On June 25, 2020 Genprex, Inc. ("Genprex" or the "Company") (Nasdaq: GNPX), a clinical-stage gene therapy company developing potentially life-changing technologies for patients with cancer and diabetes, reported that the United States Adopted Names (USAN) Council has approved the non-proprietary name quaratusugene ozeplasmid for GPX-001, formerly called Oncoprex immunogene therapy, the Company’s lead drug candidate for non-small cell lung cancer (NSCLC) (Press release, Genprex, JUN 25, 2020, View Source [SID1234561470]).

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The USAN Council is responsible for selecting simple, informative, and unique non-proprietary (generic) drug names. As a part of Genprex’s corporate communication strategy and drug nomenclature branding, the Company is also pursuing formal proprietary brand name approval for its lead drug candidate, GPX-001 (quaratusugene ozeplasmid). Obtaining regulatory approval of these adopted drug names is a necessary step in securing marketing approval.

In conjunction with the adoption of quaratusugene ozeplasmid as the Company’s non-proprietary name for GPX-001, Genprex has rebranded the naming of its unique, proprietary, non-viral nanoparticle delivery system, now referred to as its Oncoprex Nanoparticle Delivery Platform, which is the vehicle used to deliver its oncology platform technologies.

"The USAN’s adoption of our non-proprietary name is another step toward advancing our lead drug candidate, GPX-001 for non-small cell lung cancer, toward commercialization," said Rodney Varner, Chairman and Chief Executive Officer of Genprex. "We look forward to the adoption and rollout of a brand name for this drug as we continue to move along the development pathway. In the meantime, we’ve focused our branding efforts on our proprietary, non-viral nanoparticle delivery system with our recognized Oncoprex name. We believe this delivery system is a significant differentiator for GPX-001, as well as an important platform delivery system that could be used for additional drug candidates."

As a part of the rollout of its newly adopted nomenclature and to also include its gene therapy drug candidate for diabetes, referred to as GPX-002, the Company has completed an overhaul of its website, fact sheet and pipeline. For more information, please visit www.genprex.com.

On June 25, 2020 Varian Medical Systems reported that Long-term results of the Stereotactic Ablative Radiotherapy for Comprehensive Treatment of Oligometastatic Cancers (SABR-COMET) study published June 2, 2020 in the Journal of Clinical Oncology showed positive increases in overall survival for patients with multiple sites of metastasis when treated with stereotactic ablative radiotherapy (SABR) versus standard-of-care (Press release, Varian Medical Systems, JUN 25, 2020, View Source [SID1234561469]).1 Through the extended follow-up, the impact of SABR on overall survival was larger in magnitude than in the study’s initial analysis published last year in The Lancet.2

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"The durability of the randomized data indicates a paradigm shift in our approach to the treatment of patients with low burden metastatic disease," commented senior study author Suresh Senan, MRCP, FRCR, PhD, Professor of Radiation Oncology at the Amsterdam University Medical Centres in Amsterdam, the Netherlands. "These data add to a growing body of evidence that supports the use of SABR as an ablative therapy for oligometastatic cancers."

As outlined in the latest study results, patients in the international randomized phase II trial who received SABR demonstrated a 22-month improvement in 5-year median overall survival compared with patients who received a standard-of-care approach alone, corresponding to an absolute survival benefit of 24.6%.3 This is a marked improvement from the results of the initial analysis2 in which the patients receiving SABR demonstrated a 13-month improvement in median overall survival over the control group.

"The size of the effect on long-term survival in this seminal study marks a step-change in the way clinicians should treat metastases from the highest incidence cancers," said Ricky Sharma, MD, PhD, vice president of Clinical Affairs at Varian (NYSE: VAR). "With over one million stereotactic body radiotherapy cases treated on TrueBeam alone, Varian continues to invest heavily to incorporate artificial intelligence, extraordinary precision, and unrivalled patient workflow into our industry leading delivery platforms for radiosurgery. We believe our continued pursuit of innovation and investment will ultimately help change the trajectory of cancer outcomes for all patients."

While systemic therapy, including chemotherapy, has been offered to patients with multiple metastases, the SABR-COMET data add to the growing body of evidence that suggests the addition of non-invasive treatments such as SABR can improve long-term outcomes for patients. Phase III randomized trials are ongoing to confirm the magnitude of the survival benefit for patients with a variety of metastatic cancers, including the international, multi-center SABR-COMET-3 clinical trial funded by Varian.

