On July 9, 2019 Biodesix, Inc, the leader in blood-based lung cancer diagnostic solutions, reported it has entered into an agreement with Thermo Fisher Scientific (Press release, Biodesix, JUL 9, 2019, View Source [SID1234537444]). The agreement is designed to bring a blood-based next-generation sequencing (NGS) assay to market with premarket approval (PMA) classification from the U.S. Food and Drug Administration (FDA). Biodesix will work to develop all required analytical and clinical data using Thermo Fisher’s Ion Torrent Oncomine Pan-Cancer Cell-Free Assay in an effort to obtain regulatory approval from the FDA. The program will focus on an NGS-based solution for patients with advanced non-small cell lung cancer (NSCLC).

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Upon FDA approval Biodesix will have a single-site PMA (ssPMA) for an NGS liquid biopsy covering actionable markers in cancer. The designation will extend Biodesix collaborations with biopharmaceutical companies for NGS-based biomarker discovery, validation studies, and commercialization capabilities that include regulatory approval and reimbursement for companion diagnostics.

The Ion Torrent Oncomine Pan-Cancer Cell-Free Assay enables reproducible detection and analysis of tumor DNA and RNA across all major classes of somatic mutations (SNVs, indels, CNVs and fusions) from a single vial of blood within two days. Targeting 52 genes across multiple cancer types, including lung, colorectal, breast, pancreatic, thyroid and others, the cell-free total nucleic acid (cfTNA) assay has broad application for liquid biopsy clinical research applications.

"We are dedicated to providing actionable answers that physicians and patients need by leveraging the best technology available," said David Brunel, Biodesix CEO. "Building on our expertise in blood-based solutions, this assay will expand our lung cancer portfolio to provide physicians and biopharmaceutical companies with blood-based NGS assays that provide fast turn around and comprehensive answers. This agreement enables Biodesix to continue innovating much needed cancer diagnostic solutions that service clinical and biopharma partners from early discovery through global distribution."

Biodesix operates two world-class clinical laboratories regulated by the Centers for Medicare & Medicaid Services (CMS) pursuant to the Clinical Laboratory Improvement Amendments (CLIA). In addition to holding a CLIA certificate of accreditation by the College of American Pathologists (CAP), the Biodesix quality management system maintains a certification with ISO 13485, a harmonized international standard for quality management systems. The company has received approval from the New York State Department of Health Clinical Laboratory Standards of Practice (NYS CLEP) in soluble and molecular tumor markers. Biodesix labs support the company’s global products, clinical trials, and biopharmaceutical partnerships.

On July 9, 2019 OncoNano Medicine, Inc. reported the completion of $23.7 million in a second tranche of Series A financing, bringing the total Series A round to $35.4 million (Press release, OncoNano Medicine, JUL 9, 2019, View Source [SID1234537443]). The round was arranged by Salem Partners, who also participated as a principal investor. Proceeds of the financing will fuel OncoNano’s cancer imaging clinical trials and support the expansion of its technology into candidates for therapeutic applications.

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"Over the last year, OncoNano has made significant strides in the completion of a Phase 1 trial for our intraoperative cancer imaging agent, ONM-100, which saw a 100 percent imaging response in patients, as well as the expansion of the use of our pH sensitive micelle platform into exciting new areas such as therapeutics and cancer vaccines," said Ravi Srinivasan, CEO of OncoNano Medicine. "The continued support of our distinguished investors and the addition of new investors into the OncoNano family will enable us to further our mission to change how cancer is detected and treated."

ONM-100 is the first product in a platform based upon the company’s library of unique micelles that are ultra-sensitive to changes in pH. The intravenously administered imaging agent, which detects tumors and metastatic lymph nodes, is entering a Phase 2 clinical trial. The company announced earlier this year that the U.S. Food and Drug Administration (FDA) accepted its Investigational New Drug (IND) application for ONM-100 and granted a Fast Track designation in response to a separate application. OncoNano’s micelle platform is also being used to develop therapeutics, including a T-cell activator that targets lymph nodes and dendritic cells to treat cancers.

"The combination of OncoNano’s experienced executive and scientific team coupled with the progress the company is making in expanding the platform across multiple imaging and therapeutic applications underscores the tremendous interest in the company from both existing and new investors," said John Dyett, Co-Founder and Managing Director at Salem Partners, who also serves on OncoNano’s Board of Directors. "We have full confidence in the company’s potential to make a significant impact in the future of cancer care."

On July 9, 2019 Be The Match BioTherapies, an organization offering solutions for companies developing and commercializing cell and gene therapies, and Tmunity Therapeutics, Inc., a private clinical-stage biotherapeutics company, reported a partnership to accelerate patient access to life-saving cell therapies (Press release, Be The Match BioTherapies, JUL 9, 2019, View Source [SID1234537442]).

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The collaboration leverages Be The Match BioTherapies’ industry-leading cell therapy supply chain and collection network management expertise to support clinical development of Tmunity’s diversified portfolio of novel treatments that exhibit best-in-class control over T cell activation and direction in the body. These personalized next-generation immunotherapies for cancer are advancing through preclinical and clinical testing.

