On September 17, 2018 Shuwen Biotech reported that it is the first in China to launch a locally manufactured proprietary PD-L1 test kit, which can accurately determine the expression status of PD-L1 in tumor tissues, and to provide laboratory testing services for anti-PD-L1/PD-1 drug development (Press release, Shuwen Biotech, SEP 17, 2018, View Source [SID1234529452]).

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Recently, The investigation of the safety, efficacy and molecular marker efficacy of Hengrui Medicince’s anti-PD-1 drug, SHR1210, in the treatment of patients with advanced esophageal squamous cell carcinoma who failed conventional therapy was published in the March 2018 issue of Clinical Cancer Research, in which one of Shuwen Biotech’s PD-L1 detection kits was used and clinical results showed that patients positive for PD-L1 (PD-L1 expression ≥5%) have a higher objective response rate.

Shuwen Biotech’s PD-L1 kits and testing services have been used by leading pharmaceutical companies for dozens of clinical trials against PD-1 immunotherapeutics, contributing to the development of tumor immunotherapy drugs. Shuwen Biotech’s CAP-certified Shuwen Guanz Diagnostic Laboratories also successfully passed CAP’s multi-site, multi-country proficiency testing for PD-L1 testing.

On September 17, 2018 Inspyr Therapeutics reported that it has entered into an agreement with Ridgeway Therapeutics Inc. in which Ridgeway will license and assume control of certain assets relating to Inspyr’s oncology development programs, including intellectual property rights relating to adenosine antagonists owned by Inspyr (Press release, Inspyr Therapeutics, SEP 17, 2018, View Source [SID1234568253]).

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Adenosine receptors have a variety of functions in the body that are expressed through four subtypes (A1, A2A, A2B, and A3). The adenosine A2 receptor subtypes (A2R) are of particular interest as potential targets for the treatment of cancer. Extremely high levels of adenosine are found locally in the tumor microenvironment. These have a direct immunosuppressive effect on T-cells and other cell types that would otherwise attack and kill cancer cells. Inhibition of the A2R has the potential to reverse these immunosuppressive effects.

Inspyr and Ridgeway will collaborate on certain aspects of development which will include a minimum level of purchased services by Ridgeway within 18 months of this transaction. In addition, Inspyr is eligible for approximately $12 million in success-based milestones from the Transaction. Inspyr is also entitled to receive royalties on all commercial sales. In the event Ridgeway sub-licenses these assets, Inspyr is entitled to share in the proceeds of any future transaction.

On September 17, 2018 VBL Therapeutics (Nasdaq: VBLT), a clinical-stage biotechnology company focused on the discovery, development and commercialization of first-in-class treatments for cancer, reported that the company will provide a corporate overview at two events during October, as detailed below (Press release, VBL Therapeutics, SEP 17, 2018, View Source [SID1234529459]). In addition the Company will present data on its novel MOSPD2 program at ECTRIMS 2018 – European Committee for Treatment and Research in Multiple Sclerosis.

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Cantor Fitzgerald Global Healthcare Conference – Presentation Details
Date: Wednesday, October 3, 2018
Time: 10:20am Eastern Time
Location: InterContinental New York Barclay Hotel, New York
Webcast: View Source

Chardan Gene Therapy Conference – Presentation Details
Date: Tuesday, October 9, 2018
Time: 1:30pm Eastern Time
Location: Westin Grand Central Hotel, New York
Webcast: View Source

ECTRIMS 2018 – Poster Presentation Details:
Abstract: MOSPD2: A Novel Therapeutic Target for the Treatment of CNS Inflammation
Session title: Poster Session 2
Date: Thursday, October 11, 2018
Time: 5:15-7:15pm Central European Summer Time
Poster #: P871
Location: City Cube Messe Berlin

On september 17, 2018 Mersana Therapeutics, Inc. (NASDAQ:MRSN), a clinical-stage biopharmaceutical company focused on discovering and developing a pipeline of antibody drug conjugates (ADCs) based on its Dolaflexin and other proprietary platforms, reported that the U.S. Food and Drug Administration (FDA) has lifted the partial clinical hold on the Phase 1 study of XMT-1522 (Press release, Mersana Therapeutics, SEP 17, 2018, View Source [SID1234529521]).

