On November 12, 2019 Neon Therapeutics, Inc. (Nasdaq: NTGN), a clinical-stage immuno-oncology company developing neoantigen-based therapeutics, reported financial results for the third quarter ended September 30, 2019 and provided a business update (Press release, Neon Therapeutics, NOV 12, 2019, View Source [SID1234550946]).

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"We continue to make important progress in advancing our leadership in the field of neoantigen-targeted therapies and are pleased to have recently presented updates across our personalized cancer vaccine and adoptive T cell therapy programs at the SITC (Free SITC Whitepaper) Annual Meeting. In the remaining months of 2019, we look to continue building on our leadership position by completing our process development work that will enable our planned Clinical Trial Application in Europe for Phase 1 development of our neoantigen-targeted T cell therapy candidate, NEO-PTC-01," said Hugh O’Dowd, Neon’s Chief Executive Officer.

Recent Highlights

RECON Bioinformatics Platform: Neon scientists published in the scientific journal Immunity a breakthrough process for predicting which neoantigens will be presented by MHC class II molecules in the tumor microenvironment.

Predicting the relevant cancer-specific antigens is a crucial precursor to developing immunotherapies that effectively train T cells to traffic to the tumor and destroy malignant cells. In the paper, titled "Defining HLA-II ligand processing and binding rules with mass spectrometry enhances cancer epitope prediction," Neon’s proprietary mono-allelic profiling technology called MAPTAC facilitated the development of convolutional neural network-based predictors.

These algorithms achieved up to a 61-fold improvement in predicting MHC class II peptides compared to publicly available tools.

This MHC class II technology will be integrated into Neon’s RECON bioinformatics platform and is expected to improve the efficacy of immunotherapies developed by Neon by predicting recruitment of CD4+ T cells, which are believed to be in controlling tumor growth.

NEO-PV-01: Neon presented updated results at the SITC (Free SITC Whitepaper) Annual Meeting from the ongoing, multicenter Phase 1b NT-001 clinical trial evaluating NEO-PV-01, Neon’s personal neoantigen vaccine candidate, in combination with OPDIVO (nivolumab) in patients with advanced or metastatic melanoma, smoking-associated non-small cell lung cancer (NSCLC) and bladder cancer.

Across all three distinct tumor types, results demonstrated prolonged and consistent improvements in progression-free survival (PFS) and overall survival (OS) that compare favorably to that observed with checkpoint inhibitor monotherapy, based on historical benchmark data.

Further, neoantigen-specific immune responses and epitope spread to RECON-predicted targets were associated with longer PFS, and major pathological responses post-administration of NEO-PV-01 in melanoma patients were also associated with longer PFS.

The safety data for NT-001 were consistent with the safety profile for OPDIVO monotherapy. These updated results come from 82 patients who received at least one dose of OPDIVO in the Phase 1b NT-001 trial.

NEO-PTC-01: Neon presented at the SITC (Free SITC Whitepaper) Annual Meeting an update on preclinical and process development work for NEO-PTC-01, its personal neoantigen-targeted T cell therapy candidate consisting of multiple T cell populations targeting the most therapeutically relevant neoantigens from each patient’s tumor.

NEO-PTC-01 leverages Neon’s RECON bioinformatics platform to individually select a set of neoantigen targets for each patient, and NEO-STIM, its proprietary process to directly prime, activate and expand neoantigen-targeting T cells ex vivo. Neon believes that this approach will allow NEO-PTC-01, a non-engineered product that leverages peripheral blood mononuclear cells (PBMCs) as starting material, to specifically target each patient’s individual tumor with T cells that can drive a robust and persistent anti-tumor response.

In the SITC (Free SITC Whitepaper) update, Neon demonstrated that it can reproducibly generate a potent T cell product from PBMCs of melanoma patients, as well as at therapeutic scale using a healthy donor sample. This process development work showed that NEO-PTC-01 induced multiple CD8+ and CD4+ T cell responses from both the memory and the naïve T cell compartments.

Neon is focusing the initial clinical development of NEO-PTC-01 in patients with solid tumors that are refractory to checkpoint inhibitors. Neon expects to file a clinical trial application, or CTA, in Europe by the end of 2019 to evaluate NEO-PTC-01 in the solid tumor setting.

Expected Near-Term Milestones

NEO-PTC-01: Planned European CTA filing to evaluate NEO-PTC-01 in a refractory solid tumor setting (2H 2019).

NEO-PTC-01: Planned Phase 1 initiation in a refractory solid tumor setting (1H 2020).

NEO-PV-01: Planned clinical results and correlative immune data, including 12-month follow-up, from NT-002 Phase 1b trial in first-line metastatic NSCLC (Q3 2020).

Third Quarter 2019 Financial Results and Financial Guidance:

R&D Expenses: Research and development expenses were $14.1 million for the third quarter of 2019, compared to $14.4 million for the same period last year. The decrease was primarily due to a reduction in clinical development and manufacturing costs, partially offset by an increase in personnel-related costs and costs related to the preparation for the planned CTA filing in Europe for Phase 1 development of NEO-PTC-01.

G&A Expenses: General and administrative expenses were $5.1 million for the third quarter of 2019, compared to $4.6 million for the same period last year. The increase was primarily due to personnel-related costs and costs associated with being a public company.

Net Loss: Net loss was $19.0 million for the third quarter of 2019, compared to $18.4 million for the same period last year.

Cash Position: As of September 30, 2019, cash, cash equivalents and marketable securities were $44.3 million, as compared to cash, cash equivalents and marketable securities of $103.3 million as of December 31, 2018.

Financial Guidance: Based on its current operating plan, Neon expects that its existing cash and cash equivalents will enable the Company to fund its operating expenses and capital expenditure requirements into June 2020.

OPDIVO is a registered trademark of Bristol-Myers Squibb Company.