TC220 is a proprietary boronated amino acid analog developed by TAE Life Sciences to support BNCT cancer treatment and will be manufactured exclusively by Kinentia Biosciences for the US market
IRVINE, Calif., Aug. 15, 2023 /PRNewswire/ -- TAE Life Sciences has today announced a landmark agreement with Biddle Sawyer to serve as the exclusive supplier of TC220, a novel boronated amino acid analog drug for boron neutron capture therapy (BNCT). As part of this exclusive agreement, Biddle Sawyer has enlisted contract research and manufacturing organization Kinentia Biosciences to refine and streamline the drug's manufacturing process, and ultimately produce the drug in their state-of-the-art GMP facility. Kinentia Biosciences will be the exclusive manufacturer of TC220 for the US market.
Today, TAE Life Sciences is working with several renowned cancer hospitals around the world to deploy its Alphabeam™ BNCT system to conduct clinical research and begin clinical trials. This collaboration between Biddle Sawyer and Kinentia will help propel TAE Life Sciences' clinical trials pipeline forward by readying its TC220 boronated drug for the IND application process with the United States Food & Drug Administration.
"As a strategic partner to TAE Life Sciences and Kinentia, our collective mission is to push the boundaries of BNCT by manufacturing groundbreaking boronated drugs that offer many advantages to today's most common BNCT drugs. Leveraging our strong foothold in the pharmaceutical industry, we are enthusiastic about working with this group to revolutionize radiation oncology and unlock new clinical possibilities," said Lee DeWitt, VP of Business Development, Biddle Sawyer
"We are thrilled to partner with Biddle Sawyer and TAE Life Sciences on this significant long-term supply agreement for TC220. Kinentia's expertise in process refinement, backed by our comprehensive cGMP manufacturing capabilities, perfectly aligns with TAE Life Sciences' commitment to innovation and excellence in drug discovery and development," said David Fairfax, President of Kinentia Biosciences.
BNCT stands out as an innovative and distinctive biologically-targeted radiation therapy that employs a non-toxic boron-10 compound and a neutron source. When exposed to a low-energy neutron beam, this boronated compound triggers a targeted reaction, effectively eliminating cancer cells while preserving healthy tissue.
TAE Life Sciences has made a remarkable breakthrough with their exclusive drug, TC220, representing a significant leap forward in BNCT. Notably, TC220 offers several key advantages over conventional boronophenylalanine (BPA) as the boron target drug. Through pre-clinical studies, TC220 has demonstrated its ability to deliver boron more effectively to tumor cells compared to BPA. This is attributed to its enhanced solubility, prolonged retention in tumor tissue, and consistent and superior boron delivery in multiple human tumor xenografts. With these exceptional attributes, TC220 holds the potential to be applied across a broader range of clinical scenarios, thereby expanding the horizons of BNCT as a next-generation cancer treatment.
"We are driven by the mission to bring our biologically targeted radiation therapy to those fighting aggressive and recurrent cancers," said Kendall Morrison, Ph.D., Chief Science Officer at TAE Life Sciences. "This exclusive supplier deal with Biddle Sawyer and Kinentia Biosciences represents a significant milestone in our journey to deliver cutting-edge cancer treatments to patients in need."
BNCT has shown promising outcomes in clinical studies worldwide. With the availability of better boron-10 drugs like TC220 and an in-hospital neutron system like TAE Life Sciences' Alphabeam, there is a unique opportunity to improve patient care and treatment economics while reducing the burden and stresses of cancer treatment on the body.
Clinical trials for Alphabeam and proprietary boron-containing drugs are expected to commence in the United States and Europe in 2024.
BNCT is a combination treatment based on the reaction that occurs when a non-toxic compound containing boron-10 is irradiated with a low-energy neutron beam. BNCT differs radically from other radiation therapy and shows promise in becoming the next-generation cancer treatment. Research has shown BNCT has the capability of killing cancer cells that are resistant to traditional radiation therapy with limited harm to healthy tissue. Current advances in both neutron radiation technology and medicinal boron drug targeting are enabling BNCT's potential to improve patient care while also improving treatment economics. To date, approximately 2,000 patients have been treated with BNCT at research sites worldwide.
About Biddle Sawyer
Biddle Sawyer is a trusted veteran in the field of sourcing, development, and custom manufacturing, supply, marketing, and distribution of specialty and fine chemicals, excipients, and APIs, as well as offering other services to advance drug substance and drug product programs including biology, discovery, medchem, DMPK, ADME, GLP Tox, pre-formulation and formulation development. Headquartered in New York City, they have warehouses, offices, and strategic partners around the world. Their presence in North and South America, Asia, and Europe allows them to serve their many global customers efficiently, delivering high-quality low-cost products to their doors.
Over the course of 70 years, they have developed strong, long-standing relationships with CDMOs, manufacturers, transportation and shipping companies, and government agencies ensuring that transactions proceed quickly and smoothly. From an initial phone call through development, manufacturing, packing, shipping, documentation, and final delivery, they always have every detail—and their customers' interests—covered.
About Kinentia Biosciences
Kinentia Biosciences (Kinentia.) is a contract research and manufacturing organization that provides drug discovery, process development, and cGMP manufacturing to the pharmaceutical and biotechnology industries. Founded in 2007, Kinentia is headquartered in Rensselaer, NY USA. The company has a strong track record of successfully helping clients in the area of drug discovery, development, and manufacturing and works with a wide variety of healthcare-focused organizations.
About TAE Life Sciences
TAE Life Sciences is a privately held biotechnology company committed to developing a new biologically targeted radiation therapy based on Boron Neutron Capture Therapy (BNCT). TAE Life Sciences is the only company developing the next-generation targeted boron drugs and low-energy accelerator-based neutron system optimized for an in-hospital BNCT program that delivers cancer-killing radiation with cellular-level precision to treat patients with aggressive and refractory cancers. TAE Life Sciences' Alphabeam neutron system and targeted boron drugs are currently in development and have not been approved for sale. More information about TAE Life Sciences is available at www.taelifesciences.com.
SOURCE TAE Life Sciences