On July 17, 2019 AUM Biosciences (AUM), an award-winning company focused on the development of innovative and affordable oncology medicines with high unmet medical need in Asia, reported a global license agreement with Inflection Biosciences (Inflection) for exclusive worldwide rights to develop, manufacture and commercialise Inflection’s first-in-class PIM/PI3K/mTOR inhibitors (Press release, Aura Biosciences, JUL 17, 2019, View Source [SID1234537575]).

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Known as the IBL-300 series of molecules, the agreement will see AUM develop the lead candidate, IBL-302 (hereafter AUM302), which is currently in the pre-clinical stage of development with activity predicted across a range of cancers. It has been evaluated in over 700 cancer cell lines and has shown potential for clinical development in breast cancer, lung cancer, leukaemia and neuroblastoma.

AUM302 is the first ‘oral kinase inhibitor’ to uniquely inhibit three critical cancer targets (pan-PIM kinase, pan-PI3K and mTOR inhibition) via a single molecule1. Kinase inhibitors are drugs that have played an increasingly prominent role in the treatment of cancer2 and inhibiting these three targets has been shown to be more effective than inhibiting them alone.

Mr Vishal Doshi, CEO, AUM Biosciences said: "With 60% of cancers worldwide diagnosed in Asia3, we are committed to accelerating the development of high potential molecules for the benefit of patients in the region. Our unique Asia to global approach to development aims to ensure that crucial drugs are made available for Asian patients in the shortest timeframe, as well as those in need globally."

The license expands AUM’s pipeline following the recently acquired novel and highly selective Mnk inhibitor, AUM001, from Singapore’s Agency for Science, Technology and Research (A*STAR).

"Our dedication to addressing significant unmet need for cancer patients is what drives us to being at the forefront of precision medicine, technology and the delivery of high-quality personalised care. Our collaboration with Inflection Biosciences is now an important part of this dedication," Doshi added.

Mr Darren Cunningham, CEO of Inflection said: "Inflection Biosciences is committed to developing innovative targeted therapeutics for the benefit of cancer patients worldwide. We are pleased to partner with AUM Biosciences who will bring considerable drug development experience and expertise to ensure AUM302 is advanced towards regulatory approval in Asia and globally."

The advancement of AUM302 continues AUM’s focus on developing a robust industry leading pipeline of combinatorial therapies.

Combination therapy, the use of more than one type of therapy in treating a patient, is a hallmark of cancer treatment. The complexity of the disease – including its tendency to spread beyond its original site and become resistant to some drugs – underscores the need for multiple approaches to attack it. As well as being a monotherapy with three different targets, AUM302 has shown excellent combination potential, working to address the major problem of patient resistance to certain drugs.

AUM plans to commence Investigational New Drug (IND) enabling studies for AUM302 by 20201.

On July 17, 2019 Paragon Biosciences LLC — the Chicago-based life science innovator that invests in, builds, and advises bioscience companies — is reported the launch of its seventh portfolio company, Qlarity Imaging LLC, which was founded to harness the value of artificial intelligence (AI) to improve medical outcomes (Press release, Paragon Biosciences, JUL 17, 2019, View Source [SID1234537574]).

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Qlarity Imaging will further develop QuantX, the first-ever FDA-cleared computer-aided breast cancer diagnosis system in radiology. Qlarity plans to expand the diagnostic applications of its AI technology to additional image modalities and medical conditions, with the goal of improving patient care while lowering costs for hospitals and payers.

Qlarity Imaging acquired QuantX, the medical imaging AI system with intuitive displays, advanced analytics, and machine learning, initially developed at the University of Chicago based on research led by Dr. Maryellen L. Giger, and incubated at Quantitative Insights, a startup that had been launched with the support of the University of Chicago’s Polsky Center for Entrepreneurship and Innovation. A clinical study demonstrated the effectiveness of QuantX at helping radiologists interpret cancerous and non-cancerous breast lesions, leading to a 39% reduction in missed breast cancers without a reduction in specificity, as well as a 20% overall diagnostic improvement. The study led to the FDA clearance of the AI technology for breast cancer.

"By driving innovation across life sciences, Paragon fulfills its mission of improving outcomes for patients with severe medical conditions. So, we’re pleased to help further develop the first FDA-cleared, artificial intelligence-enabled diagnostic software for breast cancer MRIs," said Paragon Biosciences Chairman and CEO Jeff Aronin. "We are entering an exciting time where advances in supercomputing and machine learning make it possible for artificial intelligence to deliver on its promise for drug discovery, drug development, and diagnostics."

