National Institute of Allergy and Infectious Diseases

• Based on the viral epitopes identified by researchers at NIAID’s Vaccine Research Center (“VRC”), iBio will work with the VRC to determine if using iBio’s platform to steer immunity toward these epitopes offers advantages over other vaccine development approaches.
• Should the collaboration be successful, researchers at the VRC may assess promising candidates in both in vitro and in vivo studies, and potentially advance a lead candidate to a Phase 1 clinical trial.
• “This collaboration with the NIH represents a potential new application for, and validation of our patented AI discovery platform,” said Martin Brenner, DVM, Ph.D., iBio’s Interim Chief Executive Officer and Chief Scientific Officer.
• They encompass an amino acid sequence that folds into a distinct three-dimensional shape within the full-length viral protein.

• We recently observed durable neutralizing antibody titers at 6 months following samRNA vaccination in over 100 vaccine-naïve subjects treated within our CORAL-CEPI trial, where interim results were presented at ECCMID 2023.
• As of May 10, 2023, the company had randomized 71 of the initially planned 80 total patients.
• Both datasets were presented at the 33rd European Congress of Clinical Microbiology and Infectious Diseases (ECCMID 2023).
• In February 2023, results from a preclinical study conducted in collaboration with Gilead were presented at Conference on Retroviruses and Opportunistic Infections (CROI) 2023.

• The agency has frequently come under fire for its drug approval decisions, but attacks on its decision-making process and science itself have increased during the COVID-19 pandemic.
• Recent challenges to the FDA’s authority have emerged in the context of reproductive rights.
• I am a legal scholar whose research focuses in part on the law and ethics of the FDA’s drug approval process.
• Examining the FDA’s history reveals the unprecedented nature of the current challenges to the agency’s authority.

Events shaping FDA’s focus on safety

• In its early years, the FDA focused primarily on balancing the competing goals of consumer safety with access to experimental treatments.
• For instance, at the turn of the 20th century, Congress passed the Biologics Control Act of 1902, providing the federal government the authority to regulate vaccines.
• This act marked the beginning of modern drug regulations and the birth of the FDA as a regulatory agency.

FDA’s turn toward expanding access

• During the 1970s, questions about the limits of safety versus an individual’s right to access arose when cancer patients who wanted access to an unapproved drug derived from apricots, Laetrile, sued the FDA.
• The 1980s, however, marks the FDA’s shift toward increasing access following reports of an emerging disease – AIDS – which primarily affected gay men.
• After massive protests, Dr. Anthony Fauci, then director of the National Institute of Allergy and Infectious Diseases, proposed a parallel track program allowing eligible patients access to unapproved experimental treatments.

Future of the FDA

• While the FDA approves drugs for consumer use, it does not regulate the general practice of medicine.
• Doctors can prescribe FDA-approved drugs off-label, meaning they could prescribe a drug with a different dose, in a different way or for a different use than what the FDA has approved it for.
• The mifepristone case has broad implications for the FDA’s future and could have devastating effects on health in the U.S. Due in part to FDA involvement, public health interventions have led to a 62% increase in life expectancy in the 20th century.

• “We look forward to participating in this meeting and presenting our latest innovations for the European transplant community with our AlloSeq* portfolio of lab products for research and clinical use pre- and post-transplantation,” said Reg Seeto, CEO and President of CareDx.
• For post-transplant, CareDx offers AlloSeq HCT* chimerism testingand AlloSeq cfDNA* for labs to assess transplanted stem cells and organ health, respectively.
• CareDx also provides pre-transplant HLA typing and post-transplant surveillance testing for customers through its service lab in Stockholm, Sweden, for clinical research.
• CareDx will sponsor a symposium “Breaking New Ground: Innovative Pre- and Post-Transplant Solutions to Improve Allograft Outcomes” on Thursday, April 27.