Will the Next Great Cancer Discovery Be Made by AI?

Artificial intelligence is rapidly changing the way scientists investigate cancer. AI systems can analyze vast biological datasets, detect previously unrecognized patterns, generate hypotheses, and propose new therapeutic candidates. Some can even help design experiments to test their own predictions.

These capabilities are already translating into clinical development. One example is IAM1363, an AI-designed HER2 inhibitor currently being evaluated in patients with advanced solid tumors. Early clinical findings have demonstrated antitumor activity, providing evidence that AI-driven drug discovery can generate promising therapeutic candidates for oncology.[1, 2]

Beyond the development of new therapeutic candidates, AI is also opening opportunities for drug repurposing. In a recent study, researchers used an AI Co-Scientist system to identify potential treatments for acute myeloid leukemia. Several of the proposed candidates subsequently demonstrated activity in laboratory experiments, illustrating how AI-generated hypotheses can lead to experimentally validated findings and uncover new therapeutic opportunities.[3]

Together, these advances raise an intriguing question: Could artificial intelligence be behind the next major breakthrough in cancer research?

Increasingly, the answer appears to be yes. AI is already contributing to the discovery or new therapeutic targets and the development of promising drug candidates. But identifying a potential breakthrough is only the beginning; establishing biological significance, validating its therapeutic potential, and ultimately demonstrating meaningful benefit for patients remain key challenges.

Understanding both the possibilities and the limitations of AI is essential to assessing how it could reshape the future of oncology research.

AI Is Already Transforming Cancer Research

The impact of AI extends well beyond the design of individual drug candidates. Across oncology research, computational approaches are changing how scientists investigate disease biology, identify therapeutic targets, and develop potential treatments.

One of the most significant advances has been in protein structure prediction. For decades, determining the three-dimensional structure of proteins through experimental methods was technically demanding and often time-consuming, requiring researchers to isolate and purify proteins, prepare suitable samples, and use specialised techniques (such as X-ray crystallography, nuclear magnetic resonance spectroscopy, or cryo-electron microscopy) that could take months or even years.

AlphaFold, an AI system developed by Google DeepMind to predict the three-dimensional structures of proteins from their amino acid sequences, demonstrated that deep learning could predict many protein structures with remarkable accuracy, providing researchers with valuable insights into biological mechanisms and potential drug-binding sites.[4] The work contributed to the 2024 Nobel Prize in Chemistry.

AI is also being used to identify potential therapeutic targets within complex genomic and molecular datasets, to design and optimize drug candidates, and to discover biomarkers that help predict how a patient’s cancer will behave. Deep learning models have shown, for example, that certain genetic features of gastrointestinal tumors, such as microsatellite instability, can be predicted directly from routine pathology slides.[5] In clinical research, AI is supporting trial design and helping match patients to the studies most likely to benefit them.

Early results from drug development are encouraging, although important questions remain. A 2024 analysis of AI-discovered drug candidates reported Phase I success rates of approximately 80–90%, substantially higher than historical industry averages. However, Phase II success rates were closer to conventional benchmarks, at approximately 40%, based on a limited sample of programs.[6] These findings suggest that AI may improve the identification and development of candidates with properties suitable for early clinical testing. Whether those advantages consistently translate into better therapeutic outcomes remains to be established.

This distinction is crucial: accelerating drug discovery does not necessarily mean overcoming the biological and clinical challenges that cause promising cancer therapies to fail.

The Challenge of Understanding Cancer Biology

AI is exceptionally good at recognizing complex patterns, generating hypotheses, and exploring relationships across enormous volumes of information. But every AI system is fundamentally shaped by the data it learns from. While it can identify previously unrecognized connections, propose novel biological mechanisms, and challenge existing assumptions, its predictions are not equivalent to experimental evidence. Establishing whether these hypotheses reflect biological reality still required rigorous scientific investigation and validation.