As a leader in innovating and building life science companies, Paragon’s capabilities and investment in Qlarity Imaging provide the company with the working capital needed to further develop and implement its computer-aided diagnosis system and explore expanded uses of AI-enabled diagnostic tools. Paragon Biosciences advises its portfolio companies on how to leverage AI technology to enhance the diagnostic insight of medical devices, accelerate the pace of drug development, and increase the efficacy of novel therapies.

Qlarity’s AI-enabled image processing and diagnostic algorithms are based on decades of research by Professor of Radiology Dr. Maryellen Giger, a pioneer in the field of computer-aided diagnosis. Now an advisor to Qlarity Imaging, Dr. Giger has conducted over 30 years of research in computer-aided diagnosis, including computer vision and machine learning for breast cancer, lung cancer, prostate cancer, lupus, and bone diseases.

"When we looked at how to best commercialize and scale QuantX, the computer-aided diagnostic system originally developed at the University of Chicago, Paragon Biosciences was the perfect partner," Dr. Giger said. "Paragon is already delivering on its promise, helping Qlarity Imaging to expand its management team, pursue new product opportunities, extend its customer base, and seek additional venture financing."

With today’s announcement, Qlarity Imaging becomes the third portfolio company launched by Paragon Biosciences in less than a year and the seventh launched since 2017. Over the last 18 months, Paragon Biosciences and its financial partners have invested and committed over $500 million to help Paragon’s portfolio companies develop innovative therapies and diagnostic tools.

Paragon Biosciences anticipates innovating, investing in, and launching additional portfolio companies this year and next.

On July 17, 2019 Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) will reported its second quarter 2019 financial results on Wednesday, July 31, 2019 after the financial markets close (Press release, Vertex Pharmaceuticals, JUL 17, 2019, View Source [SID1234537573]). The company will host a conference call and webcast at 4:30 p.m. ET. To access the call, please dial (866) 501-1537 (U.S.) or +1 (720) 545-0001 (International).

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The conference call will be webcast live and a link to the webcast can be accessed through Vertex’s website at www.vrtx.com in the "Investors" section. To ensure a timely connection, it is recommended that participants register at least 15 minutes prior to the scheduled webcast. An archived webcast will be available on the company’s website.

On July 17, 2019 NuCana plc (NASDAQ: NCNA), a clinical-stage biopharmaceutical company focused on significantly improving treatment outcomes for patients with cancer, reported that the first patients have been dosed in the Phase I study of NUC-7738 (Press release, Nucana BioPharmaceuticals, JUL 17, 2019, View Source [SID1234537571]). This is the third ProTide NuCana has advanced to clinical studies and further broadens the therapeutic scope of the ProTide portfolio. NUC-7738 is NuCana’s ProTide transformation of 3’-deoxyadenosine (or cordycepin), a novel nucleoside analog with a unique mode of action, that has shown potent anti-cancer activity in preclinical studies.

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Hugh Griffith, NuCana’s Chief Executive Officer, stated: "The dosing of the first patients in this Phase I study of NUC-7738 is another major step in the expansion of NuCana’s product pipeline. NUC-7738 is our third ProTide to advance to the clinic and the first that is based on a novel nucleoside analog. We are grateful to the patients and clinicians who are making this study possible."

More information about this study may be found here.

NUC-7738 is a ProTide transformation of cordycepin, a nucleoside analog that was isolated from the fungus Cordyceps sinensis in 1950. Cordycepin has demonstrated potent anti-cancer activity in multiple preclinical studies, but has not been successfully developed primarily due to its degradation by the enzyme adenosine deaminase (or ADA). Unlike the parent nucleoside analogue, NUC-7738 is not a substrate for this enzyme and is therefore resistant to degradation by ADA. Similar to NuCana’s other ProTides, NUC-7738 is designed to generate significantly higher levels of the active anti-cancer metabolite of cordycepin, 3’-deoxyadenosine triphosphate (or 3’-dATP), directly inside cells, bypassing the resistance mechanisms of transport, activation and breakdown.

Sarah Blagden, Associate Professor of Experimental Cancer Therapeutics at The University of Oxford and Principal Investigator of the study stated: "Oxford Early Phase Trials unit has enrolled the global first cancer patient to receive NUC-7738, the latest ProTide anti-cancer agent from NuCana’s pipeline. This is an exciting study to participate in and we look forward to seeing the clinical results."

