On January 27, 2020 Oncoceutics reported that the National Brain Tumor Society (NBTS) has committed to providing more than $200,000 in funding, with the potential for multiple years, to support a Phase II clinical trial of ONC201, the first imipridone dopamine receptor D2 antagonist (DRD2), in a molecular subset of high grade gliomas (Press release, Oncoceutics, JAN 27, 2020, View Source [SID1234558315]).

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The future clinical trial will evaluate the efficacy of single agent ONC201 in patients who have a recurrent form of high-grade glioma that exhibits low expression of epidermal growth factor receptor (EGFR), which is associated with elevated DRD2 expression and ONC201 sensitivity. The trial will be led by Clark C. Chen, MD, PhD, Lyle French Chair in Neurosurgery and Head of the Department of Neurosurgery, at the University of Minnesota Medical School who is co-PI of the trial along with Joshua Allen, PhD, Senior Vice President of Research and Development at Oncoceutics. Each year, approximately 5,000 patients are affected by this subtype of gliomas in the United States for which there are no effective therapies following first-line chemoradiation.

The project builds on previous results demonstrating the safety and efficacy of ONC201 in patients with high grade gliomas, in particular those with H3 K27M-mutant gliomas. Preclinical studies, led by Dr. Chen, using tumor tissue associated with The Cancer Genome Atlas (TCGA) and patient-derived xenograft (PDX) models of glioblastoma (GBM) have identified an additional subset of high-grade gliomas that exhibit low EGFR expression and, conversely, elevated DRD2 expression. These glioma cells are highly sensitive to ONC201 treatment both in vitro and in vivo. Preliminary data from clinical trial patients with recurrent GBM that harbor these characteristics suggest that treatment with ONC201 may translate into improved survival endpoints relative to patients who do not express these biomarkers.

"NBTS is committed to rapidly and directly improving treatments for brain tumor patients," said Kirk Tanner, PhD, Chief Scientific Officer, National Brain Tumor Society. "This clinical trial aims to extend the clinical utility of ONC201 to high-grade glioma patients beyond those that harbor the H3 K27M mutation where it has shown compelling single agent efficacy."

"It is gratifying to see the work done over the past seven years in my laboratory translate into a pivotal clinical trial. I am optimistic that the insights gained from this trial will contribute to improving the lives of patients afflicted with high grade gliomas," said Clark C. Chen, MD, PhD, Lyle French Chair in Neurosurgery and Head of the Department of Neurosurgery, at the University of Minnesota Medical School.

"The NBTS’s critical support for this project represents an important milestone to further inform patient selection for clinical trials with ONC201 based on biomarkers that expand its current development scope. I am delighted that Dr. Chen’s collaboration with our team has resulted in the convincing rationale to evaluate a new biomarker approach that will hopefully result in similarly positive outcomes that we are seeing in patients with H3 K27M-mutant high grade gliomas," said Wolfgang Oster, MD, PhD, CEO and Chairman of Oncoceutics.

On January 27, 2020, Generex and ALTuCell executed an Amendment Agreement to the SPA (the "Amendment"). Under the Amendment, closing will occur within 30 days of the full execution of the Amendment, subject to the conditions to closing under the SPA (Filing, 8-K, Generex, JAN 27, 2020, View Source [SID1234553616]). The parties agreed that Generex will pay the $2.5 million closing payment from certain specifically identified sources.

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If the closing is not completed within 30 days of execution of the Amendment, SPA will lapse unless the parties agree in writing to continue the transaction. Under the Amendment, Generex agreed to fund the ongoing operations of ALTuCELL during the extension period with a payment of $100,000, to be paid within 2 business days of signing the Amendment.

If ALTuCELL chooses to cancel the transaction as a result of delays due to forces beyond the control of Generex, including government regulatory delays or extended reviews by regulators that delay approvals of corporate actions, or by natural disasters or other unforeseen events beyond the control of Generex, ALTuCELL agrees to return all
payments made by Generex.

On January 27, 2020 Stand Up To Cancer (SU2C) reported a groundbreaking initiative to increase minority representation in cancer clinical trials (Press release, SU2C, JAN 27, 2020, View Source [SID1234553611]). All future SU2C-supported research grant proposals will now be required to include and address crucial issues related to recruitment and retention of patients from ethnic groups to improve diverse participation in cancer clinical trials. The announcement was made at Stand Up To Cancer’s annual Scientific Summit, which is attended by SU2C’s leadership and 300+ prominent cancer researchers representing each of SU2C’s Dream Teams, Research Teams and individual grants.

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The lack of diverse participation in cancer clinical trials has been ongoing for decades, largely due to socio-economic, cultural, trust and other barriers.

