February 9, 2024
Barry Bunin, PhD
Founder & CEO
Collaborative Drug Discovery
“Biogen Abandons Its Controversial Alzheimer’s Drug Aduhelm.” That’s the headline in the New York Times coverage, which says “Biogen’s decision to abandon its ownership rights to Aduhelm closes out a yearslong saga that generated outrage and eroded trust in the regulatory process for bringing new medicines to market.” The article notes: “With an initial sticker price of $56,000 a year, Aduhelm was once projected to be taken by millions of Alzheimer’s patients, strain Medicare’s budget and bring in billions of dollars a year. But Aduhelm failed spectacularly in the marketplace.” Biogen reportedly brought in only $7.8 million during the first 18 months of the drug being on the market. The company said it wasn’t acting because of any concerns about the drug’s safety. The rights to Aduhelm revert to the Swiss company Neurimmune, which had licensed the drug to Biogen.
* * *
"Goodbye to Aduhelm." That’s how Derek Lowe headlined his recent blog in Science. “I was never happy about the FDA's decision to approve it, and that's putting it lightly,” Lowe writes. “That was one of the worst decisions the agency has made in my 30+ years in the drug industry, as far as I'm concerned. I wasn't alone in thinking that way, since some members of the advisory committee that recommended against that approval resigned in protest, and Medicare later declared that they would not pay for the drug unless it was for patients enrolled in another clinical trial. You know, to find out if it really had any efficacy (and especially relative to its safety profile). You know, that thing the FDA is supposed to do before approving a drug. C'mon, you remember.”
* * *
More Evidence for the Role of Prions. FIERCE Biotech carries an article about a case series just published in Nature Medicine by scientists at University College London suggesting new evidence about prions playing an initiating role in Alzheimer’s. The cases involve five patients who were given growth hormones derived from human cadavers as part of a now-obsolete childhood medical treatment who later developed early-onset Alzheimer’s disease. Keith Vossel, M.D., director of the Alzheimer’s Research Center at the University of California, Los Angeles, told FIERCE Biotech “I wouldn’t go so far as to say that it validates a theory, but I think it just adds one more strong piece of evidence for the prion-like hypothesis of Alzheimer’s seeding and trans-synaptic spreading.”
* * *
AI & Digital Twins to Make Drug Discovery “Cheaper, Faster, and More Successful.” That’s among the predictions of Paul Workman, PhD, a team leader at the Institute of Cancer Research, when asked by the American Association for Cancer Research to forecast areas of progress for 2024. Workman predicts that rapid advances in AI, chemical technology, and small- molecule chemical probes will provide the cutting-edge resources needed to expand and accelerate drug discovery for cancer. “AlphaFold could shave years off the initial phase of the oncology drug discovery pathway,” said Workman, noting that it will enable researchers to design drugs for new targets without having to wait for a crystal structure to be solved. “In some cases, it may allow researchers to design drugs against targets that couldn’t have been worked on at all before—which will have even bigger impact.” Workman is excited about the prospect of digital twins, which he describes as highly sophisticated in silico models of individual patients. “As an example, you could build the digital twin of a patient and then test how a particular drug might impact that patient’s cancer before prescribing it to them,” he explained. “I think the time will come when we will be doing much more experimentation in silico and much less in vivo, making drug discovery cheaper, faster, and more successful.”
* * *
“World-First Blood Test for Brain Cancer May Increase Survival Rates.” That’s the headline for a recent article in The Guardian about a test created by surgeons and scientists, who say it could revolutionize diagnosis, speed up treatment, and boost survival rates. The breakthrough was reported in the International Journal of Cancer. Researchers at the Brain Tumor Research Centre of Excellence, run by Imperial College London and Imperial College healthcare NHS trust, found the test could accurately diagnose a range of brain tumors, including glioblastoma (GBM), the most commonly diagnosed type of high-grade brain tumor in adults, astrocytomas oligodendrogliomas. The test had “high analytical sensitivity, specificity and precision”, the team reported. The test works by isolating glial cells that have broken free from the tumor and are found circulating in the blood. The isolated cells are then stained and can be identified under a microscope. “Through this technology, a diagnosis of inaccessible tumors can become possible through a risk-free and patient-friendly blood test,” said Dr. Nelofer Syed, who leads the Brain Tumor Research Centre of Excellence. “We believe this would be a world first as there are currently no non-invasive or non-radiological tests for these types of tumors.”
Barry A. Bunin, PhD, is the Founder & CEO of Collaborative Drug Discovery, which provides a modern approach to drug discovery research informatics trusted globally by thousands of leading researchers. The CDD Vault is a hosted biological and chemical database that securely manages your private and external data.