On June 9, 2021 NanOlogy, LLC, a clinical-stage oncology company, reported that additional data from its Phase 2 dose-rising and expansion clinical trial of intracystic NanoPac for mucinous cystic neoplasms of the pancreas were presented via poster by Somashekar Krishna, MD, MPH of The Ohio State University Wexner Medical Center and The James Comprehensive Cancer Center during Digestive Disease Week held virtually from May 21-23, 2021 (Press release, NanOlogy, JUN 9, 2021, View Source [SID1234583762]). NanoPac is composed of large surface area microparticles of pure paclitaxel designed as a drug depot for local administration and sustained drug release over several weeks. In this study, the investigational drug was delivered once or twice via endoscopic ultrasound guided fine needle injection following aspiration of cyst fluid in patients with branch duct intraductal papillary mucinous neoplasms (BD-IPMNs) or mucinous cystic neoplasms (MCNs).

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The 6-month trial enrolled 19 subjects and was completed in late 2020. The clinical study report was submitted to FDA in April 2021 and clinical trial results can be found at NCT03188991 in clinicaltrials.gov. Overall, the drug was well tolerated with no dose limiting toxicities or drug-related significant adverse events observed. Reduction in cyst volume was demonstrated in 14/19 (74%) of subjects at 6 months.

Dr. Krishna presented a series of five subjects enrolled at his clinical site in whom additional testing revealed no detectable DNA mutations in 2/4 subjects following NanoPac treatment, all of whom were positive at baseline. Absence of DNA indicates the possibility of cyst epithelial lining necrosis, a key goal in treatment. In addition, high concentrations of paclitaxel (>1000 ng/mL) were found in cyst fluid prior to the second injection at the 3-month timepoint confirming retention of NanoPac in the cyst while plasma concentrations were never greater than 3.5 ng/mL at any timepoint.

Large IPMNs or MCNs grow rapidly and are at high risk for progression to pancreatic cancer, one of the deadliest of all cancers. Surgery is recommended to eliminate the risk, but a significant number of patients refuse or cannot withstand surgery due to the associated morbidities. For these patients, there are few therapeutic options and no approved drug therapies. Additional studies of NanoPac are being considered to further evaluate its potential in these patients.

In addition to this trial, NanOlogy’s clinical programs are advancing in pancreatic, lung, genitourinary, and dermal cancers. Data from preclinical and clinical studies in a variety of solid tumors indicate persistent tumor kill, antitumoral immune response, and minimal local or systemic toxicity.

The NanOlogy large surface area microparticle (LSAM) therapeutic platform is based on a proprietary supercritical precipitation technology that converts taxane API crystals into stable LSAMs of pure drug for tumor-directed therapy and sustained drug release. The taxane particles are covered by composition of matter patents issued in the US (US 9,814,685, US 10,507,195, & US 10,993,927), Europe, Japan, and Australia all valid until 2036, plus applications pending globally. These composition of matter patents form the foundation of an extensive intellectual property portfolio protecting the investigational drugs, methods, and technology.

On June 9, 2021 Merck (NYSE: MRK), known as MSD outside the United States and Canada, reported it has entered into a procurement agreement with the United States government for molnupiravir (MK-4482) (Press release, Merck & Co, JUN 9, 2021, View Source [SID1234583778]). Molnupiravir is currently being evaluated in a Phase 3 clinical trial, the MOVe-OUT study, for the treatment of non-hospitalized patients with laboratory-confirmed COVID-19 and at least one risk factor associated with poor disease outcomes. Merck is developing molnupiravir in collaboration with Ridgeback Biotherapeutics.

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"Merck is pleased to collaborate with the U.S. government on this new agreement that will provide Americans with COVID-19 access to molnupiravir – an investigational oral therapy being studied for outpatient use early in the course of disease – if it is authorized or approved," said Rob Davis, president, Merck. "In addition to this agreement with the U.S. government, we are actively engaged in numerous efforts to make molnupiravir available globally to fulfill Merck’s commitment to widespread access."

Through the agreement, if molnupiravir receives Emergency Use Authorization (EUA) or approval by the U.S. Food and Drug Administration (FDA), Merck will receive approximately $1.2 billion to supply approximately 1.7 million courses of molnupiravir to the United States government. Merck has been investing at risk to support development and scale-up production of molnupiravir and expects to have more than 10 million courses of therapy available by the end of 2021.

Merck also plans to submit applications for emergency use or approval to regulatory bodies outside of the U.S. and is currently in discussions with other countries interested in advance purchase agreements for molnupiravir. Merck is committed to providing timely access to molnupiravir globally and intends to implement a tiered pricing approach based on World Bank data that recognizes countries’ relative ability to finance their public health response to the pandemic.

