Innovating from Strength: What this means at Helix BioPharma

At Helix BioPharma, we are determined to shape a near future where hard-to-treat cancers are able to be conquered. Driven by the reality that every day counts for those of us facing hard-to-treat cancers, we make it our mission to innovate from strength to score with precision against cancer’s biggest, most urgent challenges.

At Helix, innovating from strength means:

  1. Leaning into the expertise of our growing, world-class team to push the limits of proven science and bring life-changing therapies to patients as soon as possible;
  2. Executing on clear, purpose-driven priorities and being disciplined in how we operate; and
  3. Remaining collectively focused on lives, not just headline-making breakthroughs, ensuring that every decision has a clear path to impact and every calculated risk we take can potentially shorten the distance between meaningful treatment outcomes and those who need them most.

We innovate from strength because resistant, hard-to-treat cancers remain stubbornly difficult to overcome—but, for us, accepting this as the status quo is not an option.

1)  The Near-Term Goal: Leveling up the performance of today’s leading anti-cancer precision medicines

Helix BioPharma is advancing a proprietary platform of four bio-conjugates that target Carcinoembryonic Antigen-related Cell Adhesion Molecule 6 (CEACAM6), a cell surface protein that is associated with tumor resistance, poor survival, and cancer progression and metastasis1. CEACAM6 is overexpressed in prevalent and hard-to-treat solid tumors—including non-small cell lung cancer (NSCLC), colorectal and pancreatic cancers—but its levels are significantly low in healthy tissue, making it a highly promising target for scoring with precision against these cancers2.

At the forefront of Helix BioPharma’s CEACAM6 platform is L-DOS47 (Tumor Defence Breaker™), our lead candidate and a first-in-class antibody-enzyme conjugate (AEC) that takes the brakes off anti-cancer immunity and enhances the effectiveness of today’s immune-oncology therapies. L-DOS47 neutralizes the acidic pH of the tumor microenvironment (TME)—a hallmark of cancer associated with tumor aggressiveness and resistance to treatment, including to chemotherapy and immunotherapy.3

In Phase IB studies, L-DOS47 in combination with chemotherapy (pemetrexed / carboplatin) have shown a 75% overall response rate, including one near-complete remission, in heavily pre-treated Stage IV NSCLC patients4. Building on these highly encouraging results, our goal is to advance L-DOS47 into Phase II studies in combination with immune checkpoint inhibitor pembrolizumab for NSCLC.

2) The Mid-Term Goal: Honing candidates with a head start into first- and best-in-class oncology medicines 

At Helix BioPharma, our commitment to innovating from strength extends to our strategic approach in identifying and securing high-potential candidates. In this second facet of our strategy, we leverage our expertise to pinpoint assets backed by robust evidence and positioned for accelerated development—assets that have the potential to drastically improve the treatment experience of patients affected by hard-to-treat cancers.

(i) LEUMUNA™

LEUMUNA (ulodesine hemiglutarate), is a ground-breaking, oral immune checkpoint modulator that aims to bring long-term remission within reach to patients relapsing with leukemia after allogeneic stem cell transplantation (allo-SCT). The compound is clinically de-risked by robust Phase I and II safety data, yet stands out as a pioneering, patent-protected chemical entity with a novel method of use. LEUMUNA has been shown to significantly improve survival in mouse models of B Cell acute leukemia relapse and has been granted Orphan Drug Designation by the US FDA.

Up to 30% of patients with hematological malignancies who undergo allo-SCT experience relapse, which occurs when the donor immune system fails to recognize residual leukemia cells or doesn’t mount an effective response. For these patients, the median survival is just four months, with only 21% living beyond a year. LEUMUNA5 drives the donor immune system to recognize, target, and eradicate resurging leukemia cells by initiating Graft-versus-Leukemia effect (GvL), offering these patients new hope for long-term remission. 

(ii) GEMCEDA™

GEMCEDA is a first-in-class oral gemcitabine prodrug to enrich the spectrum of disease-limiting and life-enhancing outcomes for patients whose cancer has progressed. Gemcitabine is a chemotherapy agent found among the World Health Organization’s Model List of Essential Medicines and is one of the most widely prescribed oncology therapies worldwide6. However, it is only available in intravenous (IV) form today; many efforts to formulate gemcitabine for oral use have failed due to its low oral bioavailability of only 10%, which poses challenges in achieving therapeutic drug levels7.

GEMCEDA is an oral prodrug of gemcitabine combined with cedazuridine that has been shown to achieve bioavailability of 90% in pharmacokinetic studies—near-matching the bioavailability of its IV counterpart. This means that GEMCEDA has the potential to enable metronomic gemcitabine dosing (low, regular doses that may enhance efficacy while reducing side effects), while sparing patients the discomfort of IV administration and hospital visits, offering more time at home and a greater sense of control over their care.

With gemcitabine approved for first- and second-line treatment in NSCLC, breast, pancreatic, and ovarian cancers, GEMCEDA may qualify for expedited approval. Its potential for long-term maintenance therapy and immunotherapy combinations could significantly extend progression-free survival for patients with advanced cancers.

3) The Long-Term Goal: Forging the next generation of safe, CEACAM6-targeting bio-conjugates to outmaneuver resistance and maximize therapeutic efficacy

Leveraging our extensive experience with CEACAM6 as a therapeutic target and the latest, ground-breaking advances in antibody-drug conjugate (ADC) technology, as of 2025 Helix Biopharma is innovating from strength to advance the discovery of bio-conjugates that specifically target solid tumours overexpressing CEACAM6.

