Phase 3 trials for AstraZeneca’s (NYSE:AZN) (with University of Oxford) coronavirus vaccine have resumed in the U.K. after they were halted earlier this week over safety concerns.
On September 6, the standard review process “triggered a voluntary pause to vaccination” across all global trials to allow review of safety data by independent committees, and international regulators.
AstraZeneca said it received confirmation from the U.K.’s Medicines Health Regulatory Authority that it was safe to resume clinical trials.
“The Company will continue to work with health authorities across the world and be guided as to when other clinical trials can resume to provide the vaccine broadly, equitably and at no profit during this pandemic,” AZN said in a statement.
The University said that some 18,000 people have so far received the vaccination in trials. In large trials “it is expected that some participants will become unwell and every case must be carefully evaluated to ensure careful assessment of safety,” it added.
The Oxford-AstraZeneca study had been previously stopped in July after a participant developed neurological symptoms, but the illness was found to be unrelated to the experimental vaccine.
Two other vaccines are in huge, final-stage tests in the U.S., one by Moderna (NASDAQ:MRNA) and the other by Pfizer (NYSE:PFE) and BioNTech (NASDAQ:BNTX).
Seattle Genetics (NASDAQ:SGEN), +9% premarket and Merck (NYSE:MRK) announce two new strategic oncology collaborations.
The companies will globally develop and commercialize Seattle Genetics’ ladiratuzumab vedotin, an investigational antibody-drug conjugate (ADC) targeting LIV-1 for breast cancer and other solid tumors.
The collaboration will pursue a broad joint development program evaluating ladiratuzumab vedotin as monotherapy and in combination with Merck’s anti-PD-1 therapy Keytruda (pembrolizumab) in triple-negative breast cancer, hormone receptor-positive breast cancer and other LIV-1-expressing solid tumors.
Under the terms of the agreement, Seattle Genetics will receive a $600M upfront payment and Merck will make a $1B equity investment in 5M shares of Seattle’s common stock at a price of $200/share.
In addition, Seattle Genetics is eligible for progress-dependent milestone payments of up to $2.6B. Including the upfront payment, equity investment and milestone payments, SGEN is eligible to receive up to $4.2B.
The companies will jointly develop and commercialize ladiratuzumab vedotin and equally share profits worldwide.
Separately, Seattle Genetics has granted Merck an exclusive license to commercialize TUKYSA (tucatinib), a small molecule tyrosine kinase inhibitor, for the treatment of HER2-positive cancers, in Asia, the Middle East and Latin America and other regions outside of the U.S., Canada and Europe. SGEN retains commercial rights and will record sales in the U.S., Canada and Europe.
The Company will receive $125M million from Merck as an upfront payment, up to $65 of milestone payments, $85M in prepaid R&D payments and tiered royalties on sales of TUKYSA in Merck’s territory.
Merck will also co-fund a portion of the TUKYSA global development plan, which encompasses several trials across HER2-positive cancers, including breast, colorectal, gastric and other cancers.
Seattle Genetics will host a conference call to discuss these collaborations today at 9:00 a.m. ET.
Reuters reports that the FDA has not given the green light to resume the U.S. portion of AstraZeneca’s (NYSE:AZN) pivotal study of COVID-19 vaccine candidate AZD1222.
The trial was suspended after a UK participant fell ill after inoculation. Enrollment has restarted there but will remain on hold in the U.S. while the FDA and a safety panel investigate the event. Enrollment of new participants and other procedures have been rescheduled until at least Wednesday although it is unclear how long the FDA inquiry will take.
The trial in Brazil has restarted as well. The status of studies in South Africa and India is unknown.
Shares remain higher, but well off the intraday high.
Vaxart (NASDAQ:VXRT) jumps 16% premarket after the FDA completed review of its Investigational New Drug (IND) application for Phase 1 clinical trial evaluating the Company’s oral COVID-19 vaccine candidate. VXRT also provided an update on its COVID-19 program.
“The IND clearance and the initiation of our Phase 1 clinical trial moves us a step closer to proving the superiority of our convenient oral COVID-19 solution in the clinic. We are thus excited to start enrollment for our Phase 1 this month,” said Andrei Floroiu, CEO.
The Phase 1, dose-ranging study will be conducted in healthy adults ages 18 to 55 years old. The study’s primary objective is to examine the safety and reactogenicity of two-doses of the vaccine.
Secondary objectives include immunogenicity, duration of immune response and occurrence of symptomatic COVID-19.
Vaxart is conducting a SARS-CoV-2 challenge study in hamsters to provide efficacy data and insights into the optimal dose regimen. Results from this study are expected mid-October.
In addition, Vaxart is awaiting results from a non-human primate (NHP) challenge study that is testing its vaccine in a harmonized protocol as part of Operation Warp Speed.
See VXRT total return performance vs. peers over the past six months.
Cassava Sciences (NASDAQ:SAVA) announces final results from a 64-subject Phase 2b clinical trial evaluating lead candidate sumifilam (PTI-125) in Alzheimer’s disease (AD) patients.
Treatment with sumifilam produced statistically significant improvements in a range of AD-related biomarkers compared to placebo, the primary endpoint. The response rate, defined as patients who showed biomarker improvements, was 98%.
Sumifilam was safe and well-tolerated.
The positive outcome is a reversal of fortune for the study. In May, the company reported that the trial failed to achieve the primary endpoint due to high variability in biomarker data in the control group. It says the analysis, conducted by outside labs, is no longer valid.
Small molecule PTI-125 targets an altered form of filamin A, a scaffolding protein found throughout the body. A highly toxic form of the protein is present in the brains of AD sufferers which disrupts the normal function of neurons, leading to neurodegeneration and brain inflammation. PTI-125 is designed to restore the normal shape of filamin A in the brain, improving the function of multiple brain receptors and dampening neuroinflammation.
Development is ongoing.
Management will host a conference call this morning at 8:30 am ET to discuss the results.
Shares up 100% premarket on robust volume.
Quant rating is Bullish.