On December 6, 2021 Secura Bio, Inc. (Secura Bio) – (www.securabio.com), an integrated pharmaceutical company dedicated to the worldwide development and commercialization of impactful oncology therapies, reported that several abstracts relating to the Secura Bio product COPIKTRA (duvelisib) will be presented at the 63rd annual meeting of the American Society of Hematology (ASH) (Free ASH Whitepaper) in Atlanta, Georgia (Press release, Secura Bio, DEC 6, 2021, View Source [SID1234596527]).

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These abstracts feature new data from important ongoing or recently completed clinical trials, including:

Duvelisib in Patients with Relapsed/Refractory Peripheral T-Cell Lymphoma from the Phase 2 Primo Trial: Results of an Interim Analysis (click on title to see full abstract)

This abstract will be presented by Dr. Jonathan Brammer on Sunday, December 12, 2021: 6:00 PM-8:00 PM Hall B5 (Georgia World Congress Center).

The Combination of Duvelisib and Romidepsin (DR) Is Highly Active Against Relapsed/Refractory Peripheral T-Cell Lymphoma with Low Rates of Transaminitis: Final Results and Biomarker Analysis (click on title to see full abstract)

This abstract will be presented by Dr. Steven Horwitz on Monday, December 13, 2021: 10:30 AM-12:00 PM Hall A1 (Georgia World Congress Center).

TEMPO: A Phase 2, Randomized, Open-Label, 2-Arm Study Comparing 2 Intermittent Dosing Schedules of Duvelisib in Subjects with Indolent Non-Hodgkin Lymphoma (iNHL) (click on title to see full abstract)

This abstract will be presented by Dr. Vladimir Vorobyev on Monday, December 13, 2021: 6:00 PM-8:00 PM Hall B5 (Georgia World Congress Center).

"The presentations of new data for COPIKTRA at ASH (Free ASH Whitepaper) reflect the dedication of Secura Bio and the researchers with whom we work to develop products for the treatment of challenging hematologic malignancies in patients with important unmet needs." said Joseph M. Limber, President and CEO of Secura Bio.

About COPIKTRA (duvelisib)

COPIKTRA is an oral inhibitor of phosphoinositide 3-kinase (PI3K), and the first United States FDA approved dual inhibitor of PI3K-delta and PI3K-gamma, two enzymes known to help support the growth and survival of malignant cells. PI3K signaling may lead to the proliferation of malignant cells and is thought to play a role in the formation and maintenance of a supportive tumor microenvironment. COPIKTRA is indicated in the United States for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) after at least two prior therapies. COPIKTRA is also being developed for the treatment of peripheral T-cell lymphoma (PTCL), for which it has received Fast Track designation in the United States. COPIKTRA is being investigated in combination with other agents across several types of solid and hematologic malignancies, through investigator-sponsored studies. For more information on COPIKTRA, please visit www.COPIKTRA.com. Information about duvelisib clinical trials can be found on www.clinicaltrials.gov.

IMPORTANT SAFETY INFORMATION ABOUT COPIKTRA

WARNING: FATAL AND SERIOUS TOXICITIES: INFECTIONS, DIARRHEA OR COLITIS, CUTANEOUS REACTIONS, and PNEUMONITIS

See full prescribing information for complete boxed warning

Fatal and/or serious infections occurred in 31% (4% fatal) of COPIKTRA-treated patients. Monitor for signs and symptoms of infection. Withhold COPIKTRA if infection is suspected.
Fatal and/or serious diarrhea or colitis occurred in 18% (<1% fatal) of COPIKTRA-treated patients. Monitor for the development of severe diarrhea or colitis. Withhold COPIKTRA.
Fatal and/or serious cutaneous reactions occurred in 5% (<1% fatal) of COPIKTRA-treated patients. Withhold COPIKTRA.
Fatal and/or serious pneumonitis occurred in 5% (<1% fatal) of COPIKTRA-treated patients. Monitor for pulmonary symptoms and interstitial infiltrates. Withhold COPIKTRA.
INDICATIONS AND USAGE

COPIKTRA is a kinase inhibitor indicated for the treatment of adult patients with:

Relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) after at least two prior therapies.

WARNINGS AND PRECAUTIONS

Hepatotoxicity: Monitor hepatic function.
Neutropenia: Monitor blood counts.
Embryo-Fetal toxicity: COPIKTRA can cause fetal harm. Advise patients of potential risk to a fetus and to use effective contraception.
ADVERSE REACTIONS

The most common adverse reactions (≥20%) are diarrhea or colitis, neutropenia, rash, fatigue, pyrexia, cough, nausea, upper respiratory infection, pneumonia, musculoskeletal pain, and anemia.

DRUG INTERACTIONS

CYP3A inducers: Avoid co-administration with strong CYP3A inducers.
CYP3A inhibitors: Monitor for COPIKTRA toxicities when co-administered with strong or moderate CYP3A inhibitors. Reduce COPIKTRA dose to 15 mg twice daily when co-administered with strong CYP3A4 inhibitors.
CYP3A substrates: Monitor for signs of toxicities when co-administering COPIKTRA with sensitive CYP3A substrates.
USE IN SPECIFIC POPULATIONS

Lactation: Advise women not to breastfeed.

Please click here to see full U.S. Prescribing Information, including Boxed WARNING, for COPIKTRA (duvelisib).

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 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 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 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.