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Mersana and the FDA reached alignment on changes to the protocol, including increased monitoring as well as the exclusion of patients with advanced hepatic impairment. Although XMT-1536, Mersana’s Dolaflexin ADC targeting NaPi2b, was not subject to a clinical hold, Mersana has decided to implement similar modifications to the XMT-1536 protocol.

In addition, alternative dosing regimens will be evaluated for both clinical trials. The XMT-1522 trial will begin with a once-every-four-week dose regimen. This dosing regimen has already been implemented in the XMT-1536 trial at previously explored dose levels in order to enable a comparison of relevant doses and their impact on the safety, efficacy and PK profile of the drug candidate. The company may evaluate additional regimens as well. Data on XMT-1536 is expected in the first half of 2019.

"We are excited to resume enrollment on the XMT-1522 trial and to work with investigators to explore the full potential of both promising drug candidates in the solid tumor setting," said Anna Protopapas, Chief Executive Officer of Mersana.

About XMT-1522

XMT-1522 is a Dolaflexin ADC targeting HER2-expressing tumors. XMT-1522 contains a proprietary HER2 antibody which is conjugated with Mersana’s Dolaflexin platform — a Fleximer polymer linked with a proprietary auristatin payload. XMT-1522 provides a drug load of approximately 12 molecules per antibody, specifically designed to improve potency while simultaneously increasing tolerability. XMT-1522 has the potential to extend HER2-targeted therapy beyond the current "HER2-positive" populations into patients with lower levels of HER2 expression. The Phase 1 protocol will evaluate XMT-1522 in patients with advanced HER2-positive breast and gastric cancer, as well as advanced breast cancer with low HER2 expression and non-small cell lung cancer (NSCLC). More information on the ongoing Phase 1 clinical trial can be found at clinicaltrials.gov.

About XMT-1536

XMT-1536 is a highly potent immunoconjugate targeting the sodium-dependent phosphate transport protein (NaPi2b) and is comprised of an average of 10-15 DolaLockTM payload molecules conjugated to XMT-1535, a proprietary humanized anti-NaPi2b antibody, via the Dolaflexin ADC platform. NaPi2b is an antigen highly expressed in the majority of non-squamous NSCLC and epithelial ovarian cancer. XMT-1536 is in Phase 1 clinical trials in patients with tumors expressing NaPi2b, including ovarian cancer, NSCLC and other cancers. More information on the ongoing Phase 1 clinical trial can be found at clinicaltrials.gov.

On September 17, 2018 Halozyme Therapeutics, Inc. (NASDAQ: HALO) reported that Roche has received approval from Health Canada for a subcutaneous (SC) formulation of trastuzumab (Herceptin SC) for the treatment of patients with HER2-positive breast cancer (Press release, Halozyme, SEP 17, 2018, View Source [SID1234529462]). This is a co-formulation with Halozyme’s proprietary recombinant human hyaluronidase enzyme (ENHANZE technology).

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"We are pleased that the subcutaneous formulation of trastuzumab (Herceptin SC) has been approved in Canada," said Dr. Helen Torley, president and chief executive officer. "Patients and health care providers will now have another treatment option with the potential for a reduced administration time."

The U.S. Food and Drug Administration accepted a Biologics License Application from Genentech for a subcutaneous (SC) formulation of trastuzumab (Herceptin SC) in July 2018.

About ENHANZE Technology
Halozyme’s proprietary ENHANZE drug-delivery technology is based on its patented recombinant human hyaluronidase enzyme (rHuPH20). rHuPH20 has been shown to remove traditional limitations on the volume of biologics that can be delivered subcutaneously (just under the skin). By using rHuPH20, some biologics and compounds that are administered intravenously may instead be delivered subcutaneously. ENHANZE may also benefit subcutaneous biologics by reducing the need for multiple injections. This delivery has been shown in studies to reduce health care practitioner time required for administration and shorten time for drug administration.