Bayer and Puhe BioPharma Enter Global License Agreement for PRMT5 Inhibitor
Bayer and Suzhou Puhe BioPharma Co., Ltd., a clinical-stage biotechnology company, have entered into a global licensing agreement to develop, manufacture, and commercialize an oral, small-molecule PRMT5 inhibitor, BAY 3713372. This inhibitor specifically targets MTAP-deleted tumors, which are often resistant to traditional cancer therapies. This agreement marks a significant milestone in the development of precision oncology treatments.
Licensing Agreement Details
Under the terms of the agreement, Bayer gains an exclusive worldwide license for the MTA-cooperative PRMT5 inhibitor, which was developed by Puhe BioPharma. This inhibitor has demonstrated promising preclinical results in targeting MTAP-deleted tumors. Bayer has already begun clinical development by enrolling the first participant in a Phase I dose escalation study of the inhibitor, under the development name BAY 3713372. The clinical trial will evaluate its safety and efficacy in treating MTAP-deleted solid tumors.
Juergen Eckhardt, M.D., Head of Business Development and Licensing at Bayer’s Pharmaceuticals Division, expressed his enthusiasm about the partnership: “We are looking forward to exploring the potential of the PRMT5 inhibitor, which could significantly improve outcomes for patients with MTAP-deleted tumors, a group that often faces poor prognosis.” He further emphasized the promise of the selective targeting of cancer cells while sparing healthy cells, citing the innovative mechanism of action as a key reason for their optimism.
Promising Preclinical Results
The oral PRMT5 inhibitor, known as PH020 and now renamed BAY 3713372, has shown competitive selectivity for PRMT5 bound to MTA in preclinical studies. Additionally, the compound demonstrated the ability to penetrate the brain, making it particularly relevant for treating brain metastases and primary brain tumors, which are difficult to target with many existing therapies.
Yongqi Guo, CEO of Puhe BioPharma, highlighted the potential of the PRMT5 inhibitor in treating MTAP-deleted tumors: “Our MTA-cooperative PRMT5 inhibitor has demonstrated impressive selectivity and activity in preclinical studies. We are excited to partner with Bayer, a global leader in life sciences, to move this promising treatment forward and provide a new therapeutic option for patients worldwide.”
The Role of PRMT5 and MTAP in Cancer
PRMT5 (protein arginine methyltransferase 5) and MTAP (5’-deoxy-5′-methylthioadenosine phosphorylase) are crucial players in cell metabolism and survival. In particular, the loss of the MTAP gene, which occurs in approximately 10 to 30 percent of cancers, creates a vulnerability that can be targeted for therapeutic purposes. This genetic deletion results in the accumulation of methylthioadenosine (MTA) in tumor cells, which is associated with an aggressive cancer phenotype.
BAY 3713372 works by binding to the PRMT5-MTA complex, exploiting this specific vulnerability. By targeting this mechanism, BAY 3713372 offers a highly selective approach to treat MTAP-deficient cancer cells while sparing normal, healthy tissue.
Impact on Hard-to-Treat Cancers
The loss of the MTAP gene has been linked to several hard-to-treat cancers, including pancreatic cancer and glioblastoma. These cancers are often associated with poor prognosis and limited treatment options, making them prime targets for new and innovative therapies. Dominik Ruettinger, M.D., Ph.D., Global Head of Research and Early Development for Oncology at Bayer’s Pharmaceuticals Division, explained the importance of this treatment approach: “The loss of the MTAP gene occurs in a variety of tumor types, including those with few treatment options. We are excited to advance this program to help improve the lives of patients with high unmet medical need.”
The global license agreement between Bayer and Puhe BioPharma provides an opportunity to accelerate the development of BAY 3713372 and bring it to market for patients suffering from MTAP-deleted cancers.
BAY 3713372: A Potential Breakthrough in Precision Oncology
BAY 3713372 is an investigational compound and has not yet been approved by any health authority for use in any country or for any indication. As an oral, selective PRMT5 inhibitor, BAY 3713372 represents a potential new targeted treatment for patients with MTAP-deleted solid tumors. Its unique characteristics, including the ability to penetrate the central nervous system (CNS), make it a promising candidate for treating CNS metastases and primary brain tumors, which are often difficult to manage with conventional treatments.
The drug targets the PRMT5-MTA complex, a critical mechanism in MTAP-deficient cancer cells, with the aim of disrupting cancer cell survival. Given the unique vulnerability of these tumor cells, BAY 3713372 holds potential as a transformative agent in the treatment of various cancers.
Conclusion
The global licensing agreement between Bayer and Puhe BioPharma highlights the growing importance of precision oncology in the treatment of difficult-to-treat cancers. By targeting the PRMT5-MTA complex, BAY 3713372 offers a new approach to treating MTAP-deleted tumors, a subset of cancers that are often resistant to conventional therapies. With the initiation of Phase I clinical trials, the partnership between Bayer and Puhe BioPharma brings new hope to patients and could pave the way for a significant breakthrough in cancer treatment.
Financial details of the agreement have not been disclosed, but both companies are committed to advancing this promising therapeutic option to improve patient outcomes and address the growing need for innovative cancer therapies.
About the clinical phase I study
BAY 3713372 is investigated in a global Phase I first-in-human dose escalation study in patients with MTAP-deleted solid tumors. The clinical program aims to evaluate the safety, tolerability and pharmacokinetics, pharmacodynamics and preliminary clinical activity of BAY 3713372, a novel cancer cell specific PRMT5 inhibitor.
About Puhe BioPharma
Suzhou Puhe BioPharma Co., Ltd. is a biotechnology company dedicated to the research and development of innovative small-molecule precision therapeutics. Adhering to a strategy that addresses differentiated clinical needs, the company focuses on high-incidence, high-mortality cancers and other chronic diseases. By leveraging scientific and industrial insights, Puhe combines various advanced technologies such as next-generation kinase inhibitors, synthetic lethality, and molecular glue approaches to address complex medical challenges. For more information, go to www.puhebiopharma.com.
About Bayer
Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. In line with its mission, “Health for all, Hunger for none,” the company’s products and services are designed to help people and the planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to driving sustainable development and generating a positive impact with its businesses.
At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2024, the Group employed around 93,000 people and had sales of 46.6 billion euros. R&D expenses amounted to 6.2 billion euros. For more information, go to www.bayer.com.
