On September 24, 2020 Innova Therapeutics Inc., a biopharmaceutical company committed to developing innovative cancer therapies for patients who have inadequate treatment options, reported that the FDA has granted Rare Pediatric Disease (RPD) Designation for IVT-8086 for the treatment of Osteosarcoma (OS) (Press release, Innova Therapeutics, SEP 24, 2020, View Source [SID1234565596]). IVT-8086 is a humanized monoclonal antibody (mAb) with high affinity to a novel anticancer target, secreted frizzled-related protein 2 (SFRP2).

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"The FDA’s Rare Pediatric Disease Designation of IVT-8086 for the treatment of osteosarcoma highlights the significant unmet medical needs for patients with this devastating and life-threatening disease. IVT-8086 has the potential to become the first FDA-approved therapy for individuals with osteosarcoma in over 30 years," said Robert Ryan, Ph.D., Chief Executive Officer of Innova Therapeutics.

This research was conducted in the laboratory at the Hollings Cancer Center at the Medical University of South Carolina (MUSC) by Nancy Klauber-DeMore, MD, who is a co-founder and Professor of Surgery and BMW Endowed Chair of Cancer Research.

Hollings Cancer Center Director Raymond N. DuBois, M.D., Ph.D. said, "This is very exciting for the cancer center. This is a new designation approved by the FDA for a terrible disease in children, osteosarcoma," DuBois said. "Hollings values these kinds of partnerships that help advance the great science happening here in our laboratories. Also, translating our basic science into the clinic is a major goal of Hollings, especially when there is such a great unmet need."

The FDA grants Rare Pediatric Disease Designation for serious and life-threatening diseases that primarily affect children ages 18 years or younger and fewer than 200,000 people in the U.S. If Innova’s new drug application ("NDA") for osteosarcoma is approved, Innova may receive a priority review voucher from the FDA, which can be redeemed to obtain priority review for any subsequent marketing application or may be sold to another company for their programs.

About Osteosarcoma

Osteosarcoma is a malignant bone tumor with histological findings of osteoid or bone production. OS is a highly metastatic cancer that predominantly affects children, teenagers, and young adults. In the last 20 years, OS patients have not seen improvement in prognosis even with available treatments. The prevalence of OS is approximately 40,000 individuals in the US.

About IVT-8086

IVT-8086 has high affinity to SFRP2, which is a novel anticancer therapeutic target that is highly expressed in OS tumor cells. IVT-8086 has been shown to antagonize SFRP2 thereby blocking the non-canonical Wnt/Ca2+ pathway, resulting in decreasing tumor cell angiogenesis and cell migration, increasing tumor cell apoptosis, and rescuing T cell exhaustion.

On September 24, 2020 IncellDx, Inc., a global leader in single-cell diagnostics, reported the USPTO has issued patent US10,782,298 to IncellDx. This patent covers a number of detection platforms including flow cytometry, single-cell imaging, and circulating tumor cell (CTC) instruments (Press release, IncellDx, SEP 24, 2020, View Source [SID1234565595]). Therapies directed at the PD-L1/PD-1 axis have revolutionized cancer immunotherapy and have contributed significantly to the reduction in deaths from cancer in the US over the past few years. The methods contained in this patent allow for PD-L1 quantification on a cell-by-cell basis based on simultaneous cell typing and even DNA content.

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"This is a major milestone for IncellDx as reflected by our development and commercialization of several immuno-oncology assays. These include our launch of the OncoTect iO Lung Cancer CE-IVD kit; our new RUO OncoTect iO Bladder Cancer Assay; and the impending submission of our OncoTect iO Bladder Cancer CE-IVD kit," said Dr. Bruce Patterson, CEO of IncellDx. "We look forward to launching more diagnostics in the immuno-oncology space in support of the ongoing research efforts and the rapidly expanding pipeline of drugs aimed at promoting immune responsiveness against cancer."

On September 24, 2020 IONpath, Inc., the leader in high-definition spatial proteomics, reported the close of a $18 million Series B financing led by Samsara BioCapital, and included participation from new investor Bruker Corporation, a global leader in mass spectrometry (Press release, IONpath, SEP 24, 2020, View Source [SID1234565594]). All existing major investors contributed to the round including Genoa Ventures, ND Capital, Paladin Partners Investments, Trancos IONpath Investors, Norwich Ventures, and Vertical Venture Partners Growth Fund.

