When it comes to cancer research and drug development, there lies a vast gulf of uncertainty in the traditional approach of theory and practice. That gulf widens with the ‘somewhat manual, somewhat technical clinical trial and error methodology. Thus, the entire R&D process is not only huge time and money-consuming but also susceptible to more failed rather than successful outcomes.
It is the biggest reason why, after so many scientific and technological advancements, clinical drug development regarding cancer treatment in general and breast cancer treatment, in particular, remains a shooting in the dark realm of probability. All this leads to more patients fighting cancer, especially breast cancer, either getting under-estimated, low-risk, minimal or overestimated, and overcostly maximal therapy.
The current risk-adopted Breast Cancer therapy approach – intensive therapy for high-risk, moderate treatment for low-risk patients – is all but optimal and has a variety of undesirable consequences, most importantly, suboptimal therapy outcomes. According to recent estimates, half of the women in Europe and the US diagnosed with Breast Cancer (750,000 every year) run the risk of under-or over-treatment.
This is where the revolutionary discovering mind of Wolfgang Hackl, Founder, and CEO of OncoGenomX, has made all the difference with his diligently acting upon his innovative thoughts and out-of-the-box approach.
A Novel PredictionStar
Wolfgang shares, “Tumor typing has never facilitated optimal treatment with predictable outcomes – until now. We envision a future of precision cancer tests, enabling perfect matching of therapies and tumors, comprehensive, accurate, predictive, and actionable.”
Only a therapy that hits all tumor cells at their shared biological weak point eliminates cancer effectively as a basis for prolonged life expectancy, if not curing it. OncoGenomX provides the first AI-enabled cancer profiling technology reflective of tumor biology, clinical behavior, and pharmacological vulnerabilities of individual cancers to guide decisions on the composition of therapy regimen, combining the most effective drugs with the highest chance of conveying maximum clinical and health economic benefit.
Wolfgang states, “We know, accounting for the properties of individual cancers makes a difference to patients. For this reason, we have developed PredictionStar.”
PredictionStar is the first of its kind point-of-care technology platform, amenable to any molecular cancer diagnostics laboratory.
The technology works by using patented algorithms to analyze tumor-specific genomic, biological, pathological, and patient-specific clinical information, complemented by intelligence-augmented drug–tumor matching and calibration with real-world outcome data to guide evidence-based therapy decisions.
Wolfgang says, “Current prognosis and mutation-centrism make PredictionStar a must-have Breast Cancer diagnostic.”
OncoGenomX: A Stream of Consciousness
Prior to launching OncoGenomX, a provider of development and therapy decision support services in 2020, Wolfgang was a very successful corporate manager. In 2018, he had no aspirations to become a founder and was perfectly content with his global assignment as Global Head of Strategic Planning.
In Spring 2017, he attended a panel session at a cancer conference on ‘unsolved problems of cancer drug development and cancer therapy decision making’.
For an hour, the panel discussed the reasons why only a few preclinical innovations reach the patient and the reasons for the growing number of overtreated cancer patients. The root causes for suboptimal treatment outcomes are not dramatically different from the outcomes two decades ago, despite the bust of technical innovations allowing cancer profiling at molecular resolution.
Wolfgang recollects, “I had a stream of consciousness during that hour, and when the panel ended, I knew right then and there that I had to dedicate the rest of my career to solving these problems; that was the genesis of OncoGenomX. The most important thing I learned from that experience was the true definition of purpose and how important it is to live and work with purpose.”
A Journey of Learning
Even before the registration of OncoGenomX in October 2019, it was clear to Wolfgang and David Demanse, Co-inventor and Co-founder, that they needed an experienced start-up CEO for OncoGenomX.
But then came COVID. Nobody was inclined to take an unnecessary risk and give up their secure job for a concept idea. Wolfgang says, “That’s how I ended up as the CEO of OncoGenomX, a choice taken out of necessity that turned into the steepest learning curve in years.”
COVID did not really help with company building or fundraising. But it did not harm them either. “On the contrary, it gave me enough time to advance our business concept to maturity and to establish important contacts. Both are paying off in many ways today,” thinks Wolfgang saying that there was precious learning: Embrace unexpected developments as an opportunity to learn and grow.
Healthy Women, Healthy Future
When probed on to reveal OncoGenomX’s core values and mission, Wolfgang states them as:
- Integrity: Reputation through trust and quality
- Excellence: People, products, services
- Alignment: One team. One goal. One voice. One vision.
- Diversity: Equal opportunity, Inclusivity.
Mission: Innovating to optimize treatment development and therapeutic outcome.
Immersive Benefits of the Maximum Clinical Utility
Talking about OncoGenomX, Wolfgang says that they offer two services/products:
- R&D decision support for the cancer therapeutics industry.
- Therapy decision support for molecular diagnostics laboratories at cancer hospitals.
Cancer drug R&D today builds on preclinical assumptions. Clinical validation of the assumptions is the final step:
- You know that an innovative pathway is relevant for the survival of cell lines.
- You know that pathway inhibition stops cancer cell growth and spreading in mice.
- No certainty whether a pathway is relevant for patient tumors and which ones.
