On September 4, 2020 Following a successful $3 million seed funding round earlier this month, University of California, San Diego spinout Micronoma reported that it is commercializing a blood-based diagnostic assay that identifies a patient’s organ microbiome signature to potentially detect early-stage cancers (Press release, Micronoma, SEP 4, 2020, View Source [SID1234578343]).

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On September 4, 2020 WindMIL Therapeutics reported that Chairman and Chief Executive Officer Don Hayden will present a corporate overview at Citi’s 15th Annual BioPharma Virtual Conference on Thursday, September 8, 2020 at 4:05 pm EDT (Press release, WindMIL Therapeutics, SEP 4, 2020, View Source [SID1234568095]).

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On September 4, 2020 Kitov Pharma Ltd. ("Kitov") (NASDAQ/TASE: KTOV), a clinical-stage company advancing first-in-class therapies to overcome tumor immune evasion and drug resistance, reported receipt of notification from the Chinese Patent Office to grant two separate patents for Kitov’s lead oncology product candidates for advanced cancer patients, CM24, a monoclonal antibody targeting CEACAM1, a novel immune checkpoint that supports tumor immune evasion and survival through multiple pathways, and NT219, a dual inhibitor, novel small molecule targeting IRS1/2 and STAT3, important oncogenic drivers and major drug resistance pathways in many hard-to-treat cancers (Press release, Kitov Pharmaceuticals , SEP 4, 2020, View Source [SID1234565049]).

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The CM24 patent application, titled "Humanized antibodies against CEACAM1," covers the humanized antibodies capable of specific binding to human CEACAM1 molecules, pharmaceutical compositions and methods of their use in treating and diagnosing cancer and other conditions. This is the foundational patent within the current CM24 patent portfolio, and was previously granted in the U.S., EU and multiple rest of world countries.

The NT219 patent application, titled "Combinations of IRS/STAT3 Dual Modulators and Anti-Cancer Agents for Treating Cancer," covers the various combinations of NT219 with multiple EGFR inhibitors, including cetuximab, which was selected to be combined with NT219 for the treatment of recurrent or metastatic squamous cell carcinoma of head and neck cancer (SCCHN) as part of Kitov’s planned Phase 1/2 study.

"In recent years, China has experienced a rapid increase in the incidences of and deaths from cancer, thus escalating the need for safe and effective oncology drugs in the country," said Isaac Israel, Kitov’s Chief Executive Officer. "As such, China represents a key target market for Kitov and an opportunity for potential collaboration partners. We believe that our growing intellectual property portfolio in China is critical in supporting our goal of establishing a potential market for CM24 and NT219, if approved, in this large territory."

Kitov is currently advancing preparations to initiate a Phase 1/2 clinical trial of CM24 in combination with nivolumab (Opdivo) in patients with non-small cell lung cancer, and in combination with nivolumab in addition to nab-paclitaxel (ABRAXANE) in patients with pancreatic cancer. The trial will be conducted under a clinical collaboration agreement with Bristol-Myers Squibb Company, and is expected to begin in the second half of 2020.

A Phase 1/2 trial evaluating NT219 as monotherapy treatment of advanced solid tumors, as well as in combination with cetuximab for the treatment of recurrent and/or metastatic SCCHN or colorectal adenocarcinoma was recently initiated. Preliminary data from part one of the study, which will encompass a dose escalation evaluation of NT219 monotherapy administered weekly in patients with refractory advanced solid tumors, is expected in the second half of 2021.

On September 4, 2020 Cancer Research UK reported that Children and young people in the UK with cancers that have come back can now access new personalised treatments quicker than ever before thanks to a national tumour biopsy sequencing platform and clinical trial funded (Press release, Cancer Research UK, SEP 4, 2020, View Source [SID1234564700]).

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The genetic code of tumours are sequenced through the Stratified Medicine Paediatrics** programme, and the molecular information is used to match patients to treatments on the ESMART*** trial, which is testing multiple new targeted drugs, and treatment combinations not previously available for children and young people.

Patients may be placed on ESMART within just a few weeks of having their tumours sequenced, offering children and young people with cancer who have limited treatment options quick access to the targeted drugs most likely to work for them.

The Stratified Medicine Paediatrics programme is being run by The Institute of Cancer Research, London(link is external), and the ESMART is a European trial that is currently being rolled out across the UK. It is open at the trial’s lead centre, The Royal Marsden NHS Foundation Trust(link is external) in London, and the Royal Manchester Children’s Hospital(link is external). Further sites are to open in Birmingham, Newcastle and Great Ormond Street Hospital over the next few months.

Cancer in children and young people is rare, and when it does occur, more than 80% of those diagnosed survive their cancer for 5 years or more ****. However, this includes more common and, generally, more curable cancers. For more aggressive cancers such as neuroblastomas, and cases where cancer spreads or comes back after initial treatment, survival can be much lower and treatment options are fewer.

