On September 30, 2019 Adlai Nortye Ltd. ("Adlai Nortye" or "the Company"), a global clinical-stage biopharmaceutical company dedicated to discovery, development and commercialization of new and effective drugs with a focus on Oncology, reported at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2019 Congress the first results from a phase 1b neoadjuvant study of AN0025 (previously known as E7046), an investigational, potentially first in class oral EP4 antagonist (Press release, Adlai Nortye Biopharma, SEP 30, 2019, View Source [SID1234539895]).

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Researchers presented results from two dose levels of AN0025 in combination with the standard of care for locally advanced rectal cancer where primary resection without chemoradiotherapy is unlikely to achieve clear margins as defined by MRI. Twenty-eight high-risk patients were enrolled with 14 patients in the 250 mg cohort and 14 patients in the 500mg cohort; 25 patients were eligible for assessment. No DLT were observed in any patients. Complete clinical responses have led to 5/25 patients being managed by a watch-and-wait approach, in those who had surgery, 4/15 had pCR with 12 of these patients having clear resection margins.

The study showed that AN0025 was well tolerated in combination with chemoradiation as well as to radiotherapy followed by consolidation chemotherapy. The preliminary efficacy demonstrated encouraging clinical results in locally advanced rectal cancer.

"There is a tremendous need for new treatment strategies in rectal cancer, especially in patients with high-risk of relapse enrolled in this study. With nearly 40% of patients not requiring surgery or achieving a complete pathological response in the post-surgical specimen in this study, AN0025 in combination with the standard pre-operative treatment warrants further development. The excellent toxicity profile of this novel immunotherapy and potential combination with both conventionally fractionated radiochemotherapy or short course irradiation with consolidating chemotherapy make this strategy feasible worldwide." said lead author Dr. Lucjan Wyrwicz, MD, PhD, Department of Oncology and Radiotherapy, M. Sklodowska-Curie Memorial Cancer Center, Warsaw, Poland.

He added: "My patients are more and more often asking for organ preservation in rectal cancer and for many of them only a complete clinical response without any surgery is the desired outcome of treatment."

Commenting on the findings, Dr. Theodore S. Hong, MD, Director, Gastrointestinal Service, Associate Clinical Director, Department of Radiation Oncology, Massachusetts General Hospital, Co-Leader, Gastrointestinal Malignancies Program, Dana-Farber/Harvard Cancer Center, Professor of Radiation Oncology, Harvard Medical School, said "Given the unique mechanism of action and strong preclinical rationale, combined with the excellent tolerability and encouraging results, further study of AN0025 in preoperative therapy for rectal cancer are warranted. One question remains if there is a benefit to continuous exposure with AN0025 with FOLFOX followed by chemoradiation with AN0025 in a total neoadjuvant therapy (TNT) paradigm. Further evaluation in randomized trials is eagerly awaited." Dr. Hong was also an investigator in the study.

"We are very encouraged by these results and plan to move AN0025 plus chemoradiotherapy into a randomized confirmatory trial without delay" said Dr. Lars Birgerson, Chief Development Officer of Adlai Nortye. "We believe that the EP4 class, where AN0025 is a leading compound, holds considerable promise in combination with multiple treatments including check point inhibitors for a multitude of solid tumors."

About AN0025

AN0025 (previously E7046) is an investigational, potentially first in class oral EP4 antagonist that is believed to prevent the binding of prostaglandin E2 to its EP4 to change the immunosuppressive character of the tumor microenvironment. Based on preliminary results, it is well tolerated in patients with solid tumors.

On September 29, 2019 MonTa Biosciences reported that attends the ESMO (Free ESMO Whitepaper) conference in Barcelona to meet with Key Opinion Leaders to plan phase I trial in patients (Press release, MonTa Biosciences, SEP 29, 2019, View Source [SID1234618629]).

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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.