On November 7, 2022 Nouscom, a clinical stage immuno-oncology company developing off-the-shelf and personalized immunotherapies, reported interim data from the Phase 1b trial evaluating NOUS-PEV which demonstrated it to be safe, well tolerated, immunogenic and with signs of anti-tumor activity (Press release, NousCom, NOV 7, 2022, View Source [SID1234623264]). These data will be presented at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting, November 8-12, 2022.

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NOUS-PEV is a personalized cancer immunotherapy being evaluated in a multicenter Phase 1b open-label, dose confirmation and cohort expansion study (NCT04990479). NOUS-PEV is individually designed and manufactured to contain patient-specific neoantigens identified and selected from a patient’s own tumor biopsy. The Phase 1b trial is assessing the safety, feasibility and preliminary efficacy as per RECIST 1.1 criteria in combination with the anti-PD-1 checkpoint inhibitor pembrolizumab in patients with either locally advanced 1L melanoma or 1L non-small cell lung cancer (NSCLC) expressing more than 50% PD-L1.

The key findings to be presented at SITC (Free SITC Whitepaper) are as follows:

Manufacturing Feasibility: >90% of vaccines successfully manufactured, released and delivered to patients on time
Safety: Well tolerated with a favorable safety profile
Immunogenicity: Potent neoantigen specific immune responses were detected in all evaluable subjects with clinical responses
Biomarkers/Immune correlates of clinical efficacy: Deepening of clinical responses coincided with the increase of NOUS-PEV-induced T cells in blood; Increased T cell infiltration in the tumors; NOUS-PEV-induced neoantigen specific T cells identified in tumor biopsies in subjects with clinical responses.
Clinical Efficacy: Clinical responses correlated with biomarker analyses/predictions
Dr Oliver Bechter, MD, Principal Investigator (PI) of the trial and Professor in the Department of General Medical Oncology at the Leuven Cancer Institute (Belgium), said "I am very excited to see this initial data from patients who have received NOUS-PEV. The data demonstrated NOUS-PEV to be well tolerated and to have a good safety profile, comparable to pembrolizumab monotherapy. Nouscom has already demonstrated that its platform promotes the expansion and diversification of neoantigen-specific memory CD8+ T cells that enhance anti-tumor immunity, and the early translational data from the first three melanoma patients receiving NOUS-PEV further supports this. The higher number of relevant neoantigens that can be delivered via this platform compared to other approaches will increase the likelihood of eliciting a response. This can be crucial for patients who do not respond to anti-PD1 therapy. I look forward to seeing further data to build on this immune mechanism of action with potential to provide new effective treatment options for cancer patients."

Dr Sven Gogov, MD, Chief Medical Officer of Nouscom, added: "We are delighted with the initial data from this Phase 1b trial evaluating NOUS-PEV in solid tumors. We have developed a robust and efficient nine-week needle-to-needle GMP manufacturing process that can be scaled up as we progress in clinical development. These data further validate our proprietary platform and mechanism of action in the clinic, demonstrating that viral vector encoding cancer neoantigens drive potent and quality immune responses in metastatic cancer patients, which correlate with significant clinical responses. We look forward to presenting further data during 2023."

Poster Presentation Details:

Title: NOUS-PEV, a Novel Personalized Viral-based Prime/Boost Cancer Immunotherapy Targeting Patient-Specific Neoantigens: Interim Results from the First Subjects in the Phase 1b Study (#706)
Date: 11th November 2022
Time: 11:40-13:10 and 19:30-21:00 EST
Location: Hall C
Presenter: Dr Oliver Bechter, MD, Principal Investigator (PI) of the trial and Professor in the Department of General Medical Oncology at the Leuven Cancer Institute (Belgium)
The abstracts will be publicly available at 8am EST on 7th November 2022, and available in the Journal for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) (JITC) supplement.

About NOUS-PEV

NOUS-PEV is a personalized cancer immunotherapy designed for each patient based on selection and prioritization of mutations unique to that patient’s tumor. The strategy is based on Nouscom’s heterologous prime boost platform clinically validated by its lead off-the-shelf clinical development program NOUS-209. The platform is composed of a proprietary non-human adenoviral vector (GAd) and Modified Vaccinia Ankara viral vector (MVA). Each of the two viral vectors have the capacity to encode up to 60 personalized neoantigens selected and prioritized using the VENUS (Vaccine-Encoded Neontigens Unrestricted Selection) 1 proprietary algorithm.