For the last two years in the UK, when a young person’s cancer comes back, their tumour has been routinely sequenced through the Stratified Medicine Paediatrics programme. The findings are discussed by an expert panel of clinicians and scientists who recommend potential treatment options based on the specific gene faults identified in the tumour. But treatments have been very limited, and clinical trials often only test combinations of existing chemotherapy drugs or radiotherapy, or single molecularly targeted drugs.

The new ESMART clinical trial is now open in the UK and has been developed to radically widen the scope of treatments available for children and young people. Currently, the trial has 10 treatment arms (plus 5 more that are waiting regulatory approval) that are testing an array of therapies on their own or in combination, including targeted drugs, immunotherapies, radiotherapy and chemotherapy. And as researchers develop promising new drugs, they are quickly rolled into the study*****.

Professor Louis Chesler, who leads the Stratified Medicine Paediatrics programme at The Institute of Cancer Research, London, said: "Our Stratified Medicine Paediatrics programme goes beyond the traditional DNA sequencing of tumours, because the platform also gives us valuable information on specific features of the tumour that could be targeted by precision medicines. This was a big step forward, and it’s brilliant to now also have access to the newest treatments that we know could work for our patients.

"Combined with the ESMART trial, the Stratified Medicine Paediatrics programme gives us an outstanding array of treatments and combinations to choose from to give children and young people the best possible treatment options for them. Combined with our ongoing work of improving the diagnosis of young people’s cancer, and understanding more about what is causing treatment resistance and relapse, the future is looking more optimistic for our young patients, which is fantastic news for them and their families."

Dr Lynley Marshall, UK chief investigator of the ESMART trial and Oak Foundation Consultant in Paediatric and Adolescent Oncology Drug Development at The Royal Marsden Hospital, said: "We’ve spent years trying to get a more targeted approach to children’s cancers in place, and we’re really proud to have helped develop ESMART and to have it available in the UK."

"But more importantly, it brings hope for families that may have lived through multiple relapses. The fact of just knowing that there’s something else that they can try with the real possibility of benefit makes all the difference."

Michelle Mitchell, chief executive at Cancer Research UK, said: "Cancer in children and young people is different to that in adults, and research into these cancers faces its own challenges that can prevent progress. Our research strategy for children and young people’s cancers, launched last year, is designed specifically to help address these unique challenges and drive progress in this area."

"The Stratified Medicine Paediatrics programme and ESMART are wonderful examples of the work we fund that is revolutionising the way children and young people with cancer are treated in the UK, and I look forward to seeing the ways they develop in the future."

On September 4, 2020 Lixte Biotechnology reported that it has filed to uplist to Nasdaq, raising $11 million in the process. The uplisting comes as Lixte seeks to accelerate enrollment in a phase 1b/2 myelodysplastic syndrome (MDS) trial that is lagging behind expectations (Press release, Lixte Biotechnology, SEP 4, 2020, View Source [SID1234564593]).

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Lixte’s lead compound is protein phosphatase 2A (PP2A) inhibitor LB-100. The role PP2A plays in the regulation of processes such as cell division, DNA-damage-response and homologous recombination repair point to the potential of the enzyme as a cancer drug target. However, sporadic efforts to try to treat cancers by drugging PP2A, which date back decades, have failed to establish the target as an important part of the oncology landscape.

As Lixte sees it, the lack of interest in the enzyme stems from a belief that its ubiquity and range of functions will result in intolerable toxicity. In LB-100, Lixte, which has two full-time employees, thinks it has a molecule that is free from that feared toxicity.

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In a study of 29 solid tumor patients, two people who received LB-100 suffered dose-limiting toxicity. One in 5 participants experienced grade 3 adverse events that may have been related to the drug.

Lixte emerged from the study with a phase 2 dose and evidence linking the drug to partial responses and stable disease. A phase 1b/2 clinical trial in patients with low or intermediate-1 risk MDS started last year. Lixte plans to hold an interim analysis once 21 of the 41 subjects are enrolled, but is closing in on that target rather slower than hoped.

"Recruitment has been slow and the COVID-19 pandemic has further reduced recruitment of patients into the protocol. At the current rate of accrual, the trial would be completed over a period of four years from its initiation, with the final analysis and reporting expected by July 2023," Lixte wrote in its Securities and Exchange Commission filing.

To accelerate enrollment, Lixte plans to use additional funds to add two more MDS centers to the phase 2 part of the trial. Lixte expects to have cash reserves of $8.4 million if it hits the midpoint of its stock offering price range.

A Spanish investigator-initiated phase 1/2 trial is in the works, too, but has encountered its own set of problems. Lixte planned to start the trial during the second quarter of 2020, but, having missed that target, ran into a regulatory blockade.

"During July 2020, a Spanish regulatory body advised us that although it had approved the scientific and ethical basis of the protocol, it required that we manufacture a new inventory of LB-100 under current Spanish pharmaceutical manufacturing standards. These regulations were adopted subsequent to the production of our existing LB-100 inventory," Lixte wrote.

Lixte is still figuring out how soon it can make doses that meet the Spanish specifications, but expects a significant delay. The start of the trial is now penciled in for the third quarter of 2021.