On July 14, 2022 QIMR Berghofer and Peter MacCallum Cancer Centre reported that they have discovered a new vital clue to improving immunotherapy to fight blood cancers such as leukaemia and myeloma (Press release, QIMR Berghofer Medical Research Institute, JUL 14, 2022, View Source [SID1234616666]).

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A new type of immunotherapy called T cell engaging bispecific therapy has shown great potential for treating blood cancers and is already being widely tested in clinical trials. It acts like a missile control system by alerting and guiding the body’s own T cells to attack and eliminate blood cancer cells. However, it has remained unclear precisely how this process works and unlocking the science behind it is critical to further developing and improving the treatment to ensure better long term results.

Now research led by QIMR Berghofer cancer immunologist Dr Kyohei Nakamura has discovered that a much less common type of cell, known as iNKT cells, is like the key that turns on the missile control system enabling the immunotherapy to guide the T cells to destroy the cancer cells. By boosting the numbers of these iNKT cells, the immunotherapy is significantly more effective.

Dr Nakamura, who is Head of QIMR Berghofer’s Immune Targeting in Blood Cancers Laboratory, said the finding is a big step forward in the battle against blood cancers.

"Until now, iNKT cells have been underestimated. Our research for the first time shows how important these iNKT cells are and their critical role in boosting the efficacy of the T cell engaging bispecific therapy. We believe that this study fills in the gaps in our understanding of how the immune system is working during this therapy," Dr Nakamura said.

It is estimated that 53 Australians are diagnosed with blood cancer every day and when combined, blood cancers are the second most diagnosed cancers in the country according to the Leukaemia Foundation. Blood cancers are a complex group of diseases which are all linked by abnormalities in the blood cells affecting blood production and function.

QIMR Berghofer’s Mika Casey, the lead author of this new research, said iNKT cells are scarce in the body, and numbers are even lower in cancer patients, but they can be boosted using a relatively straight forward vaccine approach to stimulate their production.

"These iNKT cells are powerful but also they are quite rare in number. Boosting the numbers of these iNKT cells has been shown to be effective and safe in patients with multiple myeloma. We hope this approach could be a new fundamental strategy for T cell engaging bispecific therapy.

"It is such a privilege to be working on this research and with patients with blood cancer and it is so important to me to try to help them have a better quality of life. Our next step is to translate these findings into clinical testing," Ms Casey said.

The research involved collaboration with haematologist and Director of the Centre of Excellence in Cellular Immunotherapy at the Peter MacCallum Cancer Centre, Professor Simon Harrison.

"T cell engaging bispecific therapy is an off-the-shelf way that we can direct a patient’s own immune system to kill myeloma and other cancer cells. This research increases our fundamental understanding of how T cell engaging bispecific therapy works and gives us a potential path to increase its effectiveness. We are working together to translate these findings into more effective therapies for patients," said Professor Harrison.

The study was funded by the Leukaemia Foundation of Australia (with generous support from the Estate of Madella Ann Hay) and the Play for a Cure Foundation.

Leukaemia Foundation CEO Chris Tanti welcomed the research findings as another vital step towards improving health outcomes for blood cancer patients.

"We are proud to support innovative research by funding projects like this which are critical to achieving advancements in the treatment of blood cancer in this country. If we are to have any hope of reducing blood cancer mortality in Australia, we must help talented researchers to uncover powerful next generation therapies, so together we can meet our goal of zero lives lost to blood cancer by 2035," Mr Tanti said.

The study has been published in Blood Advances, a journal of the American Society of Hematology (ASH) (Free ASH Whitepaper) and can be accessed via this link View Source

On July 13, 2022 Heidelberg Pharma and Chiome Bioscience reported the signing of an exclusive, target-specific research and option agreement (Press release, Heidelberg Pharma, JUL 13, 2022, View Source [SID1234633373]). Heidelberg Pharma Research GmbH signed this collaboration, which will combine one of Chiome’s monoclonal antibodies against one specific target with Heidelberg Pharma’s proprietary ATAC platform.

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Under the terms of the agreement, Chiome will have access to Heidelberg Pharma’s Amanitin toxin-linker platform technology and has an option for an exclusive, target-specific license for global development and commercialization rights to the product candidate resulting from the research collaboration.

