Teneobio Reports Initial Data from a Phase I Study of TNB-383B in Relapsed Refractory Multiple Myeloma
- Category: Antibodies
- Published on Tuesday, 08 December 2020 12:41
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NEWARK, CA, USA I December 07, 2020 I Teneobio, Inc., a clinical stage biotech company focused on discovery and development of novel multi-specific biotherapeutic antibodies, reported initial results of a Phase I trial (https://clinicaltrials.gov/ct2/show/NCT03933735) evaluating TNB-383B in Relapsed Refractory Multiple Myeloma (R/R MM) on December 5 at the 62nd American Society of Hematology Annual Conference. TNB-383B is a fully human bispecific antibody that targets BCMA on the surface of multiple myeloma (MM) cells and CD3 on the surface of T cells in order to trigger lysis of MM cells in MM patients. The ongoing open-label multi-center trial is designed to assess the safety, pharmacokinetics and preliminary efficacy of TNB-383B administered intravenously once every 21 days.
TNB-383B demonstrated a favorable safety profile in patients with R/R MM and achieved an overall response rate (ORR) of 80% at doses ≥ 40 mg every three weeks (QW3). The most common adverse events were cytokine release syndrome (CRS), fatigue, headache, anemia, infection, and nausea. Notably, at all doses, CRS was limited to Grade 1-2, with no patient experiencing a Grade 3 CRS. No step-dosing or dose splitting was necessary in any patient. Among the responders, over 75% had very good partial response (VGPR) or better. The median Time to Response (TTR) was 3 weeks (1 cycle) and responses deepened with additional time on therapy. The multi-center escalation and expansion cohorts are ongoing so that the median Duration of Response (DOR) has not been reached.
“Immunotherapy represents the next frontier in the management of myeloma, with many different approaches being explored in clinical trials. The results with TNB-383B have been very promising with high response rates in patients with relapsed refractory myeloma and very manageable toxicity that allows for outpatient management of these patients,” said Dr. Shaji Kumar of Mayo Clinic, Rochester, and one of the Principal Investigators on this trial. “We are pleased to announce these compelling initial results. The safety profile and response rates we have seen in this initial trial validate our differentiated CD3 platform and support further development of TNB-383B in R/R MM patients,” said Ben Buelow, Teneobio’s Chief Medical Officer. “In addition to TNB-383B, we look forward to advancing multiple CD3 engaging bi-specific antibodies into the clinic, both in hematologic malignancies and solid tumors.”
TNB-383B is a fully human bispecific monoclonal antibody being developed for MM. TNB-383B was designed to bind to BCMA with high affinity and simultaneously result in T-cell binding/activation to cause destruction of tumor cells accompanied by markedly attenuated cytokine production. TNB-383B is being developed in collaboration with AbbVie Inc.
Teneobio, Inc. is a clinical stage biotechnology company developing a new class of biologics, Human Heavy-Chain Antibodies (UniAb®), for the treatments of cancer, autoimmunity, and infectious diseases. Teneobio’s discovery platform, TeneoSeek, comprises genetically engineered animals (UniRat® and OmniFlic®), next-generation sequencing, bioinformatics and high-throughput vector assembly technologies. TeneoSeek rapidly identifies large numbers of unique binding molecules specific for therapeutic targets of interest. Versatile antibody variable domains (UniDab®) derived from UniAb® can be assembled into multi-specific and multivalent therapeutic proteins, surpassing limitations of conventional antibody therapeutics. Teneobio’s “plug-and-play” T-cell engaging platform includes a diverse set of anti-CD3 antibodies for therapeutics with optimal efficacy and reduced toxicity.
Teneobio partners include AbbVie, Janssen, GSK, Kite, Poseida, Intellia, and ArsenalBio. For more information, please visit www.teneobio.com.