Aeglea BioTherapeutics Doses First Uveal and Cutaneous Melanoma Patients in Phase 1 Cohort Expansions with Pegzilarginase

On March 8, 2018 Aeglea BioTherapeutics, Inc. (NASDAQ:AGLE), a clinical-stage biotechnology company that designs and develops innovative human enzyme therapeutics for patients with rare genetic diseases and cancer, reported the dosing of the first uveal and cutaneous melanoma patients with pegzilarginase (AEB1102) in its open-label Phase 1 cohort expansions (Press release, Aeglea BioTherapeutics, MAR 8, 2018, View Source [SID1234524966]). The Company expects to report topline data, including safety and clinical activity, in the fourth quarter of 2018.

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"Given our encouraging dose escalation data with pegzilarginase, the start of these Phase 1 cohort expansions is an important next step in targeting the advanced solid tumors that we believe are vulnerable to arginine depletion," said Anthony Quinn, MB ChB, Ph.D., interim chief executive officer of Aeglea. "This is an exciting time at Aeglea as we assess the clinical activity of sustained arginine depletion in melanoma. We expect to report topline data in the fourth quarter of this year."

Aeglea also initiated studies with pegzilarginase in small cell lung cancer as monotherapy and in combination with pembrolizumab. Additionally, the Company is conducting an open-label Phase 1/2 trial and a long term extension study in patients with Arginase 1 Deficiency, a rare genetic disease. Regarding Arginase 1 Deficiency, Aeglea plans to report adult repeat dose data this month and adult and pediatric repeat dose data, along with pivotal trial design, in the second half of this year.

Jounce Therapeutics Reports Fourth Quarter and Full Year 2017 Financial Results

On March 8, 2018 Jounce Therapeutics, Inc. (NASDAQ: JNCE), a clinical stage company focused on the discovery and development of novel cancer immunotherapies and predictive biomarkers for patient enrichment, today reported financial results and provided a corporate update for the quarter and year ended December 31, 2017 (Press release, Jounce Therapeutics, MAR 8, 2018, View Source [SID1234524974]).

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"2017 was an important year of execution for Jounce, and our first year as a publicly-traded company. Our corporate progress this past year started with our initial public offering in January 2017 and expanded to the growth of our team and Board as well as our capabilities to support our broader pipeline mission. On the clinical front, we executed on the development of our lead program, JTX-2011, achieving several milestones," said Richard Murray, Ph.D., chief executive officer and president of Jounce Therapeutics. "We continue to make progress towards realizing our vision of transforming the treatment of cancer by delivering first-in-class immunotherapies that provide long-lasting benefits. With this tenet guiding our long-term growth, our goal is to leverage the great progress we have made to date and execute on our key value drivers for 2018."

Clinical and Research Highlights:
Phase 1/2 ICONIC Trial

The Phase 1/2 ICONIC trial remains on track and preliminary efficacy data are expected to be reported in the second quarter of 2018.

Two of the Phase 2 combination cohorts in the ICONIC trial, gastric cancer and triple negative breast cancer (TNBC), have met the target enrollment with completion of at least one efficacy assessment. The preliminary efficacy data have been submitted as an abstract for the 2018 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting. The abstract includes both monotherapy and combination preliminary efficacy data from these two tumor types. These data are expected to mature between the abstract submission date and the ASCO (Free ASCO Whitepaper) meeting, and therefore the Company expects to provide data on additional patients, longer-term follow-up, and additional biomarker information.

In 2018, the JTX-2011 program is expected to expand by initiating a new combination study within the adaptive ICONIC trial. While continuing to evaluate combination cohorts with a PD-1 inhibitor, a new combination is expected to begin with JTX-2011 and a CTLA-4 inhibitor. The Company believes that the inducible nature of ICOS, or Inducible T cell CO-Stimulator, will be a potential cornerstone of Jounce’s strategy in combination trials. By combining with other approved therapies, JTX-2011 may potentially maximize the benefit of immunotherapeutic approaches across a broad spectrum of indications.

jouncelogosmaller.jpg

JTX-4014

Jounce remains on track to file an Investigational New Drug, or IND, in 2018 for JTX-4014, its internal anti-PD-1 antibody. The Company views JTX-4014 as an important component of its pipeline given its belief that combination therapy will be a mainstay of cancer immunotherapy.

