On September 17, 2018 Fate Therapeutics, Inc. (NASDAQ: FATE), a clinical-stage biopharmaceutical company dedicated to the development of programmed cellular immunotherapies for cancer and immune disorders, reported that it has entered into a collaboration with ONO Pharmaceutical Co., Ltd. for the joint development and commercialization of two off-the-shelf CAR-T cell product candidates (Press release, Fate Therapeutics, SEP 17, 2018, View Source [SID1234529463]). Using Fate Therapeutics’ proprietary induced pluripotent stem cell (iPSC) product platform, the two CAR T-cell collaboration candidates will each be derived from a clonal master iPSC line engineered to completely eliminate endogenous TCR expression, insert a chimeric antigen receptor (CAR) into the TRAC locus and incorporate other anti-tumor functionality. This transformative approach enables the cost-effective production of cell-based cancer immunotherapies that are uniformly engineered, extensively characterized and homogeneous in composition, and can be consistently and repeatedly mass produced and delivered to patients in an off-the-shelf manner.

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"We are delighted to collaborate with ONO, a global leader in oncology with a long history of developing innovative breakthrough cancer drugs," said Scott Wolchko, President and Chief Executive Officer of Fate Therapeutics. "This partnership with ONO enables Fate to further enhance its expertise in targeting solid tumors and to accelerate the global development of our pipeline of off-the-shelf, iPSC-derived CAR-T cell product candidates."

Under the terms of the strategic option agreement, Fate Therapeutics and ONO will jointly advance each iPSC-derived CAR-T cell collaboration candidate to a pre-defined preclinical milestone. The first iPSC-derived CAR T-cell candidate targets an antigen expressed on certain lymphoblastic leukemias, and Fate Therapeutics retains global responsibility for development and commercialization with ONO having an option to assume responsibilities in Asia. The second candidate targets a novel antigen identified by ONO expressed on certain solid tumors, with ONO having an option to assume global responsibility for further development and commercialization and Fate Therapeutics retaining the right to co-develop and co-commercialize the candidate in the United States and Europe. For both collaboration candidates, Fate Therapeutics retains manufacturing responsibilities on a global basis.

"ONO identified Fate Therapeutics as the partner of choice for the generation of off-the-shelf CAR T-cell cancer immunotherapies in our portfolio," said Hiromu Habashita, Corporate Officer, and Executive Director of Discovery & Research of ONO. "We are excited to work with Fate Therapeutics and apply its industry-leading iPSC product platform to develop and deliver the next-generation of CAR T-cell therapies for cancer patients."

Fate Therapeutics will receive an upfront payment and committed research funding during the preclinical option period, and is eligible to receive a preclinical option exercise fee, clinical, regulatory and commercialization milestone payments and tiered royalties on net sales by ONO in connection with the development and commercialization of each collaboration product by ONO in the ONO territory

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.

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 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 16, 2018 BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160), a commercial-stage biopharmaceutical company focused on developing and commercializing innovative molecularly-targeted and immuno-oncology drugs for the treatment of cancer, reported four oral clinical data presentations on two of its late-stage investigational therapies, tislelizumab and zanubrutinib, at the 21st Annual Meeting of the Chinese Society of Clinical Oncology (CSCO) (Press release, BeiGene, SEP 16, 2018, View Source [SID1234529451]). The meeting will take place September 19 – 23 in Xiamen, China. Tislelizumab is an investigational anti-PD-1 antibody, and zanubrutinib is an investigational small molecule inhibitor of Bruton’s tyrosine kinase (BTK).

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Oral Presentations:

Title: Clinical Profile of Tislelizumab in Chinese Patients with Microsatellite Instability High (MSI-H) or Mismatch Repair-Deficient (MMRd) Solid Tumors: Preliminary Results from an Indication-Expansion Cohort
Abstract ID: 449
Location: Second Floor, Straits Hall
Date: Thursday, September 20, 2018
Time: 16:45 – 16:55 (CST)
Presenter: Lin Shen, M.D.


Title: Tislelizumab Combined with Chemotherapy as First-Line Treatment in Chinese Patients (Pts) with Advanced Lung Cancer
Abstract ID: 450
Location: First Floor, Concert Hall
Date: Friday, September 21, 2018
Time: 11:30 – 11:38 (CST)
Presenter: Jie Wang, M.D., Ph.D.


Title: Preliminary Results with Tislelizumab in Chinese Patients with Non-Small Cell Lung Cancer (NSCLC)
Abstract ID: 448
Location: First Floor, Concert Hall
Date: Friday, September 21, 2018
Time: 11:38 – 11:45 (CST)
Presenter: Qing Zhou, M.D.


Title: A Phase 1 Clinical Study to Investigate the Safety, Tolerability and Pharmacokinetics/Pharmacodynamics of BTK Inhibitor BGB-3111 in Chinese Patients with B-Cell Lymphoma
Abstract ID: N/A
Location: First Floor, G Hall
Date: Saturday, September 22, 2018
Time: 08:30 – 08:45 (CST)
Presenter: Jun Zhu, M.D.

About Tislelizumab
Tislelizumab (BGB-A317) is an investigational humanized monoclonal antibody that belongs to a class of immuno-oncology agents known as immune checkpoint inhibitors. Discovered by BeiGene scientists in Beijing, tislelizumab is designed to bind to PD-1, a cell surface receptor that plays an important role in downregulating the immune system by preventing the activation of T-cells. Tislelizumab has demonstrated high affinity and specificity for PD-1. It is potentially differentiated from the currently approved PD-1 antibodies in an engineered Fc region, which is believed to minimize potentially negative interactions with other immune cells, based on preclinical data. Tislelizumab is being developed as a monotherapy and in combination with other therapies for the treatment of a broad array of both solid tumor and hematologic cancers. BeiGene and Celgene Corporation have a global strategic collaboration for the development of tislelizumab in solid tumor cancers outside of Asia (except Japan). Tislelizumab’s new drug submission for the treatment of patients with relapsed/refractory classical Hodgkin’s lymphoma (R/R cHL) has been accepted and is under review by the National Medical Products Administration of China (NMPA, formerly known as CFDA or CDA).

About Zanubrutinib
Zanubrutinib (BGB-3111) is an investigational small molecule inhibitor of Bruton’s tyrosine kinase (BTK) that was discovered in BeiGene’s research facilities in Beijing, China. It is currently being evaluated in a broad pivotal clinical program globally and in China as a monotherapy and in combination with other therapies to treat various B-cell malignancies. Zanubrutinib is under review as a Category 1 new drug submission for the treatment of patients with relapsed/refractory mantle cell lymphoma (MCL) by the NMPA of China.