Neon Therapeutics Provides Business Update and Outlook for 2019
“We have an exciting year ahead of us in 2019, with multiple data readouts from our personal neoantigen vaccine program, NEO-PV-01, in a variety of metastatic cancer settings using a number of rational treatment combinations. We are also continuing to investigate monotherapy opportunities and look forward to sharing our plans later this year,” said Hugh O’Dowd, Neon’s Chief Executive Officer.
“We expect the upcoming data readouts to include correlations between mechanism of action and clinical response and enable development of later-stage trials that will draw on treatment combinations and target patient populations most likely to benefit from our personal cancer vaccine,” said
Neon also continues to advance its T cell programs, including the development of a library of high-quality TCRs. “I expect these programs to become increasingly important in 2019, as we continue to build a diversified clinical-stage pipeline,” Mr. O’Dowd said.
With regard to its personal neoantigen T cell program, NEO-PTC-01, Neon continues to build on data presented at the
“Data from our ongoing research give us added confidence that we can reliably generate multiple enriched neoantigen-specific T cell populations that are capable of killing tumor cells,” said Dr. Gaynor. “We believe NEO-PTC-01 has several significant advantages that could overcome the challenges of other cell therapies in the solid tumor setting and we look forward to evaluating this approach in checkpoint refractory patients.”
With respect to TCRs, Neon has been leveraging its RECON® bioinformatics engine to identify shared neoantigen epitopes and its NEO-STIM™ induction protocol to generate neoantigen-reactive T-cell receptors to these epitopes. Drawing on this work, Neon has assembled libraries of high-quality TCRs against various shared neoantigens across common HLAs.
“Our maturing T cell programs will join our vaccine programs in developing new paradigms for the treatment of solid tumors,” said Dr. Gaynor.
Pipeline Overview and Upcoming Milestones
- NT-001: Phase 1b Clinical Trial of NEO-PV-01 in the Metastatic Setting
- 52-week data expected in the first half of 2019
- NT-002: Phase 1b Clinical Trial of NEO-PV-01 in Metastatic Non-Small Cell Lung Cancer
- 52-week data expected in the second half of 2019
- NT-003: Phase 1b Clinical Trial of NEO-PV-01 in Metastatic Melanoma Combinations
- Immune monitoring data expected in the first half of 2020
- NT-004: Phase 1b Clinical Trial of NEO-PV-01 in Earlier Disease Setting
- Finalizing plans for first monotherapy study
- NC-001: Phase 1 Clinical Trial in Solid Tumor Setting: Neon intends to submit a European CTA for NEO-PTC-01, a personal neoantigen T-cell therapy, for the treatment of checkpoint refractory patients in the first half of 2019.
- NS-001: Phase 1 Clinical Trial in Subset of ER+ Breast Cancer: Neon expects to submit an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (
FDA) in the first half of 2019.
Based on its current operating plans, Neon now expects that its existing cash, cash equivalents and marketable securities will enable the Company to fund its anticipated operating expenses and capital expenditure requirements into the second quarter of 2020. As of
Neon Therapeutics is a clinical-stage immuno-oncology company and a leader in the field of neoantigen-targeted therapies, dedicated to transforming the treatment of cancer by directing the immune system towards neoantigens. Neon is using its neoantigen platform to develop both vaccine and T cell therapies, including NEO-PV-01, a clinical-stage neoantigen vaccine for the treatment of metastatic melanoma, non-small cell lung cancer, and bladder cancer; NEO-PTC-01, a neoantigen T cell therapy for the treatment of solid tumors; and NEO-SV-01, a neoantigen vaccine for the treatment of a subset of estrogen-receptor-positive breast cancer. For more information, please visit www.neontherapeutics.com.
This press release contains “forward-looking statements” of
Will O’Connor, Stern Investor Relations
Source: Neon Therapeutics, Inc.