An Overview of the Evolving Oncology Landscape: From the Mainstays of Treatment to Emerging Therapies

Cancer has long been one of the most challenging diseases in human history, affecting people across time, geographies, and backgrounds. While it once left us with few options, advances in science and medicine are opening new paths for treatment and hope. Today, the 5-year relative survival rate for all cancers combined has climbed from just 49% in the mid-1970s to 69% for diagnoses made between 2013 and 2019.1 Not surprisingly, the United States is now home to more than 18 million cancer survivors, with more than 70% living beyond 5 years after diagnosis.2 This transformation in cancer outlooks began in the late 19th and early 20th centuries with the arrival of anesthesia, antiseptics, and radiotherapy.

Radiotherapy, particularly following the discovery of X-rays in 1895 and radium shortly after, was the first modern medical innovation to offer a real chance at fighting back; but early low-energy machines could only sometimes shrink or, occasionally, eliminate localized tumors, at the cost of severe side effects.3 Today, modern 4D, image-guided systems can deliver highly modulated and targeted radiation treatments that are particularly effective for small tumors. Chemotherapy, which was first developed in the 1940s, has also been refined over the past decades. Today, it plays a critical role in the treatment of many aggressive cancers, and in some cases, such as testicular cancer or certain leukemias, it can even lead to a cure. The limitations of traditional radiotherapy and chemotherapy spurred further innovation, leading to the development of targeted agents such as EGFR inhibitors in lung cancer, HER2 therapies in breast cancer, and modern immunotherapy.4 The field is also seeing a shift towards more personalized and precision medicine, using genomic profiling and genetic testing for the DPYD gene to minimize harm while maximizing treatment outcomes.

Why Chemotherapy Remains Foundational

Chemotherapy remains a mainstay of cancer treatment, widely used by oncologists to treat aggressive or metastasized cancers. When the idea of using toxic chemicals to destroy cancerous cells was first explored in the 1940s, treatments were limited to the compound ‘nitrogen mustard’, which was originally developed as a chemical weapon.5 This was soon followed by experiments with related alkylating compounds such as chlorambucil and cyclophosphamide. Although early chemotherapeutics could sometimes cause striking tumor shrinkage, remissions were often short-lived, and there was widespread skepticism about whether cancer could ever be truly cured with drugs through the 1950s.

This began to change with breakthroughs in the following decades, as studies with chemotherapy regiments such as VAMP (Vincristine, Amethopterin [methotrexate], Mercaptopurine, and Prednisone) in childhood leukemia, and MOPP (Mechlorethamine, Oncovin [vincristine], Procarbazine, and Prednisone) in Hodgkin’s disease, demonstrated for the first time that drugs could cure advanced malignancies. Complete remission rates were seen to rise dramatically from about zero to 80%.6 Today, cytotoxic chemotherapy remains the cornerstone treatment for many solid tumors, when integrated with surgery or radiation, as a curative and palliative therapy for a variety of cancers. Advances in supportive care, including the use of growth factors, antiemetics and antimicrobial prophylaxis, has improved tolerability and permitted dose intensification, reinforcing chemotherapy’s foundational role despite the advent of targeted agents and immunotherapies.

Immunotherapy’s Game-Changing Impact

Although immunotherapy dates back to the 1890s when Coley’s toxin revealed that the immune system could fight cancer, it wasn’t until the 1950s and 1960s that the field saw real evidence of efficacy.7 Cytokine treatments such as interferon-α for hairy cell leukemia and high-dose interleukin-2 for metastatic melanoma and kidney cancer induced durable responses, even though complete remission was uncommon. The true turning point came with monoclonal antibodies in the 1970s and the 1997 approval of rituximab for CD20-positive lymphomas, ushering in a new era for targeted immunotherapy.

The 1990s also saw the discovery of immune checkpoints like CTLA-4 and PD-1/PD-L1, leading to the development of drugs like ipilimumab and pembrolizumab, which now deliver long-term responses in 23–34% of patients with some types of melanomas, lung, bladder and other cancers.8 In the 2010s, there were still more advances in immunotherapy with adoptive cell transfer therapies, such as tumor-infiltrating lymphocyte and chimeric antigen receptor (CAR) T-cell therapies, allowing for greater innovation and success in targeting and eliminating cancer cells.

While transformative, immunotherapy does present limitations, such as the development of resistance, variable patient response, immune-related side effects, and substantial financial burden.9 Making immunotherapy more effective and widely accessible will require a better understanding of why some tumors respond while others don’t, particularly the role of tumor immunogenicity and the suppressive tumor microenvironment (TME).

