Median Technologies’ Q3 Performance Shows Steady Growth, Validates the Strategy Adopted in 2018 (unaudited Figures)

On October 8, 2019 Median Technologies (Paris:ALMDT), The Imaging Phenomics Company, reported an update on its performance unaudited figures – in the third quarter of 2019 (Press release, MEDIAN Technologies, OCT 8, 2019, View Source [SID1234540115]).

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As of September 30th, 2019, the cumulated revenue for 2019 was € 6.3 million. In the first three quarters of 2019, the company has already generated equivalent revenues to the full 2018 year (€ 6.3 million). Sales in the third quarter 2019 grew to € 2.3 million, making it the fourth quarter in a row that the company experienced steady growth. Median’s revenue came solely from its iCRO1 business.

As of September 30th, 2019, the order backlog reached € 35.9 million, an increase of € 5.2 million since June 30th, 2019 and an increase of € 12.2 million compared to December 31st, 2018.

Considering the company’s positive performance and the Research Tax Credit payment (€ 1.6 million) received in July, the company increased its cash and cash equivalents to € 8.3 million, compared to € 7.9 million as of June 30th, 2019. The company’s cash burn rate has been steadily declining since the second half of 2018, down to € 0.4 million per month this quarter. The EIB (European Investment Bank) loan is expected to be finalized in Q4, 2019.

In the third quarter, the iCRO business exceeded the mark of 100 clinical studies contracted with biopharmaceutical sponsors, with a growing number of phase III studies and immuno-oncology trials (+45%). The company is experiencing an increase in repeat business with large biopharmaceutical companies, which shows a great deal of trust in Median’s performance, quality and competitiveness.

Meanwhile, Median continued to develop its imaging phenomics platform iBiopsy. A demo was successfully featured at the annual conference of the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) (ESMO – September 27th to 30th, 2019, Barcelona, Spain), creating a lot of traction and interest by pharma groups.

"Our continued iCRO excellent performance validates the strategic decisions we made in 2018. Our iCRO business is demonstrating its capacity for sustainable growth and profitability," said Fredrik Brag, CEO and co-founder of Median. "With iBiopsy, Median is at the forefront of the development of non-invasive biomarker diagnostic solutions, which are currently generating great interest from US investors. Liquid biopsy companies have multibillion-dollar valuations. In oncology, the two obvious oncology non-invasive biomarker diagnostic solutions are liquid biopsies and imaging and we intend to become the leader in imaging", he added.

Personalis, Inc. to Present at Advances in Immuno-Oncology Congress USA 2019

On October 8, 2019 Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for cancer, reported that the company will present at Advances in Immuno-Oncology Congress USA 2019 in San Diego on October 8th at 2:50 PM PDT (Press release, Personalis, OCT 8, 2019, View Source [SID1234540114]).

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The presentation, titled "Advancing Precision Oncology Biomarker Discovery with a Multidimensional Immunogenomics Platform," will describe the Personalis universal cancer immunogenomics platform, ImmunoID NeXT. In addition to an overview, the presentation will cover preliminary data from an ongoing study in which this platform is being used to evaluate IO-related biomarkers and potential tumor escape mechanisms in a cohort of melanoma patients treated with anti-PD-1 therapy.

ImmunoID NeXT is the first platform to enable comprehensive analysis of both a tumor and its immune microenvironment from a single sample. The platform can be used to investigate the key tumor- and immune-related areas of cancer biology, consolidating multiple oncology biomarker assays into one. This maximizes the biological information that can be generated from a precious tumor specimen.

The presentation will be delivered by Kedar Hastak, Ph.D., Field Application Scientist.

BostonGene Announces Cancer Research Collaboration with Washington University in St. Louis

On October 8, 2019 BostonGene Corporation (BostonGene), a Boston, Mass-based biomedical software company, reported a master agreement with Washington University School of Medicine in St. Louis to collaborate on multiple research projects (Press release, BostonGene, OCT 8, 2019, View Source [SID1234540113]).

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BostonGene’s solution will provide Washington University oncologists at Siteman Cancer Center with detailed analysis, interpretation and visualization of big data obtained from cancer patient’s genomic, transcriptomic, proteomic and imaging tests. The solution identifies all significant somatic alterations, evaluates protein expression, computes tumor clonality, tumor heterogeneity, tumor microenvironment cell type composition, hereditary predisposition, viral infestation, pharmacogenomics and predicts neoantigens for personalized vaccine development among other molecular features. BostonGene generates a visually-appealing and self-explanatory tumor schematics, called MF PortraitTM, elegantly depicting tumor activity, tumor cellular composition, activity of immune-microenvironment and other tumor-associated processes.

"We’re collaborating with BostonGene to evaluate how its technology can help us identify the best treatments for patients based on the underlying characteristics of their cancers, with the goal of increasing survival. The company’s analytics and integration of scientific and clinical knowledge is aimed at complementing and empowering the precision medicine approach for individual cancer patients," said Todd Fehniger, MD/PhD, a Washington University medical oncologist who treats patients at Siteman Cancer Center.

