On November 19, 2019 Genprex, Inc.("Genprex" or the "Company") (NASDAQ: GNPX), a clinical-stage gene therapy company, reported that its collaborators from The University of Texas MD Anderson Cancer Center ("MD Anderson") presented positive preclinical data for the combination of TUSC2 immunogene therapy with an anti-PD1 antibody, pembrolizumab, and for the combination of TUSC2 immunogene therapy, pembrolizumab, and chemotherapy for the treatment of some of the most resistant metastatic lung cancers, including the KRAS and LKB1 mutations, at the American Association of Cancer Research Tumor Immunology and Immunotherapy Meeting 2019 (Press release, Genprex, NOV 19, 2019, View Source [SID1234551459]). The TUSC2 gene is a tumor suppressor gene and is the active agent in Genprex’s Oncoprex immunogene therapy.

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The poster, entitled "Efficacy of Novel Immunogene-Combinations for KRAS and LKB1 mutant NSCLC in a Humanized Mouse Model" shows that TUSC2 confers sensitivity to checkpoint blockade for some of the most resistant metastatic human cancers, including the KRAS and LKB1 mutations, in mice with human immune cells (humanized mice) with lung metastases. When TUSC2 was combined with anti-PD1 therapy, pembrolizumab, in humanized mice with KRAS and LKB1 lung metastases, there was significantly increased antitumor activity than when compared to either agent alone. This combination and model also demonstrated TUSC2-related NK (Natural Killer) cell activation. A significantly higher percentage of CD56+NK and CD56+CD59+active NK cells, which are immune cells that have been activated to kill cancer cells, were found in the mice that received TUSC2 alone and in those that received the combination of TUSC2 and pembrolizumab than in those that received pembrolizumab alone.

The poster also shows that TUSC2 increases the effectiveness of anti-PD1 checkpoint blockade combined with platinum chemotherapy in humanized mice with lung metastases with KRAS and LKB1 mutations, thus demonstrating that TUSC2 may improve on first-line standard of care for lung cancer. The combination of TUSC2 with pembrolizumab and carboplatin, a platinum chemotherapy, in humanized mice with KRAS and LKB1 lung metastases resulted in metastasis regression significantly greater than either TUSC2 alone or pembrolizumab combined with carboplatin treatments. This model showed significantly fewer or no visible tumor nodules after treatment with the TUSC2 combination as compared with other groups, and it showed strong antitumor efficacy. The combination of TUSC2 with pembrolizumab and carboplatin resulted in complete eradication of anti-PD1 resistant lung metastases in the humanized mouse model.

"These data not only further support existing preclinical data showing that Oncoprex immunogene therapy is synergistic with anti-PD1 therapy, but they also offer new data demonstrating that Oncoprex improves on the combination of anti-PD1 therapy and chemotherapy, today’s first line standard of care for lung cancer," said Julien L. Pham, MD, MPH, President and Chief Operating Officer of Genprex. "In a sophisticated humanized mouse model, the combination of TUSC2 with pembrolizumab and carboplatin resulted in complete eradication of anti-PD1 resistant lung metastases in some of the most resistant cancer mutations. This is highly encouraging and provides us with a strong indication that the combination could lead to similar results in the clinic."

The poster authors are Ismail M. Meraz, Mourad Majidi, Meng Feng, RuPing Shao, Min Jin Ha, Jeffrey Morris, Elizabeth J. Shpall, Jack A. Roth, all of MD Anderson Cancer Center, Houston, TX. Jack A. Roth has ownership interest in and is a consultant/advisory board member for Genprex, Inc.

On November 19, 2019 Aptus Clinical reported that it has been appointed full service clinical CRO partner by Artelo Biosciences Inc. (through their fully owned UK subsidiary, Trinity R&D Ltd.) to deliver the upcoming Phase 1B/2A trial of their synthetic cannabinoid, ART27.13 (Press release, Aptus Clinical, NOV 19, 2019, View Source [SID1234551458]). This latest agreement builds on an earlier research and development partnership agreement, where Aptus successfully designed and supported the critical path pre-clinical experiments and completed key clinical strategy and planning activities for Artelo.

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Andrew Yates, ART27.13 Project Director at Trinity R&D said "We are delighted with the progress that this project has made in transitioning through the discovery phase and into preparation for clinical testing in just 16 months. The depth and breadth of experience that our Aptus colleagues have brought to this project and their flexible collaborative approach has been key in helping us achieve this significant project milestone for ART27.13. We look forward to continuing to work with Aptus and our investigators in testing the clinical utility of ART27.13 in patients with cancer associated weight loss."

Gregory D. Gorgas, President and Chief Executive Officer of Artelo Biosciences, commented, "Aptus Clinical have proved themselves to be a true partner with us on the ART27.13 project. They have approached the inevitable challenges associated with any drug project in a fully supportive and flexible way with a total focus on doing the right things to move the project forward. We look forward to continuing our collaboration Aptus on this next phase of the ART27.13 journey.