Next Development Candidate

Jounce continues to focus on its discovery programs both within and outside of its Celgene collaboration. The first tumor associated macrophage candidate, coming from Jounce’s Translational Science Platform, has advanced into IND-enabling activities. Therapies targeting these innate immune cells may potentially complement existing T cells-focused approaches, thereby providing benefit to patients with less inflamed or colder tumors.

Corporate Highlights:

In December 2017, Jounce was added to the NASDAQ Biotechnology Index as a result of meeting the eligibility requirements, including minimum market capitalization and average daily trading volume, among other criteria.

Fourth Quarter and Full Year 2017 Financial Results:

Cash Position: As of December 31, 2017, cash, cash equivalents and investments were $257.9 million, compared to $257.4 million as of December 31, 2016. This increase was primarily due to the $106.4 million in net proceeds from Jounce’s initial public offering (IPO), offset by operating costs during the year. Overall, Jounce utilized $105.9 million in net cash for the full year 2017.

Collaboration Revenue: Collaboration revenue was $13.0 million for the fourth quarter of 2017, compared to $20.3 million for the same period in 2016 and $71.6 million for the full year 2017, compared to $37.2 million for the same period in 2016. Collaboration revenue represents the revenue recognition relating to the $225.0 million upfront payment received in July 2016 upon the execution of Jounce’s global strategic collaboration with Celgene.

Research and Development (R&D) Expenses: R&D expenses were $18.6 million for the fourth quarter of 2017, compared to $10.7 million for the same period in 2016 and $67.8 million for the full year 2017, compared to $34.9 million for the same period in 2016. The increase in R&D expenses for both the fourth quarter of 2017 and the full year 2017 was due to increased employee compensation costs related to increased headcount, clinical costs related to the Phase 1/2 ICONIC trial of JTX-2011 and external research and development costs, primarily attributable to the manufacture of clinical trial materials and related activities.

General and Administrative (G&A) Expenses: G&A expenses were $6.0 million for the fourth quarter of 2017, compared to $4.7 million for the same period in 2016 and $23.1 million for the full year 2017, compared to $16.8 million for the same period in 2016. The increase in G&A expenses for both the fourth quarter of 2017 and the full year 2017 was primarily due to increased employee compensation costs related to increased headcount, facilities costs and other costs attributable to operating as a public company. In addition, the increase in G&A expenses for the full year 2017 was offset by $2.0 million of legal and accounting costs written off during 2016 as a result of the postponement of the IPO. The IPO was originally postponed for a period significantly

jouncelogosmaller.jpg

in excess of 90 days, and as a result, the previously-capitalized costs were written off to G&A expenses.

Net (Loss) Income: Net loss was $9.4 million for the fourth quarter of 2017, or a basic and diluted net loss per share attributable to common stockholders of $0.29. Net income was $5.5 million for the same period in 2016, or basic net income per share attributable to common stockholders of $0.11 and diluted net income per share attributable to common stockholders of $0.05. The change is primarily attributable to operating income recognized for the fourth quarter of 2016 as compared to an operating loss incurred for the fourth quarter of 2017. Net loss was $16.4 million for the full year 2017, or a basic and diluted net loss per share attributable to common stockholders of $0.57 compared to $13.7 million for same period in 2016, or a basic and diluted net loss per share attributable to common stockholders of $11.00. The decrease in net loss per share attributable to common stockholders is primarily due to an increase in shares of common stock outstanding post-IPO.

Financial Guidance:
Based on its current plans, Jounce expects cash burn on operating expenses and capital expenditures for the full year 2018 to be approximately $80.0 million to $100.0 million. The Company expects to record approximately $50.0 million to $60.0 million in collaboration revenue in 2018 from the continued recognition of the Celgene upfront payment received in 2016.

Given the strength of its balance sheet, Jounce continues to expect its existing cash, cash equivalents and investments to be sufficient to enable the funding of its operating expenses and capital expenditure requirements for at least the next 24 months.