"As one of the leading funders of cancer research, we believe it is our duty to ensure that minority representation in cancer clinical trials is addressed. Now, more than ever, better understanding of the role of biology in cancer treatment, advances in precision treatment, and development of new technologies demands that we also make significant improvements in diverse clinical trial participation," said SU2C CEO Sung Poblete, PhD, RN. "We are confident that this initiative will make a significant and meaningful impact to ensure all communities have equal access to potentially life-saving treatments."

Despite an overall decline in U.S. cancer deaths since 1991, not all patients have benefited equally from advances in prevention, early detection, precision medicine and targeted cancer treatments. According to the U.S. Food and Drug Administration, currently only four percent of clinical trial participants are black, and four percent are Hispanic, and 15 percent are Asian, despite minority groups overall in the U.S. having both the highest death rate and shortest survival rate for most cancers.

SU2C’s Committee for Health Equity in Cancer Clinical Trials in collaboration with SU2C scientific leadership, has developed procurement language that will now be used to solicit proposals for SU2C Dream Teams, Research Teams and other grants in the SU2C research portfolio to increase diverse participation in cancer clinical trials. SU2C now requires applicants for funding to include three critical components related to health equity:

an indication of whether the research will address the populations expected to benefit from widespread use of newly developed treatments;
patient recruitment and retention plans for including historically underrepresented racial and ethnic populations – such as the need for additional trial sites or mechanisms to reduce barriers to access; and
a letter of support from the lead institution’s Chief Diversity Officer, or an equivalent position.
By requiring these to be included in all proposals submitted moving forward, these factors will also be considered both in SU2C’s rigorous selection process, and as part of grant performance evaluation conducted in SU2C’s formal semi-annual reviews.

In addition, Stand Up To Cancer announced plans to fund up to $6.4MM for the SU2C Health Equity Breakthroughs Research Team researching cancers affecting underrepresented populations, supported by a transformational grant from Genentech, a member of the Roche Group. SU2C is expected to issue the [Request for Applications seeking proposals later in the first quarter of 2020. Proposals may address cancers that have a higher prevalence in a specific racial or ethnic population; cancers that are more deadly among specific minority populations; or may address the need for more effective treatments for specific cancers for patients of diverse backgrounds.

"Genentech is committed to improving the health and well-being of all patients, which means ensuring that scientific research and innovative treatment options are developed for every individual," said Quita Highsmith, Chief Diversity Officer at Genentech. "We are honored to partner with SU2C to support groundbreaking research that promotes health equity while working to revolutionize cancer care."

The SU2C Health Equity Breakthroughs Research Team will be selected and launched in 2020. For information, or to receive the Call for Ideas when it is issued, please visit "Funding Opportunities." To learn more about Genentech’s efforts in this area, please visit "Advancing Inclusive Research."

At the Summit, Stand Up To Cancer also introduced the new international SU2C Gastric Cancer Interception Research Team, which includes investigators from Harvard Medical School and Massachusetts General Hospital Cancer Center; University of Pennsylvania’s Perelman School of Medicine; University of Chicago; City of Hope Comprehensive Cancer Center; Memorial Sloan Kettering Cancer Center and Samsung Medical Center (South Korea).

While gastric (stomach) cancer is the third-leading cause of cancer death worldwide, it is more common in black, Hispanic, and Asian people than in white populations. New ways are needed to detect these cancers early, when they can be successfully treated. This $3MM Research Team is conducting intensive studies to identify biomarkers, such as particular bits of DNA, and cells shed from the tumor that circulate in the blood system and indicate the presence of gastric cancer. Team members have developed a new detection technology, extending the use of a pill-sized camera that can be swallowed by the patient using a new marker to "light up" cancer cells, allowing the camera to capture images of stomach tissue at risk of developing cancer. If validated in a clinical trial, these methods will help doctors screen people in groups at risk of gastric cancer. To learn more about the SU2C Gastric Cancer Interception Research Team, visit View Source

"By having Research Teams dedicated to cancers that correlate to, or greatly affect, different racial and ethnic populations, we’ll be able to ensure that strides are being made in cancers that typically affect these populations," said Edith A. Perez, MD, chairperson of the SU2C Committee for Health Equity in Cancer Clinical Trials. "Support for these teams further demonstrates our commitment to bringing breakthrough therapies to historically underrepresented racial and ethnic groups and improving overall health equity in cancer research. We are proud and excited to play such a large role in serving this unmet need and look forward to setting the tone for scientific research to come."

Dr. Poblete also noted that SU2C will be collaborating with the Black Women’s Health Imperative (BWHI) and Friends of Cancer Research in Project TEACH: Trained Empowered Advocates for Community Health (Healing), funded by the Patient-Centered Outcomes Research Institute (PCORI). Through education and outreach, this nationwide project will empower black women to effectively engage with researchers and clinicians, and to increase participation of black women in cancer-focused clinical trials.

