On December 3, 2019 Boston Biomedical, Inc. reported that the company has entered into an alliance in oncology research with three world-leading oncology centers of excellence – Columbia University, Harvard University and The Wistar Institute (Press release, Boston Biomedical, DEC 3, 2019, View Source [SID1234551899]).

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 Sumitomo Dainippon Pharma Group, which consists of Sumitomo Dainippon Pharma and its subsidiaries, Boston Biomedical and Tolero Pharmaceuticals, Inc., will have access to novel targets and platform technologies that may be discovered by the three United States institutions in the course of research projects supported by this alliance for the development of cancer drugs. Leveraging each institution’s unique technologies and therapeutic insights, specific research areas will be pursued over the five-year agreement, with input from Joint Steering Committees at each institution as well as representation from companies within the Sumitomo Dainippon Pharma Group.

"We are thrilled to be collaborating with the distinguished scientists at Columbia University, Harvard University and The Wistar Institute," said Dr. Mahmoud Mahmoudian, Senior Vice President, Head of Global Oncology External Innovation, Sumitomo Dainippon Pharma Global Oncology. "We will leverage this commitment to innovation to bring together the wealth of expert knowledge housed in these academic institutions and our Group to work on unique themes, with the goal of delivering innovative new drugs to patients."

The Sumitomo Dainippon Pharma Group positions oncology as one of its priority areas of research and is seeking new opportunities for network-based drug discovery with universities and biotech companies in Japan and the U.S. The Group has also established a Global Oncology External Innovation Hub in Cambridge, Mass., a leading hub of oncology research, to enhance collaboration with external organizations. This framework for research alliances with globally renowned U.S. academic institutions marks a significant advance in propelling drug discovery by the Group.

In a joint statement, Orin Herskowitz, Executive Director of Columbia Technology Ventures at Columbia University, Isaac Kohlberg, Chief Technology Development Officer and Senior Associate Provost at Harvard University, and Dr. Heather Steinman, Vice President of Business Development and Executive Director of Technology Transfer at The Wistar Institute, said: "We are deeply appreciative of the investment Boston Biomedical has made to establish this strategic research alliance, which aims to advance discovery and innovation in oncology for patients’ benefit. This foundational support furthers our institutions’ commitment to drive innovation for tomorrow’s discoveries and advancements in oncology."

On December 3, 2019 ArcherDX, Inc., a growth-stage molecular diagnostics company dedicated to developing breakthrough solutions that advance personalized genomic medicine, reported a non-exclusive partnership with Illumina, Inc. (NASDAQ: ILMN) to develop in-vitro diagnostic (IVD) tests for Archer’s planned portfolio of next-generation sequencing (NGS)-based companion diagnostics (Press release, ArcherDX, DEC 3, 2019, View Source [SID1234551898]).

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 scope of the agreement includes ArcherDX’s future portfolio of IVD tests used to facilitate targeted therapy selection and monitoring of Minimal Residual Disease for the management of patients with solid tumor and blood cancers. The planned IVD tests will empower commercial laboratories, hospitals and health systems to run these assays in their local laboratories worldwide.

Under the agreement, ArcherDX will develop IVD tests to run on Illumina’s NextSeq 550Dx System. ArcherDX will be responsible for obtaining necessary regulatory approvals for each IVD kit and for their subsequent commercialization. ArcherDX and Illumina entered into a similar agreement for the MiSeq Dx System in 2016.

"We are pleased to expand our development partnership with Illumina, whose large install base and highly accurate sequencing systems will accelerate our efforts to democratize access to high-quality genomic testing by developing distributable diagnostic assays that can be used to identify targeted therapy options, as well as monitor for the recurrence of disease across a wide variety of cancers," said Jason Myers, Chief Executive Officer and co-founder of ArcherDX. "These IVD tests will provide important new options for providers and patients around the world."

"Partnerships that bring exceptional clinical content to customers and patients represent an exciting opportunity in clinical genomics," said Dr. Phil Febbo, Chief Medical Officer of Illumina. "By enabling ArcherDX to develop IVD tests, we are ensuring health care providers and patients have access to a growing menu of important distributable diagnostic tests that will improve patient outcomes."

On December 3, 2019 VolitionRx Limited (NYSE AMERICAN: VNRX) ("Volition") reported results from its latest proof of concept study (Press release, VolitionRX, DEC 3, 2019, View Source [SID1234551897]). A single pre-clinical Nu.Q assay utilizing a basic microtiter plate platform detected 80% of newly diagnosed Non-Hodgkins Lymphoma ("NHL") and Leukemia cases (mixture of Acute Lymphocytic Leukemia ("ALL") and Acute Myeloid Leukemia ("AML") at 95% specificity among healthy subjects. The Area Under the Curve ("AUC") for this single assay was 91%. A number of other assays in development also demonstrated promising individual assay results with AUCs ranging from 79% to 91%.