Consider cancer genomics. A tumor can accumulate hundreds or even thousands of genetic alterations, yet only a small subset of these, known as “driver” mutations, directly contribute to disease development and progression. Distinguishing these driver mutations from passenger mutations, which accumulate along the way without contributing to cancer progression, is essential for understanding cancer biology and identifying therapeutically relevant targets.[7]

AI can help identify candidate drivers, uncover relationships between molecular alterations, and predict which mechanisms may be important. But these predictions must ultimately be tested against experimental evidence. Researchers must establish whether a proposed target plays a causal role in disease, whether modifying it produces the intended biological effect, and whether that effect can be reproduced in relevant experimental models.

Even a validated target does not guarantee a successful treatment; tumor heterogeneity, compensatory signaling pathways, acquired resistance, and effects on healthy tissues can all undermine an otherwise promising therapeutic approach.

This helps explain why translating scientific discoveries into effective cancer therapies remains so challenging, even as our understanding of cancer biology continues to advance. Historically, only around 3–4% of cancer drug programs entering clinical trials have reached approval.[8]

Many of Oncology’s Greatest Advances Began With the Unexpected

Some of oncology’s most transformative breakthroughs have emerged from unexpected observations, unconventional lines of investigation, or discoveries that challenged established scientific assumptions. History has shown that scientific progress does not always follow a predictable path, and that experimentation can reveal possibilities that researchers had neither anticipated nor initially set out to investigate. This raises an important question about the role AI might play in establishing such discoveries.

For instance, in the 1960s, physicist Barnett Rosenberg was studying the effects of electric currents on bacteria when he noticed that bacterial cells had stopped dividing. Further investigation revealed that the effect was caused not by the current itself, but by platinum compounds released from the electrodes.[9] This unexpected observation ultimately led to cisplatin, a chemotherapy drug that helped transform testicular cancer into one of the most curable solid tumors.

In the early 1980s, Barry Marshall and Robin Warren challenged the widely held belief that bacteria could not survive in the acidic environment of the stomach. Their identification of Helicobacter pylori [8] reshaped understanding of stomach disease and ultimately established a bacterial infection as a major cause of gastric cancer.

A different kind of breakthrough emerged from research into the relationship between the immune system and cancer. For much of the twentieth century, efforts to stimulate antitumor immunity produced inconsistent results until James Allison and colleagues demonstrated that blocking CTLA-4, a protein that helps regulate T-cell activity, could enhance antitumor immune responses and induce tumor rejection in experimental models.[10] This work laid important foundations for modern immune checkpoint inhibition therapy.

Similarly, KRAS, one of the most frequently mutated oncogenes in human cancer, was long considered “undruggable.” Its molecular structure appeared to offer few suitable binding sites for small molecules. This perspective changed when researchers identified a previously unrecognized pocket in the KRAS G12C mutant protein [11], opening the way for the development of targeted inhibitors, including sotorasib, which became the first FDA-approved KRAS-targeted therapy in 2021, initially for patients with advanced non-small cell lung cancer harboring the KRAS G12C mutation.[12]

These discoveries followed very different paths, but each transformed our understanding of cancer or opened new possibilities for treatment. They also illustrate that scientific breakthroughs are not always predictable: sometimes they emerge from questions researchers set out to answer, and sometimes from findings they never expected to encounter.

AI could help accelerate both kinds of discovery, identifying promising directions for investigation while bringing previously overlooked relationships to light. But determining which findings represent genuine advances in our understanding of biology, and which can ultimately translate into effective therapies, remains a question for experimental science.

From Scientific Discovery to Clinical Success

Identifying a promising therapeutic target is only the beginning of cancer drug development. Even when a biological mechanism has been established, a target may be important in one tumor type but not another. Its role may vary between patients or change as the disease progresses. And a treatment that demonstrates promising activity in preclinical models may ultimately fail to deliver sufficient benefit in the clinic.

Scientists must still determine whether a newly identified mechanism genuinely drives disease or simply appears alongside it. They must judge whether a promising target is causally important in patients, not only in cell lines or datasets. They must decide which biological observations are meaningful enough to justify years of development and substantial investment, and how new findings fit within the broader understanding of how tumors grow, adapt and resist treatment.

Above all, they must work out how promising biology can be translated into meaningful benefit for patients. That translation involves choosing the right patient population, the right dose, the right combination and the right moment in treatment. These are questions that data can inform, but rarely resolve on their own.

