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.

On June 25, 2020 Cernostics, a leader in the development of AI-driven image analysis technologies for precision medicine testing, reported publication of new clinical results demonstrating further validation of how its TissueCypher diagnostic test predicts future disease progression in patients with Barrett’s Esophagus (BE) (Press release, Cernostics, JUN 25, 2020, View Source [SID1234561465]). (Abstract available here. Full article available via journal subscription.) By identifying "at-risk" patients much earlier than traditional methods, TissueCypher provides actionable results that allow physicians to target early therapeutic interventions to prevent cancer.

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TissueCypher is the first and only precision medicine test designed, developed, and commercialized to predict which patients with Barrett’s Esophagus will progress to high-grade dysplasia (HGD) or esophageal adenocarcinoma (EAC).

In this study, funded by the NIH/NCI, patients with BE who progressed to HGD or EAC after at least one year following endoscopy (n=58) were matched to patients with BE without disease progression after a median of seven years surveillance (n=210). Results demonstrated that patients classified as high-risk by TissueCypher were at 4.7-fold increased risk for HGD/EAC compared to those classified as low-risk (p<0.0001). Furthermore, this study demonstrated that patients with non-dysplastic BE who TissueCypher scored high-risk progressed to HGD or EAC at a rate of more than 5%/year, which is at least a 10-fold increase in reported progression rates for NDBE, based on large population studies.

In an editorial accompanying the published results, Prasad G. Iyer, MD, MSc, at Mayo Clinic in Rochester, Minnesota, describes TissueCypher as the potential "Holy Grail" for Barrett’s Esophagus. "Identification of those at higher risk may allow either intensive endoscopic surveillance (to detect incident dysplasia/EAC) or proactive EET, whereas surveillance intervals could be lengthened in those at low risk. This risk prediction has been referred to as the ‘Holy Grail’ in BE."

"This is the third independent study showing that TissueCypher gives physicians crucial predictive power beyond expert diagnosis, especially in that difficult subset of patients whose true risk may go unnoticed if we rely solely on traditional methods," said lead author Jon M. Davison, MD, Associate Professor of Pathology at University of Pittsburgh in Pittsburgh, Pennsylvania.

TissueCypher’s unique advantages stem from its patented, AI-based digital platform with multi-channel fluorescence imaging that provides physicians with a more in-depth, accurate, and comprehensive view of each patient’s unique pathology.

"The TissueCypher image analysis platform simultaneously and objectively extracts protein expression information from multiple biomarkers, as well as provides a digital expression of tissue architecture and nuclear morphology," says Vani J.A. Konda, MD, Clinical Director, Center for Esophageal Diseases, at Baylor University Medical Center in Dallas, Texas, and a key opinion leader in the use of imaging and novel screening techniques to improve early detection and treatment. "The information physicians receive is meaningful, accurate, and immediately actionable." Dr. Konda has published extensively on the role of biomarkers for improving risk stratification in patients with Barrett’s Esophagus, including an upcoming review paper in the July 2020 issue of Gastroenterology & Endoscopy News.

Cernostics’ innovative technology is unique in today’s market, because tissue structure is preserved while immune, stromal, stem cell and tumor biomarkers are analyzed – all of which is done by evaluation of standard esophageal pinch biopsies readily available from the endoscopy procedure. Biomarker intensity and spatial relationships within the tissue structure are also analyzed and reported, creating an in-depth picture of the patient’s risk from which the physician can create successful patient management protocols.

TissueCypher has been tested and validated in five independent clinical studies at leading centers around the world, including Cleveland Clinic, University of Pennsylvania Medical Center, Geisinger Health, and Academic Medical Center in Amsterdam. Most recent peer-reviewed results are published currently in the June 2020 issue of the American Journal of Gastroenterology.

Using a pinch biopsy specimen routinely collected by the gastroenterologist during an endoscopy procedure, TissueCypher is easily incorporated into a physician’s current practice. The test requires no additional tools or collection devices, as are needed with other currently available diagnostic options.

About Barrett’s Esophagus

Barrett’s Esophagus (BE) affects more than three million Americans, occurring when chronic exposure to stomach acid causes the esophageal cell lining to deteriorate and undergo changes that can create an environment for cancer. Without treatment, Barrett’s can lead to EC, with a poor 5-year survival of less than 20%. Today, Barrett’s is commonly managed by surveillance, involving regular endoscopic procedures with biopsy, monitoring disease progression, and GERD-related drug therapy to control symptoms and prevent esophageal injury.

On June 25, 2020 Poseida Therapeutics, Inc., a clinical-stage biopharmaceutical company dedicated to utilizing proprietary gene engineering platform technologies to create next generation cell and gene therapeutics with the capacity to cure, reported the closing of a Series D financing round, raising $110 million (Press release, Poseida Therapeutics, JUN 25, 2020, View Source [SID1234561464]). The financing was led by funds advised by Fidelity Management Research Company, LLC, with participation by Adage Capital Management and Schonfeld Strategic Advisors. A number of current investors also participated in the financing.

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BofA Securities is acting as sole placement agent for the financing.

