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February 2024 Newsletter: Leap Day Edition

Hello friends and colleagues, 

 

As we close out a short month packed with major updates and announcements, we are using this Leap Day to recap a few of the top news stories from February. Take a look at the summaries below for a high-level overview!  


Innovative Breakthroughs in Oncology: 


AstraZeneca’s Tagrisso achieves success in advanced NSCLC maintenance trial (Feb 19, 2024) 

The FDA approved AstraZeneca's Tagrisso in combination with chemotherapy for the treatment of advanced EGFR-mutated NSCLC, following positive phase 3 data from the FLAURA2 study. This combination significantly extended median progression-free survival by almost nine months (25 months vs 16.7 months) and reduced the risk of disease progression or death by 38% compared to Tagrisso monotherapy, the active comparator in the trial. 


The Tagrisso-chemo combo regimen was added to the NCCN guidelines for NSCLC with EGFR exon 19 or exon 21 L858R mutations earlier this year as a “Category 1 Other Recommended” regimen. Tagrisso monotherapy remains the “preferred” first-line therapy, but this could change as more overall survival data becomes available from FLAURA2. 

 

Iovance Biotherapeutics wins major cell therapy approval in advanced melanoma (Feb 16, 2024) 

Iovance Biotherapeutics, a California-based biotech company focused on developing novel tumor- infiltrating lymphocyte (TIL) therapies, won an accelerated approval from the FDA for Amtagvi, a cell therapy for patients with advanced melanoma. The FDA’s decision makes Amtagvi the first modern cell therapy indicated for a solid tumor, and the first approved treatment based on TILs.  

 

All Eyes (and Investments) on Obesity: 


BioAge closes $170M oversubscribed Series D (Feb 13, 2024) 

BioAge Labs, a clinical-stage biotech company that aims to utilize the biology of human aging to develop novel treatments for metabolic diseases, landed the largest fundraise to date this year when it closed a $170 million series D led by Sofinnova Investments. The funds will be used to support phase 2 trials of the company's lead asset azelaprag, an oral apelin receptor agonist, in combination with Eli Lilly’s Zepbound, an injectable dual agonist targeting incretin hormone receptors – GIP and GLP-1.  


Existing incretin targeting treatments may cause patients to lose lean body mass during rapid weight loss. BioAge’s CEO, Kristen Fortney, Ph.D., says that preclinical data suggest combining azelaprag with incretin medicines can enhance weight loss while improving body composition and muscle function.  

On the business development front, Fortney also stated that their renewed laser-focus on metabolic diseases presents opportunities for partnerships in other therapeutic areas.  

 

Novo Holdings pays $16.5B to acquire Catalent (Feb 5, 2024) 

Novo Holdings, the investment arm of the Novo Nordisk Foundation, announced its biggest deal yet with the planned acquisition of CDMO giant, Catalent, for $16.5 billion. As part of the M&A transaction, Novo Nordisk will purchase three of Catalent’s fill-finish sites in exchange for $11 billion.  


According to Novo Nordisk, the purchase will bolster the company’s manufacturing network to support the distribution of current and future treatments for diabetes and obesity, like its blockbuster GLP-1 agonists, Ozempic and Wegovy. The announcement of this deal surprised some analysts and coincides with recent operational struggles reported by Catalent.  

 

With more news of promising clinical advancements and transformative acquisitions this month, it appears like the biotech sector is making strides in the right direction. We look forward to that momentum carrying over into March. Stay tuned for more exciting updates in the next edition of our newsletter as we continue to provide best-in-class services for commercial (strategic new product planning), corporate development, and R&D support.  

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