Search This Blog

Monday, July 20, 2020

Exelixis launches Contact-03 combo trial in kidney cancer

Exelixis (NASDAQ:EXEL) has initiated CONTACT-03, a global phase 3 pivotal trial of cabozantinib (CABOMETYX) in combination with atezolizumab (TECENTRIQ) in patients with inoperable, locally advanced or metastatic renal cell carcinoma (RCC) who progressed during or following treatment with an immune checkpoint inhibitor as the immediate preceding therapy.
CONTACT-03 is part of a clinical trial collaboration between Exelixis and Roche (OTCQX:RHHBY) that includes two additional phase 3 pivotal trials in lung and prostate cancer.
The study aims to enroll ~500 patients. The co-primary endpoints of the trial are progression-free survival per Response Evaluation Criteria in Solid Tumors (RECIST) v. 1.1 as assessed by independent review and overall survival.
Secondary endpoints include progression-free survival, objective response rate and duration of response as assessed by the investigators.
On December 19, 2019, Exelixis collaborated with Roche for three Phase 3 combination trials for patients with advanced solid tumors.

Posted by at No comments:

Intellia Therapeutics partners with GEMoaB to develop immunotherapies

Intellia (NASDAQ:NTLA) announces a research collaboration with privately held GEMoaB, wherein the companies will combine GEMoaB’s proprietary RevCAR technology platform with Intellia’s proprietary genome editing technologies to discover and develop allogeneic cellular immunotherapies for cancers and inflammatory diseases.
Under the terms of the agreement, GEMoaB will receive payments for each product based on target reservation and selection, achievement of milestones as well as tiered royalties based on net sales.
Intellia will lead the collaboration, and be responsible for clinical development and commercialization.

Posted by at No comments:

Zai Lab’s NDA for ripretinib accepted in China

Zai Lab (NASDAQ:ZLAB) and Deciphera Pharmaceuticals (NASDAQ:DCPH) announce that the China National Medical Products Administration has accepted its NDA for ripretinib (brand name Qinlock) for the treatment of adult patients with advanced gastrointestinal stromal tumor (GIST) who have received prior treatment with 3 or more kinase inhibitors, including imatinib.
On June 11, 2019 Zai Lab in-licensed exclusive ripretinib rights from Deciphera.

Posted by at No comments:

Moderna, on ‘vaccine day,’ cut at JPMorgan

Moderna Inc. (NASDAQ:MRNA) was on the receiving end of a downgrade following its outsized gains this year, up 576% in the past 52-weeks and 385% in 2020 alone, this time by JPMorgan analysts who just last week said they were “encouraged” by the recent data  which ultimately raises the odds for a successful outcome.
At the time, they stressed that the data was “far from a done deal.” Today, the market is largely expecting to see data from the Oxford/AstraZeneca (NYSE:AZN) trial, which an executive from the Lancet teased  just yesterday in a twitter post, “Tomorrow. Vaccines. Just saying.”
The downgrade is “not a call” on the expectations for the drug, but due to valuation, even as the analysts remain bullish on MRNA’s long term outlook. But the co. is now “sporting” a $37 billion market cap following its Friday rally.
Shares are weaker pre-market, off about 4%.
Analysts led by Cory Kasimov write that there are a “significant” number of unknowns and find it difficult to “pull any additional levers” in their model to justify and fundamentally recommend the stock, despite the fact that momentum could drive the stock still higher, the analysts concluded.
Investors should note that Moderna has recently sold off at times when reports of increased insider sales emerge. 

Posted by at No comments:

CanSino COVID-19 vaccine shows immune response in human trial

A COVID-19 vaccine developed by CanSino Biologics Inc and China’s military research unit has shown to be safe and induced immune response in most of the recipients who got one shot, researchers said on Monday.
The CanSino candidate, named Ad5-nCOV, is one of a handful of vaccines that have shown some promise in human testing and gear up for late-stage trials, along with projects involving Moderna, BioNTech and Inovio Pharmaceuticals.

Posted by at No comments:

1st human trial of AstraZeneca COVID-19 vaccine shows promise

AstraZeneca’s experimental COVID-19 vaccine was safe and produced an immune response in early-stage clinical trials in healthy volunteers, data showed on Monday.
The vaccine, called AZD1222 and being developed by AstraZeneca and scientists at Britain’s University of Oxford, did not prompt any serious side effects and elicited antibody and T-cell immune responses, according to trial results published in The Lancet medical journal.
“We hope this means the immune system will remember the virus, so that our vaccine will protect people for an extended period,” study lead author Andrew Pollard of the University of Oxford said.
“However, we need more research before we can confirm the vaccine effectively protects against SARS-CoV-2 (COVID-19) infection, and for how long any protection lasts,” he said.
AstraZeneca’s is among the leading vaccine candidates against a pandemic that has claimed more than 600,000 lives, alongside others in mid and late-stage trials.
These include shots being developed by China’s Sinovac Biotech, another from state-owned Chinese firm Sinopharm, and one from the U.S. biotech firm Moderna.
AstraZeneca has signed agreements with governments around the world to supply the vaccine should it prove effective and gain regulatory approval. The company has said it will not seek to profit from the vaccine during the pandemic.
Researchers said the vaccine caused minor side effects more frequently than a control group, but some of these could be reduced by taking paracetamol, with no serious adverse events from the vaccine.

Posted by at No comments:

Valneva eyes EU COVID-19 vaccine deal after agreeing to supply UK

France’s Valneva is in talks with the European Union about supplying the bloc with its possible COVID-19 vaccine, Chief Executive Thomas Lingelbach said on Monday after striking a deal with Britain.

Britain said on Monday it had agreed in principle to buy 60 million doses of the Valneva vaccine, with an option to purchase 40 million more if it proved safe, effective and suitable.
“We are talking to the EU,” Lingelbach told Reuters after the British agreement was announced. He gave no further details.
Two sources told Reuters on Friday the EU was negotiating advance purchase deals of potential COVID-19 vaccines with drugmakers Moderna, Sanofi and Johnson & Johnson, as well as biotech firms BioNTech and CureVac.
On Monday, Britain, which left the EU this year and which has not joined the bloc’s vaccine scheme, also secured early access to BioNTech’s vaccine it is developing with Pfizer.
Valneva’s Lingelbach said Britain was at the head of the queue for doses of its vaccine if it worked. “My personal working hypothesis is that the first 60 million go into the UK,” he said, although he said details were still being negotiated.
Valneva is aiming for clinical trials of the vaccine to start in November or December this year, Lingelbach said. The vaccine uses an adjuvant, or booster, by Dynavax.
The timetable is slower than some others, but he said the company’s traditional, inactivated whole virus technique could prove more effective than newer messenger RNA (mRNA) approaches used by BioNTech and Pfizer.
“No one can predict how the mRNA approaches are going to deliver going forward,” he said. “It takes a bit longer to develop those vaccines on the more conventional side. But we believe that those vaccines have a nice prospect.”

Posted by at No comments:
Subscribe to: Posts (Atom)