Researchers at Bayer HealthCare are focusing on developing cancer drugs directed at the specific targets that are responsible for the malignant behavior of tumor cells. In parallel, they are working with partners to develop specific diagnostic tests that can identify the presence of these targets in an individual patient’s tumor. Their goal is to advance more targeted therapies with companion diagnostics so that in the future each cancer patient can receive the treatment that is best suited to his or her disease.
Cancers are not all the same. Each cancerous condition is different – and requires individual treatment.
Bayer researchers are currently working in a global network on new cancer treatments geared to specific target molecules in the tumor. At the same time, they are collaborating with diagnostic companies to develop a suitable diagnostic test for each treatment.
In future, each cancer patient will receive the treatment best suited to the tumor.
Cancer is referred to as just one disease – but it manifests itself in hundreds of forms. Every cancer is different and needs a precise diagnosis as the basis for an individualized therapy. Cancer can originate from different kinds of cells in various organs and give rise to a wide range of malignant tumors.“We have to come up with an individualized strategy of treatment for every tumor by selecting the most appropriate treatment method,” says Dr. Karl Ziegelbauer, Head of the Oncology Therapeutic Research Group at Bayer HealthCare. To ensure that doctors select the right treatment or the right combination of active substances in each case, it is particularly important that the molecular characteristics of the tumor are characterized. Individualized cancer diagnostics is therefore becoming increasingly important.
Cells out of Control
The longer a person lives, the higher the likelihood of changes and damage to the genetic material of one or more of the body’s cells. If molecular repair systems then also fail, the cells may get out of control and proliferate. Doctors refer to this as a tumor, the Latin term for a swelling. Tumors may be benign or malignant.
Doctors Search for a more Personalized Treatment Strategy for each Cancer Patient
Huge advances have been made in this field in recent decades, and the way ahead is clear. “In the future, we want to gain similar control of cancers as has already been achieved with other chronic diseases such as diabetes,” explains Dr. Joachim Reischl, Head of Global Biomarker Strategy & Development at BayerHealthCare. Even if this aim still seems a long way off in the case of some types of cancer, these hopes are fully justified. The more that Bayer researchers such as Reischl and Ziegelbauer know about the specific properties of a tumor, the better they will be able to develop and use precisely targeted medicines.
“Diagnostics will in future be well and truly wedded to new therapies,” predicts Reischl. From 2018, every new Bayer cancer medicine will have an accompanying partner and companion: indeed, the buzzword in cancer medicine for some years has been “companion diagnostics”. These are tests that help to determine, even in advance of treatment, whether a particular medicine will be effective in a patient or not. “In this way, we don’t waste any time with treatment – and can avoid unnecessary side effects,” says Reischl. Companion diagnostics is not limited to cancer therapy and is already being used, for example, in treatment selection for AIDS patients.
In the future, we want to gain similar control of cancers as has already been achieved with other chronic diseases such as diabetes.
With companion diagnostics, new medicines could in future be much more precisely targeted at those patients who will benefit from them the most. “Our medicines are nowadays often so specifically tailored to particular tumor mutations that it is crucial to select the appropriate patient population whose tumor carries this mutation,” explains Reischl. As a result, substances that have shown notable effects in preclinical studies appear to be ineffective in clinical studies that do not recruit the right patient population. “It is then often worth taking a second look,” says Reischl, who goes on to describe an example from the latest research at Bayer HealthCare. In a study with 58 liver cancer patients, a positive response to a new combination therapy was evident in only four study participants. Three of these were still alive over 18 months after starting the treatment: a major success - albeit for only a few patients - given that people with liver cancer generally die within a year of diagnosis. “We should nevertheless actually have ended our study in view of the low success rate compared to the current standard of care,” explains Reischl
New, Targeted Therapies Are often only Effective in a few Patients – but there They Are very Effective
Their colleagues from Global Biomarker and Clinical Development, however, took a close look at the specific genetic changes of the patients who had benefited from the treatment and discovered that three of them did indeed have a common characteristic that was not shared by most of the other patients. They all had a mutation in a particular gene that is important for cell growth and survival. “In many types of tumors, a gene referred to as ‘Ras’ is known to mutate and consequently to become constantly active,” explains Reischl. This makes it a frequently used target for cancer researchers. The new Bayer test molecule called refametinib in combination with sorafenib seems to be very effective in this subgroup of liver cancer patients. “It is now important to confirm this finding in liver cancer patients who have been tested positive for Ras mutations,” says Reischl.
So as to single out the right patients in the future in advance of treatment, Bayer HealthCare has taken multiple partners on board: for example, the start-up company Sysmex Inostics based in Germany and the USA, which has developed a technology that can precisely identify patients with Ras mutations – simply using a sample of the patient’s blood. “Our method is highly innovative and very sensitive,” explains Dr. Frank Diehl, CSO of Sysmex Inostics.