A Partnership, Not a Replacement

As AI becomes more sophisticated, its role in scientific discovery will continue to expand. Systems are already moving beyond data analysis to generating hypotheses, proposing experiments, and contributing to the interpretation of scientific findings.

What is likely to change is the role of the scientist. As AI takes on more of the work of analyzing data and generating hypotheses, researchers will increasingly focus on the tasks that remain distinctly human: interpreting unexpected findings, challenging existing models, designing experiments that expand what is known, and making sound development decisions under uncertainty. Meaningful innovation will come from pairing the speed of machines with the curiosity and judgment of scientists.

The next major breakthrough in cancer research may well come from AI. The greater achievement will be turning that discovery into a therapy that makes a meaningful difference to patients’ lives.

 

References

1. [Author(s)]. IAM1363-01: A phase 1/1b study of a selective and brain-penetrant HER2 inhibitor for HER2-driven solid tumors. J Clin Oncol. 2024;42(16_suppl):TPS3186. doi:10.1200/JCO.2024.42.16_suppl.TPS3186

2. Iambic Therapeutics. Iambic shares clinical data from Ph1/1b study of IAM1363, a highly selective type-2 HER2 inhibitor, demonstrating monotherapy activity in heavily pretreated patients with HER2 alterations, at the 2025 ESMO Congress [press release]. October 20, 2025. Available from: https://www.iambic.ai/post/esmo-iam1363

3. Gottweis J, Weng WH, Daryin A, et al. Towards an AI co-scientist. arXiv. 2025. arXiv:2502.18864.

4. Jumper J, Evans R, Pritzel A, et al. Highly accurate protein structure prediction with AlphaFold. Nature. 2021;596(7873):583-589. doi:10.1038/s41586-021-03819-2

5. Kather JN, Pearson AT, Halama N, et al. Deep learning can predict microsatellite instability directly from histology in gastrointestinal cancer. Nat Med. 2019;25(7):1054-1056. doi:10.1038/s41591-019-0462-y

6. Jayatunga MKP, Ayers M, Bruens L, Jayanth D, Meier C. How successful are AI-discovered drugs in clinical trials? A first analysis and emerging lessons. Drug Discov Today. 2024;29(6):104009. doi:10.1016/j.drudis.2024.104009

7. Vogelstein B, Papadopoulos N, Velculescu VE, Zhou S, Diaz LA Jr, Kinzler KW. Cancer genome landscapes. Science. 2013;339(6127):1546-1558. doi:10.1126/science.1235122

8. Wong CH, Siah KW, Lo AW. Estimation of clinical trial success rates and related parameters. Biostatistics. 2019;20(2):273-286. doi:10.1093/biostatistics/kxx069

9. Rosenberg B, Van Camp L, Krigas T. Inhibition of cell division in Escherichia coli by electrolysis products from a platinum electrode. Nature. 1965;205:698-699. doi:10.1038/205698a0

10. Leach DR, Krummel MF, Allison JP. Enhancement of antitumor immunity by CTLA-4 blockade. Science. 1996;271(5256):1734-1736. doi:10.1126/science.271.5256.1734

11. Ostrem JM, Peters U, Sos ML, Wells JA, Shokat KM. K-Ras(G12C) inhibitors allosterically control GTP affinity and effector interactions. Nature. 2013;503(7477):548-551. doi:10.1038/nature12796

12. Skoulidis F, Li BT, Dy GK, et al. Sotorasib for lung cancers with KRAS p.G12C mutation. N Engl J Med. 2021;384(25):2371-2381. doi:10.1056/NEJMoa2103695

Jacek Antas

Chief Executive Officer


Jacek Antas is a shareholder of the Company, has spent more than 25 years in the financial services industry holding various positions in sales and consulting.

Mr. Antas obtained a master’s degree from the Warsaw School of Economics and has served as a board member of various
companies throughout his career.

