On August 28, 2020 Oncology Venture A/S (OV:ST) ("Oncology Venture") reported the Interim Report for the period January – June 2020 (Press release, Oncology Venture, AUG 28, 2020, View Source [SID1234564143]). The report is available as an attached document and on the company’s website.

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CEO of Oncology Venture Steve Carchedi states, "I am pleased to report on our achievements in Q2 and year to date. In spite of the current environment with the pandemic, we have made significant progress toward our new company strategy and have exceeded our goals. Only two days ago, we announced positive data from our pre-clinical testing of Stenoparib as a potential treatment of Covid-19, and that we plan to advance into human clinical studies. Earlier in the year we announced the licensing of LiPlaCis and 2X-111 to Smerud Medical Research, a deal which can result in several hundred million Swedish kronor in milestone fees – followed by significant royalties. We also secured the full development control of our Dovitinib and Stenoparib projects, and our financials are improving on all parameters. The general cost-efficiency measures we put in place are bearing fruit. Our efforts to reduce financial expenses are becoming very visible in our financial reporting, and more. As a result, I am pleased to report that our current half-year company financials for 2020 are 50% better than compared to first half-year of 2019."

Summary of the Half Year Report

Consolidated group revenue amounted to 0 MDKK (0.5 MDKK).
Consolidated group loss before depreciation amounted to -22.5 MDKK (-28.1 MDKK).
Consolidated group loss before net financials amounted to -23.1 MDKK (-28.6 MDKK).
Consolidated net result amounted to -18.9 MDKK (-36.9 MDKK).
Consolidated earnings per share (EPS) amounted to -0.14 DKK (-0.65 DKK).
2019 numbers in brackets.

Highlights during Q2 2020

On April 3, the company announced a draw-down of the first tranche of SEK 10 million under its convertible note agreement with Negma Group LTD and Park Partners GP.

On April 7, the company announced a notice to convene Annual General Meeting 2020, to be held on 22 April 2020.

On April 17, Oncology Venture announced a directed issue of 925,925 shares under its convertible note agreement with Negma Group LTD and Park Partners GP.

On 22 April, the company announced that it would test the activity of its PARP inhibitor, 2X-121, as a potential therapy for Coronavirus. The testing would be conducted by the Pathogen and Microbiome Institute at Northern Arizona University.

On 22 April, the minutes from the Annual General Meeting 2020 was published.

On May 6, Oncology Venture announced that the company had entered into a USD 5 million equity investment agreement with a new US based investor named Global Corporate Finance. The agreement runs for 36 months, during which time Oncology Venture can solely decide to exercise investments by GCF, sequentially, in a number of tranches.

On May 7, the company announced a directed share issue of 1,952,475 new shares in connection with debt conversion directed to Global Corporate Finance and a consultant.

On 29 May, Oncology Venture published its Q1 2020 report, covering the period January – March 2020.

On 8 June, the company announced that it had acquired the remaining 37% ownership in its priority Dovitinib program from investor Sass & Larsen ApS and thereby had gained full control of the company’s Dovitinib program.

On 9 June, Oncology Venture announced a directed issue of 751,879 shares under its convertible note agreement with Negma Group LTD and Park Partners GP.

On 9 June, Oncology Venture calls the first investment tranche under its share subscription agreement with Global Corporate Finance.

On 10 June, Oncology Venture announced a directed issue of 2,255,639 shares under its convertible note agreement with Negma Group LTD and Park Partners GP.

On 11 June, the company announced the termination of the agreement with its liquidity provider Sedermera Fondkommission.

On 10 June, the company announced a directed issue of 5,177,584 shares under its convertible note agreement with Negma Group LTD and Park Partners GP.

On 29 June, Oncology Venture made public that it had signed an agreement to out-license two pipeline assets as part of its prioritized portfolio strategy to Smerud Medical Research International. The deal concerned the two clinical pipeline assets, LiPlaCis and 2X-111. As a part of the terms of the deal, Oncology Venture is eligible to receive significant milestone payments as well as royalties.

