Angiex welcomes Marty J. Duvall, our new CEO

On June 22, 2022 Angiex, developer of Nuclear-Delivered Antibody-Drug Conjugate (ND-ADC) therapies for solid cancers, reported that has appointed Marty J. Duvall as chief executive officer and member of its board of directors (Press release, Angiex, JUN 22, 2022, View Source [SID1234616158]).

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Duvall brings extensive global oncology drug development and commercialization experiences from executive leadership roles in both large pharmaceutical and biotech companies. At companies that include Aventis, Merck, MGI, and ARIAD, he built successful oncology companies with a footprint across the US, Europe, and Asia. With an oncology focus over the last three decades, Duvall has helped launch and drive many successful therapeutics that have benefited patients with a wide range of cancers, including breast, lung, prostate, gastric, head and neck, brain, melanoma, myelodysplastic syndrome, leukemia, and multiple myeloma.

Angiex Founder and President, Paul Jaminet, said, "Marty joins the Angiex team at the perfect time to help drive our company forward. Together with our scientific team of leading experts in angiogenesis, vascular biology, antibody-drug conjugate chemistry, and oncology, Marty will help fully realize the promise of our transformative biology and ND-ADC technology."

"I couldn’t be more excited to join Angiex at this stage in the company’s young history. We have the opportunity to do something special here as we build on the exciting clinical results of the antibody-drug conjugate class," said Marty J. Duvall. "Our pre-clinical data is impressive, our potential to improve efficacy and therapeutic margin compared to traditional ADCs is clear, and we are now moving AGX101, our lead ND-ADC product, into clinical development."

Iain Dukes, executive chairman of Angiex and venture partner of Orbimed Advisors, said, "Bringing in an executive of Marty’s caliber is an important step for Angiex. AGX101and future drugs built on Angiex’s platform have the potential to transform the way cancer is treated, and Marty has the experience help make that happen."

Biotech start-up Immuneel Therapeutics announces India’s first Phase II patient trials for CAR-T cancer therapies alongside a
USD 15 million Series A financing

On June 21, 2022 Immuneel Therapeutics (‘Immuneel’), India’s leading biotech start-up focused on creating access to Chimeric Antigen Receptor T cell therapy (CAR-T) and other cellular immunotherapies for the management and treatment of cancers, reported that it has begun patient dosing in a CAR-T trial named "IMAGINE" (Press release, Imuneel, JUN 21, 2022, View Source [SID1234618846]). This phase II trial is the first industry sponsored CAR-T trial in India and is now actively enrolling patients at Narayana Hrudayalaya, Bengaluru.

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Founded in 2019 by Biocon founder and chairperson Kiran Mazumdar-Shaw, Dr. Siddhartha Mukherjee, eminent U.S oncologist and author of the Pulitzer prize winning novel, "The Emperor of All Maladies: A Biography of Cancer", and Dr. Kush Parmar, Immuneel is on a mission to bring cell and gene therapy programs, especially with clinical data, to India at an affordable cost. With a focus on maintaining global standards, the company is developing cutting edge programs, delivered through partnerships with leading hospitals. In 2021, the company had established the first cGMP-approved integrated cell therapy development and manufacturing facility at the Mazumdar-Shaw Cancer Centre at Narayana Health City (Bengaluru).

"Today, we are extremely proud to be able to demonstrate our focus on scientific rigor as well as clinical and manufacturing excellence by bringing CAR-T therapy to the clinic through our IMAGINE trial. This trial marks an important step forward for us in delivering transformational cell-based immunotherapies to patients, truly enabling our patients with potential cure. IMAGINE opens a world of possibilities. With our successful Series A funding, we are excited to continue building our innovation and clinical delivery engine with our investors, given their excellent track record, particularly in global healthcare and innovation." commented Dr. Arun Anand, Director & Chief Operating Officer, Immuneel Therapeutics.