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!

Commenting on these results Dr. Jake Micallef, Chief Scientific Officer at Volition said, "This is a very exciting outcome as we continue the development of our assays beyond colorectal, lung and prostate cancer. We have previously announced results from both single assay and panels of Nu.Q biomarkers but the results of this discovery study are the best single Nu.Q assay result in any cancer we have demonstrated to date. We are delighted to report such promising results for Nu.Q’s ability to detect a range of blood cancers in this small study.

The objective of this proof of concept study was to investigate a range of cancer conditions not previously studied for detection using Nu.Q assays and the results showed remarkable detection for all 3 blood cancers tested. The next steps are to evaluate these findings in independent larger clinical trials of symptomatic populations using Volition’s automated ELISA product platform whilst we also continue pre-analytics studies".

Dr. Jason Terrell, Chief Medical Officer at Volition said, "This is an important finding for us. These types of hematopoietic malignancies are difficult to diagnose. Symptoms are often vague and non-specific such as fatigue and recurrent infections and yet the definitive diagnostic tools of bone marrow or lymph node biopsy are invasive and can be expensive. There are over 700,000 new cases of NHL, ALL and AML diagnosed globally each year and approximately 415,000 deaths. Whilst clearly more studies need to be conducted, we hope that a routine blood test using our Nu.Q technology could lead to earlier diagnosis."

About the Study

Commercially obtained patient blood plasma samples were taken from 62 healthy volunteers (mean age 45 years) as well as approximately 300 patients previously diagnosed with bladder, bone, brain, esophageal, head and neck, melanoma, skin, uterine, or cervical cancers (mean age 56 years) and 54 subjects diagnosed with hematopoietic cancers (mean age 57 years).

On December 3, 2019 Piramal Enterprises Limited’s Pharma Solutions business, a leading Contract Development and Manufacturing Organization (CDMO), reported that the company will be partnering with BerGenBio ASA (OSE: BGBIO) on the development of bemcentinib for the treatment of elderly patients with relapsed Acute Myeloid Leukemia (AML) (Press release, Piramal, DEC 3, 2019, View Source [SID1234551896]). Bemcentinib was recently designated as a Fast Track drug by the U.S. Food and Drug Administration (FDA), as there are currently no marketed drugs specifically approved for relapsed AML patients, representing a significant unmet medical need.

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!

Peter DeYoung, CEO, Piramal Pharma Solutions, stated, "BerGenBio’s decision to partner with us is a validation of our integrated business model. The breadth and scale of our assets and our expertise as a leading CDMO allow us to customize services according to their needs and deliver solutions that benefit the patients."

Richard Godfrey, Chief Executive Officer of BerGenBio, stated that "Outsourcing of development and manufacturing services is a requirement for us, and we were rigorous in our due diligence of potential partners. Piramal Pharma Solutions’ capabilities – especially the Xcelerate Integrated Solutions platform – represent an ideal solution for BerGenBio."

To accelerate the timelines required for Fast Track development, PPS will be developing the drug leveraging its Xcelerate Integrated Solutions platform that delivers speed, flexibility and versatility to the drug development process. The Xcelerate platform, which addresses the industry’s growing need for preferred partner relationships, has been successfully applied to more than eighty programs.

Xcelerate Integrated Solutions takes advantage of the extensive PPS network of drug discovery and development capabilities located across its sites in North America, Europe and India. Customers benefit from streamlined and fully integrated services, all managed by a single point of contact who expedites the exchange of information and accelerates timelines.

The bemcentinib development program encompasses a fully integrated program of PPS resources that includes intermediates sourced from India, pilot process development and API validation in North America and formulation development in Europe. As part of the partnership agreement, PPS is also expected to provide commercial manufacturing of the final drug product.

On December 3, 2019 Titan Pharmaceuticals, Inc. (NASDAQ: TTNP) reported that management will present an update on the Company’s business at the first annual BioTuesdays Pre-JPM Virtual Conference on Tuesday, December 10, 2019 at 3:00 p.m. EST / 12:00 p.m. PST (Press release, Titan Pharmaceuticals, DEC 3, 2019, View Source [SID1234551895]).

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 presentation will be broadcast live and archived on Titan’s website at www.titanpharm.com/news/events.