Chimerix, Emergent, SIGA, Merck & Kelun, Inceptor, Laekna, Kriya

Pox progress, an oncology acquisition, and we look at $360M worth of biotech funding

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Story References
Chimerix, Emergent, SIGA
Merck & Kelun
Inceptor, Laekna, Kriya

About the Show
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 Life Science Today, your source for stories, insights, and trends across the life science industry. I’m your host, Dr. Noah Goodson. This week, pox-machina, an oncology acquisition, and we look at $360M worth of biotech funding.

Disclaimer

The views expressed on Life Science Today are those of the host and guests. They do not necessarily reflect the opinions of any organizations with which they are affiliated. 

Pox News Marks this Week

The same week that news of Monkeypox cases reported in the United States and Europe emerged, several moves have also happened in the biopharma industry related to the far more dangerous and deadly condition smallpox. 

First, Chimerix sold off the FDA approved smallpox treatment TEMBEXA to Emergent BioSolutions for $225M upfront and an additional $112.5M in milestone payments. The deal brings the approved therapy into Emergent’s account, who will continue to work with Chimerix to close a contract deal with  Biomedical Advanced Research and Development Authority (BARDA). With smallpox eliminated globally the value of the medication is presumed to be in response to potential release of the disease through nefarious actors. 

Later in the week the FDA approved an intravenous version of another small-pox medication TPOXX, produced by SIGA technologies. This will provide additional potential treatment options for those that may be unable to swallow capsules. This work was also funded by BARDA.

These moves all serve as a reminder of key considerations across the life science industry and some important trends. First, two years of a global pandemic highlight just how poorly many countries (and the US notably) are likely to manage the spread of a deadly infection. Second, supply chains and global political tensions continue to drive towards stockpiling of critical medications in more local or regional hubs. The infrastructure required to maintain supply chains may result in meaningful shifts, but like all infrastructure-based projects they take a long time to ramp up but will have ramifications far past the current political and economic moment. In case it’s not clear that there is governmental involvement in establishing the critical nature of supply chain stability, the FDA released draft guidance last week titled “Risk Management Plans to Mitigate the Potential for Drug Shortages.”

Monkey Pox is very unlikely to be a major issue, and with any luck DARPA’s Smallpox supplies will never be needed. But the continued approval of medications for eradicated diseases, the continued awareness that viruses spread all to easily, and the push for more regional supply chains to secure medications may have far-reaching implications in the long run. 

Merck Acquires Oncology Asset from Kelun Pharma

Merck (MSD outside US) has inked a biobucks deal with the Chinese-based oncology startup Kelun Pharma, who operates as Klus Pharma in the United States. The data are fairly sparse on what was licensed, but with nearly 20 targeted oncology, immune-oncology, and non-oncology candidates in their pipeline there is plenty to choose from. With an immediate $17M payment, followed by $30M when the deal closes, followed by up to $1.4B in total milestones this deal starts small and runs big. There is a good chance Merck is looking for oncology products that can overlap with the already dominant Keytruda. A quick glance at ClinicalTrials.gov reveals over 5000 studies that mention Keytruda. Merck will look for co-development and combo-treatments anywhere they can find them – though perhaps this is intended as a stand-alone medication. Like many other pharma's, Merck will be on the hunt in the next year to snap up and sign on affordable assets that replenish or expand their pipeline.

Three Biotech’s Still Raising Capital

This last week saw at least 3 biotechs pull in respectable funding rounds totaling over $360M.

First, Inceptor Bio pulled in a $37M series A to kick off their oncology pipeline of pre-clinical CAR-T, CAR-M, and CAR-NK therapies. What I think is interesting about Inceptor is that they have taken the broader biotech approach that has been leveraged by a couple of companies. They add increased operational demands to disperse risk and provide more product control; Rather than having a single core therapeutic they are banking on alone or a pipeline they can’t operationalize, they have acquired a manufacturing facility in Jacksonville and are developing their capabilities to manufacture cell and gene therapies as well as producing their own pipeline. This can of course runs the risk of diluted focus, but in a market where high quality production facilities are scarce and there is massive looming cell/gene therapy production demand in the next 5 years, there is real possibility to build sustainable high quality revenue streams manufacturing products yourself and others. Now, their language really stays focused on the therapeutic development, and facilities as a means to that end. Just a year out of stealth mode they are certainly making moves and carrying enough momentum for a meaningful raise.

The Chinese based Laekna Therapeutics has raised a modest $61M series D to advance their clinical pipeline. While the raise is relatively small in the series D world, they have managed to secure partnerships across a wide range of their pipeline with Novartis being their leading partner. This latest round will help them push forward their front runner, a ATK kinase inhibitor currently in a range of combination phase II oncology studies. Not much to report here but the funding will hopefully see them to major reportable data. 

The largest raise last week was from Kriya Therapeutics, who wrapped a solid $270M Series C that will be leveraged in developing their gene therapy platform. If Inceptor is blending a traditional pipeline with manufacturing support capabilities, Kriya has taken it a step further with a full biotech “platform” approach to gene therapy development. They’ve basically said ‘ok we are going to combine analytics, computational power, and manufacturing and run a ton of these developmental process end-to-end in-house.’ That’s not to say they don’t have a pipeline – they do – it’s just not where they are placing their branding focus. Just at the beginning of this year they acquired Warden Bio and their five preclinical gene therapy programs, and later in January they licensed a couple of ocular therapy programs.

They obviously want to cross-check and refine these programs behind the scenes before taking a public stand one niche clinical developmental direction. Now – it should be noted it’s going to take a lot more than a little series C cash to get any single gene-therapy to market much less a pipeline – but based on their positioning I suspect their ambition is more centered on becoming a leading technical partner at preclinical development and facilitation, shunting the clinical development burden off to partners through product sales and licensure. This is course is mostly speculation – what we know for sure is they have facilities, capabilities, a mostly opaque pipeline, and $270M. 

Closing Credits                                              

Thanks for joining me for Life Science Today, your source for stories, insights, and trends across the life science industry. Learn more at LifeScienceTodayPodcast.com. If you like what you hear, please tell a friend. Once again, I’m Dr. Noah Goodson, I’ll see you next week.