i24News interviews Professor Michael Levitt
December 15, 2022
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i24News interviews Professor Michael Levitt
NeoTX Profiled in the Jerusalem Post
Three Nobel Prize winners and an immigrant to Israel from Chicago are developing a drug that stimulates a patient’s immune system
so that it can fight cancer on its own.
“We forget we have powerful immune systems and sometimes we need a nudge to get them going,” says NeoTX chief advisor and
Nobel Prize laureate Prof. Michael Levitt. He was awarded the 2013 Nobel Prize in Chemistry for the development of computer
simulations of biological molecules. Levitt joined NeoTX last spring when it acquired InterX, a company that was using quantum mechanics to discover and design therapeutic molecules based on his work.
Two other Nobel Prize winners – Prof. Roger Kornberg, who serves as chairman of the board, and Prof. Arieh Warshel, an Israeli American biochemist – are also actively involved.
NeoTX’s technology is basically a “coating” of the cancerous tumor with bacteria, which stimulates the immune system to attack
it when it enters the body. Early results from Phase I and Phase II trials of its drug naptumomab estafenatox (NAP) show when combined with more traditional cancer therapies – such as chemotherapy – show a promising response.
“Cancer drugs can be very helpful, but they are all subject to resistance,” explains NeoTX CEO Asher Nathan. “For most patients, they only work for a certain amount of time and then the cancer breaks through…. We think the key for patients is to have responses that are going to last longer. What we are doing is not so much trying to cure cancer, but to get the immune system back on track so it can kill the cancer on its own.”
He says that on average, people develop five pre-cancer cells a day, but they don’t develop cancer because the body fights and kills these cells. “We are all getting cancer and all getting cured by our immune system,” Nathan says.
The challenge is that sometimes cancer cells can “hide themselves” from the body’s immune system so that it does not recognize them as a threat. Other times, they can influence the immune system not to kill the cancer cells or even use the immune system to thrive or multiply. NAP binds genetically engineered bacterial components to the tumor surface “fooling the immune system to thinking it is being attacked by bacteria and triggering a strong antibacterial immune response,” Nathan says.
In June, the company launched a Phase II trial in the US focused on patients with nonsmall cell lung cancer (NSCLC) who have been previously treated with chemotherapy and checkpoint inhibitors. NAP is being administered with docetaxel, a widely used cytotoxic
chemotherapeutic agent that is a standard of care for people with NSCLC. The safety of NAP in combination with docetaxel was previously shown in a small Phase I trial in the US, also involving patients with NSCLC. In that trial, one patient lived for 11 years which is much longer than would have been expected with docetaxel alone. “Patients who enroll in Phase I trials like this one are generally out of options and they know they are at the end. So, when a patient survives, it is like a miracle,” Nathan says. “This one patient was expected to live two or three more months at most. But he took the drug and after six months he was able to stop taking any drug and live cancer free. It’s not something you see everyday.”
‘We have amazing bodies’
Although Nathan says he does not want to get people’s hopes up and he would not yet tout NAP as a “new cancer breakthrough” or something that is “going to eliminate cancer,” he is confident the drug represents “a shot at working and a lot of promise.”
The company is in the midst of a new funding round and Nathan says he hopes to use the money to launch more clinical trials and develop more drugs if the Phase II results come back as he hopes by the summer of 2023. Levitt says that the world went into a panic when COVID-19 struck and there was a frenzy of pharma companies searching for vaccines and other cures. However, “there is no doubt that cancer causes much more death by any measure than the pandemic caused” and is a much more complicated disease. Therefore, he sees his work with NeoTX as something for the long term.
“If you look back 50 years, when someone would get diagnosed with cancer they would start preparing for their funeral,” he tells the Report. “Now, you can recover from cancer. We have made great progress.” But he says that the world is ready for the next revolution in cancer treatment. “I think what is novel with NeoTX is that they treat cancer by getting the body to fight the cancer better,” Levitt says.
He adds that people lived for two million years without modern medicine. Science and technology has enabled people to live longer. “NeoTX reminds us that we have amazing bodies and our bodies have amazing defense mechanisms. Tapping into these is a great idea,” he says.
When can patients potentially get access to NAP if it works?
“Very soon,” says Nathan. “If the Phase II results look good, then we hope to go into a registered Phase III trial that will take about two years. Then, by 2026 or 2027 the drug could be approved.”
