On September 29, 2019 Agendia Inc., a world leader in precision oncology for breast cancer, reported that it will present new data from their on-going clinical research at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2019, taking place from September 27 to October 1 in Barcelona, Spain (Press release, Agendia, SEP 29, 2019, View Source [SID1234539898]). The presentation, scheduled for September 29 at 12 noon, will focus on the biological characteristics of two cohorts of patients with early stage breast cancer at opposite ends of the recurrence risk spectrum: women at "Ultralow" and "Ultrahigh" risk for breast cancer recurrence.

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One of the biggest challenges physicians face when treating patients with early stage, curable breast cancer is choosing a treatment path that will mitigate the risk of recurrence, while seeking to avoid overtreatment or undertreatment. "Agendia is committed to finding answers for such patients. For this reason, it is important to conduct studies like this to better understand the genomic basis of those breast cancers which are at the extremes of low and high risk, to provide greater precision in determining appropriate therapy," stated William Audeh, MD, Chief Medical Officer of Agendia, Inc.

In this analysis, Agendia’s research team sought to identify the biological characteristics of two previously-identified subgroups of patients, those with Ultralow and Ultrahigh MammaPrint scores. Investigators employed differentially-expressed gene analysis (DEG) and gene set enrichment analysis (GSEA) to evaluate the full transcriptome data from 400 randomly chosen MammaPrint profiles. The Ultralow cohort was shown to have more homogeneous genomic profiles and enrichment of pathways favoring decreased proliferative and metastatic potential. The Ultrahigh cohort, on the other hand, demonstrated greater genomic heterogeneity with activation of pathways associated with more aggressive cancers, including those related to immune response, cell cycle regulation and DNA repair mechanisms.

"We are very excited to present these findings at ESMO (Free ESMO Whitepaper)," commented Annuska Glas, PhD, Vice President R&D and Product Support. "This important insight into the biological processes of early-stage breast cancer may help physicians identify more effective treatment strategies."

About MammaPrint
MammaPrint is an in vitro diagnostic medical device, performed as a testing service in a central laboratory, using the 70-gene expression profile of breast cancer tissue samples to assess a patient’s risk for distant metastasis within 5 years. The test is performed for breast cancer patients, with Stage I or Stage II disease, with tumor size ≤ 5.0 cm and lymph node negative. The device is FDA-cleared and CE-marked, enabling use in the European Union. MammaPrint is indicated for use by physicians as a prognostic marker only, along with other clinical-pathological factors. It is not intended to determine the outcome of disease, nor to suggest or infer an individual patient’s response to therapy. MammaPrint is the only test of its kind recommended for lymph node-negative and lymph node-positive patients by both the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) and National Comprehensive Cancer Network (NCCN). The test is also recommended by many other national and international clinical practice guidelines.

On September 29, 2019 Isofol Medical AB (publ), (Nasdaq First North Premier: ISOFOL), reported a poster presentation on the ongoing global Phase 3 AGENT clinical study in patients with metastatic colorectal cancer (mCRC) (Press release, Isofol Medical, SEP 29, 2019, View Source [SID1234539897]). The poster will be presented at the 2019 European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress, which is being held from September 27 to October 1, 2019, in Barcelona, Spain.

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Details on the presentation are as follows:

Title: Open label phase III study of arfolitixorin vs leucovorin in mFOLFOX-6 for first-line treatment of metastatic colorectal cancer: AGENT

Presentation Number: 664TiP

Presentation Time: 12 p.m. – 1 p.m. CEST

Presentation Date: September 29, 2019

Speaker: Prof Sebastian Stintzing

Session Name: Poster Display session

Location: Poster Area (Hall 4), Fira Gran Via, Barcelona, Spain

Link to the abstract and poster >>

The poster presentation is highlighting the trial design and execution to date of the AGENT study. The primary endpoint for the AGENT study is overall response rate (ORR) and key secondary endpoints include progression free survival (PFS) and duration of response (DoR). This is a randomized, multicenter, parallel-group, Phase 3 study to compare the efficacy of arfolitixorin versus leucovorin (LV) in patients with mCRC treated with 5-fluorouracil (5-FU), oxaliplatin, and bevacizumab. Patients will be randomized in a 1:1 ratio to either the investigational arm or the comparator arm. The study target is to randomize 440 patients in 18 months. An adaptive study design includes the possibility to increase the sample size to 660 patients which aim is to strengthen the statistical power for PFS. An interim analysis will be conducted after 330 patients have performed their 16 weeks scan and evaluated by the Data and Safety Monitoring Board (DSMB) who will advice the company about the sample size increase. Learn more about the global Phase 3 trial at clinicaltrials.gov.