On 30 June, the company announced a directed issue of 1,574,803 shares under its convertible note agreement with Negma Group LTD and Park Partners GP.
Highlights after the period

On 13 July, Oncology Venture announced that it had acquired full ownership of its PARP inhibitor (2X-121) program, and thereby Oncology Venture had gained full control of all three of the Company’s prioritized programs, 2X-121, Dovitinib and Ixempra, an important step in the execution of the Company’s strategy to eliminate external ownership of its key assets and retain maximum value of its priority programs.

On 14 July, the company announced a directed issue of 2,255,639 shares under its convertible note agreement with Negma Group LTD and Park Partners GP.

On 18 August, the company announced a directed issue of 1,893,939 shares under its convertible note agreement with Negma Group LTD and Park Partners GP. Thereby all outstanding convertible loan notes were converted.

On 21 August, Oncology Venture announced it has called upon the second investment tranche under its share subscription agreement with Global Corporate Finance and was issuing 5,980,020 shares at SEK 1.34 per share.

On 21 August, Oncology Venture announced that it will offer new shares in exchange for previously annulled warrants as part of clean-up of remaining obligations incurred prior to former management departure.

On 26 August, Oncology Venture announced that the company’s novel PARP inhibitor Stenoparib had shown anti-viral activity against Coronavirus in pre-clinical studies. In addition, it was announced that based on these findings, the company planned to advance the compound into human clinical trials, and moreover an update on the studies of Stenoparib as a treatment of ovarian cancer were also communicated. Finally, the announcement also made public that Stenoparib was the new name of the drug, until then known as 2X-121.
The report is available on:

View Source

On August 28, 2020 Antengene, reported that three-year old Shanghai startup originally backed by Celgene, will conduct a Hong Kong IPO that is expected to raise $200 million (Press release, Antengene, AUG 28, 2020, View Source [SID1234564141]). Focused on oncology, Antengene has 12 projects in its portfolio, a mix of in-licensed drugs and in-house R&D that it expects to test as monotherapies and in combinations. Six of its assets have started clinical trials. Last month, the company completed a $97 million Series C financing. In 2018, Antengene announced a $162 million deal to develop four Karyopharm assets in China.

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On August 28, 2020 Adaptimmune Therapeutics plc ("Adaptimmune")(Nasdaq: ADAP), a leader in cell therapy to treat cancer,reported that data from its Phase 1 trial with SPEAR T-cells targeting AFP at the virtual International Liver Congress (ILC) (Press release, Adaptimmune, AUG 28, 2020, View Source [SID1234564140]). One patient out of four dosed with 5 billion or more cells had a complete response, which was reported previously. The data also demonstrate an acceptable safety profile in patients with hepatocellular carcinoma (HCC).

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"A complete response in a patient with advanced liver cancer, and the anti-tumor activity we have reported in other patients with an acceptable safety profile, to date, further support the continued investigation of ADP-A2AFP," said Elliot Norry, Adaptimmune’s Chief Medical Officer. "We remain encouraged by the potential of this therapy and we are fully committed to developing ADP-A2AFP for people with HCC. We have reported results for four patients at doses of 5 billion cells or more and we are looking forward to sharing more data as we continue to treat patients in the expansion phase of the trial. Further, we continue to review our translational findings and are evaluating ways to improve the therapy, if necessary."

Dr. Bruno Sangro of Clinica Universidad de Navarra presented data from Cohort 3 and the expansion phase of the ADP-A2AFP Phase 1 trial during an oral presentation at ILC. Tim Meyer of University College London presented additional data from Cohorts 1 and 2 during a poster presentation. A video is available on Adaptimmune’s website (View Source) of Elliot Norry, and Mark Dudley, SVP of Early Stage Development, discussing these data. The oral presentation and poster presentation are available online through the congress web site.