NeoTX Therapeutics in the JPost:
NeoTX Interview – Geektime.com
Israeli startup NeoTX is a biopharmaceutical company that focuses on research and development in the field of oncology. Founded in 2015, NeoTX developed a Tumor Targeted Superantigen (TTS) platform technology which was inspired by the fact that the immune system is much better at killing bacteria than cancer cells. The TTS has two components: a TAA (Tumor Associated Antigen) which is a molecule that attaches to cancer cells and a Superantigen Peptide which can activate a controlled, natural, antibacterial immune response. What the TTS does, gis it coats the tumour with a superantigen (bacteria) and lets the body’s immune system do the work; the immune system attacks the bacteria and subsequently the tumour it surrounds. This ultimately converts a weak antitumoral immune response to a strong, antibacterial one, and has even worked in patients who are not responding to their standard immunotherapy treatment. TTS technology has the potential to challenge the effectiveness of other cancer treatments such as chemotherapy and CAR-T cell therapy, as the advantage of TTS that is not seen in chemotherapy, is that the immune system is used to attack cancerous tumours that develop alongside the disease and provides an active response to the development of the tumour.
We sat down with Asher Nathan, one of NeoTX’s co-founders, and CEO, to better understand the journey that brought him and NeoTX to where they are today.
Nathan is a Chicagoan who moved to Israel many years ago. He started his career at the University of Illinois where he received a BSc in chemistry and biology. He then continued his studies at The Hebrew University of Jerusalem. Since completing his education, he has had an impressive track record in the field of biotechnology; he was Managing Director at Paramount Biocapital, drug development and investment firm; founded IntelliGenne and EvoRx, two biotech companies; and served as a Managing Partner at Zoticon Bioventures, a company he co-founded. His career has led him to gain extensive experience in biotechnology, business strategy and development, and entrepreneurship. Moreover, he has authored over 25 patents in the biotechnology field.
Though Nathan has dabbled in other specialties within biotech, he has gravitated toward oncology: “Oncology has always been closest to my heart. I love the challenge. I compare it to the lure of a casino. What we are setting out to do looks easy – kill the out-of-control cancer cells without killing the healthy cells– yet no matter what you throw at them, they appear more intelligent and evolve resistance faster than we can develop new drugs.” It is this challenge that drives Nathan every day. He has two strategies for running NeoTX and that is to think differently and think big. He explained to us that to overcome such a daunting task, such as killing cancer cells, you need to have a different approach than all the other biotech companies striving to achieve the same thing. “It is nearly impossible to have a unique drug in immune oncology. It is a very crowded space as there are at least a handful of companies for every new approach. Most Companies are OK with having competition because it gives them the impression there is safety in numbers, but we have a different approach: we have managed to be the only oncology company – that I am aware of– based on superantigen technology. So, in that, it is evident that we are not afraid to swim alone in the deep waters without a lifeguard because we know whatever sunken treasures we find belong solely to us; we have found a different approach that is worth fighting for.”
On his second strategy– thinking big– Nathan explained that as an oncology company with unique technology for cancer immunotherapy, NeoTX has world-renowned drug development capabilities but lacks drug discovery competency. So, their challenge is to bring the two together: drug discovery with breakthrough technology and drug development. “By putting the two together, we have a much bigger dream: an integrated company with assets and technologies that can drive innovation into the next decade and can make us a leading company for oncology treatment.”
“When I wake up every day, I tell myself to believe in the team and product and to lead the company by example. That is what gets us through each day, which has its own challenges, triumphs, and failures. But from these experiences, we learn, and we make improvements for next time.” He went on by saying that he knows from first-hand experience how challenging it is to hit the ground running on a startup, especially in biotech, with a lack of capital and data working in a constant loop against you. But when doubts fill your thoughts, you just have to think of your purpose: “Although it’s fun to see promising ideas get funded, it is far more satisfying to be part of the action and feel the thrill of seeing patients spared certain death because of something you are doing. When you see a patient with intractable cancer whose tumour is proliferating, which typically means he should have had less than 3 months to live, respond so well to the treatment from our technology, that after 2 years, he is still cancer free, you understand that what you are doing– the struggle to make this startup a success– is well worth it.”
When we asked Nathan about his experiences here in Israel, as an entrepreneur and scientist, he gave a beautiful anecdote that sums up the spirit of Israel as the Startup Nation. He told us about a time during the COVID-19 pandemic when one of their partnered hospitals’ labs shut down. “When a patient in a trial receives our experimental drug, we need to take their blood and analyze it right away. During the peak of the pandemic, there was an instance where we unexpectedly couldn’t send it to the hospital we normally work with, so we were frantically trying to find a solution. We were able to find another unrelated hospital with a lab willing to volunteer to do the testing and a taxi driver who was patient enough to fetch it from the hospital and drive it to that lab which was in a completely different city. Such a chain of events would happen anywhere else in the world and is a true testament to our great nation.”
NeoTX was founded in 2015 by Asher Nathan (CEO), Ramona Lloyd Ph.D. (VP Regulatory), Marcel Rozencweig MD (President, Former Chief Medical Officer), Roger Kornberg Ph.D. (Chairman of the Board, Former Chief Scientist) and Robert Harow (Chief Financial Officer, Chief Operating Officer). To date, they have raised over $80 million. They are headquartered in Rehovot, Israel, with 50 employees worldwide.