CAR-T therapies, previously not available in India, have shown promising results for patients who have exhausted all other means of treatment in a range of blood cancers. These therapies are available internationally at USD 350K+ per dose, making the IMAGINE trial the first step towards bringing affordable treatments with global quality and clinical data to patients in India. The IMAGINE trial is funded by Immuneel and will include up to 24 pediatric and adult cancer patients. Immuneel has exclusive rights to ARI-0001/IMN-003A (a CD-19 CAR-T cell therapy) from Hospital Clínic de Barcelona and Institut d’Investigacions Biomèdiques August Pi i Sunyer in Spain to develop, manufacture and commercialize in India via technology transfer. ARI-0001 is approved by the Spanish Drug Agency (AEMPS) and the data available compares very favorably with U.S FDA approved products.

Ms. Kiran Mazumdar Shaw, Co-Founder & Director, Immuneel Therapeutics reacted, "This milestone is significant in building an eco-system to accelerate and make cell therapies accessible to patients in India, in line with global standards at affordable and disruptive costs. Personalized cell therapies are in their nascency the world over and we have an opportunity to differentiate through partnerships and cutting-edge innovation." Page 2 of 3 "CAR-T cell therapy in the U.S started a decade ago and has proven to be advantageous for patients who relapse following leukaemia or lymphoma treatment despite its cost which is beyond the means of most people, including Indians. With Immuneel setting up India’s first integrated center and making CAR-T therapy here at Narayana Health City (Bengaluru), we hope to reach thousands of patients in need. I would like to thank Immuneel for partnering with us for the first Phase 2 CT in India and bringing this breakthrough cancer treatment to India affordably." added Dr. Devi Shetty, Chairman, Narayana Health.

Dr. Siddhartha Mukherjee, Co-founder & Director, Immuneel Therapeutics added: "This trial will demonstrate the success of cutting-edge breakthrough CAR-T cell therapy in cancer treatment and give hope to many patients in need. Now cancer patients in India can look forward to having access to CAR-T cell therapy manufactured in India which has revolutionized cancer treatment globally."

"IMAGINE has opened up doors to a second chance at life with potential cure, both for children and adults with terminal blood cancers, and we are very excited to have this opportunity to participate in this key trial with Indian patients for a global quality product," said IMAGINE’s Principal Investigators Dr. Sharat Damodar and Dr. Sunil Bhat at Narayana Health.

In April, this year, Immuneel successfully raised close to US$ 15 million in a Series A financing round, co-led by Eight Roads Ventures, True North Fund VI LLP and F-Prime Capital, along-with contributions from other existing investors. These funds will enable the company to advance its development pipeline and scale.

Commenting on the funding, Dr. Kush M Parmar, Co-founder, Immuneel Therapeutics added, "Our goal is to provide patients in India with potentially transformative therapies and enable affordable access to CAR-T and other complex therapies. As we advance our lead programs, this financing will also allow us to continue building a committed and quality enterprise for global innovators to consider partnering with us to enable access for patients in the region."

About CD19 CAR-T cell therapy CD19 CAR-T therapy is an adoptive autologous antitumor immunotherapy for patients with resistant or refractory CD19 positive leukemia or lymphoma. This autologous product consists of a suspension of T-cells obtained from a patient, activated & genetically modified to express a chimeric antigen receptor (CAR) on its surface, in this case CD19. CAR-Ts typically consist of a binding domain, a transmembrane domain, and co-stimulatory molecules. Four CD19 CAR-T products have been approved so far globally. IMN-003A is Immuneel’s CD19 CAR-T licensed from HCB/IDIBAPS with established Phase 1 safety & efficacy data in Spain.

