Healing Horizons: Georgiamune Founder Dr. Samir Khleif Aims to Unlock the Full Potential of Cancer Immunotherapy Born in the US, and aided by the support of the Qatar Foundation's Arab Global Scholars Program, Georgiamune's solutions target all types of cancers as well as autoimmune diseases.

"The idea at the time was: is it possible to develop therapies that employ our immune systems to fight cancer?" recalls Dr. Samir Khleif when speaking about his time at the US-based National Cancer Institute (NCI)- a tenure that would eventually last a little over 15 years, from 1996 to 2012, and later lay the foundation for his US-based biotech startup Georgiamune. "When I was undergoing my oncology training at the NCI, which is part of the National Institutes of Health in the USA, there was an emerging field of study at the time called immunotherapy, which focuses on understanding how the immune system fights infections and utilizes it to fight cancer," Dr. Khleif continues. "We have known for a long time that our immune system is designed to discover and fight foreign invaders in our bodies, including viruses and bacteria. In a way, cancer is a foreign invader because it develops based on many mutations in our normal proteins. So, the idea then was to explore if it was possible to educate the immune system to identify tumors as a foreign invader."

Over time, Dr. Khleif -who introduces himself as "a physician, a medical oncologist, and a scientist"- decided that studying how the immune system works against cancers developed by viruses could help in developing therapies to help it fight other cancers as well. "One of the advantages of being both a physician and a scientist is that when you think about science, you think of its clinical applications and how it can help patients and cure diseases," he says. "As such, when I got interested in immunology, I started working as a researcher and a physician in the field of immunotherapy. Throughout my years working at the National Institutes of Health and afterwards as director of the Georgia Cancer Center at Augusta University, I conducted extensive research to further our understanding of the immune system and how we can implement it to fight cancer. Overall, I managed to secure almost 100 patents issued or pending in the field of immunotherapy and cancer research. With that I realized that the best way to utilize these patents and translate my research into therapies that could benefit cancer patients was to take the bull by the horns and start my own biotechnology company. This way, I would be able to utilize these patents, rather than leave it entirely to universities that usually are not able to commercialize these intellectual properties as effectively. So that's how it happened…"

Indeed, it was following the above series of events that Georgiamune was officially launched in 2018 in the American city of Gaithersburg. It was Dr. Khleif's time at Georgia Cancer Center that, in fact, lent itself to the startup's very name. "It's unusual but rather memorable, which is important," the founder adds with a smile. "Since we started the company four and a half years ago, we have been making new fundamental biological discoveries. We now have over 250 patents issued and pending based on our work. So far, we were able to develop 11 drugs for cancer and autoimmune diseases; three drugs are already undergoing clinical trials and we are in the process of developing more. Georgiamune is a very disruptive company in the biotechnology space, we are changing the understanding of how our immune system works and how it fights cancer and autoimmune diseases in unprecedented ways. I'm hoping that this will disrupt the whole therapeutic approach to cancer and autoimmune diseases, and that we can have a positive impact on the lives of our patients and on patient care, in general."

Source: Georgiamune

Now, one needn't delve into extensive research to understand the mammoth role Georgiomune could play in the fight against cancer. A February 2024 report by the World Health Organization showed that about one in five people develop cancer in their lifetime, while "approximately one in nine men and one in 12 women die from the disease." The report presents another worrying statistic: over 35 million new cancer cases are predicted in 2050, which is a 77% increase from the estimated 20 million cases in 2022 alone. In the absence of efficient cancer treatment, Georgiamune's promise of effective immunotherapy emerges as quite the beacon of hope.

"While immunotherapy actually led to the cure of many patients that were not able to be treated with traditional methods, like chemotherapy, radiation therapy, or surgery, just 20 years ago, it also addressed one of the most horrible aspects of treatment for cancer patients- the side effects.," Dr. Khleif elaborates. "Compared to other standard cancer therapies, immunotherapy does not cause some of the side effects such as decreased immunity, hair loss, and other symptoms. However, despite the revolution that immunotherapy led to in patient care, it has only worked for 15% of cancer patients. The remaining 85% still do not benefit from immunotherapy. So, what we're trying to do at Georgiamune is disrupt the field by advancing our understanding of the immune system and open new doors in how we treat cancer and develop novel drugs that can help the other 85% of patients that cannot benefit from currently available immunotherapy treatments."

Now, while cancer treatment remains a key point of focus for Dr. Khleif and his team, the Georgiamune services are also catered towards another major health-related area: autoimmune diseases. "Many autoimmune diseases are incurable or do not have effective therapies," Dr. Khleif adds. "Type 1 diabetes is an example, which we don't have effective treatments for besides giving insulin. So, the question is, can we develop drugs that could also treat these diseases based on our new understanding of the immune system that we are building upon at Georgiamune? Born out of this understanding is the idea of immune system reprogramming."

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Dr. Khleif then adds that the reason for targeting these two medical areas is due to a common factor between them. "In both cancer and autoimmune diseases, our immune system does not function well," he explains. "In cancer the immune system is underperforming, mainly because cancer suppresses the immune system, which leads to cancer evading the immune response. As for autoimmune diseases, it is abnormally over activated which leads to attacking our own normal tissues. Based on our new discoveries of how the immune system functions and how it fights disease, can we reprogram the immune cells and in particular, our T-cells to increase their activity and get them to supersede the suppressive mechanisms of cancer cells. This would make them more compatible to fight cancer. As for autoimmune diseases, the reprogramming would dampen down the over-active immune system and turn it back to the normal state."

