On July 15, 2019 NuVasive, Inc. (NASDAQ: NUVA), the leader in spine technology innovation, focused on transforming spine surgery with minimally disruptive, procedurally integrated solutions, reported the Company will release its second quarter 2019 earnings results on Tuesday, July 30, 2019 after the close of the market (Press release, NuVasive, JUL 15, 2019, View Source [SID1234537538]).

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NuVasive will hold a conference call on Tuesday, July 30, 2019, at 4:30 p.m. ET / 1:30 p.m. PT to discuss the results of its financial performance for the second quarter 2019. The dial-in numbers are 1-877-407-9039 for domestic callers and 1-201-689-8470 for international callers. A live webcast of the conference call will be available online from the Investor Relations page of the Company’s website at www.nuvasive.com.

After the live webcast, the call will remain available on NuVasive’s website through August 30, 2019. In addition, a telephone replay of the call will be available until August 6, 2019. The replay dial-in numbers are 1-844-512-2921 for domestic callers and 1-412-317-6671 for international callers. Please use pin number: 13691950.

On July 15, 2019 Nevro Corp. (NYSE: NVRO), a global medical device company that is providing innovative, evidence-based solutions for the treatment of chronic pain, reported that the Company will release its financial results for the second quarter ended June 30, 2019 after the market closes on August 8, 2019 (Press release, Nevro, JUL 15, 2019, View Source [SID1234537537]).

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Investors interested in listening to the conference call may do so by dialing (833) 286-5807 in the U.S. or (647) 689-4452 internationally, using Conference ID: 1694716. In addition, a live webcast, as well as an archived recording, will be available on the "Investors" section of the Company’s website at: www.nevro.com.

On July 15, 2019 Paige, the leader in computational pathology focused on building artificial intelligence (AI) to transform the clinical diagnosis and treatment of cancer, reported the publication of an article in Nature Medicine, a leading monthly journal publishing original peer-reviewed research in all areas of medicine, describing an AI system for computational pathology that achieves clinical-grade accuracy levels (Press release, Paige AI, JUL 15, 2019, View Source [SID1234537535]). The paper provides further scientific evidence that pathologists’ work in diagnosing and treating cancer can be complemented and aided through the deployment of computational decision-support systems to improve patient care.

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The team of scientists responsible for the work described in the article developed specially-designed deep learning algorithms to build a system that can detect prostate cancer, skin cancer and breast cancer with near-perfect accuracy. These algorithms are based on a vast dataset of nearly 45,000 de-identified, digitized slide images from more than 15,000 cancer patients from 44 countries.

"After years of in-depth, comprehensive modeling, training, and testing, we are thrilled that Nature Medicine has published our paper, which demonstrates our ability to train accurate classification models at unprecedented scale, and validates our mission to create the world’s first clinical-grade, artificial intelligence in pathology," said Dr. Thomas Fuchs, Co-Founder and Chief Scientific Officer of Paige, who led the work at his lab at Memorial Sloan Kettering Cancer Center (MSK).

The paper outlines how a series of novel algorithms created using datasets ten times larger than those that have been manually curated performed better and also are more generalizable. The significance of this new development hinges on the fact that curating datasets can be prohibitively expensive and time intensive. By eliminating the need to curate datasets, Paige can now develop many more highly accurate algorithms that can be built into clinical decision support products to help pathologists around the world drive better patient care.

"The publication in Nature Medicine of the algorithm developed by Dr. Fuchs’ lab is an important milestone for Paige. It demonstrates that AI has the potential to support pathologists in delivering quantitative and more accurate diagnoses, improving treatment for patients worldwide. Leveraging even larger training sets, over the past year, Paige has created novel vendor-agnostic systems that demonstrate even better accuracy," said Dr. Christopher Kanan, lead AI scientist at Paige.