Heidelberg Pharma would be eligible to receive an option fee, development- and salesrelated milestone payments of up to 105 million Euro as well as tiered royalties in the midupper single digit range.

On July 13, 2022 Genprex, Inc. ("Genprex" or the "Company") (NASDAQ: GNPX), a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes, reported that Company manufacturing leadership will present sessions on cutting edge topics in lipid-based nanoparticle delivery systems at the upcoming Next Generation Lipid-Based Nanoparticles Delivery Summit taking place from July 19-21, 2022 in Boston (Press release, Genprex, JUL 13, 2022, View Source [SID1234616706]).

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"We are extremely fortunate to have our critical manufacturing function led by Dr. Kumar and his talented team, including Dr. Shinde, and are pleased to see their well-deserved recognition as thought leaders in the rapidly evolving field of lipid nanoparticle delivery of therapeutics," said Rodney Varner, President and Chief Executive Officer of Genprex. "As we advance our lead development program in non-small cell lung cancer in Phase 1/2 clinical studies, it is more important than ever to have our gene therapy manufacturing in such capable hands and we are proud of our exceptional team."

On July 13, 2022 Anumana, Inc., an AI-driven health technology company and portfolio company of nference, reported that it has launched a multi-year strategic collaboration with Novartis Pharmaceuticals Corporation ("Novartis") to deploy a series of artificial intelligence (AI)-powered software solutions that will detect hidden cardiovascular conditions (Press release, Novartis, JUL 13, 2022, View Source [SID1234616678]). The collaboration will drive development and delivery of electrocardiogram (ECG) AI algorithms to help physicians accelerate detection and intervention for patients with previously undetected life-threatening heart disease. The ECG AI algorithm is still in development and not yet FDA authorized for commercial clinical use.

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The collaboration will support Anumana’s efforts to implement AI-enabled diagnostic software that can detect signals from ECGs that humans cannot interpret. The collaboration will initially focus on cardiovascular diseases. Working with its expert partners from Mayo Clinic, Anumana will deploy novel solutions that use AI to analyze an ECG, a widely available, painless test that records the heart’s electrical signals to identify undiagnosed left ventricular dysfunction, or a weak heart pump, which can lead to heart failure. The AI will also screen for atherosclerotic cardiovascular disease, which can lead to heart attack and stroke. In addition, an evidence-based, digital point-of-care solution will be developed to guide in optimizing guideline-directed medical therapies with the aim to lower risk for potentially avoidable hospitalizations and cardiovascular death.

"Anumana technology is designed to help physicians identify patients who are at maximum risk of heart failure, long before they develop symptoms," said Murali Aravamudan, CEO of Anumana. "Bringing together premier global organizations will allow us to expand access to best-in-class, AI-powered digital tools to benefit patients through earlier detection and intervention, when and where health care providers need it most."

"Many heart diseases develop for years before signs and symptoms appear, but the first event may be life threatening," said Paul Friedman, M.D., Chair of the Department of Cardiovascular Medicine at Mayo Clinic and Chair of Anumana’s Mayo Clinic Board of Advisors. "AI enables us to uncover hidden signals our bodies transmit to detect otherwise occult heart diseases, potentially years before symptoms appear. This collaboration has the potential to transform the use of an ubiquitous inexpensive test, the ECG, with the aim of democratizing disease detection and helping medical care teams to proactively manage heart disease ahead of time and prevent some clinical events from ever happening."

"Cardiovascular disease is a widespread and multifactorial disease and, in order to mitigate its impact, we must look beyond therapeutic innovation and reimagine how we approach cardiovascular care," said Victor Bulto, President, Novartis Innovative Medicines US. "Novartis is proud to collaborate with Anumana on innovative and data-driven solutions to better predict the risk of life-threatening heart disease, further driving forward our commitment to improving patient experiences and population health outcomes in this patient population."

The Mayo Clinic Cardiology team, led by Dr. Friedman, pioneered the application of AI in cardiology and developed several algorithms based on millions of ECGs, including a low ejection fraction algorithm that received FDA Breakthrough Device Designation in 2019 and Emergency Use Authorization for COVID-19 in 2020. Further validating the technology, a recent study presented by Mayo Clinic used a modified version of Anumana’s 12-lead ECG algorithm to detect left ventricular dysfunction with single-lead ECGs in smartwatches. These algorithms are licensed to Anumana for development of clinical solutions and have been validated by over 30 peer-reviewed publications, including a first of its kind prospective clinical impact study on low ventricular ejection fraction that was published in Nature Medicine in 2021. These software solutions are currently in development with each algorithm as a candidate for marketing authorization through an FDA DeNovo request.