For further information, please contact

Isofol Medical AB (publ)
Roger Tell, SVP, Chief Medical Officer
E­mail: [email protected]
Phone: +46 (0) 760 293 911

Investor Relations
LifeSci Advisors
Hans Herklots
E-mail: [email protected]
Phone: +41 79 598 7149

Media
LifeSci Public Relations
Alison Chen
E-mail: [email protected]
Phone: +1 646 876 4932

Certified Adviser
FNCA Sweden AB
E-mail: [email protected]
Phone: +46 8 528 003 99

About arfolitixorin

Arfolitixorin is Isofol’s proprietary drug candidate being developed to increase the efficacy of standard of care chemotherapy for advanced colorectal cancer. The drug candidate is currently being studied in a global Phase 3 clinical trial, AGENT. As the key active metabolite of the widely used folate-based drugs, arfolitixorin can potentially benefit all patients with advanced colorectal cancer, as it does not require complicated metabolic activation to become effective.

On September 29, 2019 Elevar Therapeutics reported from the ANGEL trial, a randomized phase 3 study of rivoceranib (also known as apatinib) plus best supportive care in patients with gastric or gastroesophageal junction cancer who have failed at least 2 prior lines of therapy (Press release, LSK BioPharma, SEP 29, 2019, View Source [SID1234539896]). This announcement and today’s podium presentation at the European Society for Medical Oncology’s (ESMO) (Free ESMO Whitepaper) 2019 Congress represent the first detailed public disclosure of ANGEL study data since the announcement of the topline results in June.

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"This study demonstrates the potential of rivoceranib to treat patients with late-stage gastric cancer," said Dr. Steven Norton, Elevar Therapeutics’ Vice President of Clinical Development, "this is the first multinational phase 3 study after rivoceranib’s approval in China. We look forward to further analyzing the data and believe that it will support our planned regulatory submissions."

The ANGEL trial enrolled 460 patients total in 12 countries; 308 in the rivoceranib arm and 152 in the placebo arm. In the rivoceranib arm, 186 were 3rd line while 122 were ≥4th line (a pre-specified stratification factor). In the placebo arm, 89 patients were 3rd line while 63 were ≥4th line.

The median overall survival (mOS) of the full (3rd line and ≥4th line) intention-to-treat (ITT) population was 5.8 months for the rivoceranib group versus 5.1 months for the placebo arm, a result that did not reach statistical significance (p=0.485). However, the mOS in the ≥4th line was positive and significant (p=0.0195), with a mOS result of 6.3 months for the rivoceranib arm versus 4.7 months for the placebo arm. The median progression free survival (mPFS) of the full population (3rd and ≥4th line) was also positive at 2.8 months for the rivoceranib arm versus 1.8 months for the placebo arm, a result that was highly significant (p<0.0001). The mPFS for the ≥4th line was also positive and highly significant (p<0.0001) at 3.5 months for the rivoceranib arm versus 1.7 months for the placebo arm.

The objective response rate in patients randomized with measurable disease was about 7% and the disease control rate was 42%, in alignment to what was observed in the Phase 3 Chinese study that supported the market approval in China. As expected, rivoceranib was generally well tolerated in the ANGEL study with a manageable safety profile.

The full set of data presented at ESMO (Free ESMO Whitepaper) on September 29, 2019 can be found at:

View Source

About Rivoceranib (Apatinib)
Rivoceranib is the first successful small-molecule angiogenesis inhibitor in gastric cancer. Rivoceranib acts by inhibiting angiogenesis, a critical process in cancer growth and proliferation. Specifically, rivoceranib selectively inhibits VEGFR-2 which mediates the primary pathway for tumor-mediated angiogenesis. It was approved in China (advanced gastric cancer, Dec 2014) where it is marketed by the Chinese-territory license-holder Jiangsu Hengrui Medicine Co., Ltd. Elevar Therapeutics holds the global rights (ex-China). The Company has completed a global (12 countries across Asia, US, and Europe) Phase 3 clinical trial of rivoceranib in advanced or metastatic gastric/gastroesophageal junction cancer patients ("ANGEL study"). Elevar Therapeutics is also developing rivoceranib for the treatment of patients with earlier lines of gastric cancer, colorectal cancer, hepatocellular carcinoma, and adenoid cystic carcinoma. Rivoceranib has been clinically tested in over 1,000 patients worldwide and has demonstrated efficacy in numerous cancers including gastric cancer, CRC, HCC, NSCLC, esophageal cancer, thyroid cancer, mesothelioma, and neuroendocrine tumors. It has also shown potential to significantly improve clinical outcomes in combination with chemotherapeutics and immunotherapy, as well as for maintenance therapy. Elevar Therapeutics has received notification designating rivoceranib as an orphan medicinal product for the treatment of gastric cancer from the European Commission in the European Union, the US FDA, as well as the MFDS in South Korea. The Company plans to meet with US FDA on October 24, 2019 to receive advice on regulatory submissions for monotherapy gastric cancer treatment.

