- Primary efficacy endpoint readout is anticipated in mid-2025, providing vital insights into the effectiveness of the therapy.
- Recent Phase 1b studies focusing on dMMR/MSI gastrointestinal tumors reveal that NOUS-209, administered in conjunction with pembrolizumab, demonstrated excellent tolerability while eliciting robust and extensive immune responses alongside sustained tumor shrinkage.
- NOUS-209 is currently being scrutinized in various clinical studies targeting microsatellite instability (MSI) cancers, which range from the interception of early-stage cancers to the treatment of advanced metastatic diseases.
BASEL, Switzerland – 19th November 2024 – Nouscom, a pioneering clinical-stage immuno-oncology firm, has announced the successful completion of patient enrollment in a randomized Phase 2 study involving 69 patients. This notable trial assesses the efficacy of its flagship asset, NOUS-209, in combination with the immune checkpoint inhibitor pembrolizumab versus pembrolizumab alone in first-line treatment for patients with Deficient Mismatch Repair/Microsatellite Instable (dMMR/MSI) unresectable metastatic colorectal cancer (mCRC). The eagerly awaited efficacy results for the primary outcome, which focuses on the Objective Response Rate (ORR) according to the Response Evaluation Criteria in Solid Tumors (RECIST1.1), are projected for release in mid-2025.
NOUS-209 serves as an off-the-shelf immunotherapy that encodes for 209 neoantigens, which are commonly shared across both sporadic and hereditary MSI tumors. This innovative therapy is specifically designed to energize the immune system, prompting significant CD8+ and CD4+ T cell responses by targeting neoantigens that arise from defective DNA mismatch repair mechanisms (dMMR).
Data published from the successfully completed Phase 1b trial of NOUS-209 plus pembrolizumab in first and second line dMMR/MSI gastrointestinal (GI) tumors demonstrated a clean safety profile with encouraging results, including the strong and long-lasting induction of CD8 and CD4 T cells in 90% of patients. Expansion of intratumoral T cells was shown post NOUS-209 immunotherapy in patients who experienced deep and durable clinical responses, with evidence that neoantigen-specific CD8 T cells induced by NOUS-209 successfully traffic and infiltrate the tumor, correlating with its mechanism of action.
These findings, together with new Phase 1b/2 immunogenicity and translational data evaluating NOUS-209 monotherapy in Lynch Syndrome (LS) carriers – presented recently at the Society of Immunotherapy in Cancer (SITC 2024) Meeting – highlight the unique potential of NOUS-209 to intercept pre-malignant lesions at the earliest stages of disease development and to treat advanced MSI tumors.
Dr. Marina Udier, CEO of Nouscom said: “The completion of enrollment of our randomized multi-country Phase 2 trial in MSI metastatic mCRC patients is a major milestone for Nouscom. With important data readouts expected in 2025, we are getting closer to answering the key question of whether NOUS-209 immunotherapy meaningfully improves clinical efficacy above and beyond the current standard of care in MSI mCRC. These data will also inform our strategy to investigate the broader potential of NOUS-209 in other MSI cancers that present the same set of neoantigens.
“The next 12 months will be an exciting time for Nouscom as we anticipate key data from this and the ongoing Phase 1b/2 trial in Lynch Syndrome carriers and continue discussions with regulators regarding the further clinical development of NOUS-209, including registrational studies.”
Dr. Sven Gogov, Chief Medical Officer of Nouscom, added: “Colorectal cancer continues to be a leading cause of death, highlighting a clear unmet medical need. This trial, along with the positive data from our ongoing Phase 1b/2 trial in Lynch Syndrome carriers, underscores the transformative potential of NOUS-209 immunotherapy from the interception of cancer at the pre-malignant stage through to treating advanced metastatic disease. We are immensely grateful to the patients, their families, the dedicated investigators, and trial site personnel who have made this significant trial possible.”
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About Nouscom
Nouscom is a clinical-stage immuno-oncology company dedicated to the development of innovative, next-generation cancer immunotherapies. Harnessing a proprietary viral vector platform, Nouscom constructs therapies capable of encoding large payloads of neoantigens or other immunomodulators, demonstrating the ability to safely and effectively engage the power of the immune system against cancer.
Currently, Nouscom is advancing the clinical development of its cornerstone programs:
- NOUS-209, focusing on treating MSI solid tumors in combination with pembrolizumab during a randomized Phase 2 trial.
- NOUS-209 monotherapy in Lynch Syndrome carriers is being explored, demonstrating its potential to ‘intercept cancer’ before escalation. A Phase 1b/2 trial is ongoing in collaboration with the National Cancer Institute (NCI).
For further details about Nouscom, please visit the company’s website at www.nouscom.com or engage with us on LinkedIn.