As part of its access strategy, Merck has also entered into non-exclusive voluntary licensing agreements for molnupiravir with established generic manufacturers to accelerate availability of molnupiravir in 104 low- and middle-income countries (LMICs) following approvals or emergency authorization by local regulatory agencies.

In addition to developing molnupiravir, Merck is contributing to the pandemic response by collaborating with Johnson & Johnson to support the manufacture of its COVID-19 vaccine.

This procurement of molnupiravir will be supported in whole or in part with federal funds from the Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority, in collaboration with the DOD Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND) under contract number W911QY21C0031.

About Molnupiravir

Molnupiravir (EIDD-2801/MK-4482) is an investigational, orally bioavailable form of a potent ribonucleoside analog that inhibits the replication of multiple RNA viruses including SARS-CoV-2, the causative agent of COVID-19. Molnupiravir has been shown to be active in several models of SARS-CoV-2, including for prophylaxis, treatment and prevention of transmission, as well as SARS-CoV-1 and MERS. EIDD-2801 was invented at Drug Innovations at Emory (DRIVE), LLC, a not-for-profit biotechnology company wholly owned by Emory University, and with partial funding support from the U.S. government. Since licensed by Ridgeback, all funds used for the development of EIDD-2801 by Ridgeback have been provided by Wayne and Wendy Holman and Merck.

The Phase 3 portion (Part 2) of the MOVe-OUT study, evaluating the potential of molnupiravir to reduce the risk of hospitalization or death, is ongoing. Merck currently anticipates that, pending favorable results from MOVe-OUT, the earliest possible submission for an Emergency Use Authorization for molnupiravir will be in the second half of 2021. Merck and Ridgeback Biotherapeutics plan to share further findings from the ongoing molnupiravir development program with regulatory agencies as they become available. For more information on the molnupiravir clinical trial please visit View Source

In addition, Merck plans to initiate a clinical program to evaluate molnupiravir for post- exposure prophylaxis in the second half of 2021.

On June 9, 2021 Boehringer Ingelheim, a global leader in animal health, reported the beginning of a long-term partnership with Lifebit Biotech to utilize Artificial Intelligence (AI) for the detection and early-reporting of global disease outbreaks using real-world data harvested from scientific publications and other open sources (Press release, Boehringer Ingelheim, JUN 9, 2021, View Source [SID1234583746]). Utilizing the Lifebit REAL platform, insights into the latest infectious disease outbreaks allow R&D efforts to be prioritized accordingly.

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Scientists and researchers from the two organizations will work side-by-side to combine real-world evidence and the latest AI algorithms to identify infectious disease outbreaks and respond accordingly. Lifebit REAL uses advanced analytic capabilities to automatically notify users of relevant outbreaks, such as transboundary disease spread or the emergence of pathogens, such as COVID-19. The system is built around an active learning architecture: with more relevant data ingested, the accuracy of the system increases.

As an example, over 500 million tweets, 3 million news articles and thousands of scientific papers are published every day. However, with the sea of data being so vast, it is challenging for decision makers to collate meaningful insights that are both useful and actionable. Lifebit’s system alleviates these difficulties by combining precision data harvesting techniques with proprietary cutting-edge AI algorithms to identify signals from all the data noise.

Dr. Eric Haaksma, Head of Animal Health Global Innovation Boehringer Ingelheim, shared: "External innovation is becoming an increasingly important aspect of our R&D playbook. Therefore, we are strategically partnering with Lifebit to leverage AI to monitor and interpret scientific and other sources in real-time, enabling us to track data related to animal diseases. This, in turn, will accelerate the detection process as the vast amounts of scientific relevant information being produced at many levels cannot be feasibly collected and analyzed manually."

Dr. Maria Chatzou-Dunford, CEO of Lifebit Biotech, added: "At Lifebit we thrive at connecting both, locked-up sensitive biomedical data from around the world and AI-driven automated RWE data insights – so that companies at the cutting edge of science, like Boehringer Ingelheim, can make faster and smarter decisions – delivering insights that change lives."

