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 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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ImmunOncology VPI-101 (CCL21-Vault)

VPI-101 – Lung Cancer

Drug Discovery
Pre Clinical
PHASE 1

VPI-101 – Melanoma

Drug Discovery
Pre Clinical
PHASE 1

VPI-101 – Glioblastoma

Drug Discovery
Pre Clinical
PHASE 1

VPI-101 – Melanoma + Checkpoint Inhibitor

Drug Discovery
Pre Clinical
PHASE 1

VPI-101 – Lung Cancer + Checkpoint Inhibitor

Drug Discovery
Pre Clinical
PHASE 1

VPI-101 – Colon Cancer

Drug Discovery
Pre Clinical
PHASE 1

VPI-101 – Breast Cancer

Drug Discovery
Pre Clinical
PHASE 1

VPI-101 – Pancreatic Cancer

Drug Discovery
Pre Clinical
PHASE 1

VPI-101 – Prostate Cancer

Drug Discovery
Pre Clinical
PHASE 1

VPI-101 – Head & Neck Cancer

Drug Discovery
Pre Clinical
PHASE 1

VPI-101 – Renal Cancer

Drug Discovery
Pre Clinical
PHASE 1

VPI-101 – Bladder Cancer

Drug Discovery
Pre Clinical
PHASE 1

VPI-101 – Graft Versus Host Disease

Drug Discovery
Pre Clinical
PHASE 1

ImmunOncology VPI 111, 121, 131, 141

VPI-111 (NY-ESO-Vault) – Lung Cancer

Drug Discovery
Pre Clinical
PHASE 1

VPI-111 (NY-ESO-Vault) – Glioblastoma

Drug Discovery
Pre Clinical
PHASE 1

VPI-121 (GP100-Vault) – Glioblastoma

Drug Discovery
Pre Clinical
PHASE 1

VPI-131 (IL7-Vault) – Lung Cancer

Drug Discovery
Pre Clinical
PHASE 1

VPI-131 (IL7-Vault) – Pulmonary Fibrosis

Drug Discovery
Pre Clinical
PHASE 1

VPI-141 (CCL19-Vault) – Solid Tumors

Drug Discovery
Pre Clinical
PHASE 1

ImmunActiv VPI 201, 211, 221, 231, 241, 251

VPI-201 (Chlamydia – Vault) – Chlamydia

Drug Discovery
Pre Clinical
PHASE 1

VPI-211 (HIV-Vault) – HIV/AIDS

Drug Discovery
Pre Clinical
PHASE 1

VPI-221 (Influenza-Vault) – Influenza

Drug Discovery
Pre Clinical
PHASE 1

VPI-251 (RSV-Vault) – HIV/AIDS

Drug Discovery
Pre Clinical
PHASE 1

VPI-241 (HPV) – HPV & HPV Cancers

Drug Discovery
Pre Clinical
PHASE 1

VPI-231 (Burk-Vault) – Burkholderia

Drug Discovery
Pre Clinical
PHASE 1

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© 2017 Vault Pharma. All Rights Reserved.

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.

STX101 and STX105, our lead Syntides, are stabilized peptide therapeutics that inhibit an interaction essential in the Homologous Recombination (HR) DNA repair pathway.

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​

We are developing STX101 and STX105 as monotherapy candidates for specific types of cancers which are dependent on HR for chemo evasion. We are specificially pursing STX100 compounds for efficacy towards intrahepatic cholangiocarcinomas (ICC) and castration-resistant prostate cancer (mCRPC).

​

These syntides are also being developed for combination therapy with current chemotherapy drugs, enabling a lower dosing, increased efficacy and reduced side effects.

Due to the targeting of HR, our compounds also hold particular promise for the treatment of children with Bloom’s syndrome.
STX100 series
C

STX201 pancreatic cancer
STX301 KRAS-driven cancers