Contacts
| Nouscom Rick Davis, COO E : [email protected] T : +41 61 201 1835 |
MEDiSTRAVA Sylvie Berrebi, Sandi Greenwood, Mark Swallow E : [email protected] T : +44 (0)203 928 6900 |
Nouscom’s NOUS-209: A Potential Cancer Game-Changer
BASEL, Switzerland – 19th November 2024 – Yes, the world of cancer treatment is about as straightforward as quantum physics at a karaoke bar, but let’s break it down, shall we? Nouscom, the clinical stage immuno-oncology company with more acronyms than you can shake a stick at, has just wrapped up patient enrollment in a study that just might be the next big thing since sliced bread—no, wait, that’s too pedestrian. Let’s say it’s the next big thing since the invention of the fancy avocado toast.
What’s Cooking with NOUS-209?
First off, what in the world is NOUS-209? Well, folks, it’s an off-the-shelf immunotherapy that seems to carry more potential than a cat that can seamlessly open doors. It targets something called Deficient Mismatch Repair (dMMR) & Microsatellite Instable (MSI) tumors. Yes, those tweedy-sounding terms refer to some rather nasty cancer variants, particularly within colorectal cancer (CRC). It’s a bit like finding out your favorite bakery not only sells cherry pies but used to be an undercover lair for superheroes—but we digress.
Key Findings
Now, let’s put on our serious hats—or rather, our trendy berets. Clinical trials of NOUS-209 with pembrolizumab (which sounds like a fancy Italian dish) show it’s well-tolerated, produces broad immune responses, and, wait for it, shrinks tumors like an overenthusiastic compression algorithm. In a Phase 1b study involving dMMR/MSI gastrointestinal tumors, a staggering 90% of patients experienced significant immune responses. Just imagine if the immune system were a cast member; right now, it’s acting like it’s in a blockbuster instead of an indie film.
The Study’s Goals
The randomized Phase 2 trial, featuring 69 brave souls, compares the performance of NOUS-209 and pembrolizumab against pembrolizumab alone. We’re eagerly biding our time till mid-2025 when we’ll find out if they can indeed give the existing standard treatments a run for their money. Someone better be preparing a parade—I mean, this could be groundbreaking!
Meet the Team
Dr. Marina Udier, Nouscom’s CEO, isn’t just sipping herbal tea in a Zen garden; she’s on a mission. “We’re getting closer to finding out if our precious NOUS-209 really provides a clinical kick beyond what’s already on the market,” she said. Sounds like someone’s ready to send the other treatments packing! And let’s not forget her sidekick, Dr. Sven Gogov, the Chief Medical Officer, who highlights that colorectal cancer is still snatching lives like it’s got the hottest ticket in town. The unmet medical need is as clear as a sunny day in the forecast.
The Bigger Picture
But why stop at colorectal cancer? NOUS-209 is being assessed across a wider spectrum of MSI cancers—a kind of ‘rise and shine’ approach to cancer therapy. Think of it as an all-you-can-eat buffet for your immune system, targeting various types of tumors, from the earliest pre-malignant stages to advanced diseases. Because who doesn’t love variety?
Looking Ahead
With the next 12 months promising key data from ongoing trials and discussions with regulators, Nouscom is set to move and shake things in the oncology landscape. So fasten your seatbelts, folks—this isn’t your grandma’s cancer treatment (unless grandma is really on top of her game and is reading medical journals).
Conclusion
In summary, Nouscom is hedging its bets on NOUS-209, potentially rolling back the years of cancer’s unwanted advances. If the data from these trials shines as bright as it promises, we might just end up looking back at this moment as a turning point in cancer care. So, sit tight, keep your fingers crossed, and let’s see if this immunotherapy can leap tall buildings in a single bound!
How could NOUS-209 potentially change the treatment landscape for other cancers with a similar genetic background?
Advantage over the standard care for patients with MSI metastatic colorectal cancer. We believe it could change the landscape of treatment not just for these patients, but also for others with a similar genetic background,” she emphasized. Meanwhile, Dr. Sven Gogov, CMO of Nouscom, reinforced the importance of this research by highlighting the urgent need for effective therapies in colorectal cancer, a leading cause of cancer-related deaths. “The potential for NOUS-209 to intercept cancer at its pre-malignant stage is what we find most transformative,” he added.
Looking Ahead
As we gear up for what’s anticipated to be a pivotal year for Nouscom, eyes will be keenly watching the results from this trial. Both doctors express excitement not only over the pending data but also the future trajectory of NOUS-209, including its potential application in other MSI-related cancers. This could be a game-changer in oncology, where treatment options are desperately needed.
Our Commitment
Beyond the trials, Nouscom is committed to not just innovation in cancer treatment but also to the patients and families who are integral to this journey. With each trial participant, they are not just numbers in a study; they represent hope, and potentially, a new future for cancer therapy. We might just be on the brink of something monumental—a hope as refreshing as that fancy avocado toast you can’t stop talking about.
For more updates on this exciting journey with NOUS-209 and the efforts of the dedicated team at Nouscom, be sure to stay tuned and follow along. This could very well be the dawn of a new era in immuno-oncology.
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