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 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 GlaxoSmithKline plc (LSE/NYSE: GSK) reported positive results from PRIMA (ENGOT-OV26/GOG-3012), the Phase 3 randomized, double-blind, placebo-controlled, study of ZEJULA (niraparib) as a maintenance therapy in patients with first-line ovarian cancer following platinum-based chemotherapy (Press release, GlaxoSmithKline, JUL 15, 2019, View Source [SID1234537517]). The study met its primary endpoint of a statistically significant improvement in progression free survival for women regardless of their biomarker status.

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The safety and tolerability profile of niraparib was consistent with previous clinical trials.

Dr Hal Barron, Chief Scientific Officer and President, R&D, GSK, said: "Almost 300,000 women around the world are diagnosed with ovarian cancer every year, yet only about 15% of patients are currently eligible to receive PARP inhibitors as their initial therapy. These exciting data demonstrate that ZEJULA has the potential to significantly benefit even more women with this devastating cancer."

The full results from PRIMA will be presented at an upcoming scientific meeting.

Niraparib is marketed in the United States and Europe under the trade name ZEJULA.

About PRIMA

PRIMA is a double-blind, randomized Phase 3 study designed to evaluate niraparib versus placebo in first-line Stage III or IV ovarian cancer patients. The study assesses the efficacy of niraparib as maintenance treatment, as measured by progression free survival. Platinum responsive patients were randomized 2:1 to niraparib or placebo. The trial incorporated an individualized niraparib starting dose of 200 mg once-daily in patients with baseline weight <77kg or platelet count <150K/μL and 300 mg in all other patients.

About Ovarian Cancer

Approximately 22,000 women are diagnosed each year with ovarian cancer in the United States, and more than 65,000 women are diagnosed annually in Europe. Ovarian cancer is the fifth most frequent cause of cancer death among women. Despite high response rates to platinum-based chemotherapy in the second-line advanced treatment setting, approximately 85% of patients will experience recurrence within two years.

About niraparib

Niraparib is an oral, once-daily PARP inhibitor that is currently being evaluated in three pivotal trials. The ongoing development program for niraparib includes the Phase 3 PRIMA trial, a Phase 3 trial for the treatment of patients with germline BRCA-mutated, metastatic breast cancer (the BRAVO trial), and a registrational Phase 2 treatment trial in patients with ovarian cancer (the QUADRA trial). Several combination studies are also underway, including trials of niraparib plus pembrolizumab in metastatic, triple-negative breast cancer and advanced, platinum-resistant ovarian cancer (the TOPACIO trial) and niraparib plus bevacizumab in recurrent, platinum-sensitive ovarian cancer (the ENGOT-OV24/AVANOVA trial). Janssen Biotech has licensed rights to develop and commercialize niraparib specifically for patients with prostate cancer worldwide, except in Japan.

Important Safety Information for ZEJULA

Myelodysplastic Syndrome/Acute Myeloid Leukaemia (MDS/AML), including some fatal cases, was reported in 1.4% of patients receiving ZEJULA vs 1.1% of patients receiving placebo in Trial 1 (NOVA), and 0.9% of patients treated with ZEJULA in all clinical studies. The duration of ZEJULA treatment in patients prior to developing MDS/AML varied from <1 month to 2 years. All patients had received prior chemotherapy with platinum and some had also received other DNA damaging agents and radiotherapy. Discontinue ZEJULA if MDS/AML is confirmed.

Hematologic adverse reactions (thrombocytopenia, anaemia and neutropenia) have been reported in patients receiving ZEJULA. Grade ≥3 thrombocytopenia, anaemia and neutropenia were reported in 29%, 25%, and 20% of patients receiving ZEJULA, respectively. Discontinuation due to thrombocytopenia, anaemia, and neutropenia occurred, in 3%, 1%, and 2% of patients, respectively. Do not start ZEJULA until patients have recovered from haematological toxicity caused by prior chemotherapy (≤ Grade 1). Monitor complete blood counts weekly for the first month, monthly for the next 11 months of treatment, and periodically thereafter. If haematological toxicities do not resolve within 28 days following interruption, discontinue ZEJULA, and refer the patient to a haematologist for further investigations.

