On September 24, 2020 KYAN Therapeutics, Inc. ("KYAN"), a frontier biotech company with a novel drug-dose combination optimizing platform, Optim.AI,reported that it has entered into an exclusive license agreement with Georgetown University for novel selective Class II HDAC inhibitors (Press release, KYAN Therapeutics, SEP 24, 2020, View Source [SID1234565597]). KYAN has already commenced preclinical development of the lead candidate, which has been designated as KYAN-001, with early positive results.

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In vitro and in vivo studies of KYAN-001 have shown high efficacy for Multiple Myeloma and Prostate Cancer. The low toxicity and metabolic stability of KYAN-001 indicates a better safety and tolerability profile than FDA approved pan-HDAC inhibitors which suffer from toxicity issues and side effects. KYAN-001 also uniquely inhibits HDAC4 nucleoshuttling to further drive its anti-cancer effects.

"We’re very excited to proceed with KYAN-001 because of its promising features and we are confident that we can identify optimal combination therapies across multiple cancer indications with Optim.AI," said Lisa Chow, COO and General Counsel of KYAN.

Masturah Rashid, Ph.D., Principal Scientist at KYAN, added: "It is scientifically recognized that epigenetic drugs, including HDACis, have significant cancer therapy potential but are limited in effectiveness as monotherapies. Utilizing Optim.AI, we have already pinpointed KYAN-001-based 2-drug or 3-drug combinations that outperform relapsed/refractory multiple myeloma standard of care therapies in in vitro efficacy. We also plan to interrogate combinations with drugs that are approved for other indications to identify even more optimal combinations that are nonobvious when relying on scientific rationale."

Lisa Chow further stated: "The beauty of applying Optim.AI to the development of KYAN-001 is that we will be able to cut costs and development time while also tackling unmet needs. Many programs are focused on biomarker discovery or subgrouping, which while important, tend to reduce the potential market size and leave many patients unaddressed. Optim.AI’s unique suite of proprietary analytics allows us to efficiently and accurately evaluate a vast number of combinations, an endeavor that would be prohibitively expensive and labor intensive via other methods. Therefore, we can find effective therapies for broader populations."

KYAN plans to explore at least four cancer indications for KYAN-001 and anticipates advancing KYAN-001 through to Phase I clinical trials by 2022.

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.