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"Developed by pathologists for translational researchers, IONpath’s MIBI platform delivers a revolutionary way to visualize phenotypic profiles, enabling rich, sensitive spatial analysis of tissue microenvironments," said Mike Dybbs, Partner at Samsara BioCapital and IONpath Board member. "We are excited to support IONpath in its mission to advance precision medicine and we are proud to partner with Bruker and all the company’s investors on this financing."

IONpath’s MIBI (Multiplexed Ion Beam Imaging) technology is delivering on the promise of spatial proteomics by providing unprecedented insights for translational medicine researchers. Through highly multiplexed, quantitative protein imaging with unmatched sensitivity and true subcellular resolution down to 280 nm, only MIBI technology delivers actionable insights of single cells in their complex tissue microenvironment with the throughput and reproducibility required for clinical studies.

"Bruker is honored to support IONpath in the further development and commercialization of its MIBI technology, which is helping researchers solve some of the most complex problems in solid tumor oncology," said Dr. Rohan Thakur, Executive Vice President, Bruker Corporation. "We believe the synergies between label-free MALDI imaging for endogenous metabolites, lipids, and glycans, coupled to MIBI multiplexed sub-cellular protein imaging, will accelerate adoption of mass spectrometry approaches for pathology."

"We are seeing strong traction for our MIBI technology, both in our MIBIscope instrument and our end-to-end Research Services business. We are more convinced than ever that MIBI-enabled, high-definition spatial proteomics will be a key enabler for the deployment of precision medicine in the treatment of a wide range of diseases," said Sander Gubbens, PhD, CEO of IONpath. "We are grateful for the continued support of our investors and are honored to welcome Bruker as a new investor as we expand the availability of our MIBI technology and Research Services globally."

On September 24, 2020 PTC Therapeutics, Inc. (NASDAQ: PTCT) reported that management will present a company overview at the Jefferies Virtual Gene Therapy/Editing Summit on Thursday, October 1st at 9:00 a.m. ET (Press release, PTC Therapeutics, SEP 24, 2020, View Source [SID1234565593]).

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The presentation will be webcast live on the Events and Presentations page under the investor relations section of PTC Therapeutics’ website at www.ptcbio.com and will be archived for 30 days following the presentation. It is recommended that users connect to PTC’s website several minutes prior to the start of the webcast to ensure a timely connection.

On September 24, 2020 ONCOtracker, Inc and The Binding Site Group Ltd reported they have entered into an exclusive global license and collaboration agreement to develop a novel clinical laboratory test for measuring sBCMA, which has shown promise to monitor and predict outcomes for patients with common blood-based cancers including multiple myeloma (MM) and chronic lymphocytic leukemia (CLL) and other related conditions (Press release, OncoTracker, SEP 24, 2020, View Source [SID1234565592]).

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sBCMA was first discovered in 2011 by Dr. James Berenson and colleagues at The Institute for Myeloma and Bone Cancer Research (IMBCR). Dr. Berenson’s scientific and clinical research focuses on myeloma and has demonstrated that sBCMA is found at low levels in the serum of normal patients and is elevated among patients with MM and CLL in studies involving several thousand patients. Changes in sBCMA levels have also been found to occur rapidly and correlate with patients’ clinical status in response to treatment (Ghermezi et al. Haematologica 2017; Jew et al. Brit J Haematol 2020).

Under terms of the agreement, The Binding Site Group obtains a global exclusive license to develop and commercialize a sBCMA test for multiple myeloma, CLL and additional conditions. ONCOtracker which holds patented technology regarding the testing of this biomarker for multiple myeloma patients will continue to support The Binding Site’s sBCMA research and medical affairs efforts.

"We are thrilled to partner with The Binding Site Group, the leader in myeloma diagnostics and manufacturer of Freelite, the diagnostic standard of care in multiple myeloma. They are the perfect collaborator to further develop and commercialize the sBCMA biomarker test and an ideal match for ONCOtracker," said James Berenson, MD, Founder and President of ONCOtracker.

"Binding Site has a history of collaborating with exceptional scientists and developing the utility of new markers and technologies to aid in monoclonal gammopathy patient management. With the introduction of the Freelite assay, more recently with our Mass Spectrometry collaboration and now as we seek to understand the developing role of serum BCMA measurements, we have always sought to collaborate with innovative and passionate scientists. Therefore we are delighted to announce this collaboration and excited to work with Dr. Berenson and the OncoTracker team as we add another tool to the monoclonal gammopathy patient management armamentarium," said Dr. Stephen Harding, Chief Scientific Officer of The Binding Site Group.