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James B. Murphy

Chief Financial Officer


Mr. Murphy is a certified public accountant with over thirty years of experience in finance and operations management. He is currently a consultant with Danforth Advisors LLC (“Danforth”), a leading provider of outsourced strategic and operational specialists across functions in the life sciences industry. While at Danforth, Mr. Murphy has served over fifteen private and publicly held life sciences companies as CFO and CFO Advisor, helping them secure over USD 0.5 billion in financing and successfully execute pivotal asset transactions. Mr. Murphy functions as a consultant to Helix pursuant to a consulting agreement between the Company and Danforth.

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Thomas Mehrling

Medical Adviser


Thomas Mehrling (PhD in Pharmacology and MD) has over 20 years’ experience in multinational Pharma companies developing novel oncology compounds from preclinical research through to registration. Prior to entering the industry, he spent 13 years as an MD at the University Hospital in Frankfurt, working on preclinical and translational projects. He served as Director of European Oncology at Mundipharma International (2003–2013), building the company’s first European oncology business from the ground up out of Cambridge, UK, and completing the clinical development, registration and launch of two major products in Europe, DepoCyte® and Levact® (Ribomustin® and Treanda®). In 2013, he led the establishment of the Mundipharma Group’s start-up, Mundipharma EDO, developing anti-cancer therapeutics for solid tumours out of Basel, Switzerland.

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Kim Gaspar

Director Quality Assurance


Kim is the Director of Quality Assurance at Helix BioPharma Corp. An experienced quality assurance professional with expertise in Canadian, US, and EU regulations, she has been involved in all aspects of Phase I/II biopharmaceutical product development over the years, including regulatory submissions, QC laboratory compliance, tech transfer and third-party oversight of CMC activities, clinical QA, and bioanalytical data analysis. Kim joined Helix in 2000, transitioning into QA in 2003. She holds a B.Sc in Biochemistry and a Ph.D in Veterinary Physiological Sciences, both from the University of Saskatchewan.

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Brenda Lee

Director Clinical Operations


Brenda is the Clinical Operations Director at Helix Biopharma Corp. A clinical research operations professional with 25 years of experience managing clinical trials, ranging from early Phase I to late Phase IIIb/IV studies, she brings experience in clinical study protocol writing and development, trial start-up and vendor management, and a proven track record in planning and managing clinical trials to quality standards, timelines and budget. Brenda joined Helix Biopharma Corp. in 2018, working to advance the clinical program of L-DOS47. She holds B.Sc and M.Sc. degrees from the University of Toronto, specializing in Nutritional Sciences and Human Biology.

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Jerzy Leszczynski

Director


Jerzy Leszczynski is a shareholder of the Company, has spent more than 35 years developing businesses and has served in the capacity of board member of various real estate development companies. Mr. Leszczynski obtained his Master of Science in Chemistry from the Warsaw Institute of Technology.

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Janusz Grabski

Director, Chair of Audit Committee


Janusz (John) Grabski is a lawyer specialized in corporate and real estate law with over twenty years of experience.

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Malgorzata Laube

Director


Malgorzata Laube has over 19 years of experience in nuclear medicine. In her last role with Alberta Health Services, she was the Department Supervisor, Nuclear Medicine at Royal Alexandra Hospital. Ms. Laube obtained a MSc degree in Environmental Engineering from the Warsaw University of Technology and is based in Edmonton, Alberta, Canada.

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Jacek Antas

Chairman of the Board


Jacek Antas is a shareholder of the Company, has spent more than 25 years in the financial services industry holding various positions in sales and consulting.

Mr. Antas obtained a master’s degree from the Warsaw School of Economics and has served as a board member of various
companies throughout his career.