Credit: GeekTime
NeoTX Featured in Israel21c
By Brian Blum JULY 5, 2022, 12:40 PM
Immunotherapy holds perhaps the greatest promise for fighting cancer in the 21st century. Rather than bombarding the body with toxic chemicals, as in chemotherapy, immunotherapy utilizes the immune system to neutralize malignant tumors.
The only problem: It only works in about 20 percent of patients with solid tumors.
The reason is straightforward, but still represents a vexing roadblock for cancer researchers: Tumors are not an infection coming from outside but an internal malfunction of the body’s own cells, which begin to replicate out of control.
“Cancer looks like us. It’s hard for the immune system to identify,” explains Dr. Asher Nathan, CEO of NeoTX, a Rehovot-based startup developing a novel way of knocking out tumors – by coating them in bacteria.
“Unlike with cancer, our bodies are finely tuned to attack bacteria,” Nathan says. “Bacteria is a billion years old. Our immune systems have had a long time to figure out how to effectively neutralize bacterial infections. That’s why you don’t wake up in the morning with a cold and think, ‘I’m going to die.’”
Cancer, of course, is a very different story. Compared with bacteria, “cancerous tumors are like the new kid on the block,” Nathan notes.
NeoTX is not Nathan’s first foray into medical technology; after immigrating to Israel 40 years ago from Chicago, he founded IntelliGene and EvoRX, two biotech companies formed around technologies he invented.
For NeoTX, Nathan identified and licensed a drug developed by the Swedish company Active Biotech called naptumomab estafenatox (NAP).
NAP is composed of two proteins: a genetically modified “superantigen” and an antibody that latches onto a tumor via a molecule called 5T4 found primarily on tumors.
A superantigen is a bacterial derivative that elicits a strong antibacterial immune response. NeoTX calls its technology “Tumor-Targeted Superantigen” or TTS.
Once NAP’s 5T4 antibody has attached itself to a tumor, the superantigen “reprograms” the immune system to mount an antibacterial response against the bacteria as well as the tumor.
“The concept behind this drug is, let’s coat the tumor with a bacterial molecule so that the immune system will go into ‘Defcon 1’ and attack the tumor as if it’s bacteria,” Nathan says.
The secret weapon
Once the immune system knows what to look for, it sends in the body’s secret weapon: killer T-cells.
The T-cells identify the bacteria-coated tumors, then start to create an army of cells primed to attack any superantigens they find. Nathan recommends the video below to see how T-cells work; they “grope around like a blind robot” and after hitting a superantigen, punch a hole in the cell … then insert a molecule that causes the cell to explode.”
It’s a fine balance. When fighting a bacterial infection, “the body can go crazy,” Nathan notes. “You can get a high fever that exhausts the immune system. That’s how the bacteria continue to fight. We genetically engineered our superantigen to be safer. It doesn’t generate as strong a response, but it still creates a very powerful immune reaction.”
Targeting bacteria is smart for another reason: Part of how tumors succeed in evading the body’s defenses is by releasing chemicals that weaken the immune response.
“Anything we do nearby the tumor becomes problematic,” Nathan says. But with NAP, “the tumor-killing T-cells are created far from the immune-suppressed tumor site.” Only then do they begin their journey to seek out and destroy the tumors.
Moreover, when the immune system encounters a superantigen bound to a tumor, it modifies the suppressive micro-environment around the tumor so that the body’s natural defenses are better able to kill it.
“This creates a natural, holistic and profound immune response,” Nathan says.
Reboots the immune system
But the best may be yet to come.
“When we’ve tested this drug in animals, we find that even when you try to reintroduce cancers into, say, a mouse that’s been cured by the technology, it doesn’t stick,” Nathan says.
“None of the mice that were ‘rechallenged’ got cancer again. The drug ‘wakes up’ the immune system – at least in mice – and we don’t need any more drug.”
Nathan likens it to the reboot function on a computer. “The drug reboots the immune system so it can do what it natively needs to do – remove the suppressive environment and kill as many tumor cells as possible. Then, the T-cells can go after more targets.”
NeoTX’s bacterial coating approach is currently in a Phase I trial in Israel and, based on encouraging results, has begun a Phase 2 trial in the United States with 30 patients.
One patient has non-small cell lung cancer that had metastasized to the liver. “That’s a death sentence, usually within four months,” Nathan says. The patient received NeoTX’s drug over a decade ago (prior to it being licensed from Active Biotech). “She lived for 11 years and died of something else, not her cancer.”
NAP plays particularly well with checkpoint inhibitors, another type of cancer treatment that aims to tamp down “checkpoints” created by the cancer that essentially trick the T-cells into thinking the tumor is a friend.
“It’s like a secret handshake in a college fraternity,” Nathan quips.
If the handshake were inhibited, so to speak, the T-cells would see the tumor for what it is – very much not a friend – and could attack. Combining NAP with a checkpoint inhibitor “allows our drug to kill more tumor cells,” Nathan says.
