CureLab Oncology’s Elenagen: DNA Vaccine Shows Promise in Immuno-Oncology and Beyond
August 15, 2024
CureLab Oncology’s CEO shares Insights on biotech entrepreneurship
October 21, 2024CureLab CEO Dr. Alexander Shneider Unveils Promising Cancer Treatment at 2024 MedInvest Conference
Dr. Alexander Shneider, CEO of CureLab Oncology, recently captivated the audience at the MedInvest Biotech & Pharma Conference in New York City with a presentation on Elenagen, the company’s cancer treatment currently in clinical trials. Elenagen, a plasmid-based therapeutic, has shown remarkable promise in preclinical and clinical studies, offering hope for patients with various cancers, including ovarian and breast cancer.
In his presentation, titled “Turning Cold Tumors Hot: A New Hope for Cancer Treatment,” Dr. Shneider provided an overview of Elenagen's unique mechanism of action, highlighted key clinical trial results, and discussed the company's plans for bringing this innovative therapy to market.
1. Introduction to CureLab Oncology and Elenagen
2. Mechanism of action and clinical trials
3. Applications for ovarian and breast cancer
4. Business model and investment highlights
5. CureLab Veterinary and future directions
6. Q&A
Watch the full presentation below and read the complete transcript for detailed insights into this exciting new development in cancer treatment.
And all of you know this word: next.
Next will be our company, CureLab. Quick story. But legally, I have to remind you not to buy any stock based on what you hear from me. But you're not stupid, you wouldn't be doing it anyways.
In our culture, we like all these nominations: man of a year, a woman of a year. Unfortunately, a molecule of a year.
And I would not be surprised if one day we will have a molecule p62 nominated for a molecule of a year. Because you have thousands and thousands of papers on different biological functions this molecule performs in a cell.
And all these papers are irrelevant to our work, so I don't, thanks God, I don't have to cover them now.
What we did, we took a gene, of this molecule, p62, and inserted it into a circular DNA called a plasmid, similar how to a letter would be inserted into an envelope to be properly delivered. And this new product a circular DNA plasmid encoding p62, I named it after my wife, Elena. Tomorrow and on Friday, we will be dancing here in New York and go with you.
What is trivial is that at first we tried it on a wide variety of cancer models in rodents, mice, rats. What is much less trivial than after it was successful, we tried it in cats and dogs. As you remember, the main theme of comparative medicine, that Homo sapiens is a good model for a dog.
Then we conducted CMC. Actually, we hired Aldevron, and back then, Michael Chambers and John Ballantyne, were just very young, forward-looking, poor entrepreneurs when they sold Aldevron later for 9.6 billion dollars.
John Valentine became our first investor. He told me I know every plasmid. And I know yours is one of the best I produced it.
CMC. Then, we did overseas a clinical toxicology. By the way, after my talk, I would be happy to talk to NIH guys because we submitted already our stuff to the FDA. And the FDA said everything is good, but we want you to add just a couple of experiments. We can do it at our lab, but maybe you guys from NIH can help us to save money on this.
Then we conducted phase one, demonstrating not only all great safety, but also some initial, clinical benefits. Then we did, once again, ex-US phase two clinical trial, for the deadliest form of ovarian cancer, which is called platinum-resistant ovarian cancer, and demonstrated highly statistically significant clinical benefits. And a high degree of safety.
How does it work? There are two modus operandi. There are two mechanisms which we think about already. Maybe third, fourth, and likely fifth will appear tomorrow. The original one was pretty trivial. Take a DNA, insert p62, because p62 is overly expressed in cancer cells and nowhere else, and you will have adaptive immunity against cancer cells only.
Boring, but cool. What we couldn't envision and what was a completely serendipitous discovery, so I'm the only one on this podium today who is rather lucky than smart, is that Elenagen turned cold tumors into hot ones.
Chemotherapy, radiation therapy, immune therapy. In a way, all of them do mostly one, the most important work, they increase the number of cancer-specific lymphocytes and NK cells, cancer-specific immune cells. But what would be a benefit of having these cells if they cannot penetrate a tumor? It's like Israeli soldiers who cannot penetrate Hamas tunnels.
No avail.
So, the biggest problem with so many tumors today is that we have 101 ways to generate an exuberant number of anti-cancer lymphocytes, and NK cells. But the majority of tumors are impermeable for those lymphocytes. They called cold tumors.
So, what our product, and it was a serendipitous discovery, what it does, it turns cold tumors into hot tumors. Now, if you look at these brown spots in the picture, you will see while they are brown since they’re specifically stained for CD3 lymphocyte marker. Now the tumor is filled with lymphocytes.
Why does it happen? Because the product changes tumor microenvironment, for example, it changes extracellular matrix. Typically, extracellular matrix, and I'll just give one example but there are more published, typically, a tumor extracellular matrix is dominated with collagen 1.