"BostonGene’s mission is to provide every patient with the highest probability of survival by selecting optimal cancer treatments using sophisticated analytics and integration of scientific and clinical knowledge," said Andrew Feinberg, President and CEO of BostonGene. "With our collaboration with Washington University we are transforming cancer care from treating a diagnosis to treating the patient."

Biodesix Names Dr. James Jett Chief Medical Officer

On October 8, 2019 Biodesix, Inc. the leader in lung cancer diagnostics, reported the appointment of internationally recognized lung cancer expert, James Jett, M.D., as Chief Medical Officer (Press release, Biodesix, OCT 8, 2019, View Source [SID1234540109]). Dr. Jett joins Steven Springmeyer, M.D. as co-CMO to support all aspects of the Company’s research, development and commercialization efforts. Today’s news comes as Biodesix continues to drive adoption of the recently launched Nodify XL2 proteomic nodule classifier.

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"Biodesix is a natural continuation of my gratifying career as a physician. I believe that the future of patient care in oncology and pulmonology should be designed and innovated with the patient experience as the highest priority"

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Dr. Jett joins Biodesix from Oncimmune Ltd., where he served as the Chief Medical Officer. His career includes work as a Professor of Medicine at the Mayo Medical School and the University of Pittsburgh. Dr. Jett has also served as a consultant for the National Cancer Institute in Bethesda, and he was the Editor in Chief of the Journal of Thoracic Oncology from 2006-2013. His work on academic editorial boards includes Chest, Respiratory Medicine, and the American Journal of Respiratory and Critical Care Medicine.

In addition to all aspects of the company, Dr. Jett and Dr. Springmeyer will combine expertise to focus on advancing the Biodesix lung cancer and nodule management programs. Springmeyer joined the company from Integrated Diagnostics (acquired by Biodesix in 2018) and Jett from Oncimmune (notice of acquisition in 2019).

"Biodesix is a natural continuation of my gratifying career as a physician. I believe that the future of patient care in oncology and pulmonology should be designed and innovated with the patient experience as the highest priority," said Dr. Jett. "I see Biodesix as a company leading the way in developing diagnostic tools that can help guide physicians and their patients to the most appropriate individual course of action."

"We continue to build a portfolio of best-in class lung nodule diagnostic tests along with a team of world class clinical experts," said Scott Hutton, chief operating officer, Biodesix. "We take lung cancer personally and by attracting the brightest minds in solving these complex diagnostic challenges we will continue to have a positive impact on physicians and their patients."

Triumvira Announces Grant of T Cell Antigen Coupler (TAC) Technology Patent by U.S. Patent and Trademark Office

On October 8, 2019 Triumvira Immunologics (Triumvira), a privately held biopharmaceutical company developing a novel platform for engineering T-cells to attack cancers, reported the issuance of key claims in U.S. Patent No. 10435453 entitled "Trifunctional T cell-antigen coupler and methods and uses thereof (Press release, Triumvira Immunologics, OCT 8, 2019, View Source [SID1234540108])." The allowed composition-of-matter claims describe multiple structures used in TAC constructs providing broad protection of the company’s TAC platform.

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Triumvira recently announced the clearance of its Investigational New Drug (IND) and Clinical Trial Applications (CTA) by U.S. and Canadian Health Authorities for its novel T cell therapy product TAC01-CD19 in patients with CD19-positive B-cell malignancies. The Phase 1/2 study (TACTIC-19, NCT03880279) is expected to be initiated in late 2019.

"Obtaining intellectual property protection of our TAC platform is a key milestone and confirms that TAC is a well-differentiated technology," said Dr. Paul Lammers, Triumvira’s President and CEO. "Issuance of our composition of matter claims further strengthens our position as a company pioneering novel engineered T cell approaches as we are bringing this innovative treatment to patients."

Triumvira’s preclinical data previously revealed unique biological differences of TAC-engineered T cells compared to second-generation CAR-T cells, with TAC-T cells producing greater anti-tumor efficacy and no evidence of toxicity, particularly in models of solid tumors.

About TAC01-CD19

Despite transformational efficacy with existing approved Chimeric Antigen Receptor T Cells (CAR-T), a significant unmet need remains due to substantial CAR-T toxicities and limited tumor types where CAR-T is effective. Triumvira is developing a proprietary T Cell Antigen Coupler (TAC) technology platform which is biologically distinct from CAR-T. The first of the company’s pipeline product candidates, TAC01-CD19, is a novel T cell therapy product targeting CD19 for use in B-cell malignancies. The product comprises patient-derived T cells that have been genetically engineered to express the CD19 T cell Antigen Coupler (TAC). Preclinical data suggest that TAC01-CD19 has the potential for being highly efficacious with minimal side effects in hematological malignancies.