On December 6, 2021 Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") reported that presentations on a series of abstracts highlighting updates on its in-house discovered eribulin mesylate (product name: Halaven, halichondrin class microtubule dynamics inhibitor, "eribulin"), MORAb-202, an antibody drug conjugate (ADC), and H3B-6545 (selective estrogen alpha receptor covalent antagonist), discovered by Eisai’s U.S. research subsidiary H3 Biomedicine Inc., will be given at the 44th San Antonio Breast Cancer Symposium (SABCS2021) to be held, partly virtual, from December 7 to 10, 2021, in San Antonio, Texas in the United States (Press release, Eisai, DEC 6, 2021, View Source [SID1234596453]).

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At this symposium, regarding eribulin, the result of non-clinical studies on its effects to subsequent chemotherapy through the induction of epithelial-mesenchymal transition (Abstract No: P3-06-01) is scheduled to be presented.

MORAb-202 is Eisai’s first ADC and combines Eisai’s in-house developed anti-folate receptor alpha (FR) antibody, to Eisai’s anticancer agent eribulin, using an enzyme cleavable linker. At this symposium, regarding MORAb-202, the experimental results of antitumor efficacy in Patient-Derived Xenograft models of triple-negative breast cancer (Abstract No: P5-08-02) is scheduled to be presented. In June 2021, Eisai and Bristol-Myers Squibb Company (Headquarters: the United States) entered into an exclusive global strategic collaboration agreement for the co-development and co-commercialization of MORAb-202.

In addition, regarding H3B-6545, the results of Phase II clinical study evaluating monotherapy (Abstract No: P1-17-10) and Phase 1b study evaluating the combination therapy with palbociclib (Abstract No: P1-17-03) in estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer will be presented.

Eisai positions oncology as a key therapeutic area, and is aiming to discover revolutionary new medicines with the potential to cure cancer. Eisai is aspiring to making further contribution to addressing the diverse needs of, and increasing the benefits provided to, patients with cancer, their families, and healthcare providers through creating innovative new drugs based on cutting-edge cancer research.

This release discusses investigational compounds and investigational uses for FDA-approved products. It is not intended to convey conclusions about efficacy and safety. There is no guarantee that any investigational compounds or investigational uses of FDA-approved products will successfully complete clinical development or gain FDA approval. No.21-96 December 6, 2021 Eisai Co., Ltd.

Major poster presentations at SABCS2021:

Product / Compound Abstract No. Title / Scheduled Date and Time (local time: Central Standard Time) Eribulin P3-06-01 Eribulin alters the chromatin landscape to induce MET, attenuating metastatic progression and sensitizing breast tumors to subsequent chemotherapy December 9 (Thu), 7:00AM-8:30AM MORAb-202 P5-08-02 MORAb-202, an Antibody-drug-conjugate (ADC) targeting Folate Receptor Alpha (FRα), exhibits durable anti-tumor efficacy in PDx models of TNBC December 10 (Fri), 7:00AM-8:30AM H3B-6545 P1-17-10 H3B-6545, a novel selective estrogen receptor covalent antagonist (SERCA), in estrogen receptor positive (ER+), human epidermal growth factor receptor 2 negative (HER2-) advanced breast cancer – A Phase II study December 8 (Wed), 7:00AM-8:30AM H3B-6545 P1-17-03 H3B-6545 in combination with palbociclib in women with metastatic estrogen receptor–positive (ER+), human epidermal growth factor receptor 2 (HER2)-negative breast cancer, Phase 1b study December 8 (Wed), 7:00AM-8:30AM Media Inquiries: Public Relations Department, Eisai Co., Ltd. +81-(0)3-3817-5120 [Notes to editors]

1. Eisai’s Focus on Cancer Eisai focuses on the development of anticancer drugs, targeting the tumor microenvironment (with experience and knowledge from existing in-house discovered compounds) and the driver gene mutation and aberrant splicing (leveraging RNA Splicing Platform) as areas (Ricchi) where real patient needs are still unmet, and where Eisai can aim to become a frontrunner in oncology. Eisai aspires to discover innovative new drugs with new targets and mechanisms of action from these Ricchi, with the aim of contributing to the cure of cancers.

On December 5, 2021 KDx Diagnostics, Inc. (KDx), and Lister Hospital (East and North Hertfordshire NHS Trust), Stevenage, UK, reported the launch in the United Kingdom (UK) of KDx’s URO17 test for detection of bladder cancer (Press release, KDx Diagnostics, DEC 5, 2021, View Source [SID1234596460]). This non-invasive urine test for bladder cancer is highly sensitive for identifying bladder cancer in patients with hematuria and recurrent bladder cancer during post-treatment monitoring.

