In this article I want to discuss the 5 Things happening in the world of ADCs this week that I have been keeping my eye on.

1. WuXi AppTech

WuXi is continuing their march toward world ADC domination with a further expansion of their facility in China to include a commercial manufacturing suite.

ADC Bio
MabPlex
Lonza
 

WUXI BIOLOGICS TO EXPAND INTEGRATED BIOLOGICS CONJUGATION SOLUTION CENTER TO INCLUDE COMMERCIAL MANUFACTURING – wuxibiologics.com

Clearly it is nice operating in China with a strong basis for expansion and the backing of the government to grow, and grow quickly. However, everything is not roses because the trading relationship between China and the US has been getting quite a bit of bad press recently. To that end WuXi is fighting back a bit with a lobbying effort in the US.

“WuXi AppTec raising U.S. profile to counter political attacks”, by BioCentury.

Who knows if it will be successful, but clearly this is a headwind that must be addressed to facilitate their movement into the US ADC market.

“WuXi AppTec raising U.S. profile to counter political attacks”, by BioCentury.

2. ADC Therapeutics is flush with cash

Looking at clinical results is an important but lagging indicator. If you want to know who is going to make waves in the near future, look at who is raising money. And time and again, that seems to be ADCT.

“ADC Therapeutics has raised $550M-plus in its quest for their first BLA — and here’s why that’s important”, by Endpoints News.

ADC Therapeutics has been pushing hard on their ADCT-402 molecule targeting CD19 and cash is king. I am paying close attention to these guys, because all signs point to a bright future here

3. Janet Woodcock, FDA Head of CDER, gives some insight

When the FDA speaks, pay attention. There are a ton of good nuggets about the FDA thinking regarding double-blind randomized clinical trials. Specifically, the FDA is looking at ways to prevent 50% of a cohort to be receiving a placebo when they are in late stage cancer progression. One idea is bundling trials together so that multiple trials can be tested at once. This is not without its downsides, but clearly the FDA is thinking about what can be done.

“The FDA’s Janet Woodcock talks about some big changes she’s pushing for in drug development, and agency reviews”, by Endpoints News.

*Side note – I’m sorry for not linking to the original source. Here is the Endpoints News review as I can’t find a link to the source material.

4. Manufacturing is tough

As a little dose of cold water, there was a bunch of stories this week about manufacturing issues. The first came from Bluebird Bio where they are delaying their Zynteglo launch in order to resolve some of their manufacturing issues.

“Bluebird Bio delays Zynteglo launch as manufacturing trips up another gene therapy”, by FiercePharma.

With all of the attention that gene therapy is getting, ADCs have fallen by the wayside a little bit, but clearly the new cool kid on the block is going to have a bit of reality bring it back to earth and right in line with ADCs as a new and transformative but also complex and nuanced oncology treatment.

To put an even stronger point on this fact there were more instances of further manufacturing failures in the industry this week. I am reminded of the phrase, “if you think you own your house, try not paying your property taxes and see what happens.” CDMO choice matters, and a thorough, and regular QA review is mandatory for the continued success of your operation.

“The hits keep coming: Apotex loses 31 drug approvals after FDA cites plants for ‘inadequate’ controls”, by FiercePharma.

5. A new approach to safe PBD utilization

PBDs had a bit of a rough year and went from being the savior to being something of a pariah. With the failure of Rova-T and SeaGen cancelling all of their PBD projects, there was quite the scramble to figure out what would be next. Spirogen announced at World ADC London that they are working on multiple different PBD-like payloads with lower potency.

However, in this case they are going another way. They are looking at masking the epitope of the ADC in order to increase the target specificity and therefore decrease the off-site toxicity that has been prohibitively high in PBD based ADCs to date.

“Synthesis and evaluation of pyrrolobenzodiazepine dimer antibody-drug conjugates with dual β-glucuronide and dipeptide triggers”, by ScienceDirect.

Will this approach work? Maybe. But is it worth investigation? Absolutely.

Justin’s Thoughts :

This is the inaugural article attempting to digest down the happenings in the ADC world for the week. In my experience, it is very difficult to stay up to date with all of the happenings in the industry while also working on progressing our own research.

If this sounds familiar, then you are the reason that I have tried to collate and highlight the major happenings in the ADC world this week. If you would like to see me continue to bring ADC specific summaries please let me know in the comments section and I will continue putting together summaries at the end of each week.

Also, in order to put together these summaries, I have been aggregating the links to each of the ADC specific articles / manuscripts / webinars etc. that come out during the week. If you would like to check out a list of all of the ADC articles that I have been able to find, then please check out my blog.

And if there are any articles that I have missed or that you would like to discuss, please don’t hesitate to reach out and let me know.

Have a great weekend everyone.

Justin.


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