The California Biotechnology Foundation is committed to keeping you up to date about the latest breakthroughs in biotech treatments and the impact of this industry on California and beyond. This newsletter edition, as of May 29^th, 2024, brings you the latest updates directly from the forefront of innovation. Among the notable advancements featured are:

• Biocom California released their 2024 Economic Impact Report detailing data on the performance of the life science industry in California. Read the full report here.
• Two congenitally deaf children heard for the first time, exceeding expectations and paving the way for potential treatments targeting rare forms of genetic deafness, according to the latest study from Regeneron.
• Treatments for cancer causing malignancies are on the horizon as an expanding pipeline of vaccines offers hope by training the immune system to target them.

Recent News

• Merus drug, with immunotherapy, boosts tumor response in patients with head and neck cancer
  Stat News – May 28, 2024
  Merus said that the combination of its experimental drug petosemtamab with the checkpoint inhibitor Keytruda shrank tumors in 62% of patients with head and neck cancer, according to an interim analysis of an ongoing mid-stage clinical trial.
• FDA approves biosimilars for macular degeneration, other eye diseases
  Pharma News Intelligence – May 22, 2024
  The United States FDA approved the first interchangeable biosimilars for Eylea: Yesafili and Opuviz. These medications can treat neovascular (wet) age-related macular degeneration, macular edema following retinal vein occlusion, diabetic macular edema, and diabetic retinopathy. Eylea is an FDA-approved biologic that inhibits vascular endothelial growth factor preventing abnormal blood vessel growth and slowing down or reducing retinal damage.
• FDA approves Amgen drug for tough-to-treat form of lung cancer
  Biopharma Dive – May 17, 2024
  The Food and Drug Administration granted accelerated approval to a new dual-acting drug from Amgen to treat small cell lung cancer in people whose disease has progressed following chemotherapy. The drug, which will be sold as Imdelltra, is an immunotherapy that helps T cells home in on tumor cells by binding to protein flags on the surface of both. It is the tenth so-called “bispecific” antibody to gain FDA approval in cancer, and the first in small cell lung cancer.
• Bristol Myers’ Breyanzi bags FDA nod to follow CAR-T rivals Gilead, Novartis into follicular lymphoma
  Fierce Pharma – May 16, 2024
  The FDA has broadened the use of Bristol Myers Squibb’s CAR-T therapy Breyanzi to another type of blood cancer. Breyanzi has won an accelerated approval to treat patients with relapsed or refractory follicular lymphoma (FL) after at least two prior lines of therapy. The nod came about three years after Gilead Sciences’ Yescarta became the first CD19-targeted CAR-T therapy to enter FL. Novartis’ Kymriah followed about a year later with the same third-line nod. All three meds secured accelerated approvals based on tumor shrinkage data.
• Lilly’s weekly insulin works as well as daily products, new studies show
  STAT News – May 16, 2024
  Eli Lilly reported that its experimental weekly insulin worked as well as daily basal insulin products in two late-stage studies, paving the way for the drug to compete with a similar weekly insulin developed by Novo Nordisk. In a 52-week trial of type 2 diabetes patients using insulin for the first time, those on the weekly insulin, called efsitora alfa, had a 1.34% reduction in blood sugar levels, while people on the comparator daily insulin degludec, sold as Tresiba by Novo, had a 1.26% lowering. That resulted in patients having blood sugar levels, known as A1C readings, of 6.87% and 6.95%, respectively.
• Karius snares FDA breakthrough tag for genomic infectious disease blood test
  Fierce Biotech – May 16, 2024
  Karius is adding another feather to its cap with a breakthrough designation from the FDA. The company’s DNA-based blood test for infectious diseases, designed to detect more than 1,000 pathogens from a single sample, is getting a boost at the agency toward helping manage immunocompromised patients suspected of threatening lung conditions. The Karius Test has been commercially available since 2017 as a lab-developed test, and the company has said it is currently being employed at about 400 nationwide locations—largely at cancer centers, where patients may have heightened risks of respiratory infections and pneumonia from bacteria, fungi, parasites and viruses
• FDA approves self-collection screening tests for HPV, allowing women to avoid pelvic exams for cervical cancer
  Fierce Biotech – May 15, 2024
  The FDA has approved two diagnostic devices that allow women to collect vaginal samples themselves for cervical cancer screening—a major step toward catching more early and potentially preventable cases without requiring an invasive gynecological exam. The separate self-collection offerings from BD and Roche still need to be used in a healthcare setting—they have not received agency green lights for solo, at-home use—but the two companies said the move could improve access to screening by enabling HPV testing at locations such as retail pharmacies or mobile clinics.
• FDA-approved drug targets tissue factor in cervical cance
  Scientist Live – May 10, 2024
  The FDA in the US granted full approval for biotechnology company Seagen Inc.’s Tivdak product, targeting tissue factor (TF) for the treatment of patients with recurrent or metastatic cervical cancer who have progressed on or after chemotherapy. This marks a significant advancement in the therapeutic landscape for cervical cancer, highlighting the potential of antibody-drug conjugates (ADCs) in oncology.
• After gene therapy, two congenitally deaf children hear for the first time
  STAT News – May 8, 2024
  Two congenitally deaf children can hear for the first time after being treated with gene therapy, according to data presented at a conference. The results are “jaw-droppingly good, just shocking how good. It exceeded the wildest expectations of anybody who started this work,” said Larry Lustig, an otolaryngologist at Columbia University and an investigator on the study. The new data come from a larger study by Regeneron Pharmaceuticals that will treat nearly two dozen children with a specific type of congenital hearing loss with gene therapy. The clinical trial is meant to measure safety and efficacy of DB-OTO, a gene therapy drug Regeneron is developing to treat children who have hearing loss due to changes in the otoferlin gene.
• How mRNA vaccines could be personalized cancer cures
  Axios – May 7, 2024
  An expanding pipeline of vaccines is giving patients new hope against some of the deadliest cancers, by training the body’s immune system to attack malignancies. Why it matters: This personalized approach could make conditions like melanoma and bladder, kidney, pancreatic and breast cancers treatable, and even potentially preventable, via infusion. But it still can take months to produce a personalized vaccine, giving the cancer more time to spread.
• Common diabetes drug lowers SARS-CoV-2 levels, clinical trial finds
  University of Minnesota – May 3, 2024
  Researchers from the University of Minnesota published evidence that the common diabetes drug metformin decreases the amount of SARS-CoV-2 in the body and helps reduce the risk of rebound symptoms if given early in the course of non-severe illness. The study, published in Clinical Infectious Diseases, suggests metformin may also help prevent long COVID. The researchers tested metformin against a placebo in 999 adults infected with COVID-19. More than 50% of the study enrollees were vaccinated, and treatment took place when the Omicron variant was the most dominant strain in the United States.
• MRNA vaccine effective in treating glioblastoma brain cancer in small trial
  UPI – May 2, 2024
  An experimental cancer vaccine can quickly reprogram a person’s immune system to attack glioblastoma, the most aggressive and lethal form of brain cancer, a small, preliminary study has found. The cancer vaccine is based on mRNA technology similar to that used in COVID-19 vaccines, but in this case a patient’s own tumor cells are used to create a personalized vaccine, researchers said. The vaccine teaches the immune system to see tumor cells as a dangerous virus, prompting a vigorous immune response against the cancer, researchers said.