Novel preclinical data published in Cancer Research highlighting Zantrene’s potential in colorectal and pancreatic cancers

On June 21, 2022 Race Oncology Limited ("Race") reported that two peer reviewed research poster abstracts detailing new preclinical data on the anti-cancer uses of Zantrene (also known as bisantrene or CS1) have been published in the prestigious scientific journal, Cancer Research, following their recent presentation at the American Association of Cancer Research (AACR) (Free AACR Whitepaper) Annual Conference in New Orleans, from April 8 – 13, 2022 (Press release, Race Oncology, JUN 21, 2022, View Source [SID1234616227]).

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The two posters were presented by researchers from the City of Hope Hospital and Chicago University, including Race’s Scientific Advisory Board member, Professor Jianjun Chen. They describe the use of Zantrene as a potent inhibitor of FTO – the Fat Mass and Obesity-associated protein.

The first abstract describes preclinical data demonstrating Zantrene’s ability to inhibit FTO and suppress pancreatic carcinogenesis via targeting cancer stem cell maintenance. Pancreatic cancer has few effective treatment options and patients need better treatments for this devastating disease.

The second abstract explores the use of Zantrene as an adjunctive treatment able to overcome colorectal cancer resistant to 5-FU based chemotherapy via inhibition of FTO in both cell and mouse models. Resistance to 5-FU is a significant clinical issue as this drug remains a backbone of colorectal cancer treatment.

This important research exploring Zantrene utility in pancreatic cancer and colorectal cancer complements Race’s own recent findings that Zantrene can inhibit FTO in AML, melanoma and clear cell renal cell carcinoma.

Scientists blend AI, 3D tissue imaging to identify aggressive prostate cancer

On June 21, 2022 Researchers at Case Western Reserve University and the University of Washington reported that expect to gain valuable new insights into highly aggressive prostate cancer by combining Artificial Intelligence (AI)-powered diagnostic imaging with three-dimensional (3D) tissue imaging (Press release, Case Western Reserve University, JUN 21, 2022, View Source [SID1234616172]).

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This new AI-3D collaboration will provide a never-before-seen, expanded view and understanding of prostate cancer cells, made possible by a new approach called "light sheet microscopy," the researchers said. (Seen in photo above by Mark Stone/University of Washington).

Prostate cancer is the most common non-skin cancer in the United States. Doctors will diagnose one in eight men nationally with prostate cancer, and one in 40 will die from the disease, according to the Prostate Cancer Foundation.

Anant Madabhushi, director of the Center for Computational Imaging and Personalized Diagnostics at Case Western Reserve, and Jonathan Liu, a professor of mechanical engineering and bioengineering at the University of Washington (UW), are co-leaders in the new work and will split the funding. The National Cancer Institute (NCI), part of the National Institutes of Health, is supporting the research with a five-year, $3.13 million grant.

"This is an unprecedented meshing of the two most powerful technologies in this area," said Madabhushi, also the Donnell Institute Professor of Biomedical Engineering at the Case School of Engineering. "We’ll take the AI we’ve developed and, for the first time, be able to apply it to 3D tissue-imaging that the University of Washington excels in—and gain fine, granular detail."

Liu said collaboration with Madabhushi’s lab at Case Western Reserve was "an obvious and ideal choice since developing explainable AI methods will facilitate clinical adoption of a new imaging technology such as ours."

Identifying aggressive cancer
That fine detail will hopefully reveal even more information about how to identify which prostate cancer cases will be more aggressive in patients, Madabhushi said.

Knowing that could help clinicians determine who would benefit from surgery or radiation therapy—and which patients might be actively monitored instead, he said.

Researchers could also be laying the groundwork to develop what are called "pathomic-based classifiers" of disease outcome for a host of other cancers, Madabhushi said.

Pathomics refers to the application of computer vision and AI to extract a large number of features from tissue images using data-characterization algorithms. The features can then help uncover tumors and other characteristics usually invisible to the naked eye.

Madabhushi’s lab, established in 2012, has become a global leader in the field, specializing in the detection, diagnosis and characterization of various cancers and other diseases by meshing medical imaging, machine learning and AI.