Topline data from ILC 1

·One patient had a complete response and also demonstrated a sustained reduction in serum AFP. This patient experienced disease progression, having developed new lesions at Week 32
·Overall, nine patients have been treated as of the data cutoff, of those
-Four patients have been treated with ~5 billion or more transduced cells (three in Cohort 3 and one in the expansion phase): 1 patient with the complete response, 1 with stable disease (SD), and 2 had progressive disease (PD)
-Five patients were previously treated in the first two dose cohorts with doses of 100 million and 1 billion transduced cells, respectively, and all patients had best responses of SD
·ADP-A2AFP SPEAR T-cells were associated with an acceptable safety profile with no evidence of significant T-cell related hepatotoxicity and no protocol-defined dose limiting toxicities
·Evidence of dose-dependent persistence of ADP-A2AFP SPEAR T-cells post-infusion
·Further translational evaluation is ongoing to understand indicators of response

1All data summarized are for patients with HCC with a data cut-off of July 6, 2020. Data from non-HCC patients to be presented at a future congress

Overview of Trial Design

·This is a Phase 1, open-label, dose escalation clinical trial designed to evaluate the safety and anti-tumor activity of ADP-A2AFP in patients with HCC or other AFP-expressing tumors who are not amenable to transplant, resection, or loco-regional therapy, and who failed or were intolerant to or refused standard-of-care treatment
·Dose escalation is complete, and this trial is enrolling in the expansion phase intended to treat up to 25 patients with doses up to 10 billion cells

On August 28, 2020 Merck & Co. reported that Keytruda (pembrolizumab) in combination with Pfizer’s Inlyta (axitinib) has been turned down by NICE as first-line treatment for patients with advanced renal cell carcinoma (RCC) (Press release, Merck & Co, AUG 28, 2020, View Source [SID1234564138]).

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The anti-PD-1 therapy combo was approved in Europe in September 2019 based on findings from the pivotal Phase III KEYNOTE-426 trial, which demonstrated that the drug reduced the risk of death by 47% compared with sunitinib in the indication.

However, NICE says while "short-term clinical trial evidence" shows that the combination is more effective than sunitinib for people with untreated renal cell carcinoma, "it is uncertain if there is a long-term benefit," which means that "cost-effectiveness estimates are uncertain".

Kidney cancer UK has slammed the decision.

"The decision by NICE concerning axitinib and pembrolizumab is extremely disappointing for the kidney cancer community," said the charity’s health professional nurse Susanna Smith.

"This is a combination which showed great results in the clinical trial and has been very well tolerated by people. The combination has been used widely in the US to great success since its approval…so unfortunately this decision will be leave us lagging behind in proving affective, cutting edge treatment options for patients in England and Wales."

"Axitinib and pembrolizumab improves survival significantly and has an important role to play in the treatment of kidney cancer. Rejecting the most active cancer treatments is disappointing for patients," added Professor Thomas Powles, consultant medical oncologist at St Bartholomew’s Hospital, London.

On August 28, 2020 Roche (SIX: RO, ROG; OTCQX: RHHBY) reported that the U.S. Food and Drug Administration (FDA) has approved FoundationOneLiquid CDx, Foundation Medicine’s comprehensive pan-tumour liquid biopsy test for patients with solid tumours (Press release, Hoffmann-La Roche, AUG 28, 2020, View Source [SID1234564135]). FoundationOne Liquid CDx is a comprehensive genomic profiling (CGP) test that analyses more than 300 cancer-related genes and multiple genomic signatures to optimise patient care. Cancer is a disease of the genome, driven by genetic mutations within a tumour’s DNA. CGP is used to identify these unique mutations to determine how a tumour behaves and grows, and these insights can help physicians to determine a personalised treatment plan for each individual patient based on the specific mutations identified.

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As well as approving FoundationOne Liquid CDx as a CGP test for patients with any solid tumour, the FDA approved the test for use as a companion diagnostic to identify patients who may benefit from treatment with certain prostate and lung cancer therapies, including Rubraca (rucaparib), a poly (ADP-ribose) polymerase (PARP) inhibitor for treatment in patients with BRCA 1/2-mutant metastatic castration-resistant prostate cancer, and three first-line tyrosine kinase (TKI) inhibitors for the treatment of patients with non-small cell lung cancer. By incorporating multiple genes, including several companion diagnostic biomarkers, the test can help save time versus sequential biomarker testing.

