Life Science Today 051 – Oncology Trials, CRO Industry, Annovis, Janssen

Originally Published as The Niche Podcast

Oncology on the move, an industry report looking at broader trends, good news in Alzheimer’s, and another niche oncology therapy approved.

Sponsors
https://www.thescopemethod.com

Story References
https://tinyurl.com/Niche-051-1
https://tinyurl.com/Niche-051-2
https://tinyurl.com/Niche-051-3
https://tinyurl.com/Niche-051-4
https://tinyurl.com/Niche-051-5

Music by Luke Goodson
https://www.soundcloud.com/lukegoodson

Life Science Today is your source for stories, insights, and trends across the life science industry. Expect weekly highlights about new technologies, pharmaceutical mergers and acquisitions, news about the moves of venture capital and private equity, and how the stock market responds to biotech IPOs. Life Science Today also explores trends around clinical research, including the evolving patterns that determine how drugs and therapies are developed and approved. It’s news, with a dash of perspective, focused on the life science industry.

Transcript

Introduction

Welcome to The Niche Podcast – Your weekly rundown of the biotech, pharma, clinical research, and life science industries. I’m your host, Dr. Noah Goodson. This week, oncology on the move, an industry report looking at broader trends, good news in Alzheimer’s, and another niche oncology therapy approved.


COVID19 Trends in Oncology Clinical Trials

2020 was a transitional moment in the clinical research industry. The disruption caused by a global pandemic called into question long standing policies and forced major re-evaluation of how clinical research is implemented. Early last year, reports emerged that oncology trials were being impacted by the disruptions caused through a pandemic with less than 20% of institutions still enrolling patients. A full 33% of trial stoppages last April were in oncology. These findings paired with ongoing concerns through 2021 that significant cancer diagnoses have been missed over the last year of disrupted lifestyle and disrupted care.

Despite concerns, an updated report suggests that oncology trial stoppages peaked earlier than other research areas and have predominately gotten back on track throughout t the year. There were a total of 38 trials that were either terminated or withdrawn in conjunction with the pandemic. However, 66% of trials placed on hold were back on track within 6 months. As of last week, 74 trials in oncology remained stopped. Though there are a variety of reasons this may be the case, not all of them are directly caused by the pandemic. In general, the updated numbers suggest that oncology trials faired better than other indications on average. Yes, there have been delays in some timelines, but it may be less in oncology than other therapeutic spaces. This is partially due to the intense focus on deve loping oncological products in the market, as well as the obvious time-sensitive nature of all oncological therapies. 


The Data Report

IQVIA has consistently positioned themselves as a data leader in the CRO space. Part of this strategy means they publish a Global Trends report summarizing significant data in clinical R&D. This next story, just fully and unabashedly steals their summaries and picks a few key highlights. But if you want the full story, I encourage you to get the report and read through it yourself. It should also be noted that the previous story, while I got it from a Nature publication also comes from folks at IQVIA. Obviously all this comes with multiple asterisks that IQVIA has pretty clear conflicts of interest and the report should be read with that in mind.

The first and most important data-trend in 2020 is that the clinical trials industry remains on track. While there were obvious increases in certain spaces, like vaccine development, and decreased trial starts in other therapeutic areas, the industry as a whole remains soundly on track and there was an 8% increase in total trial-starts. This gives a total of 4,686 industry driven trial starts last year. That matters because from 2010 to 2016 the net change in trial starts was 65 trials, with a mean of 3335. So for 7 years straight there was no significant change. But since 2016 there has been a 38% increase in t otal trials in the industry. This is also critical to think about when you look down the line at the billions of dollars flowing into basic research and the technologies empowering and expediting that process. Taken together with other trends we are looking at major growth moving forward for several years to come. It was not all smooth sailing.

The pandemic did dampen starts at the outbreak, but things caught back up rapidly on the back end of the year. Remote, decentralized, or virtual trials have doubled their numbers in the last 2 years. While there will likely be increased hybrid integrations, fully remote trials remain a rapidly growing, but small portion of the total industry.

In the last story, we talked about how oncology has largely remained on track. This is the opposite in certain rare-disease segments where major pauses were taken and lead to “inactivity” which gets calculated as a failure to progress. In many ways, the same forces that drove oncology back on track quickly, could serve to delay rare-disease trials.

Another key trend to consider is how complexity is impacting trials. In general, trial complexity continues to rise in terms of design, endpoints, and eligibility. Despite this net complexity indices are declining. This was driven by a decrease in total number of sites and countries included in trials. Once the world opens back up, there is clear need to expand trial access. The larger healthcare industry trend of moving to remote healthcare may contribute increased population access for trial inclusion. However, I doubt we will see that realized this year as the pandemic rages on countries like India. It will be interesting to see how patterns established during the pandemic impact total sites as well as more decentralized models moving forward.

Total R&D budgets from major pharma companies increase by $13B and have passed 20% of revenue for the first time. While there was a culling of total new products in pipelines to 2018 numbers, this is more likely an indication of how companies consolidate their focus at times of fiscal uncertainty than about the total potential pool of new therapeutics. Collaborations across the industry increased last year, driven in large part by COVID19 related activities. My hope is that moving forward we continue to craft a collaborative industry. There are other important trends we just don’t have time to discuss, like how diversity recruitment and inclusion remain largely elusive, but the big take-away should be that despite the challenges of a pandemic, clinical research remains a robust industry.


Sponsor

Developing a new product in the biopharma space is incredibly challenging. There are design barriers, capital to raise, and regulatory hurdles. The Scope Method provides consultative solutions to navigate industry specific challenges. We’ve helped companies pivot into new therapeutic spaces, designed and run decentralized clinical trials, and empowered CEOs with tools that turns their data into stories that raise capital. Find out more at thescopemethod.com.


Annovis Bio Alzheimer’s News

Annovis Bio has released data showing their lead product, ANVS401, has very positive topline and safety results for both Parkinson’s disease and Alzheimer’s. Once completed, the extended trial should set them up to pursue significant next steps with confidence. In the AD trial, patients treated with ADVS401 improved cognitive function by 30% in just 25 days compared to their baseline. Similar results were given compared to the placebo control, through the p value was not significant in the small study population. The results were even more striking in the Parkinson’s trial showing 23-35% declines in several major relevant inflammatory markers. ADVS401 is intended to stop the toxic cascades that lead to decreased function in these disease states. Annovis anticipates initiating late-phase trials later this year. In the meantime, Annovis may be determining which condition to pursue first, or double down with major bets and pursue both. Based on their current cash position from their Q1 report I do not see a mechanism whereby they would pursue a late-stage product without a significant investment of external capital. These deals are doubtless in the works.


Janssen Clears FDA in Oncology

In 2020, 25% of FDA approved new active substances were oncology products. The trend continues in 2021, as another therapy has been cleared. Janssen Pharmaceuticals received FDA clearance to treat Non-Small Cell Lung Cancer with a specific mutation known as EGFR Exon 20 Insertions with the human bispecific antibody RYBREVANT. The infused antibody solution is no walk in the park with risks and reactions commiserate with other oncology antibody infusions. However, the improved survival rate and response rate make a meaningful improvement and continue to advance the trend of diverse niche oncology therapies.


Closing Credits

Thanks for joining me on The Niche Podcast; your weekly summary of top news in the biotech, clinical trials, and life science industries. You can learn more at thenichepod.com or find us on your favorite podcast app. Like, comment, subscribe, and most of all share with your friends. If you like what you hear, please rate and review, it really helps us. Once again, I’m Dr. Noah Goodson, I’ll see you next week.