NOUS-PEV is being evaluated in a Phase 1b clinical trial in combination with the anti-PD-1 checkpoint inhibitor pembrolizumab in patients with either locally advanced 1L melanoma or 1L non-small cell lung cancer (NSCLC) expressing more than 50% PD-L1. The trial (NCT04990479) commenced in 2021 and is currently enrolling patients across multiple clinical sites in Europe.

1. Leoni et al. VENUS, a Novel Selection Approach to Improve the Accuracy of Neoantigens’ Prediction. Vaccines 9, 2021

On November 7, 2022 Nkarta, Inc. (Nasdaq: NKTX), a biopharmaceutical company developing engineered natural killer (NK) cell therapies to treat cancer, reported the presentation of two preclinical data abstracts focused on its natural killer cell pipeline and proprietary manufacturing technology at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 37TH Annual Meeting and Pre-Conference Programs (Press release, Nkarta, NOV 7, 2022, View Source [SID1234623263]).

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"Our presentations at this year’s SITC (Free SITC Whitepaper) meeting illustrate the inherent power and potential of donor-derived NK cells," said James Trager, PhD, Chief Scientific Officer of Nkarta. "Nkarta’s research team has shown that our manufacturing platform technology can expand NK cells by well over a billion-fold, while maintaining their integrity and potency. These findings could prospectively allow us to derive our CAR NK products from a very limited set of stringently selected donors. In a second study, the team has also further built on the considerable potency of our CD19-directed CAR NK candidate, NKX019."

SITC 2022 abstracts will be available on the SITC (Free SITC Whitepaper) website, View Source

Nkarta’s posters will be available for download at View Source after 9:00 a.m. ET on November 10, 2022.

Title: Large-scale expansion and engineering of human NK cells sourced from peripheral blood versus umbilical cord blood
Abstract Number: 381
Poster Presentation Date and Time: November 10, 2022, 9:00 a.m. – 9:00 p.m. ET
This study illustrates a remarkable >250-billion fold expansion of NK cells derived from peripheral blood using Nkarta’s proprietary NKSTIM cell line. NK cells maintained their potency, and showed no signs of chromosomal aberrations over an extended period of expansion. Both the expansion capacity and potency of NK cells derived from adult donors compared favorably to those from cord blood. Phenotypic analysis of expanded cells demonstrated the selective expansion or differentiation of in vivo educated NK cells. These cells could be identified and isolated from pre-expansion NK cells, and demonstrated superior expansion and native activity. These findings point the way toward selection of donors or of a specific cell population with optimal potential for expansion and potency based on straightforward phenotypic profiling.

Title: NKX019, an Off-the-Shelf CD19 CAR-NK Cell, mediates improved anti-tumor activity and persistence in combination with CD20-directed therapeutic mAbs
Abstract Number: 902
Poster Presentation Date and Time: November 11, 2022, 9:00 a.m. – 8:30 p.m. ET
In this preclinical study, the CD19-directed CAR NK, NKX019, was combined with the widely used anti-CD20 monoclonal antibodies (mAb) rituximab or obinutuzumab. These antibodies mediate both direct cell killing of CD20+ B cell malignancies, and can also mediate the antibody-dependent cellular cytotoxicity (ADCC) activity of NK cells through their interaction with CD16. Both the CAR NK cells and the monoclonal antibodies showed high potency against cell lines and primary malignant cells. When NKX019 was used with either mAb, their combined potency was greater than that of the individual agents alone. The potency of these combinations could be attributed in part to NKX019 ADCC activity, as demonstrated using an ADCC-deficient variant of rituximab and by increased degranulation of NKX019 in the presence of obinutuzumab. Results of this study point to a potential to combine these agents clinically to improve product potency and tumor targeting.

On November 7, 2022 Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) ("Navidea" or the "Company"), a company focused on the development of precision immunodiagnostic agents and immunotherapeutics, reported details of the results from the Company’s ongoing preclinical studies evaluating targeted immunotherapy for cancer based on the Manocept platform (Press release, Navidea Biopharmaceuticals, NOV 7, 2022, View Source [SID1234623257]). The results will be presented at the 37th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) ("SITC") to be held at the Boston Convention & Exhibition Center in person and virtually November 8-12, 2022 in Boston, MA. These details were embargoed by SITC (Free SITC Whitepaper) until the week of the meeting.

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The abstract, "Synthetic CD206 Targeted Constructs Carrying Paclitaxel or Novel Bisphosphonate Payloads Alter Macrophages Towards Pro-inflammatory Phenotypes; The Paclitaxel Construct Improves the Efficacy of anti-CTLA4 in CT26 Tumors" (Abstract #1161), will be presented as a poster on November 10, 9 am to 9 pm in the conference center’s poster hall.