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There are over 197,000 newly diagnosed cases of bladder cancer in Europe, and 430,000 globally, with 81,000 cases in the US alone. Accurate detection of new bladder cancer is difficult and expensive, requiring invasive camera-based testing methodology. Excitingly, KDx’s URO17 test has demonstrated 100% sensitivity and over 90% specificity in detecting bladder cancer in multiple peer-reviewed studies.

"We are excited to have the non-invasive URO17 test available in the UK to determine with high confidence whether a patient has bladder cancer. Testing has shown the URO17 urine test can detect the presence or absence of bladder cancer with high sensitivity. We are confident that the application of URO17 in clinical practices can significantly improve patient care in the UK," said Nam W. Kim, Ph.D., KDx’s CEO, and CTO.

"Bladder cancer is expensive cancer to treat due to a high rate of recurrence, and it often requires invasive procedures to diagnose. KDx’s URO17 urine test is revolutionizing how bladder cancer is detected, managed, and treated. We are excited that Lister Hospital in Stevenage is now a Core Lab offering URO17 test and that patients from all over the UK will have access to this test," said Sholeh Jahanfard, President and COO of KDx Diagnostics Inc.

Mr. Nikhil Vasdev – Consultant Urological Surgeon at Lister Hospital and Associate Medical Director for cancer services at East and North Hertfordshire NHS Trust, which runs the hospital – was the chief investigator and the lead author of a paper describing a recent study on URO17. "We are pleased to be the first NHS trust in the UK and Europe to make URO17 test available for patients," said Mr. Vasdev, who is also a Senior Clinical Lecturer at the University of Hertfordshire. "Our ability to detect bladder cancer simply, accurately, and non-invasively using URO17 will greatly improve detection at an early stage when it can be treated most effectively while minimizing the number of unnecessary and invasive procedures in patients who are suspected of having bladder cancer," he added.

Dr. Michael Chilvers – Medical Director at East and North Herts NHS Trust, said: "I am really pleased that the partnership between KDx and this Trust has led to this major step forward in the non-invasive detection of bladder cancer, and undoubtedly to improved outcomes for our patients."

On December 5, 2021 Jacobio Pharma (1167.HK) reported that it has received the Investigational New Drug (the "IND") approval of the combination therapy of KRAS G12C inhibitor JAB-21822 and Cetuximab injection from the Center for Drug Evaluation of China (the "CDE") on Dec 3, 2021 (Press release, Jacobio Pharmaceuticals, DEC 5, 2021, View Source [SID1234596458]).

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After received the approval, Jacobio will start a phase I/II, open-label, multi-center, dose-escalation and expansion clinical trial in China. The clinical trial is aiming to explore the safety, tolerability and preliminary efficacy of the combination therapy of JAB-21822 and Cetuximab in KRAS G12C mutant patients with advanced colorectal cancer.

Jacobio’s preclinical study shows that the combination therapy of JAB-21822 and Cetuximab can enhance the anti-tumor activity of JAB-21822 inhibitors in colorectal cancer tumor models, make tumor regression, and delay tumor re-growth after the cessation of using the drug.

JAB-21822 has been approved for five clinical trials in China and the United States, including mono therapies and combination therapies with either PD-1 antibody or Cetuximab to treat KRAS G12C mutant patients with advanced solid tumors including non-small cell lung cancer and colorectal cancer.

About JAB-21822

JAB-21822 is the Jacobio’s in-house innovative small molecule anti-cancer drug, which is designed to target KRAS G12C mutation. JAB-21822 has best-in-class potential among KRAS G12C inhibitors and has been approved for clinical trials in China and the United States. Internal pre-clinical head-to-head studies have shown that JAB-21822 has a superior pharmacokinetic (PK) profile and favorable tolerability as well as potential for a superior dosing profile compared with its competitors.

About Cetuximab

Cetuximab is an IgG1 monoclonal antibody against the EGF receptor. The cetuximab injection used in the clinical trial of the combination therapy is an approved treatment for RAS wild type patients with metastatic colorectal cancer, head and neck cancers and other diseases.

On December 5, 2021 Isofol Medical AB (publ) (Nasdaq Stockholm: ISOFOL), reported on December 3 that the ongoing phase III study AGENT will not reach 300 PFS events with current censoring rules based on FDA decision (Press release, Isofol Medical, DEC 5, 2021, View Source [SID1234596455]). Following this announcement, Isofol invites investors, analysts, and media to an audiocast (in English) with a Q&A-session on December 6, at 08:00 a.m. CET.

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The presentation will be held by Isofol’s CEO Ulf Jungnelius and CMO Roger Tell in English and will conclude with a Q&A session. Questions can be asked on the telephone conference or in written form through the webcast. No preregistration is needed.

Date and time
December 6, 2021, at 08:00 a.m. CET

Webcast link
View Source

Phone number
Call in details will be made available at the following link in good time before the start of the presentation:
View Source

The presentation will also be available on Isofol’s website after the broadcast.

