On June 9, 2021 Gamida Cell Ltd. (Nasdaq: GMDA), an advanced cell therapy company committed to cures for blood cancers and serious blood diseases, reported that company management will present its corporate highlights at the following investor conferences in June (Press release, Gamida Cell, JUN 9, 2021, View Source [SID1234583781]):

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JMP Securities Life Sciences Conference, June 16-17, 2021. In a fireside chat at 12:30 p.m. ET on June 16, 2021, management will discuss a corporate overview for 2021 with a special focus on multiple growth opportunities driven by advances in the development of omidubicel, a potentially life-saving NAM-enabled cell therapy with positive Phase 3 clinical data, and based on encouraging preliminary clinical results, NAM-enabled natural killer (NK) cell immunotherapies including GDA-201.
A.G.P. Summer Healthcare Symposium, June 17, 2021. The company will present its 2021 corporate highlights to investors in one-on-one meetings on June 17, 2021.
In the fourth quarter of 2021, Gamida Cell is targeting a BLA submission for omidubicel, the first potential approval of a cell therapy for blood cancer patients in need of an allogeneic bone marrow transplant. In the second half of 2021, the Company is planning an IND submission to support the initiation of a Phase 1/2 clinical study of cryopreserved, off-the-shelf GDA-201 in patients with follicular and diffuse large b-cell lymphomas.

A live webcast of the JMP Securities fireside chat will be available on the "Investors & Media" section of Gamida Cell’s website at www.gamida-cell.com, and will be available for at least 14 days following the event.

On June 9, 2021 Kojin Therapeutics Inc., the leading company developing new targeted therapeutics based on cell state and ferroptosis biology, reported with a $60 million Series A led by Polaris Partners, Newpath Partners, and Cathay Health, affiliated to Cathay Capital, with participation from Leaps by Bayer, AbbVie Inc., Eventide Asset Management, Alexandria, the Dana-Farber Cancer Institute’s Binney Street Capital, and several family offices (Press release, Kojin Therapeutics, JUN 9, 2021, View Source [SID1234583780]). The company plans to use the proceeds of the Series A to accelerate its drug discovery platform based on its groundbreaking approach to cell state and ferroptosis biology and advance a robust pipeline of therapeutics, with an initial focus on oncology.

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Founded by leading scientists Stuart Schreiber, Benjamin Cravatt, Stephanie Dougan and Vasanthi Viswanathan, Kojin has developed a proprietary approach to ferroptosis-based drug discovery that enables a selective and effective method for treating disease. For many hard-to-treat diseases, including otherwise drug-resistant cancers, diseased cells are in a state that is sensitive to ferroptosis, or iron-dependent cell death.

"At Kojin, we have pioneered a fundamentally new way of looking at biology that unlocks enormous potential for drug discovery," said Stuart Schreiber, co-founder of Kojin Therapeutics. "It’s become clear that looking at cells anatomically is less important than looking at how cells function. Understanding cell states allows us to determine how a cell behaves and to target cells previously thought untouchable in cancer and other diseases. The ferroptosis-sensitive state is just the beginning."

The company is led by Acting CEO Amir Nashat, Managing Director at Polaris, Acting President Susan Langer, former Head of Corporate Strategy at Biogen, and Chief Scientific Officer Kay Ahn, former Global Head of Molecular & Cell Pharmacology at Janssen. As part of the financing, Stuart Schreiber and Amir Nashat will join Kojin’s board of directors along with Nagesh Mahanthappa, former CEO of Scholar Rock, Tom Cahill, founder and managing partner at Newpath Partners, and Luba Greenwood, managing partner at Cathay Health.

"Preventing and curing cancer is one of the 10 big goals ("leaps"), Leaps by Bayer is focusing on. The Kojin team brings a deep biological understanding of cell states and ferroptosis that will allow us to discover mechanisms of action to treat cancers that today lack effective therapies," said Jürgen Eckhardt, Head of Leaps by Bayer. "The company’s unique insights and innovative approach to drug discovery has the potential to move us from treatment to cures, and we’re pleased to support them as they accelerate their platform to deliver on that mission."

Utilizing a novel non-genetic classification of cell states instead of conventional cell types, Kojin’s platform determines how a cell responds to its environment or how it responds to a specific drug. The company connects complex cell states to known biochemical processes such as ferroptosis to find specific targets for therapeutic intervention, tailored to each disease and targeting selectively the tissues it affects.

"Ultimately, our goal is to positively impact the lives of patients through innovative medicines," said Tom Hudson, Senior Vice President R&D and Chief Scientific Officer of AbbVie. "Kojin’s world-leading discoveries in ferroptosis biology open up new possibilities for precision medicine, enabling novel, targeted therapies that could have life changing results for so many."