In this study, results demonstrate that Navidea’s macrophage-targeting Manocept platform technology, consisting of mannosylated amine dextrans ("MAD") and carrying the therapeutic payloads paclitaxel or a novel bisphosponate, could drive the phenotype of macrophages in vitro towards a proinflammatory type (more CD80 and CD86 expression, less CD206 and CD163 expression). This is important because in tumors there exist tumor-associated macrophages ("TAMs") that are typically of the wound healing, anti-inflammatory type, and these play a key role in paradoxically shielding the tumors from the body’s immune response. Driving the TAM phenotype more towards a proinflammatory state should enable both an immune response against the tumors as well as increase the efficacy of other therapies that can work alongside the body’s immune system against the tumors.

In addition to the in vitro work using both the paclitaxel and bisphosphonate carrying constructs, in vivo studies using the MAD-paclitaxel construct in a mouse tumor model demonstrated that this construct increased the efficacy of an approved checkpoint inhibitor therapy, anti-CTLA4, reducing tumor growth by 76% compared to a saline control. Delivery of paclitaxel and bisphosphonates by this method also reduces off-target exposure and should limit toxicity.

Future studies will examine the effect of the MAD-bisphosphonate therapy with and without anti-CTLA4 therapy in the mouse tumor model. Preclinical toxicity studies will also be conducted en route to an Investigational New Drug ("IND") application.

Abstract title and session information can be found on the SITC (Free SITC Whitepaper) Annual Meeting website at: View Source

Dr. Michael Rosol, Chief Medical Officer for Navidea, said, "We are delighted by the opportunity to present these important preclinical results at this internationally recognized meeting. These results provide support for the hypothesis that our macrophage-targeted constructs can increase the efficacy of already approved therapies to significant effect, helping to rally the body’s immune response against tumors." Dr. Rosol continued, "We continue to develop the Manocept platform, using its potent ability to target macrophages, for the development of new immunotherapies for diseases including cancer."

On November 7, 2022 NanoString Technologies, Inc. (NASDAQ:NSTG), a leading provider of life science tools for discovery and translational research, reported financial results for the third quarter ended September 30, 2022 (Press release, NanoString Technologies, NOV 7, 2022, View Source [SID1234623256]).

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"We currently have orders for more than 100 CosMx systems which we expect to begin generating revenue as we ship our first CosMx systems in the coming weeks."

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Third Quarter Financial Highlights

Product and service revenue of $29.5 million
GeoMx Digital Spatial Profiler (DSP) revenue of $9.3 million. GeoMx DSP revenue includes:
Instrument revenue of $4.7 million
Consumables revenue of $4.6 million, annualized pull-through of approximately $58,000 per installed system
nCounter revenue, inclusive of all service revenue, of $20.2 million. nCounter revenue includes:
Instrument revenue of $3.3 million
Consumables revenue of $12.0 million, annualized pull-through of approximately $44,000 per installed system
Service revenue of $4.9 million
Cash, cash equivalents and short-term investments balance of $230.5 million
"During the third quarter we delivered on our top priority, which is growing our spatial biology customer base. We generated orders for approximately 60 spatial instruments, representing growth of about 70% over the prior year," said Brad Gray, president & CEO of NanoString. "We currently have orders for more than 100 CosMx systems which we expect to begin generating revenue as we ship our first CosMx systems in the coming weeks."

"The third quarter and year-to-date 2022 have presented challenges as our business mix has continued to evolve, and we have taken steps to streamline our cost structure while maintaining our investments in spatial biology. With our strong balance sheet and 2023 revenue backlog, we expect improved profitability in the future and to reach cash break-even with our current financial resources," stated NanoString’s CFO Tom Bailey.