Already, Georgiamune has three drugs undergoing clinical trials- two for cancer and one for autoimmune diseases. "These are all in very early stages and therefore have no available data at this stage- it's in progress, and as you know clinical trials take time for data to come out and we hope to start having some in the near future," Dr. Khleif reveals. "Drug development is not a fast process, because you need to pass multiple phases of clinical trials. Only after that can drugs be approved- this usually takes years."

Dr. Samir Khleif is the founder and CEO of Georgiamune. Source: Georgiamune

As patients and healthcare institutions and stakeholders thus await the release of Gorgiamune's novel drugs that aim to re-establish immune balance, Dr. Khleif shares that the final product will be effective against any type of cancer. "The type of cancer is irrelevant- whether it's colon cancer, lung cancer, or breast cancer, these therapies could work across different types of cancers," he explains. "It is the biology of that particular cancer that matters. As mentioned earlier, cancer patients have a suppressed immune system for many reasons, one important reason is that cancer cells develop many strategies to inhibit our immune system so they can develop into cancer. This is what we are trying to change and overcome- so the immune system works as it should. Based on that, immunotherapy and the reprogramming of those immune cells could eventually mirror existing immunotherapies that are effective across different diseases."

Having already completed a successful Series A round, the startup has also managed to capture the interest and support of investors along the way. "All the funding so far has come from top-tier institutional investors and blue-chip capital funds specializing in biotechnology," Dr. Khleif says. "Investors' reaction to our company's work and growth has been extremely positive. We were one of the few biotechnology companies able to raise substantial funds in 2023, which was a challenging year for biotech fundraising overall. We had to significantly upsize and increase our Series A raise target because of the high interest from investors. In the end, we secured more than double our original goal."

In the midst of such business-related milestones, the startup also partook in the Arab Global Scholars program- an online community, helmed by the education and research non-profit organization Qatar Foundation, that fosters innovation-focused connections among Arab scholars, innovators, researchers, and scientists. The program -a celebration of Arab-led contributions to the global science, technology, engineering and mathematics (STEM) field- has thus enabled Dr. Khleif to introduce Georgiamune to Qatar and the wider region. "The Arab Global Scholars gathering in Qatar was very interesting and productive," he notes. "I did not know what to expect, but I found major takeaways. One was the opportunity to meet like-minded scientists and entrepreneurs that are interested in the development of cutting-edge industries or cutting-edge technologies within their industries. The second thing is that there is a tremendous opportunity in the region for the development of such industries. From my discussions I found that Qatar and Qatar Foundation are extremely serious in their commitment to the development of the biotechnology industry. Also, the time is right. Because if you look at the map of where biotech hubs exist in the world, the MENA region is kind of a desert. This presents an opportunity, particularly now with the advancement of biotechnology and supporting technologies, including artificial intelligence (AI)."

And while his time at Arab Global Scholars introduced Dr. Khleif to the region's many opportunities and advancements, it has also allowed him to more closely observe the areas that could do with refurbishments. "Unfortunately, at this stage, the biotechnology presence in the MENA region is still low and there are not too many players in this field," the founder says. "There is a lot of advanced and transformative science coming from the academic institutions, but developing an infrastructure that can support the translation of such discoveries into a biotechnology industry is involved and requires multiple factors to exist. It takes human resources. Not just scientists, but also experts that know how to translate that science into biotech innovations and commercialization. That is a major field of expertise that currently is not significantly available in the region. The development of biotechnology supporting infrastructure, such as high-quality manufacturing facilities and a biotech informed funding apparatus, are two more important factors. As such, we must establish funds to develop those ideas from their academic incubation and turn them into biotech companies. These funds will need to be substantial, as companies in this industry usually need hundreds of millions of dollars that is usually from public and private sources that are specialized biotechnology."

Source: Georgiamune

For his endeavors in not just attempting to create what could be a major healthcare breakthrough, but also efficiently leading his business, Dr. Khleif was chosen as one of the winners of the annual Entrepreneur of the Year award by global professional services provider EY. "It's always great for people to recognize the hard work that you have done, but importantly this is an award that recognizes the whole team, because the amazing talented team of scientists, clinicians and operation that surrounds me is what makes great things happen and wonderful ideas develop into reality," Dr. Khleif says. "These awards always help to keep a person motivated and demonstrate that you are on the right path. I'm hoping this achievement would help Georgiamune and its great team to continue development of better drugs that are presently incurable that enable us to help patients and human beings around the world in overcoming those diseases."

At this point, one may certainly wonder how the founder has been able to balance between his role as a scientist and a startup founder without fumbling either of the two responsibilities. "Resilience, resilience, and resilience!" Dr. Khleif replies. "As any entrepreneur will tell you, the journey of building an organization or a company from the ground up is filled with daily challenges and unpredictability and requires continued resilience. The road is usually often filled with more challenges and doubts than highs, so you need to make sure these hurdles are temporary and that they are addressed as you continue your journey. Every day, there is a new hurdle that arises, and you need to address and solve it. That includes the development of technologies, contracts, manufacturing, fundraising, and so on."

In a pleasant revelation, Dr. Khleif shares that inculcating grit and a never-say-die attitude into his entrepreneurial journey was, in fact, quite a familiar route to take up- and will continue to steer the startup's journey in 2025 and beyond. "As scientists and physicians, we are faced with this daily- in our line of work, things don't work the first time or even the tenth time," he continues. "You must then change your hypothesis, or the way you think about the issue and be adaptable. This mindset helped me a lot in developing Georgiamune into what it has become today. When you create something from the ground up, lots of things are experimental. There are no books for this process. You could wake up and face multiple issues at once. Then you have to think out of the box and keep moving forward. Building a biotech company, and industry, is a long-term commitment and the involved investment is usually a long term one too. But it does pay back in a substantial manner!"