In other ongoing research looking at cancer vaccines, the Cancer Research Institute, in partnership with the Parker Institute for Cancer Immunotherapy, is studying a combination of a vaccine with the adjuvants Flt3 ligand and poly-ICLC plus the checkpoint inhibitor nivolumab (Opdivo) and standard-of-care radiation in castrate-resistant prostate cancer. Results are expected in the next six to 12 months, said Jill O’Donnell-Tormey, chief executive officer and director of scientific affairs at the Cancer Research Institute.
COMPANY SUMMARY On June 22, 2020, Emerald Organic Products Inc. (OTCPK: EMOR), a Nevada Corporation, changed its name to Healixa Inc., to reflect the company’s...
We may find out whether this is going to be a problem sooner than you’d think. Moderna NASDAQ: MRNA is working with the National Institute of Allergy and Infectious Diseases — which helped it design its original Covid vaccine — to test an updated version of its vaccine that targets the variant first spotted in South Africa, B.1.351. That variant appears to be able to evade immune responses triggered by earlier versions of the virus.
Look at Healixa, Inc. (OTC Pink: EMOR)
Regarding VX-864, its experimental treatment for the rare, inherited lung disease called alpha-1 antitrypsin deficiency, Vertex said a readout of a Phase 2 study is expected in the first half of the year. Last October, Vertex was forced to shelve its first drug for alpha-1 antitrypsin deficiency due to liver toxicity. Independent study monitors are taking regular looks at the safety data from the ongoing VX-864 study, and to date, patient enrollment continues, Vertex said Monday.
No legitimate reason exists for Cel-Sci to be taking this long, even accounting for Covid. The simple truth is Cel-Sci is trying to bury Multikine’s negative results, as it did previously when independent monitors tried to shut the study down twice, or when the FDA halted the study citing an “unreasonable and significant risk of illness or injury to human subjects.”
Although the company did a poor job answering questions last week — Why suddenly study a lower dose of sotorasib if the higher dose is fine? Did the FDA discover something bad in sotorasib’s safety profile during its review? — it insisted there was nothing wrong with the 960 mg dose of sotorasib. Amgen also said it was the FDA that proposed looking at the efficacy and safety of a lower dose as a “post-marketing requirement” — meaning, presumably, after the higher dose was already approved.
This program ensures the treatment centers and HCPs administering Kymriah are prepared to manage CRS and neurological toxicities. In follow up analyses of the JULIET clinical study, the Kymriah safety profile has remained consistent.1,3,4 The most common adverse reactions (incidence >20%) were CRS, infections-pathogen unspecified, diarrhea, nausea, pyrexia, fatigue, hypotension, edema, and headache.
iTeos presented the EOS-448 Phase 1 study results at the annual meeting of the American Association for Cancer Research on Saturday. The TIGIT class of immunotherapy drugs is drawing a lot of attention from academia, industry, and investors because of its potential to greatly expand the pool of patients who might benefit from so-called checkpoint inhibitors.
In 2016, Moderna received $8 million with the potential for up to $125 million from the Biomedical Advanced Research and Development Authority, a component of the U.S. Department of Health and Human Services, to accelerate development of an mRNA vaccine for Zika. (The company is still working on that project.)What makes the bankrolling of Moderna’s Covid-19 vaccine so extraordinary, Foroohar said, was the scale, which “reflects how unusual the pandemic is and the fact that this is very literally a once-in-a-lifetime event.”