"This financing supports the approach we are taking to leverage our broad proprietary gene engineering platform technologies, including the piggyBac DNA Modification System and Cas-CLOVER site-specific gene editing system, for the creation of numerous differentiated cell and gene therapy product candidates," said Eric Ostertag, M.D., Ph.D., Chief Executive Officer of Poseida.

Poseida’s portfolio includes allogeneic and autologous CAR-T product candidates in both hematological and solid tumor oncology indications, as well as liver-directed gene therapy programs in orphan genetic diseases.

On June 25, 2020 Hoffmann-La Roche reported that Rozlytrek (entrectinib) is the second histology independent drug to be recommended by NICE for use on the Cancer Drugs Fund (CDF), following a green light for Bayer’s Vitrakvi (larotrectinib) earlier this year (Press release, Hoffmann-La Roche, JUN 25, 2020, View Source [SID1234561463]).

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As a histology independent treatment, the drug targets all solid tumours that have a certain genetic mutation (a neurotrophic tyrosine receptor kinase (NTRK) gene fusion), regardless of where the cancer originated in the body.

As NICE notes, this is particularly beneficial to patients with some rare types of cancer where treatment options are currently limited.

Between 600-700 people have solid tumours with NTRK gene fusions. For those aged 12 years and older who have no satisfactory treatment options, treatment with Rozlytrek will be funded via the CDF, once a European marketing authorisation is granted.

The EMA’s human medicines committee recently backed the approval of the drug as monotherapy for adults and paediatric patients 12 years of age and older, with solid tumours expressing an NTRK gene fusion, who have a disease that is locally advanced, metastatic or where surgical resection is likely to result in severe morbidity, and who have not received a prior NTRK inhibitor.

"People across England will be among the first in Europe to benefit from a new generation of medicine that targets tumours based on their genetic make-up, rather than where they are in the body," noted Karen Lightning-Jones, head of Personalised Healthcare and Strategic Partnerships, Roche Products Limited.

"We are proud to have worked in partnership with NHSE, NICE and the Accelerated Access Collaborative, to fast-track access. We look forward to the English Genomic Medicine Service being able to operate at full capacity and help identify those patients who may benefit from entrectinib."

Meindert Boysen, deputy chief executive and director of the centre for health technology evaluation at NICE, said the decision to approve CDF funding for the drug "is another positive step forward for cancer care driven by genomics. Treatments like entrectinib, have the potential to revolutionise how we treat cancers by targeting a genetic mutation that activates tumour growth irrespective of the solid tumour’s location."

On June 25, 2020 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 a presentation at the American Association of Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting held from June 22nd-24th, 2020, illustrating a unique approach to creating drugs capable of reaching tumors hiding in organs where existing anticancer drugs cannot accumulate in therapeutic concentrations (Press release, Moleculin, JUN 25, 2020, View Source [SID1234561460]). A poster presentation entitled, "Targeting Cancer Sanctuary Sites: A Novel Approach to the Treatment of Lung Localized Tumors," provided an overview of data demonstrating that uniquely high uptake and retention of Annamycin in the lungs results in consistently high in vivo activity against wide range of lung-localized tumors in mice.

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"We are very encouraged by this data, as we believe it further demonstrates Annamycin’s anti-cancer activity against tumors that evade therapies that may be initially effective in their primary location of origin, but are protected by metastasis to sanctuary organs. In the case of sarcomas treated with the current standard of care, doxorubicin, tumors may be initially responsive in their primary location, but become unresponsive after metastasis to the lungs, which eventually becomes the most likely cause of patients’ death," commented Walter Klemp, Chairman and CEO of Moleculin. "This research also sheds light on why doxorubicin, the current standard of care for many types of cancer, is not effective against lung-localized cancer. Subsequently, we believe that Annamycin’s ability in animal models to effectively accumulate in the lungs without noticeable side effects offers unique therapeutic opportunities that should be explored for the benefit of cancer patients with lung-localized tumors."

Mr. Klemp concluded: "One of the reasons we are so excited about Annamycin’s potential to treat lung-localized tumors is its ability in animal models to accumulate in the lungs and lack of toxic side effects related to the high lung accumulation. This was once again confirmed by the data, as Annamycin accumulated in the lungs at nearly 6 times the level of doxorubicin. Importantly, Annamycin’s ability to accumulate in the lungs also led to high anti-tumor activity, which ranged from the inhibition of tumor progression to complete tumor eradication, resulting in significant improvement of survival in all the models tested. We look forward to exploring Annamycin’s clinical potential to target tumors localized in the lungs, one of the most common sites of cancer metastasis."

The accepted abstract stated, "The high cytotoxic potency of Annamycin against MDR cancer cells is related, in part, to its ability to overcome ABC transporter-mediated efflux and, in contrast to doxorubicin, achieve high intracellular uptake. A greatly increased concentration of Annamycin in the lung, as compared to doxorubicin, leads to high drug efficacy in vivo in lung-localized tumor models. In summary, our studies (1) support the hypothesis of lungs being a sanctuary site for cancer cells and (2) demonstrate that effective targeting of cancers metastatic to the lung is possible by chemical modification of clinically used but currently ineffective drugs, especially in combination with appropriate drug delivery. In more general terms, these studies indicate that the proposed approach can also lead to the identification and elimination of cancer sanctuary sites other than the lungs and creation of more effective anticancer therapies."