On September 4, 2018 Advaxis, Inc. (NASDAQ: ADXS), a late-stage biotechnology company focused on the discovery, development and commercialization of immunotherapy products, and OS Therapies LLC, a clinical-stage therapeutic company focused on the identification, development and commercialization of treatments for osteosarcoma, reported that Advaxis has granted a license to OS Therapies for the use of ADXS31-164, also known as ADXS-HER2, for evaluation in the treatment of osteosarcoma in humans (Press release, Advaxis, SEP 4, 2018, View Source [SID1234529250]).

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!

Osteosarcoma is an aggressive cancerous tumor that forms in bone. Although it is rare, osteosarcoma is the most common type of bone cancer, and is most frequently found in children and young adults. Current treatment options are limited and there have been no new treatment options in more than thirty years.

Under the terms of the license agreement, OS Therapies, in collaboration with the Children’s Oncology Group (COG)1, will be responsible for the conduct and funding of a clinical study evaluating ADXS-HER2 in recurrent, completely resected osteosarcoma. Advaxis will receive an upfront payment, reimbursement for product supply and other support, clinical, regulatory, and sales-based milestone payments, and royalties on future product sales. Additional details of the financial terms have not been disclosed.

"Advaxis is pleased to license ADXS-HER2 to OS Therapies for human clinical trials in osteosarcoma. ADXS-HER2, which is already approved in the U.S. for the adjuvant treatment of osteosarcoma in canines, has the potential to provide a new treatment option for human osteosarcoma patients," said Kenneth A. Berlin, President and Chief Executive Officer of Advaxis. "As Advaxis is primarily focused on developing neoantigen-directed therapeutics, this license agreement will allow for the clinical potential of ADXS-HER2 to be explored in osteosarcoma without financial support from Advaxis, building on earlier work performed by us with ADXS-HER2 in a Phase 1 clinical trial."

"The OS Therapies mission is to develop and commercialize new therapeutics for the treatment of osteosarcoma, a deadly and extremely underserved pediatric cancer. We are excited about the opportunity to evaluate ADXS-HER2 in this indication, as its clinical profile has shown promise to date," said Paul Romness, Chief Executive Officer of OS Therapies. "Our initial focus is on the most common genetic mutation found in osteosarcoma, and we believe that HER2, and more specifically ADXS-HER2, holds potential to impact the treatment paradigm."

1 The Children’s Oncology Group (www.childrensoncologygroup.org), a member of the NCI National Clinical Trials Network (NCTN), is the world’s largest organization devoted exclusively to childhood and adolescent cancer research with over 10,000 experts worldwide working in over 200 COG member institutions. COG’s mission is to improve the cure rate and outcome for all children with cancer.

On September 3, 2018 STORM Therapeutics, the drug discovery company focused on the discovery of small molecule therapies modulating RNA epigenetics, and The University of Cambridge reported that they have been granted a Knowledge Transfer Partnership (KTP) (Press release, STORM Therapeutics, SEP 3, 2018, View Source [SID1234561043]). The Grant, of up to £240,000, is to develop an analysis platform using the data warehouse software InterMine to help STORM advance its cancer research.

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!

STORM has established a pipeline of drug discovery programmes to develop novel, first-in-class drugs for the treatment of specific cancers and other diseases with high unmet medical need.

Keith Blundy, Chief Executive of STORM Therapeutics said: "Biology is an extremely fast paced, changing area. STORM is on the cutting edge of cancer research and keeping up with the data that is constantly being generated is vital. Previously, this data has been spread across a number of silos and gathering all of this information, as well as being able to analyse it efficiently, can be costly and prone to error. Through the KTP programme STORM is now partnered with an open-source data warehouse, InterMine, specifically for the integration and analysis of complex biological data, making it easy to query and analyse."

Gos Micklem, Principal Investigator for the InterMine project based at the Department of Genetics at the University of Cambridge said: "We are excited by this KTP award and the opportunity to collaborate with STORM. We see benefits on both sides – STORM gains our experience in large-scale data integration and the freely available open-source InterMine platform, while the adaptations that will be made to accommodate their data and interests will improve InterMine for the benefit of the broader community."

The KTP programme helps businesses in the UK by linking them with an academic organisation, enabling them to bring in new skills and the latest academic thinking to deliver a specific, strategic innovation project.

On September 3, 2018 BeiGene Ltd., a commercial-stage biopharmaceutical company focused on developing and commercializing innovative molecularly-targeted and immuno-oncology drugs for the treatment of cancer, reported that the National Medical Products Administration of China (NMPA, formerly known as CFDA), has accepted its new drug application (NDA) for its anti-PD-1 antibody, tislelizumab, for relapsed/refractory classical Hodgkin’s lymphoma (R/R cHL) (Press release, Boehringer Ingelheim, SEP 3, 2018, View Source [SID1234529412]).

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!

Since BeiGene and Boehringer Ingelheim started their collaboration in 2013, Boehringer Ingelheim’s biopharmaceutical contract manufacturing business, known as Boehringer Ingelheim BioXcellence, has been providing the Chemistry, Manufacturing, and Control (CMC) services for support of the tislelizumab. Boehringer Ingelheim assisted BeiGene with tislelizumab’s development through process and analytical method development, supply of GMP clinical material, and CMC filing support with the NMPA.

Tislelizumab is an investigational anti- PD-1 antibody being studied in a number of malignancies, such as relapsed/refractory classical Hodgkin’s Lymphoma, non-small cell lung cancer, hepatocellular carcinoma, esophageal squamous cell carcinoma, mature T-and NK-cell lymphomas, and urothelial cancer. Boehringer Ingelheim Biopharmaceuticals (China) Ltd. is committed to providing BeiGene with full contract manufacturing support and supply of tislelizumab at the highest global quality standards to serve patients with this important medicine, if approved.