Conference Call and Webcast Information:
Jounce Therapeutics will host a live conference call and webcast today at 8:00 a.m. ET. To access the conference call, please dial (866) 916-3380 (domestic) or (210) 874-7772 (international) and refer to conference ID 6198947. The live webcast can be accessed under "Events & Presentations" in the Investors and Media section of the company’s website at www.jouncetx.com. The webcast will be archived and made available for replay on the company’s website approximately two hours after the call and will be available for 30 days.

Cautionary Note Regarding Forward-Looking Statements:
Various statements in this release concerning Jounce’s future expectations, plans and prospects, including without limitation, Jounce’s expectations regarding operating expenses, capital expenditures, collaboration revenue and other financial results, release of data from the Phase 1/2 ICONIC trial, expansion of the JTX-2011 program, the filing of an IND for JTX-4014 and the timing, progress and results of preclinical studies and clinical trials for Jounce’s product candidates and any future product candidates may constitute forward-looking statements for the purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995 and other federal securities laws and are subject to substantial risks, uncertainties and assumptions. You should not place reliance on these forward looking statements, which often include words such as "anticipate," "believe," "estimate," "expect," "intend," "may," "on track," "plan," "predict," "target," "potential" or similar terms, variations of such terms or the negative of those terms. Although the Company believes that the expectations reflected in the forward-looking statements are reasonable, the Company cannot guarantee such outcomes. Actual results may

jouncelogosmaller.jpg

differ materially from those indicated by these forward-looking statements as a result of various important factors, including, without limitation, Jounce’s ability to successfully demonstrate the efficacy and safety of its product candidates and future product candidates, the preclinical and clinical results for its product candidates, which may not support further development and marketing approval, the potential advantages of Jounce’s product candidates, the development plans of its product candidates, actions of regulatory agencies, which may affect the initiation, timing and progress of pre-clinical studies and clinical trials of its product candidates, Jounce’s ability to obtain, maintain and protect its intellectual property, Jounce’s ability to manage operating expenses, Jounce’s ability to maintain its collaboration with Celgene, as well as those risks more fully discussed in the section entitled "Risk Factors" in Jounce’s most recent Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission as well as discussions of potential risks, uncertainties, and other important factors in Jounce’s subsequent filings with the Securities and Exchange Commission. All such statements speak only as of the date made, and the Company undertakes no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise

Jounce Therapeutics Reports Fourth Quarter and Full Year 2017 Financial Results

On March 8, 2018 Jounce Therapeutics, Inc. (NASDAQ:JNCE), a clinical stage company focused on the discovery and development of novel cancer immunotherapies and predictive biomarkers for patient enrichment, today reported financial results and provided a corporate update for the quarter and year ended December 31, 2017 (Press release, Jounce Therapeutics, MAR 8, 2018, View Source;p=RssLanding&cat=news&id=2336966 [SID1234524971]).

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"2017 was an important year of execution for Jounce, and our first year as a publicly-traded company. Our corporate progress this past year started with our initial public offering in January 2017 and expanded to the growth of our team and Board as well as our capabilities to support our broader pipeline mission. On the clinical front, we executed on the development of our lead program, JTX-2011, achieving several milestones," said Richard Murray, Ph.D., chief executive officer and president of Jounce Therapeutics. "We continue to make progress towards realizing our vision of transforming the treatment of cancer by delivering first-in-class immunotherapies that provide long-lasting benefits. With this tenet guiding our long-term growth, our goal is to leverage the great progress we have made to date and execute on our key value drivers for 2018."

Clinical and Research Highlights:

Phase 1/2 ICONIC Trial

The Phase 1/2 ICONIC trial remains on track and preliminary efficacy data are expected to be reported in the second quarter of 2018.
Two of the Phase 2 combination cohorts in the ICONIC trial, gastric cancer and triple negative breast cancer (TNBC), have met the target enrollment with completion of at least one efficacy assessment. The preliminary efficacy data have been submitted as an abstract for the 2018 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting. The abstract includes both monotherapy and combination preliminary efficacy data from these two tumor types. These data are expected to mature between the abstract submission date and the ASCO (Free ASCO Whitepaper) meeting, and therefore the Company expects to provide data on additional patients, longer-term follow-up, and additional biomarker information.
In 2018, the JTX-2011 program is expected to expand by initiating a new combination study within the adaptive ICONIC trial. While continuing to evaluate combination cohorts with a PD-1 inhibitor, a new combination is expected to begin with JTX-2011 and a CTLA-4 inhibitor. The Company believes that the inducible nature of ICOS, or Inducible T cell CO-Stimulator, will be a potential cornerstone of Jounce’s strategy in combination trials. By combining with other approved therapies, JTX-2011 may potentially maximize the benefit of immunotherapeutic approaches across a broad spectrum of indications.
JTX-4014