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Jonathan Davis

Advisor, ADC Discovery


Jonathan Davis received his Ph.D. from University of California, San Francisco, where he studied protein structure and function using NMR. After a post-doc at Harvard Medical School exploring RNA selection and structure in the labs of Jack Szostak and Gerhard Wagner, he went to work at EMD Serono, where his work involved improving antibody-based therapeutics, inventing a platform technology for generating heterodimeric Fcs as a basis for multifunctional molecules, and developing a novel scaffold based on an artificially-designed protein from David Baker’s lab. In 2008 he took a job at Bristol-Myers Squibb in Waltham/Cambridge MA, working on antibody discovery and platform development in a wide range of therapeutic areas, with a particular focus on multispecific therapeutics. He moved to Madison, WI in 2019 to take on the role of VP of Innovation and Strategy at Invenra, a biotech focused on bispecific antibodies, and where he is currently head of the Scientific Advisory Board. In early 2024 he left the corporate world to found Creative Antibodies, a consulting firm that helps guide companies to successful antibody discovery and development projects, from mAbs to multispecifics, ADCs, and other formats. Outside of science, Jonathan is a conservatory trained cellist, plays numerous other instruments, and founded the UCSF Orchestra (now Symphony Parnassus) in San Francisco, where he was Music Director for six years.

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Davide Guggi

Advisor, CMC


Davide graduated as a pharmacist and received his PhD in Pharmaceutical Technology and Biotechnology from the University of Vienna. He has over 20 years of experience in the pharmaceutical industry, principally in the field of oncology. At the beginning of his career, Davide led oncology business units and commercial departments at Mundipharma and Gilead across Austria and Eastern Europe. Since over 10 years he has been working as a CMC expert, covering operational and regulatory CMC functions on behalf of over 20 different small- and medium-sized biotech companies across the world. He has served as CMC Director and CSO/CTO for several years, developing both small molecules and biologics (mABs, Fab, ADCs and Radio-immuno-conjugates) from early discovery to NDA/BLA in the US, EU and Canada, with a focus on First-in-Human and Phase I/II studies in oncology indications.

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Tumor Defense Breaker™, L-DOS47


L‑DOS47 is a first‑in‑class, clinical-stage antibody‑enzyme conjugate designed to deliver a game-changing assist to anti-cancer immunity and today’s leading cancer immunotherapies for the treatment of prevalent, hard-to-treat solid tumors. The compound precisely targets CEACAM6, a cell-surface protein overexpressed in non‑small cell lung cancer (NSCLC) and other aggressive tumors, where it delivers an enzymatic payload that raises the extracellular pH of the acidic tumor microenvironment (TME). By neutralizing tumor acidity, L-DOS47 restores immune cell infiltration and activity, helps turn immunologically “cold” tumors “hot”, and enhances the therapeutic reach of immune checkpoint inhibitors. With patented composition-of-matter coverage through 2036 and demonstrated synergy with PD-1 inhibitor, pembrolizumab, L-DOS47 is poised to significantly increase the efficacy of immune checkpoint blockade and unlock broader and more durable responses in NSCLC and other aggressive solid tumors.

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LEUMUNA™


LEUMUNA™ is an oral immune checkpoint modulator designed to activate the donor immune system to recognize and fight relapsing leukemia in patients who have undergone allogeneic stem cell transplantation (allo-SCT). Although a life-saving procedure, up to 30% of patients who undergo allo-SCT see their cancer return, facing a median survival of just four months. LEUMUNA aims to offer these patients a new lease on life, by activating an immune cascade and inciting graft-versus-leukemia (GvL) effect, potentially offering long-term remission. Backed by strong preclinical data and a promising safety record from trials with its precursor compound, ulodesine, LEUMUNA offers a patient‑friendly, oral approach to a difficult-to-treat condition, with patent protection through 2041 and an Orphan Drug Designation granted by the US FDA.

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GEMCEDA™


GEMCEDA is a first-in-class oral prodrug of gemcitabine that opens up the possibility for convenient at-home administration, metronomic dosing and seamless integration into combination regimens with immune checkpoint inhibitors. To date, gemcitabine is only administered intravenously because oral forms have shown poor bioavailability of about 10%. GEMCEDA was developed as a prodrug to enable new uses of gemcitabine by combining it with cedazuridine, an enzyme inhibitor that helps boost its bioavailability to 90%. This remarkable innovation allows for greater flexibility in dosing schedules, fewer clinic visits, and a better quality of life, while achieving bioavailability on par with intravenous gemcitabine. Supported by a well‑established safety profile, scalable manufacturing, and patent coverage to 2043, GEMCEDA reimagines how chemotherapy can fit into patients’ lives.

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