TWJ101 is a novel small molecule that inhibits both histone deacetylase (HDAC) and HMG-CoA reductase (HMGR). Both are molecular targets for anti-cancer drugs. TWJ101 has shown significant anti-tumor effects in multiple preclinical models of colorectal cancer. The safety assessment studies for TWJ101 are scheduled to complete in 2017, and the IND application package is due to be submitted later in same year.

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TWJ101 presents a viable option for the treatment of mCRC and possibly other cancer types. The utility of TWJ101 in inflammation including IBD will also be explored.

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On June 19, 2017 Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) reported that it has launched Narurapid Tablets 1 mg, 2 mg, 4 mg (immediate release formulation) and Narusus Tablets 2 mg, 6 mg, 12 mg, 24 mg (once daily extended release formulation) for cancer pain treatment (generic name: hydromorphone hydrochloride) (Press release, Daiichi Sankyo, JUN 18, 2017, View Source [SID1234519621]).

Hydromorphone hydrochloride is an opiate, narcotic analgesic that has been available outside of Japan for over 80 years, and is the standard drug for the treatment of cancer pain according to WHO guidelines.

Hydromorphone hydrochloride is one of the agents publicly offered for development by the Review Committee on Unapproved Drugs and Indications with High Medical Needs*. Daiichi Sankyo decided to develop the drug in 2012, and received a grant from the Pharmaceutical Development Support Center for its development.

Daiichi Sankyo is committed to making unapproved and off-label drugs with high medical needs available to the patients who are waiting for them to be approved.

* Working group held by the MHLW that aims to promote the development of drugs and indications not yet approved in Japan, but currently available in Europe and the U.S.

Product Outline
Launch date: June 19, 2017
Product name
Narurapid Tablets 1 mg, 2 mg, 4 mg (immediate release formulation)
Generic name(JAN)
Hydromorphone hydrochloride
Price
Narurapid Tablets 1 mg: 110.60 yen/tablet
Narurapid Tablets 2 mg: 202.80 yen/tablet
Narurapid Tablets 4 mg: 371.90 yen/tablet
(Date of listing in the NHI reimbursement price list in Japan: May 24, 2017)
Indication
Analgesic for moderate to severe cancer pain
Dosage and administration
For adults under normal conditions, 4-24 mg of hydromorphone is taken orally 4-6 times a day. Adjust dosage according to symptoms.
Approved for manufacture
and marketing
March 30, 2017
Manufacture and marketing
Daiichi Sankyo Propharma Co., Ltd.
Marketing
Daiichi Sankyo Co., Ltd.

Launch date: June 19, 2017
Product name
Narusus Tablets 2 mg, 6 mg, 12 mg, 24 mg (once daily extended release formulation)
Generic name (JAN)
Hydromorphone hydrochloride
Price
Narusus Tablets 2 mg: 202.80 yen/tablet
Narusus Tablets 6 mg: 530.20 yen/tablet
Narusus Tablets 12 mg: 972.20 yen/tablet
Narusus Tablets 24 mg: 1,782.80 yen/tablet
(Date of listing in the NHI reimbursement price list in Japan: May 24, 2017)
Indication
Analgesic for moderate to severe cancer pain
Dosage and administration
For adults under normal conditions, 4-24 mg of hydromorphone is taken orally once a day. Adjust dosage according to symptoms.
Approved for manufacture and marketing
March 30, 2017
Manufacture and marketing
Daiichi Sankyo Propharma Co., Ltd.
Marketing
Daiichi Sankyo Co., Ltd.

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TaiwanJ’s dual target pipelines focuses on new chemical entities that afford concurrent HMG-CoA reductase (HMGR) and histone deacteylase (HDAC) inhibition. Both are molecular targets for new anti-cancer and anti-inflammation drugs. HDAC suppresses the expression of anti-oncogenes and promotes tumorigenesis, as well as inflammatory and immune-activation genes. HMGR is the rate-limiting enzyme for cholesterol synthesis, which is up stream of Ras family oncoproteins activation through protein prenylation, and in turn suppresses the inflammatory cascade. Furthermore, HMGR inhibition has been shown to promote the function of HDAC inhibitors.

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The dual target inhibitors show improved preclinical safety and stability profiles over existing HDAC inhibitors (HDACi), and is expected to increase therapeutic index and widen therapeutic window clinically. The anti-cancer efficacy of HDAC-HMGR dual inhibition has been shown in colorectal cancer and liver metastasis in proof-of concept preclinical studies.