On September 29, 2019 Clover Biopharmaceuticals, a biotechnology company focused on developing novel and transformative biologic therapies, reported that the first patient was dosed in another Phase I trial of SCB-313, an investigational fully-human TRAIL-Trimer fusion protein, in China for the treatment of cancer patients with malignant ascites (Press release, Clover Biopharmaceuticals, SEP 29, 2019, View Source [SID1234539894]). There are now four clinical studies evaluating SCB-313 open to recruiting patients in China and Australia across three oncology indications (malignant ascites, peritoneal carcinomatosis, and malignant pleural effusions).

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"Malignant ascites has historically posed significant challenges for both patients and clinicians, and with no efficacious therapies currently available, it remains a high unmet medical need for many cancer patients worldwide. My team and I look forward to evaluating SCB-313 as a potential new therapy for the treatment of cancer patients with malignant ascites," said Dr. Jin Li, Director of Department of Oncology at Tongji University Shanghai East Hospital, President of the Chinese Society of Clinical Oncology (CSCO) and Principal Investigator of the trial.

The Phase I, open-label, dose escalation trial in China is designed to assess the safety, tolerability, pharmacokinetics and preliminary efficacy of intraperitoneally administered SCB-313 as a single-agent for the treatment of malignant ascites.

"We are excited to work with world-renowned medical oncologist Dr. Jin Li and his team at Shanghai East Hospital. China has the largest global incidence of gastrointestinal cancers, which often cause malignant ascites, so we look forward to the results from this SCB-313 study," said Dr. Min Dong, Executive Vice President, Global Clinical Development at Clover. "Now that Clover has successfully initiated clinical studies evaluating SCB-313 in multiple countries, we hope to bring this novel and potentially first-in-class therapy to patients worldwide."

"TRAIL has long been considered a tantalizing target for cancer therapy because it can induce apoptosis in a tumor-specific manner across many different tumor types. SCB-313, which utilizes our proprietary Trimer-Tag© technology, is able to potently and uniquely target this trimerization-dependent pathway," said Dr. Peng Liang, co-founder, Chairman and President of Clover. "We believe that SCB-313 has the potential to be a best-in-class TRAIL-based therapy based on our R&D results to date, and in the months ahead, we look forward to initiating multiple new clinical studies for the treatment of intracavitary cancers."

On September 29, 2019 NOXXON Pharma N.V. (Paris:ALNOX) (Euronext Growth Paris: ALNOX), a biotechnology company focused on improving cancer treatments by targeting the tumor microenvironment (TME), reported the latest clinical results from the Phase 1/2 study of NOX-A12 in combination with Keytruda (pembrolizumab) in patients with microsatellite-stable, metastatic pancreatic and colorectal cancer in a poster presentation at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress in Barcelona, Spain (Press release, NOXXON, SEP 29, 2019, View Source [SID1234539893]).

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The combination of NOX-A12 and pembrolizumab induced an immune response, stable disease in 25% of patients and prolonged time on treatment vs. prior therapy for 35% of patients. Continued follow-up of patients has now yielded near-final overall survival statistics of 42% at 6 months and 22% at 12 months. A third patient in the enrolled population of twenty passed the one-year survival mark and continues to be followed. The study confirmed that NOX-A12 is safe and well-tolerated in advanced cancer patients both as a monotherapy and in combination with pembrolizumab and further supports the role of CXCL12 in the resistance to immunotherapy.

"Both metastatic colorectal and pancreatic cancers are indications with very limited therapeutic options. These indications have thus far remained largely unaffected by the advent of immune checkpoint inhibitors. The finding that three heavily pre-treated patients survived for more than one year shows the potential of NOX-A12 to target the tumor microenvironment in a clinically meaningful way and to enable the intended mode of action of pembrolizumab. Larger scale randomized trials with less-advanced patient populations are warranted, an opportunity we intend to pursue with a partner," said Aram Mangasarian, CEO of NOXXON.

"The encouraging survival data in this study suggests that the combination of NOX-A12 with pembrolizumab can impact the biology of the tumor in a clinically relevant manner. This is not what you would expect to see in patients at such an advanced stage of disease who had failed multiple prior lines of therapy," commented Dr. Jarl Ulf Jungnelius, CMO of NOXXON.

The poster entitled, "Phase 1/2 study with CXCL12 inhibitor NOX-A12 and pembrolizumab in patients with microsatellite-stable, metastatic colorectal or pancreatic cancer" was presented by Dr. Niels Halama, lead investigator of the trial, and the NOXXON team, on Sunday, September 29, from 12.00 – 01.00 p.m. CEST and is available on the NOXXON website.

Aram Mangasarian and Dr. Jarl Ulf Jungnelius will host a webcast poster presentation on September 30, 2019, at 09.00 a.m. CEST, to discuss significance of the latest data.

To participate: register for webcast.