Atossa Therapeutics: This Drug Developer Is Dedicated To “Transforming The Breast Cancer Paradigm”
Atossa Therapeutics is a clinical-stage biopharmaceutical company developing innovative medicines in areas of significant unmet medical need in oncology with a focus on breast cancer.
Its lead drug candidate, (Z)-endoxifen, is designed to work in all three areas of the current breast cancer paradigm: the Prevention Window, the Neoadjuvant Phase, and the Adjuvant Phase. It does this by reducing the density of breast tissue, reducing the cancer cell activity before surgery, and reducing the risk of new cancer after surgery.
Its lead drug candidate, (Z)-endoxifen, is designed to work in all three areas of the current breast cancer paradigm: the Prevention Window, the Neoadjuvant Phase, and the Adjuvant Phase. It does this by reducing the density of breast tissue, reducing the cancer cell activity before surgery, and reducing the risk of new cancer after surgery.
Transcript
00:00 Welcome, it's Michael Murray with Benzinga and here with me today is Dr. Stephen Quay,
00:06 MD, PhD and President and CEO of Atosa Therapeutics.
00:09 Dr. Quay, it's great to have you with us.
00:11 Thank you for joining us.
00:12 Great to be here, Michael.
00:13 It's great to have you here.
00:14 Let's go ahead and kick things off with a quick introduction to the company.
00:17 Can you give us a quick overview of Atosa and what you do with the company?
00:20 Sure.
00:21 Atosa Therapeutics, ATOS on NASDAQ, is a public company.
00:26 I am the founder and CEO of the company.
00:29 We're focused on breast cancer.
00:31 We have a patented drug that we're developing in all, really all phases of breast cancer.
00:36 Understood.
00:37 And what's your background specifically?
00:39 How did you come to be CEO of Atosa?
00:41 So I'm a physician scientist.
00:42 This is the seventh company I've started.
00:44 I got an MD, PhD at the University of Michigan, post-doctored at MIT, did a residency at Harvard
00:50 and taught at Stanford for about a decade when I invented the drug that's used for MRI
00:55 imaging, gadolinium.
00:57 Went off into business and now this is company number seven.
01:00 So in founding this company, my real goal is to prevent breast cancer.
01:05 Happens about 250,000 times a year in the US.
01:09 So about one every minute while we're having this conversation.
01:12 Understood.
01:13 Now tell us about Z-Undexafen.
01:14 What makes it novel?
01:16 It's one of the most exciting things that it sounds like is in your docket.
01:18 Can you give us a little bit more background on this?
01:21 So it is the most potent inhibitor of the most common breast cancer.
01:26 So ER positive breast cancer is about 80% of all breast cancers.
01:30 So that'd be 200,000 out of the 250,000 new cancers every year.
01:34 And it inhibits the cancer in three different ways, which is always good because cancers
01:39 can sometimes try to escape.
01:41 But when you're hitting it from three different sides, you're doing something very special.
01:45 It is a blocker of estrogen on the receptor.
01:48 So it just interferes with the receptor being occupied by estrogen.
01:53 It degrades the receptor, which means you have fewer receptors.
01:57 So even at the low point of its blood level, it's still doing its thing.
02:01 And it has a separate pathway, protein kinase C, beta inhibition at higher doses.
02:07 So no other hormone, drug in breast cancer does all three of those.
02:12 And endoxifen does.
02:14 Understood.
02:15 And what's the long-term vision for endoxifen and endotoxin?
02:17 What does the road look like ahead of us here?
02:19 So breast cancer starts in prevention, where you have women at high risk of breast cancer
02:24 because they have a small lesion in their breast called atypical hyperplasia, or they
02:29 have high density on mammography.
02:31 Either of those can lead to carcinoma.
02:34 So treating that phase for six months is one of the clinical trials we're doing at the
02:39 Karolinsky Institute in Stockholm.
