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]).

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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%.

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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.

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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]).

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

On December 3, 2019 CASI Pharmaceuticals, Inc. (Nasdaq: CASI), a U.S. biopharmaceutical company focused on developing and commercializing innovative therapeutics and pharmaceutical products, reported that the China National Medical Product Administration (NMPA), has approved the clinical trial applications for CNCT19 (CD19 CAR-T) in relapsed/refractory B-cell acute lymphoblastic leukemia (B-ALL) and relapsed/refractory B-cell non-Hodgkin lymphoma (B-NHL) submitted by its partner Juventas Cell Therapy Ltd., a biopharmaceutical company focused on cell therapy (Juventas) (Press release, CASI Pharmaceuticals, DEC 3, 2019, View Source [SID1234551894]). CASI previously reported its acquisition of exclusive worldwide commercial rights to CNCT19 from Juventas. Juventas has responsibility for the clinical development of CNCT19.

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Larry Zhang, CASI’s President, commented, "This is a very exciting milestone for CASI. CAR-T therapies were first approved in the United States in 2017; there are currently no CAR-T therapies marketed in China. CNCT19 will be manufactured in China at a cost significantly less than the cost of imported therapies, which ultimately enables us to make it more widely available to the Chinese patient population. We expect to start enrolling patients in early 2020."

About CNCT19
CNCT19 targets CD19, a B-cell surface protein widely expressed during all phases of B-cell development and a validated target for B-cell driven hematological malignancies. CD19-targeted CAR constructs from several different institutions have demonstrated consistently high antitumor efficacy in children and adults with relapsed B-cell acute lymphoblastic leukemia (B-ALL), chronic lymphocytic leukemia (CLL), and B-cell non-Hodgkin lymphoma (B-NHL). CD19 antigen is the most frequently used target in the CAR-T cell therapy clinical trials for hematological malignancies such as leukemia and lymphoma. CASI holds the worldwide commercial rights to CNCT19. Juventas is responsible for the development of CNCT19 with CASI’s participation on the program’s steering committee.

About Juventas
Juventas Cell Therapy Ltd. is a China-based domestic biopharmaceutical company established in 2018 focused on R&D, clinical translation and commercialization of innovative immune cell therapy. Juventas’ R&D operations are based in Beijing and its GMP facility is located in Tianjin City. More information on Juventas and its pipeline is available at www.juventas.cn.