"Many cancer patients are unable to have a tissue biopsy. FoundationOne Liquid CDx may provide a minimally-invasive option for patients who otherwise might not have benefitted from comprehensive genomic profiling," said Levi Garraway, M.D., Ph.D., Roche’s Executive Vice President, Chief Medical Officer, Head of Global Product Development and Co-Founder of Foundation Medicine Inc. "The convenience of testing a blood sample may also enable more rapid treatment decisions, so that patients can feel reassured they are not losing time to fight their disease."

FoundationOne Liquid CDx analyses circulating cell-free DNA from a patient’s blood sample and uses massively parallel sequencing to detect the four main classes of genomic alterations. The test is FDA-approved to report short variants in 311 genes including rearrangements and copy number losses in BRCA1 and BRCA2 genes. The results are delivered in an integrated report that identifies alterations matched to FDA-approved therapies. The report also delivers information about genomic signatures, including microsatellite instability and blood tumour mutational burden, as well as single gene alterations, including all NTRK fusions, to help inform the use of other therapies including immunotherapies, and provides relevant clinical trial information.

"With the acceleration towards precision therapy approaches, it is important that physicians have the highest quality tools that can provide an accurate picture of their patients’ cancers in a timely manner," said Fortunato Ciardiello, M.D., Ph.D, Professor of Medical Oncology, Director of the Division of Medical Oncology at the Università della Campania Luigi Vanvitelli, Italy. "With the approval of FoundationOne Liquid CDx physicians have the choice of two high-quality, FDA-approved comprehensive genomic profiling tests, enabling them to select the most optimal option for their patients."

The FDA approval of FoundationOne Liquid CDx was based on analytical and clinical validation studies including more than 7,500 samples and 30,000 unique variants across more than 30 cancer types. Evaluation of the platform using multiple validation methods across a broad range of tumour types demonstrated high sensitivity and specificity, even at the low allele frequencies often observed in clinical blood samples 1,2.

FoundationOne Liquid CDx is the latest addition to Foundation Medicine’s portfolio of high-quality CGP tests and the second of the company’s CGP tests to receive FDA approval. FoundationOneCDx, Foundation Medicine’s tissue-based genomic test for patients with solid tumours received FDA approval in 2017. Together, these high-quality genomic profiling tests offer physicians important options for detecting specific genomic alterations that help guide efficient, personalised treatment decisions, while reducing the time and sample needed when testing for multiple biomarkers one at a time. FoundationOne Liquid CDx can also provide complementary insights to tissue-based testing regarding tumour heterogeneity (the differences between cancer cells), and clonal evolution (how tumours evolve over time).

About FoundationOneLiquid CDx
FoundationOne Liquid CDx is a qualitative next-generation sequencing based in vitro diagnostic test for prescription use only that uses targeted high throughput hybridisation-based capture technology to analyse 324 genes utilising circulating cell-free DNA (cfDNA) isolated from plasma derived from anti-coagulated peripheral whole blood of advanced cancer patients. The test is FDA-approved to report short variants in 311 genes, including rearrangements and copy number losses in BRCA1 and BRCA2, and is a companion diagnostic to identify patients who may benefit from treatment with specific targeted therapies (listed in Table 1 of the Intended Use) in accordance with the approved therapeutic product labeling. Additional genomic findings may be reported and are not prescriptive or conclusive for labeled use of any specific therapeutic product. Use of the test does not guarantee a patient will be matched to a treatment. A negative result does not rule out the presence of an alteration. Patients who are negative for companion diagnostic mutations should be reflexed to tumour tissue testing and mutation status confirmed using an FDA-approved tumour tissue test, if available. For the complete label, including companion diagnostic indications and complete risk information, please visit www.F1LCDxLabel.com.