Paige plans to commercialize several of these solutions to address the most pressing needs in pathology to improve patient care. Paige has already built on the academic work described in Nature Medicine to develop a clinical product, based on technology currently under review by the U.S. Food and Drug Administration as a designated Breakthrough Device, for an intended indication different than the one described in the article.

All data collection, research, and analysis for this research was conducted exclusively at MSK in New York City, led by Dr. Fuchs and his student Gabriele Campanella. The publication of the study’s findings was the result of collaboration between numerous researchers and clinicians, and made possible by Paige’s partnership with MSK. All data were de-identified and did not contain any protected health information or label text. The full article, published in Nature Medicine on July 15, 2019 and titled "Clinical-grade Computational Pathology using Weakly Supervised Deep Learning on Whole Slide Images," can be found online at View Source

On July 15, 2019 Recursion, a next-gen biopharma company combining automated, experimental biology with artificial intelligence to discover and develop drugs at scale, reported the closing of a $121 million Series C financing (Press release, Recursion Pharmaceuticals, JUL 15, 2019, View Source [SID1234537534]). The round was led by Baillie Gifford’s flagship investment trust, Scottish Mortgage Investment Trust PLC, with participation by new institutional investors Intermountain Ventures, Regents of the University of Minnesota, Texas Tech University System, and select angel investors. All prior institutional investors also participated in the round, including Lux Capital, Data Collective, Mubadala Ventures, Two Sigma Ventures, Obvious Ventures, Felicis Ventures, Epic Ventures, Menlo Ventures, AME Cloud Ventures, and CRV.

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The new financing will support Recursion’s continued build-out of its machine learning-enabled drug discovery platform alongside new capabilities designed to radically accelerate new chemical entity chemistry and predict safety pharmacology. In addition, the Company will continue to advance its growing pipeline of pre-clinical and clinical assets, including clinical-stage programs for cerebral cavernous malformation and neurofibromatosis type 2.

"We’re very excited to see companies bringing innovation from different fields together to try to radically change healthcare," said Marina Record, Investment Manager at Baillie Gifford. "Recursion impressed us with its multidisciplinary effort and ambitious vision to improve our understanding of biology and discover new drugs in a way that is faster and cheaper. We are proud to support Chris and his team as they continue to build out their technology and take their programs through clinical development."

While Recursion plans to prioritize the advancement of treatments for rare diseases within its own pipeline, it will continue to forge strong partnerships with industry-leading pharmaceutical companies in a variety of therapeutic areas, including immuno-oncology, oncology, aging, and inflammation.

"In under two years since closing our Series B round, we have put two drugs discovered on our platform into clinical trials, had our first discoveries with Takeda optioned, grown our automated experimental bandwidth by an order of magnitude, expanded beyond rare diseases into new therapeutic areas like inflammation, infectious disease and immuno-oncology, grown our team from 64 to 150-plus and added all-stars from the biotech and tech worlds, and opened a state-of-the-art, 100,000 square-foot headquarters in downtown Salt Lake City," said Chris Gibson, PhD., CEO, Recursion.

Added Gibson: "We could not continue to scale up our business and achieve our mission of decoding biology to radically improve lives without this incredible investor syndicate. With these new resources, we will continue to drive toward a future in which drugs are developed — by people — with a new level of understanding about human biology that was simply not possible before machines."

For more information on Recursion’s unique approach to leveraging artificial intelligence for drug discovery and development, please visit www.recursionpharma.com.

On July 15, 2019 Provectus (OTCQB: PVCT) reported that the United States Patent and Trademark Office (USPTO) has allowed US patent (USP) application 15/804,357 for the combination of intratumoral PV-10 and systemic immunomodulatory therapy (e.g., anti-CTLA-4, anti-PD-1, and anti-PD-L1 agents) for the treatment of a range of solid tumor cancers (Press release, Provectus Biopharmaceuticals, JUL 15, 2019, View Source [SID1234537533]). Intratumoral injection of oncolytic immunotherapy PV-10 can yield immunogenic cell death in solid tumor cancers that results in tumor-specific reactivity in circulating T cells.1-5 Drug development of PV-10 includes cutaneous melanoma and cancers of the liver, such as hepatocellular carcinoma, metastatic neuroendocrine tumors, and metastatic uveal melanoma, in both monotherapy and combination therapy settings.