Why does it happen? Because the product changes tumor microenvironment, for example, it changes extracellular matrix. Typically, extracellular matrix, and I'll just give one example but there are more published, typically, a tumor extracellular matrix is dominated with collagen 1.
And Elenagen will be used, thus, in a combination with immune therapy. The bottom panel shows how in animal models it enhances classic immune adaptive therapy, but also with radiation and chemotherapies which are all working through immune cells. Okay, so it's about the product.
What's about the company? Our first focus will be predominantly on women's cancers, ovarian cancer, breast cancer. But we have also a long list of other cancers in the pipeline. Our business model is investor friendly, derisking business model.
We go to certain countries where quality of clinical trials are very high, but the market is very small. And we tell the local government, you run on your buck our clinical trial in exchange for local rights. And if it works, we bring it here to repeat and extend clinical trials here in the United States.
So we first focus on women cancers. I'll show later we have, because of the serendipitous discoveries in the mechanism, it turns out that Elenagen works for diseases of chronic inflammation outside of the cancer realm.
We have patents granted in more than 20 countries. And we have a great, rounded management team.
Here you see a clinical trial in platinum-resistant ovarian cancer where 20 women were treated either with gemcitabine alone or with gemcitabine in combination with Elenagen.
With Gemcitabine alone 50 percent of women had their disease progressed within 2. 7 months, while in combination with Elenagen it was 7. 2 months. Even more interesting is that 100 percent of women had their disease progressed within less than one year if it was chemotherapy alone. But almost 40 percent of women did not progress at all during the time of observation, if it was a combination with Elenagen.
Highly statistically significant.
Now we will repeat and extend it here in the United States. The protocol was submitted as a pre-IND to FDA and they were highly amicable. We have a great principal investigator key opinion leader in ovarian cancer world. And the fact that FDA was amicable was not surprising because we didn't write that protocol.
Gynecologic Oncology Group Foundation, which is the number one key opinion leader group wrote it with us and for us.
Another application is the deadliest form of breast cancer, triple-negative breast cancer. For example, here's a woman, 38 years old treated with CMF plus Elenagen and within six months both primary tumor and metastatic lesions gone.
In second clinical trial, we want to raise investment for is triple-negative breast cancer run here in the United States. And once again, we have KOL principal inves tigator.
Long story short with the money we are raising now, we hope to have our products to go through phase two clinical trial within 36 months and then to be licensed out.
You can study an entire geography course based on the patents, which we have already. And when I came to America, I was extremely poor and what took me out of poverty was killing somebody else's patents on behalf of big companies. Good luck to challenge our patents. We are not window dressing patents.
Our patent strategy is completely different from any other patent attempts on p62 because we're not using p62 as a target.
For the sake of saving time, and because all of you are either investors or biotech experts, I will not talk about market size because if you don't understand that breast cancer and ovarian cancer are big markets, I don't need you as investors.
We. serendipitously found that our product systemically reduces a wide range of pro-inflammatory cytokines, increasing anti-inflammatory cytokines. Immediately it led us to understanding that there are other applications of the product.
Why does it reduce chronic inflammation? It does it indirectly by influencing mesenchymal stem cells and rejuvenating mesenchymal stem cells. It immediately led us to an idea of other applications for example, diabetic food.
I'm the only good guy in the management of our company. I'm good in two ways, no good and good for nothing, but everybody else is excellent. We have business people with prior successful exits. Scientists with many thousands of references. Lawyers. Financial people, medical gurus, geographical, regional experts.
So here are all the bases for success.
Finally, we have a sister company, a separate business, which is called not CureLab Oncology, but CureLab Veterinary, which re-applies all these inventions for cats and dogs and horses. Pet animals.
We saved 10 out of 11 dogs with breast cancer. We have videos with great success with osteoarthritis. So, if you want to discuss either of these two companies, feel free to come and talk to me or approach our company later. Thank you.
You inject p62 encoding plasmid intramuscularly. You induce adaptive immune response, which now circulates all over the body. Comes to a tumor. Ah ha! Cancer cells overexpress p62. Typical immune attack. That is a boring part. It's so boring that even I could envision it.
What I couldn't envision in my imagination. We inject this plasmid. It makes mesenchymal stem cells and pro-inflammatory cytokines to shift into anti-inflammatory state.
How? Indirectly. It induces certain signals which travel, (I don't know by the way yet what those signals are), which travel long distance and reduce chronic inflammation remotely. Ah, it reduces chronic inflammation, it changes the intratumoral microenvironment. It changes the intratumoral microenvironment: a cold tumor becomes a hot tumor.
It means now anticancer lymphocytes, or whatever cells targeting cancer associated antigens, can penetrate the tumor. Now it works.
Now, there are words which belong to a museum of science history, but not to me. Welcome to the conference on Chemotherapy and Radiation Therapy. There is no such thing as chemotherapy or radiation therapy.
There is chemo-induced immune therapy. There is radiation-induced immune therapy. And there is classic immune therapy. All of them don't really work very well with cold tumors. So coming as an adjuvant, as a substitution, okay?