AstraZeneca collaboration
Pharma giant AstraZeneca is collaborating with NeoTX on the former’s own checkpoint inhibitor technology. The hope is that patients who don’t normally respond will have greater success in beating back their cancers.
Developing and commercializing any new drug can take up to 15 years and many millions of dollars. NeoTX has raised around $80 million so far. Nathan is optimistic that if NAP passes Phase 2 and 3 trials, it could hit the market as early as 2027.
While the technology has so far been tested on solid lung, esophageal and urethral cancer tumors, patients with blood cancer such as lymphoma and leukemia could benefit, too – in particular those who are candidates for CAR-T, a promising treatment that involves removing T-cells from a patient, engineering them for maximum killing ability in a lab, then reinjecting them.
CAR-T, a form of immunotherapy, tends to work well for blood cancers but poorly for solid tumors. That’s another aim for NeoTX – to provide a pharmaceutical complement that will allow CAR-T to be effective outside the blood cancer domain.
Immunotherapy has become a crowded field. “If you look at all the companies that are trying to elicit an immune system response, there are probably 1,000 out there. But for the specific mechanism we’re trying, it’s zero,” Nathan notes.
“One of our investors said to us, ‘You’re either geniuses or you’re crazy.’ I replied, ‘What makes you think it’s one or the other?’”
NeoTX has no shortage of geniuses. Roger Kornberg, the 2006 winner of the Nobel Prize in chemistry, is the company’s chief scientist (as well as a long-time collaborator with Nathan in his previous endeavors).
Michael Levitt and Arieh Warshel, who shared a Nobel in chemistry in 2013, are advisers. Dr. Marcel Rozencweig, a medical oncologist and 18-year veteran of pharma company Bristol Myers Squibb, where he was head of global oncology, is NeoTX’s president.
Recently, the head of global clinical oncology at Bayer pharmaceuticals, Dr. Scott Fields, joined NeoTX as chief medical officer.
“It is extremely rare that someone as high up as Scott Fields would leave pharma to work in such a small company,” Nathan tells ISRAEL21c. “It is even more rare that he would come to a company based in Israel.”
Cancer, sadly, isn’t going away anytime soon. “The average person develops around five cancerous or pre-cancerous cells a day,” Nathan notes.
“Our bodies are very efficient at killing, such that most people don’t get a new cancer every day. Our drug could level the playing field so the body can do what it’s meant to.”
Credit: Israel21c
NeoTX Featured in the Jerusalem Post
FDA Approval of IND Application for NAP (BioSpace)
NeoTX Therapeutics got the go-ahead from the FDA for its IND application for naptumomab estafenatox (NAP). NAP is the company’s lead Tumor Targeted Superantigen (TTS) molecule, which binds a genetically engineered bacterial determinant to the tumor surface while at the same time activating and expanding tumor specific immune cells.
Credit: BioSpace.com
Special Report on Stem Cells (DDNews)
“Conventional therapy tends to reduce tumor burden and improves symptoms but may fail to eradicate tumor-initiating cells, leading to eventual recurrence and drug resistance,” they suggested. “Therapies targeting tumor-initiating cells may, therefore, work best alongside conventional therapies that debulk the tumor mass.”
Such debulking steps may be particularly important for solid tumors, adds Stern, as therapeutics like antibodies are quite large and can be limited in their capacity to reach the target cells. Initially shrinking the tumors using chemotherapy might facilitate immunotherapeutic access.
NeoTX Therapeutics and Active Biotech, meanwhile, are working on immunotherapy with naptumomab, which fuses the Fab fragment of an antibody targeting 5T4 with an engineered bacterial superantigen that activates T cell responses.
In preclinical studies, naptumomab has shown synergistic anti-tumor effects and has extended overall survival when combined with checkpoint inhibition.
At the 2018 AACR meeting, researchers tested naptumomab and an anti-PD-1 as monotherapy or in combination in low immunogenic mouse tumor models. Although naptumomab alone showed some capacity to activate T cells and increase tumor infiltration and the anti-PD-1 had no effect, the combination more dramatically increased serum cytokines and CD8:CD4 ratio in the tumors, resulting in reduced tumor burden and prolonged media survival.
Findings like these led to a Phase 1b/2 clinical trial, currently recruiting, that combines naptumomab with AstraZeneca’s anti-PD-1 durvalumab versus advanced and metastatic solid tumors. The first patient in this study was dosed last October.
“The dosing of the first patient in our Phase 1b trial is a significant milestone for NeoTX, as it is our first clinical-stage molecule developed with our Selective T Cell Redirection (STR) platform,” said company CEO Asher Nathan in announcing the milestone. “Previous clinical studies have shown Nap to be well tolerated, and preclinical work conducted by the NeoTX team supports its broad potential in treating advanced and metastatic tumors, especially in combination with checkpoint inhibitors.”