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This prospective new patent is the third continuation of USP 9,107,887, Provectus’ first and foundational cancer combination therapy patent granted by the USPTO in 2015. It is also related to USP 9,808,524 and USP 9,839,688, which are also continuations and the Company’s second and third cancer combination therapy patents granted by the USPTO in 2017. Pfizer, Inc. (Pfizer) is a co-assignee on all four awarded and allowed patents. No formal or informal agreement exists between Provectus and Pfizer regarding potential or possible patent economics.

Dominic Rodrigues, Vice Chair of the Company’s Board of Directors, said, "This fourth addition to Provectus’ cancer combination patent family represents our continued efforts to increase the potential commercial value of investigational cancer immunotherapy PV-10. We are grateful to Pfizer for their acquiescence as we pursue further patent protection of PV-10 as well as combinations of PV-10 with checkpoint inhibitor drugs."

Mr. Rodrigues added, "This pending new patent reinforces our clinical development strategy for combining PV-10 with checkpoint inhibitor drugs. From a cancer combination therapy perspective, global anti-PD-1 and anti-PD-L1 agents are essentially clinically interchangeable, in our view, and have no notable differences except pricing. We also believe that patients suffering from certain tumor types, like non-T cell inflamed and low tumor mutation burden ones, may benefit from the combination of PV-10, an anti-CTLA-4 drug, and an anti-PD-(L)1 drug."

About PV-10

PV-10 causes acute oncolytic destruction of injected tumors, releasing damage associated molecular pattern molecules (DAMPs) and tumor antigens that initiate an immunologic cascade where local response by the innate immune system facilitates systemic anti-tumor immunity by the adaptive immune system. The DAMP release-mediated adaptive immune response activates lymphocytes, including CD8+ T cells, CD4+ T cells, and NKT cells, based on clinical and preclinical experience in multiple tumor types. T cell function can be further augmented by combining PV-10 with immune checkpoint inhibition.

PV-10 is undergoing clinical study for adult solid tumor cancers like melanoma and cancers of the liver (including metastatic neuroendocrine tumors and metastatic uveal melanoma) and preclinical study for pediatric cancers like neuroblastoma5, Ewing sarcoma, rhabdomyosarcoma, and osteosarcoma.

Orphan drug designation status has been granted to PV-10 by the U.S. Food and Drug Administration for the treatments of metastatic melanoma in 2006, hepatocellular carcinoma in 2011, neuroblastoma in 2018, and ocular melanoma (including uveal melanoma) in 2019.

PV-10’s active pharmaceutical ingredient is rose bengal disodium (RB) (4,5,6,7-tetrachloro-2’,4’,5’,7’-tetraiodofluorescein disodium salt), a small molecule halogenated xanthene. PV-10 drug product is a bright rose red solution containing 10% w/v RB in 0.9% saline for injection, which is supplied in single-use glass vials containing 5 mL (to deliver) of solution and administered without dilution to solid tumors via intratumoral injection.

Provectus’ intellectual property includes a family of US and international patents that protect the process by which pharmaceutical grade RB and related xanthenes are produced, reducing the formation of previously unknown transhalogenated impurities that exist in commercial grade RB in uncontrolled amounts. The requirement to identify and control these substances is in accordance with International Conference on Harmonisation (ICH) guidelines for the manufacturing of active pharmaceutical ingredient that is suitable for clinical trial and commercial pharmaceutical use. USPs include 8,530,675 (awarded in 2013), 9,273,022 (2016), and 9,422,260 (2017), with patent expirations ranging from 2030 to 2031.