Jounce remains on track to file an Investigational New Drug, or IND, in 2018 for JTX-4014, its internal anti-PD-1 antibody. The Company views JTX-4014 as an important component of its pipeline given its belief that combination therapy will be a mainstay of cancer immunotherapy.
Next Development Candidate

Jounce continues to focus on its discovery programs both within and outside of its Celgene collaboration. The first tumor associated macrophage candidate, coming from Jounce’s Translational Science Platform, has advanced into IND-enabling activities. Therapies targeting these innate immune cells may potentially complement existing T cells-focused approaches, thereby providing benefit to patients with less inflamed or colder tumors.
Corporate Highlights:

In December 2017, Jounce was added to the NASDAQ Biotechnology Index as a result of meeting the eligibility requirements, including minimum market capitalization and average daily trading volume, among other criteria.
Fourth Quarter and Full Year 2017 Financial Results:

Cash Position: As of December 31, 2017, cash, cash equivalents and investments were $257.9 million, compared to $257.4 million as of December 31, 2016. This increase was primarily due to the $106.4 million in net proceeds from Jounce’s initial public offering (IPO), offset by operating costs during the year. Overall, Jounce utilized $105.9 million in net cash for the full year 2017.
Collaboration Revenue: Collaboration revenue was $13.0 million for the fourth quarter of 2017, compared to $20.3 million for the same period in 2016 and $71.6 million for the full year 2017, compared to $37.2 million for the same period in 2016. Collaboration revenue represents the revenue recognition relating to the $225.0 million upfront payment received in July 2016 upon the execution of Jounce’s global strategic collaboration with Celgene.
Research and Development (R&D) Expenses: R&D expenses were $18.6 million for the fourth quarter of 2017, compared to $10.7 million for the same period in 2016 and $67.8 million for the full year 2017, compared to $34.9 million for the same period in 2016. The increase in R&D expenses for both the fourth quarter of 2017 and the full year 2017 was due to increased employee compensation costs related to increased headcount, clinical costs related to the Phase 1/2 ICONIC trial of JTX-2011 and external research and development costs, primarily attributable to the manufacture of clinical trial materials and related activities.
General and Administrative (G&A) Expenses: G&A expenses were $6.0 million for the fourth quarter of 2017, compared to $4.7 million for the same period in 2016 and $23.1 million for the full year 2017, compared to $16.8 million for the same period in 2016. The increase in G&A expenses for both the fourth quarter of 2017 and the full year 2017 was primarily due to increased employee compensation costs related to increased headcount, facilities costs and other costs attributable to operating as a public company. In addition, the increase in G&A expenses for the full year 2017 was offset by $2.0 million of legal and accounting costs written off during 2016 as a result of the postponement of the IPO. The IPO was originally postponed for a period significantly in excess of 90 days, and as a result, the previously-capitalized costs were written off to G&A expenses.
Net (Loss) Income: Net loss was $9.4 million for the fourth quarter of 2017, or a basic and diluted net loss per share attributable to common stockholders of $0.29. Net income was $5.5 million for the same period in 2016, or basic net income per share attributable to common stockholders of $0.11 and diluted net income per share attributable to common stockholders of $0.05. The change is primarily attributable to operating income recognized for the fourth quarter of 2016 as compared to an operating loss incurred for the fourth quarter of 2017. Net loss was $16.4 million for the full year 2017, or a basic and diluted net loss per share attributable to common stockholders of $0.57 compared to $13.7 million for same period in 2016, or a basic and diluted net loss per share attributable to common stockholders of $11.00. The decrease in net loss per share attributable to common stockholders is primarily due to an increase in shares of common stock outstanding post-IPO.
Financial Guidance:

Based on its current plans, Jounce expects cash burn on operating expenses and capital expenditures for the full year 2018 to be approximately $80.0 million to $100.0 million. The Company expects to record approximately $50.0 million to $60.0 million in collaboration revenue in 2018 from the continued recognition of the Celgene upfront payment received in 2016.