Credit: DDNews.com
Leveraging the Native Immune Response to Fight Cancer (Pharma’s Almanac)
Unlike checkpoint inhibitors and CAR-T cell therapies that activate the immune system artificially, selective T cell redirection technology from NeoTX activates immune cells away from the suppressive tumor environment, resulting in a powerful — yet safe — native antibacterial immune reaction.
Resurrecting a Drug with a Checkered Past
NeoTX Therapeutics is a clinical-stage immunotherapy company developing a novel technology initially licensed from Active Biotech in 2016. Naptumomab estafenatox (Nap) was being developed for the treatment of cancer by Active Biotech and had shown exciting positive results in a phase I study but failed to show sufficient efficacy in a phase II trial.
A closer examination of both studies suggested that Nap deserved further investigation. In phase I trials, a patient with non-small cell lung cancer (NSCLC) for whom three prior lines of therapy had failed was treated for six months with Nap. Even though he received no further treatments, this patient remained alive for 11 years and died of causes unrelated to cancer. The study also uncovered no concerning safety issues.
The existing results led Active Biotech to move straight to a phase II/III study without any additional pilot trial. This follow-on study was, unfortunately, conducted in renal carcinoma, for which the standard of care at the time was interferon-α. We know today that interferon-α has significant negative interactions with Nap and that these interactions led to the failure of the trial.
Benefits of a Native Immune Response
Most immunotherapies on the market are designed to elicit some form of artificial immune response. Two difficulties in artificial manipulation include the vast complexity of the immune system and our lack of an in-depth understanding of how it functions. As a result, the generation of non-natural responses can often have many negative, unintended consequences. In addition, some therapies, such as bispecifics, aim to activate all T cells. This approach faces challenges, because T cells eventually become worn out after being activated. Thus, activating all T cells can ultimately deplete their supply.
Nap differs from current standard-of-care therapies because it relies on selective T cell redirection (STR) technology, which effectively converts a weak immune response against cancer to a powerful but specific, natural, antibacterial immune reaction. Nap is a recombinant fusion protein consisting of the antigen-binding fragment of a monoclonal antibody, directed towards the tumor-associated oncofetal trophoblast glycoprotein antigen 5T4, attached to a genetically engineered form of superantigen staphylococcal enterotoxin E (SEA/E-120).
Importantly, only T cells that express the superantigen receptor — approximately 1–2% of all T cells — are activated by Nap. These T cells undergo natural expansion and activation in the permissive environment of the periphery and lymph nodes. Once activated, they multiply rapidly and traffic to the tumor. Meanwhile, NAP binds to the tumor and acts as a neoantigen mimetic that the trafficking T cells can recognize, enabling them to kill the cancer. The trafficking T cells can invade desert tumors and alter the tumor microenvironment, opening it up to further attack by other components of the immune system.
Like the NSCLC cancer patient in Active Biotech’s phase I study who lived for an additional 11 years without any further treatment, we have seen that mice treated with Nap maintain the ability to fight off cancer after treatment is completed. Specifically, mice that exhibit a complete response when treated with NAP retain the ability to fight off other subsequent cancers, remaining cancer-free.
Nap, therefore, may provide a means for overcoming drug resistance, even for rapidly evolving cancers. STR technology appear to reboot the immune system, allowing it to evolve as cancers do.
Synergy with Other Immunotherapies
In addition to breaking drug resistance by binding bacterial determinants to the tumor surface, STR technology carries the potential to augment the effectiveness of checkpoint inhibitors and other anticancer approaches. With such a powerful immune response generated by Nap, we believe that upregulation of checkpoints in the tumor microenvironment is likely to occur, thus enabling the enhanced performance of other cancer drugs, such as PD1/PDL1 inhibitors.
In fact, we believe that STR technology will be synergistic with all of the major modalities for cancer treatment, including checkpoint inhibitors, which have revolutionized the field, and traditional chemotherapy, which is still widely used for cancers that don’t respond to checkpoint inhibitors.
Clinical Investigation in Progress
Nap, NeoTX’s lead candidate and first STR platform drug, is currently in clinical development for advanced and metastatic solid tumor indications. Nap has significant potential as a monotherapy and in combination with chemotherapy, checkpoint inhibitors, and CAR-T technologies.
Previous clinical trials have found Nap to be well tolerated in hundreds of patients and demonstrated preliminary signals of efficacy. Preclinical work conducted by the NeoTX team supports its broad potential in treating advanced and metastatic tumors, especially in combination with checkpoint inhibitors.
A phase Ib clinical trial of Nap is ongoing in collaboration with AstraZeneca. The open-label, multicenter, dose-finding phase Ib study is currently enrolling. Patients are dosed with a combination of Nap and AstraZeneca’s checkpoint inhibitor IMFINZI® (durvalumab). NeoTX aims to establish the maximum tolerated dose before advancing to a larger cohort-expansion phase in the Unites States that will include indications known to respond well to checkpoint inhibitors, such as pancreatic and colon cancer.