Mirroring the most common cancers treated across the world, primary tumor types in the study were breast, lung, colorectal and prostate. All patients enrolled had one to five new metastatic lesions. Although patients treated with radiotherapy were 20% more likely to suffer adverse events, there was no long-term impairment of quality of life. The study further showed that even with SABR, patients may progress with new metastases, likely due to the presence of micrometastatic disease, but that some can receive salvage therapy with repeat SABR.

On June 25, 2020 NantHealth, Inc. (NASDAQ: NH), a next-generation, evidence-based, personalized healthcare company, reported the publication of a study in JCI Insight, a peer-reviewed journal dedicated to biomedical research from preclinical to clinical studies (Press release, NantHealth, JUN 25, 2020, View Source [SID1234561468]). This research looked into the discordance between genomic sequencing and transcriptome analysis, and how this may reflect a mechanism of resistance to therapy in tumors that has previously been under-recognized and should be subject to further investigation.

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Next-generation sequencing (NGS) of DNA has not revealed all the mechanisms underlying resistance to genomically matched drugs. This study was designed to discover another potential mechanism. Researchers evaluated data from 1,417 tumors whole-exome tumor (somatic)/normal (germline) NGS and whole-transcriptome sequencing in order to examine transcriptomic silencing of putative driver alterations. Drivers are significant in this context, compared to passenger mutations, which are not linked to targeted drug therapies. Thus the data is particularly clinically relevant because it pertains to mutations that are commonly used to prescribe drug therapies. In this large-scale study, they also determined the frequency of tumor mutations being germline, rather than somatic, in these and an additional 462 tumors with tumor and normal exomes. They found there was a high risk of germline mutations being falsely reported as somatic. In that event, clinicians may prescribe a treatment that would actually target the normal healthy germline cells in addition to tumor cells and result in greater toxicity. In examination of a set of 50 genes highly associated with cancer and targeted therapies, at least 13% of variants detected in DNA were unexpectedly not expressed.

The research confirmed that both the frequency of silenced variant transcription and the risk of falsely identifying germline mutations as somatic are important. Therefore, transcriptomics is critical in conjunction with genomics when interrogating patient tumors for actionable alterations, and to ultimately reduce the risk of therapeutic resistance.

"Exploring another mechanism of resistance to therapy and thus helping bring about a deeper understanding around the interrogation of patients’ tumors brings with it hope and excitement for the success of future therapeutics," said Dr. Sandeep "Bobby" Reddy, Chief Medical Officer, NantHealth. "NantHealth is dedicated to the fight against cancer, devoting much time to finding effective personalized cancer treatments. The recognition of transcriptomic silencing means that we may be giving targeted therapies to up to 13% of patients in whom the target is actually missing."

JCI Insight publishes well-executed, high-quality, insightful research in all biomedical specialties, including autoimmunity, gastroenterology, immunology, metabolism, nephrology, neuroscience, oncology, pulmonology, vascular biology and many others. JCI Insight builds on the editorial leadership of the JCI, one of the oldest and most respected biomedical research journals, and is self-published by the American Society for Clinical Investigation (ASCI). JCI Insight serves to fulfill the ASCI’s objective to advance medical science through the publication of clinically relevant research reports.

NantHealth is focused on using data to close the loop – connecting payers, providers, and patients. Through its software, it facilitates the delivery of precise and timely data for creating efficiency, personalized treatment, and collaboration across healthcare.

On June 25, 2020 Intensity Therapeutics, Inc., a clinical-stage biotechnology company pioneering a novel, immune-based drug approach to treat solid tumor cancers through direct tumor injection, reported the publication of results from the Company’s nonclinical research in the International Journal of Molecular Sciences (IJMS) (Press release, Intensity Therapeutics, JUN 25, 2020, View Source [SID1234561467]). The paper titled, "Intratumoral Administration of a Novel Cytotoxic Formulation with Strong Tissue Dispersive Properties Regresses Tumor Growth and Elicits Systemic Adaptive Immunity in In Vivo Models," was published in IJMS as part of a Special Issue titled The Immune Landscape in Solid Tumors. The Special Issue addresses various aspects of the molecular and cellular biology of immune cells in the context of tumors and invites experts in the field to contribute an original research article or a comprehensive review. The paper is available online (doi.org/10.3390/ijms21124493).
The paper describes the Company’s lead product candidate, INT230-6, a novel combination of cisplatin and vinblastine formulated with a unique amphiphilic diffusion enhancer molecule (SHAO) that non-covalently interacts with payloads to increase intratumoral (IT) drug dispersion when injected into solid tumors. The data reported demonstrated that INT230-6 achieved greater inhibition of tumor growth and improved survival compared to the same drugs without enhancer given intravenously or IT. INT230-6 treatment increased the number of immune infiltrating cells within injected tumors. Animals demonstrating complete responses developed systemic immunity to the cancer. INT230-6 when combined with anti-programmed cell death protein 1 (PD-1), antibodies resulted in improved survival and increased rate of complete responses. INT230-6 induced significant tumor necrosis, which induced a systemic immune-based anti-cancer attack. This research demonstrates a novel, local treatment approach for cancer that minimizes systemic toxicity while stimulating adaptive immunity.