On July 13, 2022 Calithera Biosciences, Inc. (Nasdaq: CALA), a clinical-stage, precision-oncology biopharmaceutical company, reported that updates related to the ongoing clinical programs for sapanisertib (CB-228) and mivavotinib (CB-659) will be presented at the upcoming International Association for Lung Cancer (IASLC) 2022 World Conference on Lung Cancer (WCLC) and the 2022 Pan Pacific Lymphoma Conference, respectively (Press release, Calithera Biosciences, JUL 13, 2022, View Source [SID1234616665]).

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"Following our recent announcements that we’ve enrolled patients in both the mivavotinib and sapanisertib clinical trials, we are pleased that details of the mivavotinib trial-in-progress will be shared with the esteemed group of lymphoma physicians who attend the Pan Pacific Lymphoma Conference," said Susan Molineaux, PhD, president and chief executive officer of Calithera. "We are also very interested in the data collected by Dr. Jonathan Riess and colleagues in the investigator-led phase 1 trial combining sapanisertib with telaglenastat in patients with non-small cell lung cancer, particularly given that we are evaluating sapanisertib in patients with NRF2-mutated squamous non-small cell lung cancer in our own, ongoing company-sponsored trial.

"We’re proud of the progress we’ve continued to make in both the sapanisertib and mivavotinib clinical programs since we acquired these compounds late last year, and believe they have the potential to be first-in-class treatments addressing areas of high unmet need," said Molineaux.

During the Pan Pacific Lymphoma Conference taking place July 18-22 in Koloa, Hawaii, Reem Karmali, MD, MS, associate professor of Medicine at Northwestern University, will present a poster detailing the trial design of Calithera’s phase 2 study of mivavotinib, a spleen tyrosine kinase (SYK) inhibitor. The phase 2 trial (NCT05319028), which enrolled its first patient in June, is an open-label study of mivavotinib monotherapy in patients with relapsed/refractory non-GCB (ABC) diffuse large B-cell lymphoma (DLBCL). The main objectives of the study are to confirm previously seen single-agent activity in non-GCB DLBCL patients, evaluate activity according to MYD88/CD79b mutational status, and refine dose/schedule in this patient population. Approximately 50 non-GCB DLBCL patients, with or without MYD88/CD79b mutations, will be randomized 1:1 to one of two oral dose/schedule cohorts: a continuous dosing schedule (100 mg QD) or an induction dosing schedule (120 mg QD x 14 days, then 80 mg QD starting Day 15). Data from this trial could position Calithera to initiate a study with registrational intent in biomarker-specific DLBCL populations.

During an August 9 mini oral session at IASLC/2022 WCLC, Jonathan W. Riess, MD, MS, director of Thoracic Oncology and associate professor at UC Davis Comprehensive Cancer Center, will present dose-escalation findings from a multi-center phase 1/2 investigator-initiated study evaluating sapanisertib, a potent and selective dual mTORC 1/2 inhibitor, in combination with telaglenastat (CB-839), a novel, investigational glutaminase inhibitor, in biomarker-defined cohorts of patients with advanced non-small cell lung cancer (NSCLC). Sapanisertib targets a key survival mechanism in tumors harboring NRF2 mutations, which are found in a considerable sub-population of patients across multiple solid tumor types and are generally associated with a poorer prognosis. In pre-clinical studies, combining sapanisertib and telaglenastat showed synergistic anti-tumor activity.

After evaluating five combination dosing levels in 13 patients, researchers determined that the sapanisertib/telaglenastat combination is safe and tolerable at the recommended expansion dose (2 mg sapanisertib once daily, 800 mg telaglenastat twice daily). Researchers also observed tumor shrinkage among the majority of evaluable patients (5/8), including patients with lung cancers harboring KEAP1 or NRF2 mutations. As a next step, study investigators plan to enroll patients into one of four expansion cohorts evaluating sapanisertib plus telaglenastat in squamous NSCLC with and without NRF2 or KEAP1 mutations, and adenocarcinoma NSCLC with KRAS and KEAP1 or NRF2 mutations.