Target $27
Monday, July 15, 2019
Neon Therapeutics’ Vaccine Study Demonstrates Prolonged Cancer Survival
NEO-PV-01, in combination with OPDIVO® (nivolumab), broadens the immune response to specific new cancer targets, leading to the first demonstration of improved clinical durability for a personal neoantigen-based therapy in the metastatic cancer setting
Demonstrated prolonged and consistent improvements in progression-free survival (PFS) that compare favorably to historical monotherapy checkpoint inhibitor data in each of the three distinct tumor types in trial of NEO-PV-01
Median PFS not yet reached at 13.4-month median follow-up in metastatic melanoma; median PFS of 5.6 months in metastatic non-small cell lung cancer; and median PFS of 5.6 months in metastatic bladder cancer
Data from multicenter Phase 1b trial support future randomized Phase 2 development of NEO-PV-01
Conference call today at 8:30 A.M. ET: The live webcast can be accessed on the investor page of Neon’s website at https://ir.neontherapeutics.com/. The conference call can be accessed by dialing (866) 353-0265 and using the conference ID 5596197. A replay of the webcast will be available on Neon’s website approximately two hours after the completion of the event and will be archived for up to 30 days.
NanoString Collaborates with Consortium to Accelerate Alzheimer’s Research
NanoString Technologies, Inc. (NASDAQ:NSTG), a provider of life science tools for translational research and molecular diagnostic products, today announced a collaboration with the MODEL-AD consortium that has resulted in the development of two nCounter® gene expression panels for use in Alzheimer’s disease (AD) research, and the presentation of data from several studies at the Alzheimer’s Association International Conference (AAIC) 2019 meeting. The development of the panels is described in detail, highlighting that data from AD patients was used to identify the key gene groupings to be assayed in animal models (Carter et al). In addition, the panel was used for initial characterization of novel mouse models of late-onset AD (Howell et al).
Historically, AD research and drug development have been hampered by the lack of mouse models that accurately recapitulate the disease. The MODEL-AD consortium was established in 2016 to facilitate preclinical research in Alzheimer’s disease, and is funded by a $25 million grant from the National Institutes of Health (NIH). The consortium, consisting of researchers at Indiana University (IU), The Jackson Laboratory (JAX), University of Pittsburgh, Sage Bionetworks, and the University of California Irvine, focuses on developing and characterizing AD animal models, aligning them with corresponding stages of clinical disease using translatable biomarkers, and ensuring their availability to all researchers for use in preclinical drug development, along with guidelines, protocols, and validation data.
“There is a need for novel mouse models of Alzheimer’s disease as our current models are insufficient to accurately mimic human disease,” said Bruce Lamb, Ph.D., Executive Director of the Paul and Carole Stark Neurosciences Research Institute at Indiana University. “A reproducible method to characterize novel mouse models could help establish clinical gold standards in the field.”
Motif Bio Submits Meeting Request and Package to the U.S. FDA for Iclaprim
Motif Bio plc (AIM/Nasdaq: MTFB), a clinical-stage biopharmaceutical company specialising in developing novel antibiotics, today announced that it has submitted a meeting request and package to the U.S. Food & Drug Administration (FDA) related to the Company’s lead product candidate, iclaprim. In the minutes from a May 3, 2019, Type A meeting, the FDA indicated that an additional clinical trial will be required prior to granting marketing approval of iclaprim. The Company has been encouraged by the FDA to put forth a proposal for such a study. Motif Bio has requested a Type B meeting with the Agency to discuss the proposed study population and design. The Company will provide guidance on when such a meeting will occur once FDA issues the meeting granted letter. The FDA typically schedules a Type B meeting within 60 days of request, although it can take longer.
Evotec Expands Stem Cell Platform via Acquisition
- ACQUIRED ASSETS FROM NCARDIA AG INCLUDE IP PORTFOLIO, IPSC-BASED CELLULAR PRODUCTS AND AN EXPERIENCED STEM CELL BIOLOGY TEAM
- EXPANSION OF IPSC DISCOVERY PLATFORM STRENGTHENS EVOTEC’S POSITION AS A LEADER IN INNOVATION-DRIVEN TRANSLATIONAL BIOLOGY
Evotec SE (Frankfurt Stock Exchange: EVT, MDAX/TecDAX, ISIN: DE0005664809) today announced that the Company has acquired assets from the stem cell specialist Ncardia AG to advance Evotec’s iPSC platform, one of the leading iPSC-based discovery platforms in the industry. The acquired assets include intellectual property relevant for iPSC-based phenotypic drug discovery, an existing cellular product business around iPSC-derived cells, as well as 17 strong team of stem cell biology experts operating from laboratories at the BioCampus Cologne.
The team has a proven track record of generating multiple disease-relevant cell types from iPSCs and their application in drug discovery. The combination with Evotec’s existing expertise in iPSC biology and the Company’s leading drug discovery platforms will create new opportunities for innovative biology and adds capacity for new and existing partnerships.
