The use of artificial intelligence and machine learning in drug development has been ramping up and investors are taking keen notice of the growing trend (Press release, BioSpace, APR 19, 2018, View Source [SID1234525546]). This morning London-based BenevolentAI snagged $115 million to give it a total of about $200 million in its coffers.

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BenevolentAI, which is applying artificial intelligence to develop new medicines for hard to treat diseases, said it will use the funds from the financing round to advance its artificial intelligence driven drug development programs. The company also said it will use the financing to broaden the disease areas on which it focuses, and extend its AI platform capabilities even further. Some of the proceeds from the financing round will be used to explore other science-based industries, including agriculture and energy storage, the company said.

Following the latest financing, BenevolentAI said it has a pre-money valuation of $2 billion.

BenevolentAI has 20 drug programs in its pipeline. Currently, BenevolentAI is using its platform to develop treatments for a wide range of unmet patient needs in various areas including Motor Neuron Disease, Parkinson’s disease, Glioblastoma and Sarcopenia.

The latest funding round, which was primarily supported by investors from the United States, is one of the largest in the AI pharmaceutical sector, the company said this morning. The $115 million the company gathered dwarfs the $15 million secured by the China-based AI startup XtalPi Inc. earlier this year.

Kevin Mulaney, founder and chairman of BenevolentAI, said the financial support the company received in its latest fundraising effort reflects the "rapidly growing global interest in the AI pharmaceutical sector" and the company’s position in that field.

"We have come a very long way since we founded the business in 2013. The capabilities of our technology didn’t exist six years ago. We are pioneering this sector and have evolved into a fully integrated, AI enabled drug development company with the ability to deliver better medicines at previously unimaginable speeds – this ultimately means patients will receive the right medicines, at a lower cost, in less time," Mulaney said in a statement.

The U.K. company said its drug-development portfolio shows that its AI platform can cut early-stage drug discovery by four years. Additionally, BenevolentAI said it can potentially deliver efficiencies in the entire drug development process of 60 percent against pharmaceutical industry averages – "significantly disrupting an industry that spends $180 billion a year on R&D."

The company boldly said its artificial intelligence program can "outperform human scientists" in understanding the cause of a disease and is also capable of "quickly generating drug candidates at scale."

"The technology is also able to decipher the molecular process of disease and link these disease signatures within patients to ensure that the best drug candidate is given to the best patient responders – the ‘right drugs in the right patients’," the company said on its website.

The use of artificial intelligence in drug development is becoming more and more common. In July 2017 pharma giant GlaxoSmithKline forged a $43 million deal with AI company Exscientia to spur drug development. GSK said it will be using AI to discover novel and selective small molecules for up to 10 disease-related targets across multiple therapeutic areas. Also in July 2017 the Mayo Clinic and nference launched a startup company called Qrativ that is focused on drug development that will be powered by clinical expertise and artificial intelligence. Innovator Elon Musk launched the biotech company Neuralink that has the lofty goal of linking the human brain with a computer.

On April 19, 2018 The U.S. Food and Drug Administration (FDA) approved AstraZeneca’s Tagrisso (osimertinib) for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) in tumors with epidermal growth factor receptor (EGFR) mutations (Press release, BioSpace, APR 19, 2018, View Source [SID1234525545]).

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The mutations, exon 19 deletions or exon 21 L858R mutations, will be detected by an FDA-approved test. The decision was based on data form the Phase III FLAURA clinical trial. Results were presented at the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) 2017 Congress and published in the New England Journal of Medicine.

The FLAURA trial compared Tagrisso to current first-line EGFR tyrosine kinase inhibitors, erlotinib or gefitinib, in patients who had not received previous treatment for locally-advanced or metastatic EGFR-mutation NSCLC. It met the primary endpoint of progression-free survival, and were consistent across all pre-specified patient subgroups.

Patients receiving Tagrisso had about 18.9 months on average before the disease got worse compared to 10.2 months for patients receiving traditional treatments.

Tagrisso is a third-generation, irreversible EGFR-TKI designed to inhibit both EGFR-sensitizing and EGFR T790M-resistance mutations, with clinical activity against central nervous system cancers. It has been approved in the U.S. and Brazil for first-line EGFRm advanced NSCLC, and in more than 75 countries, including the U.S., Europe, Japan and China, for patients with EGFR T790M mutation-positive advanced NSCLC. It is also being evaluated as an adjuvant and in combination with other treatments.

