Life Science Today 010 – Roche, Abbvie, I-Mab, BioNTech, Pfizer, PPD & Lupus
Originally Published as The Niche Podcast
Introduction
Welcome to The Niche Podcast – Your weekly 5-minute rundown of the biotech, clinical research, and applied science industries. I’m your host, Dr. Noah Goodson. This week, Roche earns FDA approval for a combined flu/COVID diagnostic, I-Mab signs with Abbvie for $2 billion, PPD partners to treat lupus, and BioNTech/Pfizer add more COVID candidates while Moderna adds bad press.
Roche COVID Diagnostics
Roche received emergency use authorization (EAU) from the FDA for a novel COVID19/Flu combined diagnostic test. Based on the COBAS 6800 or 8800 diagnostic systems which use real-time PCR to provide sample diagnosis, this new test is capable of distinguishing between COVID19, Influenza A, and Influenza B. With the Flu season just around the bend, combined diagnostics could be a valuable tool for care givers and public health officials to distinguish between the viruses. The advantage of this system is that it combines multiple tests from a single biological sample for cases where a differential diagnosis may be needed.
The EAU from the FDA on September 4th followed close on the heels of the September 1st announcement that Roche would be pushing their rapid diagnostic antibody test out by the end of September. While this test has yet to garner an FDA EUA it will be available throughout Europe and other parts of the globe. Preliminary studies indicate the rapid test has a sensitivity of 96.52% and a specificity of 99.68%. With a turn-around time of 15 minutes and limited lab equipment necessary it could prove critical to screening stations, particularly in rural or poor regions. Rapid tests like this tend to suffer from increased false negatives (about 1 out of 20 in this case). However, with Roche attempting to coat the diagnostic landscape with a suit of solutions, they are likely more concerned with capturing as much of the market as possible rather than a catch all single solution test. Our report on July 27th highlighted the critical role that diagnostics have played in Roche’s portfolio throughout COVID. It’s no surprise that they are pushing for more solutions in this profitable and necessary space.
Abbvie and I-Mab
Abbvie and the China based pharma company I-Mab announced a $2 billion deal last week. The partnership centers on Abbvie taking over the development and commercialization of Lemzoparlimab, I-Mab’s CD47 monoclonal antibody therapeutic that could theoretically target and treat a wide range of cancers. The top line results from the therapy claim that it has very low toxicity and is well tolerated at a single dose, however, there is no publicly available data at this time.
CD47 is a cell surface protein that is expressed in a range of cancers. The CD47 protein inhibits the immune system from successfully targeting and destroying the aberrant cells. Lemzoparlimab works by blocking these receptors and allowing the immune system to function properly to destroy cancer. The problem with most CD47 therapies is that they can cause severe and deadly anemia as red blood cells are inadvertently targeted by the immune system. The specific (and non-public) characteristics of Lemzoparlimab prevent this from happening.
The deal for Lemzoparlimab gets I-Mab $180 million in immediate cash payment, with follow-ups based on the drug hitting specific milestones through clinical trials and approval. In March of this year, Gilead acquired Forty Seven for $4.9 billion. Their leading product was also a CD47 monoclonal antibody. Abbvie is hoping to compete in the same therapeutic space, but with significantly less out of pocket on the front end.
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PPD and Lupus
PPD, the leading global clinical research organization, signed a deal with Lupus Therapeutics (LT) this week. LT is a clinical research network focused on Lupus related research projects and backed by the non-profit Lupus Research Alliance. The deal appears to be a mutually beneficial partnership. LT has a well-developed network of doctors, and more critically, a peer-to-peer patient network they call PALS which enables those suffering with Lupus to connect. This partnership can be vital to the health and well-being of those suffering from chronic diseases.
From a research perspective, improving patient interest and participation in clinical research can be a vital resource to developing new therapies. The deal is framed as a mutually beneficial network whereby LT gains PPDs broader resources and clinical management skills along with clients who may want to run clinical trials. While PPD gets access to well established sites, brand equity by being backed by a non-profit, and a population who have developed a degree of trust with the Lupus Research Alliance. It is not clear if there are financials or specific limitations to this relationship.
BioNTech, Pfizer, and Moderna
The BioNTech/Pfizer partnership has announced they are pushing a new COVID19 mRNA therapeutic into the clinical development pipeline. This brings their total to five candidates with at least one in a Phase III, 30,000-person trial and others in Phase II/III trials. The BioNTech/Pfizer partnership is still behind the front-runner Moderna on their timeline. However, their approach appears to have a bit more scientific durability. If their first candidate doesn’t work, they have a second, if that doesn’t work, they have three more. Moderna has all their eggs in one lipid nanoparticle basket. Adding to the shaky situation for Moderna, reports continue to surface of executives selling off significant portions of their stock. NPR reported last week that Moderna execs have sold more than $90 million in stock since June 1. This may be legal, but the ethics are questionable, and the optics are terrible. At business closing on Friday, the 171-year-old company Pfizer with $51.75 billion in revenue last year was down about 7% in stock prices on the year. The nine-year-old company, Moderna, who has never delivered a product to market was up 225% on the year. One of these companies may be undervalued.
Closing Credits
Thanks for joining me on The Niche Podcast; your weekly 5-minute summary of top news in the biotech, clinical trials, and applied science industries. You can 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.
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Story References
https://www.businesswire.com/news/home/20200903005517/en/PPD-Lupus-Therapeutics-Collaborate-Support-Lupus-Clinical
https://www.fiercebiotech.com/biotech/pfizer-biontech-quietly-usher-a-5th-covid-19-jab-into-clinic-analyst
https://www.npr.org/2020/09/04/908305074/bad-optics-or-something-more-moderna-executives-stock-sales-raise-concerns
https://www.roche.com/media/releases/med-cor-2020-09-04.htm
https://www.usnews.com/news/us/articles/2020-09-02/us-nih-awards-nine-companies-129-million-to-scale-up-covid-19-testing
Music by Luke Goodson