On June 9, 2021 Onxeo S.A. (Euronext Paris, NASDAQ Copenhagen: ONXEO), hereafter "Onxeo" or "the Company", a clinical-stage biotechnology company specializing in the development of innovative drugs targeting tumor DNA Damage response (DDR), in particular against rare or resistant cancers, reported that it has received from the U.S. Patent and Trademark Office (USPTO), a Notice Allowance for a patent which enhances in the United States the protection of AsiDNA, its first- in-class inhibitor of tumor DNA repair, in combination with any PARP inhibitor (PARPi) (Press release, Onxeo, JUN 9, 2021, View Source [SID1234583763]). This patent protects both the combination of AsiDNA with a PARPi and its use for the treatment of certain cancers for which the DNA repair pathway via homologous recombination (HR) is not impaired or deficient. These so-called HR-proficient tumors are significantly less sensitive to treatment with PARP inhibitors.

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This new patent completes, in a key territory, the already robust patent family protecting AsiDNA in combination with PARP inhibitors. It will provide a term of protection until 2036.

The DNA repair pathways, BRCA-dependent homologous recombination pathway and PARP pathway, are complementary and essential for tumor cell survival and proliferation. If one pathway is deficient (homologous recombination by BRCA mutation) and the other is blocked by a PARP inhibitor, the tumor cell dies. This deadly combination of two genetic mutations, called synthetic lethality, is a prerequisite to PARPi efficacy.

This patent is based on the fact that AsiDNA is able, through its original mechanism of action, to hinder DNA repair pathways, including the homologous recombination pathway. AsiDNA thus induces a context of "HR deficiency" needed by PARPi to be effective, regardless of the initial genetic context of the tumor.

"This patent represents a further recognition in the strategic US market of the very original properties of AsiDNA. We have already started the clinical demonstration that AsiDNA has the potential to reverse the resistance acquired to a PARP inhibitor, notably thanks to its effect on the drug-tolerant cells who play a key role on acquired resistance. The drug-induced synthetic lethality provided by AsiDNA opens an important new application to our lead product. Indeed, extending the efficacy of PARP inhibitors to the important group of HR-proficient patients could represent another major therapeutic opportunity," said Judith Greciet, Chief Executive Officer of Onxeo.

PARPi have demonstrated a real clinical benefit[1], particularly in the treatment of ovarian cancer with BRCA mutations, but this benefit is much reduced, or even insignificant, when homologous recombination remains active, which is the case in about 50% of patients[2].

[1] Moore et al. N Engl J Med 2018; 379:2495-2505

[2] Zeimet, A.G., Wieser, V., Knoll, K. et al. PARP inhibitors in the treatment of ovarian cancer. memo (Magazine of European Medical Oncology) 13, 198–201 (2020).

On June 9, 2021 Palleon Pharmaceuticals, a company pioneering the field of glyco-immunology to treat cancer and inflammatory diseases, reported the appointment of David Feltquate, M.D., Ph.D., as Chief Medical Officer (Press release, Palleon Pharmaceuticals, JUN 9, 2021, View Source [SID1234583779]). Dr. Feltquate is an accomplished development leader with significant industry experience in immuno-oncology clinical development, translational medicine, and diagnostic assay advancement.

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"We’re delighted to welcome David at such a pivotal moment in Palleon’s growth, as we prepare to file an IND to advance our first therapeutic candidate into the clinic later this year," said Jim Broderick, M.D., Chief Executive Officer and Founder of Palleon. "David’s extensive expertise in the development of industry-leading immuno-oncology therapeutics, alongside his training in immunology and oncology, make him a uniquely qualified leader of clinical development for Palleon’s pipeline of promising glyco-immunology therapeutics."

Prior to joining Palleon, Dr. Feltquate was the Global Head of Hematology Development and Chair of the Precision Medicine Leadership Team at Novartis. Previously, he held numerous leadership positions at BMS including Head of Oncology Early Clinical Development and Development Leader for Ipilimumab/Nivolumab Life Cycle Management. As the Nivolumab Clinical Head, Dr. Feltquate was responsible for the development of the first PD1 inhibitor from proof of concept through initial registrations in non-small cell lung cancer, melanoma, and renal cell carcinoma. Dr. Feltquate earned a B.S. in biology from the Massachusetts Institute of Technology and an M.D./Ph.D. (immunology) from University of Massachusetts Medical School. He completed internal medicine training at Dartmouth Hitchcock Medical Center and medical oncology training at Memorial Sloan Kettering Cancer Center.

"Our field has only scratched the surface of the promise of immuno-oncology to treat cancers that are untreatable today. Palleon is advancing an incredibly novel approach to unleashing the immune system to fight cancer, and the company’s platforms have additional potential to treat inflammatory diseases," said Dr. Feltquate. "I’m honored to join this pioneering team in progressing the first glyco-immunology therapeutic candidates through clinical trials, with the goal of delivering new treatment options for patients with serious diseases."