On July 17, 2019 Intensity Therapeutics, Inc., a clinical-stage biotechnology company pioneering a novel, immune-based approach to treat solid tumor cancers through direct injection of the company’s proprietary therapeutic agents, reported the publication in the journal OncoImmunology of results from nonclinical research conducted in partnership with the National Cancer Institute’s (NCI) Vaccine Branch under a Cooperative Research and Development Agreement (CRADA) (Press release, Intensity Therapeutics, JUL 17, 2019, View Source [SID1234537570]). All results and data reported in the paper were generated at the NCI.
"The results of this study are noteworthy because they demonstrate the anti-cancer benefits of INT230-6 extend beyond direct killing of the injected tumor to fighting tumors throughout the body by immune activation," said Anja C. Bloom, Ph.D., first author and former visiting postdoctoral researcher at the NCI Vaccine Branch, who conducted the majority of the work at the NCI. "We believe this is the first time that the well-known agents comprising INT230-6, cisplatin and vinblastine showed induction of a durable immune activation. We believe this result is due to the intratumoral delivery mechanisms of the compound, which appears to cause cell death that also releases antigens to initiate an adaptive immune response."

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The peer-reviewed paper entitled "Intratumorally delivered formulation, INT230-6, containing potent anticancer agents induces protective T cell immunity and memory," describes the immune response induced from direct injection of Intensity’s lead product candidate, INT230-6, into subcutaneously implanted murine colon and orthotopic breast tumors. Treatment resulted in regression from baseline in 100 percent of tumors and complete response in up to ninety percent of mice. Studies that knocked out the mouse immune cells prevented complete responses, indicating a critical role of immune cells in treatment benefit. Mice with complete responses were protected from subcutaneous and intravenous re-challenge of the cancer, revealing that long-term immunological memory was induced by INT230-6.

Complete remission of the primary tumors was accompanied by shrinking and disappearance of a number of untreated contralateral tumors when INT230-6 was combined with checkpoint inhibitors, demonstrating not only a local but also systemic immunological effect.

"Our work with Intensity Therapeutics was to evaluate the benefits of INT230-6 because of its delivery directly into solid tumors," said Jay A. Berzofsky, M.D., Ph.D., Chief of the Vaccine Branch at the National Cancer Institute. "The results show that not only was complete regression achieved in a majority of injected tumors, but T cell immunity and immunological memory to the cancer were induced, associated with regression observed also in non-injected tumors and synergy when INT230-6 was combined with anti-PD-1 and anti-CTLA-4 antibodies. The treatment converts the tumor to an endogenous vaccine. Our results suggest that intratumoral approaches can be designed to provide a new strategy for effective immunotherapy of cancer."

"Intensity Therapeutics entered into the CRADA with the NCI in 2014, and this peer-reviewed publication is the culmination of that research. The positive results described in the paper demonstrate the unique potential of our novel cancer treatment approach," said Lewis H. Bender, Founder, President and Chief Executive Officer of Intensity Therapeutics. "We are currently evaluating INT230-6 in a Phase 1/2 clinical trial and have tested the drug in 15 different types of solid tumor cancers with promising results. The research with the NCI helped us design our clinical trial, and we recently presented clinical data at ASCO (Free ASCO Whitepaper) that indicate local treatment with INT230-6 alone in certain tumor types regresses injected tumors and initiates a systemic immune activation with results similar to the effects reported in our OncoImmunology paper. The nonclinical and clinical data generated to date increase our optimism about the potential of INT230-6 to kill tumors locally, activate the immune system, reduce the side effects associated with current systemic therapies and improve patient outcomes with achievement of a long-term, durable response for a number of cancers."

About INT230-6

INT230-6, Intensity’s lead proprietary product candidate, is designed for direct intratumoral injection. The drug is comprised of two proven, potent anti-cancer agents, cisplatin and vinblastine, and a penetration enhancer molecule that helps disperse the drugs throughout tumors and diffuse into cancer cells. INT230-6 is being evaluated in a Phase 1/2 clinical study (NCT03058289) in patients with various advanced solid tumors. In preclinical studies, INT230-6 eradicated tumors by a combination of direct tumor kill and recruitment of dendritic cells to the tumor micro-environment that induced anti-cancer T-cell activation. Treatment with INT230-6 in in vivo models of severe cancer resulted in substantial improvement in overall survival compared to standard therapies. Further, INT230-6 provided complete responder animals with long-term, durable protection from multiple re-inoculations of the initial cancer and resistance to other cancers. In mouse models, INT230-6 has shown strong synergy with checkpoint blockage, including anti-PD-1 and anti-CTLA4 antibodies. INT230-6 was discovered from Intensity’s DfuseRxSM platform.