Dr Cord Dohrmann, Chief Scientific Officer of Evotec, commented: “IPSC is a game changing technology with broad applicability across a variety of different indications and drug discovery and development phases. Additional expertise and capacity in the iPSC space as well as a substantial partner network will allow us to further accelerate our efforts to build a world-leading iPSC translational biology platform across different disease areas. We warmly welcome our new team within the Evotec Family.”
No financial details of the transaction were disclosed.
About Evotec and iPSC
Induced pluripotent stem cells (also known as iPS cells or iPSCs) are a type of pluripotent stem cell that can be generated directly from adult cells. The iPSC technology was pioneered by Shinya Yamanaka’s lab in Kyoto, Japan, who showed in 2006 that the introduction of four specific genes encoding transcription factors could convert adult cells into pluripotent stem cells. He was awarded the 2012 Nobel Prize along with Sir John Gurdon “for the discovery that mature cells can be reprogrammed to become pluripotent”. Pluripotent stem cells hold great promise in the field of regenerative medicine. Because they can propagate indefinitely, as well as give rise to every other cell type in the body (such as neurons, heart, pancreatic and liver cells), they represent a single source of cells that could be used to replace those lost to damage or disease.
AstraZeneca cooperating on CRL decision for Farxiga in type-1 diabetes
AstraZeneca today announced that the US Food and Drug Administration (FDA) has issued a complete response letter regarding the supplemental New Drug Application for Farxiga (dapagliflozin) as an adjunct treatment to insulin to improve glycaemic control in adult patients with type-1 diabetes (T1D), when insulin alone does not provide adequate glycaemic control.
AstraZeneca will work closely with the FDA to discuss the next steps.
Farxiga was recently approved in Europe (5mg) and Japan (5mg, potential up-titration to 10mg) under the name Forxiga, as an adjunct to insulin in adults with T1D.
Reassuring Chinese data nudges shares higher
Surprisingly upbeat economic soundings from China lifted the global markets mood on Monday, pushing world shares towards an 18-month high and steering the Aussie dollar and copper upwards.
Investors were waiting for a torrent of second-quarter corporate earnings this week and a G7 finance chiefs meeting in France, but there was plenty to be getting on with before that.
China’s second quarter annual GDP growth rate fell to a 27-year low of 6.2% as expected, but its quarterly growth reading of 1.6% was ahead of forecasts and June reports on industrial production, retail sales and urban investment were also well above expectations.
Shanghai and Hong Kong stock markets had ended marginally positive, only held back by the concern that such a brisk pickup in activity may see economic policymakers ease back on the monetary and fiscal stimulus measures that were deemed largely responsible for the acceleration.
A report by Reuters that Washington may approve licenses for companies to restart new sales to Huawei in as little as two weeks also improved the mood in China’s tech sector, while a steady start in Europe left MSCI’s world index eyeing Feb. 2018 highs. <.FTEU3> [.EU]
“It is no surprise that China is slowing down and if you look at the other components of the data like retail sales and industrial production, they are looking a little bit better than expected,” said CMC Markets analyst David Madden.
“Traders seem to be content to maintain a bit of optimism.”
With the S&P 500 closing in record territory again on Wall Street on Friday and above 3,000 for the first time, markets are confident the U.S. Federal Reserve will cut its key interest rate by at least a quarter point late this month.
In currency markets, the Australian dollar, often played as a liquid proxy for the Chinese yuan, sprang to its highest since July 4 against the dollar as it ticked higher against the yen and the Swiss franc. [/FRX]
At 12.39%, the Vix volatility gauge <.VIX> had its lowest close since April. Ten-year Treasury yields continued to nudge higher, with the yield curve between 3 months and 10 years – whose inversion for much of the past two months was widely seen as a harbinger of recession over the next couple of years – back probing positive territory for the first since mid-May.
Most euro zone government bond yields edged down from recent 3 1/2-week highs in early moves, although the reassuring signs from the global economy meant the moves were small in scale.
Germany’s benchmark 10-year bond yield was down just a basis point at minus 0.25% <DE10YT=RR>, edging off Friday’s 3 1/2-week high but still about 16 basis points above record lows reached earlier this month.
“The whole movement in bonds lost steam last week,” said Norbert Wuthe, a rates strategist at Bayerische Landesbank.
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Commodities markets struggled to make up their minds about how to interpret the Chinese data.
Brent crude was off 10 cents at $66.62. U.S. crude fell 21 cents to $60 a barrel, although that also came after both contracts had posted their biggest weekly gains in three weeks on diplomatic tensions in the Middle East and cuts in U.S. oil production. [O/R]
Gold slipped to 1,414.25 an ounce, drifting away from a recent six-year top of $1,438.60, but most industrial metals climbed on the data and nickel prices were boosted by additional supply worries from major producer Indonesia.
“This (China data) is a big relief. It seems that the government’s support has eventually had some positive impact on the economy, especially in the seasonally weak month of June,” said analyst Helen Lau of Argonaut Securities.
Later in the week, U.S. retail sales and industrial production data will provide clues about the health of the world’s largest economy. The U.S. Federal Reserve will release its ‘Beige Book’ on Wednesday, which investors will scour for comments on how trade tensions were affecting the business outlook.
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