Platform Technology
Because the superantigen is the same, regardless of the cancer being targeted, the STR approach is indeed a platform technology. The homing molecule can be designed to target many different types of tumor cells, allowing the development of a range of novel drug products.
Due to its potential as a truly general solution for cancer treatment, STR technology is attracting significant attention. Once we gather more data from the ongoing clinical trials and are able to present hard and fast clinical evidence, we expect to see that interest materialize in the form of numerous partnerships for the investigation of combination treatments with Nap and other existing cancer therapies.
Separately, NeoTX is actively exploring in-licensing deals and partnerships that could give the company access to new early-stage drugs that could be complementary to the STR platform. This activity will be funded in part by cash ($45 million) raised in a Series C financing round that closed in February 2020. To date, we have raised over $60 million, all from private investors.
Our team at NeoTX includes both highly experienced scientists, such as Nobel Prize winner Prof. Roger Kornberg, and people with expertise in drug development and commercialization, such as the well-known drug developers Dr. Marcel Rozencweig and Dr. Robert Kramer. Early-stage clinical research is conducted in Israel and backed by highly experienced investigators interested in novel medications. Later-stage trials will be conducted in the United States and managed from our U.S. office.
Going forward, our strategy for growth revolves around discovering, acquiring, and developing technologies that exploit novel mechanisms that enhance the immune system’s ability to attack tumors and developing business partnerships that leverage our STR platform technology. Because we want to stay focused on the development of novel therapies with real potential to impact patient lives, we intend to commercialize proprietary products through corporate alliances.
Credit: Pharma’s Almanac.com
Neotx closes $45M C round for second coming of immuno-oncology agent (BioWorld)
DUBLIN – Neotx Therapeutics Ltd. raised $45 million in a series C round to continue clinical development of an immuno-oncology agent that already has a long clinical history behind it. Its lead molecule, naptumomab estafenatox, is a fusion protein comprising an antibody fragment that recognizes the oncofetal antigen 5T4 and a bacterial “super-antigen” comprising a modified version of the Staphylococcal enterotoxin A.
Credit: bioworld.com
NeoTX Closes $45 Million Series C Financing
REHOVOT, Israel, Feb. 19, 2020 (GLOBE NEWSWIRE) — NeoTX Therapeutics, a clinical-stage biotechnology company leveraging its proprietary Selective T cell Redirection (STR) platform to develop targeted anticancer immunotherapies, has closed a $45 million Series C financing. In conjunction with the financing, former vice chairman of The Blackstone Group, J. Tomilson Hill, Chairman of NDFOS Co., Ltd, Andrew Kim, Paul T. Marinelli and Nobel laureate Dr. Roger Kornberg, the chief scientific officer of NeoTX have joined the NeoTX Board of Directors. To date, NeoTX has raised over $60 million. NeoTX plans to use the Series C proceeds to advance its STR platform for the treatment of advanced and metastatic solid tumors as well as to in-license new technologies.
“With the funds raised in this financing, we intend to complete the dose escalation phase of the Phase 1b trial of naptumomab estafenatox (“Nap”) in combination with durvalumab and continue to develop our patented STR platform,” said Asher Nathan, chief executive officer of NeoTX. “Our platform, which uniquely leverages the body’s natural antibacterial immune response to selectively redirect T cells to kill the tumor, has the potential to be applicable in a variety of solid tumor indications and in combination with other immunotherapies. We look forward to the clinical advancement of Nap and expanding our platform in order to provide new options to patients suffering from advanced cancers.”
The open-label, multicenter, dose-finding Phase 1b study of Nap (NCT03983954) is currently enrolling. Patients are dosed with a combination of Nap and AstraZeneca’s (NYSE: AZN) checkpoint inhibitor IMFINZI® (durvalumab). NeoTX aims to establish the maximum tolerated dose before advancing to a larger cohort expansion phase in the Unites States.
Israeli co NeoTX Therapeutics raises $45m (Globes)
Israeli clinical-stage biotechnology company NeoTX Therapeutics has closed a $45 million Series C financing round. The Rehovot-based company is leveraging its proprietary Selective T cell Redirection (STR) platform to develop targeted anticancer immunotherapies.
To date, NeoTX has raised over $60 million. NeoTX plans to use the proceeds of the latest financing round to advance its STR platform for the treatment of advanced and metastatic solid tumors as well as to in-license new technologies.
NeoTX CEO Asher Nathan said, “With the funds raised in this financing, we intend to complete the dose escalation phase of the Phase 1b trial of naptumomab estafenatox (Nap) in combination with durvalumab and continue to develop our patented STR platform. Our platform, which uniquely leverages the body’s natural antibacterial immune response to selectively redirect T cells to kill the tumor, has the potential to be applicable in a variety of solid tumor indications and in combination with other immunotherapies. We look forward to the clinical advancement of Nap and expanding our platform in order to provide new options to patients suffering from advanced cancers.”
