for one cohort and three times for the other. For the two-dose group, it will take 8 days to complete administration, and 15 days for the three-dose group. Existing chemotherapy with docetaxel usually takes 3~6 months due to the fact that there needs to be a 3-week recovery period between doses.

It is remarkable that such dosing frequency of 7-day interval is the same as was applied to animal testing. In case of conventional chemotherapy, the patients must have a recovery period after drug injection due to severe side effects caused by the drug's toxicity. That's why the dosing interval from efficacy testing on animals is not equally adopted to human testing typically.

Mr. Park said, "Polytaxel showed excellent therapeutic efficacy in remission of tumors by 67% up to 83% with just three doses on days 1, 8, and 15 in pre-clinical trials. Nevertheless, there was no decrease at all in body weight, the most important indicator of toxicity."

Dr. Jin Geun-Woo, head of Hyundai Bioscience R&D, said, "Cytotoxic drug-based chemotherapy has not made significant progress for several decades because the dosing interval applied to animals cannot be applied directly to humans due to drug toxicity." He explained, "It is inevitable for humans to have a recovery period for a period of time so that normal cells damaged by drug toxicity can recover after the previous dose, and the problem is that cancer cells also recover during such recovery period."

Dr. Jin said, "We have conducted dozens of animal testing with the goal of applying the same dosing interval to animals and humans, and we have finally found the appropriate dosing interval to satisfy it." He said, "Polytaxel is a safe drug that is effective even if administered below the non-toxic level, which enables the same dosing interval to be applied for both humans and animals."

Pancreatic cancer is known as one of the hardest-to-cure kinds with the lowest survival rate among the top 10 cancers, with a 5-year survival rate of 7.9% and a 10-year survival rate of only 1%, because early diagnosis is almost impossible and drug delivery is structurally difficult. In the last 20 years since 2003, 174 candidates have been designated as orphan drugs for the treatment of pancreatic cancer by the U.S. Food and Drug Administration (FDA), but only three have actually been approved.

Mr. Park explained, "The decision to select pancreatic cancer as the clinical target indication for Polytaxel is part of our strategy to accelerate the approval process through fast track by proving the safety and efficacy of Polytaxel in the most intractable cancer." He said, "In the pharmacokinetics study we conducted at Japan's Sekisui Medical, Polytaxel, although it is a polymer substance, was verified to be well delivered to the pancreas, which has been known to be hard to reach in drug delivery."

Lee Hwa-Jeong, professor of pharmacy at Ewha Womans University, who participated as a panelist at the conference, said, "It is very impressive that Polytaxel achieved a concentration in tumors 10 times higher than that in normal tissue at preclinical study, proving great tumor-targeting property." Peter Koo, former Yale University Medical School professor, said, "It will be a positive thing, if Polytaxel gets successfully approved, that we will have more combination anticancer treatment options." Mr. Koo also recommended a continuing research to be conducted on the use of immuno-oncology drugs in combination.

Hyundai Bioscience has performed rigorous R&D efforts to establish the formulation of Polytaxel suitable for mass production or CMC (chemistry, manufacturing and controls), and finally completed its NOAEL therapy, a pain-free chemotherapy. NOAEL therapy is a novel therapy in that Polytaxel is administered below no-observed-adverse-effect level (NOAEL) in vivo, so that cancer may be treated without side effects. Hyundai Bioscience had previously announced the feasibility of this at the Global Bio Conference (GBC) held in Seoul in 2018 and 2019.