Beyond the Breakthrough: Where Oncology Still Needs Better Answer

Cancer remains one of the defining healthcare challenges of our time. In 2022 alone, it claimed approximately 9.7 million lives worldwide.[1] Behind that figure are individuals, families, and communities affected by a disease that transcends geography, income level, and age. Today, an estimated one in five people will develop cancer during their lifetime.[2]

The scale of this burden shapes not only clinical priorities but also the decisions of policymakers, researchers, healthcare systems, and investors seeking to support the next generation of cancer therapies.

Over the past two decades, oncology has experienced remarkable progress. Immune checkpoint inhibitors, targeted therapies matched to specific tumor genomics, antibody-drug conjugates (ADCs), and CAR-T cell therapies have transformed treatment options for many people living with cancer. Diseases once associated with poor prognoses can now, in some cases, be managed for years.

Yet despite these advances, cancer remains far from a problem solved. Many tumors continue to evade treatment, relapse remains common, and effective options are still lacking for numerous aggressive and difficult-to-treat cancers. The most important questions in oncology are no longer simply whether we can treat cancer, but why some cancers remain resistant, why outcomes vary so dramatically, and how we can deliver the right treatment to the right person at the right time.

The Persistent Challenge of Resistance and Relapse

One of oncology’s greatest obstacles in cancer’s ability to adapt. Tumors are not static diseases; they evolve under therapeutic pressure. As treatment eliminates sensitive cancer cells, resistant populations can emerge through genetic mutations, metabolic reprogramming, or changes in interactions with the immune system.

This challenge is particularly evident in immuno-oncology, where approximately 70% of patients either fail to respond to immune checkpoint inhibitors or eventually develop resistance after an initial response.[3]

The biological mechanisms underlying resistance are highly diverse, involving alterations in antigen presentation, immune signaling pathways, and the composition of the tumor microenvironment. This complexity helps explain why resistance remains one of the field’s most significant unsolved problems and why continued scientific innovation is essential.

The Cost of Late Diagnosis

For many cancers, outcomes are heavily influenced by when the disease is detected.

Pancreatic cancer is a start illustration of this reality. Overall five-year survival remains approximately 13%, largely because the disease is often diagnosed only after it has spread beyond the pancreas. When detected while still localized, five-year survival rises to roughly 44%.[4]

Advances in molecular diagnostics are also reshaping treatment decisions after diagnosis. In non-small cell lung cancer (NSCLC), comprehensive molecular profiling has been associated with improved survival outcomes by enabling the selection of therapies matched to actionable biomarkers.[5]

These findings highlight the growing importance of biomarkers, liquid biopsy technologies, and molecular diagnostics as critical components of modern cancer care.

The Unmet Need in Rare and Aggressive Cancers

While significant progress has been made in several common cancers, many aggressive malignancies continue to have limited treatment options.

Pancreatic cancer remains one of the clearest examples. Although it is not among the most frequently diagnosed cancers, it is already the third-leading cause of cancer-related death in the United States.[6] Median survival for patients with the metastatic disease is roughly 11 to 12 months on current standard-of-care regimens, and the disease is projected to become the second leading cause of cancer deaths in the US by the end of this decade.[6][7]

Developing therapies for these and rare cancers presents unique challenges. Smaller patient populations can make clinical trial enrollment difficult, while the aggressive biology of many tumors may narrow the window for therapeutic intervention. Identifying eligible participants often requires broader geographic recruitment and specialized testing, adding complexity and cost to clinical development.

Yet these are often the areas where advances could have the greatest impact. The cancers associated with the poorest outcomes frequently represent the greatest opportunities for meaningful clinical progress.

Precision Oncology: Progress with Gaps Still to Close

The concept of precision oncology has evolved from aspiration to clinical reality. Increasingly, treatment decisions are guided not only by where a tumor originates but by its molecular and biological characteristics.

This shift reflects a growing understanding that tumors sharing the same anatomical location can differ profoundly in their genomic drivers, immune landscapes, and metabolic behavior. These differences often determine how a tumor responds to therapy.

Evidence from NSCLC has demonstrated that treatment guided by comprehensive molecular profiling can improve outcomes even in advanced-stage disease.[5]

However, access to advanced molecular profiling remains uneven. Many individuals still begin treatment without a complete molecular characterization of their disease. Expanding access to precision diagnostics and developing therapies that address the specific biology driving each tumor remain critical priorities for the field.