Until now, researchers were using machine learning to focus entirely on two-dimensional images.

"We believe that we’ll be able to train our AI to interrogate 3D tissue images with the same success we have had with two-dimensional images," Madabhushi said. "But there are so many new possibilities for finding new information in 3D."

How 3D fits in
Liu and his team have developed a new, non-destructive method that images entire 3D biopsies instead of just a slice. This technique provides full-view images of the tissue and improved predictions of whether the patient had an aggressive cancer.

Jonathan Liu
"With the success of our open-top light-sheet microscopy technologies, an obvious next challenge to overcome was processing and analyzing the massive feature-rich 3D datasets that we were generating from clinical specimens," Liu said. He said collaborating with Madabhushi’s lab at Case Western Reserve was an "obvious and ideal choice, since developing explainable AI methods will facilitate clinical adoption of a new imaging technology such as ours."

"This (grant) will help us to scale up our existing collaboration to demonstrate that computational 3D pathology can improve critical treatment decisions for diverse populations of men with prostate cancer," Liu said.

The 3D images, of course, provide more information than a 2D image. In this case, that means details about the intricate tree-like structure of the glands throughout the tissue.

The advances in 3D technology made by Liu were detailed in a paper published in December 2021 in the journal Cancer Research. Madabushi and three others at Case Western Reserve contributed to the academic paper.

The UW researchers reported in that paper that the 3D features made it easier for a computer to identify which patients were more likely to have cancer return within five years.

Liu had said in a UW news blog that this "non-destructive 3D pathology" would become increasingly valuable in clinical decision-making, such as which patients would require more aggressive treatment or respond to certain drugs.

This new NCI grant complements work supported in an ongoing U.S. Department of Defense grant led by Madabhushi, with Liu as a collaborator. That project combines AI and light sheet-based 3D tissue-imaging technology for studying health disparities in prostate cancer.

U.S. Department of Defense Awards $5.1 Million to Humanetics Corporation for Continued Development of Radiation Countermeasure

On June 21, 2022 Minneapolis-based Humanetics Corporation (Humanetics) reported that it has entered into a new $5.1 million cooperative research agreement with the U.S. Department of Defense (DOD) to continue advanced development of BIO 300, a medical countermeasure to protect military personnel and first responders from the harm caused by radiation exposure (Press release, Humanetics, JUN 21, 2022, View Source [SID1234616156]).

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The new funding will be used to create, manufacture, and test a new formulation of BIO 300 that can be self-administered using an auto injector. Auto injectors are commonly used by the military to deliver fast-acting drugs such as atropine and naloxone. This new formulation of BIO 300 will complement the existing suite of oral formulations in the Humanetics portfolio that have been tested extensively and are in phase 2 trials. It is envisioned that the DOD would have access to both oral and auto injectable forms of BIO 300, which each have a unique use case.

"With the increasing potential for use of radiological or nuclear weaponry in the current global environment, especially with events in Ukraine, it’s a strategic imperative to protect our armed forces and first responders from radiation exposure and enable them to operate in areas of concern," said Ronald Zenk, President and CEO at Humanetics.

BIO 300’s radioprotective attributes were originally discovered by researchers within the DOD at the Armed Forces Radiobiology Research Institute. The drug was licensed to Humanetics Corporation, which is leading its advanced development toward FDA approval. In parallel to the drug’s development for use as a medical countermeasure, Humanetics is evaluating the drug in clinical trials to determine its potential to reduce the toxic side effects of radiation in cancer patients and to reduce lung damage in COVID-19 long-haulers.

"We are enthused and encouraged by the DOD’s continued investment in the development of BIO 300 as a medical countermeasure," said Zenk. "We see this drug not only providing protection for our warfighters, but also for our embassy personnel around the world and civilian populations who are at risk of radiation exposure from nuclear incidents and, furthermore, to improve the lives of cancer and COVID-19 patients."