Innovations in healthcare helps solving health challenges

"The biomedical and technological revolution transforming healthcare at an unprecedented pace is taking place now", Stefan Oelrich, board member and president of Bayer AG's Pharmaceuticals Division, said at virtual Pharma Media Day on Jan. 13.

Under the theme "Transforming Healthcare. Transforming Bayer," the event was attended by speakers from Bayer, its partners and leading experts. The event addressed several worldwide healthcare challenges, and breakthrough innovations in the areas of cell and gene therapy, and digital health.

Cell and Gene Therapy platform for patients

Genetic diseases caused by faulty genes appear in almost every cell in a body, making them nearly impossible to tackle via standard medicine methods. For patients suffering from genetic disorders, treatment was limited to alleviating the symptoms.

Cell and gene therapies have the potential to shift the paradigm of treatment to cure the diseases. Based on this, Bayer’s development portfolio of cell and gene therapies comprises seven advanced assets in different stages of clinical development. These are focused on multiple therapeutic areas with high unmet need, like neurodegenerative, neuromuscular and cardiovascular indications, with leading programs in Pompe disease, Parkinson’s disease, hemophilia A, and congestive heart failure.

Cell and gene therapies offer the possibility to address the root cause.

Bayer has just established a new Cell and Gene Therapy Platform. This platform steers Bayer’s strategy in the area and orchestrates all activities along the value chain providing an innovation ecosystem for all partners, including BlueRock Therapeutics and Asklepios BioPharmaceutical (AskBio), two companies fully owned by Bayer but independently operated.

BlueRock Therapeutics recently announced the U.S. Food and Drug Administration (FDA) had cleared their Investigational New Drug application to proceed with a Phase I study in patients with advanced Parkinson’s disease. This will be the first trial in the United States to study pluripotent stem cell-derived dopaminergic neurons in patients with Parkinson's disease and a big step forward for the stem cell field.

Gene therapy aims to treat or cure a disease by delivering genetic material into a patient's cells

Empowering patients through Integrated Care

Digital healthcare offerings have become an important pillar of modern healthcare. By using artificial intelligence, machine learning, and vast amounts of data, digital solutions empower patients with tracking and managing their health conditions anytime, anywhere.

"By focusing on the individual patient, not their disease, Integrated Care is the path to truly inclusive and personalized healthcare," said Jeanne Kehren, senior VP of Digital and Commercial Innovation and member of the Pharmaceuticals Executive Committee at Bayer AG.

Integrated Care is a key element of Bayer's digital business strategy in pharma. In collaboration, Bayer and the digital health company Informed Data Systems Inc. (IDS/One Drop) are expanding their business based on IDS’s existing diabetes management platform. This solution was downloaded more than three million times.

DNA molecule.

Together, the companies are now creating new health offerings to address the needs of patients in the areas of cardiovascular diseases, women's health and oncology. Experts from both companies are jointly working on the first two modules, which are to become available within a year.

Growing a robust pipeline: New approaches for unmet medical needs

Bayer is continuing to build a strong development pipeline advancing more than 50 projects through the clinic with a focus on cardiovascular diseases, oncology and women's health.

The company highlighted two promising pipeline programs in mid-stage development demonstrating medical innovation at Bayer.

Factor XI (FXI)-targeting compounds, a new class of anticoagulants, is comprised of three investigational assets. A small molecule oral FXIa-inhibitor has commenced a Phase IIb program (PACIFIC), planning to enroll more than 4,000 patients in total.

In addition, an anti-FXIa antibody and a FXI-ligand-conjugated antisense oligonucleotide (FXI-LICA), have recently started Phase II trials, in patients with end-stage kidney disease. FXI-pathway inhibition may offer protection from thromboembolic events without increased risk of bleeding. This may provide a treatment option to patients for whom currently no suitable therapeutic options are available.

With its P2X3 multi-indication program, Bayer highlighted another important candidate in mid-stage development. At Bayer, the promise of P2X3 antagonists was first identified for endometriosis within the company's strategic research alliance with Evotec, a Germany-based drug discovery and development company.

P2X3 also has a prominent role in several other medical conditions associated with pain and neurogenic hypersensitivity like chronic coughing, overactive bladders and neuropathic pain.

As of today, Bayer has entered Phase IIb clinical trials for refractory and/or unexplained chronic coughing, with a trial in endometriosis soon to follow. In addition, Phase IIa clinical studies have commenced for overactive bladders and diabetic neuropathic pain.

At the same time, the company is also delivering on its late-stage pipeline in the areas of oncology and cardiovascular disease including a number of potential products. In the area of oncology, for example, darolutamide (jointly developed with Orion Corporation), a differentiated treatment option that extends survival for men with non-metastatic castration-resistant prostate cancer who are at high risk of developing metastatic disease (nmCRPC) shows a favorable safety profile.

In the field of women’s healthcare, Bayer recently added a highly attractive asset to its development portfolio through the acquisition of KaNDy Therapeutics. BAY-342 (formerly NT-814) is a first in class, non-hormonal, once-daily, oral neurokinin-1,3 receptor antagonist for the treatment of vasomotor symptoms (hot flashes and night sweats) during menopause, planned to start Phase III development in 2021.