Given the strength of its balance sheet, Jounce continues to expect its existing cash, cash equivalents and investments to be sufficient to enable the funding of its operating expenses and capital expenditure requirements for at least the next 24 months.

Conference Call and Webcast Information:

Jounce Therapeutics will host a live conference call and webcast today at 8:00 a.m. ET. To access the conference call, please dial (866) 916-3380 (domestic) or (210) 874-7772 (international) and refer to conference ID 6198947. The live webcast can be accessed under "Events & Presentations" in the Investors and Media section of the company’s website at www.jouncetx.com. The webcast will be archived and made available for replay on the company’s website approximately two hours after the call and will be available for 30 days.

Cautionary Note Regarding Forward-Looking Statements:

Various statements in this release concerning Jounce’s future expectations, plans and prospects, including without limitation, Jounce’s expectations regarding operating expenses, capital expenditures, collaboration revenue and other financial results, release of data from the Phase 1/2 ICONIC trial, expansion of the JTX-2011 program, the filing of an IND for JTX-4014 and the timing, progress and results of preclinical studies and clinical trials for Jounce’s product candidates and any future product candidates may constitute forward-looking statements for the purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995 and other federal securities laws and are subject to substantial risks, uncertainties and assumptions. You should not place reliance on these forward looking statements, which often include words such as "anticipate," "believe," "estimate," "expect," "intend," "may," "on track," "plan," "predict," "target," "potential" or similar terms, variations of such terms or the negative of those terms. Although the Company believes that the expectations reflected in the forward-looking statements are reasonable, the Company cannot guarantee such outcomes. Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, including, without limitation, Jounce’s ability to successfully demonstrate the efficacy and safety of its product candidates and future product candidates, the preclinical and clinical results for its product candidates, which may not support further development and marketing approval, the potential advantages of Jounce’s product candidates, the development plans of its product candidates, actions of regulatory agencies, which may affect the initiation, timing and progress of pre-clinical studies and clinical trials of its product candidates, Jounce’s ability to obtain, maintain and protect its intellectual property, Jounce’s ability to manage operating expenses, Jounce’s ability to maintain its collaboration with Celgene, as well as those risks more fully discussed in the section entitled "Risk Factors" in Jounce’s most recent Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission as well as discussions of potential risks, uncertainties, and other important factors in Jounce’s subsequent filings with the Securities and Exchange Commission. All such statements speak only as of the date made, and the Company undertakes no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise.

OncoCyte Announces Initial Results of DetermaVu™ Feasibility on New Platforms; Enhancements May Increase Lung Cancer Diagnostic Test’s Clinical Performance

On March 8, 2018 OncoCyte Corporation (NYSE American:OCX), a developer of novel, non-invasive liquid biopsy tests for the early detection of cancer, reported on the development and commercial launch timeline of DetermaVu, its liquid biopsy lung cancer diagnostic test (Press release, BioTime, MAR 8, 2018, View Source;p=RssLanding&cat=news&id=2337172 [SID1234524610]).

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As reported in November 2017, during the process of running initial samples for the Clinical Validation Study inconsistent analytic results were observed by OncoCyte’s technical team. OncoCyte determined that this was caused by a variance in the lots of consumables used in the sample-processing system that analyzes blood samples for markers that may indicate whether lung nodules found in patients are benign or suspicious. OncoCyte has been actively engaged with NanoString to more completely understand the issues that have delayed the DetermaVu validation study. The work with NanoString is ongoing. The work to date continues to support OncoCyte’s conclusion that the previous studies of DetermaVu were not impacted by this consumables issue and the positive results reported previously have not changed.

In addition to assessing the NanoString platform’s commercial applicability, OncoCyte is actively evaluating alternative assay platforms for use with its molecular biology diagnostic testing. OncoCyte is announcing the encouraging initial results of its initial clinical sample feasibility study on the Illumina Sequencing platform. The Illumina platform is a market-leading platform for molecular biology testing in the clinical Laboratory Developed Test (LDT) space. While further testing is needed, OncoCyte’s initial results indicate that the Illumina platform could provide consistent and robust support for the further clinical development studies that are necessary for the commercialization of DetermaVu.

