Week of April 24, 2023

This week we look at a World Health Organization meeting on mRNA, using artificial intelligence to streamline clinical trials, Food and Drug Administration approval of a new blood cancer treatment and an upcoming Johnson & Johnson spinout. Finally, we highlight the resumption of a phase 2 trial on an HIV treatment.

Each week we highlight five things affecting the life sciences industry. Here’s the latest.

Over 200 international participants met in Cape Town to discuss the mRNA Technology Transfer Programme focusing on expanding manufacturing capabilities in low- and middle-income countries. The initiative aims to provide equitable access to mRNA vaccines by increasing manufacturing capacity and fostering regional collaborations. Afrigen, the mRNA technology hub facility in Cape Town, celebrated the inauguration of its end-to-end mRNA vaccine development and production facility, showcasing growth in manufacturing capabilities.

Health technology company myTomorrows has launched the beta version of TrialSearch AI, an AI tool designed to simplify the search process for clinical trials and expanded access programs (EAPs). The tool uses the GPT series of LLM AI models developed by OpenAI to identify pre-approval treatments based on a patient’s profile. Physicians can enter a de-identified patient profile into the tool, which then provides a list of relevant clinical trials and, if appropriate, EAPs. MyTomorrows is currently accepting requests from physicians to trial the tool.

The FDA has approved Omisirge, a cell therapy that accelerates the recovery of white blood cells and reduces infection risk in patients aged 12 and older with blood cancers. Omisirge is administered as a single intravenous dose containing healthy stem cells from a donor’s umbilical cord blood. The treatment has shown promising results but carries some potential severe side effects. Gamida Cell Ltd. has been granted approval for this therapy.

Johnson & Johnson is preparing to spin out its Kenvue unit, which includes well-known consumer health brands such as Band-Aid, Aveeno, Tylenol, Neutrogena, Zyrtec and Listerine, in an initial public offering. J&J is hoping to raise at least $3.5 billion in the offering at a valuation of $40 billion. Kenvue has been operating as a business unit of J&J and posted a 7.4% increase in sales in the first quarter. While IPO activity has been limited lately, J&J is confident that a spin out will be viewed by investors as less risky than a traditional IPO.

Merck has resumed a phase 2 study of a therapy that combines Merck’s oral drug regimen Islatravir and Gilead’s Sunlenca to combat HIV. The trial was halted by the FDA when it was determined that the treatment was causing a reduction in patients’ lymphocyte and CD4+ T-cell levels. Merck modified the program by reducing the dose of Islatravir and the FDA hold was lifted. The company is also launching multiple new phase 3 studies testing the medication with its FDA-approved HIV drug Pifeltro.

Source link: https://realeconomy.rsmus.com/5-things-to-know-in-life-sciences-week-of-april-24-2023/ by Justin Culbertson at realeconomy.rsmus.com