Check Up: Biden-Xi meeting could finally end opioids crisis in the US; and recent ASX biotech winners
Health & Biotech
Health & Biotech
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China’s President Xi has landed in San Francisco last night for his first visit to the US since 2017.
Of the many pressing issues to be discussed, Biden and Xi are expected to announce an agreement that would see Beijing crack down on fentanyl.
According to a report from Bloomberg, China would go after chemical companies to stem the flow of both fentanyl and the source material used to make the deadly synthetic opioid.
In return, Biden would lift restrictions on China’s forensic police institute, an entity the US alleges is responsible for human-rights abuses.
The rise of fentanyl, an anaesthetic turned street drug, has brought on an opioid crisis in the US, with the country declaring it an epidemic in 2017.
Overdose deaths remain a leading cause of death in the US, and the majority of those involve opioids.
As per the stats, more than 150 people in the US die each day from overdoses related to synthetic opioids like fentanyl.
Fentanyl is up to 100 times as powerful as morphine in its prescription form, and 50 times as powerful as heroin.
Just 2 milligrams, equal to a few grains of salt, can cause a fatal overdose.
According to the US Drug Enforcement Administration (DEA), Mexico and China are the primary sources for fentanyl and fentanyl-related substances trafficked directly into the US.
Although Mexican cartels are largely responsible for the export of fentanyl, those cartels often use Chinese components to make the drug.
The DEA said China was the source of pretty much all inbound shipments of high-purity fentanyl into the US over the last few years.
US national security adviser, Jake Sullivan, said: “I won’t get too far ahead of the meeting, and I’ll let the President speak for himself after he has the chance to meet with President Xi.
“But we believe that there are areas where our interests overlap, like our efforts to combat the illicit fentanyl trade.”
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There’s been a bit of news flow coming out of Imugene in the last couple of weeks.
First, the company reported that its Phase 1 MAST (Metastatic Advanced Solid Tumours) trial evaluating novel cancer-killing virus CF33-hNIS (VAXINIA) showed that all treatments to date have been determined safe and tolerable.
As of 31 October, 34 patients have been dosed with VAXINIA during the continuing dose escalation phase.
Imugene also announced dosing of the first patient in a Phase 1b clinical trial using azer-cel (allogeneic off-the-shelf CD19 CAR T, a type of cell therapy), manufactured and supplied from its state-of-the-art facility in North Carolina.
Following completion of the Phase 1b study, Imugene says there is potential to start this therapy as a registrational study in 2024. and become the first approved allogeneic CAR T cell therapy for cancer.
NOX just continues to surge after announcing in early October that the US FDA has has granted Orphan Drug Designation (ODD) status to Noxopharm’s CRO-67 preclinical drug candidate, for the treatment of pancreatic cancer.
“So what’s unique about our CRO-67 is that it has what we call dual cell activity,” CEO of Noxopharm, Gisela Mautner, told Stockhead.
“It kills the cancer cells of course, that’s number one, but it also breaks the barrier cells [around the tumour] by softening them up and depriving the tumour of its nurturing.”
Separately, recent animal study has shown that Noxopharm’s SOF-VAC mRNA vaccine enhancer significantly reduces mRNA-driven inflammation by as high as 50%.
The ability of SOF-VAC to reduce these inflammatory side effects has several potential benefits, such as enabling mRNA vaccines to be given with higher doses – creating longer-lasting protection and a decrease in the frequency of booster shots require.
4DX has been one of the best performing biotechs this week after announcing that its XV LVAS scanning device has been included into the US Centers for Medicare & Medicaid Services (CMS).
Medicare is an important public health insurance scheme for US adults aged 65 years and over; and as of 1 March, there were 65.7 million people enrolled in the program.
The inclusion today means that from 1 January 2024, XV LVAS scans conducted in a US hospital outpatient facility for Medicare patients can be billed to CMS.
CMS has accepted the reimbursement request and finalised assignment of the Category III CPT code for XV LVAS to the rate of US$299 per scan.
4DX’s XV LVAS uses X-rays to create detailed images of lung movement and function during breathing. It gives clinicians a clearer picture of lung health for pulmonary disorders including asthma, COPD, cystic fibrosis, and even cancer.
IDT has been rising after saying it is well placed to benefit from the rapid growth in the medicinal cannabis and psychedelic markets, given that IDT is one of the select few facilities that comply with the recently introduced GMP regulations.
During the last quarter, IDT’s potential sales pipeline also continued to grow, with the company generating 75 potential sales leads and signing confidentiality agreements with 15 potential clients.
In the quarter, the company also submitted proposals worth an additional $11.3 million, and secured sales contracts worth $1.2 million.
The market darling has been surging after reporting that its Rett Syndrome drug, DAYBUE, generated net sales in Q3 of US$66.9 million, up from US$23.2 million in Q2.
The company also guided the market for net sales of DAYBUE in Q4 of between US$80 million and US$87.5 million.
Neuren reported that 800 patients used DAYBUE as at 30 September, and this surge in initial demand has exceeded pre-launch expectations.
Around 81% of patients remain on DAYBUE treatment at four months, while 80% of lives are now covered by formal reimbursement plans.
The company also reported separately that all study visits are complete in its Phase 2 clinical trial of NNZ-2591 in Phelan-McDermid syndrome (PMS).
Top-line results from the trial are expected to be available in December.