Why Oncology Continues to Command Long-Term Attention

Cancer’s persistence, complexity, and societal impact make oncology fundamentally different from many other therapeutic areas.

The global oncology biopharmaceutical market was valued at approximately USD 130.6 billion in 2024 and is projected to reach USD 268.3 billion by 2034.[8] These projections reflect more than market expansion; they reflect a continuing need for better therapies as cancer incidence rises worldwide and scientific understanding deepens.

Drug development in oncology is also inherently long-term. Bringing a new therapy from discovery to approval can take 10 to 15 years,[9] with development costs frequently reaching into the billions of dollars.[10] Progress and value are often measured incrementally through clinical validation, expanded indications, and the development of rational combination approaches.

This long development horizon can create periods where market sentiment and scientific progress diverge. However, the fundamental drivers of oncology innovation remain unchanged: significant unmet need, continued advances in biology, and a steady flow of emerging therapeutic modalities.

How Innovation-Driven Companies Are Shaping the Next Phase of Oncology

The future of oncology is increasingly being defined by a deeper understanding of tumor biology. Rather than relying solely on broadly acting cytotoxic therapies, researchers are developing treatments designed to address the specific mechanisms that allow tumors to survive, grow, and evade immune surveillance.

At Helix BioPharma, this approach is reflected in the development of L-DOS47, a CEACAM6-targeting antibody-enzyme conjugate designed to modify the acidic tumor microenvironment in NSCLC, and in the exploration of CEACAM6-targeting strategies more broadly across difficult-to-treat solid tumors L-DOS47 is further based on the understanding that characteristics of the tumor microenvironment can contribute directly to treatment resistance and disease progression, and that altering these conditions may enhance therapeutic effectiveness.

This biology-driven approach increasingly characterizes the next generation of oncology innovation. Future advances are likely to emerge not from a single breakthrough, but from a growing ability to understand the unique vulnerabilities of individual tumors and translate those insights into more effective therapies.

The challenges in oncology remain substantial. Yet so too does the opportunity to improve outcomes for the millions of people worldwide whose lives continue to be affected by the disease.

 

References:

1. World Health Organization / IARC. New report on global cancer burden in 2022 by world region and human development level. April 4, 2024. https://www.iarc.who.int/news-events/new-report-on-global-cancer-burden-in-2022-by-world-region-and-human-development-level/

2. World Health Organization / IARC. Global cancer burden growing, amidst mounting need for services. February 1, 2024. https://www.who.int/news/item/01-02-2024-global-cancer-burden-growing–amidst-mounting-need-for-services

3. Pérez-Ruiz E, Melero I, Kopecka J, Sarmento-Ribeiro AB, García-Aranda M, De Las Rivas J. Cancer immunotherapy resistance based on immune checkpoints inhibitors: targets, biomarkers, and remedies. Drug Resist Updat. 2020;53:100718. doi:10.1016/j.drup.2020.100718.

4. Pancreatic Cancer Action Network. Pancreatic cancer survival rate. Updated January 2026. https://pancan.org/facing-pancreatic-cancer/about-pancreatic-cancer/survival-rate/

5. Baron JM, Widatalla S, Gubens MA, Khalil F. Real-World Biomarker Test Ordering Practices in Non-Small Cell Lung Cancer: Interphysician Variation and Association With Clinical Outcomes. JCO Precis Oncol. 2024;8:e2400039. doi:10.1200/PO.24.00039

6. Rahib L, Coffin T, Kenner B. Factors Driving Pancreatic Cancer Survival Rates. Pancreas. 2025;54(6):e530-e536. Published 2025 Jul 1. doi:10.1097/MPA.0000000000002489

7. O’Reilly EM, Wainberg ZA, Hendifar AE, et al. Daraxonrasib or chemotherapy in previously treated metastatic pancreatic cancer. N Engl J Med. Published online May 31, 2026. doi:10.1056/NEJMoa2605555.

8. Global Market Insights Inc. Oncology biopharmaceuticals market size, forecasts 2025-2034. https://www.gminsights.com/industry-analysis/oncology-biopharmaceuticals-market

9. Fang C, Zhou P, Zhang X, He Y, Yang Q. Artificial intelligence in oncology drug development and management: a precision medicine perspective. Front Oncol. 2025;15:1609827. Published 2025 Dec 4. doi:10.3389/fonc.2025.1609827

10. Drugs.com. How the FDA drug approval process works: steps and timeline. Last updated April 15, 2026. https://www.drugs.com/fda-approval-process.html

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™

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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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