- No idea where inhibition of the pathway will take a patient.
Consequences for clinical validation: duration (8-10 years), cost (750M USD per new drug application), and late failure risk (4 of 5 pivotal trials).
- You are certain of the clinical relevance of an innovative treatment approach.
- You know in which tumors the treatment will be efficacious.
- You know the target patient population.
- You see how comparable treatment mechanisms impacted the disease course of real-world patients.
- Clinical testing is a winning exercise rather than a failure-prone search expedition.
Treatment decision-making today:
- You know the molecular tumor status.
- No idea which treatment will be effective.
- No idea where treatment will take a patient.
PredictionStar-guided treatment decision-making:
- You know which treatments are efficacious.
- You see how these treatments impacted the disease course of real-world patients.
- You have an 85% chance of offering the most promising treatment.
- Durable disease control – an option for all patients.
A Revolutionary Approach Minimizing the Risk of Failure and Liability
According to Wolfgang, the limitations of today’s breast cancer tests are the reason for today’s risk-adapted treatment paradigm: Low risk – moderate treatment. High risk – intensive treatment. In case of doubt: intensive treatment.
The consequence: a ratio of 1:1 overtreatment risk.
Wolfgang reveals, “With PredictionStar, you have an 85% chance to offer patients the most promising and correct amount of treatment.”
- Confidence and trust in treatment recommendations.
- Legitimate hope for durable disease control, and a healthier and happier life.
Strict adherence to treatment guidelines provides legal certainty for hospitals and doctors. Still, it does not protect against inquiries from insurance for excessive treatment costs or from patient attorneys for dissatisfaction with the treatment result.
Additional benefits of PredictionStar are cost savings and increased patient satisfaction, and consequently, expected lower risk of legal action due to dissatisfaction with the therapy result.
Opening Pathways of Clinically Validated Treatment
Giving a brief description of the software, Wolfgang says that PredictionStar is the first method that traces the known breast cancer types down to distinct biological and clinical subtypes.
Our studies revealed that PredictionStar has the potential to guide the prescription of more than 20 anti-cancer treatments, Wolfgang explains, “Thanks to our leadership in understanding the underpinning biological defects of cancer and how they relate to established and investigational treatment pathways, for the first time, we enable the identification of tumor-specific treatment mechanisms, both clinically validated and investigational.
Our findings are based on the results of analyses of three independent data sets (N>4,500 patients). Clinical trials are planned to substantiate our results clinically.”
Establishing an Evidence-Based Clinical Reality
Elaborating on the emerging trends of the new generation and how he plans to fulfill the ever-evolving needs of the healthcare sector by integrating these emerging trends, Wolfgang says that he sees three big needs /trends to fill the gap in the cancer care sector:
- A biological theory of cancer, explaining the different complexities of cancer.
A general biological theory. And special biological theories to deal with entities.
- A software-enabled solution capable of analyzing individual cancers in alignment
with the new theories, with the aim to propose the most promising treatment mechanisms for each individual tumor.
- Up-to-date comparative real-world outcome data to make an evidence-based decision making a clinical reality
Wolfgang adds, “With PredictionStar, we are striving to achieve exactly this, thus, getting closer in realizing the theoretical ideal of precision medicine.”
Surmounting the Adversities by Building a Team of Champions
Speaking about the biggest challenges he has faced, Wolfgang says that it was finding the people who shared his vision and who were willing to take risks in times of uncertainty: Conceptualizing OncoGenomX and PredictionStar was a daunting and lonely task.
And the most important lessons he has learned in his professional journey so far, Wolfgang expresses, “Through fortunate circumstances, I met Marco Witteveen, Seppo Maekinen, and Karl Anderson, who made OncoGenomX seem like a possibility. Finding these people made me realize that if I want to build a successful company, I need to build a team first.”
All three agreed to help build OncogenomX, take an enormous risk, and defer a salary rooted in their belief in the vision for OncoGenomX.
Sharing the Wisdom Drug
Wolfgang’s advice to the budding entrepreneurs and enthusiasts aspiring to venture into this sector is precise. He suggests,
- Start with a purpose!
- Believe and trust in yourself!
- Embrace failure as a learning opportunity!
Predicting The Healthiest Future
When asked where he sees himself in the future and how he envisions scaling OncoGenomX’s successful journey in the healthcare sector, Wolfgang adds that to achieve market authorisation for PredictionStar, completion of two translational studies and one registration study is required.
Wolfgang states further, “My core strength is development. In the short-term, I therefore see myself in the role of OncoGenomX’ s Head of Development. In addition, I aspire to a role in which I can pass on my humble experiences: All knowledge that I have acquired during my career I have gained through exchanges with others like Barbara L Weber, Christoph Lengauer, and Steven Laken, who knew a lot more than I did at the time. Everything I have achieved, I have achieved with the support of others.”
“I feel it is an obligation to pass one’s experience to those who are hungry enough.”
And for PredictionStar, Wolfgang wishes to pass the upcoming clinical tests to make the service amenable to patients in need, first breast cancer patients, then other cancers, and clinical and biomedical application areas beyond cancer.