"It’s an exciting moment for Tmunity as we widen our clinical pipeline of investigational immunotherapies to address a broad range of solid tumor and hematological cancers—and Be The Match BioTherapies is the ideal partner to help advance that work," said Usman "Oz" Azam, MD, president and chief executive officer of Tmunity. "We look forward to working together to deliver powerful new options for patients and to bring about the future of cell therapy."

Be The Match BioTherapies will support Tmunity’s ongoing work to advance T cell immunotherapies. These efforts will include the management of cell therapy supply chain and logistics, supported by the company’s MatchSource Supply Chain Software. In addition, Be The Match BioTherapies will qualify, develop and train a network of collection centers to help ensure the collection of consistent, compliant and high-quality cell starting material. To gain efficiencies in site qualification, Tmunity will receive licensed access to quality system audit results through the Quality System Audit Program (QSAP).

"Be The Match BioTherapies was built to empower the development and delivery of next-generation cell and gene therapies like those being developed by Tmunity," said Chris McClain, MBA, vice president, Sales and New Business Development, Be The Match BioTherapies. "We are eager to help speed access to Tmunity’s innovative therapies for patients in need."

On July 9, 2019 CSI Laboratories (CSI) and Synergy Capital Investments (Synergy) reported the transition of a convertible note to equity stake in CSI, a state of the art, specialized cancer diagnostic center (Press release, CSI Laboratories, JUL 9, 2019, View Source [SID1234537441]).

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"The security purchase agreement, originally issued in 2017, supported a significant transformation around revenue cycle, sales and operational management that improved our profitability," said Chief Executive Officer and Chief Financial Officer, Chris Wicker. "The note positioned CSI to expand capabilities through the implementation of cutting-edge informatics and the addition of the second testing facility in Jupiter, FL that opened earlier in 2019. We are very pleased to continue our partnership with Synergy as a shareholder and build on CSI’s robust performance."

CSI executed a considerable financial turnaround in the past two years, and the financial outlook is positive for sustained planned growth.

Munir Karimi, Chief Executive Officer of Synergy, assumes a seat on the Board of Directors of CSI. Said Karimi, "We have been working closely with the CSI team for the past couple of years. This is an excellent time to participate on the equity side given their strong financial performance, outstanding executive guidance, and medical thought leadership. The investment reflects our excitement and optimism for CSI’s continued momentum and reinforces our support of CSI Laboratories."

On July 9, 2019 PureTech Health plc (LSE: PRTC) ("PureTech"), an advanced biopharmaceutical company developing novel medicines for dysfunctions of the Brain-Immune-Gut (BIG) axis, reported that the United States Patent and Trademark Office (USPTO) has issued U.S. Patent No. 10,344,091 to support the Company’s internal immuno-oncology product candidate, LYT-200 (Press release, PureTech Health, JUL 9, 2019, View Source [SID1234537440]). The patent covers compositions of matter directed to fully human anti-galectin-9 antibodies, which PureTech intends to develop for historically difficult-to-treat cancers including pancreatic, colorectal, and cholangiocarcinoma, among other cancer types. PureTech intends to file an investigational new drug (IND) application for LYT-200 in the first half of 2020.

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"PureTech’s galectin-9 antibody has been designed to address the challenges encountered with current immuno-oncology treatments due to redundancies in the immunosuppressive tumor microenvironment. Our now patented antibody composition leverages a new mechanism of action to disrupt the immunosuppressive environment, potentially enabling the body’s immune system to attack cancers that have historically been hard to treat," said Joe Bolen, Ph.D., chief scientific officer of PureTech. "This patent provides important coverage for our immuno-oncology program, and we look forward to continuing the development of LYT-200 to address the tremendous patient need that exists."

Galectin-9 induces robust immunosuppression that allows tumors to evade immune system attack. It is a foundational immune modulator that is expressed in the tumor microenvironment, on tumor cells, and in the blood of cancer patients, globally inducing and maintaining immunosuppression in cancer. High galectin-9 expression has been demonstrated in a number of patient tumor samples, including those that do not respond well to current checkpoint inhibitors. By blocking galectin-9, PureTech’s potentially first-in-class, fully human, monoclonal antibody is designed to intercept the immunosuppressive pathways that galectin-9 stimulates, potentially enabling an immune-mediated response against tumors. While existing therapies have not been sufficiently effective in the treatment of aggressive tumors, PureTech’s approach has shown favorable drug properties and safety in pre-clinical models, and it is being explored as both a single-agent and in combination with other modalities for cancer treatment, including other immunotherapies and chemotherapies.

About LYT-200
PureTech’s immuno-oncology program, LYT-200, is a fully human, potentially first-in-class, IgG4 monoclonal antibody designed to target galectin-9, which is a fundamental immunosuppressive mechanism in hard-to-treat cancers such as pancreatic, colorectal, and cholangiocarcinoma, among other tumor types. LYT-200 has demonstrated proof-of-concept in both mouse and preclinical human cancer models, indicating that targeting galectin-9 activates T cells in tumors and reduces tumor growth, which could significantly extend survival. These data suggest that LYT-200 has strong potential to be used as both a monotherapy and in combination with existing immuno-oncology therapies. PureTech intends to file an investigational new drug (IND) application for LYT-200 in the first half of 2020.