The Japan Patent Office has issued a Decision to Grant a Patent to BrainStorm Cell Therapeutics (NASDAQ:BCLI) entitled “Method of Qualifying Cells” protecting NurOwn. The patent covers cell populations that are therapeutic for the treatment of ALS and the method of qualifying the cells for therapeutic use.
Wednesday, November 13, 2019
AC Immune EPS beats by CHF0.30, misses on revenue
AC Immune (NASDAQ:ACIU): Q3 Non-GAAP EPS of CHF0.26; GAAP EPS of CHF0.25 beats by CHF0.30.
Revenue of CHF33.41M (+1346.3% Y/Y) misses by CHF13.68M.
Phase 1/2 study underway for Bicycle’s BT5528
The first patient has been dosed in the Phase 1 dose-escalation portion of a Phase 1/2 clinical trial evaluating Bicycle Therapeutics’ (NASDAQ:BCYC) BT5528 in patients with EphA2-expressing solid tumors.
BT5528 is a second-generation Bicycle Toxin Conjugate (BTC) that uses a valine-citrulline cleavable linker and a cytotoxin MMAE payload. The company says it has a better safety profile than antibody-drug conjugates.
Marker Therapeutics down on leukemia study delay
Thinly traded micro cap Marker Therapeutics (NASDAQ:MRKR) is down 16% premarket on light volume in apparent reaction to its disclosure that its Phase 2 clinical trial, Marker AML, evaluating its MultiTAA T-cell therapy in post-allogeneic hematopoietic stem cell transplant AML patients has been placed on clinical hold by the FDA until it signs off on the IND.
The agency has requested additional information related to certain quality and technical specifications for two reagents supplied by third-party vendors that the company uses in its manufacturing process.
The company submitted a written response on October 28 and expects a response within 30 days. It plans to launch the study in 2020.
Aquestive up 4% premarket on Riluzole license deal
Thinly traded micro cap Aquestive Therapeutics (NASDAQ:AQST) perks up 4% premarket on light volume in reaction to its agreement with Italian drugmaker Zambon S.p.A. granting the latter development and commercialization rights to Riluzole Oral Film in the EU for the treatment of ALS.
Under the terms of the deal, Aquestive will receive an upfront payment, development and sales milestones and low double-digit royalties on net sales. Zambon will be responsible for regulatory filings and commercialization while Aquestive will be responsible for development and manufacturing.
Therapix Bio up 20% on encouraging THX-110 data in obstructive sleep apnea
Thinly traded nano cap Therapix Biosciences (TRPX +20.1%) is up on a 14x surge in volume in reaction to positive results from a single-arm open-label study evaluating lead candidate THX-110 in adults with obstructive sleep apnea (OSA).
10 patients were enrolled and nine completed the trial (one dropped out due to treatment-related dizziness). 56% (n=5/9) showed significant improvement in their condition as measured by a scale called AHI with an average value reduction of ~54%.
Two participants experienced mild side effects that resolved when THC (psychoactive component of cannabis) dosages were reduced to 5 mg/day.
THX-110, a combination of the dronabinol (synthetic THC) and palmitoylethanolamide, a cannabinoid mimetic, is also being developed to treat Tourette syndrome and pain.
Tuesday, November 12, 2019
Getting cancer drugs to brain is difficult: new ‘road map’ may make it easier
The human brain has some remarkable capabilities – including the ability to block cancer drugs from effectively reaching cancer cells in the brain.
The greatest obstacle when it comes to treating cancer that has spread to the brain is the blood-brain barrier, the brain’s natural defense mechanism that is a collection of blood vessels that can filter out what goes in and out of the brain.
Purdue University scientists have provided the first comprehensive characterization of both the blood-brain and blood-tumor barriers in brain metastases of lung cancer, which will serve as a road map for treatment development. The work was recently published in Oncotarget.
The research was led by Tiffany Lyle, assistant professor of veterinary anatomic pathology, whose work focuses on the pathology of the blood-brain barrier. As the principal investigator of the Comparative Blood-Brain Barrier Laboratory, she and her team have collaborated with scientists at Purdue and the Indiana University Simon Cancer Center.
“Brain metastases occur most frequently in patients diagnosed with breast and lung cancer and melanoma,” Lyle said. “These metastases have a devastating survival rate, mostly because it’s so difficult to get drugs into the brain tissue because of the blood-brain barrier.”
Brain metastases, or secondary brain tumors, occur when cancer cells spread from their original site to the brain. This happens in 10% to 30% of adults with cancer, according to the Mayo Clinic.
When cancer cells invade the brain, the blood-brain barrier transitions into the blood-tumor barrier, and this transition still presents a roadblock for effective drug delivery to the brain. The formation of the blood-tumor barrier has been insufficiently characterized in lung cancer until now, Lyle said.
“We wanted to see what changes in the blood-brain barrier were occurring rapidly and which ones were sustained over time,” Lyle said. “Identifying those changes and pinpointing when they occur during the transition will be critical to developing treatment plans and being able to identify where, and when, cancer cells need to be targeted.”
The blood-brain and blood-tumor barriers were analyzed in animal models with non-small-cell cancer cells and immunofluorescent imaging. Researchers also validated their findings by studying the blood-tumor barrier of brain metastases in human post-mortem tissue.
Scientists observed that one of the sustained changes during the transition from the blood-brain barrier to the blood-tumor barrier was in one of the largest cell types in the brain that has numerous functions. These cells are known as astrocytes. Lyle said that discovery alone will be key when it comes to future treatment development.
“Identifying when that change occurs during the transition is critical because it tells us when and where the brain vasculature prevents effective drug delivery,” Lyle said.
Lyle also heads the Comparative Blood-Brain Barrier Laboratory at Purdue and is already collaborating with Yoon Yeo, a professor in the Department of Industrial and Physical Pharmacy, to work on improving drug delivery. Being able to truly target cancer drugs to diseased tissue could improve quality of life in patients, Lyle said.
“A goal of our research is to meaningfully contribute to the evolving field of personalized medicine and provide patients who have received a devastating diagnosis a sense of hope for treatment possibilities,” Lyle said.
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The work was funded by the Showalter Foundation and the Indiana Clinical Translational Sciences Institute.
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