Steve McConchie, Chief Executive Officer of Aptus Clinical, added, "Cancer related anorexia affects about 60% of advanced cancer patients and is an area where new treatment options are desperately needed. As a full-service Clinical CRO focused on transforming promising projects into valued medicines we are honoured to have been selected to deliver a trial that is so important for both Artelo and patients with cancer."

Photo (Left to right): William O’Brien, FD Trinity R&D; Andy Yates ART273 Project Leader, Trinity R&D; Kath Lowry, Snr Project Manager, Aptus Clinical; Greg Gorgas, President and CEO Artelo Biosciences; Steve McConchie, CEO Aptus
Clinical

On November 19, 2019 Epigenomics AG (FSE: ECX, OTCQX: EPGNY, the "Company") reported its financial results (IFRS, unaudited) for the first nine months of 2019 (Press release, Epigenomics, NOV 19, 2019, View Source [SID1234551457]).

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Major Events After the End of the Reporting Period

On November 7, 2019, after the end of the reporting period, Epigenomics successfully completed a capital increase with gross proceeds of approximately EUR 8.3 million. The shares from the private placement were allocated to multiple investors, including, in particular, institutional investors from the U.S.A. and Germany.
On November 21, 2019, Dr. Elvira D’Andrea, one of the authors of the microsimulation model comparing outcomes of colorectal cancer screening methods, including the Epi proColon blood test, will present at the 12th European Public Health Conference of the European Public Health Association. In addition, Dr. D’Andrea, together with her colleague Dr. Medhi Najafzadeh, co-author of the model, will participate in an investor conference call on November 21 where they will discuss a summary of the presentation entitled "Quantifying the impact of adherence to screening on colorectal cancer incidence and mortality".
Greg Hamilton, CEO of Epigenomics AG: "I would like to take this opportunity to thank all our existing and new shareholders, who participated in our capital increase, for the confidence they have placed in Epigenomics. The funds raised will enable us to continue to execute on our major goal, reimbursement for our blood test Epi proColon in the U.S.A. In addition, we are looking forward to the conference call with Dr. D’Andrea and her co-author Dr. Najafzadeh in which they will present their positive study results of the microsimulation model to interested investors".

Key figures

Product revenue for the first nine months increased 28% to EUR 818 thousand compared to the same period last year. Total revenue for the period decreased year-on-year to EUR 847 thousand (9M 2018: EUR 1,315 thousand) due to lower licensing revenue.
Research and development costs increased by EUR 1.2 million to EUR 5.7 million in the 9-month period due to expenses related to the post-approval study for Epi proColon and the HCC study in the U.S.A.
Selling and administrative expenses increased from EUR 6.0 million (9M 2018) to EUR 6.9 million.
EBITDA (before share-based payment expenses) decreased from EUR -8.0 million in the comparable period of 2018 to EUR -9.7 million.
The net loss for the period was EUR -10.0 million (9M 2018: EUR -8.7 million); the loss per share fell to EUR 0.28 (9M 2018: EUR 0.36) due to the higher number of shares after the capital increase in the second half of 2018.
Cash consumption increased to EUR 10.9 million in the first three quarters of 2019 (9M 2018: EUR 6.9 million) mainly due to an increased R&D spend and changes in working capital.
As of September 30, 2019, liquidity amounted to EUR 6.3 million (including marketable securities) compared to EUR 17.1 million at year-end 2018.

Outlook 2019
Revenue

As disclosed in the prospectus for the capital increase in November 2019, the Company expects full-year 2019 revenue in a range of EUR 1.0 million to EUR 1.5 million.
EBITDA

For EBITDA before share-based payment expenses, Epigenomics forecasts a range of EUR -12.5 million to EUR -14.0 million for the full year 2019.
Further information
The interim statement for the first nine months of 2019 (unaudited) is available on the Epigenomics website: View Source

Conference call for analysts and investors
Epigenomics AG will host a conference call for analysts and investors today at 3:30 pm (CET) / 9:30 am (EST). The webcast can be accessed on the Company’s website: View Source

The dial-in numbers for the conference call are:
Dial-in number Germany: +49 30 2332 257 28
Dial-in number UK: +44 20 3872 0880
Dial-in number USA: +1 862-701-2734

Participants are kindly asked to dial in 10 minutes prior the start of the call.
An audio replay of the conference call will be provided on the Epigenomics’ website subsequently.

On November 19, 2019 Oncopeptides reported Interim result of Q3 2019 (Press release, Oncopeptides, NOV 19, 2019, View Source [SID1234551456]).

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Financial overview July 1 – September 30, 2019
Net sales amounted to SEK 0.0 M (0.0)
Loss for the period was SEK 189.8 M (loss: 94.0)
Loss per share, before and after dilution, was SEK 3.53 (loss: 2.14)
On September 30 cash and cash equivalents amounted to SEK 1,122.3 M (488.9)
Significant events during the period July 1 – September 30, 2019
In late August it was announced that Klaas Bakker, MD, PhD, was appointed as Chief Medical Officer and assumed his duties in early November
In mid-September new interim data in RRMM patients with extramedullary disease (EMD) from the pivotal Phase 2 HORIZON trial were presented at the International Myeloma Workshop
At the end of September, it was announced that the patient recruitment in the pivotal Phase 2 HORIZON trial had been completed
Financial overview of the group

1) Earlier periods have been adjusted to reflect correction of errors, see note 7.