Sysmex Inostics is capitalizing on a finding that is set to become increasingly important for the future of medicine. Cours-ing through our blood are not just blood cells, protein molecules and immune cells but also cell residues and DNA fragments shed by the tumor into the bloodstream. Sysmex Inostics has devel-oped technology that allows these scraps of genetic material to be tested for particular mutations. “Simply by taking a blood sample, we can diagnose whether a patient has a higher chance of benefiting from the new Bayer active substance refametinib in combination with sorafenib,” explains Diehl. And in the future, according to Reischl, the tests could also be used for more than initial diagnosis. “With blood-based tests we have the opportunity to monitor the course of a cancer and the effect of the treatment.” Companion diagnostics are not limited to blood tests, however. Conventional methods can also be used to seek specific characteristics in patients’ tissues. To this end, Bayer HealthCareis working together with experienced diagnostics firms such as Qiagen andVentana.
is the Latin term for a swelling.
Networked and Local Tumor Research: the Biopolis Cooperation Model in Singapore
The right network is therefore crucial for successfully combating cancer. “As a global company, we are also turning our attention to treatments for the different groups of patients throughout the world – ideally, on-the-spot,” explains Professor Eckhard Ottow, Head of Global External Innovation & Alliances. He and his team coordinate Bayer HealthCare’s strategic partnerships worldwide. “These alliances give us access to knowledge about the locally dominating cancers, allowing us to benefit from the existing experiences, and we can then accelerate the translation of research from the lab to the clinic,” explains Dr. Hwee Ching Ang, who is responsible for alliances between BayerHealthCare and research institutes and hospitals in the small South-East Asian island nation of Singapore, where nearly one in three of the population dies of cancer. This cooperation is just one example from the global Bayer research network.
Interview: Dr. Boon Cher Goh
Dr. Boon Cher Goh is Head and Senior Consultant in the Department of Hematology/?Oncology at the National University Cancer Institute of Singapore.research spoke to him about the cooperation projects with Bayer‘s cancer researchers.
What can the clinical studies conducted at the National University Hospital in Singapore offer patients?
It means that we can offer our patients additional therapeutic options, albeit always in connection with blood and tissue biopsies. After all, clinical trials are always by definition experimental. Some of the trial participants have already benefited, but of course it is never possible to help all patients.
How do physicians profit from these studies?
We are naturally extremely proud to have contributed to advances in clinical research with the latest technology, which have led to us being involved in the clinical development of some very interesting drugs. It is always a scientific challenge to help patients with tumor diseases that have not responded to the existing standard treatments. That spurs us on to think of better ways to treat cancer.
And what about the researchers?
Laboratory researchers share the same vision to make new discoveries that can impact patients’ lives. In order to do so, they know that they have to work together closely with physicians who provide the critical clinical questions that need answering.
Why are you looking for partners such as Bayer? What can you learn from each other?
Bayer has a wide range of experience in drug development, which leads to a great diversity of strategies and products that can then be evaluated in clinical trials. The cooperation between Bayer’s drug development research teams and our more academically oriented researchers can be a highly effective mechanism to make great discoveries. Bayer scientists use a plethora of technologies to select patients for clinical trials on the basis of data and tumor characteristics. This is very forward-thinking approach, in my opinion.
“In recent years, Singapore has developed into a hot-spot for life sciences in Asia,” says Ottow, substantiating Bayer’s involvement there. The country’s government has for some years specifically backed investment in biomedical research – and has successfully brought together elite researchers from all over the world in an R&D center called Biopolis. Bayer HealthCare has been benefiting from this innovative environment for five years now and has expanded the alliances to form a network for translational oncology that aims to work in particular on treatments for patients in Asia. Partners include the Cancer Science Institute at the National University of Singapore (NUS), the National University Hospital, the National Cancer Centre, and the Singapore Bioimaging Consortium. “Bayer’s researchers often have new ideas for active substances and we have contact with precisely those patients who could benefit,” says Dr. Boon Cher Goh, a doctor at the National University Cancer Institute, explaining the win-win situation. He is currently in charge of a clinical study in patients with stomach cancer. The new active ingredient acts precisely at the root of the disease – and can intervene directly in the dysregulation in tumor cells. “We often combine our new medicines with other molecules or even with chemotherapy,” continues Ziegelbauer. “Sometimes, the doctors also have to keep adapting the therapies to the individual course of the disease, as cancer cells fight for their survival – and may develop resistance.“
Bayer’s researchers often have new ideas for active substances and we have contact with precisely those patients who could benefit.
Despite all research activities, the war on cancer will probably never be fully won. With the research on innovative combinations of individualized diagnostics and personalized active substances, however, Bayer researchers can in the future hopefully help to make this malevolent disease perhaps seem somewhat less fearsome.
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