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Exelixis to Release Second Quarter 2019 Financial Results on Wednesday, July 31, 2019

On July 17, 2019 Exelixis, Inc. (NASDAQ: EXEL) reported that its second quarter 2019 financial results will be released on Wednesday, July 31, 2019 after the markets close (Press release, Exelixis, JUL 17, 2019, View Source [SID1234537576]). At 5:00 p.m. EDT / 2:00 p.m. PDT, Exelixis management will host a conference call and webcast to discuss the results and provide a general business update. Access to the event is available via the Internet from the company’s website.

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To access the webcast link, log onto www.exelixis.com and proceed to the News & Events / Event Calendar page under the Investors & Media heading. Please connect to the company’s website at least 15 minutes prior to the conference call to ensure adequate time for any software download that may be required to listen to the webcast. Alternatively, please call 855-793-2457 (domestic) or 631-485-4921 (international) and provide the conference call passcode 6687332 to join by phone.

A telephone replay will be available until 8:00 p.m. EDT on August 2, 2019. Access numbers for the telephone replay are: 855-859-2056 (domestic) and 404-537-3406 (international); the passcode is 6687332. A webcast replay will also be archived on www.exelixis.com for one year.

AUM Biosciences Expands Pipeline With Global License for First-in-class Targeted Cancer Therapy

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]).

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.

Paragon Biosciences Launches Qlarity Imaging to Advance the First FDA-Cleared Artificial Intelligence Breast Cancer Diagnosis System

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]).

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.

Vertex to Announce Second-Quarter 2019 Financial Results on July 31

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).

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.

NuCana Announces First Patients Dosed in Phase I Study of NUC-7738

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.

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."