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.

On July 9, 2019 XBiotech (NASDAQ: XBIT) reported that the Medical Research Council (MRC), part of UK Research and Innovation, has awarded funding to study bermekimab therapy in a Phase 2 multi-center study in advanced cancers (Press release, XBiotech, JUL 9, 2019, View Source [SID1234537437]). The MRC will provide funding for all clinical costs of the Phase 2 study to treat patients with advanced lung, pancreatic and ovarian cancers. The MRC uses leading medical researchers to evaluate and award grants based on the mission "to improve human health through world-class medical research." [View Source

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The phase 2 study will be conducted at multiple cancer centers across the UK. Patients will receive eight weekly doses of bermekimab and be assessed for tumor-related wasting and other quality of life symptoms (using the EORTC QLQ-C30). The study was developed in conjunction with the National Institute for Health Research (NIHR) Cancer & Nutrition Collaboration and the National Cancer Research Institute (NCRI) Supportive and Palliative Care Group.

Barry J. A. Laird, M.D., Senior Lecturer in Palliative Medicine at the University of Edinburgh’s Cancer Research Centre, Institute of Genetics and Molecular Medicine, and Consultant in Palliative Medicine at St Columba’s Hospice in Edinburgh will head the study. Dr. Laird commented, "In patients with cancer, loss of weight, decreased activity and impaired quality of life are often regarded as inevitable with limited treatments available. Using immunotherapy to abrogate this disease process is a new approach. We are grateful to the MRC and to XBiotech for supporting this trial."

John Simard, President & CEO of XBiotech, commented, "We are pleased that the medical experts at the MRC have committed resources to the bermekimab program in oncology. We are grateful to Dr. Baird for his work in advancing a novel clinical protocol and for bringing this important immunotherapy to patients in the UK. Bermekimab has proven to significantly benefit patients with advanced cancer. We are eager to provide bermekimab in support of the planned clinical study and to help patients suffering from advanced cancer."

Bermekimab targets the inflammatory cytokine interleukin-1a and has been used in other innovative oncology studies. The Company previously met its primary endpoint in a randomized double-blind, placebo-controlled study with bermekimab for the treatment of advanced colorectal cancer. The primary endpoint in the study was a novel symptom cluster, which assessed a combination of physical symptoms—pain, fatigue, anorexia and muscle wasting—that are key measures of patient quality of life and predictors of survival. Patients treated with bermekimab were significantly more likely to achieve the primary endpoint compared to placebo (33% vs 17%, respectively); moreover, patients who achieved the primary endpoint had one-fifth as many serious adverse events, were twice as likely to have stable disease (according to RECIST criteria), showed significant and clinically relevant improvement in all life quality measures, and had almost three-fold increase in survival compared to failures.

About True Human Therapeutic Antibodies
XBiotech’s True Human antibodies are derived without modification from individuals who possess natural immunity to certain diseases. With discovery and clinical programs across multiple disease areas, XBiotech’s True Human antibodies have the potential to harness the body’s natural immunity to fight disease with increased safety, efficacy and tolerability.