Credit: en.globes.co.il
NeoTX’s $45 million Series C to fund Phase I trial (The Pharma Letter)
Israeli company NeoTX, a biotech firm with a selective t-cell redirection (STR) platform for developing…
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NeoTX raises $45m for STR immunotherapy enhancing platform (Pharmaceutical Technology)
Israel-based NeoTX has closed its Series C financing round with $45m raised; this brings the company’s total funding to $60m.
NeoTX chief executive officer Asher Nathan said: “With the funds raised in this financing, we intend to complete the dose escalation phase of the Phase 1b trial of naptumomab estafenatox (Nap) in combination with durvalumab and continue to develop our patented STR [Selective T cell Redirection] platform.”
The company uses the STR platform to improve the response rate of current immunotherapies targeting solid tumours. Nathan explains: “Our platform, which uniquely leverages the body’s natural antibacterial immune response to selectively redirect T cells to kill the tumour, has the potential to be applicable in a variety of solid tumour indications and in combination with other immunotherapies.”
Nap is NeoTX’s lead programme and it directly targets tumours expressing the 5T4 antigen, which includes many advanced and metastatic solid tumours. NeoTX licensed the drug from Active Biotech in 2016, and began enrolling and dosing patients in its Phase 1b study in October 2019.
In this study, Nap is combined with AstraZeneca’s anti-programmed cell death-1 (PD1) checkpoint inhibitor Imfinzi (durvalumab); this follows the signing of a February 2019 collaboration between NeoTX and AstraZeneca. NeoTX also believes its drug has promise as a monotherapy in various solid tumours.
Nathan commented: “We’re looking forward to bringing this therapy to patients suffering from advanced cancers that have thus far been unresponsive to therapy with checkpoint inhibitors alone.”
The company also wants to use this $45m funding to in-license further technologies and products.
Credit: Pharmaceutical Technology
Israeli biotech NeoTX lands $45M series C for combo I-O cancer trials (Fierce Biotech)
NeoTX Therapeutics has nabbed a healthy $45 million third funding round as it looks to continue work on its early-stage cancer combo test and in-license new tech.
The Rehovot, Israel-based biotech is working on a Selective T cell Redirection (STR) platform for its oncology immunotherapies and now brings its total funding haul to $60 million.
NeoTX plans said in a brief update that it plans to use the series C proceeds to advance its STR platform “for the treatment of advanced and metastatic solid tumors as well as to in-license new technologies.”
Naptumomab estafenatox (aka Nap) is the lead compound in NeoTX’s STR platform and is designed to target the 5T4 antigen, which the biotech says is present on “many tumors.” The experimental drug was licensed from Active Biotech four years ago after it failed to help kidney cancer patients and was ditched by its original owner.
NeoTX is hoping it can brush off this flop and combine it with the right therapy to kick-start it into action. Part of the cash will be used for its ongoing, open-label phase 1 of Nap in combination with AstraZeneca’s checkpoint inhibitor Imfinzi (durvalumab) in solid tumors that have spread.
The trial started last year, and it “aims to establish the maximum tolerated dose in the dose-escalation Phase 1b study before advancing to a cohort expansion study.”
When first working on STR, Active Biotech said the platform in preclinical tests could boost the anti-tumor activity of checkpoint inhibitors (such as Imfinzi) and can “lead to long-lasting immunity against the tumor.” Studies will now try to prove this.
“With the funds raised in this financing, we intend to complete the dose escalation phase of the Phase 1b trial of Nap in combination with durvalumab and continue to develop our patented STR platform,” said Asher Nathan, CEO of NeoTX.
“Our platform, which uniquely leverages the body’s natural antibacterial immune response to selectively redirect T cells to kill the tumor, has the potential to be applicable in a variety of solid tumor indications and in combination with other immunotherapies. We look forward to the clinical advancement of Nap and expanding our platform in order to provide new options to patients suffering from advanced cancers.”
Credit: Fierce Biotech
After digging through discards, biotech startup is making a $45M bet it can fix a failed cancer therapy (Endpoints News)
The results were clear: Naptumomab estafenatox failed to prolong overall survival for renal cell carcinoma patients in a large trial, definitively enough that Active Biotech effectively shelved it in 2013.
But three years later NeoTX, a scavenger startup that had been digging through drugs that failed in hopes of finding a subpopulation with a biomarker that the original developer had missed, stumbled upon the data and saw the unexpected gem they were looking for.
Asher Nathan
“Their Phase I data was stellar, great Phase I, and then they had this Phase II that failed primarily because they added the wrong drug,” Asher Nathan, CEO and co-founder of NeoTX, told Endpoints News as he unveils $45 million in new financing.
Interferon alpha was “absolutely the wrong drug” to combine with naptumomab estafenatox as it negated certain qualities of the experimental fusion protein, Nathan said. More importantly, Active Biotech didn’t really know just the kind of potential they had in a platform tech that binds to the tumor and coat it with a bacterial “superantigen” that attracts an immune attack.