"Kojin’s stellar team and lineup of world-leading scientists, clinicians, investors and drug developers are a testament to the potential impact of its differentiated biology on hard-to-treat diseases," said Luba Greenwood, Managing Partner of Cathay Health. "As a cross-border investment platform spanning the US, Europe and Asia, we look forward to bringing the global outlook, resources and health ecosystem to support and further develop Kojin’s pioneering scientific discovery that stands to address multiple large, unmet medical needs across the world."

"We are proud to be working with leading scientists and investors on our shared vision to create transformative medicines for patients," said Susan Langer, Acting President of Kojin Therapeutics. "Kojin’s approach to utilize cell state and ferroptosis biology could open new avenues for the treatment of a variety of debilitating diseases including immune-based disorders, cancer, fibrosis and neurodegeneration."

The members of Kojin’s Scientific Advisory Board include:

Stuart Schreiber, Ph.D., Morris Loeb Professor of Chemistry and Chemical Biology at Harvard University, a co-Founder of the Broad Institute, and a member of the National Academy of Sciences, National Academy of Medicine, and American Academy of Arts and Sciences
Benjamin Cravatt, Ph.D., Professor and Norton B. Gilula Chair of Chemical Biology in the Department of Chemistry at The Scripps Research Institute
Stephanie Dougan, Ph.D., Assistant Professor, Microbiology and Immunobiology, Harvard Medical School, Investigator, Cancer Immunology and Virology, Dana-Farber Cancer Institute
Sean Morrison, Ph.D., director of the Children’s Medical Center Research Institute at UT Southwestern and a Howard Hughes Medical Institute investigator
George Demetri, MD, director of the Sarcoma Center at Dana-Farber, director of the Ludwig Center at Dana-Farber/Harvard Cancer Center, and executive director for Clinical and Translational Research at the Ludwig Institute for Cancer Research
Joel Barrish, Ph.D., Cofounder and Chief Scientific Officer at Jnana Therapeutics
Steve Davidsen, Ph.D., Vice President, Oncology Discovery, AbbVie Biopharmaceuticals

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."

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 Magellan Rx Management, a division of Magellan Health, Inc. (NASDAQ: MGLN), reported annualized savings of over $40 million for five health plan customers who were early adopters of its oncology biosimilar medical benefit drug management solution (Press release, Magellan Health Services, JUN 9, 2021, View Source [SID1234583777]). This comprehensive approach encourages the use of oncology therapeutic biosimilars over more expensive reference products, when clinically appropriate. Savings figures are expected to grow even further as more customers have adopted the program since its inception and the market shift to biosimilars accelerates.

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"Magellan Rx continues to be a market leader and disrupter in delivering leading-edge solutions for the evolving healthcare landscape, and our health plan partners are recognizing real savings through these programs while maintaining a high quality level of care for their members," said Steve Cutts, PharmD, senior vice president and general manager, specialty, Magellan Rx Management. "We have been tracking the emergence of biosimilars and started to deliver biosimilar-first solutions as early as 2016. It’s our commitment to staying ahead of the trend that has made us a trusted partner in medical benefit management for nearly two decades."

Health plan customers implemented the program, which focuses on promotion of biosimilars for three oncology products, on or before January 1, 2020. Most of the current savings were achieved with the first two products that had biosimilar availability (see graphic), and preliminary results with the third product are promising. According to Magellan Rx’s internal data, these biosimilars can cost payers up to 40% less than their respective reference brands.

"We knew we wanted to collaborate with a medical pharmacy expert," said Carly Rodriguez, pharmacy director at Moda Health, a health plan that implemented the program with success. "We were looking for a partner that would do more than save our plan on rising specialty costs, but that would continue to support our members with Moda’s signature quality of care. In partnering with Magellan Rx, we know we have the right experts on our side and we anticipate expanding the program to additional biosimilar agents, as clinically appropriate."

These positive results, after just one year, reflect the growing need for management programs that deliver lower cancer treatment costs for payers and patients while maintaining high standards of care. Magellan Rx develops cost-effective and leading-edge strategies for medical benefit drug management across several categories, offering flexible solutions that can also operate outside of the traditional payer-PBM relationship. Health plans can leverage the extensive clinical expertise and experience at Magellan Rx by delegating specialty and medical drug management services while retaining a separate PBM. Read more about Magellan Rx’s total specialty drug management solutions. To learn more about Magellan Rx Management’s history of biosimilar management, visit, Magellan Insights.