Trastuzumab

I'm a physician by training, but I had also done a postdoc in Mark Green's lab at Penn.

He, of course, is the man who developed the technology that led to Herceptin and a lot of other targeted cancer treatments, antibody-based cancer treatments.

So after being at University of Pennsylvania for a number of years, I saw a lot of people who were leaving academia, starting biotech companies, doing good science, but they had no idea how to develop a drug.

So I decided to take a different path.

And this followed on zongurtinib, which also has an accelerated approval indication in this space.

So the first thing I want to talk about is the press release of FAM, Trastuzumab, Durex, TKN.

This press release says that the percentage of HER2 mutant lung cancer is 2 to 4%.

But if you look closer at the press release, they're really only referring to lung adenocarcinoma.

HER2 also has an extracellular and intracellular domain, and mutations can happen in either domain.

The most common mutations happen in the intracellular domain, and these are the exon 20 insertions, and these are what are targeted by our HER2 DKIs, as well as fam-trastuzumab-derx-tcan.

The rest of the mutations are extracellular, and these are only targeted by FAM, Trastuzumab, DERX, TKAN.

And I only mention this because I will not be focusing on the extracellular domain here because these patients can only be targeted with FAM, Trastuzumab, DERX, TKAN.

And so, you know, just for people in the audience that can think of clinical trials as a phase three, for example, when we looked at in triple negative breast cancers, adding immunotherapy to the chemotherapy, that had to be tested out and shown to be better than just chemo alone.

Same thing with Herceptin for HER2 positive breast cancers.

Now, we've had that on the market for years and years, but it re- it initially started as a clinical trial, and it now changes the entire algorithm of how we treat women with HER2 positive breast cancers.

And those are just two simple, um, examples, but I thought it was worth pausing here just to explain for anybody who might not know.

You know, i-in that long am-amount of time, it's been quite varied.

I started as a scientist doing really oncology diagnostics development in breast and prostate, again, through the tools enabling kind of discovery of biomarkers through that, including biosensors and flow cytometry, to even working at Dako, where we launched the very first companion diagnostic test, which in fact was with breast cancer and, uh, HERCEP Test and Herceptin.

You know, I've spent a bunch of time in the hemonc space as well as in the molecular space when it comes to that, and also quite a bit of time in gastroenterology.

Hmm.

No, it's a very nice result.

HER2 has been known for a while, and years ago, Herceptin was tried in this setting, a naked antibody, and that didn't really work much.

So I think using the ADCs make a lot of sense, and it's very impressive, and I think it gives us a new option for our patients.

I wonder if we can get even more specific someday by looking at the specific mutation and whether the receptor is internalized or not, and I think that probably makes a difference as well.

Very interesting.

Interestingly, when I question my personal medical oncologist, who actually wrote the foreword to my book and is at the top of the top of the top, he is the father of Herceptin, which saves so many women now who are her two positive cancer patients.

And when I asked him about Dr. Blooming and Estrogen Matters, and he said, look, I know him, he's wonderful, but I have my own thoughts specifically for me, right? Especially with the recurrence.

And so that's where that conversation with your oncologist, with your team, with your other doctors is very important because the general rule is, you know what, systemic, So we're talking about the transdermal patch or oral.