Targeted Therapies & Precision Medicine

The broad toxicity limitations of non-specific chemotherapy spurred the development of drugs that can precisely target features that are unique to cancer cells. This type of treatment may be used to attack cancer cells directly or to support other treatments like chemotherapy. The prototype ‘imatinib’, which was approved for chronic myelogenous leukemia in 2001, works by binding the Bcr-Abl tyrosine kinase and shutting down the enzyme that causes unchecked cell division.10 This approach transformed the outlook for a once-fatal disease into one with near-normal life expectancy.

Today’s targeted therapies include monoclonal antibodies like trastuzumab and bevacizumab, which latch onto cell-surface receptors or growth factors to interrupt the signals that incite cancer cells to grow and form new blood vessels.11 Small-molecule tyrosine kinase inhibitors (TKIs) such as gefitinib for EGFR-mutant lung cancer or lapatinib for HER2-positive breast cancer can enter cells to block overactive enzymes. More recent advances include antibody–drug conjugates (ADCs) that combine a targeting antibody with a potent chemotherapy payload.12 By matching tumor-specific molecular profiles with targeted therapies, precision medicine aims to achieve deeper remissions with fewer off-target effects.

The Hybrid Future of Oncology: Why Breakthroughs and Foundations Must Move Forward Together

In cancer care today, it’s tempting to speak in absolutes: that immunotherapy is replacing chemotherapy, that targeted therapies are rendering conventional approaches obsolete, that what’s next will finally fix what’s broken. But real progress in oncology rarely comes in absolutes; it comes in combinations, in context, and in continuation. As discussed in one of our recent blog articles, approximately 90 oral chemotherapy agents have been approved by the FDA over the past 20 years, with over 900 chemotherapy agents currently in development.13 In this landscape, our oral chemotherapy candidate, GEMCEDA™, stands out as a first-in-class oral gemcitabine that achieves unprecedented IV-comparable bioavailability and presents new ways to fight and better ways to live for people with advanced cancers.

At Helix BioPharma, we are developing therapies that reflect the hybrid reality of modern oncology. Our pipeline spans both legacy and emerging treatment modalities: L-DOS47, a tumor microenvironment modifier designed to enhance the effectiveness of immune checkpoint inhibitors; GEMCEDA, an oral chemotherapy that modernizes a longstanding treatment backbone; LEUMUNA, an immune checkpoint modulator under evaluation for hematological malignancies; and a pipeline of CEACAM6-targeting antibody–drug conjugates (ADCs) and radionuclide–drug conjugates (RDCs) engineered to deliver potent cytotoxic or radiotherapeutic payloads with precision. Together, these programs exemplify our strategy of integrating new and established mechanisms to address cancer’s complexity from multiple angles. The most effective cancer treatments are already being shaped not by what replaces what, but by how we strategically combine the strengths of each. At Helix BioPharma, we’re not just prepared for this reality; we operate as a part of it.

References

1 https://acsjournals.onlinelibrary.wiley.com/doi/10.3322/caac.21820

2 https://pmc.ncbi.nlm.nih.gov/articles/PMC11542986/

3 https://pmc.ncbi.nlm.nih.gov/articles/PMC9720583/

4 https://pmc.ncbi.nlm.nih.gov/articles/PMC6243123/

5 https://pmc.ncbi.nlm.nih.gov/articles/PMC10310991/

6 https://aacrjournals.org/cancerres/article/68/21/8643/541799/A-History-of-Cancer-Chemotherapy

7 https://pmc.ncbi.nlm.nih.gov/articles/PMC11717579/

8 https://www.annalsofoncology.org/article/S0923-7534(24)03910-3/fulltext

9 https://pmc.ncbi.nlm.nih.gov/articles/PMC9708058/

10 https://onlinelibrary.wiley.com/doi/10.1155/2014/357027

11 https://pmc.ncbi.nlm.nih.gov/articles/PMC10037059/

12 https://www.sciencedirect.com/science/article/pii/S2211383523002320

13 https://www.helixbiopharma.com/blog/helix-biopharmas-strategic-vision-for-next-generation-cancer-therapies/

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.

This will close in 0 seconds

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.

This will close in 0 seconds

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.

This will close in 0 seconds

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.

This will close in 0 seconds

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.

This will close in 0 seconds

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.

This will close in 0 seconds

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.

This will close in 0 seconds

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.

This will close in 0 seconds

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.

This will close in 0 seconds

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.

This will close in 0 seconds

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.

This will close in 0 seconds

[sibwp_form id=1]

This will close in 0 seconds

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.



Read more

This will close in 0 seconds

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.



Read more

This will close in 0 seconds

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.



Read more

This will close in 0 seconds