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 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 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 BioNTech SE, a clinical-stage biotechnology company focused on patient-specific immunotherapies for the treatment of cancer and other serious diseases, reported the completion of a USD 325 million Series B financing round, making it one of the largest single private funding rounds for a biotechnology company in European history (Press release, BioNTech, JUL 9, 2019, View Source [SID1234537427]). The fund raising was upsized and was led by Fidelity Management & Research Company with participation from both new and existing investors, including Redmile Group, Invus, MiraeAsset Financial Group, Platinum Asset Management, Jebsen Capital, Steam Athena Capital, BVCF Management and the Struengmann Family Office. Two-thirds of the funding came from new investors. The proceeds of the financing will support the continued advancement of BioNTech’s therapeutics pipeline and manufacturing infrastructure.

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"BioNTech has executed on a highly disruptive business strategy that aims to change the treatment paradigm for cancer patients," said Helmut Jeggle, Chairman of BioNTech. "We value the continued participation of our existing investors and welcome new investors to this powerful global syndicate representing North America, Asia and Europe."

Prof. Ugur Sahin, CEO and Co-Founder of BioNTech added: "This financing round is a significant milestone that recognizes our scientific and initial clinical track record to date. With our ongoing focus on bringing together transformative technologies, it is exciting to have the support from high-technology investors who see the accelerating convergence of biology with bioinformatics, robotics and artificial intelligence as an opportunity to develop more precise, efficacious and cost-effective individualized immunotherapies."

The funding follows the Series A financing of USD 270 million announced in January 2018, led by Redmile Group. The previous financings have enabled BioNTech to advance a pipeline of seven product candidates in eight ongoing clinical trials, to establish a second GMP manufacturing license for production of its individualized neoantigen specific immunotherapies and to expand its antibody platform, most recently, through the acquisition of a Phase I/IIa program against pancreatic cancer from MabVax Therapeutics Inc. In conjunction with the MabVax Therapeutics acquisition of assets, the company has also recently established its US research and development facility in San Diego, California.

On July 9, 2019 CytomX Therapeutics, Inc. (Nasdaq: CTMX), a clinical-stage oncology-focused biopharmaceutical company pioneering a novel class of investigational antibody therapeutics based on its Probody therapeutic technology platform, reported the second target selection by its partner AbbVie under the companies’ 2016 Discovery Collaboration and Licensing Agreement to discover and develop Probody drug conjugates ("PDC") (Press release, CytomX Therapeutics, JUL 9, 2019, View Source [SID1234537428]). The target selection triggers a $10 million payment to CytomX from AbbVie. This is the second of two research targets available to AbbVie under the agreement. The companies are also advancing a clinical-stage asset, CX-2029, under a global co-development and licensing agreement.

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"The initiation of this additional program with AbbVie and the associated milestone payment reflects the growing strength of clinical proof of concept CytomX has achieved in support of the Probody platform. It also further underscores the potential of our unique technology to make meaningful differences for cancer patients. We are excited to start this new program with our AbbVie colleagues," said Sean McCarthy D.Phil., president, chief executive officer and chairman of CytomX Therapeutics.

About the Discovery Collaboration and Licensing Agreement

Under the terms of the April 2016 Discovery Collaboration and Licensing Agreement, AbbVie receives exclusive worldwide rights to develop and commercialize PDCs against up to two targets, which were selected in March 2017 and June 2019. In each case, CytomX is responsible for certain research and pre-clinical activities with AbbVie leading pre-clinical and clinical development and commercialization of products arising from the collaboration. CytomX received an upfront payment of $10 million for each target selection and is eligible to receive up to $275 million in development, regulatory and commercial milestone payments and royalties in the high single to low teens from commercial sales of any resulting PDCs.

About the CX-2029 Co-Development and Licensing Agreement

Pursuant to the April 2016 Co-Development and Licensing Agreement, CytomX and AbbVie are also co-developing CX-2029, a PDC against CD71. CD71, also known as transferrin receptor 1 ("TfR1"), is a cell surface protein that is essential for iron uptake in dividing cells, is highly expressed in a number of solid and hematologic cancers and has attractive molecular properties for efficient delivery of cytotoxic payloads to tumor cells. CytomX received an upfront payment of $20 million, is eligible to receive up to $470 million in development, regulatory and commercial milestone payments, pending the achievement of pre-determined outcomes. CytomX is responsible for research activities and leading early-stage clinical development of CX-2029. AbbVie will lead global commercial activities with CytomX eligible to receive a profit share in the U.S. and tiered double-digit royalties on net product sales outside of the U.S. CytomX retains an option to co-promote in the U.S. CytomX initiated PROCLAIM-CX-2029, a Phase 1 dose escalation trial, in June 2018.