Operational Highlights

Spatial Biology

Spatial Biology System Orders: Secured customer orders for approximately 60 spatial biology systems, including approximately 20 GeoMx DSP systems and approximately 40 CosMx Spatial Molecular Imager (SMI) systems, bringing total CosMx orders to date to more than 100 systems
CosMx Publication in Nature Biotechnology: Published a paper describing the technical details and performance of the CosMx SMI, including the spatial imaging of 1,000 RNAs and 100 proteins in mapped at single-cell and subcellular resolution generated from non-small cell and breast cancer tissue
GeoMx Studies Featured on Covers of Two Major Scientific Journals: Peer-reviewed papers using the GeoMx Human Whole Transcriptome Atlas (WTA) and the GeoMx Cancer Transcriptome Atlas, respectively, featured on the covers of the August issue of Nature Genetics and the September 18 issue of Clinical Cancer Research
Visiopharm Collaboration: Announced a collaboration with Visiopharm for co-development of integrated workflows for GeoMx and the AtoMx Spatial Informatics Platform that leverage AI-driven image analysis capabilities of Visiopharm
GeoMx Installed Base: Grew installed base to approximately 330 GeoMx DSP systems as of September 30, 2022, representing 47% growth over the prior year
GeoMx Publications: Continued growth of peer-reviewed publications utilizing GeoMx DSP technology, with approximately 30 new publications in the third quarter, bringing the cumulative total to approximately 160 peer-reviewed publications as of September 30, 2022
nCounter

nCounter Installed Base: Grew installed base to approximately 1,105 nCounter Analysis Systems as of September 30, 2022, representing 7% growth over the prior year
Publications: Surpassed 6,100 cumulative peer-reviewed publications utilizing nCounter technology as of September 30, 2022
Corporate

Portfolio Prioritization and Streamlined Cost Structure: Adjusting cost and organization structure to support objective of reaching cash flow breakeven utilizing existing balance sheet resources by maintaining key investments in spatial biology while realigning manufacturing capacity and reducing certain non-critical commercial and R&D initiatives
2022 Outlook

The company updated its 2022 outlook, with results expected as follows:

Orders for over 200 spatial biology systems, consistent with previous guidance
Cumulative orders for approximately 140 CosMx systems expected by the end of 2022, representing a total revenue value of more than $30 million
Total product and service revenue of $125 to $127 million, as compared to previous guidance of $140 to $150 million, reflecting an order mix that is weighted more heavily to CosMx, with material CosMx revenue recognition expected to begin in 2023
nCounter revenue, inclusive of all service revenue, of $83 to $84 million, as compared to previous guidance of $90 to $95 million
Adjusted EBITDA loss of approximately $100 million, as compared to previous guidance of $75 to $85 million
Financial Results

We have elected to present selected non-GAAP, or adjusted, financial measures, including Adjusted EBITDA. These adjusted financial measures are calculated excluding certain items that may make it more challenging to compare our GAAP operating results across periods. Such items may include collaboration revenue, stock-based compensation, depreciation and amortization, or one-time charges such as transaction related fees and expenses or restructuring charges and severance costs. A reconciliation of adjusted financial measures to the nearest comparable GAAP financial measure can be found in the tables at the end of this press release.

Supplemental Information

As a supplement to the table above, we have posted to the investor relations section of our website, at View Source, supplemental financial data that include our adjusted financial measures as compared to the nearest comparable GAAP financial measures, for the third quarter and the nine months ended September 30, 2022 and for each quarter of and the full year of 2021.

Conference Call

Management will host a conference call today beginning at 1:30 pm PT / 4:30 pm ET to discuss these results and answer questions. Investors and other interested parties can register for the call in advance by visiting View Source After registering, an email confirmation will be sent including dial-in details and unique conference call codes for entry. Registration is open throughout the call, but to ensure connection for the full call, registration in advance is recommended. The link to the webcast and audio replay will be made available at the Investor Relations website: www.nanostring.com. A replay of the call will be available beginning November 7, 2022 at 7:30pm ET through midnight ET on November 14, 2022. To access the replay, dial (866) 813-9403 or (929) 458-6194 and reference Conference ID: 931170. The webcast will also be available on our website for one year following the completion of the call.

On November 7, 2022 Moleculin Biotech, Inc., (Nasdaq: MBRX) ("Moleculin" or the "Company"), a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting highly resistant tumors and viruses, reported that it will report its financial results for the quarter ended September 30, 2022 on Thursday, November 10th (Press release, Moleculin, NOV 7, 2022, View Source [SID1234623255]). Moleculin management will host its inaugural quarterly conference call and live audio webcast to discuss the operational and financial results at 5:00 PM ET that same day.

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The call will be led by Walter Klemp, Chairman and Chief Executive Officer of Moleculin and Jonathan Foster, Executive VP & Chief Financial Officer of Moleculin. Interested participants and investors may access the conference call by dialing (877) 407-0832 (domestic) or (201) 689-8433 (international) and referencing the Moleculin Biotech Conference Call. The live webcast will be accessible on the Events page of the Investors section of the Moleculin website, moleculin.com, and will be archived for 90 days.