It has also been approved in the U.S. for second-line treatment of patients with metastatic EGFRm NSCLC, whose disease has on or after a first-line EGFR-TKI round of therapy and who have developed the secondary T790 mutation. The drug received both Breakthrough Therapy and Priority Review designations from the FDA in 2017 for the first-line setting.

"Today’s FDA approval of Tagrisso in the first-line setting is an exciting milestone for patients and our company," said Dave Fredrickson, executive vice president, Head of the Oncology Business Unit at AstraZeneca, in a statement. "Tagrisso delivered unprecedented median progression-free survival data across all pre-specified patient subgroups, including patients with or without CNS metastases, and could prolong the lives of more patients without their tumors growing or spreading."

The drug is being evaluated in Europe and Japan as a first-line treatment, with regulatory decisions expected in the second half of this year. AstraZeneca has projected that Tagrisso could, at its peak, bring in $4 billion per year.

Lung cancer accounts for about one-fifth of all cancer deaths, more than breast, prostate and colorectal cancers combined. It is the leading cause of cancer death for both men and women. About 10 to 15 percent of patients in the U.S. and Europe and about 30 to 40 percent in Asia, have EGFRm NSCLC. They are especially sensitive to EGFR-TKI treatments, but those cancers typically develop resistance to that treatment, leading to disease progression.

"The approval of osimertinib in the first-line setting represents a major advance in the treatment of patients with EGFR mutations and a significant change in the treatment paradigm," stated Suresh Ramalingam, principal investigator of the FLRUA trial, a researcher with the Winship Cancer Institute of Emory University in Atlanta. "Osimertinib provides robust improvements in progression-free survival with no unexpected safety signals compared to the previous generation of EGFR inhibitors."

On April 19, 2018 Bio-Path Holdings, Inc., (NASDAQ: BPTH), a biotechnology company leveraging its proprietary DNAbilize antisense RNAi nanoparticle technology to develop a portfolio of targeted nucleic acid cancer drugs, reported that data from pre-clinical studies supporting the potential of prexigebersen (BP1001, liposomal Grb2 antisense), in the treatment of solid tumors in gynecologic malignancies were presented in a poster at the annual meeting of the American Association for Cancer Research (AACR) (Free AACR Whitepaper), which took place in Chicago, IL (Press release, Bio-Path Holdings, APR 19, 2018, View Source [SID1234525544]).

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The poster titled, "Grabbing GRB2: The use of Liposome-incorporated Grb2 antisense oligonucleotides as a novel therapy in gynecologic malignancies," was presented by Olivia D. Lara, M.D., University of Texas MD Anderson Cancer Center, Department of Gynecologic Oncology during the Experimental and Molecular Therapeutics Poster Session. The data summarize results from studies investigating the expression of GRB2 in a series of in vitro experiments in high-grade serous (HGSC) and uterine (UC) carcinoma models. The study also examined the biological effects of prexigebersen in HGSC mice models (OVCAR 5), first in a dose-defining experiment then in combination with standard dose paclitaxel.

The data showed there was an eighty-six percent (86%) decrease in tumor burden (p<0.05), and multinodular burden (p<0.01) in the combination prexigebersen/paclitaxel group compared to control. In addition, there was no apparent toxicity with mice on combination therapy losing less weight than the paclitaxel-only group (P = 0.005).

"We are delighted to present these very encouraging findings at this year’s AACR (Free AACR Whitepaper) before an audience of the world’s leading cancer researchers and clinicians," stated Peter H. Nielsen, chief executive officer of Bio-Path Holdings. "Our research continues to suggest that prexigebersen-based combination therapy may offer an attractive method for targeting solid tumors and these findings establish the GRB2/GAB2 complex as an important target for prexigebersen. We look forward to advancing this promising therapy in gynecologic and other solid tumor cancers and plan to initiate first-in-human studies as early as the end of this year."