On December 4, 2021 Kazia Therapeutics Limited (NASDAQ: KZIA; ASX: KZA), an oncology-focused drug development company, reported that positive final data from a phase II clinical study of paxalisib as first line therapy in patients with glioblastoma (NCT03522298) (Press release, Kazia Therapeutics, DEC 4, 2021, View Source [SID1234596461]). The results confirm the previously reported safety and efficacy profile with paxalisib in this high unmet need disease.

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Key Points

The study recruited 30 patients with newly diagnosed glioblastoma and unmethylated MGMT promotor status, a genetic profile which confers primary resistance to temozolomide, the only existing FDA-approved drug treatment for first line treatment.
60mg once daily was identified as the maximum tolerated dose (MTD) and selected for future studies.
Median overall survival (OS) in the intent-to-treat (ITT) population (n=30) was 15.7 months (11.1 – 19.1), which compares very favourably to 12.7 months historically reported with temozolomide in this patient group.1
Median progression-free survival (PFS) in the ITT population was 8.4 months (6.6 – 10.2), representing a substantial increment over the comparable figure of 5.3 months associated with temozolomide.
In the modified ITT (mITT) population (n=27), which includes only those patients evaluable for efficacy, OS increased to 15.9 months (12.8 – 19.1).
The safety profile of paxalisib was highly consistent with previous clinical studies: hyperglycaemia, oral mucositis, and skin rash were among the most common drug-related toxicities.
Kazia expects to receive a final clinical study report in 1Q CY2022 and intends to seek publication of these data in a peer-reviewed scientific journal thereafter.
Kazia CEO, Dr James Garner, commented, "We are delighted to report positive final data from the completed phase II study of paxalisib. The data continue to demonstrate a clear efficacy signal and favourable safety profile, suggesting a meaningful advantage over temozolomide, the existing standard of care, and validating our decision last year to join the GBM AGILE pivotal study. We have gleaned invaluable insights from this trial, and we are tremendously grateful to the investigators and to the patients who participated. Our task now, as we move rapidly toward a potential marketing authorization, is to confirm and quantify the benefit associated with paxalisib in glioblastoma patients. This indeed is the focus of our participation in GBM AGILE, which commenced recruiting to the paxalisib arm in January 2021. We are increasingly also exploring additional patient populations for which a brain penetrant PI3K/mTOR inhibitor may provide significant advantages over the standard of care."

Professor Patrick Wen, Principal Investigator at Dana Farber Cancer Institute, commented "We are pleased to see the phase II study of paxalisib successfully completed. This data supports the inclusion of paxalisib in the GBM AGILE study, which has recently expanded to Canada. Glioblastoma remains a disease in urgent need of new therapeutic options, and we look forward to seeing further data for paxalisib from GBM AGILE in due course."

Clinical Trial Design

The phase II study of paxalisib was an adaptive trial, conducted in two stages. The first stage sought to determine the most appropriate dose in newly diagnosed patients. The second stage was intended to provide additional information on dosing and to seek a preliminary efficacy signal in order to de-risk transition to a larger, pivotal study.

Consistent with these objectives, the primary objective of the study was to evaluate the safety and tolerability of paxalisib in patients with newly diagnosed glioblastoma. The secondary objectives included typical pharmacokinetic parameters, and efficacy endpoints including overall survival (OS) and progression-free survival (PFS).

The phase II study was conducted in 30 patients at six centres in the United States. It was a single arm study in which all patients received paxalisib as a monotherapy. As such, all data must be interpreted in the context of historical comparators. Specifically, Kazia has referred to the pivotal study of temozolomide, the only existing FDA-approved drug for this patient population. Such comparisons are always inexact, and this study was not designed either to precisely quantify the benefit associated with paxalisib or to demonstrate statistical significance. Rather, these are among the objectives of the ongoing GBM AGILE pivotal trial.

Next Steps

On the basis of earlier interim analyses of this study, Kazia made the decision in 4Q CY2020 to commence participation in the GBM AGILE pivotal study. This global trial recruited its first patient to the paxalisib arm in January 2021 and recruitment is ongoing. Kazia provisionally expects indicative data in CY2023.

Seven other studies of paxalisib are ongoing in other forms of primary brain cancer and in various forms of cancer that has metastasized to the brain. The company is working with investigators to crystalise the timing of initial data read-outs from these studies. Kazia had expected at least two further read-outs by the end of CY2021. Clinicians have now indicated that data early in CY2022 is most likely. The company will continue to keep shareholders closely informed as it receives further feedback from investigators.

Having successfully concluded the phase II study in glioblastoma, the investigators are composing a manuscript for submission and publication to a peer-reviewed academic journal in 2022. Once the data has been more thoroughly analysed, Kazia expects to share further detail with investors as it becomes available.