On October 7, 2021 Loxo Oncology at Lilly, a research and development group of Eli Lilly and Company (NYSE: LLY), reported that preclinical characterization data for two new agents, LOXO-783 and LOXO-435, will be presented at the 2021 AACR (Free AACR Whitepaper)-NCI-EORTC Virtual AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper), held October 7-10, 2021 (Press release, Eli Lilly, OCT 7, 2021, View Source [SID1234590915]). The data will be presented as part of the plenary session titled "New Drugs on the Horizon II" as well as in individual poster presentations.
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LOXO-783 is a potent, highly mutant-selective and brain-penetrant allosteric PI3Kα H1047R inhibitor that is designed to spare wild-type PI3Kα, other PI3K isoforms, and other kinases. LOXO-435 is a potent and highly isoform-selective FGFR3 inhibitor with preserved activity against FGFR3 gatekeeper resistance mutations. Investigational new drug applications (INDs) are planned for both programs in 2022.
"LOXO-783 and LOXO-435 each represent years of diligent work by our discovery teams to build molecules that meet exacting target product profiles. In the case of both PI3Kα H1047R-mutated cancers and FGFR3-mutated cancers, patients deserve medicines purpose-built to their disease biology and we believe that these molecules have the potential to markedly improve on the efficacy and tolerability of existing agents," said Jacob Van Naarden, chief executive officer of Loxo Oncology at Lilly and President of Lilly Oncology. "We look forward to filing INDs for both programs in 2022 and subsequently moving into the clinic."
Details on oral and poster presentations are below:
Presentation Title: Discovery of mutant-selective PI3Kα and isoform-selective FGFR3 inhibitors: Insights from the Loxo Oncology at Lilly Discovery Model
Presentation Date & Time: Saturday, October 9, 4:00 p.m. ET
Session: Plenary Session 6: New Drugs on the Horizon II
Presenter: David Hyman, M.D.
Poster Title: Preclinical characterization of LOXO-435 (LOX-24350), a potent and highly isoform-selective FGFR3 inhibitor
Abstract Number: 141
Available: Thursday, October 7, 9 a.m. ET
Presenter: Joshua Ballard
Poster Title: Preclinical characterization of LOXO-783 (LOX-22783), a highly potent, mutant-selective and brain-penetrant allosteric PI3Kα H1047R inhibitor
Abstract Number: 142
Available: Thursday, October 7, 9 a.m. ET
Presenter: Anke Klippel, Ph.D.
About Loxo Oncology at Lilly
Loxo Oncology at Lilly was created in December 2019, combining the Lilly Research Laboratories oncology organization and Loxo Oncology, which was acquired by Lilly in early 2019. Loxo Oncology at Lilly brings together the focus and spirit of a biotech with the scale and resources of large pharma, with the goal of rapidly delivering impactful new medicines for people with cancer. Our approach centers on creating new oncology medicines that unequivocally work early in clinical development and will matter to patients.