On June 16, 2017 DelMar Pharmaceuticals (Nasdaq: DMPI) ("DelMar" and "The Company"), a biopharmaceutical company focused on the development of unique new cancer therapies designed to save and improve lives, reported the presentation of a poster at The Society for Neuro-Oncology’s 4th Pediatric Neuro-Oncology Basic and Translational Research Conference (Press release, DelMar Pharmaceuticals, JUN 16, 2017, View Source [SID1234519624]). The forum takes place at the Wyndham New Yorker Hotel in New York City on June 15-16, 2017 .

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The Company’s presentation entitled "Dianhydrogalactitol (VAL-083) overcomes p53-mediated chemo-resistance and displays synergy with topoisomerase inhibitors" was presented the evening of Thursday, June 15.

The authors highlight the current absence of a viable standard-of-care for patients with pediatric high-grade gliomas (pHGG). This is because the only approved agent for this indication, temozolomide (TMZ), is rendered inactive due to pediatric brain tumors having a high expression of a TMZ-inactivating enzyme called MGMT* and a low expression of the TMZ-activating MMR** pathway proteins.

In prior clinical trials, DelMar Pharmaceuticals’ lead product candidate VAL-083 demonstrated activity against this dire pediatric cancer. The poster emphasizes the fact that VAL-083 maintains functionality regardless of the MGMT or MMR status of pHGG, and is also not affected by the p53 status of the cancer cells. In vitro, VAL-083 has been shown to cause a robust and irreversible S/G2 arrest of the cancer cells, potentially then leading to cancer cell apoptosis. The poster provides the rationale for a detailed clinical investigation of VAL-083 in pediatric high-grade gliomas both as a single agent or in combination with currently available therapies such as TMZ or topoisomerase inhibitors.

*MGMT= 06-methylguanine-DNA methyltransferase
**MMR= mismatch repair

"DelMar Pharmaceuticals is excited to share the promising horizon that VAL-083 results have shown in the treatment of pediatric brain tumor," said Jeffrey Bacha, chairman & CEO of DelMar. "We are conscious of the difference VAL-083 could make in the lives of patients and their families, and we are driven by the determination of improving patient outcomes. We are confident that our research efforts will make an impactful contribution to the community and this area of science."

About VAL-083

Dianhydrogalactitol (VAL-083) is a "first-in-class", DNA-targeting agent that introduces interstrand DNA cross-links at the N7-position of guanine leading to DNA double-strand breaks and cancer cell death. VAL-083 has demonstrated clinical activity against a range of cancers including GBM in historical clinical trials sponsored by the U.S. National Cancer Institutes.

VAL-083 has been granted an orphan drug designation by the U.S. FDA Office of Orphan Products for the treatment of glioma, medulloblastoma and ovarian cancer, and in Europe for the treatment of malignant gliomas.

DelMar has demonstrated that VAL-083’s anti-tumor activity against GBM is unaffected by the expression of MGMT in vitro. Further details regarding these studies can be found at View Source

DelMar’s recent outcomes in Phase 1-2 clinical trials suggested that VAL-083 may offer a clinically meaningful survival benefit for patients with recurrent GBM following treatment with both TMZ and bevacizumab. A well-tolerated dosing regimen of 40mg/m2/day on days 1, 2, and 3 of a 21-day cycle was selected for study in subsequent GBM clinical trials.

DelMar has embarked human clinical trials for VAL-083 across every line of GBM therapy. These trials include, i) an ongoing single-arm, biomarker driven, Phase 2 study to determine if VAL-083 treatment of MGMT-unmethylated adult GBM patients at first recurrence/progression, prior to bevacizumab improves overall survival, compared to historical control with lomustine (clinicaltrials.gov identifier: NCT02717962). ii) A pivotal, controlled Phase 3 study in temozolomide-Avastin Recurrent GBM ("STAR-3") to evaluate overall survival versus salvage chemotherapy (clinicaltrials.gov identifier: NCT03149575). iii) A single arm, biomarker driven, Phase 2 study to confirm the tolerability and efficacy of VAL-083 in combination with radiotherapy in newly diagnosed MGMT-unmethylated GBM patients whose tumors are known to express high MGMT levels. (clinicaltrials.gov identifier: NCT03050736). The results of these studies may support a new treatment paradigm in chemotherapeutic regimens for the treatment of GBM.

About Glioblastoma Multiforme (GBM)

Glioblastoma (GBM) is the most common and aggressive primary brain cancer. Current standard of care includes surgery, radiation and treatment with temozolomide (TMZ), however nearly all tumors recur and the prognosis for recurrent GBM is dismal. Most GBM tumors have unmethylated promoter status for O6-methylguanine-DNA-methyltransferase (MGMT); a validated biomarker for TMZ-resistance. Second-line treatment with anti-angiogenic agent bevacizumab has not improved overall survival (OS) and 5-year survival is less than 3%.