On April 19, 2018 Argos Therapeutics, Inc. (Nasdaq:ARGS), an immuno-oncology company focused on the development and commercialization of individualized immunotherapies based on the Arcelis precision immunotherapy technology platform, reported interim results from its randomized, active controlled, open-label, multi-center Phase 3 ADAPT trial of Rocapuldencel-T in combination with sunitinib/standard-of-care for the treatment of newly diagnosed metastatic renal cell carcinoma. Based on these results, the Company has decided to discontinue the trial (Press release, Argos Therapeutics, APR 19, 2018, View Source [SID1234525543]).

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As previously reported, a total of 462 patients with previously untreated advanced or metastatic renal cell carcinoma were enrolled in the ADAPT trial and randomized 2:1 between combination treatment with Rocapuldencel-T and sunitinib (combination arm) vs. sunitinib monotherapy (control arm) after undergoing cytoreductive nephrectomy. The Company recently submitted a protocol amendment to the U.S. Food and Drug Administration providing for four co-primary endpoints focused on various measures of survival. Based upon review of the interim data, the Company does not believe that it would achieve these endpoints if the trial were to be continued. After consulting with the principal investigators of the trial, the Company has therefore decided to discontinue the trial and has informed the FDA of its decision.

The most recent interim analysis was conducted after 51 new events (deaths) had occurred since the time of the February 2017 interim analysis. Median overall survival for the intent-to-treat patient population, one of the four co-primary endpoints, was estimated using the Kaplan-Meier method. The estimated median overall survival for the combination arm was 28.2 months (95% Confidence Interval (CI): 23.4, 35.2) compared to 31.2 months (95% CI: 23.0, 44.5) for the control arm. The hazard ratio was 1.10 (95% CI: 0.85, 1.42). The two other co-primary endpoints that were evaluated at this time, including overall survival for the patients who remained alive at the time of the February 2017 interim analysis and overall survival for all patients for whom at least 12 months of follow-up was available, also did not demonstrate a favorable result. A fourth endpoint, five-year survival, was not evaluated because there was insufficient data at this time to perform this analysis.

Based on a review of the status of its internal programs, resources and capabilities, Argos plans to explore a wide range of strategic alternatives that may include a potential merger or sale of the Company, among other potential alternatives that could maximize both near and long-term value for our shareholders. The Company has retained Stifel, Nicolaus & Company, Incorporated to serve as its financial advisor in the process.

Argos does not have a defined timeline for the exploration of strategic alternatives and is not confirming that the process will result in any strategic alternative being announced or consummated. Argos does not intend to discuss or disclose further developments during this process unless and until its Board of Directors has approved a specific action or otherwise determined that further disclosure is appropriate.

Argos also today reported that it does not expect to regain compliance with The Nasdaq Capital Market continued listing requirements by the April 24, 2018 deadline. As a result, Argos expects that its common stock will be delisted from The Nasdaq Capital Market and that trading in the Company’s common stock on The Nasdaq Capital Market will be suspended effective at the open of business on April 23, 2018. The Company has filed an application to transfer trading and quotation of its common stock to the OTCQB Venture Market, operated by OTC Markets Group Inc., under its current trading symbol "ARGS," effective as of April 23, 2018. Quotation and trading information for the common stock will be available on www.otcmarkets.com.

On April 19, 2018 Amgen (NASDAQ:AMGN) reported that it will report its first quarter 2018 financial results on Tuesday, April 24, 2018, after the close of the U.S. financial markets (Press release, Amgen, APR 19, 2018, View Source;p=RssLanding&cat=news&id=2343565 [SID1234525542]). The announcement will be followed by a conference call with the investment community at 2 p.m. PT. Participating in the call from Amgen will be Robert A. Bradway, chairman and chief executive officer, and other members of Amgen’s senior management team.

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Live audio of the conference call will be simultaneously broadcast over the internet and will be available to members of the news media, investors and the general public.

The webcast, as with other selected presentations regarding developments in Amgen’s business given by management at certain investor and medical conferences, can be found on Amgen’s website, www.amgen.com, under Investors. Information regarding presentation times, webcast availability and webcast links are noted on Amgen’s Investor Relations Events Calendar. The webcast will be archived and available for replay for at least 90 days after the event. (Press release, Amgen, APR 19, 2018, View Source;p=RssLanding&cat=news&id=2343565 [SID1234525542])