“This is a natural immune response as opposed to if you look at other technologies like bispecifics, where they gauge CD3 molecules, that’s something you’ll never find in nature,” Nathan said.
So the Israeli biotech licensed the drug from Active for $250,000 upfront, and has been collaborating to start a Phase I that tests a combo of nap and AstraZeneca’s checkpoint drug, Imfinzi (durvalumab).
Roger Kornberg
Roger Kornberg, a Nobel laureate, Stanford cancer researcher and longtime friend of Nathan’s, helped guide the company’s pivot to focus on this approach, which they call selective T cell redirection or STR. And longtime Bristol-Myers Squibb exec Marcel Rozencweig is onboard as CMO, leading a small office in Princeton, New Jersey in preparation for a trial expansion to the US.
They are enrolling patients with a wide range of solid tumors to the Phase Ib dose escalation trial — from pancreatic adenocarcinoma and ovarian cancer to prostate cancer and triple negative breast cancer — as naptumomab targets the oncofetal antigen 5T4.
Other drugmakers have mounted efforts to hone in on 5T4, ranging from Sanofi and Oxford Biomedica’s Phase III cancer vaccine to Pfizer’s early-stage antibody-drug conjugate to Genmab’s preclinical CD3/5T4 bispecific.
Marcel Rozencweig
NeoTX is also working on a second candidate hitting a different target specifically tailored to glioblastoma. They’ve brought David Reardon of Dana Farber on for that program, which also utilizes the bacterial component.
The team of around 20 has some powerful — if unconventional — backers. For the Series C, they enticed “one of the top 10 richest people in the world,” former Blackstone vice chairman Tomilson Hill, American businessman Paul Marinelli as well as Korean investor Andrew Kim.
Credit: Amber Tong
NeoTX Therapeutics’s CEO, Asher Nathan, interviewed by Karen Jagoda on the Empowered Patient Podcast
NeoTX was featured on a popular patient radio podcast.
Dr. Asher Nathan, CEO of NeoTX talks about the company’s work developing immunotherapies for a wide range of solid tumors using their proprietary Selective T Cell Redirection (STR) platform. This technology enables therapies that bind a genetically engineered super antigen to the tumor surface which trigger a native, controlled immune response that can kill the cancer with potentially fewer side effects than currently available therapies. Asher discusses the company’s lead STR molecule, NAP, which is being developed to treat advanced cancers. NAP, which has potential as both a monotherapy and in combination with checkpoint inhibitors, is currently in a Phase 1B clinical trial in collaboration with AstraZeneca.
Download the transcript here
T Cell Redirection Drives Natural Immune Response Against Solid Tumors with Asher Nathan NeoTX (Empowered Patient Podcast)
Dr. Asher Nathan, CEO of NeoTX talks about the company’s work developing immunotherapies for a wide range of solid tumors using their proprietary Selective T Cell Redirection (STR) platform. This technology enables therapies that bind a genetically engineered super antigen to the tumor surface which trigger a native, controlled immune response that can kill the cancer with potentially fewer side effects than currently available therapies. Asher discusses the company’s lead STR molecule, NAP, which is being developed to treat advanced cancers. NAP, which has potential as both a monotherapy and in combination with checkpoint inhibitors, is currently in a Phase 1B clinical trial in collaboration with AstraZeneca.
Credit: empoweredpatientradio.com
T Cell Redirection Drives Natural Immune Response Against Solid Tumors with Asher Nathan NeoTX (Empowered Patient Podcast)
NeoTX commences dosing in Phase Ib trial of naptumomab (Clinical Trials Arena)
NeoTX Therapeutics has dosed the first patient in a Phase Ib clinical trial of a naptumomab estafenatox and Imfinzi (durvalumab) combination for the treatment of solid tumours.
Designed as immunotherapy, naptumomab stimulates the immune system to identify and kill tumour cells. The drug triggers certain T cells outside the tumour microenvironment and redirects the immune cells to attack the tumours.
In preclinical studies involving different tumour models, naptumomab demonstrated the potential for a synergistic effect with checkpoint inhibitors.
NeoTX Therapeutics licensed the drug from Active Biotech in 2016. As part of the licence agreement, NeoTX has to carry out the development and commercialisation of the drug in oncology indications.
Imfinzi is a checkpoint inhibitor developed by AstraZeneca. It is a human monoclonal antibody that inhibits the PD-L1 interaction with PD-1 and CD80.
Imfinzi has approvals for the treatment of unresectable, stage III non-small cell lung cancer (NSCLC) and advanced bladder cancer. The drug is also being developed for various other solid tumours.
The open-label, multi-centre, dose-finding Phase Ib trial will investigate the safety and tolerability of naptumomab plus Imfinzi for treating advanced or metastatic tumours in around 45 patients who received prior therapies.
Credit: www.clinicaltrialsarena.com
NeoTX commences dosing in Phase Ib trial of naptumomab (Clinical Trials Arena)