Originally Published as The Niche Podcast
Genentech’s next tech, GSK divests to invest, Bristol Myers Squibb checks oncology, Cassava Sciences raises capital, Libtayo gets expanded FDA approval, and Hyperfine turns on hyperdrive.
Sponsors
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Story References
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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, Genentech’s next tech, GSK divests to invest, Bristol Myers Squibb checks oncology, Cassava Sciences raises capital, Libtayo gets expanded FDA approval, and Hyperfine turns on hyperdrive.
Genentech’s Next Tech
Genentech has been releasing a series of results for their next-gen ocular injectable Faricimab. Last week, they put out more details and connected the dots. Faricimab has shown significant benefit in combatting both diabetic macular edema (DME) and age-related macular degeneration (nAMD). For years DME and nAMD have been treated by VEGF inhibiting injectables that are either monthly or bi-weekly. Having spent a couple hundred hours in an Ophthalmology clinic I can attest first-hand to the burden these therapies place on patients. Not only are monthly or bi-weekly intraocular injections incredibly uncomfortable, they also increase the probability of patient non-compliance through missed appointments. This in turn decreases the effectiveness of extent therapies, including Genentech’s own Lucentis.
The advancement from Faricimab is that between 40% and 50% of patients only need one injection every four months, with 70% needing them every three months or greater. The bispecific antibody works by inhibiting both angiopoietin-2 and VEGF-A. This inhibition stabilizes blood vessels, improving vision, and decreasing retinal degradation from the underlying diseases.
With multiple trials behind Faricimab expect FDA applications for DME and nAMD to move through this year. While it won’t take over clinic over-night, this will likely be a leading treatment for both diseases in the near-term. It is worth noting that other therapies are in development in the same space including injectables, oral therapies, implants, and gene therapies. Assuming Faricimab gets the greenlight, there may be significant alternatives in the mid to long term.
GSK Divest and Invest
GSK has reached an agreement with Sandoz, a Novartis division, to sell off a chunk of its antibiotics business in a deal valued at $500M. GSK is attempting to clean up their portfolio and get movement from it’s extensive R&D endeavors. Sandoz will get control of the Cephalosporins line including Zinnat, Zinacef, and Fortum. These are off-patent drugs with major global distribution and recognition. But GSK sees value in the future, not in maintenance and distribution of common treatments. The deal involves a $350M cash payment and $150M in milestones. For GSK this gives them increased focus, for Sandoz this gives increased market control of generics.
Bristol Myers Squibb Oncology Diversity
Bristol Myers Squibb (BMS) has made a deal worth up to $1.3B with Molecular Templates to develop next-gen oncology therapies. Molecular Templates has developed Engineered Toxin Body (ETB) platform which works in some way through the “forced internalization of tarted receptors” and “enzymatic inactivation of ribosomes.” So basically they have some centralized mechanism of cellular function and they are identifying targets to apply ETB too. Now, that may be a misread on my part, but their pipeline is all based on ETB and covers a variety of targets, with their lead candidate heading to phase II as a CD20 monotherapy. BMS probably sees this deal as portfolio expanding. They only put out $70M up front with the other 95% of the offer is tied up in milestone achievements. For an up-and-coming company like Molecular Templates, this gives them big name legitimacy and the capital needed to push into further clinical development.
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, change trajectory through clinical insights, and empowered CEOs with tools that turns their data into stories that raise capital. The Scope Method will help you develop data driven strategic processes. Find out more at thescopemethod.com.
Cassava Sciences
Cassava Sciences has raised $200M in a registered direct offering to continue developing their Alzheimer’s therapy. Simufilam is designed to treat Alzheimer’s by restoring the shape of altered filamin A scaffolding protein, which can be impacted by Aß plaque buildup in the brain. A 2017 paper showed that Simufilam can restore filamin A shape and undercut the course of Alzheimer’s in a mouse model. Now, like many Alzheimer’s therapies in the graveyard, they have promising serological and safety data from early trials along with animal model results. With major players, like Biogen’s Aducanumab likely on track for approval this summer, it’s hard to know if Cassava has the capital to compete. However, perhaps with some ultra-promising phase II results they will be able to garner more significant backing for a phase III ramp-up.
FDA Approves Libtayo
Sanofi has received FDA approval for Libtayo, a PD-1 inhibitor immunotherapy, for the treatment of advanced basal cell carcinoma. Libtayo has been on the market for certain forms of squamous cell carcinoma since 2018. Basal cell carcinoma is the most frequently occurring cancer globally. While numerous front-line treatments exist, the cancer often grows resistant over time. Libtayo adds a significant second line of defense through a distinct mechanism of action. Like other PD-1 inhibitors, more targets are probably in the pipeline as Sanofi seeks approval for as many indications as possible.
Hyperfine Heading for Hyperdrive
Hyperfine has raised a $90M series D to aggressively scale up their commercial pipeline. A year ago, they received FDA clearance for their portable head and neck MRI machine. This new capital should send them into hyperdrive. The MRI is a massive move forward in imagine and diagnostics. It can be wheeled directly to a patient’s bedside, setup and run-in minutes using a normal outlet, and provide rapid diagnostics right to an iPad. I firmly expect to see these showing up in hospitals and clinics around the world. It is almost literally a no-brainer addition to diagnostic, palliative, and surgical workflows. It cannot and should not replace current full-scale devices. But will be a valuable asset across clinics. Depending on how reimbursements are structured for this device, it could pay for itself in a week of use. It’s no surprise that Hyperfine oversubscribed their funding round.
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.