Hypertension and hypertensive crisis have been reported in patients receiving ZEJULA. Grade 3-4 hypertension occurred in 9% of patients receiving ZEJULA vs 2% of patients receiving placebo in Trial 1, with discontinuation occurring in <1% of patients. Monitor blood pressure and heart rate monthly for the first year and periodically thereafter during treatment with ZEJULA. Closely monitor patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension. Manage hypertension with antihypertensive medications and adjustment of the ZEJULA dose, if necessary.

Based on its mechanism of action, ZEJULA can cause foetal harm. Advise females of reproductive potential of the potential risk to a foetus and to use effective contraception during treatment and for 6 months after receiving their final dose. Because of the potential for serious adverse reactions from ZEJULA in breastfed infants, advise lactating women to not breastfeed during treatment with ZEJULA and for 1 month after receiving the final dose.

In clinical studies, the most common adverse reactions (Grades 1-4) in ≥10% of patients included: thrombocytopenia (61%), anaemia (50%), neutropenia (30%), leukopenia (17%), palpitations (10%), nausea (74%), constipation (40%), vomiting (34%), abdominal pain/distention (33%), mucositis/stomatitis (20%), diarrhoea (20%), dyspepsia (18%), dry mouth (10%), fatigue/asthenia (57%), decreased appetite (25%), urinary tract infection (13%), aspartate aminotransferase (AST)/alanine aminotransferase (ALT) elevation (10%), myalgia (19%), back pain (18%), arthralgia (13%), headache (26%), dizziness (18%), dysgeusia (10%), insomnia (27%), anxiety (11%), nasopharyngitis (23%), dyspnoea (20%), cough (16%), rash (21%) and hypertension (20%).

Common lab abnormalities (Grades 1-4) in ≥25% of patients included: decrease in haemoglobin (85%), decrease in platelet count (72%), decrease in white blood cell count (66%), decrease in absolute neutrophil count (53%), increase in AST (36%) and increase in ALT (28%).

On July 15, 2019 Vaccitech, a clinical-stage T cell immunotherapy company developing viral vectors as vaccines to treat and prevent Cancer and Infectious Diseases, reported that it has appointed Mariem Charafeddine as Chief Medical Officer (Press release, Vaccitech, JUL 15, 2019, View Source [SID1234537519]).

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Mariem brings over 15 years’ experience in the Biopharmaceutical Industry, spent both advancing the clinical development and commercialisation of Infectious Disease products, and in delivering post-marketing monitoring of licensed medical products. Mariem has previously worked in international medical leadership roles and drug development in Infectious Diseases.

She joins Vaccitech after 6 years at Abbvie, where she most recently served as Medical Director for Pharmacovigilance and Patient Safety Sciences, Infectious Diseases and Neurosciences. Mariem’s prior roles include Global Clinical Development at AbbVie and Hoffmann-La Roche/Genentech, as well as Medical Manager at Hoffmann-La-Roche in France. She is a qualified physician, with clinical practice and research experience focused in Infectious Diseases and Hepatology. Mariem also holds a Master’s degree in Marketing Management, gained from ESCP Europe.

Mariem will oversee the development of Vaccitech’s growing clinical-stage pipeline and will help implement the global clinical development strategy and medical plans across Vaccitech’s therapeutic and prophylactic vaccine products.

"We are delighted to have Mariem join our team as we advance towards the Phase 2b read-outs of our lead clinical program in influenza," said Tom Evans, Vaccitech CEO. "Her wide-ranging clinical development and post-marketing expertise in infectious diseases also puts us in great stead ahead of first in human studies for our HPV and HBV therapeutics. We look forward to her input on how best to develop our vaccines for the patients that need them."

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.