Conference call for investors, analysts and the media
The Interim Report Q3 2019 and an operational update will be presented by CEO Jakob Lindberg and members of Oncopeptides management team, Tuesday November 19, 2019 at 13:30 (CET). The conference call will also be streamed via a link on the website: www.oncopeptides.com.

Phone numbers for participants from:
Sweden: +46 8 505 583 59
Europe: +44 3333 009 034
USA: +1 833 823 05 89

Financial calendar
Year-end Report 2019: February 20, 2020
Interim Report Q1, 2020: May 26, 2020
Annual General Meeting May 26, 2020

On November 19, 2019 BerGenBio ASA (OSE:BGBIO), a clinical-stage biopharmaceutical company developing novel, selective AXL kinase inhibitors for multiple cancer indications, reported its results for the third quarter 2019 (Press release, BerGenBio, NOV 19, 2019, View Source [SID1234551455]).

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A presentation and live webcast by the Company’s management will take place today at 10.00 am CET in Oslo, please see below for details.

Richard Godfrey, Chief Executive Officer of BerGenBio, commented: ​"During the quarter we have continued working to expand our proof of concept trials in AML and NSCLC. Our goal is to confirm that the addition of our selective AXL inhibitor bemcentinib can substantially improve patient outcomes across both these indications. This will inform clinical strategy and position for late stage clinical development, and we remain committed to progressing bemcentinib through to regulatory approval."

Operational Highlights – Third quarter 2019

Non-Small Cell Lung Cancer (NSCLC)

Cohort A of the Phase II clinical trial (BGBC008) evaluating bemcentinib in combination with KEYTRUDA in patients with NSCLC met its primary endpoint.
Primary endpoint of Overall Response Rate (ORR) was met, with 33% ORR in cAXL positive patients; five times the response rate of cAXL negative patients (7%)
Response rate three times greater than that seen with Keytruda monotherapy reported in earlier clinical trials in similar patients.
Secondary endpoint of median Progression Free Survival (mPFS) reported significant 3-fold improvement in cAXL positive vs negative patients,
Data were presented at the prestigious High Impact Clinical Trial session at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) (6-10 November 2019) conference in Washington DC.
Proprietary Composite AXL Immune Score (cAXL) suggests patients that express AXL in both their tumor and immune cells report significantly improved clinical benefit from bemcentib combination with Keytruda.
Data from Cohort A of BGBC008 was also presented in an oral presentation at the 2019 World Conference on Lung Cancer (WCLC) and as a poster the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress (ESMO) (Free ESMO Whitepaper).
Data suggest bemcentinib has potential to enhance patient responses and overall survival, when treated in combination with a PD-1 inhibitor, particularly in patients with no or limited expression of PD-L1, this is a very significant patient population, and a very encouraging development.
The clinical trial BGBC008 is ongoing in two additional cohorts; B) in Check Point Inhibitor refractory patients and C) in CPI/chemotherapy combination refractory patients. Preliminary data read out is anticipated in the first half of 2020.
Acute Myeloid Leukaemia (AML)

U.S Food and Drug Administration (FDA) has granted bemcentinib Fast Track Designation for the treatment of elderly patients with AML whose disease has relapsed.
The purpose of the Fast Track designation is to get important new drugs to the patients earlier
The Fast Track program is designed to facilitate the development and expedite the regulatory review of new drugs to treat serious conditions without any treatment options.
Phase IIa clinical trial data has shown that bemcentinib in combination with low-intensity chemotherapy (LDAC) in elderly AML patients is well tolerated and efficacious.
Preliminary responses were reported in 43% of evaluated patients, with complete responses in a substantially higher percentage of patients compared to previously observed/historical benchmarks in single-agent cytarabine.
Trial has been expanded to include an additional 28 patients to verify this early proof of concept, preliminary data from this expanded trial will be reported in the first half of 2020.
​Financial highlights

Revenue for the third quarter 2019 and the nine months ended 30 September 2019 respectively amounted to NOK 0 million (NOK 0 million) and NOK 8.7 million (NOK 0 million). The revenue was received in Q1 2019 from ADCT as a clinical milestone payment.
Total operating expenses for the third quarter and the nine months ended 30 September 2019 respectively amounted to NOK 47.5 million (NOK 38.1 million) and NOK 154.0 million (NOK 143.6 million).
Cash and Cash equivalents at end of Q3 2019 NOK 289.5 million (NOK 398.2 in Q3 2018).
Presentation and Webcast Details

A presentation by BerGenBio’s senior management team will take place today at 10:00 am CET at:

Arctic Securities
Haakon VIIs gate 5
Oslo

The presentation will webcast live and the link will be available at www.bergenbio.com in the section Investors/Financial Reports. A recording will be available shortly after the webcast has finished.

The results report and presentation will be available at www.bergenbio.com in the section: Investors/Financial Reports from 7:00 am CET.