Heralded as oncology’s next revolution, ADCs consist of a small-molecule drug linked to an antibody that targets and delivers the drug directly to the tumor cells, sparing healthy cells and significantly improving treatment outcomes in a number of cancers. At Helix BioPharma, we are drawing on the latest advancements in design, conjugation, and payload technology to develop bi-specific ADCs and radionuclide drug conjugates (RDCs) for gastrointestinal, gynecological, and other solid tumors.   

4) The Fuelling Force: A growing, world-class team united behind a hyper-focused strategy

Helix BioPharma innovates from strength by being disciplined in how we operate. We’ve streamlined our organization, focusing on key programs and building a team with a stellar track record and deep domain knowledge poised to make the biggest impact.

Since June 2024, we have strengthened our team with leading experts, including:

  • Thomas Mehrling, MD, PhD — An Oncologist – Pharmacologist and Helix Biopharma’s Chief Medical Officer, Dr. Mehrling has 20 years’ experience shaping the oncology landscape with multinational Pharma companies and introducing groundbreaking cancer drugs across Europe that achieved sales nearing USD1 billion.
  • James B. Murphy, CPA (via Danforth Advisors) — A certified public accountant and Helix BioPharma’s Acting CFO, Mr. Murphy has served over fifteen private and public life sciences companies as CFO / CFO Advisor, helping them secure over USD 0.5 billion in financing and successfully execute pivotal asset transactions.
  • Jonathan Davis, PhD — An expert in therapeutic antibodies and Helix BioPharma’s Director of ADC Discovery, Dr. Davis has over 15 years’ experience leading discovery and innovation strategies for diverse therapeutic antibody formats, from  monoclonal antibodies (mAbs) to multispecifics and bi-specific ADCs.
  • Davide Guggi, PhD — A Chemistry, Manufacturing, and Controls (CMC) expert and Helix BioPharma’s Chief Technology Officer, Dr. Guggi has over a decade of CMC expertise across 20+ global biotech firms, driving the end-to-end development of small molecules and biologics—including mABs, ADCs, and radio-immuno conjugates—from discovery to new drug applications (NDA) and biologics license applications (BLA) in the US, EU, and Canada.

With a streamlined focus and high-impact hires, we are strategically deploying resources to accelerate L-DOS47 and our pre-IND candidates toward clinical milestones by 2026.

5) Innovating from Strength

At Helix BioPharma, innovating from strength is not just a strategy—it’s how we turn potential into progress. By maximizing our candidates, prioritizing high-impact opportunities, and executing with precision, we strive to deliver smarter therapies to those who need them most. And by building on what we know—our scientific expertise, our data, and our strategic positioning—we are creating a portfolio that is not only differentiated but also de-risked and highly investable.

Because at the end of the day, innovation matters only if it changes lives. And that is exactly what we are here to do.

References:

1 Zhao, D et al. CEACAM6 expression and function in tumor biology: A comprehensive review. Discov Oncol. 2024 May 25;15(1):186. doi: 10.1007/s12672-024-01053-6.

2 Pandey, R et al. Carcinoembryonic antigen cell adhesion molecule 6 (CEACAM6) in Pancreatic Ductal Adenocarcinoma (PDA): An integrative analysis of a novel therapeutic target. Sci Rep 9, 18347 (2019). https://doi.org/10.1038/s41598-019-54545-9.

3 Bogdanov A et al. Tumor acidity: From hallmark of cancer to target of treatment. Front Oncol. 2022 Aug 29;12:979154. doi: 10.3389/fonc.2022.979154.

4 Piha-Paul S et al. A Phase 1, Open-Label, Dose-Escalation Study of L-DOS47 in Combination With Pemetrexed Plus Carboplatin in Patients With Stage IV Recurrent or Metastatic Nonsquamous NSCLC. JTO Clin Res Rep. 2022 Sep 16;3(11):100408. doi: 10.1016/j.jtocrr.2022.100408.

5 Chen YF et al. Allogeneic stem cell transplantation in the treatment of acute myeloid leukemia: An overview of obstacles and opportunities. World J Clin Cases. 2023 Jan 16;11(2):268-291. doi: 10.12998/wjcc.v11.i2.268; Michallet, M et al. Relapse After Allogeneic Hematopoietic Stem Cell Transplantation for Hematological Malignancies: Factors Impacting Its Occurrence and Treatment Options for a Better Management. Blood. 2011 Nov 18; 118(1): 4093. https://doi.org/10.1182/blood.V118.21.4093.4093.

6 Ciccolini J et al. Pharmacokinetics and pharmacogenetics of Gemcitabine as a mainstay in adult and pediatric oncology: An EORTC-PAMM perspective. Cancer Chemother Pharmacol. 2016 Jul;78(1):1-12. doi: 10.1007/s00280-016-3003-0.

7 Thompson BR et al. Pharmacokinetics of gemcitabine and its amino acid ester prodrug following intravenous and oral administrations in mice. Biochem Pharmacol. 2020 Oct;180:114127. doi: 10.1016/j.bcp.2020.114127.

2 Reply on “Innovating from Strength: What this means at Helix BioPharma”

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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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