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"The results reported in the paper provided the pre-clinical rationale to advance INT230-6 into clinical development," said Lewis H. Bender Founder, President and CEO of Intensity Therapeutics and lead author on the paper. "Our clinical research conducted to-date is consistent with the results of this paper; data suggests that the dispersion, tumor-killing and immune activation properties of INT230-6 observed in mice are translating to humans. We are looking forward to initiating phase 2 clinical cohorts later this year combining INT230-6 with our partners’ products, Merck’s pembrolizumab and Bristol Myers Squibb’s ipilimumab, in cancers with high unmet medical need."

About INT230-6

INT230-6, Intensity’s lead proprietary product candidate, is designed for direct intratumoral injection. INT230-6 was discovered using Intensity’s proprietary DfuseRxSM technology platform. The drug is comprised of two proven, potent anti-cancer agents, cisplatin and vinblastine, and a penetration enhancer molecule that helps disperse the drugs throughout tumors for diffusion into cancer cells. In preclinical studies, INT230-6 eradicated tumors by a combination of direct tumor killing, release of tumor antigens and recruitment of immune cells to the tumor. Results generated by both the Company and the National Cancer Institute (NCI) showed treatment with INT230-6 in in vivo models of severe cancer resulted in substantial improvement in overall survival compared to standard therapies. Further, INT230-6 provided complete responses in animals with long-term protection from multiple re-challenges of the initial cancer and resistance to other cancers. The Company’s research published in the International Journal of Molecular Sciences and jointly with the NCI as part of Intensity’s collaborative research, published in July 2019 in the Journal OncoImmunology, also showed strong synergy when INT230-6 was combined with anti-PD-1 and anti-CTLA-4 antibodies. INT230-6 is being evaluated in a Phase 1/2 clinical study (NCT03058289) in patients with various advanced solid tumors. There have been no dose limiting adverse events observed in patients to date, even when dosing into deep tumors in the lung and liver. Several patients demonstrated tumor shrinkage, symptomatic improvement, and evidence of cancer cell death and immune cell activation on tumor biopsy. In combination cohort with pembrolizumab the Company reported the safety of combination was comparable to INT230-6 monotherapy.

On June 25, 2020 IntelGenx Technologies Corp. (TSX-V:IGX) (OTCQB:IGXT) ("IntelGenx" or the "Corporation") reported that the holders ("Debentureholders") of its 8.0% convertible unsecured subordinated debentures due June 30, 2020, originally issued on July 12, 2017 and August 8, 2017 (the "Debentures"), have approved the proposed amendments to the Debentures at the convened meeting of debentureholders held today (Press release, IntelGenx, JUN 25, 2020, View Source [SID1234561466]). As a result, the maturity date of the CDN$7,577,000 principal amount Debentures will be extended from June 30, 2020 to June 30, 2022 and the conversion price will be reduced from CDN$1.35 to CDN$0.50. The changes are expected to be effective as of June 30, 2020.

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As a result of the extension of the maturity date of the Debentures, the previously announced intention to repay the principal on the Debentures in common Shares on June 30, 2020 is no longer required and will not occur.

Listing and Trading Information

The Debentures are listed on the TSX Venture Exchange (the "Exchange") under the symbol "IGX.DB". They will continue to be listed under the symbol "IGX.DB" following the amendments. The Debentures will not trade or be quoted on an accrued interest basis (i.e. they will trade and be quoted on an interest flat basis). All bids, offers and trades in the Debentures must reflect both the capital portion of the Debentures and all accrued interest. The Exchange will not report accrued interest in regard to any trade in the Debentures made through the facilities of the Exchange. The Debentures, which were issued in the minimum principal amount of $1,000 each, will be quoted based on $1,000 principal amounts with all trades being made in multiples of $1,000 principal amounts (excluding any amount for interest). For example, an order to buy $5,000 principal amount will be given as an order to buy 5,000. An order to sell $20,000 principal amount will be shown as an order to sell 20,000. An order for 1,500, for example, is not acceptable since all trades must be made in multiples of $1,000. The minimum trading unit of Debentures is $1,000 principal amount and a board lot of Debentures is $1,000 principal amount.