Lyndal Hesterberg, OncoCyte’s Senior Vice President of Research and Development, stated, "The initial feasibility results on an established clinical platform may provide OncoCyte with an alternative path to clinical validation and commercial launch of the DetermaVu product in 2018. We will be pursuing the next steps to further assess the Illumina platform, along with other commercially established clinical molecular testing platforms, and we are encouraged by the results of this initial feasibility study."

OncoCyte has also identified ways that potentially may enhance the lung cancer signal identified by DetermaVu and has incorporated this approach into a revised algorithm. This revised algorithm was tested on about 60 clinical samples and resulted in accuracy (as measured by Area Under the Curve (AUC) data) equivalent or superior to previously reported results, although the error bar or potential range of results from this small sample set is wide and the results must be confirmed in a larger sample set.

Because of these developments, OncoCyte is extending its evaluation of the commercial molecular diagnostic platforms by doing a follow-on study utilizing a larger set of clinical samples. The Company expects to complete the process during the second quarter of 2018. After concluding this process, data will be available to determine which platform delivers the most accurate, consistent and robust test results while maintaining a reasonable cost of goods. The Company then intends to complete product development on the selected platform by carrying out an R&D Validation Study followed by an Analytical Validation Study. If these studies are successfully completed, OncoCyte intends to conduct a Clinical Validation Study. Clinical validation is the final step prior to commercial launch, which is still anticipated during 2018. OncoCyte has collected all the samples necessary for carrying out all these studies.

"The results from our recent evaluation of commercially available molecular testing platforms support our continued confidence in DetermaVu as a confirmatory test for the diagnosis of early stage lung cancer," commented William Annett, President and Chief Executive Officer.

About DetermaVu

DetermaVu is OncoCyte’s confirmatory, non-invasive, liquid biopsy test intended to facilitate clinical decision making in lung cancer diagnosis. DetermaVu is being developed as an intermediate step to confirm the absence of cancer between imaging modalities (LDCTs) detecting suspicious lung nodules and downstream invasive procedures that determine if the nodules are malignant.

DetermaVu is a trademark of OncoCyte Corporation.

TyrNovo to Present at BIO-Europe Spring® 2018 Conference

On March 8, 2018 Kitov Pharmaceuticals (NASDAQ: KTOV; TASE: KTOV), an innovative biopharmaceutical company, reported that Dr. Gil Ben-Menachem, VP Business Development of TyrNovo, a Kitov Pharmaceuticals company, will present recent results from pre-clinical studies with NT219, a novel dual inhibitor of STAT3 and IRS1/2, at the 2018 BIO-Europe Spring Conference at the RAI Convention Center, in Amsterdam, The Netherlands (Press release, Kitov Pharmaceuticals , MAR 8, 2018, View Source [SID1234524562]).

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NT219 is an innovative, unique small molecule targeting IRS1/2 and STAT, two signal proteins that are part of an anti-cancer drug resistance mechanism. In various preclinical models where NT219 was administered in combination with various oncology therapies, outstanding efficacy in preventing acquired resistance and reversing tumor resistance was demonstrated.

Details on the presentation are as follows:

Presenter: Dr. Gil Ben-Menachem
Category: Oncology
Date and Time: Tuesday, 13 March, 2018, 4:45 PM
Location: Room E105, RAI Convention Center

BIO-Europe Spring is a registered trademark of EBD Group AG and the Biotechnology Industry Organization

About NT219

NT219 is a small molecule that presents a new concept in cancer therapy by promoting the degradation and the phosphorylation of two oncology-related checkpoints, Insulin Receptor Substrates (IRS) 1 and signal transducer and activator of transcription 3 (STAT3), respectively. While targeted anti-cancer drugs inhibit the "ON" signal, NT219 activates the "OFF" switch, extensively blocking major oncogenic pathways. In pre-clinical trials, NT219, in combination with several approved cancer drugs, displayed potent anti-tumor effects and increased survival in various cancers, including sarcoma, melanoma, pancreatic, lung, ovarian, head & neck, prostate and colon cancers, by preventing the tumors from developing drug resistance and reversing resistance after it has been acquired