On January 27, 2020 PharmaMar (PHM:MSE) and Bionical Emas, a global specialist Clinical Research Organization (CRO) have reported the launch of an Expanded Access Program (EAP) for lurbinectedin to treat patients in the United States (U.S.) with relapsed Small Cell Lung Cancer (SCLC), who are unable to enter clinical trials and there are no appropriate alternative treatments (Press release, PharmaMar, JAN 27, 2020, View Source [SID1234553610]).

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Dr. Jack West, Associate Clinical Professor, City of Hope Cancer Center, Duarte, CA, said: "I welcome the availability of lurbinectedin through the EAP as an option for patients. This disease has few compelling alternatives in this setting, so this would be a very welcome option for physicians and patients alike."

SCLC is a very aggressive cancer that is usually diagnosed with advanced, often metastatic disease, thus limiting the role of traditional approaches and usually posing a worse prognosis when compared to other lung cancers1. In the U.S., approximately 10-15% of lung cancers are small cell1. Approximately 30,000 new cases of SCLC are recorded in the U.S. every year2. The treatment of relapsed SCLC has not changed substantially in more than two decades.

SCLC is one of PharmaMar’s priority research areas. In December 2019, the Company announced the filing of lurbinectedin’s New Drug Application (NDA) for the treatment of relapsed SCLC with the FDA under the "accelerated approval" program.

"SCLC is a devastating disease for patients and their families, having limited effective treatment options. We are excited to be able to provide access to lurbinectedin to eligible patients across the U.S.," said Tom Watson, Executive Vice President, Bionical Emas.

"I am happy to see the launch of the lurbinectedin EAP in the U.S. today. Relapsed SCLC is a very aggressive disease with existing second line treatments showing only limited effectiveness. As oncology physicians, we are constantly looking for new treatment options for our patients. There is only one approved drug for the second line treatment which has modest benefit and significant side effects, and there are currently no other open EAPs. Providing access to this new option for patients requires time and investment from the Company and it is greatly appreciated by physicians in the clinic," said Dr. William Jeffrey Petty, Professor, Hematology and Oncology, Wake Forest Baptist Health, Winston-Salem, North Carolina.

Healthcare professionals wishing to request access to lurbinectedin under the EAP or who would like to find out more should do so by emailing [email protected].

On January 27, 2020 Arix Bioscience plc ("Arix", LSE: ARIX) a global venture capital company focused on investing in and building breakthrough biotech companies, reported that its discovery portfolio company Quench Bio has emerged from stealth mode with the completion of a Series A financing (Press release, Arix Bioscience, JAN 27, 2020, View Source [SID1234553601]). This follows a period of company creation, with seed investment and close involvement by Arix.

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Led by a team of drug developers and scientists with deep experience in inflammation and small molecule drug discovery, Quench Bio’s lead therapeutic approach centres on inhibiting the protein Gasdermin D, which has recently been discovered as a key target at the core of multiple inflammatory cell death pathways, including pyroptosis and NETosis. This is at the cutting edge of contemporary drug development and a field of significant commercial interest by big pharma.

The company has built a highly experienced leadership team, led by Chief Executive Officer Samantha Truex, the former Chief Business Officer of Padlock Therapeutics, which was acquired by Bristol Myers Squibb in 2016.

Arix and Atlas Venture co-founded and seeded the company in 2018 along with co-founders Mark Tebbe, Ph.D., Chief Technology Officer, and Mike Nolan, Ph.D., Head of Biology, together with Arturo Zychlinsky and Herbert Waldmann, both Directors at The Max Planck Institute who collaborated with the Lead Discovery Center on inhibitors of NETosis and gasdermin.

In addition to Arix and its co-founding investor Atlas Venture, RA Capital led the Series A and were joined by AbbVie Ventures. Josh Resnick, Managing Director and co-head of Ventures at RA Capital and Adam Houghton, Head of AbbVie Ventures will join the board, alongside existing directors Jonathan Tobin of Arix Bioscience and Bruce Booth of Atlas Venture. Additionally, Arix’s John Cassidy will continue his role as Board Observer.

Jonathan Tobin, Investment Director at Arix and Board Director of Quench Bio, commented: "We are excited and privileged to work alongside such a distinguished team of entrepreneurs and co-investors to develop first-in-class medicines that could make a major difference to patients suffering from chronic inflammatory and auto-immune diseases. The genesis of Quench originated from our long-standing relationship with the Lead Discovery Center in Germany and its close connections with the Max Planck Society. It exemplifies the advantage of Arix’s transatlantic approach, combining the best of European and US science and talent."

Samantha Truex, Chief Executive Officer of Quench Bio, commented: "The successful financing underscores the potential of our innovative approach. We are delighted by the strong support from Arix as well as our existing and new investors and I look forward to leveraging their extensive experience as we develop multiple programs to target severe inflammatory diseases."