02:41 Neoadjuvant phase, where they've just been diagnosed, but they haven't been treated yet,
02:45 a six-week to maybe three- or four-month period of time.
02:48 We're trying to reduce the cancer size in that period to make the surgery simpler.
02:53 And then the adjuvant phase, which is what you give a woman after her surgery to prevent
02:58 a local recurrence or to prevent a new cancer in the other breast.
03:02 Because once you've had breast cancer in one breast, you're more likely to get it in another.
03:06 So endoxifen is right from the sort of the alpha to the omega of breast cancer.
03:11 Got it.
03:12 And you also have three ongoing phase two trials.
03:14 Can you tell us a little bit about each of them and where they stand currently?
03:17 Sure.
03:18 So the trial to prevent breast cancer is being done in Sweden.
03:23 It's a six-month on-drug trial, placebo-controlled, 240 women.
03:27 So 120 will get a placebo, 120 will get the active drug.
03:32 And we're looking at the density of the breast on mammography being reduced in three months,
03:36 six months, because that is a surrogate for reduced incidence of cancer.
03:40 And then we'll look at durability out 18 months.
03:43 So last woman should start that six-month drug treatment in December this year, meaning
03:48 by June we should finish dosing.
03:51 By July we should be reporting very exciting results from that trial.
03:56 Neoadjuvant trial is being done at the Mayo Clinic and at UCSF, in Mayo Clinic in premenopausal
04:03 women only, UCSF in both premenopausal and postmenopausal women.
04:08 But again, this is treating the women in that window between their diagnosis and their therapy,
04:14 again, about a month, maybe four months, looking for reduction in size of the tumor, reduction
04:19 in a marker of cell growth called Ki67, reduction in imaging, MRI size of the tumors.
04:27 So those are the two trials in the neoadjuvant phase.
04:30 Got it.
04:31 Now, Stephen, you guys just presented at the Cancer Fitzgerald Global Healthcare Conference
04:34 of 2023.
04:35 Can you talk to us about this presentation?
04:37 What were you at the conference to share?
04:39 Well, it was a sort of a new format.
04:41 I've been doing biotech for a little while here.
04:44 A new format called a fireside chat.
04:47 So we basically, like we're doing here, had an interactive conversation.
04:51 I think it's much more informative when I talk to all the shareholders, and it was a
04:55 standing room only presentation.
04:57 They really appreciated the informal format.
05:00 So the key points there were to get across that we have these three major trials in prevention
05:06 and in neoadjuvant phase.
05:07 They all have readouts beginning in June or July of next year and going into the end of
05:12 next year.
05:13 So this is a great time to get in the stock because we'll be presenting data.
05:18 So a year from now, you'll know about the results of these trials.
05:21 Got it.
05:22 That's excellent news.
05:23 And a final question for you as we close out here.
05:25 We want to understand what kind of impact has AI had on cancer research from your perspective?
05:30 What impact is it going to have in the next five years?
05:32 Yeah, so we're actually doing some work in AI from the perspective of thinking about,
05:39 gosh, if endoxifen does these special things and is so different from other drugs in breast
05:44 cancer, maybe it has a role in other cancers.
05:47 There's a very complex analysis that looks at 15,000 different parameters in a cell and
05:53 then looks at what could affect those 15,000.
05:56 It's a mathematical formula that's way beyond the human brain to be able to process.
06:01 So we've partnered with an AI company to have us look at where endoxifen could have roles
06:06 outside of breast cancer.
06:09 And we haven't told you what the outcome is, but we're pretty excited about that program.
06:12 So AI has got a great future, but it has a great present at Atosa Therapeutics right
06:18 now.
06:19 Wonderful.
06:20 Dr. Stephen Quay, MD, PhD, President and CEO of Atosa Therapeutics.
06:23 We really want to thank you for joining us here today, sharing more about what Atosa
06:27 is doing.
06:28 And we certainly look forward to seeing what happens in the future.
06:30 Good speaking with you.
06:37 (upbeat music)