Originally Published as The Niche Podcast
Gilead gets FDA approval in oncology, Bio-Techne acquires Asuragen, AI for tumor targeting, and Achilles completes $175M IPO.
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Music by Luke Goodson
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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.
Introduction
Welcome to The Niche Podcast – Your weekly rundown of the biotech, clinical research, and life science industries. I’m your host, Dr. Noah Goodson. This week, Gilead gets FDA approval in oncology, Bio-Techne acquires Asuragen, AI for tumor targeting, and Achilles completes $175M IPO.
The FDA Approves Trodelvy for Metastatic Triple-Negative Breast Cancer
Gilead Science has received approved from the FDA to treat metastatic triple-negative breast cancer (TNBC) with Trodelvy. The approval is specific to patients who have received two or more prior systemic therapies. During a Phase III study, Trodelvy showed significant results compared to other chemotherapies, including a 57% reduction in disease progression or death, and a median overall survival of 11.8 compared to 6.9 months. Basically, it doubled your chances and your life expectancy on average. TNBC is a severe cancer and accounts for about 15% of breast cancer cases. Even with Trodelvy the risks remain high. The disease tends to be aggressive and options are limited. 52% of patients on Trodelvy experienced neutropenia, which is a severe deficit in neutrophil white blood cells, and many experienced severe diarrhea, but only 5% of patients needed to discontinue treatment due to side effects. All in all, it’s a major step forward in treating an aggressive cancer.
Trodelvy is a first in class antibody topoisomerase inhibitor conjugate combines monoclonal antibody targeting of Trop-2 receptors with an SN-38 topoisomerase inhibitor that stops DNA repair and causes apoptotic cell death. This allows the targeting of cancerous cells via the antibody portion and their death via the topoisomerase inhibitor, but is also the specific reason for the known side effects. Trodelvy remains under investigation for a variety of additional oncological indications.
Bio-Techne Completes $300M+ Acquisition of Asuragen, Inc.
Bio-Techne has completed their acquisition of the genetics and oncology testing company Asuragen for $215M up front along with up to $105M in future milestones. The deal sees all of Asuragen’s assets come under the Bio-Techne umbrella, including a variety of key laboratory tests in targeting both DNA and RNA, and primarily based on PCR analysis. The increasing demand for targeted oncological and genetic targets means accurate laboratory tests are a must. Since 2013, Bio-Techne has made about an acquisition a year in the space to continue filling out their portfolio, culminating with the $250M+ acquisition of Exosome Diagnostics in 2018, following by an acquisition hiatus. Along with their intellectual assets, Asuragen brings a 50,000 sq ft GMP compliant CLIA-certified lab and team to the table. How these will be integrated into the larger Bio-Techne family is not clear from currently released statements. Bio-techne has maintained previously acquired brands as subsidiaries, so I expect a similar approach for Asuragen.
Bio-Techne is continuing to grow their portfolio in a time of increasing demand for effective and accurate laboratory testing, they have positioned themselves as a leader in the space. As of this writing they have a market cap of $15.7B. In fact, their stock has increased 4x in the last 5 years. With a nearly ~90% stock value increase in the last year. Their a 2020 fiscal income (not revenue but income) was $157.4M. Based on this cash-positive position, I imagine there may be more acquisitions by Biotechne in the back half of 2020.
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AI Finds Your Tumors
Vysioneer has received FDA clearance for their tumor-auto-contouring radio-therapy solution. AI is now determining how your radio-therapy is given. Ok, that’s not really the case. It’s more like a very sophisticate visualization algorithm to help physicians determine where a tumor in your brain begins and ends. If you’re receiving an oncology radio-therapy for a brain tumor you want to get all of the tumor and none of non-tumor. Vysioneer’s platform helps solve this problem. It doesn’t remove the physicians, but it does save them 30% of the time and improve their precision and accuracy. Vysioneer’s solution is a perfect example of how complex technology can be clinically validated and then integrated into a workflow in a way that enhances outcomes. I think of it like a really fancy edge finding tool to crop parts of an image in photoshop. It won’t make you a graphic artist, but if you are one, this can save you time and enhance your outcomes. This is a similar idea, successfully applied to brain tumors.
Achilles Therapeutics Closes $175.5M IPO
Achilles Therapeutics has closed a $175.5M IPO. The oncology personalized cell therapy company has two products in phase I/IIa clinical trials. The first targets non-small cell lung cancer and the second is focused on recurrent or metastatic melanoma. Both these should sound familiar because these are not rare-diseases or obscure cancers. These are common throughout the world. So how does Achilles plan to break into these major market? This answer is at the forefront of what you might imagine in cell-based personalized medicine. In fact, it sounds a bit science-fiction.
When cells become cancerous they accumulate a number of DNA mutations. Some of these mutations make it to cell surface proteins. These mutated surface proteins are call neoantigens. Using a proprietary process, Achilles collects a sample from each patient, identifies the neoantigens specific to their cancer. They then create clonal neoantigen T cells (cNeT). So the process, in total layman’s terms is identify the markers specific to your cancer, clone out T cells that target just these cells, put them in your body, see you later cancer. If this sounds mildly reticent of CAR-T cell therapy it’s not totally dissimilar in big picture, though definitely not identical.
In theory, this is the idealized concept of what personalized medicine in oncology could look like. Now the question is, will work in practice? We’ll have to wait and see if Achilles is the greatest warrior in fighting cancer or if there is a missing piece of armor in this developmental strategy.
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.