Daiichi Sankyo Announces Launch of Narurapid® Tablets and Narusus® Tablets for Cancer Pain Treatment

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.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!


Pipeline Review Check


Vault Pharma

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Company
Platform
Pipeline
Collaborations
News
Contact

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

Company
Management Team
Scientific Board
Board of Directors

Pipeline
ImmunOncology
ImmunActiv

Collaborations
Academic Research Partners
Corporate Partnerships
Government Grants

Vault Pharma

Platform
News
Contact

© 2017 Vault Pharma. All Rights Reserved.

TWJ101

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.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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.

Pipeline Review Check

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

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

​

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

Juno Therapeutics Presents TRANSCEND NHL 001 Trial Data at International Conference on Malignant Lymphoma

On June 17, 2017 Juno Therapeutics, Inc. (NASDAQ: JUNO), a biopharmaceutical company developing innovative cellular immunotherapies for the treatment of cancer, today reported data from the TRANSCEND trial of JCAR017 in relapsed and refractory (r/r) aggressive B cell non-Hodgkin lymphoma (NHL) at the 2017 International Conference on Malignant Lymphoma in Lugano, Switzerland (Press release, Juno, JUN 17, 2017, View Source [SID1234519575]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

JCAR017 is Juno’s investigative chimeric antigen receptor (CAR) T cell product candidate that targets CD19, a protein expressed on the surface of almost all B cell malignancies, and uses a defined composition of CD4 to CD8 T cells and a 4-1BB costimulatory domain, which differentiates it from other current CD19-directed CAR T product candidates. JCAR017 has been granted Breakthrough Therapy designation by the FDA for treatment of r/r aggressive large B cell NHL and PRIME designation by the European Medicines Agency for treatment of r/r diffuse large B cell lymphoma (DLBCL), a type of NHL.

"We are pleased to again present TRANSCEND data, which show compelling results in the treatment of aggressive relapsed or refractory NHL," said Sunil Agarwal, M.D., Juno’s President of Research and Development. "High rates of durable responses and the early survival data are especially exciting, as is the emerging safety profile. The majority of TRANSCEND patients experienced no cytokine release syndrome or neurotoxicity at all. While still early, these data suggest that JCAR017 could be administered on an outpatient basis."

Data were presented by Jeremy Abramson, M.D., of Massachusetts General Hospital Cancer Center, from the multicenter TRANSCEND trial (ABSTRACT #128), a Phase 1 study that has treated a total of 67 patients with r/r aggressive B cell NHL, including those with DLBCL or follicular lymphoma grade 3B, as of a data cutoff date of May 4, 2017.

TRANSCEND NHL 001 is a dose-finding study of JCAR017, which is administered following fludarabine/cyclophosphamide lymphodepletion. Patients received one of two dose levels (50 or 100 million cells). They were then evaluated for pharmacokinetics, disease response, and safety outcomes, including common CAR T side effects such as cytokine release syndrome (CRS) and neurotoxicity (NT).

Notably, the TRANSCEND NHL 001 protocol includes patients with forms of B cell NHL that would exclude them from trials of other CAR T product candidates, including those with ECOG 2 performance status, central nervous system (CNS) involvement of their lymphoma, and those relapsed after allogeneic bone marrow transplant.

Data for the DLBCL cohort were presented in two groups: core and full. The core analysis group (N=44) includes patients that represent the population that Juno plans to move forward into a pivotal trial in the second half of 2017. The core group includes patients with DLBCL (de novo and transformed from follicular lymphoma) that are ECOG Performance Status 0-1. The full analysis group includes all r/r patients in the DLBCL cohort (N=55), including 11 patients with poor performance status or niche subtypes of aggressive NHL. Both the core and full groups received conforming product, with at least one month follow-up, and with a data cutoff date of May 4, 2017, for this presentation.

"CAR T cell therapy represents an important step forward in providing options for these highly chemotherapy refractory patients and addresses a significant unmet medical need," said Dr. Abramson. "I am particularly excited about the emerging efficacy and safety profile with JCAR017, which could ultimately prove to be optimal therapy for patients with relapsed and refractory DLBCL."

Key data and findings:
Core Group (N=44)
Combining data across dose levels:
Overall response rate (ORR) is 86% (38/44) and the complete response (CR) is 59% (26/44).
Three-month ORR is 66% (21/32) and CR is 50% (16/32). Of patients in response at three months, 90% (9/10) continue in response at six months.

Early data suggest a dose response relationship at three months:
Dose level 1 (50 million cells) ORR is 58% (11/19) and CR is 42% (8/19).
Dose level 2 (100 million cells) ORR is 78% (7/9) and CR is 56% (5/9).
97% (37/38) of responding patients are alive and in follow-up as of May 4, 2017.
2% (1/44) experienced severe CRS and 18% (8/44) experienced severe NT.
66% (29/44) did not experience any CRS or NT. No deaths were reported from CRS or NT.
There was one Grade 5 adverse event of diffuse alveolar damage, which the investigator assessed as possibly related to fludarabine, cyclophosphamide, and JCAR017 treatment, occurring on day 23 in an 82-year-old subject who refused mechanical ventilation for progressive respiratory failure while neutropenic on growth factors and broad spectrum antibiotics and antifungals. This patient had no CRS and Grade 3 neurotoxicity resolution before the Grade 5 event.

Full Dataset (N=55)
Combining data across dose levels:
Best ORR is 76% (41/54) and CR is 52% (28/54).
Three-month ORR is 51% (21/41) and CR is 39% (16/41).
2% (1/55) experienced severe CRS and 16% (9/55) experienced severe NT. 60% (33/55) did not experience any CRS or NT. No deaths reported from CRS or NT.
Early data do not suggest a dose toxicity relationship at the doses tested:
Severe CRS rate is 3% (1/30) at dose level 1 and 0% (0/19) at dose level 2.
Severe NT rate is 20% (6/30) at dose level 1 and 11% (2/19) at dose level 2.
11% (6/55) received tocilizumab and 24% (13/55) received dexamethasone.
The most frequently reported treatment-emergent adverse events were neutropenia (35%), CRS (35%), and fatigue (31%).

Manufacturing
Product was available for 98% (86/88) of patients apheresed. TRANSCEND patients receive product made at JuMP, Juno’s manufacturing facility in Bothell, Washington. Juno expects commercial production will be accomplished in less than 21 days, and Juno is investing in manufacturing infrastructure to enable a smooth prescribing experience with a reliable delivery time at market entry.

About Juno’s Chimeric Antigen Receptor (CAR) and T Cell Receptor (TCR) Technologies
Juno’s CAR and TCR technologies genetically engineer T cells to recognize and kill cancer cells. Juno’s CAR T cell technology inserts a gene for a particular CAR into the T cell, enabling it to recognize cancer cells based on the expression of a specific protein located on the cell surface. Juno’s TCR technology provides the T cells with a specific T cell receptor to recognize protein fragments derived from either the surface or inside the cell. When either type of engineered T cell engages the target protein on the cancer cell, it initiates a cell-killing response against the cancer cell. JCAR014 and JCAR017 are investigational product candidates and their safety and efficacy have not been established.