Akebia has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing, 10-Q, Akebia, 2017, MAY 9, 2017, View Source [SID1234521594]).

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!

On May 9, 2017 Sierra Oncology, Inc. (NASDAQ: SRRA), a clinical stage drug development company focused on advancing next generation DNA Damage Response (DDR) therapeutics for the treatment of patients with cancer, today reported its financial and operational results for the first quarter ended March 31, 2017 (Press release, Sierra Oncology, MAY 9, 2017, View Source [SID1234519049]).

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!

"During the quarter, we continued to advance our lead DDR-targeting drug candidate, SRA737, in two ongoing Phase 1 clinical trials, while concurrently proposing design amendments to these studies that we believe could augment their potential for success," said Dr. Nick Glover, President and CEO of Sierra Oncology. "As we prepare to implement these enhancements, we also remain focused on driving patient enrollment with the objective of providing an initial update from these trials in early 2018."

During the first quarter, Sierra successfully transferred sponsorship of the two ongoing Phase 1 clinical trials for its checkpoint kinase 1 (Chk1) inhibitor, SRA737, to the company. This transfer positioned Sierra to submit protocol amendments seeking to incorporate the prospective enrollment of patients with genetically-defined tumors, determined using Next-Generation Sequencing, that harbor genomic alterations hypothesized to confer sensitivity to Chk1 inhibition via synthetic lethality.

First Quarter 2017 Financial Results (all amounts reported in U.S. currency)
Research and development expenses were $8.0 million for the first quarter of 2017, compared to $6.6 million for the first quarter of 2016. The increase was primarily due to an increase in third-party manufacturing and research costs related to SRA737 and SRA141. These costs were partially offset by a decrease in clinical trial and personnel-related costs due to the discontinuation of PNT2258. Research and development expenses included non-cash stock based compensation of $1.0 million for both the first quarter of 2017 and of 2016.

General and administrative expenses were $3.1 million for the first quarter of 2017, compared to $4.0 million for the first quarter of 2016. This decrease was primarily due to a decrease in professional fees, business development expenses and personnel-related costs. General and administrative expenses included non-cash stock based compensation of $0.5 million for the first quarter 2017, compared to $0.4 million for the first quarter 2016.
Net loss was $11.1 million for the first quarter of 2017, compared with a net loss of $10.5 million for the first quarter of 2016.

Cash and cash equivalents totaled $125.0 million as of March 31, 2017, compared to $109.0 million as of December 31, 2016. This increase was due to an underwritten public offering of 21,847,636 shares of common stock in February 2017, pursuant to which the company raised net proceeds of $27.4 million, net of underwriting discounts, commissions and offering expenses. The company believes that its existing cash and cash equivalents will be sufficient to fund current operating plans through approximately mid-2019. At March 31, 2017, there were 52,268,443 shares of common stock issued and outstanding, and stock options to purchase 7,615,052 shares of common stock issued and outstanding.

On May 9, 2017 Elasmogen Ltd, focused on the development of next generation biologics, and Feldan Therapeutics, focused on intracellular delivery of proteins, reported a research collaboration with Amgen, to develop and deliver novel intracellular biologics (Press release, Elasmogen, MAY 9, 2017, View Source [SID1234637762]). The collaboration combines the unique capabilities of Feldan’s Shuttle platform and Elasmogen’s soloMER technology to develop the delivery system and binding domains to two undisclosed intracellular targets for Amgen.

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!

The Feldan Shuttle technology is a novel peptide-based delivery method that enables the highly efficient introduction of foreign proteins into cells. Elasmogen’s soloMER’s are the smallest naturally occurring binding domains. Their small size and robust nature, particularly the resistance to changes in pH and ability to bind in intracellular conditions makes them the perfect complement to Feldan’s technology.

"Currently all approved biologic antibody therapeutics act on extracellular targets but intracellular delivery enables access to a much greater number of targets," said François-Thomas Michaud, CEO, Feldan Therapeutics. "Intracellular delivery and binding of biologics can bridge the gap between small molecules and biologics."

"This is an exciting opportunity to demonstrate the performance and capabilities of the combined Shuttle-soloMER technology. The expertise provided by Amgen will significantly accelerate the development of this potential new class of therapeutics," said Caroline Barelle, CEO, Elasmogen.

In 2016, Feldan and Elasmogen established an exclusive partnership for the development of intracellular biologics. Working together, their research teams have demonstrated both intracellular and intranuclear delivery of soloMER binding domains.

On May 10, 2017 Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) reported that atezolizumab did not meet its primary endpoint of statistically meaningful improvement in overall survival (OS) compared to chemotherapy in the phase III IMvigor211 study in patients with locally advanced or metastatic urotherial carcinoma (mUC) whose disease progressed during or following a platinum-containing chemotherapy (Press release, Chugai, MAY 10, 2017, View Source [SID1234518961]). The safety profile of atezolizumab in this study was consistent with those observed in previous studies, with no new or unexpected adverse events. The results observed in people treated with atezolizumab in IMvigor 211 were generally consistent with those observed in a similar group of people in the Phase II IMvigor 210 study. However, the chemotherapy arm results were better than study design assumptions. The data of the study will be presented in the future.

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!

"The previous studies showed atezolizumab helped people with locally advanced or mUC. We were hopeful that we could show a similar result in this study," said Dr. Yasushi Ito, Senior Vice President and Head of the Project Life Cycle Management Unit. "We will be working together with Roche to better understand the results and determine the next steps."

About the IMvigor211 Study
The global phase III, multi-centre, open label, randomized controlled study designed to evaluate the safety and the efficacy of atezolizumab compared to chemotherapy* (vinflunine, paclitaxel or docetaxel) in patients with locally advanced or mUC whose disease progressed during or following platinum-containing regimen.
・ The primary endpoint of this study is OS.
・ Secondary endpoints include safety, overall response rate, progression free survival, and duration of response.
931 patients were randomized into groups with a one to one ratio to receive either one of the chemotherapies vinflunine (320 mg/m2) / paclitaxel (175 mg/m2) / docetaxel (75 mg/m2) or atezolizumab (1,200 mg) by intravenous injection once every three weeks. Treatment with atezolizumab was continued as long as the principal investigator determined that the patient was receiving a clinical benefit or until an unacceptable adverse event was confirmed.

* As paclitaxel and docetaxel are not approved for the indication of UC in Japan, reimbursement of the use of two drugs for the treatment of UC is officially allowed by the Ministry of Health, Labour, and Welfare. Vinflunine is not approved in Japan.

About atezolizumab
Atezolizumab is a monoclonal antibody designed to target a protein called PD-L1 (programmed death ligand-1), which is expressed on tumour cells and tumour-infiltrating immune cells. PD-L1 binds to PD-1 and B7.1, both found on the surface of T cells, causing inhibition of T cells. By blocking this coupling, atezolizumab releases the suppression of T cells and promotes T cells to attack tumour cells.
Atezolizumab (overseas brand name: Tecentriq) is the anti-PD-L1 immune checkpoint inhibitor and was granted accelerated approval for the second line treatment of locally advanced or mUC by the FDA in May, 2016. The FDA also granted accelerated approval for atezolizumab as the treatment of metastatic non-small cell lung cancer (NSCLC) who have disease progression during or following platinum-containing chemotherapy in October, 2016 and as the first line treatment of locally advanced or mUC who are ineligible for cisplatin chemotherapy in April, 2017. In Japan, the new drug application of atezolizumab for the treatment of unresectable advanced or recurrent NSCLC was filed in February, 2017.

Valeant has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission .

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!