MD Anderson and Taiho Pharmaceutical Collaborate to Develop Therapies for Brain Metastases

The University of Texas MD Anderson Cancer Center and Taiho Pharmaceutical have formed a collaboration to do preclinical and early clinical research on potential therapies to treat brain metastases and those with cancers refractory to available therapies.

The 3-year collaboration will focus on small molecules developed by Taiho. Investigators from MD Anderson will focus on the translational research for product candidates and lead initial clinical studies.

The collaboration was a natural extension of an extensive research framework between MD Anderson’s Translational Research to Advance Therapeutics and Innovation in Oncology (TRACTION) platform and the institution’s Brain Metastasis Clinic, said Timothy Heffernan, PhD, executive director of TRACTION. 

TRACTION is focused on translational research and is a core component of MD Anderson’s Therapeutics Discovery division. “Our mission is to define definitive clinical properties by leverage, disease modeling, clinical pharmacology, biomarker development and eventually providing the entire clinical development package for evaluation in the Brain Metastasis Clinic,” Heffernan said.

For the collaboration with Taiho, the TRACTION team will focus on the cancers with a high incidence of brain metastases, including lung cancer, melanoma, breast cancer, renal cell carcinoma. The goal, Heffernan said, is to model the disease for new insights that are emerging from the Brain Metastasis Clinic and then, through a process of reverse translation, provide new insights that can be evaluated.

Investigators from the Brain Metastasis Clinic will then conduct clinical trials assessing early safety and efficacy in preparation for a phase 3 trial, said Hussein Tawbi, MD, PhD, who co-founded the clinic 2 years ago. The Clinic is a unique multi-disciplinary effort established by MD Anderson to offer improved care for patients with brain metastases, including a more streamlined treatment process and better access to appropriate clinical trials

“One of the goals for our clinic is to expedite brain-directed therapies and facilitate drug development for these patients,” he said.

The Brain Metastasis Clinic team often discusses recent developments with colleagues in TRACTION, working to develop strategies for the clinical development of novel agents in specific patient populations, Tawbi said in an interview. This led to a partnership between the groups within MD Anderson, including experts in a variety of clinical areas, to design novel clinical trials that would be appropriate for patients with brain metastases. 

“This is truly an unprecedented effort that integrates translational research with the clinical development expertise of our colleagues in the Brain Metastasis Clinic,” Heffernan said in an interview. “Through this patient-driven approach, we aim to drive innovation and accelerate therapeutic development for patients with brain metastases.”

In the collaboration with Taiho, MD Anderson will conduct the early trials for the therapies being studied. Taiho, Tawbi said, has been very deliberate in developing agents that penetrate the brain. The TRACTION team will be able to reproduce in their models what we see in the clinic so that we can ask the question, in their models, which is the best molecule, which is the best target, and what is the best strategy. And based on his findings, we can design the most effective phase 1/2 trials that can help us take the drug all the way from preclinical all the way to the patient.”

The development of effective treatment approaches for these patients with brain metastasis has been hampered because they often are excluded from clinical trials. 

MD Anderson is currently conducting 14 trials of therapies to treat patients with metastasis. 

References

1. MD Anderson and Taiho Pharmaceutical announce collaboration to accelerate development of novel therapies for brain metastases and other unmet medical needs. News release. The University of Texas MD Anderson Cancer Center and Taiho Pharmaceutical. September 24, 2020. Accessed October 20, 2020. https://bit.ly/35d8Ulq​